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Gabapentin Milpharm 800 Mg Film-Coated Tablets

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Package leaflet: Information for the patient

Gabapentin Milpharm 600 mg film-coated tablets Gabapentin Milpharm 800 mg film-coated tablets

Gabapentin

Read all of this leaflet carefully before you start taking this medicine because it contains important information foryou.

•    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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

In this leaflet:

1.    What Gabapentin Milpharm Tablets is and what it is used for

2.    What you need to know before you take Gabapentin Milpharm Tablets

3.    How to take Gabapentin Milpharm Tablets

4.    Possible side effects

5.    How to store Gabapentin Milpharm Tablets

6.    Contents of the pack and other information

1. What Gabapentin Milpharm Tablets is and what it is used for

Gabapentin Milpharm Tablets 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 Milpharm Tablets is gabapentin.

Gabapentin Milpharm 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 Gabapentin Milpharm Tablets for you to help treat your epilepsy when your current treatment is not fully controlling your condition. You should take Gabapentin Milpharm Tablets in addition to your current treatment unless told otherwise. Gabapentin Milpharm Tablets 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. What you need to know before you takeGabapentin Milpharm Tablets

Do not take Gabapentin Milpharm Tablets:

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

Warnings and precautions

•    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 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 Milpharm Tablets 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 Milpharm Tablets.

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'

Muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell or have a high temperature it may be caused by an abnormal muscle breakdown which can be life-threatening and lead to kidney problems. You may also experience discoloration of your urine, and a change in blood test results (notably blood creatine phosphokinase increased). If you experience any of these signs or symptoms, please contact your doctor immediately.

Other medicines and Gabapentin Milpharm Tablets

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

Medicines containing morphine

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

Antacids for indigestion

If Gabapentin Milpharm Tablets and antacids containing aluminium and magnesium are taken at the same time, absorption of Gabapentin Milpharm Tablets from the stomach may be reduced. It is therefore recommended that Gabapentin Milpharm Tablets is taken at the earliest two hours after taking an antacid.

Gabapentin Milpharm Tablets:

•    is not expected to interact with other antiepileptic drugs 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 Milpharm Tablets with food and drink and alcohol

Gabapentin Milpharm Tablets can be taken with or without food.

Pregnancy and breast-feeding and fertility Pregnancy

Gabapentin Milpharm Tablets 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 yourdoctor.

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

Breastfeeding

Gabapentin Tablets, the active substance of Gabapentin Milpharm, is passed on through human milk. Because the effect on the baby is unknown, it is not recommended to breast-feed while using Gabapentin Milpharm Tablets.

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

Driving and using machines

Gabapentin Milpharm Tablets 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 yourability to perform these activities.

3. How to take Gabapentin Milpharm Tablets

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 foryou.

If you have the impression that the effect of Gabapentin Milpharm Tablets 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 Milpharm Tablets 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 Milpharm Tablets until yourdoctortells you to stop.

Method and route of administration

Gabapentin Milpharm Tablets is for oral use. Always swallow the tablets with plenty of water. Epilepsy, the usual dose Is:

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

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

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 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 kidneys 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 Milpharm Tablets than you should

Higher than recommended doses may result in an increase in side 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

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Milpharm Tablets than your doctor prescribed. Take along any tablets 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 Milpharm Tablets

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 Milpharm Tablets

Do not stop taking Gabapentin Milpharm Tablets 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 Milpharm Tablets suddenly or before yourdoctortells you, there is an increased risk of seizures.

If you haveanyfurtherquestionsonthe 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, 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 Milpharm Tablets 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 Milpharm Tablets.

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 Milpharm Tablets.

If you are on haemodialysis, tell your doctor is 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 less 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.

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.

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.

•    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.

•    Breakdown of muscle fibers (rhabdomyolysis)

•    Change in blood test results (creatine phosphokinase increased)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible sideeffects not listed in this leaflet. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Free phone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.

5. Howto store Gabapentin Milpharm Tablets

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 the month.

Store below 25°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

•    The active substance is gabapentin.

Each film-coated tablet contains 600 mg gabapentin.

Each film-coated tablet contains 800 mg gabapentin.

•    The other ingredients in are: Maize starch, crospovidone (Type A), copovidone (VA 64), microcrystalline cellulose (KG-1000), microcrystalline cellulose (PH-102), magnesium stearate

coating material: Hydroxypropyl cellulose, talc What Gabapentin Milpharm Tablets looks like and contents of the pack

Film-coated tablet

Gabapentin Milpharm 600 mg tablets are white, biconvex, elliptical, film-coated tablets, with deep break line on both sides and debossed with 'D' and '24' on either side of the break line on one side and plain on other side.

The tablet can be divided into equal doses.

Gabapentin Milpharm 800 mg tablets are white, biconvex, elliptical, film-coated tablets, with deep break line on both sides and debossed with 'D' and '25' on either side of the break line on one side and plain on other side.

The tablet can be divided into equal doses.

Gabapentin Milpharm film-coated tablets are available in

Polyamide/Aluminium/PVC - Aluminium foil blister pack: 10, 20, 30, 50, 60, 90,100, 200 and 500 tablets

HDPE container: 20 and 500 tablets Not all pack sizes may be marketed

Marketing Authorisation Holder

Milpharm Limited

Ares, Odyssey Business Park

West End Road, South Ruislip HA4 6QD

United Kingdom

Manufacturer

APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta

This medicinal product is authorised in the Member States of the EEA under the following names:

France:    GABAPENTINE AUROBINDO 600 mg/ 800 mg, comprime pellicule

Germany:    Gabapentin Aurobindo 600 mg/ 800 mg Filmtabletten

Netherlands:    Gabapentine Aurobindo 600 mg/ 800 mg, filmomhulde tabletten

Portugal:    Gabapentina Aurobindo 600/ 800 mg comprimidos revestidos por

pelicula

Spain:    Gabapentina Aurobindo 600 mg/ 800 mg comprimidos recubiertos con

pelicula

United Kingdom: Gabapentin Milpharm 600mg/ 800mg film-coated tablets

This leaflet was last revised in 01/2014.

P150