Package leaflet: Information for the user

ZONISAMIDE RATIOPHARM 25 mg, 50 mg AND 100 mg CAPSULES, HARD

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.

What is in this leaflet:

1.    What Zonisamide Ratiopharm is and what it is used for

2.    What you need to know before you take Zonisamide Ratiopharm

3.    How to take Zonisamide Ratiopharm

4.    Possible side effects

5.    How to store Zonisamide Ratiopharm

6.    Contents of the pack and other information

1.    What Zonisamide Ratiopharm is and what it is used for

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

Zonisamide Ratiopharm 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).

Zonisamide Ratiopharm 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 Zonisamide Ratiopharm

Do not take Zonisamide Ratiopharm if you:

•    are allergic to zonisamide or any of the ingredients in this medicine (listed in section 6)

•    are allergic to other sulphonamide medicines. Examples include: sulphonamide antibiotics, thiazide diuretics, and sulfonylurea antidiabetes medicines.

Warnings and precautions

Zonisamide Ratiopharm 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).

Talk to your doctor or pharmacist before taking Zonisamide Ratiopharm 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, Zonisamide Ratiopharm is not recommended for you

•    are elderly, as your dose of Zonisamide Ratiopharm 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 Zonisamide Ratiopharm (see section 4 Possible side effects)

•    suffer from liver problems, as your dose of Zonisamide Ratiopharm may need adjusting

•    suffer from kidney problems as your dose of Zonisamide Ratiopharm 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. Zonisamide Ratiopharm 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 Zonisamide Ratiopharm 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 Zonisamide Ratiopharm.

Children and adolescents

Talk to your doctor about the following risks:

• 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. Zonisamide Ratiopharm 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 and Zonisamide Ratiopharm”). 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 Zonisamide Ratiopharm

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

•    Zonisamide Ratiopharm 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

•    Zonisamide Ratiopharm 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 Zonisamide Ratiopharm, which may require an adjustment of your dose of Zonisamide Ratiopharm.

Zonisamide Ratiopharm with food and drink

Zonisamide Ratiopharm can be taken with or without food.

Pregnancy, breast-feeding and fertility

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

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

Tell your doctor immediately if you might be, or are pregnant, or are planning to get pregnant.

You must only take Zonisamide Ratiopharm 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 Zonisamide Ratiopharm.

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

Zonisamide Ratiopharm 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 Zonisamide Ratiopharm affects you in this way.

3. How to take Zonisamide Ratiopharm

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

The recommended adult dose

When you take Zonisamide Ratiopharm 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 usual dose is 300 mg once a day.

When you take Zonisamide Ratiopharm 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 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.

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 usual 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 Zonisamide Ratiopharm is too strong or too weak, talk to your doctor or pharmacist.

•    Zonisamide Ratiopharm capsules MUST be swallowed whole with water.

•    Do not chew the capsules.

•    Zonisamide Ratiopharm can be taken once or twice daily, as instructed by your doctor.

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

If you take more Zonisamide Ratiopharm than you should

If you may have taken more Zonisamide Ratiopharm 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 Zonisamide Ratiopharm

•    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 Zonisamide Ratiopharm

•    Zonisamide Ratiopharm 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 Zonisamide Ratiopharm, 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.

Zonisamide Ratiopharm 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 antiepileptics such as Zonisamide Ratiopharm 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 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 Zonisamide Ratiopharm.

The most common side effects of Zonisamide Ratiopharm 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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Zonisamide Ratiopharm

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

This medicine does not require any special storage conditions.

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 Zonisamide Ratiopharm contains

•    The active substance is zonisamide.

Zonisamide Ratiopharm 25 mg Capsules, Hard contain 25 mg of zonisamide.

Zonisamide Ratiopharm 50 mg Capsules, Hard contain 50 mg zonisamide.

Zonisamide Ratiopharm 100 mg Capsules, Hard contain 100 mg zonisamide.

•    The other ingredients that are present in the capsule contents are: cellulose, microcrystalline, sodium laurilsulfate, silica, colloidal hydrated and hydrogenated vegetable oil type I.

•    The capsule shell contains: titanium dioxide (E171), gelatin, additionally the 50 mg capsule shell contains black iron oxide (E172) and 100 mg capsule shell contains red iron oxide (E172).

•    The imprinting ink cointains shellac, propylene glycol, strong ammonia solution, black iron oxide (E172) and potassium hydroxide.

What Zonisamide Ratiopharm looks like and contents of the pack

•    Zonisamide Ratiopharm 25 mg hard gelatin size 4 capsules, approx. 14 mm x 5 mm, with white cap and white body, filled with white to off white granulate, printed with “25” on the body.

•    Zonisamide Ratiopharm 50 mg hard gelatin size 3 capsules, approx. 16 mm x 6 mm, with grey cap and white body, filled with white to off white granulate, printed with “50” on the body.

•    Zonisamide Ratiopharm 100 mg hard gelatin size 1 capsules, approx. 19 mm x 7 mm, with orange cap and white body, filled with white to off white granulate, printed with “100” on the body.

Zonisamide Ratiopharm 25 mg Capsules, Hard are packed in blisters of 7, 14, 28, 30, 56, 60 or 100 capsules, hard.

Zonisamide Ratiopharm 50 mg Capsules, Hard are packed in blisters of 7, 14, 28, 30, 56, 60 or 100 capsules, hard.

Zonisamide Ratiopharm 100 mg Capsules, Hard are packed in blisters of 7, 14, 28, 30, 56, 60, 98, 100 or 196 (98 x 2 - multipack) capsules, hard.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Ratiopharm GmbH, Graf-Arco-Str. 3, Ulm, 89079, Germany

Manufacturer

TEVA Gyogyszergyar Zrt., Debrecen, Pallagi ut 13, H-4042, Hungary *OR

Teva Operations Poland Sp. z.o.o, ul. Mogilska 80., Krakow, 31-546, Poland *OR

Merckle GmbH, Ludwig-Merckle-StraBe 3, Blaubeuren, 89143, Germany *OR

Teva Pharma B.V., Swensweg 5, Haarlem, 2031 GA, The Netherlands

This leaflet was last revised in 10/2015.

PL 15773/0929 PL 15773/0930 PL 15773/0931

* Only the actual site of batch release will appear on the printed version of the leaflet