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PACKAGE LEAFLET: INFORMATION FOR THE USER

Gabapentin Mylan 600 mg Tablets Gabapentin Mylan 800 mg Tablets

(gabapentin)

What is in this leaflet:

1.    What Gabapentin Mylan is and what it is used for

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

3.    How to take Gabapentin Mylan

4.    Possible side effects

5.    How to store Gabapentin Mylan

6.    Contents of the pack and other information

1.    WHAT GABAPENTIN MYLAN IS AND WHAT 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 Mylan is gabapentin.

Epilepsy: Gabapentin Mylan 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 this medicine for you to help treat your epilepsy when your current treatment is not fully controlling your condition. You should take Gabapentin Mylan in addition to your current treatment unless told otherwise. Gabapentin Mylan can also be used on its own to treat adults and children over 12 years of age.

Peripheral neuropathic pain: Gabapentin Mylan is used to treat 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.

2.    WHAT YOU NEED TO KNOW Before YOU TAKE gabapentin MYLAN

Do not take Gabapentin Mylan

-    if you are allergic to gabapentin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Gabapentin Mylan:

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

-    if you are on haemodialysis (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 antiepileptics 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 Mylan 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 this medicine.

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'.

Other medicines and Gabapentin Mylan

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Medicine containing morphine

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

Antacids for indigestion

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 Mylan is taken at least two hours after taking an antacid.

Gabapentin Mylan:

•    is not expected to interact with other antiepileptics 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

Gabapentin Mylan with food and drink

This medicine can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Gabapentin Mylan 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 (foetus), particularly when more than one seizure medication is taken at the same time. Therefore, whenever possible and only under 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 if you become pregnant, think you might be pregnant or are planning to become pregnant while taking this medicine.

Gabapentin, the active substance of Gabapentin Mylan, is excreted in human milk. Because the effect on the baby is unknown, it is not recommended to breastfeed your baby while taking this medicine.

Driving and using machines

Gabapentin Mylan 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.

3. HOW TO TAKE GABAPENTIN MYLAN

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will determine what dose is appropriate for you.

If you have the impression that the effect of Gabapentin Mylan 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 this medicine normally except if you have problems with your kidneys.

Peripheral Neuropathic Pain:

Adults

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.

Epilepsy:

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 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 the 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 tablets each day, usually 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.

Gabapentin Mylan is not recommended for use in children below 6 years of age.

Method and route of administration

Gabapentin Mylan is for oral use. You should swallow the tablets whole with plenty of water or they may be halved depending on dose required.

Continue taking this medicine until your doctor tells you to stop.

If you take more Gabapentin Mylan 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. Take along any tablets 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 Mylan

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 a forgotten dose.

If you stop taking Gabapentin Mylan

Do not stop taking this medicine 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 Mylan 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, this medicine 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 such as 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).

•    this medicine 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 this medicine.

Call your doctor right away if you have any of the following symptoms:

•    skin rash

•    itchy, lumpy, 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 Mylan.

If you are on haemodialysis, tell your doctor if you develop muscle pain and/or weakness.

Other side effects include:

Very common side-effects (may affect more than 1 in 10 people):

•    Viral infection

•    Feeling drowsy, dizziness, lack of coordination

•    Feeling tired, fever

Common side-effects (may affect 1 to 10 people):

•    Pneumonia, respiratory infection, urinary tract infection, inflammation of the ear or other infections

•    Low white blood cell counts

•    Loss of appetite, increased appetite

•    Anger towards others, confusion, mood swings, depression, anxiety, nervousness, difficulty with thinking

•    Seizures, 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

•    A feeling of dizziness or 'spinning' (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 pains, indigestion, constipation, dry mouth or throat, wind (flatulence)

•    Facial swelling, bruises, rash, itch, acne

•    Joint pain, muscle pain, back pain, twitching

•    Difficulties with erection

•    Swelling in the legs and arms or swelling that may involve the face, trunk and limbs, difficulty with walking, weakness, pain, feeling unwell, flu-like symptoms

•    Decrease in white blood cells, increase in weight

•    Accidental injury, fracture, minor injury to the surface of the skin (abrasion)

Uncommon side-effects (may affect 1 to 100 people):

•    Allergic reaction such as itchy, lumpy, skin rash (hives)

•    Decreased movement

•    Racing heartbeat

•    Swelling that may involve the face, trunk and limbs

•    Abnormal blood test results suggesting problems with the liver

Since introduction to the market the following side-effects have been reported (Frequency not known: cannot be estimated from the available data):

•    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

•    Inflammation of the liver, yellowing of the skin and eyes

•    Acute kidney failure, incontinence

•    Increased breast tissue, breast enlargement

•    Adverse events following the abrupt discontinuation of this medicine (anxiety, difficulty sleeping, feeling sick, pain, sweating), chest pain

•    Blood glucose changes in patients with diabetes

•    Breakdown of muscle fibres (rhabdomyolysis)

•    Change in blood test results (creatine phosphokinase increased).

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

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

5.    HOW TO STORE Gabapentin MYLAN

Keep this medicine out of the sight and reach of children.

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

Do not store above 25°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.    CONTENTS OF THE PACK AND OTHER INFORMATION

What Gabapentin Mylan contains

-    The active substance is gabapentin.

-    Each tablet contains 600 mg gabapentin.

-    Each tablet contains 800 mg gabapentin.

-    The other ingredients are hydroxypropylcellulose, mannitol, poloxamer 407, crospovidone (Type A), talc, magnesium stearate

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