Package leaflet: Information for the patient

Gabapentin Rivopharm 600 mg film-coated Tablets Gabapentin Rivopharm 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. 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.

In this leaflet:

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

2.    What you need to know before you take Gabapentin Tablets

3.    How to take Gabapentin Tablets

4.    Possible side effects

5.    How to store Gabapentin Tablets

6.    Contents of pack and other information

1.    WHAT GABAPENTIN TABLETS ARE AND WHAT THEY ARE USED FOR

Gabapentin Tablets belong to a group of medicines used to treat epilepsy and peripheral neuropathic pain (long lasting pain caused by damage to the nerves).

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

2.    WHAT YOU NEED TO KNOW BEFORE YOU TAKE GABAPENTIN TABLETS

Do not take Gabapentin Tablets

-    if you are allergic (hypersensitive) to gabapentin or any of the other ingredients of Gabapentin Tablets (listed in section6).

Take special care with Gabapentin Tablets

-    if you suffer from kidney problems your doctor may prescribe a different dosing schedule

-    if you are onnaemodialysis (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 Gabapentin Tablets 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 the symptoms to look out for while you are taking Gabapentin Tablets.

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'

Muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell or have a high temperature it may be caused by an abnormal muscle breakdown which can be life-threatening and lead to kidney problems. You may also experience discoloration ofyour urine, and a change in blood test results (notably blood creatine phospho-kinase increased). If you experience any of these signs or symptoms, please contact your doctor immediately.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently have 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 Tablets.

-    Antiacids for indigestion. If Gabapentin Tablets and antiacids

containing aluminium and magnesium are taken at the same time, absorption of Gabapentin Tablet from the stomach may be reduced.

It is therefore recommended that Gabapentin Tablets are taken at the earliest two hours after taking an antacid

Gabapentin Tablets

-    is not expect to interact with other anti-epileptic 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.

Taking Gabapentin Tablets with food and drink

Gabapentin Tablets can be taken with or without food.

Pregnancy

Gabapentin Tablets 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 ofgabapen-tin 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 Tablets. Do not suddenly discontinue taking this medicine as this may lead to a breakthrough seizure, which coula have serious consequences for you and your baby.

Breastfeeding

Gabapentin, the active substance of Gabapentin Tablets, is passed on through human milk.

Because the effect on the baby is unknown, it is not recommended to breast-feed while using Gabapentin Tablets.

Ask your doctor or pharmacist for advice before taking any medicine

Driving and using machines

Gabapentin Tablets 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.

3. HOW TO TAKE GABAPENTIN TABLETS

Always take Gabapentin Tablets 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 recommended 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.

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

Peripheral Neuropathic Pain, the recommended dose is:

Adults:

Take the number of tablets as instructed by your doctor. Your doctor will usually build up your dose gradually. The usual 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.

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 tablets 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 tablets is too strong or too weak, talk to your doctor or pharmacist as soon as possible.

Method of administration

Gabapentin tablets is for oral use. Always swallow the tablets with plenty of water. The tablet can be divided into equal halves.

Continue taking Gabapentine until your doctor tells you to stop.

If you take more Gabapentin Tablets than you should

Higher than recommended doses may result in an increase in undesirable 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 ifyou take more Gabapentin Tablets than your doctor prescribed. Take along any tablets that you have not taken, together with the container andthe label so that the hospital can easily tellwhat medicine you have taken.

If you forget to take Gabapentin Tablets

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 Tablets

Do not stop taking Gabapentin Tablets 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 Gabapentin Tablets 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, Gabapentin Tablets 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)

ersistent stomach pain, feeling sick and being sick as these may e symptoms of acute pancreatitis (an inflamed 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 orblood 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 first 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 (may affect more than 1 in 10 people):

•    Viral infection

•    Feeling drowsy, dizziness, lack of coordination

•    Feeling tired, fever

Common (may affect up to 1 in 10 people):

•    Pneumonia, respiratory infection, 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

•    Highblood 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, flu-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 (may affect up to 1 in 100 people):

•    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

•    Mental impairment

•    Fall

•    Increase in blood glucose levels (most often observed in patients with diabetes)

Rare (may affect up to 1 in 1,000 people):

•    Loss of consciousness

•    Decrease in blood glucose levels

After marking Gabapentin tablets 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 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

•    Breakdown of muscle fibers (rhabdomyolysis)

•    Change in blood test results (creatine phosphokinase increased)

•    Problems with sexual functioning including inability to achieve a sexual climax, delayed ejaculation

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

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.goy.uk/yellowcard

By reporting"' side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE GABAPENTIN TABLETS

Keep out of the reach and sight of children.

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

Do not store Gabapentin Tablets above 25°C. Store in the original package in order to protect from moisture

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. CONTENT OF THE PACK AND OTHER INFORMATION

What Gabapentin Tablets contain

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

The other ingredients in Gabapentin Tablets are:

Tablet core: Poloxamer type 407, Copovidone, Sodium Starch Glycolate type A, Hydrogenated vegetable oil, Talc, Colloidal silica anhydrous. Coating: Polyvinyl alcohol, Titanium dioxide (E171), Macrogol, Talc.

What Gabapentin Tablets look like and contents of the pack

Gabapentin 600 mg film-coated tablets are white oval film-coated tablets embossed with '600, supplied in PVC/PE/PVDC/aluminium foil blister packs of 20, 30, 45, 50, 84, 90, 100, 200, 500 tablets.

Not all pack sizes may be marketed.

Gabapentin 800 mg film-coated tablets are white oval film-coated tablets embossed with '800, supplied in PVC/PE/PVDC/aluminium foil blister packs of 20, 30, 45, 50, 84, 90, 100, 200, 500tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Rivopharm UK, 6th floor, 28 Kingsway, London WC2B 6JR, UK

Manufacturers

wSynerLAB - Laboratoires BTT

Zone Industrielle de Krafft 67150 Erstein

FRANCE

Rivopharm UK Ltd.

30th Floor, 40 Bank Street Canary Wharf London E14 5NR

This leaflet was last revised in 05/2015