Saturday 7 July 2012

Gabapentin Capsules 100mg, 300mg, 400mg





Gabapentin 100mg, 300mg and 400mg capsules




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



  • Keep this leaflet. You may need to read it again.

  • 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 you have any further questions, ask your doctor or pharmacist

  • 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 Gabapentin capsules are and what they are used for

2. Before you take Gabapentin capsules

3. How to take Gabapentin capsules

4. Possible side effects

5. How to store Gabapentin capsules

6. Further information






What Gabapentin capsules are and what they are used for



Gabapentin capsules belong to a group of medicines used to treat:



  • various forms of epilepsy – Gabapentin capsules can be used on its own in adults and children aged 12 years and over or in combination with other medicines to treat epilepsy in adults and children aged 6 years and over.

  • peripheral neuropathic pain - This is long lasting pain caused by damage to the nerves.




Before you take Gabapentin capsules




Do not take Gabapentin capsules



  • if you are allergic (hypersensitive) to gabapentin or any of the other ingredients of Gabapentin capsules (see section 6).




Tell your doctor before taking Gabapentin capsules if you



  • suffer with different types of seizures including absences.

A small number of people being treated with anti-epileptics such as Gabapentin have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.





Taking other medicines



Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. In particular:



  • medicines containing morphine (strong pain killer), as morphine may increase the effect of Gabapentin capsules.

  • antacids containing aluminium and magnesium (used to reduce stomach acid) - if taken at the same time, absorption of Gabapentin capsules from the stomach may be reduced. It is therefore recommended that Gabapentin capsules are taken at least two hours after taking an antacid.




Urine Tests



Gabapentin capsules may interfere with urine tests. If you require a urine test, tell your doctor or hospital that you are taking Gabapentin capsules.





Pregnancy and breastfeeding



Gabapentin capsules should not be taken during pregnancy, unless advised by your doctor.



Contact your doctor immediately if you become pregnant, think you might be pregnant or are planning to become pregnant while taking Gabapentin capsules.



Other medicines used to treat seizures may increase the risk of harm to the foetus, particularly when more than one seizure medication is taken at the same time. Therefore, whenever possible and only under the advice of your doctor, you should try to take only one seizure medication during pregnancy.



Do not suddenly stop taking this medicine as this may lead to breakthrough seizures, which could have serious consequences for you and your baby.



If you are taking Gabapentin capsules, do not breastfeed, unless advised to by your doctor, as this medicine will pass into breast milk and may harm the baby.





Driving and using machines



When taking Gabapentin capsules you may become drowsy, dizzy or feel tired, especially at the start of treatment or after a dose increase. Make sure you are not affected before driving or operating machinery.





Sugar intolerance



The capsules contain lactose monohydrate. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.






How to take Gabapentin capsules



Always take Gabapentin capsules exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.



Gabapentin capsules are usually taken three times a day (morning, afternoon and evening). Always swallow the capsules whole with plenty of water, with or without food.



Your doctor will determine what dose is appropriate for you. If you are an elderly patient (over 65 years old), have kidney disease or are having haemodialysis you should take Gabapentin capsules as prescribed by your doctor.



Continue taking Gabapentin capsules until your doctor tells you to stop.




Dosage



  • Epilepsy:
    Adults and children aged 12 years or over:

    The usual starting dose is between 300mg and 900mg each day. The dose may then be increased gradually to a maximum of 3600mg each day.
    Children aged 6 years and above:

    The dose depends on the body weight your child. The treatment is started with a low initial dose which is gradually increased over a period of about 3 days. The usual dose to control epilepsy is 25-35mg per kg per day.

    Gabapentin capsules are not recommended for use in children below 6 years of age.

  • Peripheral neuropathic pain:

    The usual starting dose is between 300mg and 900mg each day. The dose may then be increased gradually to a maximum of 3600mg each day.




If you take more Gabapentin capsules than you should



If you or someone else accidentally takes too many capsules, or if you think a child has swallowed any, contact your doctor or go to your nearest hospital casualty department immediately. As Gabapentin capsules may make you drowsy, it is recommended that you ask someone else to drive you to the doctor or hospital, or that you call an ambulance. Symptoms of an overdose are dizziness, double vision, slurred speech, drowsiness and mild diarrhoea.





If you forget to take Gabapentin capsules



If you miss a dose, take it as soon as you remember, unless it is time for your next dose. Do not take a double dose to make up for a forgotten dose.





If you stop taking Gabapentin capsules



Do not stop taking this medicine suddenly, as your symptoms may get worse. Your doctor will reduce the dose gradually, you may experience anxiety, difficulty sleeping, feeling sick, pain, sweating.






Possible side effects



Like all medicines, Gabapentin capsules can cause side effects, although not everybody gets them.



Contact your doctor at once if the following effects happen:



  • allergic reactions such as difficulty breathing, swelling of the face, lips, trunk and limbs, hives, skin rash and redness or severe skin reactions such as flushing, blisters and ulcers.

  • low white blood cell counts or decreased platelets (causing increased bruising, nosebleeds, sore throats), pneumonia, urinary tract or viral infections, other infections, inflammation of the pancreas (causing pain and tenderness in the stomach and back) or liver (causing yellowing of the skin and eyes).

Tell your doctor or pharmacist if the following side effects occur or get worse:



Very common (occurs in more than 1 in 10 users)



  • feeling drowsy, dizziness, lack of coordination, fever.

Common (occurs in more than 1 in 100 users)



  • feeling unwell, flu-like symptoms, sore throat, cough, dry mouth or throat, runny nose.

  • loss of appetite, increased appetite, being or feeling sick, problems with teeth, inflamed gums, diarrhoea, stomach pain, indigestion, constipation, flatulence, increase in weight.

  • anger towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty with thinking, jerky movements, twitching, difficulty with speaking or coordination, increased, decreased or absent reflexes, loss of memory, tremor, difficulty sleeping, headache, spinning sensation.

  • ‘pins and needles’, decreased sensation, facial swelling, bruises, rash, itch, acne, unusual eye movement, blurred vision, double vision, joint, muscle or back pain.

  • high blood pressure, flushing or dilation of blood vessels.

  • incontinence, difficulties with erection.

  • swelling of the legs and arms, difficulty with walking, weakness, pain, accidental injury, fracture, abrasion.

Uncommon (occurs in less than 1 in 100 users)



  • abnormal blood test results suggesting problems with the liver.

Rare (occurs in less than 1 in 1000 users)



  • blood glucose changes in diabetics.

  • hair loss, hallucinations (seeing things that are not there), problems with abnormal movements such as writhing, jerking movements and stiffness, ringing in the ears.

  • acute kidney failure, chest pain, racing heartbeat.
    Not known: breast enlargement in both men and women.

Children



  • The following effects were only reported in children: respiratory infection, inflammation of the ear, convulsions and bronchitis.

  • Common (occurs in more than 1 in 100 users) – aggressive behaviour, restlessness and hyperactivity.

If you notice any other side effects not listed, please tell your doctor or pharmacist.





How to store Gabapentin capsules



Keep out of the reach and sight of children.



Do not store the capsules above 25°C.



Do not use Gabapentin capsules after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.



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 Gabapentin capsules contains



The active substance (the ingredient that makes the medicine work) is gabapentin. Each capsule contains either 100mg, 300mg or 400mg gabapentin.



The other ingredients in the capsules are lactose monohydrate, maize starch, talc. The capsule shell contains titanium dioxide (E171) and gelatin, yellow iron oxide (E172) (300mg and 400mg capsules) and red iron oxide (E172) (400mg capsules only).



The printing ink contains Shellac (E904), titanium dioxide (E171) and Brilliant Blue FCF Lake (E133).





What Gabapentin capsules looks like and contents of the pack



Gabapentin 100mg capsules are white, the 300mg capsules are yellow and the 400mg capsules are orange.



The packs contain: 100 capsules.





Marketing Authorisation Holder and Manufacturer




Actavis

Barnstaple

EX32 8NS

UK





Revision date November 2008






Actavis

Barnstaple

EX32 8NS

UK



RIVPL007






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