Topiramate 25mg, 50mg, 100mg and 200mg film-coated Tablets
Read all of this leaflet carefully before you start taking this medicine.
- 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1. What topiramate is and what it is used for
- 2. Before you take topiramate
- 3. How to take topiramate
- 4. Possible side effects
- 5. How to store topiramate
- 6. Further information
What Topiramate Is And What It Is Used For
Topiramate is a medicine which affects chemicals in the brain that are involved in sending signals to the nerves.
Epilepsy:
Topiramate is used to treat some types of seizure:
- Partial seizures (seizures - affecting only part of the brain) and/or
- Generalised tonic-clonic seizures. These are sometimes called Grand Mal seizures and affect all of the brain. They have:
- A ‘tonic phase’ when the patient falls unconscious and their muscles suddenly tense up, and
- A ‘clonic phase’ when the patient’s muscles contract and relax rapidly, causing convulsions.
It is used on its own to treat epilepsy in adults and adolescents over 12 years of age. It is also used with other medicines to treat epilepsy in adults, adolescents and children of 6-12 years of age.
Migraine prevention:
Topiramate is also used to prevent frequently recurring migraine headaches in adults when earlier treatment with other medicines was not effective. It is not intended to treat an individual migraine attack.
Before You Take Topiramate
Do not take topiramate:
- If you are allergic (hypersensitive) to topiramate or any of the other ingredients of this medicine (see section 6).
- For the prevention of migraine if you are pregnant or of child bearing age and you are not using an effective method of contraception (see pregnancy and breast-feeding).
Take special care and check with your doctor before taking topiramate:
- If you or a family member have or have had kidney stones. Topiramate can increase the risk of kidney stones. Your doctor may ask you to drink more water.
- If you are having haemodialysis your dose may need to be adjusted.
- If you have problems with your kidneys or liver. Your doctor may want to prescribe a lower dose.
- A small number of people being treated with anti-epileptics such as topiramate have had thoughts of harming or killing themselves. If at any point you have these thoughts, immediately contact your doctor.
- If you have a severe respiratory condition (such as asthma or chronic obstructive pulmonary disease (COPD).
- If you have status epilepticus (when the brain is in persistent seizure).
- If you have diarrhoea.
- If you have recently had an operation.
- If you have a fatty and protein rich (ketogenic) diet.
- If you have ever had porphyria.
- Topiramate can cause you to sweat less than normal, especially in children. This can cause your body temperature to rise during exercise and exposure to warm environments. Therefore, it is important to drink plenty of water during treatment, especially if you are taking exercise or if the weather is hot. This will reduce the risk of heat-related side effects, like headache and nausea (feeling sick).
- You may experience significant and continuing weight loss while taking topiramate. Therefore, your doctor should monitor your weight regularly. If he/she considers that you are losing too much weight you should eat more food. If a child taking topiramate tablets does not gain enough weight the amount of food being eaten should be increased.
Eye Problems
- Contact your doctor straight away if you suddenly get blurred vision, painful or red eyes. This could be a sign of raised pressure within the eye (glaucoma). It can happen to adults and children, usually during the first month of treatment.
- If you develop any other problems with your eyes, you should tell your doctor straight away. Your doctor may:
- Ask you to see an eye specialist
- Advise you how to stop using topiramate. You may need to see your epilepsy specialist to make sure that your epilepsy is kept under control.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is because topiramate and other medicines can affect the way each other works.
In particular tell your doctor if you are taking the following medicines:
- Other antiepileptic medicines such as phenytoin or carbamazepine.
- Digoxin for heart failure.
- Hydrochlorothiazide or triamterene (water tablets).
- Medicines for diabetes such as metformin, pioglitazone or glibenclamide.
- Medicines for depression, such as amitriptyline, imipramine, moclobemide
- Diazepam (a sedative)
- Proguanil (to treat malaria)
- Omeprazole (for ulcers and other conditions caused by too much stomach acid)
- Acetazolamide (for a number of conditions including glaucoma, fluid retention and epilepsy)
- High doses of vitamin C
- Haloperidol (for mental illness)
- Propranolol (for high blood pressure)
- Any medicines that make you sleepy or less alert (including tranquillisers, anti-depressants and sleeping pills).
- Oral contraceptives. Your contraception may not be as effective. You should consult your doctor, if your menstrual bleeding patterns change (e.g. if you experience breakthrough bleeding, spotting or if you miss a period).
If any of the above apply to you, or you are not sure, talk to your doctor or pharmacist.
Taking topiramate with food and drink
- You can take the tablets with or without food.
- It is important to drink plenty of water when taking topiramate, especially if you exercise or when it is hot.
- You should be careful how much alcohol you drink while taking topiramate. The combined effect might make you feel less alert than usual.
Pregnancy and breast-feeding
- Tell your doctor if you are pregnant, think you might be pregnant or if you intend to become pregnant. Your doctor will discuss with you if you should continue to take topiramate.
- Topiramate may cause an increased risk of birth defects in your developing baby
- Tell your doctor if you are breast-feeding. Your doctor may ask you to stop breast-feeding as topiramate may reach your baby through your milk.
- You must not take topiramate to prevent migraine attacks if you are pregnant.
- You must not take topiramate if you are a woman of child bearing age and you are not using effective contraception.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Topiramate may make you feel sleepy, dizzy or affect your judgment. You may also have problems with your vision. If any of these things happen to you, do not drive or use any tools or machines.
Important information about some of the ingredients of topiramate
This medicine contains lactose. Contact your doctor before taking this medicine if you have an intolerance to some sugars.
How To Take Topiramate
Always take topiramate exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Usually the daily dose is taken as two separate single doses. Do not break or chew the tablets. Swallow the tablets whole with plenty of water. You can take the tablets with or without food.
Epilepsy
Your doctor will start treating you with a low dose. He will slowly increase the dose to the lowest amount needed to control your epilepsy.
If you are taking only topiramate to treat your epilepsy
Adults and adolescents of more than 12 years of age:
- The usual starting dose is 25mg topiramate as a single evening dose for one week.
This dose may be increased by your doctor at weekly or fortnightly intervals by either 25mg or 50mg until your seizures are controlled. - The usual maintenance dose is 100mg per day (50mg in the morning and 50mg in the evening) but your doctor may tell you to use a higher or lower dose.
- The maximum daily recommended dose is 400mg.
If you are taking topiramate plus other medicines that treat your epilepsy
Adults and adolescents of more than 12 years of age:
- The usual starting dose is 25mg to 50mg topiramate as a single evening dose for one week. This dose may be increased by your doctor at weekly or fortnightly intervals by either 25mg or 50mg until you seizures are controlled.
- The usual dose is 200mg to 400mg topiramate per day, given in two doses, but your doctor may tell you to use a higher or lower dose.
Children aged 6 to 12 years:
- Your doctor will work out the dose needed. This will depend on the weight of your child. The dose may be increased slowly at weekly or fortnightly intervals until your child’s seizures are controlled.
Prevention of frequently recurring migraine headaches
It is important that you follow your doctor’s instructions carefully to help reduce the chance of getting a migraine headache.
Do not use topiramate in children and adolescents to prevent migraine headaches
Adults:
- The usual starting dose is 25mg topiramate as a single evening dose for one week.
This dose may be increased by your doctor at weekly intervals by 25mg. - The usual maintenance dose is 100mg per day in two divided doses of 50mg in the morning and 50mg at night.
However, your doctor will tell you to use a higher or lower dose, if appropriate.
People with liver or kidney problems.
- If you have liver or kidney disease your doctor may tell you to take a lower dose of topiramate than those described above.
- If you have to undergo haemodialysis, your doctor may tell you to follow a different dosing schedule than those described above.
If you are not sure how many tablets to take or when to take them ask your doctor.
If you forget to take topiramate
If you forget to take a dose at the right time, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not take two doses at or near the same time
If you stop taking topiramate
Do not suddenly stop taking this medicine without first checking with your doctor. If you are to stop taking this medicine, your doctor will reduce the dose of topiramate you are taking gradually, usually over several weeks. This will reduce the chance that you will have epileptic seizures or rebound migraine headaches.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible Side Effects
Like all medicines, topiramate can cause side effects, although not everybody gets them.
Side effects are more likely to happen when you start taking topiramate or when your dose is increased. Side effects are often mild and gradually disappear as your body becomes used to the medicine.
Stop taking topiramate and see a doctor or go to hospital straightaway if you notice any of the following serious side effects. You may need urgent medical attention.
- Swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice itching of the skin or a nettle rash. This may mean you are having an allergic reaction
- Blistering or peeling of the skin around the lips, eyes, mouth, nose and genitals. You may also have flu-like symptoms and fever. These could be signs of a serious illness called Stevens-Johnson syndrome
- Fits or convulsions (seizures)
Tell your doctor straightaway if you notice any of the following serious side effects
- Thoughts of harming or killing yourself
- Yellowing of your skin or eyes or changes in the way your liver is working shown by a blood test. These may be signs of liver problems or liver failure.
- Any eye problems, including, double vision, blurred vision, short-sightedness or eye pain. These may be signs of raised pressure within the eye (angle closure glaucoma).
If any of the above applies to you, or you are not sure, tell your doctor straightaway
If any of the following side effects gets serious, or lasts longer than a few days, tell your doctor or pharmacist:-
Very common (affects more than 1 in 10 people)
- Feeling dizzy, tired or sleepy
- Numbness or tingling of your skin (paraesthesia)
- Feeling sick (nausea), diarrhoea, stomach pain or indigestion
- Weight loss, loss of appetite, dry mouth or changes in the way things taste
- Headaches
- Difficulty concentrating, slow thinking, feeling confused or forgetful
- Feeling anxious or nervous, having mood swings or depression
- Language and speech problems
- Co-ordination problems
Common (affects less than 1 in 10 people)
- Feeling weak
- Pain in your bones
- Difficulty sleeping
- Difficulty breathing, slow heart rate, nausea and feeling confused. This could be due to too much acid in your blood (metabolic acidosis)
- Feeling tired, faint, dizzy or having pale skin. These could be symptoms of anaemia.
- Getting infections more often than usual or bruising more easily than usual. These could be signs of a blood problem such as leucopenia, neutropenia or thrombocytopenia
- Lack of feeling or emotion (apathy) or feeling unusually happy (euphoria)
- Finding it harder than usual to control your emotions
- Feeling restless or more aggressive than usual
- Reduced sex drive
- Constipation, stomach pains
- Loss of hair (alopecia)
- Lack of control over passing water (urinary incontinence)
- Heavy nose bleeds
- Rash of dark red spots under the skin
- Blood in your urine or pain in the lower back or genital area. These may be signs that you have kidney stones.
- Shaking (tremor), changes in the way you walk, unusual eye movements
- Being unable to get or maintain an erection (impotence)
- Period problems
Uncommon side effects (affects less then 1 in 100 people)
- Seeing or hearing things which are not there (hallucinations)
- Changes in your behaviour or thinking such as feeling that you can’t trust anyone, avoiding situations where you need to mix with other people, having outbursts of anger, compulsive behaviour
- Breathing problems such as shortness of breath or difficulty breathing
- Diarrhoea, being sick (vomiting), dry mouth
- Red, sore or inflamed skin around hair roots, This could be due to an infection called folliculitis
- Itchy skin
- Unusually reduced or slow body movements (hypokinesia)
- Feeling dazed, less alert or aware of your surroundings than usual (stupor)
Rare (affects less than 1 in 1,000 people)
- Sweating less than usual, particular during exercise or hot weather. This is more likely to happen in children
Children of 6 years of age or older:
In clinical studies with children of 6 years of age or older, the following additional effects were observed: abnormally increased muscular movements (hyperkinesias), abnormal behaviour, increased salivation.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How To Store Topiramate
Keep out of the reach and sight of children.
Do not use topiramate after the expiry date which is stated on the blister and the carton. The expiry date refers to the last day of that month.
Do not store above 25ºC.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further Information
What topiramate contains:
Each film-coated tablet contains 25mg, 50mg, 100mg or 200mg of the active substance topiramate.
The other ingredients are: lactose monohydrate, microcrystalline cellulose, pregelatinised starch, croscarmellose sodium, magnesium stearate.
- The 25mg tablets are coated with hypromellose, titanium dioxide (E171) and macrogol 6000.
- The 50mg and 100mg tablets are coated with hypromellose, titanium dioxide (E171), macrogol 8000 and iron oxide yellow (E172).
- The 200mg tablets are coated with hypromellose, titanium dioxide (E171), macrogol 8000 and iron oxide red (E172).
What Topiramate film-coated Tablets look like and contents of the pack
25mg tablets are white circular and biconvex, with bevelled edges and marked TP on one side and 25 on the other.
50mg tablets are light yellow circular and biconvex with bevelled edges and marked TP on one side and 50 on the other.
100mg tablets are dark yellow circular and biconvex, with bevelled edges and marked TP on one side and 100 on the other.
200mg tablets are red, circular and biconvex, with bevelled edges and marked TP on one side and 200 on the other.
Topiramate film-coated Tablets are available in blisters packs of 60 tablets.
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Manufacturer:
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This leaflet was last revised in August 2009
‘Winthrop’ is a registered trademark © 2009, Winthrop Pharmaceuticals.
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