•    swelling of the legs and arms, difficulty with walking, weakness, pain, accidental injury, fracture, abrasion.

Uncommon (occurs in less than 1 in 100 users)

•    slowed movements.

•    fall.

•    difficulty with thinking.

•    high blood sugar (most often observed in patients with diabetes).

Rare (occurs in less than 1 in 1000 users)

•    blood glucose changes in diabetics.

•    hair loss, hallucinations (seeing things that are not there), problems with abnormal movements such as writhing, jerking movements and stiffness, ringing in the ears.

•    acute kidney failure, chest pain, racing heartbeat.

•    abnormal blood test results suggesting problems with the liver.

•    low blood sugar (most often observed in patients with diabetes).

•    loss of consciousness.

Not known (frequency cannot be estimated from the data)

•    breast enlargement in both men and women.

•    worsening of myoclonus (muscle spasms), fainting.

•    low blood sodium level.

Children

•    The following effects were only reported in children: respiratory infection, inflammation of the ear, convulsions and bronchitis.

•    Common (occurs in more than 1 in 100 users) - aggressive behaviour, restlessness and hyperactivity.

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.gov.uk/yellowcard

50854514 AAAH9056

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

0 How to store gabapentin capsules

Keep out of the reach and sight of children.

Do not store the capsules above 25°C.

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

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

The active substance (the ingredient that makes the medicine work) is gabapentin.

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

The other ingredients in the capsules are lactose monohydrate, maize starch, talc. The capsule shell contains titanium dioxide (E171) and gelatin, yellow iron oxide (E172) (300mg and 400mg capsules) and red iron oxide (E172) (400mg capsules only).

The printing ink contains Shellac (E904), propylene glycol (E1520), black iron oxide (E172) and potassium hydroxide (E525).

What gabapentin capsules looks like and contents of the pack

Gabapentin 100mg Capsules are white, i the 300mg capsules are yellow and the ! 400mg capsules are orange.

The packs contain: 100 capsules.

Marketing Authorisation Holder and Manufacturer

Actavis, Barnstaple, EX32 8NS, UK Revision date May 2015

vactavis

Actavis, Barnstaple, EX32 8NS, UK

Read all of this leaflet carefully before you start taking this medicine.

•    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 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 leaflet, please tell your doctor or pharmacist.

In this leaflet:

0 What Gabapentin capsules are and what they are used for 0 Before you take Gabapentin capsules

0 How to take Gabapentin capsules

Possible side effects 0 How to store Gabapentin capsules

0 Further information

0 What Gabapentin capsules are and what they are used for

Gabapentin capsules belong to a group of medicines used to treat:

•    various forms of epilepsy -

Gabapentin capsules can be used on their own in adults and children aged 12 years and over or in combination with other medicines to treat epilepsy in adults and children aged 6years and over.

•    peripheral neuropathic pain - This is long lasting pain caused by damage to the nerves.

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^ 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).

Tell your doctor before taking Gabapentin capsules if you

•    suffer with different types of seizures including absences.

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 'Contactyour doctor immediately if you experience any of the following symptoms after taking this medicine as they can be serious'

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. In particular:

•    medicines containing morphine (strong pain killer), as morphine may increase the effect of Gabapentin capsules.

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296x210 Leaflet Reel Fed Bi Fold Profile (BST)

• antacids containing aluminium and magnesium (used to reduce stomach acid)- if taken at the same time, absorption of Gabapentin capsules from the stomach may be reduced.

It is therefore recommended that Gabapentin capsules are taken at least two hours after taking an antacid.

Urine Tests

Gabapentin capsules may interfere with urine tests. If you require a urine test, tell your doctor or hospital that you are taking Gabapentin capsules.

Pregnancy and breastfeeding

Gabapentin capsules should not be taken during pregnancy, unless advised by your doctor.

Contact your doctor immediately if you become pregnant, thinkyou might be pregnant or are planning to become pregnant while taking Gabapentin capsules.

Other medicines used to treat seizures may increase the 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 stop taking this medicine as this may lead to breakthrough seizures, which could have serious consequences for you and your baby.

If you are taking Gabapentin capsules do not breastfeed, unless advised to by your doctor, as this medicine will pass into breast milk and may harm the baby.

Driving and using machines

When taking Gabapentin capsules you may become drowsy, dizzy or feel tired, especially at the start of treatment or after a dose increase. Make sure you are not affected before driving or operating machinery.

Sugar intolerance

The capsules contain lactose monohydrate. If your doctor has told

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you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

E] How to take Gabapentin capsules

Always take Gabapentin capsules exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Gabapentin capsules are usually taken three times a day (morning, afternoon and evening). Always swallow the capsules whole with plenty of water, with or without food.

Your doctor will determine what dose is appropriate for you. Ifyouarean elderly patient (over 65 years old), have kidney disease or are having haemodialysis you should take Gabapentin capsules as prescribed by your doctor.

Continue taking Gabapentin capsules until your doctor tells you to stop.

Dosage

Epilepsy:

Adults and children aged 12 years or over:

The usual starting dose is between 300mg and 900mg each day.The dose may then be increased gradually to a maximum of 3600mg each day.

Children aged 6 years and above:

The dose depends on the body weight of your child.The treatment is started with a low initial dose which is gradually increased over a period of about 3 days. The usual dose to control epilepsy is 25-35mg per kg per day.

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

Peripheral neuropathic pain:

The usual starting dose is between 300mg and 900mg each day.The dose may then be increased gradually to a maximum of 3600mg each day.

If you take more Gabapentin capsules than you should

If you or someone else accidentally takes too many capsules, or if you think a child has swallowed any, contact your doctor or go to your nearest hospital casualty department immediately. As

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Gabapentin capsules may make you drowsy, it is recommended that you ask someone else to drive you to the doctor or hospital, or that you call an ambulance. Symptoms of an overdose are dizziness, double vision, slurred speech, drowsiness and mild diarrhoea.

If you forget to take Gabapentin capsules

If you miss 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 capsules

Do not stop taking this medicine suddenly, as your symptoms may get worse. Your doctor will reduce the dose gradually, you may experience anxiety, difficulty sleeping, feeling sick, pain, sweating.

□ Possible side effects

Like all medicines, Gabapentin capsules can cause side effects, although not everybody gets them.

Contact your doctor at once if the

following effects happen:

•    allergic reactions such as difficulty breathing, swelling of the face, lips, trunkand limbs, hives, skin rash and redness or severe skin reactions such as flushing, blisters and ulcers.

•    low white blood cell counts or decreased platelets (causing increased bruising, nosebleeds, sore throats), pneumonia, urinary tract or viral infections, other infections, inflammation of the pancreas (causing pain and tenderness in the stomach and back) or liver (causing yellowing of the skin and eyes, tiredness or fever).

•    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 hospitalised 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.

Tell your doctor or pharmacist if the

following side effects occur or get worse: Very common (occurs in more than 1 in 10 users)

•    feeling drowsy, dizziness, lack of coordination, fever.

Common (occurs in more than 1 in 100 users)

•    feeling unwell, flu-like symptoms, sore throat, cough, dry mouth or throat, runny nose.

•    loss of appetite, increased appetite, being or feeling sick, problems with teeth, inflamed gums, diarrhoea, stomach pain, indigestion, constipation, flatulence, increase in weight.

•    anger towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty with thinking, jerky movements, twitching, difficulty with speaking or coordination, increased, decreased or absent reflexes, loss of memory, tremor, difficulty sleeping, headache, spinning sensation.

•    'pins and needles', decreased sensation, facial swelling, bruises, rash, itch, acne, unusual eye movement, blurred vision, double vision, joint, muscle or back pain.

•    high blood pressure, flushing or dilation of blood vessels.

•    incontinence, difficulties with erection.

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