The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 25258/0226.
Gabapentin Glenmark 600_800 mg film-coated tablets
Gabapentin Glenmark 600 mg film-coated tablets
Gabapentin Glenmark 800 mg film-coated tablets
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 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 substance in Gabapentin Glenmark Tablets is gabapentin.
Talk to your doctor or pharmacist before taking 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.
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 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.
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 can be taken with or without food.
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.
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.
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.
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.
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.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Do not take more medicine than prescribed.
Your doctor will determine what dose is appropriate for you.
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.
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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Stop using Gabapentin Glenmark and seek medical attention immediately if you notice any of the following symptoms:
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:
These symptoms may be the first signs of a serious reaction. A doctor should examine you to decide if you should continue taking Gabapentin.
Other side effects include:
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Additionally in clinical studies in children, aggressive behaviour and jerky movements were reported commonly.
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1,000 people):
Not known: frequency cannot be estimated from the available data)
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.
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 blister / bottle and carton after “EXP”. The expiry date refers to the last day of that month.
PVC/PVDC – Aluminum Blister Pack: Do not store above 25°C.
Aluminum – Aluminum Blister Pack and Bottle Pack: Do not store above 30°C.
Store in the original package in order to protect from moisture.
<Only for bottles>
Shelf life after first opening of the bottle: 120 days.
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.
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
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.
This leaflet was last revised in 01/2023