Zonegran 300 mg orodispersible tablets

Zonegran is an antiepileptic medicine.

Zonegran is used to treat adults who are already taking other antiepileptic medicines but are still experiencing 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).

Do not take Zonegran:

If you:

• are allergic to any of the ingredients in Zonegran (see section 6. Further information),
• are allergic to other sulphonamide medicines. Examples include: sulphonamide antibiotics, thiazide diuretics, and sulfonylurea antidiabetes medicines.

Take special care with Zonegran:

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).

Before you take Zonegran, tell your doctor if you:

• are younger than 18 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 or severe skin rash when taking Zonegran (see section 4 Possible Side Effects).
• suffer from liver problems, as your dose of Zonegran may need adjusting.
• 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.
• weigh less than 40 kg, 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.

Taking other medicines

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 when taken with medicines that can cause kidney stones, like topiramate.
• 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.

Taking Zonegran with food and drink

Zonegran can be taken with or without food.

Pregnancy and breastfeeding

If you are a woman of childbearing age you must use adequate contraception while taking and for one month after stopping Zonegran.
Tell your doctor immediately if you might be, or are pregnant, or are planning to get pregnant. 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 breastfeed whilst taking or for one month after stopping Zonegran.

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 orodispersible tablets contain a sweetener called aspartame (E951), which is a source of phenylalanine and may be harmful for people with phenylketonuria (see Section 6 ? Further Information).

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

The usual adult dose

• 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 usual 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.

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

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 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 product, ask your doctor or pharmacist.

Like all medicines, Zonegran 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 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.

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 headaches, drowsiness, shortness of breath and loss of appetite as this could be a sign that your blood level of bicarbonate is too low, which your doctor may need to monitor or treat.

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. The frequency of possible side effects listed below is defined using the following convention:

• very common (affects more than 1 user in 10)
• common (affects 1 to 10 users in 100)
• uncommon (affects 1 to 10 users in 1,000)
• rare (affects 1 to 10 users in 10,000)
• very rare (affects less than 1 user in 10,000)
• not known (frequency cannot be estimated from the available data).

Very common side effects

• 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

• 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, allergic reactions, fever, tiredness, flu-like symptoms.
• 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.

Uncommon side effects

• 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

• 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), itching.
• 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.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep Zonegran out of the reach and sight of children.

Do not use Zonegran after the expiry date 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 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.

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

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: bovine 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., Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom.

Manufacturer

Eisai Manufacturing Ltd, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom.

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

BelgiëBelgiqueBelgien Eisai Europe Ltd. TélTel 32 0 2 735 45 34 LuxembourgLuxemburg Eisai Europe Ltd. TélTel 32 0 2 735 45 34 BelgiqueBelgien

Eisai Ltd. Te. 359 2 810 39 96 Magyarország Eisai GesmbH Tel.36 1 230 43 20

eská republika Eisai GesmbH organizaní sloka Tel. 420 242 485 839 Malta Associated Drug Company Ltd. Tel 356 2124 2751

Danmark Eisai AB Tlf 46 08 501 01 600 Sverige Nederland Eisai Europe Ltd. TélTel 32 0 2 735 45 34 België Belgique

Deutschland Eisai GmbH Tel 49 0 696 65 850 Norge Eisai AB Tlf 46 08 501 01 600 Sverige

Österreich Eisai GesmbH Tel 43 0 1 535 1980-0 Eesti Eisai Ltd. Tel 44 0 208 600 1400 Ühendkuningriik

Arriani Pharmaceuticals S.A. 30 210 668 3000 Polska Eisai Ltd. Tel 44 0208 600 1400 Wielka Brytania

España Eisai Farmacéutica, S.A. Tel 34 91 455 94 55 Portugal Eisai Farmacêutica, Unipessoal Lda Tel 351 214 875 540

France Eisai SAS Tél 33 1 47 67 00 05 România Eisai Ltd. Tel 40 21 301 7469

Slovenija Eisai Ltd. Tel 386 0 1 426 7015 Ireland Eisai Ltd. Tel 44 0208 600 1400 United Kingdom Ísland Eisai AB Sími 46 0 8 501 01 600 Svíjóð Slovenská republika Eisai GesmbH organizaní sloka Tel 420 242 485 839 eská republika

Italia Eisai S.r.l. Tel 39 02 5181401 SuomiFinland Eisai AB PuhTel 46 08 501 01 600 Ruotsi

Sverige Eisai AB Tel 46 08 501 01 600 Arriani Pharmaceuticals S.A. 30 210 668 3000

United Kingdom Eisai Ltd. Tel 44 0 208 600 1400 Latvija Eisai Ltd. Tel 44 0208 600 1400 Lielbritnija

Lietuva
Eisai Ltd.
Tel: + 44 (0)208 600 1400
(Jungtin- Karalyst-)

This leaflet was last approved in