• 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 side effects not listed in this leaflet. See section 4.

1. What Topiramate is and what it is used for
2. What you need to know before you take Topiramate
3. How to take Topiramate
4. Possible side effects
5. How to store Topiramate
6. Contents of the pack and other information

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

Migraine prevention

• you must not use Topiramate if you are pregnant.
• if you are a woman who is able to become pregnant, you must not take Topiramate, unless you use highly effective contraception (birth control) during your treatment. See below under “Pregnancy, breast-feeding and fertility – Important advice for women”.

Treatment of epilepsy

• you must not use Topiramate if you are pregnant, unless no other treatment gives sufficient seizure control for you.
• if you are a woman who is able to become pregnant, you must not take Topiramate unless you use highly effective contraception (birth control) during your treatment. Do not stop taking Topiramate or your contraception until you have discussed this with your doctor. Your doctor will advise you further and make sure you are aware of and understand all of the risks of taking Topiramate during pregnancy and the risks of seizures during pregnancy. See below under “Pregnancy, breast-feeding and fertility – Important advice for women”.

Make sure you read the patient guide that you will receive from your doctor.

A patient card is provided with the Topiramate package to remind you of the risks in pregnancy.

If you are not sure if the above applies to you, talk to your doctor or pharmacist before using Topiramate.

Talk to your doctor or pharmacist before taking Topiramate if you:

• have kidney problems, especially:
  • kidney stones
  • high levels of calcium in your urine
  • if a member of your family has or ever had kidney stones
  • or you are getting kidney dialysis
• have a history of blood and body fluid abnormality (metabolic acidosis) which may be associated with:
  • severe breathing problems
  • severe or prolonged diarrhoea
  • surgery
  • or a high fat, low carbohydrate (ketogenic) diet
• have liver problems
• have eye problems, especially glaucoma
• have a growth problem
• are a woman who is able to become pregnant. Topiramate can harm an unborn child when taken during pregnancy. Highly effective contraception (birth control) must be used during your treatment and for at least 4 weeks after the last Topiramate dose. See section ‘pregnancy and breastfeeding’ for further information.
• are pregnant. Topiramate can harm an unborn child when taken during pregnancy.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Topiramate.

If you have epilepsy, it is important that you do not stop taking your medicine without first consulting your doctor.

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 antiepileptic 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’):

• difficulty thinking, remembering information, or solving problems
• being less alert or aware
• feeling very sleepy with low energy

At higher doses of Topiramate, the risk of developing these symptoms may increase.

You may experience an increase in fits (seizures) or have a different type of seizure; if this happens, talk to your doctor.

If you develop any problems with your vision and/or your eyes, you should contact your doctor immediately.

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:

• other medicines that impair or decrease your thinking, concentration, or muscle coordination (e.g. central nervous system depressant medicines such as muscle relaxants and sedatives e.g. diazepam).
• hormonal contraceptives. Topiramate can affect how well some hormonal contraceptive (birth control) methods work. An additional barrier method of contraception such as a condom or pessary/diaphragm should be used. You should talk to your doctor about the best kind of contraception to use while you are taking Topiramate.

Tell your doctor if your menstrual bleeding changes while you are taking hormonal contraceptives and Topiramate. Irregular bleeding may occur. In this case, continue taking the hormonal contraceptives and inform your doctor.

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 antiepileptic medicines, risperidone, lithium, hydrochlorothiazide, haloperidol (used to treat mental health problems), metformin, pioglitazone, glibenclamide, (used to treat diabetes), amitriptyline, moclobemide, imipramine (used to treat depression), propranolol, diltiazem, digoxin, (used to treat heart conditions), flunarizine, (used to treat migraine), proguanil (used to prevent malaria), omeprazole (used to treat indigestion), venlafaxine (a medicine used to treat depression) and 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 Topiramate.

You can take Topiramate with or without food. You should avoid drinking alcohol when taking Topiramate.

Important advice for women who are able to become pregnant

Topiramate can harm an unborn child. If you are a woman who is able to become pregnant, talk to your doctor about other possible treatments. Visit your doctor to review your treatment and discuss the risks at least once a year.

Migraine prevention

• For migraine, you must not use Topiramate if you are pregnant.
• For migraine, you must not use Topiramate if you are a woman who is able to become pregnant unless you are using highly effective contraception (birth control).
• Before the start of treatment with Topiramate a pregnancy test should be performed in a woman who is able to become pregnant.

Treatment of epilepsy

• For epilepsy, you must not use Topiramate if you are pregnant, unless you and your doctor have agreed that no other treatment gives sufficient seizure control for you.
• For epilepsy, you must not use Topiramate if you are a woman who is able to become pregnant unless you are using highly effective contraception. Do not stop taking Topiramate or your contraception (birth control) until you have discussed this with your doctor. Your doctor will make sure you have received information about the risks of taking Topiramate during pregnancy and about the risks of seizures during pregnancy, which may put you or your unborn child at risk.
• Before the start of treatment with Topiramate a pregnancy test should be performed in a woman who is able to become pregnant.

The risks of topiramate when taken during pregnancy. The risks apply whether topiramate is taken for migraine prevention or treatment of epilepsy:

There is a risk of harm to the unborn child if Topiramate is used during pregnancy.

• If you take Topiramate during pregnancy, your child has a higher risk for birth defects. In women who take topiramate, around 4 - 9 children in every 100 will have birth defects. This compares to 1-3 children in every 100 born to women who do not have epilepsy and do not take an antiepileptic treatment. Particularly, cleft lip (split in the top lip) and cleft palate (split in the roof of the mouth) have been observed. Newborn boys may also have a malformation of the penis (hypospadia). These defects can develop early in pregnancy, even before you know you are pregnant.
• If you take Topiramate during pregnancy, your child may have a 2- to 3-fold higher risk for autism spectrum disorders, intellectual disabilities, or attention deficit hyperactivity disorder (ADHD) compared with children born to women with epilepsy not taking antiepileptic medication.
• If you take Topiramate during pregnancy, your child may be smaller and weigh less than expected at birth. In one study, around 18 in every 100 children of mothers taking topiramate during pregnancy were smaller and weighed less than expected at birth, while around 5 in every 100 children born to women without epilepsy and not taking antiepileptic medication were smaller and weighed less than expected at birth.
• Talk to your doctor if you have questions about this risk during pregnancy.
• There may be other medicines to treat your condition that have a lower risk of birth defects.

Need for contraception (birth control) in women who are able to become pregnant:

• If you are a woman who is able to become pregnant, talk to your doctor about other possible treatments instead of Topiramate. If the decision is made to use Topiramate, you must use highly effective contraception during your treatment and for at least 4 weeks after the last Topiramate dose.
• One highly effective contraception (such as an intrauterine device) or two complementary contraceptives such as birth control pill together with a barrier method of birth control (such as a condom or pessary/diaphragm) must be used. Talk to your doctor about what contraception is most appropriate for you.
• Topiramate can affect how well some hormonal contraceptive (birth control) methods work. If you are taking hormonal contraceptives an additional barrier contraceptive method (such as a condom or pessary/diaphragm) should be used.
• Tell your doctor if you experience irregular menstrual bleeding.

Use of Topiramate in girls:

If you are a parent or a caregiver of a girl treated with Topiramate, you must contact her doctor immediately once your child experiences her first period (menarche). The doctor will inform you about the risks to an unborn child due to topiramate exposure during pregnancy, and the need for using highly effective contraception.

If you wish to become pregnant while taking Topiramate:

• Schedule an appointment with your doctor.
• Do not stop using your contraception until you have discussed this with your doctor.
• If you take Topiramate for epilepsy, do not stop taking it until you have discussed this with your doctor. Suddenly stopping Topiramate can cause seizures to start again or happen more often or last longer than before. This may put you or your unborn child at risk.
• Your doctor will reassess your treatment as they may need to change or stop your medicine. The doctor will counsel you about the risks of Topiramate during pregnancy. He/she may also refer you to another specialist.

If you have become pregnant or think you may be pregnant while taking Topiramate:

• Schedule an urgent appointment with your doctor.
• If you are taking Topiramate to prevent migraine, stop taking the medicine straight away, and contact your doctor. Your doctor will assess your condition and discuss your options with you.
• If you are taking Topiramate for epilepsy, do not stop taking this medicine unless your doctor tells you to. Suddenly stopping Topiramate can cause seizures to start again or happen more often or last longer than before. This may put you or your unborn child at risk.
• If you are taking Topiramate for epilepsy, your doctor will assess your condition and discuss options with you. Your doctor will make sure you are aware of and understand all the risks of Topiramate during pregnancy. They may advise that you need to switch to another medicine to treat your epilepsy. If so, they will explain how to make the change to this new medicine.
  He/she may also refer you to another specialist.
• If Topiramate is used during pregnancy for epilepsy, you will be monitored closely to check how your unborn child is developing.

Make sure you read the patient guide that you will receive from your doctor.

A patient card is provided with the Topiramate package to remind you of topiramate risks in pregnancy.

Breast-feeding

The active substance in this medicine (topiramate) passes into breast milk. Effects have been seen in breastfed babies of treated mothers, including diarrhoea, 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 breast-feed while taking topiramate must tell the doctor as soon as possible if the baby experiences anything unusual.

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.

This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’.

[For 200 mg tablets only]

This medicinal product contains sunset yellow aluminium lake (E110) and allura red aluminium lake (E129), which may cause allergic reactions.

• See a doctor right away. Take the medicine pack with you.
• You may feel sleepy, tired or less alert; lack coordination; have difficulty speaking or concentrating; have double or blurred vision; feel dizzy due to low blood pressure; feel depressed or agitated; or have abdominal pain or seizures (fits).
• Overdose can happen if you are taking other medicines together with Topiramate.

• If you forget to take a dose, take it as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue as usual. If you miss two or more doses, contact your doctor.
• Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

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.

Very common (may affect more than 1 in 10 people):

• Weight loss
• Tingling, pain and/or numbness of various body parts
• Drowsiness, sleepiness or tiredness
• Dizziness
• Diarrhoea
• Feeling sick (nausea)
• Stuffy, runny nose and sore throat

Common (may affect up to 1 in 10 people):

• Weight gain
• Decrease or loss of appetite
• Feeling tired, breathless with pale skin- this may be caused by reduced number of red blood cells
• Difficulty falling or staying asleep
• Problems with speech or speech disorder, slurred speech
• Clumsiness, or lack of coordination, feeling of unsteadiness when walking
• Decreased ability to complete routine tasks
• Uncontrolled trembling or shaking in the arms, hands or legs
• Reduced sense of touch or sensation
• Uncontrollable movement of the eyes
• Distorted sense of taste
• Visual disturbance, such as blurred vision, double vision, difficulty focussing
• Sensation of spinning, ringing sound in the ears, ear pain
• Shortness of breath
• Nose bleeds
• Being sick (vomiting)
• Constipation
• Gastritis, stomach pain or discomfort
• Indigestion
• Dry mouth
• Tingling or numbness of the mouth
• Hair loss
• Joint pain or swelling
• Muscle spasms, muscle twitching, muscle weakness or muscle pain
• Chest pain (which is caused by the muscles and bones in the chest)
• Fever
• Loss of strength
• General feeling of feeling unwell
• Cough

Uncommon (may affect up to 1 in 100 people):

• Abnormal blood counts, including reduced platelet count (you may bruise or bleed more easily), or increased eosinophils
• Increase in liver enzymes
• Elevated mood
• Showing and feeling no emotion, unusual suspiciousness, panic attack
• Irregular heartbeat or slowness of the heart beat
• Swollen glands in the neck, armpit or groin
• Problems with verbal communication
• Drooling
• Restlessness or increased mental and physical activity
• Decreased wakefulness or alertness
• Unusual feeling or sensation that may precede a migraine or a certain type of seizure
• Loss of consciousness
• Fainting and feeling faint
• Excessive sleepiness
• Slow or diminished movements, uncontrolled repetitive twitching of muscles
• Disturbed or poor quality sleep (e.g. waking early in the morning)
• Impaired or distorted sense of smell
• Problems with handwriting or speech, such as stuttering or constantly repeating words
• Feeling of movement under the skin
• Eye problems including dry eyes, light sensitivity, involuntary twitching, tearing, enlarged pupil, seeing flashes of light, abnormal sensations in the eye
• Hoarseness of the voice
• Gas or wind
• Heartburn
• Loss of sensitivity to touch or altered sense of touch that may feel unpleasant, which can affect the mouth of face
• Bleeding gums
• Fullness or bloating
• Painful or burning sensations in the mouth
• Breath odour
• Loss of taste
• Leakage of urine and/or stools, blood in urine
• Urgent desire to urinate
• Skin discolouration
• Localised swelling in the skin
• Swelling of the face
• Swelling of the joints
• Musculoskeletal stiffness or muscle fatigue
• Low potassium levels in the blood
• Increased appetite
• Increased thirst and drinking abnormally large amounts of fluid
• Low blood pressure or decrease in blood pressure that occurs when you stand up, which may make you feel dizzy or faint
• Breathlessness, especially after exercise
• Hot flushing, feeling warm
• Flu like illness
• Cold extremities (e.g. hands and face)
• Feeling drunk
• Problems with learning
• Disturbances in sexual function (erectile dysfunction, loss of libido)
• Hallucinations
• Decreased verbal communication
• Feeling tearful or crying

Rare (may affect up to 1 in 1,000 people):

• Feeling hopeless
• Uncontrolled shaking which may affect the tongue, hands or head when performing tasks
• Decreased bodily movement, being unreactive
• Excessive skin sensitivity
• Impaired sense of smell
• Odour
• Swelling in the tissues around the eye, problems with vision in dim light, lazy eye
• Raynaud’s syndrome. A disorder affecting the blood vessels, in the fingers, toes, ears and causing pain and cold sensitivity
• Blood bicarbonate decreased which will show up in blood tests

Not Known (frequency cannot be estimated from the available data):

• Swelling of the clear covering of the eye surface (conjunctiva)
• Inflammation of the eye (uveitis) with symptoms such as eye redness, pain, sensitivity to light, runny eyes, seeing small dots or getting blurred vision.

The side effects in children are generally similar to those seen in adults. However, some side effects are either seen more frequently in children and/or can be more severe in children than in adults. Side effects which may be more severe include decreased or loss of sweating and increase of the acid level in the blood. Side effects which may occur more frequently in children include upper respiratory tract illnesses.

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is topiramate. Each film-coated tablet contains 25 mg, 50 mg, 100 mg or 200 mg topiramate per tablet.

The other ingredients are:

• Tablet core: microcrystalline cellulose, povidone K29-32, silica colloidal anhydrous, sodium starch glycolate (type A), magnesium stearate.
• Film-coat: titanium dioxide (E171), hypromellose (E464), macrogol 400, polysorbate 80 (E433) (25 mg only), iron oxide yellow (E172) (50 mg, 100 mg only), allura red (E129), sunset yellow (E110) and indigo carmine (E132) (200 mg only) (see section 2 “Topiramate 200 mg contains sunset yellow aluminium lake (E110) and allura red aluminium lake (E129)”).

Your medicine comes in the form of a film-coated tablet that should look like the following:

25 mg: White, round, film-coated tablet with sides that curve outwards, marked with “G” on one side and “TO” over “25” on the other.

50 mg: Yellow, round, film-coated tablet with sides that curve outwards, marked with “G” on one side and “TO” over “50” on the other.

100 mg: Yellow, round, film-coated tablet with sides that curve outwards, marked with “G” on one side and “TO” over “100” on the other.

200 mg: Red, round, film-coated tablet with sides that curve outwards, marked with “G” on one side and “TO” over “200” on the other.

The medicinal product is available in aluminium foil blisters in pack sizes of 10, 15, 20, 28, 30, 50, 60, 90, 100, 200 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturers: