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Gabapentin Medreich 300mg Capsules

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Gabapentin Medreich 100mg Capsules Gabapentin Medreich 300mg Capsules Gabapentin Medreich 400mg Capsules

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 you 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

1. WHAT GABAPENTIN IS AND WHAT IT IS USED FOR

The name of your medicine is Gabapentin Medreich 100mg, 300mg or 400mg Capsules (called gabapentin throughout this leaflet).

Gabapentin belongs to a group of medicines used:

•    to treat epilepsy,

•    to relieve long lasting pain caused by damage to the nerves (peripheral neuropathic pain).

To treat epilepsy: gabapentin is used to treat various forms of epilepsy in adults and children over 6 years old.

Your doctor will prescribe gabapentin if your current treatment is no longer fully controlling your epilepsy. You should take gabapentin in addition to your current treatment.

If your doctor considers that it is necessary, gabapentin can also be used on its own.

To relieve peripheral neuropathic pain:

Peripheral neuropathic pain is a long lasting pain caused by damage to the nerves.

A variety of different diseases can cause this type of pain (primarily occurring in the legs and/or arms), such as diabetes (high blood sugar) or shingles (disease caused by the varicella virus). These pains may be felt as hot, burning, throbbing, shooting, stabbing, sharp, cramping, aching, tingling, numbness, pins and needles etc.

Gabapentin is used to treat these long lasting pains.

BEFORE YOU TAKE GABAPENTIN

Do not take gabapentin:

•    if you are allergic (hypersensitive) to the active substance of this medicine (gabapentin) or to any of the other ingredients of this medicine (refer to section 6.Further information).

Take special care with gabapentin and check with your doctor or pharmacist before using this medicine if:

•    You suffer from kidneys problems

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 the symptoms to look out for while you are taking gabapentin.

Read the description of these symptoms in section 4 of this leaflet under Tell your doctor straight away’. Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.

If you are taking any medicines containing morphine, please tell your doctor or pharmacist as morphine may increase the effect of gabapentin.

The absorption of gabapentin from the stomach may be reduced if you are taking any medicines used to treat ulcer (antacids containing aluminium and magnesium) at the same time. It is therefore recommended that gabapentin is taken at the earliest two hours after taking an antacid.

Gabapentin is not expected to interact with other drugs against epilepsy or your oral contraceptive pill. Gabapentin may change the results of some laboratory tests. If you require a urine test tell your doctor or hospital that you are taking gabapentin.

Taking Gabapentin Capsules with food and drink

Gabapentin can be taken with or without food.

Pregnancy

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

Gabapentin should not be taken during pregnancy, unless your doctor advises it. Effective contraception must be used by women of child-bearing age.

Contact your doctor immediately if you become pregnant, think you might be pregnant or are planning to become pregnant while taking gabapentin.

No specific studies in pregnant women have been done with this medicine. However other medications used to treat seizures have reported an increased risk of harm to the foetus, particularly when several medications against epilepsy were taken at the same time.

Therefore, whenever possible, your doctor will advise you to take only one medication against epilepsy during your pregnancy.

Do not suddenly discontinue taking this medicine. The seizures may reappear, which could have serious consequences for you and your baby.

Breastfeeding

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

This is because gabapentin can pass into the mother’s milk. As 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 cause dizziness, drowsiness and tiredness.

If you use this medicine, you should not drive, operate complex machinery or engage in other potentially hazardous activities, until you know how this medicine affects you Important information about some of the ingredients in Gabapentin Capsules:

These capsules contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

HOW TO TAKE GABAPENTIN

Always take Gabapentin Capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Dosage

Your doctor will determine what dose is appropriate for you.

If you take gabapentin to relieve peripheral neuropathic pain:

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 300mg and 900mg each day.

Thereafter, the dose may be increased progressively up to a maximum of 3600mg each day. Your doctor will tell you to take the dose in 3 divided doses, i.e. once in the morning, once in the afternoon and once in the evening.

If you take gabapentin to treat your epilepsy:

Adults and adolescents over 12 years old:

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 300mg and 900mg each day.

Thereafter, the dose may be increased progressively up to a maximum of 3600mg each day. Your doctor will tell you to take the dose in 3 divided doses, i.e. once in the morning, once in the afternoon and once in the evening.

Children aged 6 years old and older:

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

Gabapentin is not recommended for use in children under 6 years old.

Particular groups of patients

If you have problems with your kidneys (because of a renal failure due to your age or a disease), your doctor may prescribe a different dosing schedule and/or dose.

If you are an elderly patient (over 65 years old), you should take gabapentin as indicated (except if you have problems with your kidneys).

Route of administration

Always swallow the capsules whole with plenty of water.

Duration of treatment

Continue taking gabapentin until your doctor tells you to stop. You should not stop taking this medicine without medical advice.

If you take more gabapentin than you should: call your doctor or go to the nearest hospital emergency unit immediately. Take along any capsules that are left, 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. However, if it is within two hours of the next dose, skip the missed dose and go back to the regular dosing schedule. Do not take a double dose to make up for a forgotten dose.

If you 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.

POSSIBLE SIDE EFFECTS

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

Stop taking gabapentin and see a doctor straight away if:

•    you get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice itchy, lumpy rash (hives) or nettle rash (urticaria). This may mean you are having an allergic reaction to Gabapentin Capsules.

•    you have blistering, peeling or bleeding of the skin around the lip, eyes, mouth, nose and genitals. You may also have flu-like symptoms and a high temperature. These could be signs of Stevens-Johnson syndrome.

•    you get symptoms such as: yellowing of your skin or whites of your eyes, tiredness and fever. This may be due to inflammation of the liver or changes in the way your liver is working.

•    you develop signs such as persistent stomach pain, feeling sick (nausea), and/or being sick (vomiting). This could be a sign of pancreatitis.

Tell your doctor straight away if:

•    you develop muscle pain and/or weakness and you are also on haemodialysis

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 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 you notice any of the following side effects:

Very common (affects more than 1 person in 10):

•    ‘flu’ like symptoms such as tiredness, fever, body and muscle pain, runny or blocked nose, sore throat

•    feeling drowsy, dizzy, lack of coordination.

Common (affects less than 1 person in 10):

•    you may get infections more easily or more often than usual. This includes pneumonia, respiratory infections, urinary tract infections or ear infections.

•    frequent infections such as fever, severe chills, sore throat or mouth ulcers. This may be due to a lower than normal white blood cell count (shown by a blood test)

•    loss of appetite (anorexia), increase in appetite, increase in weight,

•    anger towards others, confusion, fluctuation in mood, depression, anxiety, nervousness, strange or unusual thoughts,

•    convulsions, jerky movements, difficulty speaking, loss of memory, tremor, difficulty sleeping, headache, problems with skin sensitivity such as warming, decreased sensation, coordination difficulties, unusual eye movements, increased, decreased or absent reflexes,

•    blurred vision, double vision,

•    vertigo,

•    high blood pressure, flushing or dilatation of blood vessels,

•    difficulty breathing, bronchitis, sore throat, cough, dry or runny nose,

•    being sick (vomiting), feeling sick (nausea), problems with teeth, inflamed gums, diarrhoea, stomach pain, indigestion, constipation, dry mouth or throat, flatulence,

•    swelling of the face, redness or itching of the skin, blood spots on the skin, acne

•    joint pain, muscle pain, back pain, twitching,

•    difficulty in getting or keeping an erection,

•    swelling in the legs and arms, difficulty in walking, weakness, pain or feeling unwell,

•    accidental injury, fracture, abrasion.

Uncommon (affects less than 1 person in 1,000) :

•    unusually slow or reduced body movements,

•    very fast, uneven or forceful heartbeat (palpitations),

•    swelling that may involve the face, body and limbs,

•    liver problems shown by blood tests.

Rare (affects less than 1 person in 10,000):

•    incontinence (leakage of urine which you cannot control).

Frequency not known (cannot be estimated from available data) :

•    bruising more easily than usual. This could be because of a blood problem (thrombocytopenia),

•    seeing or hearing things which are not there (hallucinations),

•    problems with abnormal movements such as writhing, jerking movements and stiffness,

•    ringing in the ears (tinnitus),

•    serious kidney disease (acute kidney failure),

•    side effects following the sudden stopping of gabapentin (anxiety, difficulty in sleeping, feeling sick, pain, sweating), chest pain,

•    blood glucose variations in patients with diabetes,

•    breast enlargement in men or women,

•    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,

•    alopecia (hair loss).

Additionally in clinical studies in children, aggressive behaviour and jerky movements were reported commonly.

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.

HOW TO STORE GABAPENTIN CAPSULES

Keep out of reach and sight of children.

Do not store above 25°C.

Do not use these 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.

FURTHER INFORMATION

What Gabapentin Capsules contains

The active substance is Gabapentin. Each capsule contains 100mg, 300mg or400mg of gabapentin. The other ingredients are:

•    Capsules Fill - Lactose Monohydrate, Maize Starch, Talc.

•    Capsule shell - Yellow Iron Oxide (E172), Red Iron Oxide (E172), Titanium Dioxide (E71), Gelatin.

•    Printing Ink - Shellac Glazze, Titanium Dioxide and FD&C Blue 1 /Brilliant blue FCF Lake (E133).

What Gabapentin Capsules look like and contents of the pack

Gabapentin Medreich 100mg Capsules are white/white hard gelatin capsules marked 'MG 100'. Gabapentin Medreich 300mg Capsulas are yellow/yellow hard gelatin capsules marked 'MG 300'. Gabapantin Medreich 400mg Capsules are orange/orange hard gelatin capsules marked 'MG 400'. Pack Size: 100

Marketing Authorisation Holder

MEDREICH PLC, Warwick House, Plane Tree Crescent, Feltham TW13 7HF, UK E-mail: info@medreich.co.uk

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This leaflet was last approved in {02/2014}