ZONEGRAN 25 mg HARD CAPSULES

Introduction

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 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.

Contents of the pack and other information

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

1. What is Zonegran and what is it used for

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

Zonegran is used to treat partial seizures that affect only a part of the brain, with or without secondary generalisation.

Zonegran can be used:

• On its own to treat seizures in adults.
• With other antiepileptics 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 sulfonamides, e.g. sulphonamide antibiotics, thiazide diuretics and sulphonylurea antidiabetics;
• if you are allergic to peanuts or soya, do not use this medicine.

Warnings and precautions

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

The use of Zonegran may result in high blood ammonia levels, which could affect brain function, especially if you are also taking other medicines that may increase ammonia levels (e.g. valproate), if you have a genetic disorder that results in too much ammonia in the body (urea cycle disorder), or if you have liver disease. Tell your doctor immediately if you feel abnormally sleepy or confused.

Talk to your doctor or pharmacist before you start taking Zonegran:

• if you are under 12 years old, as you may have a higher risk of decreased sweating, heat stroke, pneumonia and liver problems. Zonegran is not recommended in children under 6 years old.
• if you are elderly, as you may need to have your dose of Zonegran adjusted, and you may have a higher chance of developing an allergic reaction, serious skin reaction, swelling of legs and feet and itching when taking Zonegran (see section 4. Possible side effects).
• if you have liver problems, as you may need to have your dose of Zonegran adjusted.
• if you have eye problems such as glaucoma.
• if you have kidney problems, as you may need to have your dose of Zonegran adjusted.
• if you have had kidney stones before, as you may have a higher risk of having more kidney stones. Reduce the risk of having kidney stones by drinking plenty of water.
• if you live in a hot place or are going on holiday to a hot place. Zonegran can make you sweat less, which can result in your body temperature increasing. Reduce the risk of overheating by drinking plenty of water and keeping cool.
• if you are underweight or have lost a lot of weight, as Zonegran can make you lose even more weight. Tell your doctor, as they may need to monitor you.
• if you are pregnant or could become pregnant (for more information, see the section “Pregnancy, breast-feeding and fertility”).

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

Children and adolescents

Talk to your doctor about the following risks:

• Weight: you should check your child’s weight monthly and see a doctor as soon as possible if they are not gaining enough weight. Zonegran is not recommended in children who are underweight or have a poor appetite, and should be used with caution in children with a weight below 20 kg.

• Increased acid levels in the blood and kidney stones: reduce these risks by making sure your child drinks plenty of water and does not take any other medicine that may cause kidney stones (see “Other medicines”). Your doctor will check your child’s blood bicarbonate levels and kidney function (see also section 4).

Do not give this medicine to children under 6 years old as it is not known if the possible benefits are greater than the risks in this age group.

Other medicines and Zonegran

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

• Zonegran should be used with caution in adults if taken with medicines that may cause kidney stones, such as topiramate or acetazolamide. In children, this combination is not recommended.
• Zonegran may increase the levels of medicines such as digoxin and quinidine in the blood, and it may be necessary to reduce the dose of these medicines.
• Other medicines such as phenytoin, carbamazepine, phenobarbitone and rifampicin may decrease the levels of Zonegran in the blood, which may require an adjustment of the dose of Zonegran.

Taking Zonegran with food and drink

Zonegran can be taken with or without food.

Pregnancy, breast-feeding and fertility

Women of childbearing potential have to use effective contraception during treatment with Zonegran 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. Do not stop treatment without discussing it with your doctor.

You should only take Zonegran during pregnancy if your doctor advises it. Research has shown a higher risk of birth defects in children of women who take antiepileptics. One study showed that children whose mothers used zonisamide during pregnancy were smaller than expected for their age at birth, compared to children whose mothers were treated with lamotrigine monotherapy. Make sure you are fully informed about the risks and benefits of using zonisamide for epilepsy during pregnancy.

Do not breast-feed while you are taking Zonegran or for one month after stopping Zonegran.

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

Driving and using machines

Zonegran can affect concentration, reaction and ability to react, and may make you feel sleepy, especially at the start of treatment or after a dose increase. If Zonegran affects you in this way, be extra careful when driving or using machines.

Important information about some of the ingredients of Zonegran

Zonegran contains orange yellow S (E110) and allura red AC (E129)

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

Zonegran contains soya oil. Do not use this medicine if you are allergic to peanuts or soya.

3. How to take Zonegran

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

Recommended dose in adults

If you are taking Zonegran on its own:

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

If you are taking Zonegran with other antiepileptics:

• The initial dose is 50 mg a day divided into two equal doses of 25 mg.
• This can 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 have kidney or liver problems.

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

• The initial dose is 1 mg per kg body weight once a day.
• This can be increased by 1 mg per kg body weight at intervals of one to two weeks.
• The recommended daily dose is between 6 mg and 8 mg per kg for a child with a body weight of up to 55 kg or between 300 mg and 500 mg for a child with a body weight above 55 kg (the lower of the two doses) once a day.

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

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

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

If you take more Zonegran than you should

If you have taken more Zonegran than you should, tell the person taking care of you (family or friend), your doctor or pharmacist, or contact the nearest hospital emergency department and take the medicine with you. You may feel drowsy and may lose consciousness. You may also feel sick, have stomach pain, muscle spasms, eye movements, feel faint, have a slow heart rate and decreased kidney function. Do not try to drive.

If you forget to take Zonegran

• If you forget to take a dose, do not worry; take the next dose at the usual time.
• Do not take a double dose to make up for a forgotten dose.

If you stop taking Zonegran

• Zonegran is intended to be taken as a long-term medicine. Do not reduce the dose or stop taking the medicine unless your doctor tells you to.
• If your doctor advises you to stop treatment, they will reduce the dose gradually to decrease the risk of you having 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 (sulfonamides) that may cause severe allergic reactions, serious skin reactions and blood disorders, which very rarely can be fatal.

Contact your doctor immediately if:

• you have difficulty breathing, swelling of the face, lips or tongue or severe skin reaction, as these symptoms can be signs of a severe allergic reaction.
• you have signs of overheating: high body temperature with little or no sweating, fast heart rate and breathing, muscle cramps and confusion.
• you have had thoughts of self-harm or suicide. A small number of people taking antiepileptics such as Zonegran have had thoughts of self-harm or suicide.
• you have muscle pain or feel weak, as this can be a sign of abnormal muscle breakdown that can lead to kidney problems.
• you have sudden back or stomach pain, pain when urinating or blood in the urine, as this can be a sign of kidney stones.
• you have vision problems such as eye pain or blurred vision while taking Zonegran.

Contact your doctor as soon as possible if:

• you have unexplained skin rash, as this can become a more serious skin reaction.
• you feel especially tired or feverish, have a sore throat, swollen glands or bruise more easily, as this can be a sign of a blood disorder.
• you have signs of increased acid levels in the blood: headache, sleepiness, difficulty breathing and loss of appetite. You may need medical attention or treatment.

Your doctor may decide that you should stop taking Zonegran.

The most common side effects of Zonegran are all mild. They occur during the first month of treatment and often decrease as treatment continues. In children aged 6 to 17 years, the side effects were consistent with those described below, except for the following: pneumonia, dehydration, decreased sweating (frequent) 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 bicarbonate levels (a substance that prevents the blood from becoming acidic) in the blood

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

• difficulty sleeping, unusual or abnormal thoughts, feeling anxious or unstable.
• slow thinking, loss of concentration, speech problems, abnormal sensation in the skin (tingling), tremor, involuntary eye movements.
• kidney stones.
• skin rash, itching, allergic reactions, fever, tiredness, flu-like symptoms, hair loss.
• bruising (a small bruise caused by blood from a broken blood vessel in the skin).
• weight loss.
• nausea, indigestion, stomach pain, diarrhoea (loose stools), constipation.
• swelling of legs and feet.

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

• aggression, suicidal thoughts, attempted suicide.
• vomiting.
• inflammation of the gallbladder or gallstones.
• urinary stones.
• lung infection/inflammation, urinary tract infections.
• low potassium levels in the blood and seizures/convulsions.

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), epileptic status (prolonged or repeated seizures).
• respiratory disorders, breathing difficulties, lung inflammation.
• pancreatitis (severe stomach or back pain)
• liver problems, kidney failure, increased creatinine levels (a waste product that the kidneys should normally remove) in the blood.
• serious skin reactions or skin peeling (you may feel unwell and have a fever at the same time).
• abnormal muscle breakdown (you may have muscle pain or weakness) that can lead to kidney problems.
• swollen glands, blood disorders (reduction in the number of blood cells, which can make you more likely to get infections and make you pale, tired and feverish, and bruise more easily).
• decreased sweating, excessive body temperature.
• glaucoma, which is a blockage of the drainage of fluid from the eye that causes increased pressure inside the eye. There may be eye pain, blurred vision or decreased vision, and these 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 Spanish Medicines Monitoring System for Human Use www.notificaRAM.es By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 on the carton after EXP. The expiry date is the last day of the month indicated.

Do not store above 30°C.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and additional information

Composition of Zonegran

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

• The other ingredients present in the capsule content are: microcrystalline cellulose, hydrogenated vegetable oil (soybean) and sodium lauryl sulfate.
• The capsule shell contains: gelatin, titanium dioxide (E171), shellac, propylene glycol, potassium hydroxide, black iron oxide (E172). Additionally, the 100 mg capsule shell contains orange yellow S (E110) and allura red (E129).

See section 2 for important information about the ingredients: orange yellow S (E110), allura red (E129) and hydrogenated vegetable oil (soybean).

Appearance of the product and package contents

• Zonegran 25 mg hard capsules have a white opaque body and a white opaque capsule 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 capsule 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 capsule cap, and are printed with a logo and “ZONEGRAN 100” in black.

The Zonegran capsules are packaged in blisters which are packaged in cartons 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 marketed.

Marketing authorisation holder

Amdipharm Limited

3 Burlington Road,

Dublin 4, D04 RD68,

Ireland

e-mail: medicalinformation@advanzpharma.com

Manufacturer

Eisai GmbH,

Edmund-Rumpler-Straße 3,

60549 Frankfurt am Main,,

Germany

You can request more information about this medicine by contacting the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

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