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PAGE 1: FRONT FACE (INSIDE OF REEL)

PACKAGE LEAFLET: INFORMATION FOR THE USER

Gabapentin 100/300/400 mg capsules

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

1.    What Gabapentin capsules are and what they are used for

Gabapentin belongs to a group of medicines used to treat epilepsy and neuropathic pain.

Epilepsy: Your medicine is used to treat various forms of epilepsy (seizures that are initially limited to certain parts of the brain, whether the seizure spreads to other parts of the brain or not). Your doctor will prescribe your medicine for you to help treat your epilepsy when your current treatment is not fully controlling your seizures. You should take your medicine in addition to your current treatment unless told otherwise. Your medicine can also be used on its own to treat adults and children over 12 years of age.

Neuropathic pain (in adults only): Your medicine is used to treat long lasting pain caused by damage to the nerves. A variety of different diseases can cause peripheral (primarily occurring in the legs and/or arms) neuropathic pain, such as diabetes or shingles. Pain sensations may be described as hot, burning, throbbing, shooting, stabbing, sharp, cramping, aching, tingling, pins and needles etc. Another symptom may be numbness.

2.    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 - Further information).

Take special care with Gabapentin capsules if you suffer from reduced kidney function, as your kidneys may not be able to cope with the recommended dose. Talk to your doctor as you may need a smaller dose.

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

Important information about potentially serious reactions

A small number of people taking Gabapentin get an allergic reaction or potentially serious skin reaction, which may develop into more serious problems if they are not treated. You need to know these symptoms to look out for while you are taking Gabapentin CT capsules. Read the description of these symptoms in section 4. of this leaflet under 'Contact your doctor immediately if you experience any of the following symptoms after taking this medicine as they can be serious'.

Your medicine may interfere with some laboratory tests, if you require a urine test tell your doctor or hospital that you are taking Gabapentin capsules.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained with or without a prescription;

•    morphine may increase the effect of your medicine

•    antacids (containing aluminium and magnesium) may reduce the absorption of your medicine from the stomach. It is therefore recommended you take your medicine at least two hours after taking an antacid

Your medicine is not expected to interact with other seizure medication or the oral contraceptive pill.

Taking Gabapentin capsules with food and drink

Your medicine can be taken with or without food. The capsules should be swallowed whole with a glass of water.

Pregnancy and breast-feeding

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

This medicine should not be taken during pregnancy, unless you are told otherwise by your doctor.

If you become pregnant, or are planning to become pregnant, contact your doctor immediately. Effective contraception must be used by women who wish to have children in the future.

Do not suddenly stop taking this medicine as this may lead to breakthrough seizure, which could have serious consequences for you and your baby. There have been no studies on the use of Gabapentin in pregnant women, but other seizure medications have reported an increased 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.

The active substance of your medicine (Gabapentin), is excreted in human milk. It is not recommended to breast-feed while using this medicine, because the effect on your baby is unknown.

Driving and using machines

Your medicine may cause dizziness, problems with coordination, drowsiness and tiredness. You should not drive, operate complex machinery or engage 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 capsules

The capsules 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.

3.    How to take Gabapentin capsules

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

Always take your medicine exactly as your doctor has told you. Your doctor will determine what dose is appropriate for you. If you have any concerns about your dose, speak to your doctor or pharmacist. Continue taking your medicine until your doctor tells you to stop.

•    Your medicine can be taken with or without food. And should be swallowed whole with a glass of water.

•    Elderly patients (over 65 years of age) may require a smaller dose, because of reduced kidney function.

•    If you suffer from reduced kidney function, your doctor may need to give you a smaller dose.

Epilepsy:

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 300 mg and 900 mg each day

•    thereafter, the dose may be increased stepwise up to a maximum of 3600 mg each day and your doctor will tell you to take this in 3 divided doses, i.e. once in the morning, once in the 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 against your child's 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 25-35 mg/kg/day. It is usually given in 3 divided doses, by taking the capsules each day, usually once in the morning, once in the afternoon and once in the evening

Neuropathic Pain (only in 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 300 mg and 900 mg each day

•    thereafter, the dose may be increased stepwise up to a maximum of 3600 mg each day and your doctor will tell you to take this in 3 divided doses, i.e. once in the morning, once in the afternoon and once in the evening

If you take more Gabapentin capsules than you should

call your doctor or go to the nearest hospital emergency unit immediately. Take along any capsules or tablets that are left, the container and the label so that the hospital can easily tell what medicine you have taken.

If you forget to take Gabapentin capsules

Take your dose as soon as you remember. Do not take a double dose to make up for a forgotten dose.

If you stop taking Gabapentin capsules

Do not stop taking your medicine unless your doctor tells you to, sudden discontinuation may result in withdrawal effects (anxiety, difficulty sleeping, feeling sick, pain, sweating). It is recommended that your treatment is stopped gradually over a minimum period of one week. If you stop taking your medicine suddenly, or before your doctor tells you, then 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 capsules can cause side effects, although not everybody gets them. Stop taking your medicine and seek medical help immediately, if you have any of the following allergic reactions; difficulties in breathing, swollen face, tongue or throat, itch and rash, convulsions, severe reduced kidney function, reduction in the number of white blood cells (leucopenia), reduction in blood platelets (thrombocytopenia). Contact your doctor immediately if you experience any of the following symptoms after taking this medicine as they can be serious Gabapentin capsules 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 a rash when you get this type of reaction. It may cause you to be hospitalized or to stop Gabapentin capsules.

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 first signs of a serious reaction. A doctor should examine you to decide if you should continue taking Gabapentin capsules.

Other possible side effects

Very common (more than 1 in 10 persons treated):

•    viral infection

•    feeling drowsy, dizziness, lack of co-ordination

•    feeling tired, fever

Common (less than 1 in 10, but more than 1 in 100 persons treated):

•    aggressive behaviour in children (this was reported during clinical studies)

•    pneumonia, respiratory infection, urinary tract infection, inflammation of the ear

•    reduction in the number of white blood cells, which makes infections more likely (leucopenia)

•    anorexia, increased appetite

•    anger towards others, confusion, changes in mood, depression, anxiety, nervousness, difficulty with thinking

•    convulsions, jerky movements, difficulty with speaking, loss of memory, tremors, difficulty sleeping, headache, sensitive skin, decreased sensation, rapid involuntary eye movements, increased/decreased or absent reflexes

•    blurred vision, double vision

•    vertigo

•    high blood pressure, flushing or dilation of blood vessels

•    difficulty breathing, bronchitis, sore throat, cough, dry nose

•    vomiting (being sick), nausea (feeling sick), problems with teeth, inflamed gums, diarrhoea, stomach pain, indigestion, constipation, dry mouth or throat, flatulence

•    facial swelling, bruises, rash, itching, acne

•    joint pain, muscle pain, back pain, twitching

•    difficulties with erection

•    swelling in the legs and arms, difficulty with walking, weakness, pain, feeling unwell, flu-like symptoms

•    increase in weight

Uncommon (less than 1 person in 100 persons treated):

•    Allergic reaction such as hives

•    Slow or diminished movements

•    Racing heartbeat

•    Swelling that may involve the face, trunk and limbs

•    Elevated liver function tests

Not known (frequency of side effects cannot be estimated from the available data):

•    decreased platelets (blood clotting cells)

•    hallucinations

•    problems with abnormal movements such as writhing, jerking movements and stiffness

•    state of severe, persistent seizures ("Status epilepticus") on abrupt withdrawal

•    ringing in the ears

•    inflammation of the pancreas

•    inflammation of the liver, yellowing of the skin and eyes

•    severe skin reactions that require immediate medical attention, swelling of the lips and face, skin rash and redness, hair loss

•    twitching of muscles

•    acute kidney failure, incontinence

•    breast enlargement (female), breast development (male)

•    adverse events following the abrupt discontinuation of gabapentin (anxiety, difficulty sleeping, feeling sick, pain, sweating), chest pain. Sudden unexplained deaths have been reported where a causal relationship to treatment with gabapentin has not been established.

•    blood glucose fluctuations in patients with diabetes

In patients on haemodialysis due to end-stage renal failure, muscular weakness has been reported.

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.

5.    How to store Gabapentin capsules

Keep out of the reach and sight of children.

Do not store above 25°C. Store in the original package.

Do not use your medicine after the expiry date which is stated on the carton.

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 capsules contain

Each hard capsule contains either 100 mg, 300 mg or 400 mg gabapentin.

Capsule content: lactose anhydrous, maize starch and talc.

Capsule shell: gelatin and the following colours:

100 mg capsules: titanium dioxide (E 171).

300 mg capsules: titanium dioxide (E 171), yellow iron oxide (E 172).

400 mg capsules: titanium dioxide (E 171), red and yellow iron oxides (E 172).

Printing Ink: shellac, propylene glycol, ammonia solution, potassium hydroxide, black iron oxide.

What Gabapentin capsules look like and contents of the pack

The 100 mg capsules are white with the imprinting "100" on one side and "G" on the other.

The 300 mg capsules are yellow with the imprinting "300" on one side and "G" on the other.

The 400 mg capsules are orange with the imprinting "400" on one side and "G" on the other.

Pack sizes:

Blisters: 10, 20, 50, 90, 100, 200 (2x100), 250 capsules.

Hospital pack: 500 (5x100), 1000 (10x100) capsules.

Unit dose: 20x1,60x1, 100x1 capsule.

Bottles: 50, 100, 250 capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

MA holder: ratiopharm GmbH, Graf-Arco-Str.3, D-89079 Ulm, Germany.

Manufacturer: TEVA UK Limited, Eastbourne, BN22 9AG.

This leaflet was last approved in December 2012.    tev* uk limited    88267-D