Asmanex Twisthaler Powder

Pronunciation: moe-MET-a-sone
Generic Name: Mometasone
Brand Name: Asmanex Twisthaler

Asmanex Twisthaler Powder is used for:

Preventing or reducing the frequency and seriousness of bronchial asthma attacks. It is also used in certain asthma patients when adding an inhaled corticosteroid may decrease the amount of other types of corticosteroids needed. Asmanex Twisthaler Powder does not help during an acute asthma attack.

Asmanex Twisthaler Powder is a corticosteroid. It works by reducing inflammation in the airways.

Do NOT use Asmanex Twisthaler Powder if:

• you are allergic to any ingredient in Asmanex Twisthaler Powder or to milk proteins


• you are having an asthma attack (eg, sudden, severe onset or worsening of asthma symptoms, such as chest tightness, cough, shortness of breath, wheezing)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Asmanex Twisthaler Powder:

Some medical conditions may interact with Asmanex Twisthaler Powder. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have active or inactive tuberculosis or a positive skin test for tuberculosis


• if you have an infection of the respiratory tract, any untreated infection (fungal, bacterial, parasitic, viral), measles, chickenpox, herpes simplex in or around the eye, eczema, or if you have recently received a vaccination


• if you have increased pressure in the eye, glaucoma, cataracts, diarrhea, osteoporosis (weak bones), or a family history of osteoporosis


• if you will be confined to a bed or chair for a prolonged period of time

Some MEDICINES MAY INTERACT with Asmanex Twisthaler Powder. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticonvulsants (eg, phenytoin) or corticosteroids (eg, prednisone) because the risk of serious side effects, such as weakened bones, may be increased


• Ketoconazole because it may increase the risk of Asmanex Twisthaler Powder's side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Asmanex Twisthaler Powder may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Asmanex Twisthaler Powder:

Use Asmanex Twisthaler Powder as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Asmanex Twisthaler Powder. Talk to your pharmacist if you have questions about this information.


• Hold the inhaler upright and remove the cap by twisting in a counter-clockwise direction. Exhale fully. Place the mouthpiece in your mouth and firmly close your lips around the mouthpiece. Take a fast, deep breath. You may not be able to feel or taste the medicine after you inhale it. Remove the inhaler from your mouth and hold your breath for about 10 seconds. Breathe out slowly. Do not breathe out through the inhaler.


• Gently wipe the mouthpiece dry. Replace the cap by gently pressing down and rotating the cap in a clockwise direction until a click is heard. If you do not replace the cap, your next dose will not be properly loaded.


• Rinse your mouth with water after each dose. Spit out the rinse water. This will help to decrease the risk of developing a fungal infection of the mouth from Asmanex Twisthaler Powder.


• Throw away the inhaler 45 days after opening the foil pouch or when the dose counter reads zero, whichever comes first.


• Use Asmanex Twisthaler Powder on a regular schedule to get the most benefit from it.


• Continue to use Asmanex Twisthaler Powder even if you feel well. Do not miss any doses.


• If you miss a dose of Asmanex Twisthaler Powder, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Asmanex Twisthaler Powder.

Important safety information:

• Asmanex Twisthaler Powder is for oral inhalation only. Do not get it in your eyes. If you get it in your eyes, rinse right away with cool water.


• Do NOT take more than the recommended dose. If your symptoms do not get better within 2 weeks or if they get worse, check with your doctor.


• Asmanex Twisthaler Powder will not stop an asthma attack once it has already started. Be sure to carry a short-acting bronchodilator (eg, albuterol) with you at all times to treat any breathing problems that may occur between doses of Asmanex Twisthaler Powder (eg, severe or sudden onset of wheezing, shortness of breath). If you have any questions about which medicines stop asthma attacks, check with your doctor or pharmacist.


• If you are also using a bronchodilator inhaler, be sure to always carry the bronchodilator inhaler with you to use during asthma attacks.


• Asmanex Twisthaler Powder may sometimes cause severe breathing problems right after you use a dose. If this happens, use your short-acting bronchodilator. Contact your doctor or seek other medical care at once.


• Use caution if you switch from an oral steroid (eg, prednisone) to Asmanex Twisthaler Powder. It may take several months for your body to make enough natural steroids to handle events that cause physical stress. Such events may include injury, surgery, infection, loss of blood electrolytes, or a sudden asthma attack. These may be severe and sometimes fatal. Contact your doctor right away if any of these events occur. You may need to take an oral steroid (eg, prednisone) again. Carry a card at all times that says you may need an oral steroid (eg, prednisone) if any of these events occur.


• If your symptoms do not get better or if they get worse, check with your doctor. Do not increase the dosage.


• Contact your health care provider at once if you have an asthma attack and do not get relief from your bronchodilator inhaler.


• Asmanex Twisthaler Powder may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.


• If you have not had chickenpox, shingles, or measles, avoid contact with anyone who does. If exposed, contact your doctor at once.


• Tell your doctor or dentist that you take Asmanex Twisthaler Powder before you receive any medical or dental care, emergency care, or surgery.


• Check with your doctor before having any vaccinations while you are using Asmanex Twisthaler Powder.


• Lab tests, including lung function, may be performed while you use Asmanex Twisthaler Powder. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Asmanex Twisthaler Powder.


• Asmanex Twisthaler Powder should be used with extreme caution in CHILDREN younger than 4 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Asmanex Twisthaler Powder while you are pregnant. It is not known if Asmanex Twisthaler Powder is found in breast milk. If you are or will be breast-feeding while you use Asmanex Twisthaler Powder, check with your doctor. Discuss any possible risks to your baby.

Contact your health care provider if WITHDRAWAL symptoms (eg, joint or muscle pain, lack of energy, depression) occur after you stop using Asmanex Twisthaler Powder. Do not suddenly stop using Asmanex Twisthaler Powder without first checking with your doctor.

Possible side effects of Asmanex Twisthaler Powder:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Decreased appetite; flu-like symptoms; headache; indigestion; nausea; runny nose; sinus swelling; sore throat; stomach pain or upset; stuffy nose.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; lack of energy; menstrual changes or painful menstruation; mental or mood changes; muscle or bone pain; new or worsening breathing problems; shakiness; shortness of breath; swelling; tiredness; vision changes; vomiting; weakness; wheezing; white curd-like patches or rash in the mouth.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Asmanex Twisthaler side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Asmanex Twisthaler Powder:

Store Asmanex Twisthaler Powder in a dry place at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Asmanex Twisthaler Powder out of the reach of children and away from pets.

General information:

• If you have any questions about Asmanex Twisthaler Powder, please talk with your doctor, pharmacist, or other health care provider.


• Asmanex Twisthaler Powder is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Asmanex Twisthaler Powder. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Asmanex Twisthaler resources

• Asmanex Twisthaler Side Effects (in more detail)
• Asmanex Twisthaler Use in Pregnancy & Breastfeeding
• Asmanex Twisthaler Drug Interactions
• Asmanex Twisthaler Support Group
• 6 Reviews for Asmanex Twisthaler - Add your own review/rating

Compare Asmanex Twisthaler with other medications

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• Hay Fever
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Levatol

Pronunciation: pen-BUE-toe-lol
Generic Name: Penbutolol
Brand Name: Levatol

Do not suddenly stop taking Levatol. Sharp chest pain, irregular heartbeat, and sometimes heart attack may occur if you suddenly stop Levatol. The risk may be greater if you have certain types of heart disease. Your doctor should slowly lower your dose over several weeks if you need to stop taking it. This should be done even if you only take Levatol for high blood pressure. Heart disease is common and you may not know you have it. Limit physical activity while you are lowering your dose. If new or worsened chest pain or other heart problems occur, contact your doctor right away. You may need to start taking Levatol again.

Levatol is used for:

Treating mild to moderate high blood pressure. It may be used alone or with other medicines. It may also be used for other conditions as determined by your doctor.

Levatol is a beta-blocker. It works by slowing down the heart and decreasing the amount of blood it pumps out. This decreases blood pressure, helps the heart pump more efficiently, and reduces the workload on the heart.

Do NOT use Levatol if:

• you are allergic to any ingredient in Levatol


• you have a very slow heartbeat, heart block, uncontrolled heart failure, or shock caused by severe heart problems


• you have asthma


• you are currently taking mibefradil

Contact your doctor or health care provider right away if any of these apply to you.

Before using Levatol:

Some medical conditions may interact with Levatol. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have or have ever had an adrenal gland tumor (pheochromocytoma); lung or breathing problems (eg, asthma, chronic bronchitis, chronic obstructive pulmonary disease [COPD], emphysema); blood vessel problems; diabetes; kidney problems; low blood sugar; or an overactive thyroid


• if you have low blood pressure or a history of heart problems (eg, heart attack, slow or irregular heartbeat, heart failure, chest pain or angina), blood circulation problems, or liver problems


• if you will be having surgery

Some MEDICINES MAY INTERACT with Levatol. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Antiarrhythmics (eg, flecainide), calcium channel blockers (eg, nifedipine, diltiazem, verapamil), catecholamine-depleting agents (eg, reserpine), digoxin, diuretics (eg, furosemide, hydrochlorothiazide), fingolimod, mefloquine, mibefradil, or vasodilators (eg, hydralazine) because the risk of certain side effects may be increased (eg, very slow heart rate, very low blood pressure, fainting, severe dizziness, light-headedness)


• Clonidine because stopping either it or Levatol suddenly can lead to a severe increase in blood pressure


• Barbiturates (eg, phenobarbital) or indomethacin because they may decrease Levatol's effectiveness


• Alfuzosin, insulin, nateglinide, prazosin, or repaglinide because the risk of their side effects may be increased by Levatol


• Sympathomimetics (eg, albuterol) or theophyllines (eg, aminophylline) because their effectiveness may be decreased by Levatol


• Epinephrine because its effectiveness may be decreased and the risk of its side effects may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Levatol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Levatol:

Use Levatol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Levatol may be taken with or without food.


• Take Levatol at the same time each day.


• Continue to use Levatol even if you feel well. Do not miss any doses.


• If you miss a dose of Levatol, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Levatol.

Important safety information:

• Levatol may cause dizziness or light-headedness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Levatol. Using Levatol alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.


• Levatol may cause dizziness, light-headedness, or fainting. Alcohol, hot weather, exercise, and fever can increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Also, sit or lie down at the first sign of dizziness, light-headedness, or weakness.


• Do not suddenly stop taking Levatol without first checking with your doctor. If your doctor decides you should no longer use Levatol, you will need to stop Levatol gradually according to your doctor's instructions.


• It may take up to 2 weeks or longer for Levatol to fully work. Do not change your dose without checking with your doctor.


• Patients being treated for high blood pressure often feel tired or run down for a few weeks after beginning therapy. Continue taking your medication even though you may not feel quite "normal." Contact your doctor or pharmacist about any new symptoms.


• Levatol may mask certain signs of overactive thyroid (eg, fast heartbeat). If you have or may have overactive thyroid, do not suddenly stop taking Levatol. Suddenly stopping Levatol could worsen your condition. Discuss any questions or concerns with your doctor.


• If you have a history of any severe allergic reaction, talk with your doctor. You may be at risk of an even more severe allergic reaction if you come into contact with the substance that caused your allergy. Some medicines used to treat severe allergies may also not work as well while you are using Levatol.


• If your doctor has instructed you to check your blood pressure and heart rate regularly, be sure to do so.


• Do not take any medicines used for colds, congestion, or weight loss without first talking with your doctor or pharmacist.


• Diabetes patients - Levatol may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Diabetes patients - Levatol may mask signs of low blood sugar, such as a rapid heartbeat. Be sure to watch for other signs of low blood sugar. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your vision change; give you a headache, chills, or tremors; or make you more hungry. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Before having any surgical or dental procedures or receiving emergency treatment, tell the doctor or dentist in charge that you are receiving Levatol.


• Levatol may interfere with certain lab tests, including the glaucoma screening test. Be sure your doctor and lab personnel know you are taking Levatol.


• Lab tests may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.


• Use Levatol with caution in the ELDERLY because they may be more sensitive to its effects, especially slow heartbeat.


• Use Levatol with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using Levatol during pregnancy. It is unknown if Levatol is excreted in breast milk. If you are or will be breast-feeding while you are using Levatol, check with your doctor or pharmacist to discuss the risks to your baby.

If you suddenly stop taking Levatol, you may experience WITHDRAWAL symptoms, including worsening chest pain along with possible heart attack.

Possible side effects of Levatol:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; headache; indigestion; light-headedness; nausea; tiredness; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fainting; fever with aching and sore throat; mental or mood changes (eg, confusion, depression, short-term memory loss); severe or persistent dizziness; severe or persistent stomach pain; shortness of breath; slow or irregular heartbeat; sudden, unexplained weight gain; swelling of the hands, ankles, or feet; unusual bruising or bleeding; wheezing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Levatol side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include difficulty breathing; fainting; severe dizziness or light-headedness; shortness of breath; slow or irregular heartbeat; swelling of the hands, ankles, or feet; wheezing.

Proper storage of Levatol:

Store Levatol at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Levatol out of the reach of children and away from pets.

General information:

• If you have any questions about Levatol, please talk with your doctor, pharmacist, or other health care provider.


• Levatol is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Levatol. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Levatol resources

• Levatol Side Effects (in more detail)
• Levatol Use in Pregnancy & Breastfeeding
• Drug Images
• Levatol Drug Interactions
• Levatol Support Group
• 0 Reviews for Levatol - Add your own review/rating

• Levatol Prescribing Information (FDA)


• Levatol Concise Consumer Information (Cerner Multum)


• Levatol Advanced Consumer (Micromedex) - Includes Dosage Information

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Midazolam 2mg / ml, solution for injection (hameln)

MIDAZOLAM 2 mg/ml INJECTION

Midazolam

This leaflet will provide you with important information about your medicine. Please read it carefully before your medicine is administered. If, after reading it, you still have some questions, please consult your doctor or pharmacist.

In this leaflet:

• 1. What Midazolam 2 mg/ml Injection is and what it is used for



• 2. Before you use your medicine



• 3. How to use your medicine



• 4. Possible side effects



• 5. Storing your medicine

Midazolam 2 mg/ml Injection is a clear, colourless, sterile solution contained in clear glass ampoules. Each 1 ml of this solution contains 2 mg of midazolam.

Inactive ingredients:

The solution also contains sodium chloride, hydrochloric acid and water for injections.

Pack sizes:

The injection is available in packs of 5,10, 25, 50 and 100 ampoules containing 5 ml of solution.

Holder of Product Licence:

hameln Pharmaceuticals ltd

Gloucester

United Kingdom

Manufacturer:

hameln Pharmaceuticals gmbh

Langes Feld 13

31789 Hameln

Germany

PL 01502/0060

What Midazolam 2 Mg/Ml Injection Is And What It Is Used For

Midazolam belongs to a group of medicines called benzodiazepines. It can cause you to fall asleep, and it can also have a calming effect.

Midazolam can be given by injection into a vein (intravenously), by a drip (infusion), injection into a muscle (intramuscular) or via rectal administration. This medicine is used in adults and children for sedation and anaesthesia during investigations and treatment. It is also used as a premedication to calm patients before treatment, and to sedate patients in intensive care units.

Midazolam can be used alone or with other medicines used in anaesthesia.

Before You Use Your Medicine

This medicine must not be used:

• if you are allergic to the group of medicines known as benzodiazepines or any of the other ingredients of Midazolam 2 mg/ml Injection.



• if you have severe difficulty in breathing or are very short of breath and are to undergo conscious sedation (a state of calm or drowsiness where you remain awake).

Take special care with Midazolam 2 mg/ml Injection:

Let your doctor know if you

• are over 60 years of age.


• are routinely short of breath.


• have myasthenia gravis (a disease causing muscle weakness).


• have a kidney, liver or heart condition.


• have a history of alcohol or drug abuse.


• are taking any other medicines including those not prescribed by your doctor (see Taking other medicines).


• are, or may be pregnant.

Special care needs to be taken if midazolam is used in babies or children. Let your doctor know if your child has a heart condition.

If this is so the doctor knows to monitor you or your child more carefully or adjust the dose specially.

When given intravenously, Midazolam 2 mg/ml Injection can slow down your breathing and heart rate. On rare occasions this has caused breathing or the heart to stop. To avoid this, doses are given slowly and are as low as possible.

When given as a premedication, how patients respond to midazolam varies considerably. Therefore you will be checked closely to ensure you receive the right dose for you.

Pregnancy

You must tell your doctor or dentist if you are pregnant, or if you think you are pregnant. They can then decide if this medicine is suitable for you.

If your doctor decides you should be given this medicine during late pregnancy, labour or caesarean section, your baby might have an irregular heart beat, a low body temperature, floppiness and breathing and feeding difficulties. You may be at risk of inhaling vomit into your lungs.

Breastfeeding

Midazolam may pass into breast-milk, therefore, if you are breast feeding you should not do so for 24 hours after receiving this medicine.

Driving and using machines

This medicine may make you sleepy, forgetful or affect your concentration and co-ordination. This may affect your performance at skilled tasks, e.g. driving or operating machinery. Your doctor should advise you when you can start these again.

You should always be accompanied home by a responsible adult after your treatment.

Important information about some of the ingredients of Midazolam 2 mg/ml Injection

This medicinal product contains 3.39 mg sodium per ml. This should be taken into consideration for patients on a controlled sodium diet.

Taking other medicines

Please inform your doctor if you are taking or have recently taken any other medicines, even those not prescribed by your doctor.

This is extremely important, as using more than one medicine at the same time can strengthen or weaken the effect of the medicines involved. For example, the effects of Midazolam 2 mg/ml Injection may be intensified by medicines such as tranquilisers, hypnotics (sleep inducing drugs), sedatives, antidepressants, narcotic analgesics (very strong pain killers), antiepileptics (for treating epilepsy), anaesthetics and some antihistamines (for the treatment of allergies).

The effects of midazolam may also be increased by medicines such as antifungals, antibiotics, drugs used to treat blood pressure and digestive problems and some drugs used to treat HIV and AIDS.

Alcohol

Alcohol may increase the sedative effects of midazolam and should therefore be avoided. Do not drink alcohol until your doctor tells you it is all right to do so.

How To Use Your Medicine

Dosage and route of administration

Your doctor will decide on a suitable dose for you. Doses vary considerably and will depend on the planned treatment and the sedation required.

Your weight, age, general condition of health, response to the drug and whether other medicines are required at the same time will also influence the dose that you receive.

If you are to receive strong painkillers, you will receive these first and then have your midazolam dose adjusted specially for you.

Midazolam 2 mg/ml Injection is given slowly, by injection into a vein (intravenously), by a drip (infusion), injection into a muscle (intramuscular) or via rectal administration.

Long term treatment

Patients who receive long term treatment with midazolam may become tolerant (their medicine becomes less effective) or dependent upon their medicine.

After treatment for a long time (such as in an intensive care unit) the following withdrawal symptoms may occur: headaches, muscle pain, anxiety, tension, restlessness, confusion, irritability, inability to sleep, mood changes, hallucinations and convulsions. Your doctor will reduce your dose gradually to avoid these effects happening to you.

Overdose

Your medicine will be given by a doctor. If you think you have been given too much medicine please tell your doctor.

Possible Side Effects

Like all medicines, midazolam can have side effects. The following undesirable effects have been reported very rarely.

Skin disorders: rash, allergic reaction, Itchiness.

Nervous system disorders: drowsiness and prolonged sedation, reduced alertness, confusion, euphoria (an excessive feeling of wellbeing), hallucinations, tiredness, headache, dizziness, and difficulty co-ordinating muscles.

Temporary memory loss has been reported. How long this lasts will depend on how much midazolam you were given and you may experience this after your treatment. In isolated cases this has been prolonged.

Reactions such as agitation, muscle spasms and muscle tremors, restlessness, hostility, rages, aggression, excitement and assault, have been reported. These have been observed more when a high dose has been given, or administered too quickly. Children and the elderly are more susceptible to these reactions.

Convulsions have been reported more frequently in premature infants and new-born babies.

Patients can become dependent on midazolam after prolonged intravenous use. It is important that you are withdrawn from your medicine gradually to avoid withdrawal symptoms, including withdrawal convulsions (see 3. How to use your medicine - Long term treatment).

Gastrointestinal disorders: feeling sick, vomiting, hiccough, constipation, dry mouth.

Heart and breathing disorders: severe events include breathing complications (sometimes causing the breathing or heart to stop), low blood pressure, changes in heart rate, flushing, fainting and headache, shortness of breath, blockage of airway.

Life-threatening incidents are more likely to occur in the elderly, those already experiencing breathing difficulties or heart problems, particularly when the injection is given too rapidly or at a high dose. Patients under 6 months old are more likely to develop breathing problems, so they will be dosed very gradually and their breathing and oxygen levels observed.

General disorders: general allergic reactions: skin reactions (rash, itchiness), heart and blood system reactions, wheezing, anaphylactic shock (a life-threatening allergic reaction).

Injection site disorders: redness and pain, swelling and redness of veins, blood clots.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Storing Your Medicine

Your doctor will not use the drug after the expiry date shown on the ampoule and carton. The ampoules should be stored in the outer carton to protect them from light, in a safe place and out of reach of children.

If only part of an ampoule is used, the remainder should be discarded.

Further information

You can get further information on Midazolam 2 mg/ml Injection from your doctor or pharmacist.

Date of Preparation/Last review July 2004

43862/29/04

Lotrimin Topical

Generic Name: clotrimazole (Topical route)

kloe-TRIM-a-zole

Commonly used brand name(s)

In the U.S.

• Clotrim Antifungal


• Cruex Prescription Strength


• Lotrimin


• Lotrimin AF


• Mycelex

In Canada

• Canesten


• Clotrimaderm


• Desenex


• Myclo-Derm


• Neo-Zol

Available Dosage Forms:

• Lotion


• Solution


• Cream

Therapeutic Class: Antifungal

Chemical Class: Imidazole

Uses For Lotrimin

Clotrimazole topical preparations are used to treat fungus infections on the skin.

This medicine is available both over-the-counter (OTC) and with your doctor's prescription.

Before Using Lotrimin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

This medicine has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of topical clotrimazole in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Fentanyl


• Tacrolimus


• Trimetrexate

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of clotrimazole

This section provides information on the proper use of a number of products that contain clotrimazole. It may not be specific to Lotrimin. Please read with care.

Apply enough clotrimazole to cover the affected and surrounding skin areas, and rub in gently.

Keep this medicine away from the eyes.

When clotrimazole is used to treat certain types of fungus infections of the skin, an occlusive dressing (airtight covering, such as kitchen plastic wrap) should not be applied over the medicine. To do so may cause irritation of the skin. Do not apply an occlusive dressing over this medicine unless you have been directed to do so by your doctor.

To help clear up your infection completely, it is very important that you keep using this medicine for the full time of treatment , even if your symptoms begin to clear up after a few days. Since fungus infections may be very slow to clear up, you may have to continue using this medicine every day for several weeks or more. If you stop using this medicine too soon, your symptoms may return. Do not miss any doses .

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage forms (cream, lotion, and solution):
  
  • Fungal infections (treatment):
    
    • Adults and children—Use two times a day, morning and evening.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Lotrimin

If your skin problem does not improve within 4 weeks, or if it becomes worse, check with your doctor.

Lotrimin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• Skin rash, hives, blistering, burning, itching, peeling, redness, stinging, swelling, or other sign of skin irritation not present before use of this medicine

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Lotrimin Topical side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Lotrimin Topical resources

• Lotrimin Topical Side Effects (in more detail)
• Lotrimin Topical Use in Pregnancy & Breastfeeding
• Lotrimin Topical Support Group
• 0 Reviews for Lotrimin Topical - Add your own review/rating

Compare Lotrimin Topical with other medications

• Tinea Corporis
• Tinea Pedis

Zymar Drops

Pronunciation: ga-ti-FLOKS-a-sin
Generic Name: Gatifloxacin
Brand Name: Zymar

Zymar Drops are used for:

Treating eye infections caused by certain bacteria.

Zymar Drops are a fluoroquinolone antibiotic. It works by stopping the production of proteins that bacteria need to survive.

Do NOT use Zymar Drops if:

• you are allergic to any ingredient in Zymar Drops or similar medicines (eg, ciprofloxacin)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Zymar Drops:

Some medical conditions may interact with Zymar Drops. Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines or other substances


• if you wear contact lenses


• if you have heart problems, including a slow heartbeat, a history of lack of blood supply to your heart, or hardening of the arteries


• if you have a history of low blood potassium levels, diabetes, or kidney or liver problems


• if you have Alzheimer disease, tendonitis, a history of seizures or other central nervous system problems, or increased pressure in the head

Some MEDICINES MAY INTERACT with Zymar Drops. Because little, if any, of Zymar Drops are absorbed into the blood, the risk of it interacting with another medicine is low. Tell your health care provider if you are taking any other medicines.

Ask your health care provider if Zymar Drops may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Zymar Drops:

Use Zymar Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Zymar Drops are only for the eye. Do not get it in your nose or mouth.


• To use Zymar Drops in the eye, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eyelid for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.


• To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.


• Remove excess medicine around your eye with a clean tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.


• If you are using other kinds of eye drops, wait at least 5 minutes before applying the other medicines.


• Do not wear contact lenses while you are using Zymar Drops. Take care of your contact lenses as directed by the manufacturer. Check with your doctor before you use them.


• Zymar Drops works best if it is used at the same time each day.


• To clear up your infection completely, use Zymar Drops for the full course of treatment. Keep using it even if you feel better in a few days.


• Discard the medicine if it changes color, turns cloudy, or if it contains particles.


• If you miss a dose of Zymar Drops, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Zymar Drops.

Important safety information:

• If your symptoms do not get better within 7 days or if they get worse, check with your doctor.


• Zymar Drops may cause temporary blurred vision. Use Zymar Drops with caution. Do not drive or perform other possibly unsafe tasks if you cannot see clearly.


• Long-term or repeated use of Zymar Drops may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.


• Be sure to use Zymar Drops for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Zymar Drops may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.


• Zymar Drops should not be used in CHILDREN younger than 1 year old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Zymar Drops while you are pregnant. It is not known if Zymar Drops are found in breast milk. If you are or will be breast-feeding while you use Zymar Drops, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Zymar Drops:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bad taste in the mouth; blurred vision; eye discharge; headache; irritation, pain, dryness, or redness of the eyes; itchy eyes; tearing; watery eyes.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); persistent eye redness; swelling of the eye or eyelid.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Zymar side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Zymar Drops:

Store Zymar Drops between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not freeze. Do not store in the bathroom. Keep Zymar Drops out of the reach of children and away from pets.

General information:

• If you have any questions about Zymar Drops, please talk with your doctor, pharmacist, or other health care provider.


• Zymar Drops are to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Zymar Drops. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Zymar resources

• Zymar Side Effects (in more detail)
• Zymar Dosage
• Zymar Use in Pregnancy & Breastfeeding
• Zymar Support Group
• 6 Reviews for Zymar - Add your own review/rating

Compare Zymar with other medications

• Conjunctivitis
• Conjunctivitis, Bacterial
• Ophthalmic Surgery

Occlusal

1. Name Of The Medicinal Product

Occlusal.

26% w/w cutaneous solution

2. Qualitative And Quantitative Composition

Salicylic Acid 26% w/w.

For excipients, see 6.1

3. Pharmaceutical Form

Cutaneous solution

A colourless to pale yellow solution with a characteristic smell of nail varnish

4. Clinical Particulars

4.1 Therapeutic Indications

Occlusal is indicated for the treatment and removal of common and plantar warts (verrucae).

4.2 Posology And Method Of Administration

For topical application.

Prior to application soak wart in warm water for five minutes. Remove loose tissue with a brush, emery board, pumice or abrasive sponge, being careful to avoid causing pin-point bleeding or abrading the surrounding healthy skin. Dry thoroughly with a towel not used by others to avoid contagion. Carefully apply Occlusal twice to the wart using the brush applicator allowing the first application to dry before applying the second. Thereafter repeat treatment once daily or as directed by physician. Do not apply to surrounding healthy skin. Clinically visible improvement should occur in one to two weeks but maximum effect may be expected after four to six weeks.

There are no differences in dosage for children, adults or the elderly.

4.3 Contraindications

Hypersensitivity to salicylic acid or to any of the excipients.

Occlusal should not be used by diabetics or patients with impaired blood circulation. Do not use if the wart or surrounding skin is inflamed or broken. Do not use on moles, birthmarks, unusual warts with hair growth, on facial warts, or in the anal or perineal region.

4.4 Special Warnings And Precautions For Use

Occlusal is for external use only. Do not permit contact with eyes or mucous membranes. If contact occurs flush with water for 15 minutes. Do not allow contact with normal skin around wart. Avoid using on areas of broken or damaged skin. Discontinue treatment if excessive irritation occurs. Excessive prolonged use of topical salicylic acid may result in symptoms of salicylism and must therefore be avoided.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

There are no known interactions when used as indicated. However, topical salicylic acid may increase the absorption of other topically applied medicines. Concomitant use of Occlusal and other topical medicines on the treated wart should therefore be avoided.

4.6 Pregnancy And Lactation

Whilst there are no known contra-indications to use of Occlusal during pregnancy and lactation, the safety has not been established. Occlusal should therefore be used with caution or following professional advice.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

A localised irritant reaction may occur if Occlusal is applied to normal skin surrounding the wart. This may normally be controlled by temporarily discontinuing the use of Occlusal and by being careful to apply the solution only to the wart itself when treatment is resumed.

4.9 Overdose

Symptoms of systemic salicylate poisoning have been reported after the application of salicylic acid to large areas of skin and for prolonged periods. Salicylism may also occur in the unlikely event of large quantities being ingested. Salicylism is unlikely to occur if Occlusal is used as indicated.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Wart and anticorn preparations

ATC code: D11AF

Salicylic acid has bacteriostatic and fungicidal actions, but it is its keratolytic properties which are important for this medicinal product. When applied externally it produces slow and painless destruction of the epithelium. Salicylic acid is usually applied in the form of a paint in a collodian base (10 to 17%) or as a plaster (20 to 50%) to destroy warts or corns.

5.2 Pharmacokinetic Properties

Salicylic acid may be percutaneously absorbed. However, there is no evidence of any systemic absorption from the use of Occlusal.

5.3 Preclinical Safety Data

No other information relevant to the prescriber other than that already stated in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Polyvinyl butyral

Dibutyl phthalate

Isopropyl alcohol

Butyl acetate

Acrylates copolymer

6.2 Incompatibilities

Not applicable

6.3 Shelf Life

2 years.

6.4 Special Precautions For Storage

Do not store above 25°C

6.5 Nature And Contents Of Container

The product is presented in a 10ml amber glass bottle with cap brush assembly. The cap brush assembly comprises of a black cap and a white polythene wand nylon brush with stainless steel staple.

6.6 Special Precautions For Disposal And Other Handling

Occlusal is flammable and should be kept away from flame or fire. Keep the bottle tightly capped when not in use. Do not allow the solution to drip from the brush onto the bottle neck thread, otherwise subsequent opening of the bottle may be difficult.

7. Marketing Authorisation Holder

Alliance Pharmaceuticals Limited

Avonbridge House

2 Bath Road

Chippenham

Wiltshire, SN15 2BB

UK

8. Marketing Authorisation Number(S)

PL 16853/0071

9. Date Of First Authorisation/Renewal Of The Authorisation

7^th September 1998/18^th May 2005

10. Date Of Revision Of The Text

28^th April 2011

Josamycin

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

J01FA07

CAS registry number (Chemical Abstracts Service)

0016846-24-5

Chemical Formula

C42-H69-N-O15

Molecular Weight

828

Therapeutic Category

Antibacterial: Macrolide

Chemical Name

Leucomycin V, 3-acetate 4B-(3-methylbutanoate)

Foreign Names

• Josamycinum (Latin)
• Josamycin (German)
• Josamycine (French)
• Josamicina (Spanish)

Generic Names

• Josamicina (OS: DCIT)
• Josamycin (OS: JAN, USAN, BAN)
• Josamycine (OS: DCF)
• EN 141 (IS)
• Leucomycin A₃ (IS)
• Josamycin (PH: BP 2010, JP XIV, Ph. Eur. 6)
• Josamycinum (PH: Ph. Eur. 6)
• Josamycin Propinonate (OS: BANM, JAN)
• JM-P (IS: Yamanouchi)
• Josamycin-2A-propionat (IS)
• YS-20-P (IS)
• Josamycin Propionate (PH: BP 2010, JP XIV, Ph. Eur. 6)
• Josamycini propionas (PH: Ph. Eur. 6)

Brand Names

• Iosalide
  Astellas, Italy



• Josacine
  Bayer Santé, France



• Josalid
  Sandoz, Austria; Sandoz, Costa Rica; Sandoz, Dominican Republic; Sandoz, Guatemala; Sandoz, Nicaragua; Sandoz, Panama; Sandoz, El Salvador



• Josallet
  Showa Yakuhin Kako, Japan



• Josamycin
  Astellas, China



• Wilprafen
  Astellas, Russian Federation; Mack, Luxembourg; Mack, Romania



• Cortifluoral (Josamycin and Diflucortolone)
  Bayer, Italy



• Iosalide
  Astellas, Italy



• Josacine
  Bayer Santé, France



• Josalid
  Biochemie, United Arab Emirates; Biochemie, Bahrain; Biochemie, Cyprus; Biochemie, Jordan; Biochemie, Kuwait; Biochemie, Lebanon; Biochemie, Qatar; Biochemie, Saudi Arabia; Biochemie, Sudan; Biochemie, Yemen; Sandoz, Austria; Sandoz, Costa Rica; Sandoz, Dominican Republic; Sandoz, Guatemala; Sandoz, Nicaragua; Sandoz, Oman; Sandoz, Panama; Sandoz, El Salvador



• Josamamallet
  Showa Yakuhin Kako, Japan



• Josamina
  Novag, Spain



• Josamy
  Astellas, China; Astellas, Japan

International Drug Name Search

Glossary

BAN	British Approved Name
BANM	British Approved Name (Modified)
DCF	Dénomination Commune Française
DCIT	Denominazione Comune Italiana
IS	Inofficial Synonym
JAN	Japanese Accepted Name
OS	Official Synonym
PH	Pharmacopoeia Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

GLUCOPHAGE 500 mg and 1000mg powder for oral solution in sachets

1. Name Of The Medicinal Product

GLUCOPHAGE 500 mg powder for oral solution in sachets

GLUCOPHAGE 1000 mg powder for oral solution in sachets

2. Qualitative And Quantitative Composition

Each sachet contains 500 mg metformin hydrochloride corresponding to 390 mg metformin base.

Each sachet contains 1000 mg metformin hydrochloride corresponding to 780 mg metformin base.

Excipients: contains aspartame.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Powder for oral solution.

White, odourless powder

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of type 2 diabetes mellitus, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control.

• In adults, Glucophage may be used as monotherapy or in combination with other oral antidiabetic agents or with insulin.

• In children from 10 years of age and adolescents, Glucophage may be used as monotherapy or in combination with insulin.

A reduction of diabetic complications has been shown in overweight type 2 diabetic adult patients treated with metformin as first-line therapy after diet failure (see section 5.1).

4.2 Posology And Method Of Administration

Adults:

Monotherapy and combination with other oral antidiabetic agents:

The usual starting dose is 500 mg or 850 mg metformin hydrochloride 2 or 3 times daily given during or after meals.

After 10 to 15 days the dose should be adjusted on the basis of blood glucose measurements. A slow increase of dose may improve gastrointestinal tolerability. In patients receiving a high metformin hydrochloride dose (2 to 3 grams per day), it is possible to replace two Glucophage 500 mg doses with one Glucophage 1000 mg dose.

The maximum recommended dose of metformin hydrochloride is 3 g daily, taken as 3 divided doses.

If transfer from another oral antidiabetic agent is intended: discontinue the other agent and initiate metformin at the dose indicated above.

Combination with insulin:

Metformin and insulin may be used in combination therapy to achieve better blood glucose control. Metformin hydrochloride is given at the usual starting dose of 500 mg or 850 mg 2 or 3 times daily, while insulin dosage is adjusted on the basis of blood glucose measurements.

Elderly:

Due to the potential for decreased renal function in elderly subjects, the metformin dosage should be adjusted based on renal function. Regular assessment of renal function is necessary (see section 4.4).

Children and adolescents:

Monotherapy and combination with insulin

• Glucophage can be used in children from 10 years of age and adolescents.

• The usual starting dose is 500 mg or 850 mg metformin hydrochloride once daily, given during or after meals.

After 10 to 15 days the dose should be adjusted on the basis of blood glucose measurements. A slow increase of dose may improve gastrointestinal tolerability. The maximum recommended dose of metformin hydrochloride is 2 g daily, taken as 2 or 3 divided doses.

Preparation:

The powder should be poured into a glass and 150 ml water should be added to obtain a clear to slightly opalescent solution. The solution should be taken immediately after being prepared. If necessary, the solution may be stirred.

4.3 Contraindications

• Hypersensitivity to metformin or to any of the excipients.

• Diabetic ketoacidosis, diabetic pre-coma.

• Renal failure or renal dysfunction (creatinine clearance < 60 ml/min).

• Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock.

• Acute or chronic disease which may cause tissue hypoxia such as: cardiac or respiratory failure, recent myocardial infarction, shock.

• Hepatic insufficiency, acute alcohol intoxication, alcoholism.

4.4 Special Warnings And Precautions For Use

Lactic acidosis: Lactic acidosis is a rare, but serious (high mortality in the absence of prompt treatment), metabolic complication that can occur due to metformin accumulation. Reported cases of lactic acidosis in patients on metformin have occurred primarily in diabetic patients with significant renal failure. The incidence of lactic acidosis can and should be reduced by assessing also other associated risk factors such as poorly controlled diabetes, ketosis, prolonged fasting, excessive alcohol intake, hepatic insufficiency and any condition associated with hypoxia. Diagnosis: The risk of lactic acidosis must be considered in the event of non-specific signs such as muscle cramps with digestive disorders as abdominal pain and severe asthenia. This can be followed by acidotic dyspnea, abdominal pain, hypothermia and coma. Diagnostic laboratory findings are decreased blood pH, plasma lactate levels above 5 mmol/l, and an increased anion gap and lactate/pyruvate ratio. If metabolic acidosis is suspected, metformin should be discontinued and the patient should be hospitalised immediately (see section 4.9).

Renal function:

As metformin is excreted by the kidney, creatinine clearance (this can be estimated from serum creatinine levels by using the Cockcroft-Gault formula) should be determined before initiating treatment and regularly thereafter:

• at least annually in patients with normal renal function,

• at least two to four times a year in patients with creatinine clearance at the lower limit of normal and in elderly subjects.

Decreased renal function in elderly subjects is frequent and asymptomatic. Special caution should be exercised in situations where renal function may become impaired, for example when initiating antihypertensive therapy or diuretic therapy and when starting therapy with a non-steroidal anti-inflammatory drug (NSAID).

Administration of iodinated contrast media:

The intravascular administration of iodinated contrast media in radiologic studies can lead to renal failure. This may induce metformin accumulation and may expose to lactic acidosis. Metformin must be discontinued prior to, or at the time of the test and not be reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal (see section 4.5).

Surgery:

Metformin must be discontinued 48 hours before elective surgery under general, spinal or peridural anaesthesia. Therapy may be restarted no earlier than 48 hours following surgery or resumption of oral nutrition and only if normal renal function has been established.

Children and adolescents:

The diagnosis of type 2 diabetes mellitus should be confirmed before treatment with metformin is initiated.

No effect of metformin on growth and puberty has been detected during controlled clinical studies of one-year duration but no long-term data on these specific points are available. Therefore, a careful follow-up of the effect of metformin on these parameters in metformin-treated children, especially prepubescent children, is recommended.

Children aged between 10 and 12 years:

Only 15 subjects aged between 10 and 12 years were included in the controlled clinical studies conducted in children and adolescents. Although efficacy and safety of metformin in these children did not differ from efficacy and safety in older children and adolescents, particular caution is recommended when prescribing to children aged between 10 and 12 years.

Other precautions:

All patients should continue their diet with a regular distribution of carbohydrate intake during the day. Overweight patients should continue their energy-restricted diet.

The usual laboratory tests for diabetes monitoring should be performed regularly.

Metformin alone does not cause hypoglycaemia, but caution is advised when it is used in combination with insulin or other oral antidiabetics (e.g. sulfonylureas or meglitinides).

Glucophage powder for oral solution contains aspartame, a source of phenylalanine. It is recommended to consider this fact before treatment is initiated in patients with phenylketonuria.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Concomitant use not recommended:

Alcohol:

Acute alcohol intoxication is associated with an increased risk of lactic acidosis, particularly in case of:

fasting or malnutrition, hepatic insufficiency.

Avoid consumption of alcohol and alcohol-containing medicinal product.

Iodinated contrast media:

Intravascular administration of iodinated contrast media may lead to renal failure, resulting in metformin accumulation and an increased risk of lactic acidosis.

Metformin must be discontinued prior to, or at the time of the test and not be reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal (see section 4.4).

Combinations requiring precautions for use:

Medicinal products with intrinsic hyperglycaemic activity (e.g. glucocorticoids (systemic and local routes) and sympathomimetics):

More frequent blood glucose monitoring may be required, especially at the beginning of treatment. If necessary, adjust the metformin dosage during therapy with the respective medicinal product and upon its discontinuation.

Diuretics, especially loop diuretics:

They may increase the risk of lactic acidosis due to their potential to decrease renal function.

4.6 Pregnancy And Lactation

Pregnancy

Uncontrolled diabetes during pregnancy (gestational or permanent) is associated with increased risk of congenital abnormalities and perinatal mortality.

A limited amount of data from the use of metformin in pregnant women does not indicate an increased risk of congenital abnormalities. Animal studies do not indicate harmful effects with respect to pregnancy, embryonic or fetal development, parturition or postnatal development (see section 5.3).

When the patient plans to become pregnant and during pregnancy, it is recommended that diabetes is not treated with metformin but insulin be used to maintain blood glucose levels as close to normal as possible, to reduce the risk of malformations of the foetus.

Lactation

Metformin is excreted into human breast milk. No adverse effects were observed in breastfed newborns/infants. However, as only limited data are available, breast-feeding is not recommended during metformin treatment.A decision on whether to discontinue breast-feeding should be made, taking into account the benefit of breast-feeding and the potential risk to adverse effects on the child.

Fertility

Fertility of male or female rats was unaffected by metformin when administered at doses as high as 600 mg/kg/day, which is approximately three times the maximum recommended human daily dose based on body surface area comparisons.

4.7 Effects On Ability To Drive And Use Machines

Metformin monotherapy does not cause hypoglycaemia and therefore has no effect on the ability to drive or to use machines.

However, patients should be alerted to the risk of hypoglycaemia when metformin is used in combination with other antidiabetic agents (e.g. sulfonylureas, insulin or meglitinides).

4.8 Undesirable Effects

During treatment initiation, the most common adverse reactions are nausea, vomiting, diarrhoea, abdominal pain and loss of appetite which resolve spontaneously in most cases. To prevent them, it is recommended to take metformin in 2 or 3 daily doses and to increase slowly the doses.

The following adverse reactions may occur under treatment with metformin. Frequencies are defined as follows: very common: >1/100, <1/10; uncommon >1/1,000, <1/100; rare >1/10,000, <1/1,000; very rare <1/10,000.

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Metabolism and nutrition disorders:

very rare:

Lactic acidosis (see section 4.4).

Decrease of vitamin B12 absorption with decrease of serum levels during long-term use of metformin. Consideration of such aetiology is recommended if a patient presents with megaloblastic anaemia.

Nervous system disorders:

Common: Taste disturbance

Gastrointestinal disorders:

very common: Gastrointestinal disorders such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite. These undesirable effects occur most frequently during initiation of therapy and resolve spontaneously in most cases. To prevent them, it is recommended that metformin be taken in 2 or 3 daily doses during or after meals. A slow increase of the dose may also improve gastrointestinal tolerability.

Hepatobiliary disorders:

very rare: Isolated reports of liver function tests abnormalities or hepatitis resolving upon metformin discontinuation

Skin and subcutaneous tissue disorders:

very rare: Skin reactions such as erythema, pruritus, urticaria

Paediatric population

In published and post marketing data and in controlled clinical studies in a limited paediatric population aged 10-16 years treated during 1 year, adverse event reporting was similar in nature and severity to that reported in adults.

4.9 Overdose

Hypoglycaemia has not been seen with metformin hydrochloride doses of up to 85 g, although lactic acidosis has occurred in such circumstances. High overdose of metformin or concomitant risks may lead to lactic acidosis. Lactic acidosis is a medical emergency and must be treated in hospital. The most effective method to remove lactate and metformin is haemodialysis.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Blood glucose lowering drugs. Biguanides; ATC code: A10BA02

Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose. It does not stimulate insulin secretion and therefore does not produce hypoglycaemia.

Metformin may act via 3 mechanisms:

(1) reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis.

(2) in muscle, by increasing insulin sensitivity, improving peripheral glucose uptake and utilization.

(3) and delay of intestinal glucose absorption.

Metformin stimulates intracellular glycogen synthesis by acting on glycogen synthase.

Metformin increases the transport capacity of all types of membrane glucose transporters (GLUTs) known to date.

In clinical studies, use of metformin was associated with either a stable body weight or modest weight loss.

In humans, independently of its action on glycaemia, metformin has favourable effects on lipid metabolism. This has been shown at therapeutic doses in controlled, medium-term or long-term clinical studies: metformin reduces total cholesterol, LDL cholesterol and triglyceride levels.

Clinical efficacy:

The prospective randomised study (UKPDS) has established the long-term benefit of intensive blood glucose control in adult patients with type 2 diabetes.

Analysis of the results for overweight patients treated with metformin after failure of diet alone showed:

- a significant reduction of the absolute risk of any diabetes-related complication in the metformin group (29.8 events/1000 patient-years) versus diet alone (43.3 events/1000 patient-years), p=0.0023, and versus the combined sulfonylurea and insulin monotherapy groups (40.1 events/1000 patient-years), p=0.0034;

- a significant reduction of the absolute risk of diabetes-related mortality: metformin 7.5 events/1000 patient-years, diet alone 12.7 events/1000 patient-years, p=0.017;

- a significant reduction of the absolute risk of overall mortality: metformin 13.5 events/1000 patient-years versus diet alone 20.6 events/1000 patient-years (p=0.011), and versus the combined sulfonylurea and insulin monotherapy groups 18.9 events/1000 patient-years (p=0.021);

- a significant reduction in the absolute risk of myocardial infarction: metformin 11 events/1000 patient-years, diet alone 18 events/1000 patient-years (p=0.01).

Benefit regarding clinical outcome has not been shown for metformin used as second-line therapy, in combination with a sulfonylurea.

In type 1 diabetes, the combination of metformin and insulin has been used in selected patients, but the clinical benefit of this combination has not been formally established.

Paediatric population

Controlled clinical studies in a limited paediatric population aged 10-16 years treated during 1 year demonstrated a similar response in glycaemic control to that seen in adults.

5.2 Pharmacokinetic Properties

Absorption:

After an oral dose of metformin hydrochloride tablet, maximum plasma concentration (C_max) is reached in approximately 2.5 hours (t_max). Absolute bioavailability of a 500 mg or 850 mg metformin hydrochloride tablet is approximately 50-60% in healthy subjects. After an oral dose, the non-absorbed fraction recovered in faeces was 20-30%.

After oral administration, metformin absorption is saturable and incomplete. It is assumed that the pharmacokinetics of metformin absorption is non-linear.

At the recommended metformin doses and dosing schedules, steady state plasma concentrations are reached within 24 to 48 hours and are generally less than 1 microgram/ml. In controlled clinical trials, maximum metformin plasma levels (C_max) did not exceed 5 microgram/ml, even at maximum doses.

Food decreases the extent and slightly delays the absorption of metformin tablets. Following oral administration of a 850 mg tablet, a 40% lower plasma peak concentration, a 25% decrease in AUC (area under the curve) and a 35-minute prolongation of the time to peak plasma concentration were observed. The clinical relevance of these findings is unknown.

Metformin hydrochloride powder for oral solution was shown to be bioequivalent to metformin hydrochloride tablet at a 500 mg dose with respect to C_max and AUC in healthy fed subjects.

Distribution:

Plasma protein binding is negligible. Metformin partitions into erythrocytes. The blood peak is lower than the plasma peak and appears at approximately the same time. The red blood cells most likely represent a secondary compartment of distribution. The mean volume of distribution (Vd) ranged between 63-276 l.

Metabolism:

Metformin is excreted unchanged in the urine. No metabolites have been identified in humans.

Elimination:

Renal clearance of metformin is> 400 ml/min, indicating that metformin is eliminated by glomerular filtration and tubular secretion. Following an oral dose, the apparent terminal elimination half-life is approximately 6.5 hours.

When renal function is impaired, renal clearance is decreased in proportion to that of creatinine and thus the elimination half-life is prolonged, leading to increased levels of metformin in plasma.

Paediatric population

Single dose study: After single doses of metformin hydrochloride 500 mg paediatric patients have shown similar pharmacokinetic profile to that observed in healthy adults.

Multiple dose study: Data are restricted to one study. After repeated doses of 500 mg twice daily for 7 days in paediatric patients the peak plasma concentration (C_max) and systemic exposure (AUC0-t) were reduced by approximately 33% and 40%, respectively compared to diabetic adults who received repeated doses of 500 mg twice daily for 14 days. As the dose is individually titrated based on glycaemic control, this is of limited clinical relevance.

5.3 Preclinical Safety Data

Preclinical data reveal no special hazard for humans based on conventional studies on safety, pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and reproductive toxicity.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Acesulfame potassium

Aspartame (E951)

Citric acid, anhydrous

Erythritol

Maize starch

Pullulan PI-20

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

2 years

6.4 Special Precautions For Storage

This medicinal product does not require any special storage conditions

6.5 Nature And Contents Of Container

Powder in paper/aluminium/polyethylene sachets

Pack of 20, 30 or 60 single-dose sachets

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

Merck Serono Limited

Bedfont Cross, Stanwell Road

Feltham, Middlesex

TW14 8NX

United Kingdom

8. Marketing Authorisation Number(S)

PL 11648/0088

PL 11648/0090

9. Date Of First Authorisation/Renewal Of The Authorisation

19th November 2008

10. Date Of Revision Of The Text

10/2010