Zonisamide Viso Farmaceutica 100 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Zonisamide Viso Farmacéutica 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Zonisamida Viso Farmacéutica is and what it is used for

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

Zonisamida Viso Farmacéutica 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).

Zonisamida Viso Farmacéutica can be used:

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

2. What you need to know before starting to take Zonisamide Viso Farmacéutica

Do not take Zonisamide Viso Farmacéutica:

• 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 be fatal (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 medicines 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 experience unusual drowsiness or confusion.

Consult your doctor or pharmacist before starting zonisamide:

• if you are under 12 years of age, as you may have an increased risk of experiencing *reduced sweating, heat stroke, pneumonia, and liver problems*. The use of zonisamide is not recommended in children under 6 years of age.
• if you are elderly, as the dose of zonisamide may need to be adjusted, and you may have a higher likelihood of developing an allergic reaction, severe rash, swelling of legs and feet, and itching while taking zonisamide (see section 4. Possible adverse effects).
• if you have liver problems, as the dose of zonisamide may need to be adjusted.
• if you have kidney problems, as the dose of zonisamide may need to be adjusted.
• if you 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 enough water.
• if you live in or are traveling to a hot climate, as zonisamide may reduce sweating, which could lead to an increase in body temperature. Reduce the risk of overheating by drinking enough water and keeping cool.
• if you 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.
• if you are pregnant or could become pregnant (for further information, see section “Pregnancy, breastfeeding and fertility”).

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

Children and adolescents

Consult your doctor regarding the following risks:

• Weight: You should 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 acid levels in the blood 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 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 not known whether the potential benefits outweigh the risks in this age group.

Use of Zonisamida Viso Farmacéutica with other medicines

Inform 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 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 might require adjustment of the zonisamide dose.

Taking Zonisamida Viso Farmacéutica with food and drinks

Zonisamide may be taken with or without food.

Pregnancy, breastfeeding, and fertility

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

If you plan to become pregnant, speak with your doctor before stopping contraception and before becoming pregnant about the possibility of switching to other appropriate treatments. If you are or think you may be pregnant, inform your doctor immediately. Do not discontinue treatment without consulting your doctor.

Zonisamide should only be taken during pregnancy if specifically instructed by your doctor. Research shows an increased risk of birth defects in children of women who take antiepileptic medicines. The risk of birth defects or neurodevelopmental disorders (problems in brain development) for your child after taking Zonegran 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 are fully informed 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. Studies conducted in animals have shown changes in fertility parameters.

Driving and use of machines

Zonisamide may affect concentration and reaction/response ability, and may cause drowsiness, especially at the beginning of treatment or after increasing the dose. Exercise particular caution when driving vehicles or operating machinery if zonisamide affects you in this way.

3. How to take Zonisamide Viso Farmacéutica

Follow exactly the instructions for the administration of Zonisamide Viso Farmacéutica provided by your doctor. If in doubt, please consult your doctor or pharmacist again.

Recommended dose in adults

If you are taking Zonisamide Viso Farmacéutica alone:

• The initial dose is 100 mg once daily.
• It may be increased by 100 mg at intervals of two weeks.
• The recommended dose is 300 mg once daily.

If you are taking Zonisamide Viso Farmacéutica 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 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 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 intervals of one to two weeks.
• The recommended daily dose is between 6 mg and 8 mg per kg for a child with a body weight up to 55 kg, or between 300 mg and 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 Viso Farmacéutica is too strong or too weak, inform your doctor or pharmacist.

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

If you take more Zonisamide Viso Farmacéutica than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested. 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, decreased respiratory rate, and impaired kidney function. Do not attempt to drive.

If you forget to take Zonisamide Viso Farmacéutica

• 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 missed doses.

If you stop taking Zonisamide Viso Farmacéutica

• Zonisamide is intended to be taken as a long-term medication. 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 experiencing 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, zonisamide can cause adverse effects, although not everyone experiences them.

Zonisamida belongs to a group of medicines (sulfonamides) that can cause serious allergic reactions, severe rashes, and blood disorders, which very rarely may lead to 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 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 the back or stomach, pain when urinating, or notice 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 develop an unexplained rash, as it may progress to a more severe rash or skin peeling.
• you feel particularly tired or feverish, have a sore throat, swollen glands, or notice you bruise more easily, as this may indicate 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 most frequently reported adverse effects of zonisamide are generally 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 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 sensations (tingling), tremor, involuntary eye movements.
• kidney stones.
• rashes, itching, allergic reactions, fever, fatigue, flu-like symptoms, hair loss.
• bruising (small bruises caused by blood from broken blood vessels under the skin).
• weight loss.
• nausea, indigestion, stomach pain, diarrhea, 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.

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), status epilepticus (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 cells, which may make you more prone to infections, appear pale, feel 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 causing increased internal eye pressure. Eye pain, blurred vision, or reduced vision may occur and could be signs of glaucoma.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist. This includes any possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es

By reporting adverse effects, you can help provide 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 expiry date stated on the blister and the outer carton 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 carton, or any visible signs of medicine degradation. 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 your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Zonisamide Viso Farmacéutica

The active substance in Zonisamide Viso Farmacéutica is zonisamide.

Zonisamide Viso Farmacéutica 100 mg hard capsules contain 100 mg of zonisamide.

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

• The capsule shell contains: gelatin and titanium dioxide (E171). In addition, the shell of the 100 mg capsules contains quinoline yellow (E104) and erythrosine (E127).

Appearance of Zonisamide Viso Farmacéutica and pack contents

Zonisamide Viso Farmacéutica 100 mg hard capsules have an opaque red cap and an opaque white body, marked with a "G" and "744", approximately 19.20 ± 0.5 mm in size.

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

Only some pack 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

For further information about this medicinal product, please contact 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 leaflet: May 2023

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