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Gabapentin Teva 600mg Film-Coated Tablets

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TEVA

PAGE 1: FRONT FACE (INSIDE OFREEL)

GABAPENTINTEVA 600 mg AND 800 mg FILM-COATED TABLETS Gabapentin

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you start

taking this medicine.

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

♦    Ifyou have any further questions, askyour doctor or pharmacist.

♦    This medicine has been prescribed foryou. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

♦    Ifany ofthe side effects gets serious, orifyou notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

IN THIS LEAFLET:

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

I WHATGABAPENTIN ISANDWHAT 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 Tablets is gabapentin.

Gabapentin is used to treat:

♦    Various forms ofepilepsy (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 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 can also be used on its own to treat adults and children over 12 years of age.

Peripheral neuropathic pain

♦    Peripheral neuropathic pain (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, numbness, pins and needles, etc.

DO NOT take Gabapentin:

♦ if you are allergic (hypersensitive) to gabapentin or any of the other ingredients of Gabapentin.

Take special care with Gabapentin

♦    ifyou sufferfrom kidney problems

♦    ifyou are on haemodialysis, tell yourdoctor if you develop muscle pain and/or weakness

♦    ifyou develop signs such as persistent stomach pain, feeling sick and being sick; contact your doctor immediately.

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 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.

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'. Taking other medicines

♦    Please tell yourdoctor or pharmacist ifyou are taking or have recently taken any other medicines, including medicines obtained without a prescription

♦    Ifyou are taking any medicines containing morphine, please tell your doctor or pharmacist as morphine may increase the effect of Gabapentin

♦    Gabapentin is not expected to interact with other anti-epileptic drugs or the oral contraceptive pill

*    Gabapentin may interfere with some laboratory tests; if you require a urine test tell your doctor or hospital that you are taking Gabapentin.

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.

Taking Gabapentin with food and drink

♦    Gabapentin can be taken with orwithout food. Pregnancy and breast-feeding

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

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 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 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 discontinue taking this medicine as this may lead to breakthrough seizure, which could have serious consequences for you and your baby

♦    Contact your doctor immediately ifyou become pregnant, think you might be pregnant or are planning to become pregnant while taking Gabapentin

♦    Gabapentin, the active substance of Gabapentin Tablets, is excreted in human milk. Because the effect on the nursing infant is unknown, it is not recommended to breast-feed your baby while using Gabapentin.

Driving and using machines

♦    Gabapentin may produce dizziness, 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.

HOWTOTAKE 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. Ifyou have the impression that the effect of Gabapentin is too strong or too weak, talk to your doctor or pharmacist.

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.

Continue taking Gabapentin until your doctor tells you to stop.

The usual dose for treating epilepsy Gabapentin is not recommended for use in children below 6 years of age.

Adults and adolescents:

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 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 tablet(s) each day, usually once in the morning, once in the afternoon and once in the evening.

The usual dose for treating Peripheral Neuropathic Pain:

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

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♦ 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.

Method and route of administration Gabapentin is for oral use. Always swallow the tablets whole with plenty of water.

If you take more Gabapentin 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 if you take more Gabapentin than your doctor prescribed. Take along any tablets that are left 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.

Ifyou 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 1 week. 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.

Like all medicines, Gabapentin can cause side effects, although not everybody will get them. Contactyour doctor immediately if you experience severe skin reactions such as swelling of the lips and face, skin rash and redness, and/or hair loss. 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 yourskin or ofthe whites of the eyes

♦    Unusual bruising or bleeding

♦    Severe fatigue orweakness

♦    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 side effects (which may affect more than 1 person in 10):

♦    viral infection

♦    feeling drowsy, dizziness, lack of coordination

♦    feeling tired, fever.

Common side effects (which may affect more than 1 person in 100):

♦    pneumonia, respiratory infection, urinarytract infection, infection, inflammation of the ear

♦    low white blood cell counts

♦    anorexia, increased appetite

♦    angertowards others, confusion,fluctuation in mood, depression, anxiety, nervousness, difficulty with thinking

♦    convulsions, jerky movements, difficulty with speaking, loss of memory, tremor, difficulty sleeping, headache, sensitive skin, decreased sensation, 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

♦    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 side effects (which may affect more than 1 person in 1000):

♦    allergic reaction such as hives

♦    decreased movement

♦    racing heartbeat

♦    swelling that may involve the face, trunkand 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

♦ inflammation ofthe pancreas

♦ inflammation ofthe liver, yellowing ofthe skin and eyes

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

♦    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.

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.

HOWTO 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. The expiry date refers to the last day of that month.

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

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 Teva contains

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

♦    The other ingredients are:

Core: povidone, cellulose, microcrystalline, crospovidone, talc, hydrogenated vegetable (soyabean) oiiType I

Coating: hypromellose,titanium dioxide (E171), macrogol 400.

What Gabapentin Teva looks like and contents of the pack

♦    Gabapentin 600 mg Tablets are white to off-white, oval shaped, bevelled edged, film-coated tablets, engraved "7173" on one side, and "93" on the other side.

♦    Gabapentin 800 mg Tablets are white to off-white, oval shaped, bevelled edged, film-coated tablets, engraved "7174" on one side, and "93" on the other side.

♦    GabapentinTablets are available in blister packs of 10, 28, 50, 84, 90,100 or200 tablets, or in bottles (HDPE) of 28, 50, 90, 100, 200 or 500 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holderand company responsible for manufacture:

TEVA UK Limited, Eastbourne, BN22 9AG, England. This leaflet was last revised: December 2013

PL 00289/0593-0594

63706-Y

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