Gabapentin Glenmark 600 mg film-coated tablets

• 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.

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

• 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.

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

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.
• Before taking this medicine, tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or illegal drugs; it may mean you have a greater risk of becoming dependent on Gabapentin Glenmark

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.

Some people may become dependent on Gabapentin Glenmark (a need to keep taking the medicine). They may have withdrawal effects when they stop using Gabapentin Glenmark (see section 3, “How to take Gabapentin Glenmark” and “If you stop taking Gabapentin Glenmark”). If you have concerns that you may become dependent on Gabapentin Glenmark, it is important that you consult your doctor.

If you notice any of the following signs whilst taking Gabapentin Glenmark, it could be a sign that you have become dependent.

• You feel you need to take the medicine for longer than advised by your prescriber
• You feel you need to take more than the recommended dose
• You are using the medicine for reasons other than prescribed
• You have made repeated, unsuccessful attempts to quit or control the use of the medicine
• When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again

If you notice any of these, speak to your doctor to discuss the best treatment pathway for you, including when it is appropriate to stop and how to do this safely.

Serious skin rashes including Stevens-Johnson syndrome, toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with gabapentin. Stop using gabapentin and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Read the description of serious 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.

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 can be taken with or without food.

• If you are pregnant or think you may be pregnant, you must tell your doctor straight away and discuss possible risks the medicine you are taking might pose to your unborn baby.
• You should not stop your treatment without discussing this with your doctor.
• If you are planning to become pregnant you should discuss your treatment with your doctor. <or pharmacist> as early as possible before you become pregnant.
• If you are breastfeeding or planning to breastfeed, ask your doctor <or pharmacist> for advice before taking this medicine.

Pregnancy

Gabapentin Glenmark can be used during the first trimester of pregnancy if needed.

If you plan to become pregnant or if you are pregnant or think you may be pregnant, talk to your doctor straight away.

If you have become pregnant and you have epilepsy, it is important that you do not stop taking your medicine without first consulting your doctor, as this may worsen your illness. Worsening of your epilepsy may put you and your unborn child at risk.

In a study reviewing data from women in Nordic countries who took gabapentin in the first 3 months of pregnancy, there was no increased risk of birth defects or problems with the development of brain function (neurodevelopment disorders). However, babies of women who took gabapentin during pregnancy had an increased risk of low birth weight and preterm birth.

If used during pregnancy, gabapentin may lead to withdrawal symptoms in newborn infants. This risk might be increased when gabapentin is taken together with opioid analgesics (drugs for treatment of severe pain).

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.

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.

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.

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.

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.

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.

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 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.

Do not suddenly stop taking Gabapentin Glenmark. If you want to stop taking Gabapentin Glenmark, discuss this with your doctor first. They will tell you how to do this. If your treatment is stopped it should be done gradually over a minimum of 1 week. After stopping a short or long-term treatment with Gabapentin Glenmark, you need to know that you may experience certain side effects, so-called withdrawal effects. These effects can include seizures, anxiety, difficulty sleeping, feeling sick (nausea), pain, sweating, shaking, headache, depression, feeling abnormal, dizziness, and feeling generally unwell. These effects usually occur within 48 hours after stopping Gabapentin Glenmark. If you experience withdrawal effects, you should contact your doctor.

• Decreased platelets (blood clotting cells)
• Suicidal thoughts, Hallucinations
• Problems with abnormal movements such as writhing, jerking movements and stiffness
• Ringing in the ears
• 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)
• Becoming dependent on Gabapentin Glenmark (‘drug dependence’)

After stopping a short or long-term treatment with Gabapentin Glenmark, you need to know that you may experience certain side effects, so-called withdrawal effects (see “If you stop taking Gabapentin Glenmark”)

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.

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

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.