ZONISAMIDE TEVA 50 mg HARD CAPSULES

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

Do not take Zonisamide Teva:

• 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, for example sulfonamide antibiotics, thiazide diuretics and sulfonylurea antidiabetics.

Warnings and precautions

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

The use of zonisamide may result in high levels of ammonia in the blood, which could change 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 disorders. Tell your doctor immediately if you feel unusually drowsy or confused.

Consult your doctor or pharmacist before taking Zonisamide Teva if you:

• are under 12 years old, as you may have a higher risk of decreased sweating, heat stroke, pneumonia and liver problems. Zonisamide is not recommended in children under 6 years old.
• are elderly, as it may be necessary to adjust the dose of zonisamide, and you may have a higher risk of developing an allergic reaction, serious skin rash, swelling of legs and feet and itching when taking zonisamide (see section 4. Possible side effects).
• have liver problems, as it may be necessary to adjust the dose of zonisamide.
• have eye problems such as glaucoma
• have kidney problems, as it may be necessary to adjust the dose of zonisamide.
• have previously had kidney stones, as you may be at higher risk of having more kidney stones. Reduce the risk of having kidney stones by drinking plenty of water.
• live in a hot place or go on holiday to a hot place. Zonisamide can make you sweat less, which can result in your body temperature rising. Reduce the risk of overheating by drinking plenty of water and staying cool.
• are underweightor have lost a lot of weight, as zonisamide can make you lose more weight. Tell your doctor, as it may be necessary to monitor you.
• are pregnant or think you may be pregnant (see section “Pregnancy, breast-feeding and fertility” for more information)

If any of these statements apply to you, tell your doctor before taking Zonisamide Teva.

Children and adolescents

Consult your doctor about the following risks:

• Weight: you should check your child’s weight monthly and go to the doctor as soon as possible if they are not gaining enough weight. Zonisamide 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 medicine that may cause kidney stones (see Use of Zonisamide Teva with other medicines). Your doctor will check your child’s blood bicarbonate levels and kidneys (see also section 4).

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

Use of Zonisamide Teva with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

• Zonisamide should be used with caution in adults if taken with medicines that may cause kidney stones, such as topiramateor acetazolamide. In children, this combination is not recommended.
• Zonisamide may increase the levels in the blood of medicines such as digoxinand quinidine, and it may be necessary to reduce the dose of these medicines.
• Other medicines such as phenytoin, carbamazepine, phenobarbitaland rifampicinmay decrease the levels in the blood of zonisamide, which may require an adjustment of the dose of Zonisamide Teva.

Taking Zonisamide Teva with food and drinks

Zonisamide Teva can be taken with or without food.

Pregnancy, breast-feeding and fertility

Women of childbearing potential have to use effective contraception during treatment with zonisamide and for one month after stopping zonisamide.

If you plan to become pregnant, talk to your doctor before stopping contraception and before becoming pregnant about the possibility of switching to other suitable treatments. If you are or think you may be pregnant, tell your doctor immediately. Do not stop treatment without discussing it with your doctor.

You should only take zonisamide during pregnancy if your doctor advises it. Research has shown a higher risk of birth defects in children of women who take antiepileptics.

The risk of birth defects or developmental neurological disorders (problems with brain development) for your child after taking zonisamide during pregnancy is not known. 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 by your doctor about the risks and benefits of using zonisamide for epilepsy during pregnancy.

Do not breast-feed while taking zonisamide and for one month after stopping zonisamide.

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

Driving and using machines

Zonisamide may affect your concentration, ability to react/respond, and may make you feel drowsy, especially at the start of treatment or after a dose increase. If zonisamide affects you in this way, be especially careful when driving or using machines.

Sodium

This medicine contains less than 1 mmol sodium (23 mg) per hard capsule, i.e. it is essentially “sodium-free”.

3. How to take Zonisamide Teva

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

The recommended dose in adults is

If you are taking Zonisamide Teva 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 Zonisamide Teva 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, if you are elderly or if you have kidney or liver problems.

Use in children (6 to 11 years) and adolescents (12 to 17 years) weighing 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 6 mg to 8 mg per kg for a child with a body weight of up to 55 kg or 300 mg to 500 mg for a child with a body weight above 55 kg (the lower of the two doses) once a day.

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

If you think that the action of Zonisamide Teva is too strong or too weak, talk to your doctor or pharmacist.

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

If you take more Zonisamide Teva than you should

Go to the doctor immediately. Take the medicine pack with you. You can also call the national poison centre, phone number 91 562 04 20, indicating the medicine and the amount taken. 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 attempt to drive.

If you forget to take Zonisamide Teva

• 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 Zonisamide Teva

• Zonisamide Teva 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 taking Zonisamide Teva, the dose will be reduced gradually to decrease the risk of having more seizures.

If you have any further questions on 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 all people suffer from them.

Zonisamide belongs to a group of medicines (sulfonamides) that can cause severe allergic reactions, severe skin rashes, and blood disorders, which can very rarely cause death.

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 that you are having a severe allergic reaction.
• have signs of excessive heat- high body temperature with little or no sweating, rapid heartbeat and breathing, muscle cramps, and confusion.
• have thoughts of self-harm or suicide. A small number of people who were receiving treatment with antiepileptics such as Zonisamide Teva had thoughts of self-harm or suicide.
• have muscle painor feel weak, as this may be a sign of abnormal muscle breakdown that can lead to kidney problems.
• have sudden back or stomach pain, painful urination, or blood in the urine, as this may be a sign of kidney stones.
• experience vision problems such as eye pain or blurred vision while taking Zonisamide Teva.

Contact your doctor as soon as possible if you:

• have an unexplained rash, as it may become a more severe rash or skin peeling.
• feel especially tired or feverish, have a sore throat, swollen glands, or notice that you bruise more easily, as this may mean that you have a blood disorder.
• have signs of increased acid levels in the blood: headaches, drowsiness, difficulty breathing, and loss of appetite. Medical monitoring or treatment may be necessary.

Your doctor may decide that you should stop taking Zonisamide Teva.

The most frequently reported adverse effects of zonisamide are all mild. They occur during the first month of treatment and often decrease as treatment continues. In children from 6 to 17 years old, the adverse effects were consistent with those described below, except for the following exceptions: pneumonia, dehydration, decreased sweating (frequent), and abnormal liver enzymes (infrequent).

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, decrease in bicarbonate levels (a substance that prevents blood from becoming acidic) in the blood

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

• difficulty sleeping, unusual or unaccustomed thoughts, feeling of anxiety or emotional instability.
• slow thinking, loss of concentration, speech disorders, abnormal sensation in the skin (tingling), tremors, involuntary eye movements.
• kidney stones.
• rashes, itching, allergic reactions, fever, fatigue, flu-like symptoms, hair loss.
• bruising (a small hematoma caused by blood from a broken blood vessel in the skin).
• weight loss, nausea, indigestion, stomach pain, diarrhea (loose stools), constipation.
• swelling of legs and feet.

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

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

Very rare adverse effects: may affect up to 1 in 10,000 people

• hallucinations, memory loss, coma, malignant neuroleptic syndrome (inability to move, sweating, fever, incontinence), epileptic status (prolonged or repeated seizures).
• respiratory disorders, difficulty breathing, lung inflammation.
• pancreatitis (severe stomach or back pain)
• liver problems, kidney failure, increased creatinine levels (a waste product that the kidneys should normally remove).
• severe skin rashes or 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 have infections and feel pale, tired, and feverish, and bruise more easily).
• decreased sweating, excessive body temperature.
• glaucoma, which is a blockage of the drainage of the fluid in the eye that causes an increase in the internal pressure of the eye. It can cause eye pain, blurred vision, or decreased vision and can be signs of glaucoma.

• Reporting of adverse effects
• If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Zonisamida Teva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the blister pack and on the packaging after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

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

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines that you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Zonisamida Teva

• The active ingredient is zonisamide.

Zonisamida Teva 50 mg hard capsules EFG contains 50 mg of zonisamide.

• The other ingredients present in the capsule content are: microcrystalline cellulose, sodium lauryl sulfate, colloidal hydrated silica, and hydrogenated vegetable oil type I.
• The capsule shell contains: titanium dioxide (E171), gelatin, and iron oxide black (E172).
• The printing ink contains: shellac, propylene glycol, strong ammonia solution, iron oxide black (E172), and potassium hydroxide.

Appearance of the Product and Package Contents

Zonisamida Teva 50 mg hard capsules EFG: hard gelatin capsule size 3, approximately 16 mm x 6 mm, with a gray cap and a white body, filled with a white or off-white granulate, printed with "50" on the body.

The hard capsules of Zonisamida Teva 50 mg are packaged in blister packs of 7, 14, 28, 30, 56, 60, or 100 hard capsules.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma S.L.U.

C/Anabel Segura, 11 Edificio Albatros B, 1ª Planta

28108 Alcobendas, Madrid

Manufacturer

TEVA Gyógyszergyár Zrt.

Pallagi út 13

4042 Debrecen

Hungary

or

Teva Operations Poland Sp. z.o.o.

ul. Mogilska 80, Krakow

31-546

Poland

or

Merckle GmbH

Ludwig-Merckle-Straße 3,

89143 Blaubeuren

Germany

or

Teva Pharma B.V.

Swensweg 5, Haarlem

2031 GA

Netherlands

This medicine is authorized in the Member States under the following names:

Germany: Zonisamid-ratiopharm 50 mg Hartkapseln

Denmark: Zonisamide Teva

Spain: Zonisamida Teva 50 mg hard capsules EFG

France: Zonisamide Teva 50 mg gélule

Netherlands: Zonisamide Teva 50mg harde capsules

Portugal: Zonisamida Ratiopharm

Sweden: Zonisamide Teva

United Kingdom: Zonisamide Ratiopharm 50 mg Capsules, Hard

Date of the last revision of this prospectus:May 2023

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/80452/P_80452.html

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