ZONISAMIDE VISO FARMACEUTICA 25 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Zonisamide Viso Pharmaceutical 25 mg Hard Capsules EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, 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. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Zonisamide Viso Pharmaceutical is and what it is used for
2. What you need to know before you take Zonisamide Viso Pharmaceutical
3. How to take Zonisamide Viso Pharmaceutical
4. Possible side effects
5. Storage of Zonisamide Viso Pharmaceutical
6. Contents of the pack and other information

1. What Zonisamide Viso Pharmaceutical is and what it is used for

Zonisamide Viso Pharmaceutical contains the active substance zonisamide and is used as an antiepileptic.

Zonisamide Viso Pharmaceutical is used to treat seizuresthat affect only a part of the brain (partial seizures), which may or may not be followed by a seizure that affects the entire brain (secondary generalization).

Zonisamide Viso Pharmaceutical may be used:

• On its own to treat convulsive seizures in adults.
• With other antiepileptics to treat convulsive seizures in adults, adolescents, and children aged 6 years and older.

2. What you need to know before you take Zonisamide Viso Pharmaceutical

Do not take Zonisamide Viso Pharmaceutical:

• 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, 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 blood ammonia levels, which could alter 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 results in excessive ammonia production in the body (urea cycle disorder), or if you have liver disorders. Inform 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 reduced sweating, heat stroke, pneumonia, and liver problems.Zonisamide is not recommended for use in children under 6 years old.
• if 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 legs and feet, and itching when taking zonisamide (see section 4. Possible side effects).
• if you have liver problems, as it may be necessary to adjust the dose of zonisamide.
• if you have kidney problems, as it may be necessary to adjust the dose of zonisamide.
• if 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.
• if you live in a hot place or are going on vacation 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.
• if you are underweight or have lost a lot of weight, as zonisamide can make you lose more weight. Inform your doctor, as it may be necessary to monitor you.
• if you are pregnant or could become pregnant (for more information, see the section "Pregnancy, breastfeeding, and fertility").

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

Children and adolescents

Consult your doctor about the following risks:

• 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 old, as it is not known if the potential benefits are greater than the risks in this age group.

Use of Zonisamide Viso Pharmaceutical with other medicines

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

• 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 possibly increase blood levels of medicines such as digoxin and quinidine, and 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 may require an adjustment of the zonisamide dose.

Taking Zonisamide Viso Pharmaceutical with food and drinks

Zonisamide can 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 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 consulting 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 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 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 start of treatment or after increasing the dose. Be especially careful when driving vehicles or operating machines if zonisamide affects you in this way.

3. How to take Zonisamide Viso Pharmaceutical

Follow exactly the administration instructions of Zonisamide Viso Pharmaceutical given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Recommended dose in adults

If you take Zonisamide Viso Pharmaceutical 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 Viso Pharmaceutical 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 may be increased more slowly if you experience side effects or have liver or kidney 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 mg and 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 over 55 kg (the lower of these 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 Viso Pharmaceutical is too strong or too weak, talk to your doctor or pharmacist.

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

If you take more Zonisamide Viso Pharmaceutical than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, stating the medicine and the amount taken. You may feel drowsy and may lose consciousness. You may also feel like vomiting, have stomach pain, muscle spasms, eye movement, feel like you are going to faint, have a slow heart rate, and decreased respiratory and kidney function. Do not attempt to drive.

If you forget to take Zonisamide Viso Pharmaceutical

• If you forget to take a dose, do not worry; take the next dose at the recommended time.
• Do not take a double dose to make up for forgotten doses.

If you stop taking Zonisamide Viso Pharmaceutical

• 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, zonisamide 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 severe skin 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 painor 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.
• you experience visual problems such as eye pain or blurred vision while taking zonisamide.

Contact your doctor as soon as possible if:

• you suffer from unexplained skin rash, as it may become a more severe skin rash or peeling.
• you feel especially tired or feverish, have a sore throat, swollen glands, or notice that you bruise more easily, as this may mean 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 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, decreased 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 anomalies, abnormal sensation in the skin (tingling), tremor, involuntary eye movement.
• kidney stones.
• skin 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 stool), 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 convulsive crises/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 state (prolonged or repeated convulsions).
• 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 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 these may 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: www.notificaram.es

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Zonisamide Viso Farmacéutica

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 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 carton, or any visible signs of deterioration in the medicine. Return the packaging to your pharmacist.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at 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 Viso Farmacéutica

The active ingredient of Zonisamide Viso Farmacéutica is zonisamide.

Zonisamide Viso Farmacéutica 25 mg hard capsules contain 25 mg of zonisamide.

• The other ingredients present in the capsule content are: microcrystalline cellulose, hydrogenated vegetable oil, and sodium lauryl sulfate. The printed ink contains shellac (E904), potassium hydroxide, and black iron oxide (E172).

• The capsule shell contains: gelatin and titanium dioxide (E171).

Appearance of Zonisamide Viso Farmacéutica and Package Contents

Zonisamide Viso Farmacéutica 25 mg hard capsules have a white opaque cap and body, with a "G" and a "742", approximately 14.40 ± 0.5 mm in size.

Zonisamide Viso Farmacéutica is available in blister packs with packages containing: 14, 28, 56, 84, 98, and 196 capsules.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Glenmark Pharmaceuticals s.r.o

Fibíchova 143

566 17 Vysoké Mýto

Czech Republic

You can request more information about this medicine by contacting the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

Date of revision of this prospectus:May 2023

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