ZONISAMIDE MYLAN 25 MG HARD CAPSULES, ZONISAMIDE SUERTE 25 MG HARD CAPSULES - patient leaflet, side effects, dosage

Zonisamide Mylan 25mg hard capsules

Your medicine is known by the above names, but will be referred to as Zonisamide Mylan throughout this leaflet.

Patient Information Leaflet

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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

• 1) What Zonisamide Mylan is and what it is used for

• 2) What you need to know before you take Zonisamide Mylan

• 3) How to take Zonisamide Mylan

• 4) Possible side effects

• 5) How to store Zonisamide Mylan

• 6) Contents of the pack and other information

1) what zonisamide mylan is and what it is used for

Zonisamide Mylan contains the active substance zonisamide, and is used as an antiepileptic medicine.

Zonisamide Mylan is used to treat seizures that affect one part of the brain (partial seizure), which may or may not be followed by a seizure affecting all of the brain (secondary generalisation).

Zonisamide Mylan may be used:

• on its own to treat seizures in adults
• with other antiepileptic medicines to treat seizures in adults, adolescents, and children aged 6 years and above.

2) what you need to know before you take zonisamide mylan

Do not take Zonisamide Mylan

• if you are allergic to zonisamide or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to other sulfonamide medicines. Examples include: sulfonamide antibiotics, thiazide diuretics, and sulfonylurea antidiabetes medicines.

Warnings and precautions

Zonisamide Mylan belongs to a group of medicines (sulfonamides) which can cause severe allergic reactions, severe skin rashes, and blood disorders, which very rarely can be fatal (see section 4. Possible Side Effects).

A small number of people being treated with antiepileptics such as zonisamide have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.

Serious rashes occur in association with zonisamide therapy, including cases of Stevens-Johnson syndrome.

The use of Zonisamide Mylan may lead to high levels of ammonia in the blood which could lead to a change in brain function, especially if you are also taking other medicines which can increase ammonia levels (for example valproate), have a genetic disorder causing build-up of too much ammonia in the body (urea cycle disorder), or if you have liver problems. Tell your doctor immediately if you become unusually drowsy or confused.

Talk to your doctor or pharmacist before taking Zonisamide Mylan if you:

• are younger than 12 years old, as you may be at greater risk of decreased sweating, heat stroke, pneumonia and liver problems. If you are younger than 6 years old, Zonisamide Mylan is not recommended for you
• are elderly, as your dose of Zonisamide Mylan may need adjusting, and you may be more likely to develop an allergic reaction, severe skin rash, swelling of the feet and legs, and itchiness when taking Zonisamide Mylan (see section 4 Possible Side Effects)
• suffer from liver problems, as your dose of Zonisamide Mylan may need adjusting
• have eye problems such as glaucoma
• suffer from kidney problems as your dose of Zonisamide Mylan may need adjusting
• have previously suffered from kidney stones, as you may be at increased risk of developing more kidney stones. Reduce the risk of kidney stones by drinking sufficient water
• live in a place or are on holiday in a place where the weather is warm. Zonisamide Mylan can make you perspire less, which can cause your body temperature to increase. Reduce the risk of overheating by drinking sufficient water and keeping cool
• are underweight, or have lost a lot of weight as Zonisamide Mylan can cause you to lose more weight. Tell your doctor as this may need to be monitored.
• are pregnant or could become pregnant (see section ‘pregnancy, breast-feeding and fertility’ for further information).

If any of these applies to you, tell your doctor before you take Zonisamide Mylan.

Children and adolescents

Talk to your doctor about the following risks:

Preventing overheating and dehydration in children

Zonisamide Mylan can cause your child to sweat less and overheat and if your child is not treated this can lead to brain damage and death. Children are most at risk especially in hot weather.

When your child is taking Zonisamide Mylan:

• keep your child cool especially in hot weather
• your child must avoid heavy exercise especially when the weather is hot
• give your child plenty of cold water to drink
• your child must not take these medicines:

carbonic anhydrase inhibitors (like topiramate and acetazolamide), and anticholinergic agents (like clomipramine, hydroxyzine, diphenhydramine, haloperidol, imipramine and oxybutynin).

If your child’s skin feels very hot with little or no sweating, becomes confused, has muscle cramps, or your child’s heartbeat or breathing becomes rapid:

• take your child to a cool, shaded place
• sponge your child’s skin with cool (not cold) water
• give your child cold water to drink
• seek urgent medical assistance.
• Body weight: You should monitor your child’s weight every month and see your doctor as soon as possible if your child is not gaining enough weight. Zonisamide Mylan is not recommended for children who are underweight or have a small appetite, and should be used with caution in those below 20 kg.
• Increased acid level in the blood and kidney stones: Reduce these risks by ensuring that your child drinks enough water and is not taking any other medicine which could cause kidney stones (see Other medicines). Your doctor will monitor your child’s blood bicarbonate levels and kidneys (see also section 4).

Do not give this medicine to children below the age of 6 years because it is not known for this age group whether the potential benefits are greater than the risks.

Other medicines and Zonisamide Mylan

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

• Zonisamide Mylan should be used carefully in adults when taken with medicines that can cause kidney stones, like topiramate or acetazolamide. In children, this combination is not recommended.
• Zonisamide Mylan could possibly increase your blood levels of medicines like digoxin and quinidine, and so a reduction in their dose may be required.
• Other medicines like phenytoin, carbamazepine, phenobarbitone and rifampicin can decrease your blood levels of Zonisamide Mylan, which may require an adjustment of your dose of Zonisamide Mylan.

Zonisamide Mylan with food and drink

Zonisamide Mylan can be taken with or without food.

Pregnancy, breast-feeding and fertility

• If you are pregnant, or think you may be pregnant, you must tell your doctor straight away and discuss possible risks the epilepsy medicine you are taking might pose to your unborn baby.
• If you are planning to become pregnant you should discuss your epilepsy treatment with your doctor as early as possible before you become pregnant.
• You should not stop your treatment without discussing this with your doctor. Suddenly stopping may lead to breakthrough seizures which may harm you and your unborn baby. It is important that your epilepsy remains well controlled.

Pregnancy

You must only take Zonisamide Mylan during your pregnancy if your doctor tells you to. If you are a woman of childbearing age you must use adequate contraception while taking Zonisamide Mylan and for one month after stopping Zonisamide Mylan. Studies have shown an increased risk of physical birth abnormalities in children of women taking epilepsy medicines during pregnancy. The risk of physical birth abnormalities may increase when more than one epilepsy medicine is used at the same time. Where possible, your doctor should consider using one epilepsy medicine to control your epilepsy. More research is needed to better understand whether taking Zonisamide Mylan during pregnancy increases the risk of having a baby born with a physical abnormality or a learning or thinking disability.

Studies have shown that babies born to mothers using Zonisamide Mylan during pregnancy were smaller than expected for their age at birth, compared with babies born to mothers treated with lamotrigine monotherapy.

Do not breast-feed whilst taking, or for one month after stopping Zonisamide Mylan.

There are no clinical data available on the effects of zonisamide on human fertility. Studies in animals have shown changes in fertility parameters.

Driving and using machines

Zonisamide Mylan may affect your concentration, ability to react/respond, and may make you feel sleepy, particularly at the beginning of your treatment or after your dose is increased. Be especially careful while driving or operating machinery if Zonisamide Mylan affects you in this way.

Zonisamide Mylan contains sodium

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

3) how to take zonisamide mylan

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended adult dose

When you take Zonisamide Mylan on its own:

• The starting dose is 100mg taken once a day.
• This may be increased by up to 100mg at intervals of two weeks.
• The recommended dose is 300mg once a day.
• The starting dose is 50mg daily taken in two equal doses of 25mg.
• This may be increased by up to 100mg at intervals of one to two weeks. The recommended daily dose is between 300mg and 500mg.
• Some people respond to lower doses. The dose may be increased more slowly if you experience side effects, are elderly or if you suffer from kidney or liver problems.
• The starting dose is 1mg per kg of body weight taken once a day.
• This may be increased by 1mg per kg of body weight at intervals of one to two weeks.
• The recommended daily dose is 6 to 8mg per kg for a child with a body weight of up to 55 kg or 300 to 500mg for a child with a body weight more than 55 kg (which ever dose is lower) taken once a day.

Example: A child who weighs 25 kg should take 25mg once a day for the first week, and then increase the daily dose by 25mg at the start of each week until a daily dose between 150 to 200mg is reached.

If you feel that the effect of Zonisamide Mylan is too strong or too weak, talk to your doctor or pharmacist.

• Zonisamide Mylan capsules must be swallowed whole with water.
• Do not chew the capsules.
• Zonisamide Mylan can be taken once or twice daily, as instructed by your doctor.
• If you take Zonisamide Mylan twice a day, take half the daily dose in the morning and half in the evening.

If you take more Zonisamide Mylan than you should

If you may have taken more Zonisamide Mylan than you should, tell a carer (relative or friend), your doctor or pharmacist immediately, or contact your nearest hospital casualty department, taking your medicine with you. You may become sleepy and could lose consciousness. You might also feel sick, have a sore stomach, muscle twitches, eye movement, feel faint, have a slowed heartbeat, and reduced breathing and kidney function. Do not try to drive.

If you forget to take Zonisamide Mylan

• If you forget to take a dose, don’t worry: take the next dose when it is due.
• Do not take a double dose to make up for a forgotten dose.
• Zonisamide Mylan is meant to be taken as a long-term medicine. Do not reduce your dose or stop your medicine unless your doctor tells you to.
• If your doctor advises you to stop taking Zonisamide Mylan your dose will be reduced gradually to lower the risk of more 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.

Zonisamide Mylan belongs to a group of medicines (sulfonamides) that can cause severe allergic reactions, severe skin rashes, and blood disorders, which very rarely can be fatal.

Contact your doctor immediately if you:

• have difficulty breathing, a swollen face, lips or tongue, or a severe skin rash as these symptoms may indicate that you are having a severe allergic reaction
• have signs of overheating – high body temperature but little or no sweating, rapid heartbeat and breathing, muscle cramps, and confusion
• have thoughts of harming or killing yourself. A small number of people being treated with anti- epileptics such as Zonisamide Mylan have had thoughts of harming or killing themselves
• have pain in your muscles or a feeling of weakness, as this may be a sign of abnormal muscle breakdown which can lead to kidney problems
• get a sudden pain in your back or stomach, have pain on urinating (passing water) or notice blood in your urine, as this may be a sign of kidney stones
• develop visual problems such as eye pain or blurred vision while taken zonisamide.
• have an unexplained skin rash, as this could develop into a more severe skin rash or skin peeling
• feel unusually tired or feverish, have a sore throat, swollen glands, or find that you bruise more easily, as this may mean you have a blood disorder
• have signs of increased acid level in the blood- headaches, drowsiness, shortness of breath and loss of appetite. Your doctor may need to monitor or treat this.

Your doctor may decide that you should stop using Zonisamide Mylan.

The most common side effects of Zonisamide Mylan are mild. They occur during the first month of treatment and usually decrease with continued treatment. In children ages 6 – 17 years old, side effects were consistent with those described below with the following exceptions: pneumonia, dehydration, sweating decreased (common), abnormal liver enzymes (uncommon), middle ear infection, sore throat, sinus and chest infections, cough, nosebleeds, runny nose, stomach pain, vomiting, rash, eczema and fever.

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

• agitation, irritability, confusion, depression
• poor muscle coordination, dizziness, poor memory, sleepiness, double vision
• loss of appetite, decreased blood levels of bicarbonate (a substance that prevents your blood from becoming acidic).
• difficulty sleeping, strange or unusual thoughts, feeling anxious or emotional
• slowed thoughts, loss of concentration, speech abnormalities, abnormal skin sensation (pins and needles), tremor, involuntary movement of the eyes
• kidney stones
• skin rashes, itching, allergic reactions, fever, tiredness, flu-like symptoms, hair loss
• ecchymosis (a small bruise caused by blood leaking from broken blood vessels in the skin)
• loss of weight, nausea, indigestion, stomach pains, diarrhoea (loose stools), constipation
• swelling of the feet and legs
• vomiting
• mood swings
• increased blood levels of creatinine (a waste product that your kidneys should normally remove)
• increased levels of liver enzymes in the blood.
• anger, aggression, thoughts of suicide, suicide attempt
• gall bladder inflammation, gallstones
• urinary stones
• lung infection / inflammation, urinary tract infections
• low blood potassium levels, convulsions/se­izures
• breathing disorders
• hallucinations
• abnormal urine tests.
• memory loss, coma, neuroleptic malignant syndrome (inability to move, sweating, fever, incontinence), status epilepticus (prolonged or repeated seizures)
• shortness of breath, inflammation of the lungs
• inflammations of the pancreas (severe pain in the stomach or back)
• liver problems, kidney failure
• severe rashes or skin peeling (at the same time you may feel unwell or develop a fever)
• abnormal muscle breakdown (you may feel pain or weakness in your muscles) which can lead to kidney problems
• swollen glands, blood disorders (reduction in the number of blood cells, which can make infection more likely and can make you look pale, feel tired and feverish, and bruise more easily)
• decreased sweating, overheating
• problems with your urine
• increased blood levels of creatine phosphokinase or urea which can be seen in a blood test
• abnormal results from liver function tests
• glaucoma, which is a blockage of fluid in the eye causing increased pressure in the eye. Eye pain, blurred vision or decreased vision may occur and can be signs of glaucoma.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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 zonisamide mylan

• Keep out of the sight and reach of children.
• Do not take this medicine after the expiry date printed on the carton or blister label. The expiry date refers to the last day of the month.
• This medicine does not require any special storage conditions.
• If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
• 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.

6) contents of the pack and other information

What Zonisamide Mylan contains:

Zonisamide Mylan 25mg hard capsules:

The active substance is zonisamide. Each capsule contains 25mg of zonisamide.

The other ingredients are:

• – capsule contents: microcrystalline cellulose, hydrogenated vegetable oil and sodium laurilsulfate

• – capsule shell: gelatin and titanium dioxide (E171)

• – printing ink: shellac, black iron oxide (E172) and potassium hydroxide

Zonisamide Mylan 50mg hard capsules:

The active substance is zonisamide. Each capsule contains 50mg of zonisamide.

The other ingredients are:

• – capsule contents: microcrystalline cellulose, hydrogenated vegetable oil and sodium laurilsulfate

• – capsule shell: gelatin and titanium dioxide (E171)

• – printing ink: shellac and iron oxide red (E172)

Zonisamide Mylan 100mg hard capsules:

The active substance is zonisamide. Each capsule contains 100mg of zonisamide.

The other ingredients are:

• – capsule contents: microcrystalline cellulose, hydrogenated vegetable oil and sodium laurilsulfate

• – capsule shell: gelatin and titanium dioxide (E171)

• – printing ink: shellac, black iron oxide (E172) and potassium hydroxide

What Zonisamide Mylan looks like and contents of the pack

• Zonisamide Mylan 25mg hard capsules have a white body and a white cap, marked ‘Z 25’ in black and contain a white/almost white powder.
• Zonisamide Mylan 50mg hard capsules have a white body and white cap, marked ‘Z 50’ in red and contain a white/almost white powder.
• Zonisamide Mylan 100mg hard capsules have a white body and white cap, marked ‘Z 100’ in black and contain a white/almost white powder.

Zonisamide Mylan 25mg capsules are available in blister packs containing 14 capsules.

Zonisamide Mylan 50mg capsules are available in blister packs containing 28 and 56 capsules.

Zonisamide Mylan 100mg capsules are available in blister packs containing 56 capsules.

PLGB 46420/0484 Zonisamide Mylan 25mg hard capsules

PLGB 46420/0485 Zonisamide Mylan 50mg hard capsules ____

PLGB 46420/0486 Zonisamide Mylan 100mg hard capsules |POM|

Who makes and repackages your medicine?

Your medicine is manufactured by EJ. Uriach y Compania S.A., Av. Cami Reial, 51–57, 08184 Palau-Solita i Plegamans – Barcelona, Spain. Procured from within the EU and repackaged by the Product Licence holder: Suerte Pharma Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.

Leaflet date: 05.01.2022

Blind or partially sighted?

Is this leaflet hard to see or read?

Call 020 8839 3000 to obtain the leaflet in a format suitable for you.

Zonisamide Suerte 25mg hard capsules

Your medicine is known by the above names, but will be referred to as Zonisamide Suerte throughout this leaflet.

Patient Information Leaflet

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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

What is in this leaflet:

• 1) What Zonisamide Suerte is and what it is used for

• 2) What you need to know before you take Zonisamide Suerte

• 3) How to take Zonisamide Suerte

• 4) Possible side effects

• 5) How to store Zonisamide Suerte

• 6) Contents of the pack and other information

1) what zonisamide suerte is and what it is used for

Zonisamide Suerte contains the active substance zonisamide, and is used as an antiepileptic medicine.

Zonisamide Suerte is used to treat seizures that affect one part of the brain (partial seizure), which may or may not be followed by a seizure affecting all of the brain (secondary generalisation).

Zonisamide Suerte may be used:

• on its own to treat seizures in adults
• with other antiepileptic medicines to treat seizures in adults, adolescents, and children aged 6 years and above.

2) what you need to know before you take zonisamide suerte

Do not take Zonisamide Suerte

• if you are allergic to zonisamide or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to other sulfonamide medicines. Examples include: sulfonamide antibiotics, thiazide diuretics, and sulfonylurea antidiabetes medicines.

Warnings and precautions

Zonisamide Suerte belongs to a group of medicines (sulfonamides) which can cause severe allergic reactions, severe skin rashes, and blood disorders, which very rarely can be fatal (see section 4. Possible Side Effects).

A small number of people being treated with antiepileptics such as zonisamide have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.

Serious rashes occur in association with zonisamide therapy, including cases of Stevens-Johnson syndrome.

The use of Zonisamide Mylan may lead to high levels of ammonia in the blood which could lead to a change in brain function, especially if you are also taking other medicines which can increase ammonia levels (for example valproate), have a genetic disorder causing build-up of too much ammonia in the body (urea cycle disorder), or if you have liver problems. Tell your doctor immediately if you become unusually drowsy or confused.

Talk to your doctor or pharmacist before taking Zonisamide Suerte if you:

• are younger than 12 years old, as you may be at greater risk of decreased sweating, heat stroke, pneumonia and liver problems. If you are younger than 6 years old, Zonisamide Suerte is not recommended for you
• are elderly, as your dose of Zonisamide Suerte may need adjusting, and you may be more likely to develop an allergic reaction, severe skin rash, swelling of the feet and legs, and itchiness when taking Zonisamide Suerte (see section 4 Possible Side Effects)
• suffer from liver problems, as your dose of Zonisamide Suerte may need adjusting
• have eye problems such as glaucoma
• suffer from kidney problems as your dose of Zonisamide Suerte may need adjusting
• have previously suffered from kidney stones, as you may be at increased risk of developing more kidney stones. Reduce the risk of kidney stones by drinking sufficient water
• live in a place or are on holiday in a place where the weather is warm. Zonisamide Suerte can make you perspire less, which can cause your body temperature to increase. Reduce the risk of overheating by drinking sufficient water and keeping cool
• are underweight, or have lost a lot of weight as Zonisamide Suerte can cause you to lose more weight. Tell your doctor as this may need to be monitored.
• are pregnant or could become pregnant (see section ‘pregnancy, breast-feeding and fertility’ for further information).

If any of these applies to you, tell your doctor before you take Zonisamide Suerte.

Children and adolescents

Talk to your doctor about the following risks:

Preventing overheating and dehydration in children

Zonisamide Suerte can cause your child to sweat less and overheat and if your child is not treated this can lead to brain damage and death. Children are most at risk especially in hot weather.

When your child is taking Zonisamide Suerte:

• keep your child cool especially in hot weather
• your child must avoid heavy exercise especially when the weather is hot
• give your child plenty of cold water to drink
• your child must not take these medicines:

carbonic anhydrase inhibitors (like topiramate and acetazolamide), and anticholinergic agents (like clomipramine, hydroxyzine, diphenhydramine, haloperidol, imipramine and oxybutynin).

If your child’s skin feels very hot with little or no sweating, becomes confused, has muscle cramps, or your child’s heartbeat or breathing becomes rapid:

• take your child to a cool, shaded place
• sponge your child’s skin with cool (not cold) water
• give your child cold water to drink
• seek urgent medical assistance.
• Body weight: You should monitor your child’s weight every month and see your doctor as soon as possible if your child is not gaining enough weight. Zonisamide Suerte is not recommended for children who are underweight or have a small appetite, and should be used with caution in those below 20 kg.
• Increased acid level in the blood and kidney stones: Reduce these risks by ensuring that your child drinks enough water and is not taking any other medicine which could cause kidney stones (see Other medicines). Your doctor will monitor your child’s blood bicarbonate levels and kidneys (see also section 4).

Do not give this medicine to children below the age of 6 years because it is not known for this age group whether the potential benefits are greater than the risks.

Other medicines and Zonisamide Suerte

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

• Zonisamide Suerte should be used carefully in adults when taken with medicines that can cause kidney stones, like topiramate or acetazolamide. In children, this combination is not recommended.
• Zonisamide Suerte could possibly increase your blood levels of medicines like digoxin and quinidine, and so a reduction in their dose may be required.
• Other medicines like phenytoin, carbamazepine, phenobarbitone and rifampicin can decrease your blood levels of Zonisamide Suerte, which may require an adjustment of your dose of Zonisamide Suerte.

Zonisamide Suerte with food and drink

Zonisamide Suerte can be taken with or without food.

Pregnancy, breast-feeding and fertility

• If you are pregnant, or think you may be pregnant, you must tell your doctor straight away and discuss possible risks the epilepsy medicine you are taking might pose to your unborn baby.
• If you are planning to become pregnant you should discuss your epilepsy treatment with your doctor as early as possible before you become pregnant.
• You should not stop your treatment without discussing this with your doctor. Suddenly stopping may lead to breakthrough seizures which may harm you and your unborn baby. It is important that your epilepsy remains well controlled.

Pregnancy

You must only take Zonisamide Suerte during your pregnancy if your doctor tells you to. If you are a woman of childbearing age you must use adequate contraception while taking Zonisamide Suerte and for one month after stopping Zonisamide Suerte. Studies have shown an increased risk of physical birth abnormalities in children of women taking epilepsy medicines during pregnancy. The risk of physical birth abnormalities may increase when more than one epilepsy medicine is used at the same time. Where possible, your doctor should consider using one epilepsy medicine to control your epilepsy. More research is needed to better understand whether taking Zonisamide Suerte during pregnancy increases the risk of having a baby born with a physical abnormality or a learning or thinking disability.

Studies have shown that babies born to mothers using Zonisamide Suerte during pregnancy were smaller than expected for their age at birth, compared with babies born to mothers treated with lamotrigine monotherapy.

Do not breast-feed whilst taking, or for one month after stopping Zonisamide Suerte.

There are no clinical data available on the effects of zonisamide on human fertility. Studies in animals have shown changes in fertility parameters.

Driving and using machines

Zonisamide Suerte may affect your concentration, ability to react/respond, and may make you feel sleepy, particularly at the beginning of your treatment or after your dose is increased. Be especially careful while driving or operating machinery if Zonisamide Suerte affects you in this way.

Zonisamide Suerte contains sodium

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

3) how to take zonisamide suerte

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended adult dose

When you take Zonisamide Suerte on its own:

• The starting dose is 100mg taken once a day.
• This may be increased by up to 100mg at intervals of two weeks.
• The recommended dose is 300mg once a day.

When you take Zonisamide Suerte with other antiepileptic medicines:

• The starting dose is 50mg daily taken in two equal doses of 25mg.
• This may be increased by up to 100mg at intervals of one to two weeks.
• The recommended daily dose is between 300mg and 500mg.
• Some people respond to lower doses. The dose may be increased more slowly if you experience side effects, are elderly or if you suffer from kidney or liver problems.

Use in children (aged 6 to 11 years) and adolescents (aged 12 to 17 years) weighing at least 20 kg:

• The starting dose is 1mg per kg of body weight taken once a day.
• This may be increased by 1mg per kg of body weight at intervals of one to two weeks.
• The recommended daily dose is 6 to 8mg per kg for a child with a body weight of up to 55 kg or 300 to 500mg for a child with a body weight more than 55 kg (which ever dose is lower) taken once a day.

Example: A child who weighs 25 kg should take 25mg once a day for the first week, and then increase the daily dose by 25mg at the start of each week until a daily dose between 150 to 200mg is reached.

If you feel that the effect of Zonisamide Suerte is too strong or too weak, talk to your doctor or pharmacist.

• Zonisamide Suerte capsules must be swallowed whole with water.
• Do not chew the capsules.
• Zonisamide Suerte can be taken once or twice daily, as instructed by your doctor.
• If you take Zonisamide Suerte twice a day, take half the daily dose in the morning and half in the evening.

If you take more Zonisamide Suerte than you should

If you may have taken more Zonisamide Suerte than you should, tell a carer (relative or friend), your doctor or pharmacist immediately, or contact your nearest hospital casualty department, taking your medicine with you. You may become sleepy and could lose consciousness. You might also feel sick, have a sore stomach, muscle twitches, eye movement, feel faint, have a slowed heartbeat, and reduced breathing and kidney function. Do not try to drive.

If you forget to take Zonisamide Suerte

• If you forget to take a dose, don’t worry: take the next dose when it is due.
• Do not take a double dose to make up for a forgotten dose.
• Zonisamide Suerte is meant to be taken as a long-term medicine. Do not reduce your dose or stop your medicine unless your doctor tells you to.
• If your doctor advises you to stop taking Zonisamide Suerte your dose will be reduced gradually to lower the risk of more 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.

Zonisamide Suerte belongs to a group of medicines (sulfonamides) that can cause severe allergic reactions, severe skin rashes, and blood disorders, which very rarely can be fatal.

Contact your doctor immediately if you:

• have difficulty breathing, a swollen face, lips or tongue, or a severe skin rash as these symptoms may indicate that you are having a severe allergic reaction
• have signs of overheating – high body temperature but little or no sweating, rapid heartbeat and breathing, muscle cramps, and confusion
• have thoughts of harming or killing yourself. A small number of people being treated with anti- epileptics such as Zonisamide Suerte have had thoughts of harming or killing themselves
• have pain in your muscles or a feeling of weakness, as this may be a sign of abnormal muscle breakdown which can lead to kidney problems
• get a sudden pain in your back or stomach, have pain on urinating (passing water) or notice blood in your urine, as this may be a sign of kidney stones
• develop visual problems such as eye pain or blurred vision while taken zonisamide.
• have an unexplained skin rash, as this could develop into a more severe skin rash or skin peeling
• feel unusually tired or feverish, have a sore throat, swollen glands, or find that you bruise more easily, as this may mean you have a blood disorder
• have signs of increased acid level in the blood- headaches, drowsiness, shortness of breath and loss of appetite. Your doctor may need to monitor or treat this.

Your doctor may decide that you should stop using Zonisamide Suerte.

The most common side effects of Zonisamide Suerte are mild. They occur during the first month of treatment and usually decrease with continued treatment. In children ages 6 – 17 years old, side effects were consistent with those described below with the following exceptions: pneumonia, dehydration, sweating decreased (common), abnormal liver enzymes (uncommon), middle ear infection, sore throat, sinus and chest infections, cough, nosebleeds, runny nose, stomach pain, vomiting, rash, eczema and fever.

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

• agitation, irritability, confusion, depression
• poor muscle coordination, dizziness, poor memory, sleepiness, double vision
• loss of appetite, decreased blood levels of bicarbonate (a substance that prevents your blood from becoming acidic).
• difficulty sleeping, strange or unusual thoughts, feeling anxious or emotional
• slowed thoughts, loss of concentration, speech abnormalities, abnormal skin sensation (pins and needles), tremor, involuntary movement of the eyes
• kidney stones
• skin rashes, itching, allergic reactions, fever, tiredness, flu-like symptoms, hair loss
• ecchymosis (a small bruise caused by blood leaking from broken blood vessels in the skin)
• loss of weight, nausea, indigestion, stomach pains, diarrhoea (loose stools), constipation
• swelling of the feet and legs
• vomiting
• mood swings
• increased blood levels of creatinine (a waste product that your kidneys should normally remove)
• increased levels of liver enzymes in the blood.
• anger, aggression, thoughts of suicide, suicide attempt
• gall bladder inflammation, gallstones
• urinary stones
• lung infection / inflammation, urinary tract infections
• low blood potassium levels, convulsions/se­izures
• breathing disorders
• hallucinations
• abnormal urine tests.
• memory loss, coma, neuroleptic malignant syndrome (inability to move, sweating, fever, incontinence), status epilepticus (prolonged or repeated seizures)
• shortness of breath, inflammation of the lungs
• inflammations of the pancreas (severe pain in the stomach or back)
• liver problems, kidney failure
• severe rashes or skin peeling (at the same time you may feel unwell or develop a fever)
• abnormal muscle breakdown (you may feel pain or weakness in your muscles) which can lead to kidney problems
• swollen glands, blood disorders (reduction in the number of blood cells, which can make infection more likely and can make you look pale, feel tired and feverish, and bruise more easily)
• decreased sweating, overheating
• problems with your urine
• increased blood levels of creatine phosphokinase or urea which can be seen in a blood test
• abnormal results from liver function tests
• glaucoma, which is a blockage of fluid in the eye causing increased pressure in the eye. Eye pain, blurred vision or decreased vision may occur and can be signs of glaucoma.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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 zonisamide suerte

• Keep out of the sight and reach of children.
• Do not take this medicine after the expiry date printed on the carton or blister label. The expiry date refers to the last day of the month.
• This medicine does not require any special storage conditions.
• If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
• 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.

6) contents of the pack and other information

What Zonisamide Suerte contains:

Zonisamide Suerte 25mg hard capsules:

The active substance is zonisamide. Each capsule contains 25mg of zonisamide.

The other ingredients are:

• – capsule contents: microcrystalline cellulose, hydrogenated vegetable oil and sodium laurilsulfate

• – capsule shell: gelatin and titanium dioxide (E171)

• – printing ink: shellac, black iron oxide (E172) and potassium hydroxide

Zonisamide Suerte 50mg hard capsules:

The active substance is zonisamide. Each capsule contains 50mg of zonisamide.

The other ingredients are:

• – capsule contents: microcrystalline cellulose, hydrogenated vegetable oil and sodium laurilsulfate

• – capsule shell: gelatin and titanium dioxide (E171)

• – printing ink: shellac and iron oxide red (E172)

Zonisamide Suerte 100mg hard capsules:

The active substance is zonisamide. Each capsule contains 100mg of zonisamide.

The other ingredients are:

• – capsule contents: microcrystalline cellulose, hydrogenated vegetable oil and sodium laurilsulfate

• – capsule shell: gelatin and titanium dioxide (E171)

• – printing ink: shellac, black iron oxide (E172) and potassium hydroxide

What Zonisamide Suerte looks like and contents of the pack

• Zonisamide Suerte 25mg hard capsules have a white body and a white cap, marked ‘Z 25’ in black and contain a white/almost white powder.
• Zonisamide Suerte 50mg hard capsules have a white body and white cap, marked ‘Z 50’ in red and contain a white/almost white powder.
• Zonisamide Suerte 100mg hard capsules have a white body and white cap, marked ‘Z 100’ in black and contain a white/almost white powder.