Zonegran 100 mg hard capsules

Patient Information Leaflet

Introduction

Package leaflet: Information for the user

Zonegran 25 mg, 50 mg and 100 mg hard capsules

(zonisamide)

Read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Zonegran is and what it is used for
2. What you need to know before taking 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.

Zonezag is used to treat seizures affecting one part of the brain (partial seizures), which may or may not be followed by a seizure affecting the entire brain (secondary generalization).

Zonegran can be used:

• Alone to treat seizures in adults.
• In combination with other antiepileptic medicines to treat seizures in adults, adolescents, and children aged 6 years and older.

2. What you need to know before starting Zonegran

Do not take Zonegran:

• if you are allergic to zonisamide or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other sulfonamides, for example: sulfonamide antibiotics, thiazide diuretics, or sulfonylurea antidiabetic agents;
• 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 serious allergic reactions, severe rashes, and blood disorders, which very rarely may lead to death (see section 4. Possible side effects).

The use of Zonegran may lead to high levels of ammonia in the blood, which could alter brain function, especially if you are also taking other medications that can increase ammonia levels (e.g., valproate), if you have a genetic disorder causing excessive ammonia production in the body (urea cycle disorder), or if you have liver disorders. Inform your doctor immediately if you experience unusual drowsiness or confusion.

Consult your doctor or pharmacist before starting Zonegran:

• if you are under 12 years of age, as you may have an increased risk of reduced sweating, heatstroke, pneumonia, and liver problems. The use of Zonegran is not recommended in children under 6 years of age.
• if you are elderly, as a dose adjustment of Zonegran may be required, and you may have a higher risk of developing allergic reactions, severe rash, swelling of the legs and feet, and itching while taking Zonegran (see section 4. Possible side effects).
• if you have liver problems, as a dose adjustment of Zonegran may be necessary.
• if you have eye problems such as glaucoma.
• if you have kidney problems, as a dose adjustment of Zonegran may be necessary.
• if you have previously had kidney stones, as you may be at increased risk of developing further kidney stones. Reduce the risk of kidney stones by drinking enough water.
• if you live in or are traveling to a hot climate. Zonegran may reduce your sweating, which could lead to an increase in body temperature. Reduce the risk of overheating by drinking enough water and keeping cool.
• if you are underweight or have lost a significant amount of weight, as Zonegran may cause further weight loss. Inform your doctor, as monitoring may be necessary.
• if you are pregnant or could become pregnant (for more information, see section “Pregnancy, breastfeeding and fertility”).

If any of these situations apply to you, inform your doctor before taking Zonegran.

Children and adolescents

Consult your doctor regarding the following risks:

• Weight: You should monitor your child's weight monthly and consult a doctor as soon as possible if your child does not gain sufficient weight. Zonegran is not recommended in children who are underweight or have poor appetite, and it should be used with caution in children weighing less than 20 kg.

• Increased blood acid levels and kidney stones: Reduce these risks by ensuring your child drinks enough water and does not take any other medication that may cause kidney stones (see Other Medicines). Your doctor will monitor your child's blood bicarbonate levels and kidney function (see also section 4).

Do not administer this medicine to children under 6 years of age, as it is not known whether the potential benefits outweigh the risks in this age group.

Other medicines and Zonegran

Inform your doctor or pharmacist if you are using or have recently used any other medicine, including those obtained without a prescription.

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

Taking Zonegran with food and drinks

Zonegran may be taken with or without food.

Pregnancy, breastfeeding, and fertility

Women of childbearing age must use effective contraception during treatment with Zonegran and for one month after stopping Zonegran.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. Do not stop treatment without consulting your doctor.

You should only take Zonegran during pregnancy if specifically instructed by your doctor. Research shows an increased risk of birth defects in children of women who take antiepileptic medicines. One study showed that children whose mothers used zonisamide during pregnancy were smaller than expected for their gestational age at birth, compared to children whose mothers were treated with lamotrigine monotherapy. Make sure you receive detailed information about the risks and benefits of using zonisamide for epilepsy during pregnancy.

Do not breastfeed while taking Zonegran or for one month after stopping Zonegran.

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

Driving and use of machines

Zonegran may affect concentration and reaction/responsiveness, and may cause drowsiness, especially at the beginning of treatment or after a dose increase. If Zonegran affects you in this way, take special care when driving or operating machinery.

Important information about some of the components of Zonegran

Zonegran contains Sunset Yellow FCF (E110) and Allura Red AC (E129)

Zonegran 100 mg hard capsules contain a yellow dye called Sunset Yellow FCF (E110) and a red dye called Allura Red AC (E129), which may cause allergic-type reactions.

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

3. How to take Zonegran

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

Recommended dose in adults

If you are taking Zonegran alone:

• The starting dose is 100 mg once daily.
• It may be increased by 100 mg at two-week intervals.
• The recommended dose is 300 mg once daily.

If you are taking Zonegran with other antiepileptic medicines:

• The starting dose is 50 mg per day, divided into two equal doses of 25 mg each.
• The dose 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 adverse effects, are elderly, or have renal or hepatic impairment.

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

• The starting dose is 1 mg per kg body weight once daily.
• This may 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 up to 55 kg, or between 300 mg and 500 mg for a child with a body weight above 55 kg (whichever is lower), taken once daily.

Example: a child weighing 25 kg should take 25 mg once daily during the first week; then the daily dose should be increased by 25 mg at the beginning of each week until reaching a daily dose of 150 to 200 mg.

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

• Zonegran capsules must be swallowed whole with water.
• Do not chew the capsules.
• Zonegran may be taken once or twice daily, according to your doctor's instructions.
• If you take Zonegran twice daily, take half of the daily dose in the morning and the other half at night.

If you take more Zonegran than you should

If you have taken more Zonegran than you should, inform your caregiver (family member or friend), your doctor or pharmacist immediately, or contact the emergency department of the nearest hospital, and bring the medicine with you. You may feel drowsy and could lose consciousness. You may also experience nausea, stomach pain, muscle spasms, eye movements, feeling faint, slow heartbeat, reduced breathing rate, and impaired kidney function. Do not attempt 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 forgotten doses.

If you stop taking Zonegran

• Zonegran is intended to be taken as a long-term medication. Do not reduce the dose or stop taking the medicine unless instructed by your doctor.
• If your doctor advises you to discontinue treatment, they will gradually reduce the dose to minimize the risk of having more seizures.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Zonegran belongs to a group of medicines (sulfonamides) that may cause serious allergic reactions, severe rashes, 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 a severe rash, as these symptoms may indicate you are having a serious allergic reaction.
• you have signs of overheating: high body temperature with little or no sweating, rapid heartbeat and breathing, muscle cramps, and confusion.
• you have had thoughts of self-harm or suicide. A small number of people taking antiepileptic medicines such as Zonegran have had thoughts of self-harm or suicide.
• you have muscle pain or feel weak, as this may be a sign of abnormal muscle breakdown which can lead to kidney problems.
• you have sudden pain in your back or stomach, pain when urinating, or notice blood in your urine, as this may be a sign of kidney stones.
• you experience visual problems such as eye pain or blurred vision while taking Zonegran.

Contact your doctor as soon as possible if:

• you develop an unexplained rash, as it may progress to a more serious rash or skin peeling.
• you feel unusually tired or feverish, have a sore throat, swollen glands, or notice you bruise more easily, as this may indicate you have a blood disorder.
• you have signs of increased acid levels in the blood: headache, drowsiness, difficulty breathing, and loss of appetite. Medical monitoring or treatment may be necessary.

Your doctor may decide that you should stop taking Zonegran.

The adverse effects of Zonegran most commonly reported are all mild in nature. They occur during the first month of treatment and often decrease with continued treatment. In children aged 6 to 17 years, adverse effects were consistent with those described below, except for the following exceptions: pneumonia, dehydration, decreased sweating (frequent), and abnormal liver enzymes (uncommon).

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

• agitation, irritability, confusion, depression
• poor muscle coordination, dizziness, poor memory, drowsiness, double vision
• loss of appetite, decreased levels of bicarbonate (a substance that prevents blood from becoming too acidic) in blood

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

• difficulty sleeping, unusual or strange thoughts, feeling anxious or mood instability.
• slowed thinking, difficulty concentrating, speech abnormalities, abnormal skin sensations (tingling), tremor, involuntary eye movements.
• kidney stones.
• rashes, itching, allergic reactions, fever, fatigue, 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, diarrhea, constipation.
• swelling of legs and feet.

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

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

Rare adverse 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, difficulty breathing, lung inflammation.
• pancreatitis (severe stomach or back pain).
• liver problems, kidney failure, increased levels of creatinine (a waste product normally eliminated by the kidneys) in blood.
• severe rashes or skin peeling (you may also feel unwell and have a fever at the same time).
• abnormal muscle breakdown (you may have muscle pain or weakness) which can lead to kidney problems.
• swollen glands, blood disorders (reduction in blood cells, which may make you more prone to infections, feel pale, tired and feverish, and bruise more easily).
• decreased sweating, excessive body temperature.
• glaucoma, which is a blockage of fluid drainage from the eye leading to increased internal eye pressure. Eye pain, blurred vision, or vision loss may occur and can be signs of glaucoma.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 stated on the blister pack and on the carton after EXP. The expiry date refers to 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 pack, or carton, or any visible signs of degradation in the medicine. Return the pack to your pharmacist.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other 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 components in the capsule contents are: microcrystalline cellulose, hydrogenated vegetable oil (soya), and sodium lauryl sulfate.
• The capsule shell contains: gelatin, titanium dioxide (E171), shellac, propylene glycol, potassium hydroxide, and 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 following components: sunset yellow FCF (E110), allura red (E129), and hydrogenated vegetable oil (soya).

Appearance of the product and contents of the pack

• Zonegran 25 mg hard capsules have an opaque white body and an opaque white cap, printed with a logo and “ZONEGRAN 25” in black.
• Zonegran 50 mg hard capsules have an opaque white body and an opaque grey cap, printed with a logo and “ZONEGRAN 50” in black.
• Zonegran 100 mg hard capsules have an opaque white body and an opaque red cap, printed with a logo and “ZONEGRAN 100” in black.

Zonegran capsules are packed in blisters, which are then packed into 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.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Amdipharm Limited
Unit 17, Northwood House,
Northwood Crescent, Northwood,
Dublin 9, D09 V504,
Ireland
e-mail: [email protected]

Manufacturer

Eisai GmbH,
Edmund-Rumpler-Straße 3,
60549 Frankfurt am Main,
Germany

SKYEPHARMA PRODUCTION S.A.S.
Zone Industrielle Chesnes Ouest,
55 rue du Montmurier,
SAINT QUENTIN FALLAVIER
38070, FRANCE

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

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