PACKAGE LEAFLET: INFORMATION FOR THE USER

Gabapentin DOUBLE-E PHARMA 100 mg capsules, hard Gabapentin DOUBLE-E PHARMA 300 mg capsules, hard Gabapentin DOUBLE-E PHARMA 400 mg capsules, hard

gabapentin

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, 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 ifyou notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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 capsules, hard (called Gabapentin capsules in the rest of this leaflet) belong to a group of medicines used to treat epilepsy and peripheral neuropathic pain (long lasting pain caused by damage to the nerves).

Gabapentin capsules are 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 capsules for you to help treat your epilepsy when your current treatment is not fully controlling your condition. You should take Gabapentin capsules in addition to your current treatment unless told otherwise. Gabapentin capsules 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.    BEFORE YOU TAKE GABAPENTIN CAPSULES Do not take Gabapentin capsules:

■    ifyou are allergic (hypersensitive) to gabapentin or any of the other ingredients of Gabapentin capsules.

Take special care with Gabapentin capsules:

•    ifyou suffer from kidney problems your doctor may prescribe a different dosing schedule;

•    ifyou are on haemodialysis (to remove waste products because of kidney failure), tell your doctor ifyou develop muscle pain and/or weakness;

•    ifyou 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 capsules 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 capsules. Read the description of these symptoms in section 4 of this leaflet under 'Contactyour doctor immediately ifyou experience any of the following symptoms after taking this medicine as they can be serious'

Taking other medicines - Please tell your doctor or pharmacist ifyou are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Medicines containing morphine - Ifyou are taking any medicines containing morphine, please tell your doctoror pharmacist asmorphine mayTncrease the effect of Gabapentin capsules.

Antacids for indigestion - If Gabapentin capsules and antacids containing aluminium and magnesium are 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 the earliest two hours after taking an antacid.

Gabapentin capsules:

•    are not expected to interact with other antiepileptic drugs or the oral contraceptive pill;

•    may interfere with some laboratory tests, ifyou require a urine test tell your doctor or hospital what you are taking;

Taking Gabapentin capsules with food and drink - Gabapentin capsules can be taken with or without food.

Pregnancy - Gabapentin capsules 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 ifyou become pregnant, think you might be pregnant or are planning to become pregnant while taking Gabapentin capsules. Do not suddenly discontinue taking this medicine as this may lead to a breakthrough seizure, which could have serious consequences for you and your baby.

Breast-feeding - Gabapentin, the active substance of Gabapentin capsules, is passed on through human milk.

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

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

Driving and using machines - Gabapentin capsules 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.

Important information about some of the ingredients of Gabapentin capsules - Gabapentin capsules contain lactose (a type of sugar). If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

3.    HOW TO TAKE GABAPENTIN CAPSULES

Always take Gabapentin capsules exactly as your doctor has told you. You should check with your doctor or pharmacist ifyou are not sure. Your doctor will determine what dose is appropriate for you. Ifyou have the impression that the effect of Gabapentin capsules 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 Gabapentin capsules unless you have problems with your kidneys. Your doctor may prescribe a different dosing schedule and/or dose ifyou have problems with your kidneys. Continue taking Gabapentin capsules until your doctor tells you to stop.

Method and route of administration

Gabapentin capsules are for oral use. Always swallow the capsules whole with plenty of water. Epilepsy, the usual dose is:

Adults and adolescents: Take the number of capsules 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 capsule(s) each day, usually once in the morning, once in the afternoon and once in the evening.

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Gabapentin capsules are not recommended for use in children below 6 years of age. Peripheral Neuropathic Pain, the usual dose is:

Adults: Take the number of capsules 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.

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 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. Take along any capsules that you have not taken, together with the container and the label so that the hospital can easily tell what medicine you have taken. As 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, loss of consciousness, drowsiness and mild diarrhoea.

If you forget to take Gabapentin capsules - 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 capsules - Do not stop taking Gabapentin capsules 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 capsules 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 capsules 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)

•    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 rash when you get this type of reaction. It may cause you to be hospitalised 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.

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 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, 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 a 1000):

•    Allergic reactions 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 • Fall • Difficulty with thinking • High blood sugar (most often observed in patients with diabetes)

Rare side-effects (which may affect less than 1 person in 1000):

•    Low blood sugar (most often observed in patients with diabetes) • Loss of consciousness

Not known: frequency cannot be estimated from the available data (reported since introduction to the market):

•    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 • Hyponatraemia

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

5.    HOWTO STORE GABAPENTIN CAPSULES

Keep out of the sight and reach of children.

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.

Do not store Gabapentin capsules above 30°C.

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 contains - The active substance is gabapentin. Each hard capsule, contains either 100 mg, 300 mg or 400 mg gabapentin.

The other ingredients in Gabapentin capsules are: Capsule contents: Lactose monohydrate, maize starch and talc. Capsule shell: gelatin. The lOOmg capsules contain the colouring El 71 (Titanium dioxide); the 300mg capsules contain the colourings: El 71 (Titanium dioxide) and El 72 (yellow iron oxide) and the 400mg capsules contain the colourings: El 71 (Titanium dioxide) and E172 (red and yellow iron oxide). The printing ink used on all capsules contains shellac, Iron oxide black (E172).

What Gabapentin capsules look like and contents of the pack-The 100 mg capsules are white hard capsules marked with "100". The 300 mg capsules are yellow hard capsules marked with "300". The 400 mg capsules are orange hard capsules marked with "400". Supplied in PVC/PVDC/aluminium foil blister packs of 100 capsules.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder - DOUBLE-E PHARMA LTD. 7th Floor, Hume House, Ballsbridge, Dublin 4, Ireland

Manufacturers- Laboratoires BTT, Zl de Krafft, 67150 Erstein, France.

Rivopharm UK Ltd, 30th Floor, 40 Bank Street, Canary Wharf, London E14 5NR This leaflet was last revised in 02.2016

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