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Zonegran (zonisamide) – Package leaflet - N03AX15

Updated on site: 11-Oct-2017

Medication nameZonegran
ATC CodeN03AX15
Substancezonisamide
ManufacturerEisai Ltd

Package leaflet: Information for the user

Zonegran 25 mg, 50 mg, and 100 mg hard capsules zonisamide

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 your 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 Zonegran is and what it is used for

2.What you need to know before you take Zonegran

3.How to take Zonegran

4.Possible side effects

5.How to store Zonegran

6.Contents of the pack and other information

1.What Zonegran is and what it is used for

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

Zonegran 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).

Zonegran 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 Zonegran

Do not take Zonegran:

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 sulphonamide medicines. Examples include: sulphonamide antibiotics, thiazide diuretics, and sulfonylurea antidiabetes medicines,

if you are allergic to peanut or soya, do not use this medicinal product.

Warnings and precautions

Zonegran belongs to a group of medicines (sulphonamides) which can cause severe allergic reactions, severe skin rashes, and blood disorders, which very rarely can be fatal (see section 4. Possible side effects).

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

Talk to your doctor or pharmacist before taking Zonegran 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, Zonegran is not recommended for you.

are elderly, as your dose of Zonegran 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 Zonegran (see section 4 Possible side effects).

suffer from liver problems, as your dose of Zonegran may need adjusting.

have eye problems such as glaucoma.

suffer from kidney problems as your dose of Zonegran 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. Zonegran 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 Zonegran can cause you to lose more weight. Tell your doctor as this may need to be monitored.

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

Children and adolescents

Talk to your doctor about the following risks:

Preventing overheating and dehydration in children

Zonegran 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 Zonegran:

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. Zonegran 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 Zonegran

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

Zonegran 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

Zonegran 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 Zonegran, which may require an adjustment of your dose of Zonegran.

Zonegran with food and drink

Zonegran can be taken with or without food.

Pregnancy, breast-feeding and fertility

If you are a woman of childbearing age you must use adequate contraception while taking and for one month after stopping Zonegran.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

You must only take Zonegran during your pregnancy if your doctor tells you to. Research has shown an increased risk of birth defects in children of women taking anti-epileptic medicines.

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

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

Zonegran 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 Zonegran affects you in this way.

Important information about some of the ingredients of Zonegran

Zonegran contains sunset yellow FCF (E110) and allura red AC (E129)

Zonegran 100 mg hard capsules contain a yellow colour called sunset yellow FCF (E110) and a red colour called allura red AC (E129), which may cause allergic reactions.

Zonegran contains soya oil. If you are allergic to peanut or soya, do not use this medicinal product.

3.How to take Zonegran

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

The recommended adult dose

When you take Zonegran on its own:

The starting dose is 100 mg taken once a day.

This may be increased by up to 100 mg at intervals of two weeks.

The recommended dose is 300 mg once a day.

When you take Zonegran with other antiepileptic medicines:

The starting dose is 50 mg daily taken in two equal doses of 25 mg.

This may be increased by up to 100 mg at intervals of one to two weeks.

The recommended daily dose is between 300 mg and 500 mg.

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 1 mg per kg of body weight taken once a day.

This may be increased by 1 mg per kg of body weight at intervals of one to two weeks.

The recommended daily dose is 6 to 8 mg per kg for a child with a body weight of up to 55 kg or 300 to 500 mg 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 25 mg once a day for the first week, and then increase the daily dose by 25 mg at the start of each week until a daily dose between 150 to 200 mg is reached.

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

Zonegran capsules must be swallowed whole with water.

Do not chew the capsules.

Zonegran can be taken once or twice daily, as instructed by your doctor.

It you take Zonegran twice a day, take half the daily dose in the morning and half in the evening.

If you take more Zonegran than you should

If you may have taken more Zonegran 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 heart beat, and reduced breathing and kidney function. Do not try to drive.

If you forget to take Zonegran

If you forget to take a dose, don’t worry: take the next dose when it is due.

Do not take double the dose to make up for the forgotten dose.

If you stop taking Zonegran

Zonegran 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 Zonegran 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.

Zonegran belongs to a group of medicines (sulphonamides) 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 Zonegran 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 taking Zonegran

Contact your doctor as soon as possible if you:

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 Zonegran.

The most common side effects of Zonegran 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) and abnormal liver enzymes (uncommon).

Very common side effects (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)

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

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.

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

anger, aggression, thoughts of suicide, suicide attempt.

vomiting.

gall bladder inflammation, gallstones.

urinary stones.

lung infection / inflammation, urinary tract infections.

low blood potassium levels, convulsions/seizures.

Very rare side effects (may affect up to 1 in 10,000 people):

hallucinations, memory loss, coma, neuroleptic malignant syndrome (inability to move, sweating, fever, incontinence), status epilepticus (prolonged or repeated seizures).

breathing disorders, shortness of breath, inflammation of the lungs.

inflammations of the pancreas (severe pain in the stomach or back)

liver problems, kidney failure, increased blood levels of creatinine (a waste product that your kidneys should normally remove).

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.

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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.How to store Zonegran

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 blister and the carton after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C.

Do not use this medicine if you notice any damage to the capsules, blister or carton or any visible signs of deterioration in the medicine. Return the pack to your pharmacist.

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 Zonegran contains

The active substance in Zonegran is zonisamide.

Zonegran 25 mg hard capsules contain 25 mg of zonisamide. Zonegran 50 mg hard capsules contain 50 mg zonisamide. Zonegran 100 mg hard capsules contain 100 mg zonisamide.

The other ingredients that are present in the capsule contents are: microcrystalline cellulose, hydrogenated vegetable oil (from soyabean) and sodium laurilsulfate.

The capsule shell contains: gelatin, titanium dioxide (E171), shellac, propylene glycol, potassium hydroxide, black iron oxide (E172). Additionally the 100 mg capsule shell contains sunset yellow FCF (E110) and allura red (E129).

See Section 2 for important information about the ingredients: sunset yellow FCF (E110) and allura red AC (E129) and hydrogenated vegetable oil (from soyabean).

What Zonegran looks like and contents of the pack

-Zonegran 25 mg hard capsules have a white opaque body and a white opaque cap and are printed with a logo and “ZONEGRAN 25” in black.

-Zonegran 50 mg hard capsules have a white opaque body and a grey opaque cap and are printed with a logo and “ZONEGRAN 50” in black.

-Zonegran 100 mg hard capsules have a white opaque body and a red opaque cap and are printed with a logo and “ZONEGRAN 100” in black.

Zonegran capsules are packaged in blister packs supplied in boxes containing:

-25 mg: 14, 28, 56 and 84 capsules

-50 mg: 14, 28, 56 and 84 capsules

-100 mg: 28, 56, 84, 98 and 196 capsules.

Not all pack sizes may be available.

Marketing Authorisation Holder

Eisai Ltd., European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom. e-mail: EUmedinfo@eisai.net

Manufacturer

Eisai Manufacturing Ltd, European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN,

United Kingdom.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Lietuva

Eisai Europe Ltd.

Eisai Ltd.

Tél/Tel: +32 (0)2 502 58 04

Tel. + 44 (0) 208 600 1400

 

(Jungtinė Karalystė)

България

Luxembourg/Luxemburg

Eisai Ltd.

Eisai Europe Ltd.

Teл.: + 44 (0) 208 600 1400

Tél/Tel: +32 (0)2 502 58 04

(Обединено кралство)

(Belgique/Belgien)

Česká republika

Magyarország

Eisai GesmbH organizační složka

Valeant Pharma Magyarország Kft.

Tel.: +420 242 485 839

Tel: +36 1 345 5900

Danmark

Malta

Eisai AB

Associated Drug Company Ltd.

Tlf: + 46 (0) 8 501 01 600

Tel: +356 2277 8000

(Sverige)

 

Deutschland

Nederland

Eisai GmbH

Eisai BV.

Tel: + 49 (0) 69 66 58 50

Tel: + 31 (0) 900 575 3340

Eesti

Norge

Eisai Ltd.

Eisai AB

Tel: + 44 (0) 208 600 1400

Tlf: + 46 (0) 8 501 01 600

(Ühendkuningriik)

(Sverige)

Ελλάδα

Österreich

Arriani Pharmaceuticals S.A.

Eisai GesmbH

Τηλ: + 30 210 668 3000

España

Polska

Eisai Farmacéutica, S.A.

Eisai Ltd.

Tel: + (34) 91 455 94 55

Tel.: + 44 (0) 208 600 1400

 

(Wielka Brytania)

France

Portugal

Eisai SAS

Eisai Farmacêutica, Unipessoal Lda

Tél: + (33) 1 47 67 00 05

Tel: + 351 214 875 540

 

România

Hrvatska

Eisai Ltd.

Eisai Ltd.

Tel: + 44 (0) 208 600 1400

Tel: + 44 (0) 208 600 1400

(Marea Britanie)

Ireland

Slovenija

Eisai Ltd.

Eisai Ltd.

Tel: + 44 (0) 208 600 1400

Tel: + 44 (0) 208 600 1400

(United Kingdom)

(Velika Britanija)

Ísland

Slovenská republika

Eisai AB

Eisai GesmbH organizační složka

Sími: + 46 (0)8 501 01 600

Tel.: +420 242 485 839

(Svíþjóð)

(Česká republika)

Italia

Suomi/Finland

Eisai S.r.l.

Eisai AB

Tel: + 39 02 5181401

Puh/Tel: + 46 (0) 8 501 01 600

 

(Ruotsi)

Κύπρος

Sverige

Arriani Pharmaceuticals S.A.

Eisai AB

Τηλ: + 30 210 668 3000

Tel: + 46 (0) 8 501 01 600

(Ελλάδα)

 

Latvija

United Kingdom

Eisai Ltd.

Eisai Ltd.

Tel: + 44 (0) 208 600 1400

Tel: + 44 (0) 208 600 1400

(Lielbritānija)

 

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu

Package leaflet: Information for the user

Zonegran 25 mg, 50 mg, 100 mg and 300 mg orodispersible tablets zonisamide

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 your 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 Zonegran is and what it is used for

2.What you need to know before you take Zonegran

3.How to take Zonegran

4.Possible side effects

5.How to store Zonegran

6.Contents of the pack and other information

1. What Zonegran is and what it is used for

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

Zonegran 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).

Zonegran 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 Zonegran

Do not take Zonegran:

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 sulphonamide medicines. Examples include: sulphonamide antibiotics, thiazide diuretics, and sulfonylurea antidiabetes medicines.

Warnings and precautions

Zonegran belongs to a group of medicines (sulphonamides) which can cause severe allergic reactions, severe skin rashes, and blood disorders, which very rarely can be fatal (see section 4. Possible side effects).

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

Talk to your doctor or pharmacist before taking Zonegran 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, Zonegran is not recommended for you.

are elderly, as your dose of Zonegran 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 Zonegran (see section 4 Possible side effects).

suffer from liver problems, as your dose of Zonegran may need adjusting.

have eye problems such as glaucoma.

suffer from kidney problems as your dose of Zonegran 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. Zonegran 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 Zonegran can cause you to lose more weight. Tell your doctor as this may need to be monitored.

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

Children and adolescents

Talk to your doctor about the following risks:

Preventing overheating and dehydration in children

Zonegran 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 Zonegran:

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. Zonegran 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 Zonegran

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

Zonegran 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

Zonegran 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 Zonegran, which may require an adjustment of your dose of Zonegran.

Zonegran with food and drink

Zonegran can be taken with or without food.

Pregnancy, breast-feeding and fertility

If you are a woman of childbearing age you must use adequate contraception while taking and for one month after stopping Zonegran.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

You must only take Zonegran during your pregnancy if your doctor tells you to. Research has shown an increased risk of birth defects in children of women taking anti-epileptic medicines.

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

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

Zonegran 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 Zonegran affects you in this way.

Important information about some of the ingredients of Zonegran

Zonegran contains aspartame (E951)

Zonegran orodispersible tablets contain a sweetener called aspartame (E951), which is a source of phenylalanine and may be harmful for people with phenylketonuria

3. How to take Zonegran

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

The recommended adult dose

When you take Zonegran on its own:

The starting dose is 100 mg taken once a day.

This may be increased by up to 100 mg at intervals of two weeks.

The recommended dose is 300 mg once a day.

When you take Zonegran with other antiepileptic medicines:

The starting dose is 50 mg daily taken in two equal doses of 25 mg.

This may be increased by up to 100 mg at intervals of one to two weeks.

The recommended daily dose is between 300 mg and 500 mg.

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 1 mg per kg of body weight taken once a day.

This may be increased by 1 mg per kg of body weight at intervals of one to two weeks.

The recommended daily dose is 6 to 8 mg per kg for a child with a body weight of up to 55 kg or 300 to 500 mg 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 25 mg once a day for the first week, and then increase the daily dose by 25 mg at the start of each week until a daily dose between 150 to 200 mg is reached.

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

Orodispersible tablets:

Zonegran orodispersible tablets are moisture-sensitive, so handle them with dry hands.

Peel back the foil of a single blister cell and press the back of the blister pocket to push the tablet out. Do not push the tablet through the foil.

Place the tablet on your tongue until it melts and is easy to swallow.

The melted tablet may be swallowed with or without water.

Zonegran can be taken once or twice daily, as instructed by your doctor.

If you take Zonegran twice a day, take half the daily dose in the morning and half in the evening.

If you take more Zonegran than you should

If you may have taken more Zonegran 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 heart beat, and reduced breathing and kidney function. Do not try to drive.

If you forget to take Zonegran

If you forget to take a dose, don’t worry: take the next dose when it is due.

Do not take double the dose to make up for the forgotten dose.

If you stop taking Zonegran

Zonegran 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 Zonegran 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.

Zonegran belongs to a group of medicines (sulphonamides) 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 Zonegran 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 taking Zonegran.

Contact your doctor as soon as possible if you:

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 Zonegran.

The most common side effects of Zonegran 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) and abnormal liver enzymes (uncommon).

Very common side effects (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)

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

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.

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

anger, aggression, thoughts of suicide, suicide attempt.

vomiting.

gall bladder inflammation, gallstones.

urinary stones.

lung infection / inflammation, urinary tract infections.

low blood potassium levels, convulsions/seizures.

Very rare side effects (may affect up to 1 in 10,000 people):

hallucinations, memory loss, coma, neuroleptic malignant syndrome (inability to move, sweating, fever, incontinence), status epilepticus (prolonged or repeated seizures).

breathing disorders, shortness of breath, inflammation of the lungs.

inflammations of the pancreas (severe pain in the stomach or back)

liver problems, kidney failure, increased blood levels of creatinine (a waste product that your kidneys should normally remove).

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.

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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Zonegran

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 blister and the carton after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special temperature storage conditions.

Store in the original package in order to protect from light and moisture. The orodispersible tablet is moisture sensitive so should be taken immediately after opening the blister.

Do not use this medicine if you notice any damage to the orodispersible tablets, blister or carton or any visible signs of deterioration in the medicine. Return the pack to your pharmacist.

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 Zonegran contains

The active substance in Zonegran is zonisamide.

Zonegran 25 mg orodispersible tablets contain 25 mg of zonisamide. Zonegran 50 mg orodispersible tablets contain 50 mg of zonisamide. Zonegran 100 mg orodispersible tablets contain 100 mg zonisamide. Zonegran 300 mg orodispersible tablets contain 300 mg zonisamide.

The other ingredients that are present in the 25 mg, 50 mg, and 100 mg orodispersible tablets are: fish gelatin, mannitol (E421), aspartame (E951), and orange flavour.

The other ingredients that are present in the 300 mg orodispersible tablets are: gelatin, mannitol (E421), aspartame (E951), and orange flavour.

See Section 2 for important information about the ingredient, aspartame (E951).

What Zonegran looks like and contents of the pack

Zonegran orodispersible tablets are white to off-white, circular tablets, debossed with the tablet strength (“25”, “50”, “100” or “300”).

Zonegran orodispersible tablets are packaged in blister packs supplied in boxes containing:

25 mg: 14 and 28 orodispersible tablets

50 mg: 14 and 28 orodispersible tablets

100 mg: 56 and 98 orodispersible tablets

300 mg: 28 and 98 orodispersible tablets

Not all pack sizes may be available.

Marketing Authorisation Holder

Eisai Ltd., European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom. e-mail: EUmedinfo@eisai.net

Manufacturer

Eisai Manufacturing Ltd, European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN,

United Kingdom.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Lietuva

Eisai Europe Ltd.

Eisai Ltd.

Tél/Tel: +32 (0)2 502 58 04

Tel. + 44 (0) 208 600 1400

 

(Jungtinė Karalystė)

България

Luxembourg/Luxemburg

Eisai Ltd.

Eisai Europe Ltd.

Teл.: + 44 (0) 208 600 1400

Tél/Tel: +32 (0)2 502 58 04

(Обединено кралство)

(Belgique/Belgien)

Česká republika

Magyarország

Eisai GesmbH organizační složka

Valeant Pharma Magyarország Kft.

Tel.: +420 242 485 839

Tel: +36 1 345 5900

Danmark

Malta

Eisai AB

Associated Drug Company Ltd.

Tlf: + 46 (0) 8 501 01 600

Tel: +356 2277 8000

(Sverige)

 

Deutschland

Nederland

Eisai GmbH

Eisai BV.

Tel: + 49 (0) 69 66 58 50

Tel: + 31 (0) 900 575 3340

Eesti

Norge

Eisai Ltd.

Eisai AB

Tel: + 44 (0) 208 600 1400

Tlf: + 46 (0) 8 501 01 600

(Ühendkuningriik)

(Sverige)

Ελλάδα

Österreich

Arriani Pharmaceuticals S.A.

Eisai GesmbH

Τηλ: + 30 210 668 3000

España

Polska

Eisai Farmacéutica, S.A.

Eisai Ltd.

Tel: + (34) 91 455 94 55

Tel.: + 44 (0) 208 600 1400

 

(Wielka Brytania)

France

Portugal

Eisai SAS

Eisai Farmacêutica, Unipessoal Lda

Tél: + (33) 1 47 67 00 05

Tel: + 351 214 875 540

 

România

Hrvatska

Eisai Ltd.

Eisai Ltd.

Tel: + 44 (0) 208 600 1400

Tel: + 44 (0) 208 600 1400

(Marea Britanie)

Ireland

Slovenija

Eisai Ltd.

Eisai Ltd.

Tel: + 44 (0) 208 600 1400

Tel: + 44 (0) 208 600 1400

(United Kingdom)

(Velika Britanija)

Ísland

Slovenská republika

Eisai AB

Eisai GesmbH organizační složka

Sími: + 46 (0)8 501 01 600

Tel.: +420 242 485 839

(Svíþjóð)

(Česká republika)

Italia

Suomi/Finland

Eisai S.r.l.

Eisai AB

Tel: + 39 02 5181401

Puh/Tel: + 46 (0) 8 501 01 600

 

(Ruotsi)

Κύπρος

Sverige

Arriani Pharmaceuticals S.A.

Eisai AB

Τηλ: + 30 210 668 3000

Tel: + 46 (0) 8 501 01 600

(Ελλάδα)

 

Latvija

United Kingdom

Eisai Ltd.

Eisai Ltd.

Tel: + 44 (0) 208 600 1400

Tel: + 44 (0) 208 600 1400

(Lielbritānija)

 

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu

Annex IV

Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Scientific conclusions

Taking into account the PRAC Assessment Report on the PSUR for zonisamide, the scientific conclusions of CHMP are as follows:

An article published during the interval reported on a case of angle closure and myopic shift secondary to zonisamide where the author noted the association with this type of reaction and other sulphonamide derivatives such as topiramate. Following a review of the literature and cumulative reports of ocular related terms, the MAH concluded that a causal association between secondary angle closure glaucoma and zonisamide is possible.

Five cases were presented by the MAH where the time to onset was within hours/days of zonisamide initiation or dose increase, most of the patients were young (20s-40s plus one 7 year old child) without a history of eye disorders and resolution/improvement occurred shortly after discontinuation of zonisamide. The paediatric patient was also taking another sulfa containing medicine (trichlormethiazide). These five cases did not include the original literature report which concerned a 39-year-old woman who presented with sudden vision loss with a concurrent bilateral frontal headache. No changes in health were reported other than initiating zonisamide for refractory migraines 2 weeks prior. Ocular history was significant only for low myopia. With discontinuation of zonisamide, the patient experienced full recovery.

An overview of all terms reported within the Eye Disorders SOC (n = 114 reports) included reports which may be related symptoms of this reaction such as vision blurred (n=22), visual impairment (n=16), visual acuity reduced (n=7), ocular discomfort (n=2), ocular hyperaemia (n=2) and myopia (n=4).

Zonegran is a benzisoxazole derivative, which contains a sulfonamide group. Angle closure glaucoma secondary to sulfa derived medicines is acknowledged in the literature and it is thought that the mechanism relates to choroidal swelling that pushes the iris or ciliary body forward or deforms the iris so that it is retracted into the angle. The product information for topiramate and other sulfa derived medicines includes a warning in SmPC section 4.4 and listed terms in SmPC section 4.8.

Information is available on six well documented cases suggestive of a causal association between zonisamide and angle closure glaucoma while other reports have been received with terms possibly relating to this reaction. Although these numbers are small given the post-marketing exposure of zonisamide (1.7 million patient years cumulatively), the cases are sufficiently well documented and the association is also supported by the literature regarding sulfonamide derived medicines.

Therefore, in view of the data presented in the reviewed PSUR, the PRAC considers that changes to the product information of medicinal products containing zonisamide are warranted. The CHMP agrees with the scientific conclusions made by the PRAC.

Grounds for the variation to the terms of the marketing authorisation

On the basis of the scientific conclusions for zonisamide the CHMP is of the opinion that the benefit-risk balance of the medicinal product containing zonisamide is unchanged subject to the proposed changes to the product information

The CHMP recommends that the terms of the marketing authorisation should be varied.

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