ZONISAMIDE SANDOZ 25 mg HARD CAPSULES

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

Do not take Zonisamide Sandoz:

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6),
• if you are allergic to other sulfonamides, such as sulfonamide antibiotics, thiazide diuretics, and sulfonylurea antidiabetics.

Warnings and precautions

Zonisamide belongs to a group of medicines (sulfonamides) that can cause severe allergic reactions, serious skin rashes, and blood disorders, which can very rarely 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 affect brain function, especially if you are also taking other medicines that can increase ammonia levels (e.g., valproate), if you have a genetic disorder that causes too much ammonia to be produced in the body (urea cycle disorder), or if you have liver disease. Tell your doctor immediately if you feel unusually drowsy or confused.

Consult your doctor or pharmacist before starting to take zonisamide if:

• you are under 12 years old, as you may be at higher risk of decreased sweating, heat stroke, pneumonia, and liver problems. Zonisamide is not recommended for use in children under 6 years of age,
• you are elderly, as it may be necessary to adjust the dose of zonisamide, and you may be more likely to develop an allergic reaction, serious skin rash, swelling of the legs and feet, and itching when taking zonisamide (see section 4. Possible side effects),
• you have liver problems, as it may be necessary to adjust the dose of zonisamide,
• you have eye problems such as glaucoma,
• you have kidney problems, as it may be necessary to adjust the dose of zonisamide,
• you 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,
• you live in a hot place or are going 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,
• you are underweight or have lost a lot of weight, as zonisamide can make you lose more weight.
• you are pregnant or think you may be pregnant (see the section "Pregnancy, breastfeeding, and fertility" for more information).

Tell your doctor, as you may need to be monitored.

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

Children and adolescents

Consult your doctor about the following risks:

• Body weight: you should check your child's weight monthly and see a 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 ensuring your child drinks plenty of water and does not take any medicine that can cause kidney stones (see other medicines). Your doctor will check your child's blood bicarbonate levels and kidney function (see also section 4).

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

Taking Zonisamida Sandoz 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 can cause kidney stones, such as topiramate or acetazolamide. In children, this combination is not recommended.
• Zonisamide may increase the levels of medicines such as digoxin and quinidine in the blood, and it may be necessary to reduce the dose of these medicines.
• Other medicines such as phenytoin, carbamazepine, phenobarbital, and rifampicin may decrease the levels of zonisamide in the blood, which may require an adjustment of the dose of zonisamide.

Taking Zonisamida Sandoz with food and drinks

Zonisamide can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Women of childbearing age must use effective contraceptive measures 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 taking this medicine without talking to your doctor.

You should only take zonisamide during pregnancy if your doctor advises it. Research shows 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. A 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 can affect concentration, reaction capacity, and may cause drowsiness, especially at the start of treatment or after increasing the dose. If zonisamide affects you in this way, be especially careful when driving or using machines.

Zonisamide Sandoz contains sodium

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

3. How to take Zonisamide Sandoz

Follow exactly the administration instructions of this medicine given by your doctor. If you are not sure, consult your doctor or pharmacist again.

The recommended dose in adults is:

If you take zonisamide alone:

• the initial dose is 100 mg once a day,
• it can be increased by up to 100 mg at 2-week intervals,
• the recommended dose is 300 mg once a day.

If you take zonisamide with other antiepileptics:

• the initial dose is 50 mg per day divided into two equal doses of 25 mg,
• it can be increased by up to 100 mg at 1- to 2-week intervals,
• the recommended daily dose is between 300 mg and 500 mg,
• some people respond to lower doses. The dose can be increased more slowly if you experience side effects or have kidney or liver problems.

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

• the initial dose is 1 mg per kg of body weight once a day,
• it can be increased by 1 mg per kg of body weight at 1- to 2-week intervals,
• the recommended daily dose is between 6 and 8 mg per kg of body weight for a child with a body weight of up to 55 kg or between 300 and 500 mg for a child with a body weight over 55 kg (the lower of the two doses) once a day.

Example: a child who weighs 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 the effect of zonisamide is too strong or too weak, tell your doctor or pharmacist.

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

If you take more Zonisamide Sandoz than you should

If you have taken more zonisamide than you should, tell the person taking care of you (family or friend), your doctor, or pharmacist, or contact the emergency department of the nearest hospital and take the medicine with you. You may feel drowsy and may lose consciousness. You may also feel like vomiting, have stomach pain, muscle spasms, eye movements, feel like you are going to faint, have a slow heart rate, and decreased respiratory and kidney function. Do not try to drive.

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

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 forgotten doses.

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 your doctor tells you to.
• If your doctor advises you to stop treatment, they will gradually reduce the dose to minimize 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,
• you have signs of excessive heat: 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 receiving treatment with antiepileptics 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 that can lead to kidney problems,
• you have sudden back or stomach pain, painful urination, or blood in your urine, as this may be a sign of kidney stones.
• Develop visual problems such as eye pain or blurred vision while taking Zonisamide.

Contact your doctor as soon as possible if:

• you suffer from unexplained rash, as it may become a more severe rash or skin peeling,
• you 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,
• you 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.

The adverse effects of zonisamide most frequently reported are 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, strange 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 stones,
• pulmonary 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), status epilepticus (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 (at the same time, you may feel unwell and have a fever).
• 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 fluid in the eye that causes increasing pressure in the eye. It can cause eye pain, blurred vision, or decreased vision and may be signs of glaucoma.

Reporting 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 leaflet. 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 Zonisamide Sandoz

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 carton after EXP. The expiration date is 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 carton, or any visible signs of deterioration in the medicine. Return the carton to your pharmacist.

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

6. Package Contents and Additional Information

Composition of Zonisamide Sandoz

Zonisamide Sandoz 25 mg hard capsules

• The active ingredient is zonisamide. Each capsule contains 25 mg of zonisamide.
• The other ingredients are:

Capsule content: 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.

Zonisamide Sandoz 50 mg hard capsules

• The active ingredient is zonisamide. Each capsule contains 50 mg of zonisamide.
• The other ingredients are:

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

Capsule shell: gelatin, titanium dioxide (E171).

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

Zonisamide Sandoz 100 mg hard capsules

• The active ingredient is zonisamide. Each capsule contains 100 mg of zonisamide.
• The other ingredients are:

Capsule content: 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 Package Contents

Zonisamide 25 mg hard capsules have a white opaque body with a white opaque cap, size 4, 14.4 mm, marked with "Z 25" in black.

Zonisamide 50 mg hard capsules have a white opaque body with a white opaque cap, size 3, 15.8 mm, marked with "Z 50" in red.

Zonisamide 100 mg hard capsules have a white opaque body with a white opaque cap, size 1, 19.3 mm, marked with "Z 100" in black.

Zonisamide Sandoz capsules are packaged in blister packs, which are packaged in cartons 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 medicine 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 ????????? ?????? 25 mg / 50 mg / 100 mg ?????? ???????

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

Slovak Republic Zonisamid Sandoz 25 mg / 50 mg / 100 mg

Date of the last revision of this leaflet: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/