GABAPENTIN 800 MG FILM-COATED TABLETS

PACKAGE LEAFLET: INFORMATION FOR THE USER
UNITED KINGDOM

100, 300 & 400mg Capsules, Hard 600 & 800mg Film-coated Tablets
Gabapentin
Read all of this leaet carefully before you start taking this medicine.
Keep this leaet. You may need 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 leaet, please tell your doctor or pharmacist.

Gabapentin

whether the seizure spreads to other parts of the brain or not). Your doctor will prescribe Gabapentin for you to help treat your epilepsy when your current treatment is not fully controlling your condition. You should take Gabapentin in addition to your current treatment unless told otherwise. Gabapentin [MAH] can also be used on its own to treat adults and children over 12 years of age. Peripheral neuropathic pain (long lasting pain caused by damage to the nerves). A variety of different diseases can cause peripheral neuropathic pain (primarily occurring in the legs and/or arms), such as diabetes or shingles. Pain sensations may be described as hot, burning, throbbing, shooting, stabbing, sharp, cramping, aching, tingling, numbness, pins and needles etc.

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. Medicines containing morphine If you are taking any medicines containing morphine, please tell your doctor or pharmacist as morphine may increase the effect of Gabapentin. Antacids for indigestion If Gabapentin and antacids containing aluminium and magnesium are taken at the same time, absorption of Gabapentin from the stomach may be reduced. It is therefore recommended that Gabapentin is taken at the earliest two hours after taking an antacid. Gabapentin: is not expected to interact with other antiepileptic drugs or the oral contraceptive pill. may interfere with some laboratory tests, if you require a urine test tell your doctor or hospital what you are taking.

this medicine as this may lead to a breakthrough seizure, which could have serious consequences for you and your baby. Gabapentin, the active substance of Gabapentin, is passed on through human milk. Because the effect on the baby is unknown, it is not recommended to breast-feed while using Gabapentin. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Gabapentin may produce dizziness, drowsiness and tiredness. You should not drive, operate complex machinery or take part in other potentially hazardous activities until you know whether this medication affects your ability to perform these activities.

Important information about some of the ingredients of Gabapentin
Gabapentin capsules, hard contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

2. BEFORE YOU TAKE GABAPENTIN
Do not take Gabapentin
if you are allergic (hypersensitive) to gabapentin or any of the other ingredients of Gabapentin.

In this leaet:
1. What Gabapentin is and what it is used for 2. Before you take Gabapentin 3. How to take Gabapentin 4. Possible side effects 5. How to store Gabapentin 6. Further information

Taking Gabapentin with food and drink
Gabapentin can be taken with or without food.

3. HOW TO TAKE GABAPENTIN
Always take Gabapentin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Your doctor will determine what dose is appropriate for you. Epilepsy, the usual dose is: Adults and adolescents: Take the number of capsules or tablets as instructed. Your doctor will usually build up your dose gradually. The starting dose will generally be between 300mg and 900mg each day. Thereafter, the dose may be increased as instructed by your doctor up to a maximum of 3600mg each day and your doctor will tell you to take this in 3separate doses, i.e. once in the morning, once inthe afternoon and once in the evening. Children aged 6 years and above: The dose to be given to your child will be decided by your doctor as it is calculated

Take special care with Gabapentin
if you suffer from kidney problems your doctor may prescribe a different dosing schedule if you are on haemodialysis (to remove waste products because of kidney failure), tell your doctor if you develop muscle pain and/or weakness if you develop signs such as persistent stomach pain, feeling sick and being sick contact your doctor immediately as these may be symptoms of acute pancreatitis (an inamed pancreas) 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.

Pregnancy and breast feeding
Gabapentin should not be taken during pregnancy, unless you are told otherwise by your doctor. Effective contraception must be used by women of child-bearing potential. There have been no studies specically looking at the use of gabapentin in pregnant women, but other medications used to treat seizures have reported an increased risk of harm to the developing baby, particularly when more than one seizure medication is taken at the same time. Therefore, whenever possible, you should try to take only one seizure medication during pregnancy and only under the advice of your doctor. Contact your doctor immediately if you become pregnant, think you might be pregnant or are planning to become pregnant while taking Gabapentin. Do not suddenly discontinue taking

1. WHAT GABAPENTIN IS AND WHAT IT IS USED FOR
Gabapentin belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain (long lasting pain caused by damage to the nerves). The active ingredient in Gabapentin is gabapentin. Gabapentin is used to treat: Various forms of epilepsy (seizures that are initially limited to certain parts of the brain,

against your childs weight. The treatment is started with a low initial dose which is gradually increased over a period of approximately 3 days. The usual dose to control epilepsy is 2535mg per kg per day. It is usually given in 3 separate doses, by taking the capsule(s) or tablet(s) each day, usually once in the morning, once in the afternoon and once in the evening. Gabapentin is not recommended for use in children below 6 years of age Peripheral Neuropathic Pain, the usual dose is: Adults: Take the number of capsules or tablets as instructed by your doctor. Your doctor will usually build up your dose gradually. The starting dose will generally be between 300mg and 900mg each day. Thereafter, the dose may be increased as instructed by your doctor up to a maximum of 3600mg each day and your doctor will tell you to take this in 3 separate doses, i.e. once in the morning, once in the afternoon and once in the evening. If you have kidney problems or are receiving haemodialysis Your doctor may prescribe a different dosing schedule and/or dose if you have problems with your kidneys or are undergoing haemodialysis. If you are an elderly patient (over 65 years of age), you should take the normal dose of Gabapentin unless you have problems with your kidneys. Your doctor may prescribe a different dosing schedule and/or dose if you have problems with your kidneys. If you have the impression that the effect of Gabapentin is too strong or too weak, talk to your doctor or pharmacist as soon as possible.

If you take more Gabapentin than you should
Higher than recommended doses may result in an increase in side effects including loss of consciousness, dizziness, double vision, slurred speech, drowsiness and diarrhoea. Call your doctor or go to the nearest hospital emergency unit immediately if you take more Gabapentin than your doctor prescribed. Take along any capsules or tablets that you have not taken, together with the container and the label so that the hospital can easily tell what medicine you have taken.

If you forget to take Gabapentin
If you forget to take 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
Do not stop taking Gabapentin unless your doctor tells you to. If your treatment is stopped it should be done gradually over a minimum of 1week. If you stop taking Gabapentin suddenly or before your doctor tells you, there is an increased risk of seizures. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Gabapentin can cause side effects, although not everybody gets them.

Contact your doctor immediately if you experience any of the following symptoms after taking this medicine as they can be serious:
severe skin reactions that require immediate attention, swelling of the lips and face, skin
You will nd more about GABAPENTIN on the back of this leaet

Method and route of administration
Oral use. Always swallow the capsules or tablets whole with plenty of water. Continue taking Gabapentin until your doctor tells you to stop.

rash and redness, and/or hair loss (these may be symptoms of a serious allergic reaction) persistent stomach pain, feeling sick andbeing sick as these may be symptomsofacute pancreatitis (an inamed pancreas) Gabapentin may cause a serious or life-threatening allergic reaction that may affect your skin or other parts of your body such as your liver or blood cells. You may or may not have rash when you get this type of reaction. It may cause you to be hospitalized or to stop Gabapentin. Call your doctor right away if you have any of the following symptoms: skin rash hives fever swollen glands that do not go away swelling of your lip and tongue yellowing of your skin or of the whites of the eyes unusual bruising or bleeding severe fatigue or weakness unexpected muscle pain frequent infections These symptoms may be the rst signs of a serious reaction. A doctor should examine you to decide if you should continue taking Gabapentin. If you are on haemodialysis, tell your doctor if you develop muscle pain and/or weakness Other side effects include: Very common side-effects (affects more than 1 user in 10): Viral infection Feeling drowsy, dizziness, lack of coordination Feeling tired, fever Common side-effects (affects 1 to 10 users in 100): Pneumonia, respiratory infections, urinary tract infection, inammation of the ear or other infections Low white blood cell counts Anorexia, increased appetite

Anger towards others, confusion, mood changes, depression, anxiety, nervousness, difculty with thinking Convulsions, jerky movements, difculty with speaking, loss of memory, tremor, difculty sleeping, headache, sensitive skin, decreased sensation (numbness), difculty with coordination, unusual eye movement, increased, decreased or absent reexes Blurred vision, double vision Vertigo High blood pressure, ushing or dilation of blood vessels Difculty breathing, bronchitis, sore throat, cough, dry nose Vomiting (being sick), nausea (feeling sick), problems with teeth, inamed gums, diarrhoea, stomach pain, indigestion, constipation, dry mouth or throat, atulence Facial swelling, bruises, rash, itch, acne Joint pain, muscle pain, back pain, twitching Difculties with erection (impotence) Swelling in the legs and arms, difculty with walking, weakness, pain, feeling unwell, u-like symptoms Decrease in white blood cells, increase in weight Accidental injury, fracture, abrasion Additionally in clinical studies in children, aggressive behaviour and jerky movements were reported commonly. Uncommon side-effects (affects 1 to 10 users in 1,000): Allergic reaction such as hives Decreased movement Racing heartbeat Swelling that may involve the face, trunk and limbs Abnormal blood test results suggesting problems with the liver. Since introduction to the market the following side-effects have been reported: Decreased platelets (blood clotting cells) Hallucinations Problems with abnormal movements such as writhing, jerking movements and stiffness

Ringing in the ears A group of side effects that could include swollen lymph nodes (isolated small raised lumps under the skin), fever, rash, and inammation of liver occurring together Yellowing of the skin and eyes (jaundice), inammation of the liver Acute kidney failure, incontinence Increased breast tissue, breast enlargement Adverse events following the abrupt discontinuation of gabapentin (anxiety, difculty sleeping, feeling sick, pain, sweating), chest pain Blood glucose uctuations in patients with diabetes If any of the side effects become serious, or if you notice any side effects not listed in this leaet, please tell your doctor or pharmacist.

5. HOW TO STORE GABAPENTIN
Keep out of the reach and sight of children. Do not use Gabapentin after the expiry date which is stated on the carton label and blister foil after EXP. The expiry date refers to the last day of that month. Gabapentin capsules, hard: do not store above 30C Gabapentin lm-coated tablets: do not store above 25C. 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.

6. FURTHER INFORMATION
What Gabapentin contains
Gabapentin capsules, hard The active substance is gabapentin. Each hard capsule contains either 100mg, 300mg or 400mg gabapentin.

The other ingredients in Gabapentin capsules are: Capsule contents: lactose monohydrate maize starch talc Capsule shell 100 mg: gelatin sodium laurilsulfate titanium dioxide (E171) Capsule shell 300 mg: gelatin sodium laurilsulfate titanium dioxide (E171) yellow iron oxide (E172) Capsule shell 400 mg: gelatin sodium laurilsulfate titanium dioxide (E171) yellow iron oxide (E172) red iron oxide (E172) Printing ink: shellac titanium dioxide (E171) Indigocarmine aluminium salt (E132) Gabapentin lm-coated tablets The active substance is gabapentin. Each lm-coated tablet contains either 600mg or 800mg gabapentin The other ingredients in Gabapentin lm-coated tablets are: Poloxamer 407 (ethylene oxide and propylene oxide) copovidone maize starch magnesium stearate Fim-coating: Opadry white YS-1-18111 Hydroxypropylcellulose Talc

The 300 mg capsules are yellow hard capsules marked with G and 5027. The 400 mg capsules are orange hard capsules marked with G and 5028. Supplied in PVC/PVDC/aluminium foil blisters of 20, 30, 50, 60, 84, 90, 98, 100, 200, 500, 1000capsules. Not all pack sizes may be marketed. Film-coated tablets The tablets 600 mg tablets are white, elliptical lm-coated tablets with a bisecting score on both sides and debossed with NT and 16 on one side. The 800 mg tablets are white, elliptical lmcoated tablets with a bisecting score on both sides and debossed with NT and 26 on one side. The tablet can be divided into equal halves. Supplied in PVC/PE/PVDC/aluminium foil blisters or PVC/PVDC/aluminium foil blisters of 20, 30, 45, 50, 60, 84, 90, 100, 200, 500 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder Pzer Limited, Sandwich, Kent, CT13 9NJ, UK Manufacturer Pzer Manufacturing Deutschland GmbH Betriebssttte Freiburg Mooswaldallee 1 D-79090 Freiburg Germany Company contact address: Medical Information Department, Pzer Limited, Walton Oaks, Dorking Road, Tadworth, Surrey KT20 7NS. Telephone: 01304 616 161. This medicinal product is authorised in the Member States of the EEA under the following names: Austria Gabapentin Pzer 300/400 mg Hartkapseln; Gabapentin Pzer 600/800 mg Filmtabletten

Gabapentine Pzer 100/300/ 400 mg glules/ harde capsules/ Hartkapseln; Gabapentine Pzer 600/800 mg comprims pelliculs/ lmomhulde tabletten/ Filmtabletten Denmark Gabapentin Pzer Finland Gabapentin Pzer France Gabapentine Pzer Germany Gabapentin Pzer 100/300/ 400 mg Hartkapseln; Gabapentin Pzer 600/800mg Filmtabletten Ireland Gabapentin Pzer 100/300/ 400 mg Hard Capsules; Gabapentin Pzer 600/800 mg Film-Coated Tablets Italy Gabapentin Pzer 100/300/ 400 mg capsule rigide; Gabapentin Pzer 600/800mg compresse rivestite con lm Luxembourg Gabapentine Pzer 100/300/ 400 mg glules; Gabapentine Pzer 600/800 mg comprims pelliculs Portugal Gabapentina Parke-Davis Romania Gabapentin Pzer Sweden Gabapentin Pzer UK Gabapentin 100/300/400 mg Hard Capsules; Gabapentin 600/800 mg Film Coated Tablets This leaet was last revised in: July 2011 Company Reference: dNN 1_0 (UK)

Belgium

What Gabapentin looks like and contents of the pack
Capsules, hard The 100 mg capsules are white hard capsules marked with G and 5026.