Gabapentin Glenmark 800 mg film-coated tablets

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

• 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.

What is in this leaflet:

1. What Gabapentin Glenmark is and what it is used for
2. What you need to know before you take Gabapentin Glenmark
3. How to take Gabapentin Glenmark
4. Possible side effects
5. How to store Gabapentin Glenmark
6. Contents of the pack and other information

Gabapentin Glenmark 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). The doctor treating you or your child 6 years of age and older will prescribe Gabapentin Glenmark to help treat epilepsy when the current treatment is not fully controlling the condition. You or your child 6 years of age and older should take Gabapentin Glenmark Film-coated Tablets in addition to the current treatment unless told otherwise. Gabapentin Glenmark Film-coated 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.

Do not take Gabapentin Glenmark:

• if you are allergic (hypersensitive) 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 Glenmark:

• 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)
• if you have nervous system disorders, respiratory disorders, or you are more than 65 years old, your doctor may prescribe you a different dosing regimen.

Cases of abuse and dependence have been reported for gabapentin from the post-marketing experience. Talk to your doctor if you have a history of abuse or dependence.

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 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 Glenmark 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 Glenmark

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor (or pharmacist) if you are taking or have been recently taking any medicines for convulsions, sleeping disorders, depression, anxiety, or any other neurological or psychiatric problems.

Medicines containing opioids such as morphine

If you are taking any medicines containing opioids (such as morphine), please tell your doctor or pharmacist as opioids may increase the effect of gabapentin. In addition, combination of gabapentin with opioids may cause sleepiness, sedation, decrease in breathing, or death.

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 Glenmark is taken at the earliest two hours after taking an antacid.

Gabapentin Glenmark:

• 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 Glenmark with food

Gabapentin Glenmark can be taken with or without food.

Pregnancy, breast-feeding and fertility

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

Pregnancy

Gabapentin Glenmark 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 if you become pregnant, think you might be pregnant or are planning to become pregnant while taking Gabapentin Glenmark. 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 Glenmark, is passed on through human milk. Because the effect on the baby is unknown, it is not recommended to breast-feed while using Gabapentin Glenmark.

Fertility

There is no effect on fertility in animal studies.

Driving and using machines

Gabapentin Glenmark film-coated 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 your ability to perform these activities.

Epilepsy, the recommended 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 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 is not recommended for use in children below 6 years of age.

Peripheral Neuropathic Pain, the recommended 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 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 are an elderly patient (over 65 years of age), you should take the normal dose of this medicine 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.

If you have the impression that the effect of Gabapentin Glenmark Tablets is too strong or too weak, talk to your doctor or pharmacist as soon as possible.

Method of administration

Gabapentin Glenmark Tablets is for oral use. Always swallow the tablets with plenty of water.

The tablet can be divided into equal halves.

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

If you take more Gabapentin Glenmark 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 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 Glenmark

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 Glenmark

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 suddenly or before your doctor tells you, there is an increased risk of seizures.

After marketing Gabapentin 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
• Breakdown of muscle fibers (rhabdomyolysis)
• Change in blood test results (creatine phosphokinase increased)
• Problems with sexual functioning including inability to achieve a sexual climax, delayed ejaculation
• Low blood sodium level
• Anaphylaxis (serious, potentially life threatening allergic reaction including difficulty breathing, swelling of the lips, throat, and tongue, and hypotension requiring emergency treatment)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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.co.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

What Gabapentin Glenmark contains

The active substance is gabapentin.

Each film-coated tablet contains 600 mg gabapentin.

Each film-coated tablet contains either 800 mg gabapentin.

The other ingredients are:

Tablet core: Poloxamer 407, copovidone, maize starch and magnesium stearate.

Film-coating: Ready to use coating material [Hypromellose (E464), Titanium Dioxide (E171), Macrogol 400 (E1521), Polysorbate 80 (E433)], Macrogol 8000 and Talc

What Gabapentin Glenmark looks like and contents of the pack

Film-coated tablet

White to off white, oval shaped, biconvex scored film coated tablets debossed with “G” and “31” on one side, approximately 17.40 ± 0.2 mm in length

The tablet can be divided into equal doses.

White to off white, oval shaped, biconvex scored film coated tablets debossed with “G” and “13” on one side, approximately 19.10 ± 0.2 mm in length

The tablet can be divided into equal doses.

Gabapentin Glenmark comes in blisters containing 1, 10, 30, 45, 50, 60, 84, 90, 100, 120, 180, 200 film-coated tablets and in bottles with 100, 500 and 1000 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer

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

Germany - Gabapentin Glenmark 600 mg / 800 mg Filmtabletten

Denmark - Gabapentin Glenmark

United Kingdom – Gabapentin Glenmark 600 mg / 800 mg Film-coated Tablets

Austria - Gabapentin Glenmark 600 mg / 800 mg Filmtabletten

Spain - Gabapentin Viso Farmacéutica 600 mg / 800 mg comprimidos recubiertos con película EFG

Finland - Gabapentin Glenmark 600 mg / 800 mg kalvopäällysteiset tabletit

Poland - EPIGAPENT