Zonisamide Teva 100 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Zonisamida Teva 100 mg hard capsules EFG

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

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

Leaflet contents:

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

1. What Zonisamida Teva is and what it is used for

Zonisamida Teva contains the active substance zonisamide and is used as an antiepileptic.

Zonisamide 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).

Zonisamide can be used:

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

2. What you need to know before starting Zonisamida Teva

Do not take Zonisamida Teva:

• 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, and sulfonylurea antidiabetics.

Warnings and precautions

Zonisamide 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 zonisamide may cause 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 become unusually drowsy or confused.

Consult your doctor or pharmacist before starting to take Zonisamide Teva if you:

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

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

Children and adolescents

Consult your doctor regarding the following risks:

• Weight: you must monitor your child's weight monthly and consult a doctor as soon as possible if they do not gain sufficient weight. Zonisamide 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 medication that may cause kidney stones (see Use of Zonisamida Teva with 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 unknown whether the potential benefits outweigh the risks in this age group.

Use of Zonisamida Teva with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

• Zonisamide should be used with caution in adults if taken together with medicines that may cause kidney stones, such as topiramate or acetazolamide. This combination is not recommended in children.
• Zonisamide may possibly increase blood levels of medicines 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 zonisamide, which could require an adjustment of the dose of Zonisamida Teva.

Taking Zonisamida Teva with food and drinks

Zonisamida Teva may be taken with or without food.

Pregnancy, breastfeeding, and fertility

Women of childbearing potential must use effective contraceptive methods during treatment with zonisamide and for one month after stopping zonisamide.

If you plan to become pregnant, speak with your doctor before stopping contraceptives and before attempting pregnancy about the possibility of switching to other appropriate treatments. If you are or think you may be pregnant, inform your doctor immediately. You must not stop your treatment without consulting your doctor.

Zonisamide should only be taken during pregnancy if specifically prescribed by your doctor. Research shows an increased risk of birth defects in children of women taking antiepileptic medicines. The risk of birth defects or neurodevelopmental disorders (problems in brain development) for your child after taking zonisamide during pregnancy is unknown. 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 receive detailed information about the risks and benefits of using zonisamide for epilepsy during pregnancy.

Do not breastfeed while taking zonisamide or during 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 use of machines

Zonisamide may affect concentration and the ability to react/respond, and may cause drowsiness, especially at the beginning of treatment or after increasing the dose. If zonisamide affects you in this way, take special care when driving or operating machinery.

Sodium

This medicine contains less than 1 mmol of sodium (23 mg) per hard capsule; i.e., essentially "sodium-free".

3. How to take Zonisamide Teva

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

Recommended dose in adults

If you are taking Zonisamide Teva alone:

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

If you are taking Zonisamide Teva with other antiepileptic medicines:

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

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

• The starting dose is 1 mg per kg of body weight once daily.
• This may be increased by 1 mg per kg of 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 between 300 mg and 500 mg for a child with a body weight above 55 kg (whichever is lower), 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 Zonisamide Teva is too strong or too weak, inform your doctor or pharmacist.

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

If you take more Zonisamide Teva than you should

Seek medical help immediately. Take the medicine pack with you. You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken. 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 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 for long-term use. DO NOT reduce the dose or stop taking the medicine unless instructed by your doctor.
• If your doctor advises you to stop taking Zonisamide Teva, they will gradually reduce the dose to decrease 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.

Zonisamide belongs to a group of medicines (sulfonamides) that can cause severe allergic reactions, severe rashes, and blood disorders, which very rarely may 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 that you are having a severe allergic reaction.
• have signs of overheating – 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 taking antiepileptic medicines such as Zonisamida Teva have had thoughts of self-harm or suicide.
• have muscle pain or feel weak, as this may be a sign of abnormal muscle breakdown which can lead to kidney problems.
• have sudden back or stomach pain, pain when urinating, or notice blood in your urine, as this may be a sign of kidney stones.
• experience vision problems such as eye pain or blurred vision while taking Zonisamida Teva.

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.
• feel unusually tired or feverish, have a sore throat, swollen glands, or notice you are bruising more easily, as this may mean you have a blood disorder.
• 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 Zonisamida Teva.

The adverse effects of zonisamide 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: 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 the 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 sensation (tingling), tremor, involuntary eye movements
• kidney stones
• rashes, 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 pains, diarrhoea (loose stools), 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 blood potassium levels and seizures/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), epileptic status (prolonged or repeated seizures)

• breathing disorders, difficulty breathing, lung inflammation

• pancreatitis (severe stomach or back pain)

• liver problems, kidney failure, increased creatinine levels (a waste product normally eliminated by the kidneys)

• severe rashes or skin peeling (you may also feel unwell and have a fever)

• abnormal muscle breakdown (you may have muscle pain or weakness) which can lead to kidney problems

• swollen glands, blood disorders (reduction in blood cell count, 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 in the drainage of fluid from the eye leading to increased internal eye pressure. Eye pain, blurred vision, or vision loss may occur and could be signs of glaucoma.

• Reporting of adverse effects

• If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Zonisamide Teva

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 pack and the outer packaging following EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any 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 degradation in the medicine. Return the pack to your pharmacist.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE point at your pharmacy. If you have any doubts, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Zonisamida Teva

• The active substance is zonisamide.

Zonisamida Teva 100 mg hard capsules EFG contains 100 mg of zonisamide.

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

Appearance of the product and contents of the pack

Zonisamida Teva 100 mg hard capsules EFG: hard gelatin capsule size no. 1, approximately 19 mm x 7 mm, with an orange cap and a white body, filled with white or off-white granules, printed with "100" on the body.

Zonisamida Teva 100 mg hard capsules are packaged in blisters of 7, 14, 28, 30, 56, 60, 84, 98, 100 or 196 (2 x 98 – multipack) hard capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma S.L.U.
C/Anabel Segura, 11 Edificio Albatros B, 1st Floor
28108 Alcobendas, Madrid, Spain

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

This medicinal product is authorized in Member States under the following names:

Germany: Zonisamid-ratiopharm 100 mg Hartkapseln
Denmark: Zonisamide Teva
Spain: Zonisamida Teva 100 mg cápsulas duras EFG
France: Zonisamide Teva 100 mg gélule
Netherlands: Zonisamide Teva 100mg harde capsules
Portugal: Zonisamida Ratiopharm
Sweden: Zonisamide Teva
United Kingdom: Zonisamide Ratiopharm 100 mg Capsules, Hard

Date of the most recent review of this summary: May 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included on the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/80450/P_80450.html

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