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 this 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 further questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.

• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

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

2.What you need to know before you start taking Zonisamida Sandoz

3.How to take Zonisamida Sandoz

4.Possible side effects

5Storage of Zonisamida Sandoz

6.Contents of the pack and additional information

Zonisamida Sandoz contains the active ingredient zonisamida, and is used as an antiepileptic.

Zonisamida is used to treat seizures that affect a part of the brain (partial seizures), which may or may not be followed by a seizure that affects the whole brain (secondary generalization).

Zonisamida may be used:

• alone to treat convulsive seizures in adults,
• with other antiepileptics to treat convulsive seizures in adults, adolescents, and children 6 years of age and older.

Do not take Zonisamida Sandoz:

• if you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6),
• if you are allergic to other sulfonamides, for example: sulfonamide antibiotics, thiazide diuretics, and sulfonylurea antidiabetics.

Warnings and precautions

Zonisamida belongs to a group of medications (sulfonamides) that may cause severe allergic reactions, severe rashes, and blood disorders, which very rarely may cause death (see section 4. Possible side effects).

The use of zonisamida may cause high levels of ammonia in the blood, which could change brain function, especially if you are also taking other medications that can increase ammonia levels (e.g., valproate), if you have a genetic disorder that causes excessive ammonia production in the body (urea cycle disorder), or if you have liver disorders. Inform your doctor immediately if you feel drowsy or confused in an unusual way.

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

• you are under 12 years old, as you may be at higher risk of presentingdecreased sweating,heatstroke, pneumonia, and liver problems. Zonisamida is not recommended for children under 6 years old,
• you are elderly, as you may need to adjust the zonisamida dose, and you may be at higher risk of developing an allergic reaction, severe rash, leg and foot swelling, and itching when taking zonisamida (see section 4. Possible side effects),
• you have liver problems, as you may need to adjust the zonisamida dose,
• you have eye problems such as glaucoma,
• you have kidney problems, as you may need to adjust the zonisamida dose,
• you have previously had kidney stones, as you may be at higher risk of having more kidney stones.Reduce the risk of kidney stones by drinking enough water,
• you live in a hot place or are going on vacation to a hot place. Zonisamida may cause you to sweat less, which can lead to a higher body temperature.Reduce the risk of heatstroke by drinking enough water and staying cool,
• you are underweight or have lost a lot of weight, as zonisamida may cause you to lose more weight.
• you are pregnant or may become pregnant (see the "Pregnancy, breastfeeding, and fertility" section for more information).

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

Inform your doctor if any of these statements apply to you before taking zonisamida.

Children and adolescents

Consult your doctor about the following risks:

• Weight:you should monitor your child's weight monthly and see your doctor as soon as possible if they are not gaining enough weight. Zonisamida is not recommended for children who are underweight or have a poor appetite, and should be used with caution in children with a weight under 20 kg.
• Increased blood acidity and kidney stones: reduce these risks by ensuring your child drinks enough water and does not take any medication that can cause kidney stones (see other medications). Your doctor will monitor your child's blood bicarbonate levels and kidneys (see also section 4).

Do not administer this medication to children under 6 years old, as the potential benefits may not outweigh the risks in this age group.

Taking Zonisamida Sandoz with other medications

Inform your doctor or pharmacist if you aretaking, havetakenrecentlyor may need to take any other medication.

• Zonisamida should be used with caution in adults if taken with medications that can cause kidney stones, such as topiramate or acetazolamide. In children, this combination is not recommended.
• Zonisamida may increase blood levels of medications such as digoxin and quinidine, and therefore may need to be reduced.
• Other medications such as phenytoin, carbamazepine, phenobarbital, and rifampicin may decrease blood levels of zonisamida, which may require adjustment of the zonisamida dose.

Taking Zonisamida Sandoz with food and drinks

Zonisamida can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Women of childbearing age must use effective contraceptive measures during zonisamida treatment and for one month after stopping zonisamida.

If you plan to become pregnant, talk to your doctor before stopping contraceptives and before becoming pregnant about the possibility of switching to other suitable treatments. If you are or think you may be pregnant, inform your doctor immediately.Do not stop taking this medication without consulting your doctor.

Only take zonisamida during pregnancy if your doctor indicates it. Research shows a higher risk of birth defects in children of women taking antiepileptic medications. The risk of birth defects or neurological developmental disorders (brain development problems) for your child after taking zonisamida during pregnancy is unknown. A study showed that babies born to mothers taking zonisamida 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 zonisamida for epilepsy during pregnancy.

Do not breastfeed while taking zonisamida or for one month after stopping zonisamida.

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

Driving and operating machinery

Zonisamida may affect concentration, reaction time, and may cause drowsiness, especially at the beginning of treatment or after increasing the dose. If zonisamida affects you in this way, be extra careful when driving or operating machinery.

Zonisamida Sandoz contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor.This medicationindicated by your doctor.In case of doubt, consult your doctor or pharmacist again.

The recommended dose in adultsis:

If you take zonisamide alone:

• The initial dose is 100 mg once a day,
• It can be increased up to 100 mg in two-week intervals,
• The recommended dose is 300 mg once a day.

If you take zonisamide with other antiepileptic medications:

• The initial dose is 50 mg per day divided into two equal doses of 25 mg,
• It can be increased up to 100 mg in 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 can be increased more slowly if you experience side effects or have kidney or liver problems.

Use in children (6 to 11 years old) and adolescents (12 to 17 years old) 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 in intervals of one to two weeks,
• The recommended daily dose is between 6 to 8 mg per kg of body weight for a child weighing up to 55 kg or between 300 to 500 mg for a child weighing more than 55 kg (the lower dose) 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 beginning of each week until the daily dose of 150 to 200 mg is reached.

If you estimate that the action of zonisamide is too strong or too weak, inform your doctor or pharmacist.

• 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 at night.

If you take more Zonisamide Sandoz than you should

If you have taken more zonisamide than you should, inform immediately the person who takes care of you (family member or friend), your doctor or pharmacist, or contact the nearest hospital emergency service and bring the medication with you. You may feel drowsy and may lose consciousness. You may also feel like vomiting, have stomach pain, muscle spasms, eye movement, feel like fainting, have a slow heart rate and decreased respiratory rate and renal function. Do not attempt to drive.

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

If you forgot to take Zonisamide Sandoz

• If you forgot to take a dose, do not worry; take the next dose at the usual time.
• Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Zonisamide Sandoz

• Zonisamide is intended to be taken as a long-term medication. Do not reduce the dose or stop taking the medication unless your doctor tells you to.
• If your doctor advises you to stop treatment, he will gradually reduce the dose to minimize the risk of having more seizures.

If you have any other questions about the use of thismedication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

Immediately contact your doctor if:

• you have difficulty breathing, swelling of the face, lips, or tongue, or severe rash, as these symptoms may indicate a severe allergic reaction,
• you have signs of excessive heat: high body temperature with little or no sweating, rapid heartbeat, and rapid 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 that may lead to kidney problems,
• you have sudden back or stomach pain, pain when urinating, or notice 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 have unexplained rash, as it may become a more severe rash or skin peeling,
• you feel extremely tired or feverish, have a sore throat, swollen glands, or notice that you bruise easily, as this may indicate a blood disorder,
• you have signs of increased blood acidity: headaches, drowsiness, difficulty breathing, and loss of appetite. Medical control or treatment may be necessary.

Your doctor may decide that you should stop taking zonisamide.

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

Very common side 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 bicarbonate levels in the blood.

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

• difficulty sleeping, unusual or strange thoughts, feeling anxious or emotionally unstable,
• slow thinking, loss of concentration, speech abnormalities, strange sensation in the skin (tingling), tremor, involuntary eye movements,
• kidney stones,
• rashes, itching, allergic reactions, fever, fatigue, flu-like symptoms, hair loss,
• bruising, swelling, or redness of the skin,
• loss of weight, nausea, indigestion, stomach pain, diarrhea, constipation,
• swelling of the legs and feet.

Rare side effects: may affect up to 1 in 100 people

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

Very rare side 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 eliminate),
• severe rashes or skin peeling (may also feel unwell and have a fever).
• abnormal muscle breakdown (may have muscle pain or weakness) that may lead to kidney problems,
• swollen glands, blood disorders (reduced number of blood cells, which may make you more prone to infections and feel pale, tired, and feverish, and bruise easily),
• decreased sweating, excessive body temperature.
• Glaucoma, which is a blockage of fluid in the eye that causes increasing pressure in the eye. It may cause eye pain, blurred vision, or decreased vision, and may be a sign of glaucoma.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de medicamentos de Uso Humano:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe blister pack and packagingafter CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Do not use this medication if you observe any sign of deterioration in the capsules, blister pack or packaging, or any visible sign of deterioration in the medication. Return the packaging to your pharmacist.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Zonisamida Sandoz

Zonisamida Sandoz 25 mg hard capsules

• The active ingredient is zonisamida.Each capsule contains 25 mg of zonisamida.
• The other componentsare:

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

Capule coating: gelatin, titanium dioxide (E171).

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

Zonisamida Sandoz 50 mg hard capsules

• The active ingredient is zonisamida.Each capsule contains 50 mg of zonisamida.
• The other componentsare:

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

Capule coating: gelatin, titanium dioxide (E171).

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

Zonisamida Sandoz 100 mg hard capsules

• The active ingredient is zonisamida.Each capsule contains 100 mg of zonisamida.
• The other componentsare:

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

Capule coating: gelatin, titanium dioxide (E171).

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

Appearance of the product and contents of the package

Zonisamida 25 mg hard capsules have a white opaque body with a white opaque cap, size No. 4, 14.4 mm, marked with “Z 25” in black.

Zonisamida 50 mg hard capsules have a white opaque body with a white opaque cap, size No. 3, 15.8 mm, marked with “Z 50” in red.

Zonisamida 100 mg hard capsules have a white opaque body with a white opaque cap, size No. 1, 19.3 mm, marked with “Z 100” in black.

Zonisamida Sandoz capsules are packaged in blisters that are in turn packaged in 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 responsible

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer responsible

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 with the following names:

MaltaZonisamide – 1 A Pharma 25 mg / 50 mg / 100 mg hard capsules

Bulgaria???????????????25 mg / 50 mg / 100 mg?????????????

Czech RepublicZonisamid Sandoz 25 mg / 50 mg / 100 mg tvrdé tobolky

CyprusZonisamide Sandoz 25mg / 50 mg / 100 mg

GermanyZonisamid – 1 A Pharma 25 mg / 50 mg / 100 mg Hartkapseln

DenmarkZonisamide 1A Farma

EstoniaZonisamide Sandoz

SpainZonisamida Sandoz 25 mg / 50 mg / 100 mg cápsulas duras EFG

FranceZonisamide Sandoz 25 mg / 50 mg / 100 mg gélule

CroatiaZonisamid Sandoz 25 mg / 50 mg / 100 mg tvrde kapsule

ItalyZonisamide Sandoz

LithuaniaZonisamide Sandoz 25 mg / 50 mg / 100 mg kietosios kapsules

LatviaZonisamide Sandoz 25 mg / 50 mg / 100 mg cietas kapsulas

NetherlandsZonisamide Sandoz 25 mg /50 mg / 100 mg, harde capsules

PolandZonisamide Sandoz

SwedenZonisamide1A Farma

SloveniaZonisamid Sandoz 25 mg / 50 mg / 100 mg trde capsule

SlovakiaZonisamid Sandoz 25 mg / 50 mg / 100 mg

Last review date of thisleaflet:May 2023

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/