Omacor

OMACOR

1000 mg soft capsules

Omega-3-acid ethyl esters 90

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may want to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

If any of the side-effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Omacor is and what it is used for

2. Before you take Omacor

3. How to take Omacor

4. Possible side effects

5. How to store Omacor

6. Further information

What Omacor Is And What It Is Used For

Omacor contains highly purified omega-3 polyunsaturated fatty acids.

Omacor belongs to a group of so called reducers of cholesterol and triglycerides.

Omacor is used:

• together with other medicines for treatment after a heart attack.


• to treat certain forms of increased triglycerides (fats) in the blood after changes to the diet have not worked.

Before You Take Omacor

Do not take Omacor, if

• you are allergic (hypersensitive) to the main ingredient or any of the other ingredients of Omacor (see Section: Important information about some of the ingredients, and Section 6: Further Information).

If any of the above applies to you, do not take this medicine, and talk to your doctor.

Take special care with Omacor if:

• you are due to have or have had surgery recently


• you have had a trauma recently


• you have a kidney problem


• you have diabetes which is not controlled


• you have problems with your liver. Your doctor will monitor any effects Omacor may have on your liver with blood tests.

If any of the above applies to you, talk to your doctor or pharmacist before taking this medicine.

Using other medicines

If you are using a medicine to stop blood clotting in your arteries, such as warfarin, you may need extra blood tests and your usual dose of your blood thinning medicine may have to be changed.

Please tell your doctor or pharmacist if you are using or have recently used other medicines including medicines obtained without prescription.

Taking Omacor with food or drink

You should take the capsules at meal times. This is to help lower the chances of side effects that affect the area in and around the stomach (the gastro-intestinal area).

Use in elderly

Use Omacor with care if you are over 70 years.

Use in children

Children should not take this medicine.

Pregnancy and breast-feeding

You should not take this medicine if you are pregnant or breast-feeding, unless your doctor decides it is absolutely necessary.

Ask your doctor or pharmacist for advice before using any medicine.

Driving and using machines

This medicine is not likely to affect you being able to drive or use any tools or machines.

Important Information about some of the ingredients

Omacor may contain soya-bean oil. If you are allergic to peanut or soya, do not use this medicinal product.

How To Take Omacor

Always take Omacor exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

• Swallow the capsules with a drink of water.


• You may take the capsules at meal times to help reduce gastro-intestinal side effects.


• Your doctor will decide how long you should take this medicine.

Dose after a heart attack

The usual dose is one capsule a day.

Dose to treat high blood triglyceride levels (high levels of fat in the blood or hypertriglyceridaemia)

The usual dose is 2 capsules a day, as recommended by a doctor.

If the medicine is not working well enough at this dose, your doctor may increase this to 4 capsules a day.

If you take more of Omacor than you should

If you accidentally take more of this medicine than you should, do not worry, as this is unlikely to need special treatment.

If you forget to take Omacor

If you miss a dose, take it when you remember unless it is almost time for your next dose, in which case take the next dose as usual. Do not take a double dose (twice the dose recommended by your doctor) to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Omacor Side Effects

Like all medicines, Omacor can cause side effects, although not everybody gets them. The following are side effects that may happen with this medicine:

Common side effects (occur in 1 to 10 users in 100):

• stomach problems and indigestion (dyspepsia)


• feeling sick (nausea)

Uncommon side effects (occur in 1 to 10 users in 1,000):

• abdominal and stomach pain


• allergic reactions


• dizziness


• problems with taste


• diarrhoea


• being sick (vomiting)

Rare side effects (occur in 1 to 10 users in 10,000):

• headache


• acne


• itchy rash (pruritus)


• high blood sugar levels


• liver problems

Very rare side effects (occur in less than 1 in 10,000 users):

• blood in your stools


• low blood pressure


• dry nose


• raised red skin rash (hives or urticaria)


• changes in the results of certain blood tests

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Omacor

• Keep out of the reach and sight of children.


• Do not use Omacor after the expiry date which is printed on the carton and the label. The expiry date refers to the last day of the month.


• Do not store Omacor above 25°C. Do not freeze.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information

What Omacor contains

The active substances are omega-3-acid ethyl esters, 1000 mg of omega-3-acid ethyl esters 90 comprising 460 mg eicosapentaenoic acid (EPA) and 380 mg docosahexaenoic acid (DHA) ethyl esters (these substances are called omega-3 polyunsaturated fatty acids) including as antioxidant 4 mg d-alpha- tocopherol (mixed with a vegetable oil e.g. soya-bean oil).

The soft capsule shell is made up of gelatin, glycerol and purified water.

What Omacor looks like and contents of the pack

Omacor capsules are transparent soft gelatin capsules containing pale yellow oil.

Omacor is available in the following pack sizes:

• 1 x 20 capsules


• 1 x 28 capsules


• 1 x 60 capsules


• 1 x 100 capsules


• 10 x 28 capsules

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The marketing authorisation holder and manufacturer of Omacor is:

Pronova BioPharma Norge AS

1327 Lysaker

Norway

This leaflet was last updated: April 2010

Omacor is supplied in the United Kingdom by

Abbott Healthcare Products Limited

Mansbridge Road

Southampton

SO18 3JD

1070990 Laetus 35

Tekamlo

Generic Name: aliskiren and amlodipine (AL is KYE ren and am LOE de peen)

Brand Names: Tekamlo

What is this drug?

Aliskiren is an anti-hypertensive (blood pressure lowering) medication. It works by decreasing substances in the body that narrow blood vessels and raise blood pressure.

Amlodipine is in a group of drugs called calcium channel blockers. Amlodipine relaxes (widens) blood vessels and improves blood flow.

The combination of aliskiren and amlodipine is used to treat high blood pressure (hypertension).

Aliskiren and amlodipine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about this drug?

Do not use aliskiren and amlodipine if you are pregnant. It could harm the unborn baby. Stop using this medication and tell your doctor right away if you become pregnant. You should not take this medication if you are allergic to aliskiren or amlodipine, or if you are also using cyclosporine (Gengraf, Neoral, Sandimmune) or itraconazole (Sporanox).

Before you take aliskiren and amlodipine, tell your doctor if you have kidney or liver disease, congestive heart failure, coronary artery disease, an electrolyte imbalance (such as low potassium or magnesium), if you are on a low-salt diet, or if you have ever had an allergic reaction to a blood pressure medication.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

What should I discuss with my health care provider before taking this drug?

You should not take this medication if you are allergic to aliskiren or amlodipine, or if you are also using cyclosporine (Gengraf, Neoral, Sandimmune) or itraconazole (Sporanox).

To make sure you can safely take aliskiren and amlodipine, tell your doctor if you have any of these other conditions:

• 
  

  kidney disease (or if you are on dialysis);

  
  


• 
  

  liver disease;

  
  


• 
  

  congestive heart failure;

  
  


• 
  

  coronary artery disease (hardened arteries);

  
  


• 
  

  an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);

  
  


• 
  

  if you are on a low-salt diet; or

  
  


• 
  

  if you have ever had an allergic reaction to a blood pressure medication, such as benazepril (Lotensin), candesartan (Atacand), enalapril (Vasotec), lisinopril (Prinivil, Zestril), losartan (Cozaar, Hyzaar), olmesartan (Benicar, Azor), quinapril (Accupril), ramipril (Altace), telmisartan (Micardis, Twynsta), valsartan (Diovan, Exforge), and others.

  
  

FDA pregnancy category D. Do not use aliskiren and amlodipine if you are pregnant. Stop using this medication and tell your doctor right away if you become pregnant. Aliskiren and amlodipine can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control while taking aliskiren and amlodipine. It is not known whether this medication passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking aliskiren and amlodipine.

How should I take this drug?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your chest pain may become worse when you first start taking amlodipine or when your dose is increased. Call your doctor if your chest pain is severe or ongoing.

Aliskiren and amlodipine may be taken with or without food, but take it the same way each time.

Your blood pressure will need to be checked often. Visit your doctor regularly.

Conditions that may cause very low blood pressure include: vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low-salt diet, or taking diuretics (water pills). Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life. Store at room temperature away from moisture and heat.

See also: Tekamlo dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include rapid heartbeats, severe dizziness, warmth or tingly feeling, and fainting.

What should I avoid while taking this drug?

Avoid taking this medication with foods that are high in fat, which can make it harder for your body to absorb aliskiren.

This drug side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• 
  

  swelling in your hands, ankles, or feet;

  
  


• 
  

  feeling like you might pass out; or

  
  


• 
  

  chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.

  
  

Less serious side effects may include:

• 
  

  diarrhea;

  
  


• 
  

  stomach pain, upset stomach; or

  
  


• 
  

  cough.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect this drug?

Tell your doctor about all other heart or blood pressure medications you are taking.

Tell your doctor about all other medicines you use, especially:

• 
  

  atorvastatin (Lipitor, Caduet), simvastatin (Zocor, Simcor, Vytorin, Juvisync);

  
  


• 
  

  antifungal medication such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend);

  
  


• 
  

  a potassium supplement such as K-Dur, Klor-Con;

  
  


• 
  

  salt substitutes that contain potassium; or

  
  


• 
  

  a diuretic (water pill).

  
  

This list is not complete and other drugs may interact with aliskiren and amlodipine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Tekamlo resources

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

• Tekamlo Prescribing Information (FDA)


• Tekamlo Advanced Consumer (Micromedex) - Includes Dosage Information


• Tekamlo MedFacts Consumer Leaflet (Wolters Kluwer)


• Tekamlo Consumer Overview

Compare Tekamlo with other medications

• High Blood Pressure

Where can I get more information?

• Your pharmacist can provide more information about aliskiren and amlodipine.

See also: Tekamlo side effects (in more detail)

MiraLax Powder for Oral Solution

Pronunciation: pol-ee-ETH-il-een GLIE-col
Generic Name: Polyethylene Glycol-3350
Brand Name: Examples include GlycoLax and MiraLax

MiraLax Powder for Oral Solution is used for:

Treating occasional constipation.

MiraLax Powder for Oral Solution is a laxative. It works by softening the stool and increasing the frequency of bowel movements by retaining water in the stool.

Do NOT use MiraLax Powder for Oral Solution if:

• you are allergic to any ingredient in MiraLax Powder for Oral Solution


• you have blockage of the stomach or intestine (nausea, vomiting, stomach pain, or bloating); loss of strength in the intestinal muscles; chronic inflammation and ulceration of the bowel; holes in the intestine; or an enlarged colon

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

Before using MiraLax Powder for Oral Solution:

Some medical conditions may interact with MiraLax Powder for Oral Solution. 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

Some MEDICINES MAY INTERACT with MiraLax Powder for Oral Solution. However, no specific interactions with MiraLax Powder for Oral Solution are known at this time.

Ask your health care provider if MiraLax Powder for Oral Solution 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 MiraLax Powder for Oral Solution:

Use MiraLax Powder for Oral Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with MiraLax Powder for Oral Solution. Talk to your pharmacist if you have questions about this information.


• Use the measuring cap that comes with MiraLax Powder for Oral Solution to measure your dose. Mix the medicine in 4 to 8 oz of liquid unless your doctor tells you otherwise. You may mix MiraLax Powder for Oral Solution in water, juice, soda, coffee, or tea.


• Do not use MiraLax Powder for Oral Solution for more than 2 weeks unless directed to do so by your doctor.


• If you miss a dose of MiraLax Powder for Oral Solution and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use MiraLax Powder for Oral Solution.

Important safety information:

• It may take 2 to 4 days for MiraLax Powder for Oral Solution to work.


• Follow the diet and exercise program given to you by your health care provider to produce more regular bowel habits.


• The risk of abnormal blood electrolyte levels and dependence on laxatives may be greater if you take MiraLax Powder for Oral Solution in high doses or for a long time. Do NOT take more than the recommended dose or use for longer than 2 weeks without checking with your doctor.


• Do not take MiraLax Powder for Oral Solution with other laxatives or stool softeners, unless directed by your doctor.


• MiraLax Powder for Oral Solution should be used with extreme caution in CHILDREN; safety and effectiveness in 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 MiraLax Powder for Oral Solution while you are pregnant. It is not known if MiraLax Powder for Oral Solution is found in breast milk. If you are or will be breast-feeding while you use MiraLax Powder for Oral Solution, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of MiraLax Powder for Oral Solution:

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:

Cramps; diarrhea; excessive or frequent bowel movements; gas; nausea; stomach bloating.

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).

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: MiraLax 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 severe or prolonged stomach cramps or diarrhea.

Proper storage of MiraLax Powder for Oral Solution:

Store MiraLax Powder for Oral Solution 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 MiraLax Powder for Oral Solution out of the reach of children and away from pets.

General information:

• If you have any questions about MiraLax Powder for Oral Solution, please talk with your doctor, pharmacist, or other health care provider.


• MiraLax Powder for Oral Solution 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 MiraLax Powder for Oral Solution. 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 MiraLax resources

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

Compare MiraLax with other medications

• Bowel Preparation
• Constipation
• Constipation, Acute