Zonegran 50 mg hard capsules

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).

 

 

The use of  Zonegran 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 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.
• 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 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 should not stop your treatment without discussing this with your doctor.

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. A study showed that babies born to mothers using zonisamide during pregnancy were smaller than expected for their age at birth, compared with babies born to mothers treated with lamotrigine monotherapy. Make sure you are fully informed about the risks and the benefits of using zonisamide for epilepsy during pregnancy.

 

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 HPRA Pharmacovigilance

Website: www.hpra.ie. 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 GmbH

Edmund-Rumpler-Straße 3   

60549 Frankfurt am Main

Germany

e-mail: medinfo_de@eisai.net

 

Manufacturer

Eisai GmbH

Edmund-Rumpler-Straße 3   

60549 Frankfurt am Main

Germany

 

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

 

België/Belgique/Belgien Eisai SA/NV Tél/Tel: +32 (0)800 158 58	Lietuva Eisai GmbH Tel: + 49 (0) 69 66 58 50 (Vokietija)
България Eisai GmbH Teл.: + 49 (0) 69 66 58 50 (Германия)	Luxembourg/Luxemburg Eisai SA/NV Tél/Tel: +32 (0)800 158 58 (Belgique/Belgien)
Česká republika Eisai GesmbH organizačni složka Tel: + 420 242 485 839	Magyarország Ewopharma Hungary Ltd. Tel: +36 1 200 46 50
Danmark Eisai AB Tlf: + 46 (0) 8 501 01 600 (Sverige)	Malta Cherubino LTD +356 21343270
Deutschland Eisai GmbH Tel: + 49 (0) 69 66 58 50	Nederland Eisai B.V. Tel: + 31 (0) 900 575 3340
Eesti Eisai GmbH Tel: + 49 (0) 69 66 58 50 (Saksamaa)	Norge Eisai AB Tlf: + 46 (0) 8 501 01 600 (Sverige)
Ελλάδα Arriani Pharmaceutical S.A. Τηλ: + 30 210 668 3000	Österreich Eisai GesmbH Tel: + 43 (0) 1 535 1980-0
España Eisai Farmacéutica, S.A. Tel: + (34) 91 455 94 55	Polska Eisai GmbH Tel: + 49 (0) 69 66 58 50 (Niemcy)
France Eisai SAS Tél: + (33) 1 47 67 00 05	Portugal Eisai Farmacêtica, Unipessoal Lda Tel: + 351 214 875 540
Hrvatska Eisai GmbH Tel: + 49 (0) 69 66 58 50 (Njemačka)	România Eisai GmbH Tel: + 49 (0) 69 66 58 50 (Germania)
Ireland Eisai GmbH Tel: + 49 (0) 69 66 58 50 (Germany)	Slovenija Eisai GmbH Tel: + 49 (0) 69 66 58 50 (Nemčija)
Ísland Eisai AB Sími: + 46 (0)8 501 01 600 (Svíþjóð)	Slovenská republika Eisai GesmbH organizačni složka Tel.: + 420 242 485 839 (Česká republika)
Italia Eisai S.r.l. Tel: + 39 02 5181401	Suomi/Finland Eisai AB Puh/Tel: + 46 (0) 8 501 01 600 (Ruotsi)
Κύπρος Arriani Pharmaceuticals S.A. Τηλ: + 30 210 668 3000 (Ελλάδα)	Sverige Eisai AB Tel: + 46 (0) 8 501 01 600
Latvija Eisai GmbH Tel: + 49 (0) 69 66 58 50 (Vācija)	United Kingdom (Northern Ireland) Eisai GmbH Tel: +49 (0) 69 66 58 50 (Germany)

 

This leaflet was last revised in 06/2021

 

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

Zone/0011/2021