PACKAGE LEAFLET: Information for the patient

>Product name< 600 mg film-coated tablets >Product name< 800 mg film-coated tablets

Gabapentin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

•    Keep this leaflet. 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet (see section 4).

What is in this leaflet:

1.    What >Product name< is and what it is used for

2.    What you need to know before you take >Product name<

3.    How to take >Product name<

4.    Possible side effects

5.    How to store >Product name<

6.    Contents of the pack and other information

What >Product name< is and what it is used for

>Product name< 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 >Product name< is gabapentin. Gabapentin 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 >Product name< for you to help treat your epilepsy when your current treatment is not fully controlling your condition. You should take>Product name< in addition to your current treatment unless told otherwise. >Product name< 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.

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2. What you need to know before you take >Product name<

Do not take >Product name<

-if you are allergic to gabapentin, soya, peanut or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking >Product name<

-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 inflamed 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.

Important information about potentially serious reactions

A small number of people taking >Product name< 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 >Product name<.

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’.

Other medicines and >Product name<

Tell your doctor or pharmacist if you are taking, have recently taken or might take 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 >Product name<.

Antacids for indigestion

If >Product name< and antacids containing aluminium and magnesium are taken at the same time, absorption of >Product name< from the stomach may be reduced. It is therefore recommended that >Product name< is taken at the earliest two hours after taking an antacid.

>Product name<

- 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.

>Product name< with food and drink

>Product name< can be taken with or without food.

Pregnancy

>Product name< 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 specifically 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 >Product name<. Do not suddenly discontinue taking this medicine as this may lead to breakthrough seizure, which could have serious consequences for you and your baby.

Breast feeding

Gabapentin, the active substance of >Product name<, is passed on through human milk. Because the effect on the baby is unknown, it is not recommended to breast-feed while using >Product name<.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

>Product name< 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.

>Product name< contains lecithin of soya.

If you are allergic to peanut or soya, do not take this medicine.

How to take >Product name<

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

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Your doctor will determine what dose is appropriate for you.

If you have the impression that the effect of >Product name< is too strong or too weak, talk to your doctor or pharmacist as soon as possible.

If you are an elderly patient (over 65 years of age), you should take the normal dose of >Product name< 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.

Continue taking >Product name< until your doctor tells you to stop.

Method and route of administration

>Product name< is for oral use. Always swallow the tablets whole with plenty of water.

Epilepsy, the usual dose is: Adults and adolescents:

Take the number of 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 as instructed by your doctor up to a maximum of 3600 mg 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.

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 per kg of body weight per day. It is usually given in 3 separate doses, by taking the tablet(s) each day, usually once in the morning, once in the afternoon and once in the evening.

>Product name< is not recommended for use in children below 6 years of age.

Peripheral Neuropathic Pain, the usual dose is:

Adults:

Take the number of 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 as instructed by your doctor up to a maximum of 3600 mg 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.

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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 take more >Product name< 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 >Product name< than your doctor prescribed. Take along any 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 >Product name<

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 >Product name<

Do not stop taking >Product name< unless your doctor tells you to. If your treatment is stopped it should be done gradually over a minimum of 1 week. If you stop taking >Product name< 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 rash and redness and/or hair loss (these may be symptoms of a serious allergic reaction);

•    persistent stomach pain, feeling sick and being sick as these may be symptoms of acute pancreatitis (an inflamed pancreas).

•    >Product name< 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 >Product name<.

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

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•    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 >Product name<.

If you are on haemodialysis, tell your doctor if you develop muscle pain and/or weakness.

Other side effects include:

Very common side effects (may affect more than 1 in 10people):

•    Viral infection

•    Feeling drowsy, dizziness, lack of coordination

•    Feeling tired, fever

Common side effects

(may affect up to 1 in 10people):

•    Pneumonia, respiratory infections, urinary tract infection, inflammation of the ear or other infections

•    Low white blood cell counts

•    Anorexia, increased appetite

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

•    Convulsions, jerky movements, difficulty with speaking, loss of memory, tremor, difficulty sleeping, headache, sensitive skin, decreased sensation (numbness), difficulty with coordination, unusual eye movement, 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, itch, acne

•    Joint pain, muscle pain, back pain, twitching

•    Difficulties with erection (impotence)

•    Swelling in the legs and arms, difficulty with walking, weakness, pain, feeling unwell, flulike 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

(may affect up to 1 in 100people):

•    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 inflammation of liver occurring together

•    Yellowing of the skin and eyes (jaundice), inflammation of the liver

•    Acute kidney failure, incontinence

•    Increased breast tissue, breast enlargement

•    Adverse events following the abrupt discontinuation of gabapentin (anxiety, difficulty sleeping, feeling sick, pain, sweating), chest pain

•    Blood glucose fluctuations in patients with diabetes

Other possible side effects

Lecithin of soya may very rarely cause allergic reactions.

Reporting od side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

How to store >Product name<

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blisters. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What >Product name< contains

The active substance is gabapentin. Each film-coated tablet contains 600 mg 800 mg gabapentin.

The other ingredients in >Product name< tablets are:

Tablet core: macrogol 4000; pregelatinised starch from maize; silica, colloidal anhydrous; magnesium stearate;

Film-coating: poly(vinyl alcohol); titanium dioxide (E171); talc;lecithin of soya; xanthan gum.

What >Product name< looks like and contents of the pack

Film-coated tablet

The 600 mg film-coated tablets are white, capsule-shaped film-coated tablets with a logo (600) embossed on one side.

The 800 mg film-coated tablets are white, capsule-shaped film-coated tablets.

Supplied in PVC/aluminium blister packs of 50 film coated tablets,

60 film coated tablets,

90 film coated tablets,

100 film coated tablets,

200 film coated tablets,

200 (2x100) film coated tablets, samples with 20 film coated tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder

[To be completed nationally]

Manufacturer [To be completed nationally]

This medicinal product is authorised in the Member States of the EEA under the following names:

Gabapentin Sandoz 600/800 mg filmomhulde tabletten

Gabapentin Sandoz

GABAPENTINE SANDOZ 600/800 mg, comprime pellicule Gabapentine Sandoz 600/800 mg filmomhulde tabletten Gabapentina Sandoz

Gabapentina Sandoz 600/800 comprimidos recubierto con peHcula Gabapentin 1A-Farma 600/800 mg filmdragerade tabletter

United Kingdom:    Gabapentin Sandoz 600/800 mg Tablets

This leaflet was last revised in {MM/YYYY}.

[To be completed nationally]