Zonisamide Sandoz 25 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Zonisamida Sandoz 25 mg hard capsules EFG

Zonisamida Sandoz 50 mg hard capsules EFG

Zonisamida Sandoz 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, ask 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 may 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.

Contents of the package leaflet

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

2. What you need to know before taking Zonisamida Sandoz

3. How to take Zonisamida Sandoz

4. Possible side effects

5. Storage of Zonisamida Sandoz

6. Contents of the pack and other information

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

Zonisamida Sandoz 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 antiepileptics to treat convulsive seizures in adults, adolescents, and children aged 6 years and older.

2. What you need to know before starting to take Zonisamide Sandoz

Do not take Zonisamide Sandoz:

• if you are allergic to the active substance 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 result in death (see section 4. Possible side effects).

Serious rashes have been reported in association with zonisamide treatment, including cases of Stevens-Johnson syndrome.

The use of zonisamide 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 problems. Inform your doctor immediately if you feel unusually drowsy or confused.

Consult your doctor or pharmacist before starting zonisamide 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,
• you are elderly, as the dose of zonisamide may need to be adjusted, and you may have a higher risk of developing an allergic reaction, severe rash, swelling of the legs and feet, or itching while taking zonisamide (see section 4. Possible side effects),
• you have liver problems, as the dose of zonisamide may need to be adjusted,
• you have eye problems such as glaucoma,
• you have kidney problems, as the dose of zonisamide may need to be adjusted,
• you have previously had kidney stones, as you may be at higher risk of developing further kidney stones. Reduce the risk of kidney stones by drinking enough water,
• you live in or are traveling to a hot climate. Zonisamide may reduce sweating, which could cause your body temperature to rise. Reduce the risk of overheating by drinking enough water and keeping cool,
• you are underweight or have lost a lot of weight, as zonisamide may cause further weight loss,
• you are pregnant or could become pregnant (see the section "Pregnancy, breastfeeding, and fertility" for more information).

Inform your doctor, as monitoring may be necessary.

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

Children and adolescents

Consult your doctor regarding the following risks:

Preventing excessive heat and dehydration in children Zonisamide may cause your child to sweat less or experience excessive body heat, which can lead to brain damage or death if not treated. Children are the most vulnerable population, especially on hot days. While your child is taking zonisamide: keep them cool, especially on hot days, your child should avoid strenuous exercise, particularly in hot weather, give your child plenty of cold water to drink, your child should not take the following medications: carbonic anhydrase inhibitors (such as topiramate and acetazolamide) and anticholinergics (such as clomipramine, hydroxyzine, diphenhydramine, haloperidol, imipramine, and oxybutynin). If your child's skin is very hot with little or no sweating, if the child is confused or has muscle cramps, or if their heartbeat or breathing is rapid: move the child to a cool, shaded place; sponge the child's skin with cool (not cold) water; give the child cold water to drink; seek immediate medical help.

• Body weight: You should monitor your child's weight monthly and contact the 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 other medications). 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.

Taking Zonisamida Sandoz with other medicines

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

• Zonisamide should be used with caution in adults if taken 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 a dose reduction of these medicines may be necessary.
• Other medicines such as phenytoin, carbamazepine, phenobarbital, and rifampicin may decrease zonisamide blood levels, which may require adjustment of the zonisamide dose.

Taking Zonisamida Sandoz with food and drinks

Zonisamide may be taken with or without food.

Pregnancy, breastfeeding, and fertility

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

If you intend to become pregnant, speak with your doctor before stopping contraception and prior to becoming pregnant about the possibility of switching to other suitable treatments. If you are or think you may be pregnant, inform your doctor immediately. You must not stop taking this medicine without first discussing it with your doctor.

Zonisamide should only be taken during pregnancy if 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 babies born to mothers who used zonisamide during pregnancy were smaller than expected for their age at birth, compared to babies born to mothers treated with lamotrigine monotherapy. Make sure you are fully informed about the risks and benefits of using zonisamide for epilepsy during pregnancy.

Do not breastfeed while taking zonisamide or 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 concentration, reaction/response ability, and may cause drowsiness, especially at the beginning of treatment or after a dose increase. If zonisamide affects you in this way, take special care when driving or using machines.

Zonisamida Sandoz contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; this is essentially "sodium-free".

3. How to take Zonisamide Sandoz

Follow exactly the instructions given by your doctor for the administration of this medicine. If in doubt, consult your doctor or pharmacist again.

The recommended dose in adults is:

If you are taking zonisamide alone:

• the initial dose is 100 mg once daily,
• it may be increased by up to 100 mg at two-week intervals,
• the recommended dose is 300 mg once daily.

If you are taking zonisamide with other antiepileptic medicines:

• the initial dose is 50 mg per day divided into two equal doses of 25 mg,
• it may be increased by up to 100 mg at one- to two-week intervals,
• 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 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 of body weight once daily,
• it may be increased by 1 mg per kg of body weight at one- to two-week intervals,
• the recommended daily dose is between 6 to 8 mg per kg of body weight for a child with a body weight of up to 55 kg or between 300 to 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 zonisamide is too strong or too weak, tell your doctor or pharmacist.

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

If you have taken more Zonisamide Sandoz than you should

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

If you have taken more zonisamide than you should, contact your doctor, pharmacist, or call the Toxicology Information Service at 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Zonisamide Sandoz

• 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 a missed dose.

If you stop taking Zonisamide Sandoz

• Zonisamide is intended to be taken as a long-term medicine. 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 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 experiences them.

Zonisamide 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 that you are experiencing 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 zonisamide 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 develop vision problems such as eye pain or blurred vision while taking Zonisamide.

Contact your doctor as soon as possible if:

• you develop an unexplained rash, as it could progress to a more severe rash or skin peeling,
• you 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,
• 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 zonisamide.

The adverse effects of zonisamide most frequently reported are 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 blood levels of bicarbonate (a substance that prevents blood from becoming too acidic).

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

• difficulty sleeping, unusual or strange thoughts, feeling anxious or emotionally unstable,
• slowed thinking, difficulty concentrating, speech abnormalities, unusual skin sensations (tingling), tremor, involuntary eye movements,
• kidney stones,
• rashes, itching, allergic reactions, fever, fatigue, flu-like symptoms, hair loss,
• bruising (small haematomas caused by blood from broken blood vessels under the skin),
• weight loss, nausea, indigestion, stomach pain, diarrhoea, 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,
• inflammation of the pancreas (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 cells, which may make you more prone to infections, look pale, feel tired and feverish, and bruise more easily),
• decreased sweating, excessive body temperature.
• Glaucoma, which is a blockage of fluid in the eye causing increasing pressure within the eye. This may cause eye pain, blurred vision, or vision loss, and may be signs of glaucoma.

Reporting of adverse effects

If you experience any type of 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 Sandoz

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

No special storage conditions are required.

Do not use this medicine if you notice any signs of deterioration in the capsules, blister pack, or packaging, 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. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Zonisamida Sandoz

Zonisamida Sandoz 25 mg hard capsules

• The active substance is zonisamide. Each capsule contains 25 mg of zonisamide.
• The other components are:

Capsule contents: microcrystalline cellulose, hydrogenated vegetable oil and sodium lauryl sulfate.

Capsule shell: gelatin, titanium dioxide (E171).

Printing ink: shellac, black iron oxide (E172) and potassium hydroxide.

Zonisamida Sandoz 50 mg hard capsules

• The active substance is zonisamide. Each capsule contains 50 mg of zonisamide.
• The other components are:

Capsule contents: microcrystalline cellulose, hydrogenated vegetable oil and sodium lauryl sulfate.

Capsule shell: gelatin, titanium dioxide (E171).

Printing ink: shellac and red iron oxide (E172).

Zonisamida Sandoz 100 mg hard capsules

• The active substance is zonisamide. Each capsule contains 100 mg of zonisamide.
• The other components are:

Capsule contents: microcrystalline cellulose, hydrogenated vegetable oil and sodium lauryl sulfate.

Capsule shell: gelatin, titanium dioxide (E171).

Printing ink: shellac, black iron oxide (E172) and potassium hydroxide.

Appearance of the product and contents of the pack

Zonisamida 25 mg hard capsules have an opaque white body and opaque white cap, size 4, 14.4 mm long, printed with “Z 25” in black.

Zonisamida 50 mg hard capsules have an opaque white body and opaque white cap, size 3, 15.8 mm long, printed with “Z 50” in red.

Zonisamida 100 mg hard capsules have an opaque white body and opaque white cap, size 1, 19.3 mm long, printed with “Z 100” in black.

Zonisamida Sandoz capsules are packaged in blister packs, which are then placed in cardboard boxes containing:

• 25 mg: 14, 28 and 56 capsules.
• 50 mg: 14, 28 and 56 capsules.
• 100 mg: 28, 56, 98 and 196 capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Noucor Health, S.A.

Avda. Camí Reial, 51-57

08184 Palau-solità i Plegamans (Barcelona)

Spain

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1, Sachsen-Anhalt

39179 Barleben

Germany

or

Lek d. d.

Verovskova ulica 57

1526 Ljubljana

Slovenia

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Malta Zonisamide – 1 A Pharma 25 mg / 50 mg / 100 mg hard capsules

Bulgaria Зонисамид 25 mg / 50 mg / 100 mg твърди капсули

Czech Republic Zonisamid Sandoz 25 mg / 50 mg / 100 mg tvrdé tobolky

Cyprus Zonisamide Sandoz 25mg / 50 mg / 100 mg

Germany Zonisamid – 1 A Pharma 25 mg / 50 mg / 100 mg Hartkapseln

Denmark Zonisamide 1A Farma

Estonia Zonisamide Sandoz

Spain Zonisamida Sandoz 25 mg / 50 mg / 100 mg cápsulas duras EFG

France Zonisamide Sandoz 25 mg / 50 mg / 100 mg gélule

Croatia Zonisamid Sandoz 25 mg / 50 mg / 100 mg tvrde kapsule

Italy Zonisamide Sandoz

Lithuania Zonisamide Sandoz 25 mg / 50 mg / 100 mg kietosios kapsules

Latvia Zonisamide Sandoz 25 mg / 50 mg / 100 mg cietas kapsulas

Netherlands Zonisamide Sandoz 25 mg /50 mg / 100 mg, harde capsules

Poland Zonisamide Sandoz

Sweden Zonisamide 1A Farma

Slovenia Zonisamid Sandoz 25 mg / 50 mg / 100 mg trde capsule

Slovakia Zonisamid Sandoz 25 mg / 50 mg / 100 mg

Date of the most recent revision of this leaflet: May 2023

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