Active ingredient
- gabapentin
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
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 25258/0256.
Gabapentin Glenmark 100, 300, 400 mg capsules
Package leaflet: Information for the user
Gabapentin Glenmark 100 mg capsules
Gabapentin Glenmark 300 mg capsules
Gabapentin Glenmark 400 mg capsules
gabapentin
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Gabapentin Glenmark Capsules are and what they are used for
2. What you need to know before you take Gabapentin Glenmark Capsules
3. How to take Gabapentin Glenmark Capsules
4. Possible side effects
5. How to store Gabapentin Glenmark Capsules
6. Contents of the pack and other information
1. What Gabapentin Glenmark Capsules are and what they are used for
Gabapentin Glenmark Capsules 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 Capsules is gabapentin.
Gabapentin Glenmark capsules are used to treat:
2. What you need to know before you take Gabapentin Glenmark Capsules
Do not take Gabapentin:
Warnings and precautions
Talk to your doctor or pharmacist before taking Gabapentin Glenmark Capsules:
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.
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 Capsules
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 Capsules are taken at the earliest two hours after taking an antacid.
Gabapentin:
Gabapentin Glenmark Capsules with food
Gabapentin Glenmark Capsules 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 Capsules 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 Capsules. 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 Capsules, 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 Capsules.
Fertility
There is no effect on fertility in animal studies.
Driving and using machines
Gabapentin Glenmark Capsules 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.
Gabapentin Glenmark Capsules contains lactose
Gabapentin Glenmark Capsules contain lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Gabapentin Glenmark Capsules
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will determine what dose is appropriate for you.
Epilepsy, the recommended dose is
Adults and adolescents
Take the number of capsules 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 capsule(s) each day, usually once in the morning, once in the afternoon and once in the evening.
Gabapentin Glenmark is not recommended for use in children below 6 years of age.
Peripheral Neuropathic Pain, the recommended dose is
Adults
Take the number of capsules 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 Gabapentin Glenmark Capsules 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 Capsules is too strong or too weak, talk to your doctor or pharmacist as soon as possible.
Method of administration
Gabapentin Glenmark Capsules are for oral use. Always swallow the capsules with plenty of water.
Continue taking Gabapentin Glenmark Capsules until your doctor tells you to stop.
If you take more Gabapentin Glenmark Capsules 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 Glenmark Capsules than your doctor prescribed. Take along any capsules 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 Capsules
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 Capsules
Do not stop taking Gabapentin Glenmark Capsules 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 Glenmark Capsules 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:
These symptoms may be the first signs of a serious reaction. A doctor should examine you to decide if you should continue taking Gabapentin Glenmark Capsules.
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)
After marketing Gabapentin the following side effects have been reported:
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.
5. How to store Gabapentin Glenmark Capsules
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. The expiry date refers to the last day of that month.
Do not store above 30°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
What Gabapentin Glenmark Capsules contains
The active substance in Gabapentin Glenmark Capsules is gabapentin
Gabapentin Glenmark 100 mg capsules contain 100 mg of gabapentin.
Gabapentin Glenmark 300 mg capsules contain 300 mg gabapentin.
Gabapentin Glenmark 400 mg capsules contain 400 mg gabapentin.
The other ingredients that are present in the capsule contents are: lactose monohydrate, maize starch and talc.
The capsule shell contains: gelatin, titanium dioxide (E171) and sodium lauryl sulphate. Additionally the 300 mg capsule shell contains iron oxide yellow (E172) and the 400 mg capsules shell contains iron oxide yellow (E172) and iron oxide red (E172).
The printing ink contains Shellac and Black iron oxide (E172).
What Gabapentin Glenmark Capsules looks like and contents of the pack
Gabapentin Glenmark 100 mg Capsules are packaged in blisters supplied in boxes containing: 1, 10, 30, 45, 50, 60, 84, 90, 100, 120, 180 and 200 and containers with 20, 50, 100, 200, 200 (multi-pack containing 2 bottles of 100 capsules), 300, 500 and 1000 hard capsules.
Gabapentin Glenmark 300 mg Capsules are packaged in blisters supplied in boxes containing: 1, 10, 30, 45, 50, 60, 84, 90, 100, 120, 180 and 200 and containers with 50, 100, 200, 200 (multi-pack containing 2 bottles of 100 capsules), 300, 500 and 1000 hard capsules.
Gabapentin Glenmark 400 mg Capsules are packaged in blisters supplied in boxes containing: 1, 10, 30, 45, 50, 60, 84, 90, 100, 120, 180 and 200 and containers with 50, 100, 200, 200 (multi-pack containing 2 bottles of 100 capsules), 300, 500 and 1000 hard capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Manufacturer
Other sources of information:
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only).
Please be ready to give the following information:
Product Name Reference Number
Gabapentin Glenmark 100 mg Capsules PL 25258/0256
Gabapentin Glenmark 300 mg Capsules PL 25258/0257
Gabapentin Glenmark 400 mg Capsules PL 25258/0258
This is a service provided by the Royal National Institute of Blind People.
This medicinal product is authorised in the Member States of the EEA under the following names:
The Netherlands Gabapentine Glenmark 100 / 300 / 400 mg harde capsules
United Kingdom Gabapentin Glenmark 100 mg, 300 mg, 400 mg Capsules
Germany Gabapentin Glenmark 100mg, 300mg, 400mg Hartkapseln
Spain Gabapentin Viso Farmacéutica 100 mg, 300 mg, 400 mg Hard Capsules
This leaflet was last revised in 12/2021.
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