Active ingredient
- topiramate
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 are: PL 25258/0060, PL 25258/0061, PL 25258/0062, PL 25258/0063.
Topiramate Glenmark 25mg, 50mg, 100mg and 200mg film-coated tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Topiramate Glenmark 25mg film-coated tablets
Topiramate Glenmark 50mg film-coated tablets
Topiramate Glenmark 100mg film-coated tablets
Topiramate Glenmark 200mg film-coated tablets
Topiramate
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 Topiramate tablets are and what they are used for
2. What you need to know before you take Topiramate tablets
3. How to take Topiramate tablets
4. Possible side effects
5. How to store Topiramate tablets
6. Contents of the pack and other information
1. WHAT TOPIRAMATE TABLETS ARE AND WHAT THEY ARE USED FOR
Topiramate belongs to a group of medicines called “anti-epileptic medicines”. It is used:
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TOPIRAMATE TABLETS
Do not take Topiramate tablets
If you are not sure if the above applies to you, talk to your doctor or pharmacist before using this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if you:
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using this medicine.
It is important that you do not stop taking your medicine without first consulting your doctor.
You should also talk to your doctor before taking any medicine containing topiramate that is given to you as an alternative to topiramate.
You may lose weight if you use topiramate so your weight should be checked regularly when using this medicine. If you are losing too much weight or a child using this medicine is not gaining enough weight, you should consult your doctor.
A small number of people being treated with anti-epileptic medicines such as topiramate have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.
Topiramate can cause serious skin reactions, tell your doctor immediately if you develop a skin rash and/or blisters (see also section 4 ‘Possible side effects’).
Topiramate may in rare cases cause high levels of ammonia in the blood (seen in blood tests) which can lead to a change in brain function, especially if you are also taking a medicine called valproic acid or sodium valproate. Since this may be a severe condition, tell your doctor immediately if the following symptoms occur (see also section 4 ‘Possible side effects’):
At higher doses of Topiramate, the risk of developing these symptoms may increase.
Other medicines and Topiramate tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Topiramate and certain other medicines can affect each other. Sometimes the dose of some of your other medicines or topiramate will have to be adjusted.
Especially, tell your doctor or pharmacist if you are taking:
Tell your doctor if your menstrual bleeding changes while you are taking birth control pills and Topiramate.
Keep a list of all the medicines you take. Show this list to your doctor and pharmacist before you start a new medicine.
Other medicines you should discuss with your doctor or pharmacist include other anti-epileptic medicines, risperidone, lithium, hydrochlorothiazide, metformin, pioglitazone, glibenclamide, amitriptyline, propranolol, diltiazem, venlafaxine, flunarazine, St. John's wort (Hypericum perforatum) (a herbal preparation used to treat depression), warfarin used to thin the blood.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using this medicine.
Topiramate tablets with food and drink
You can take Topiramate with or without food. Drink plenty of fluids during the day to prevent kidney stones while taking topiramate.You should avoid drinking alcohol when taking topiramate.
Pregnancy and breast-feeding
Migraine prevention
Topiramate can harm an unborn baby. You must not use Topiramate if you are pregnant. You must not use Topiramate for migraine prevention if you are a woman of childbearing potential unless you are using effective contraception. Talk to your doctor about the best kind of contraception and whether Topiramate is suitable for you. Before the start of treatment with Topiramate a pregnancy test should be performed.
Treatment of epilepsy:
If you are a woman of childbearing potential you should talk to your doctor about other possible treatments instead of Topiramate. If the decision is made to use Topiramate, you should use effective contraception. Talk to your doctor about the best kind of contraception to use while you are taking Topiramate. Before the start of treatment with Topiramate a pregnancy test should be performed.
Talk to your doctor if you wish to become pregnant.
As with other anti-epileptic medicines, there is a risk of harm to the unborn child if topiramate is used during pregnancy. Make sure you are very clear about the risks and the benefits of using topiramate for epilepsy during pregnancy.
Breast-feeding
The active substance in Topiramate passes into human milk. Effects have been seen in breastfed babies of treated mothers, including diarrhea, feeling sleepy, feeling irritable, and poor weight gain. Therefore, your doctor will discuss with you whether you abstain from breast-feeding or whether to abstain from treatment with Topiramate. Your doctor will take into account the importance of the medicine to the mother and the risk for the baby.
Mothers who breastfeed while taking topiramate must tell the doctor as soon as possible if the baby experiences anything unusual.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Dizziness, tiredness, and vision problems may occur during treatment with topiramate. Do not drive or use any tools or machines without talking to your doctor first.
Topiramate tablets contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Topiramate tablets 50mg film-coated tablets contain sunset yellow which may cause allergic reactions.
The bottles of Topiramate tablets contain a canister of silica gel desiccant. The desiccant canister must not be swallowed.
Other ingredients
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. HOW TO TAKE TOPIRAMATE TABLETS
Always take Topiramate tablets exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
If you take more Topiramate tablets than you should
Overdose can happen if you are taking other medicines together with Topiramate tablets
If you forget to take Topiramate tablets
If you stop taking Topiramate tablets
Do not stop taking this medicine unless told to do so by your doctor. Your symptoms may return. If your doctor decides to stop this medication, your dose may be decreased gradually over a few days.
If you have any further questions on the use of this product ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Topiramate tablets can cause side effects, although not everybody gets them.
Tell your doctor, or seek medical attention immediately if you have the following side effects:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
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)
Other side effects include the following, if they get serious, please tell your doctor or pharmacist:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
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)
Children
The side effects in children are generally similar to those seen in adults But the following side effects may be more common in children than adults:
Other side effects that mayoccur in children are:
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
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 www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE TOPIRAMATE TABLETS
Keep this medicine out of the sight and reach of children.
Do not use Topiramate tablets after the expiry date which is stated on the blister/bottle and the outer carton. The expiry date refers to the last day of that month.
Plastic bottles
Blisters
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 to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Topiramate Tablets contain
What Topiramate Tablets look like and contents of the pack
Film-coated tablet
Topiramate Tablets 25mg film-coated tablets: round, white, film-coated tablets with ‘G’ engraved on one side and ‘25’ on the other.
Topiramate Tablets 50mg film-coated tablets : round, yellow, film-coated tablets with ‘G’ engraved on one side and ‘50’ on the other.
Topiramate Tablets 100mg film-coated tablets : round, yellow, film-coated tablets with ‘G’ engraved on one side and ‘100’ on the other.
Topiramate Tablets 200mg film-coated tablets : round, pink, film-coated tablets with ‘G’ engraved on one side and ‘200’ on the other.
Topiramate Tablets 25mg, 50mg, 100mg and 200mg film-coated tablets are available in plastic bottles with tamper-proof, flip-open caps containing 20, 28, 30, 50, 56, 60, 100 and 200* tablets and a dessicant cannister. The desiccant must not be swallowed.
Topiramate Tablets 25mg, 50mg, 100mg and 200mg film-coated tablets are also available in aluminium foil blisters of 4, 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 100, 120 and 200* tablets. *Not all packs sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Manufacturer:
This medicinal product is authorised in the Member States of the EEA under the following names:
DE Topiramat Glenmark 25 /50 /100 /200 mg Filmtabletten
CZ Topimark 25 /50 /100 mg
NL Topiramaat Glenmark 25 /50 /100 /200 mg Filmomhulde tabletten
PL Toramat
SK Topimark 25 /50 /100 mg
UK Topiramate 25 /50 /100 /200 mg Film-coated tablets
This leaflet was last revised in May 2021
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+44 (0)1923 202 950