Prospect: Information for the User

Zonisamida Viso Pharmaceutical 50 mg Hard Capsules EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. What isZonisamida Viso Pharmaceuticaland for what it is used

2. What you need to know before starting to takeZonisamida Viso Pharmaceutical

3. How to takeZonisamida Viso Pharmaceutical

4. Possible adverse effects

5. Storage ofZonisamida Viso Pharmaceutical

6. Contents of the package and additional information

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

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

Zonisamida Viso Farmacéutica may be used:

• Alone to treat convulsive seizures in adults.
• With other antiepileptics to treat convulsive seizures in adults, adolescents, and children 6 years and older.

Do not take Zonisamida Viso Farmacéutica:

• if you are allergic to zonisamide or 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 antidiabetic drugs.

Warnings and precautions

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

The use of zonisamide 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 zonisamide:

• if you are under 12 years old, as you may have a higher risk of developingdecreased sweating, heatstroke, pneumonia, and liver problems.Zonisamide is not recommended for children under 6 years old.
• if you are elderly, as you may need to adjust the dose of zonisamide, and you may have a higher risk of developing an allergic reaction,severe skin rash,swelling of legs and feet, and itching when taking zonisamide (see section 4. Possible side effects).
• if you have liver problems, as you may need to adjust the dose of zonisamide.
• if you have kidney problems, as you may need to adjust the dose of zonisamide.
• if you have previously had kidney stones, as you may be at a higher risk of developing more kidney stones.Reduce the risk of developing kidney stones by drinking enough water.
• if you live in a hot place or are going on vacation to a hot place. Zonisamide may cause you to sweat less, which can lead to an increased body temperature.Reduce the risk of overheating by drinking enough water and staying cool.
• if you are underweight or have lost a lot of weight, as zonisamide may cause you to lose more weight. Inform your doctor, as you may need to be monitored.
• if you are pregnant or could become pregnant (see section “Pregnancy, breastfeeding, and fertility” for more information).

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 must monitor your child's weight monthly and see your doctor as soon as possible if they are not gaining enough weight.Zonisamide 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 it is not known if the potential benefits outweigh the risks in this age group.

Use of Zonisamida Viso Farmacéutica with other medications

Inform your doctor or pharmacist if you are using or have recently used any other medication, including those purchased without a prescription.

• Zonisamide 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.
• Zonisamide may increase the levels of medications such as digoxin and quinidine in the blood, and therefore may require a reduction in the dose of these medications.
• Other medications such as phenytoin, carbamazepine, phenobarbital, and rifampicin may decrease the levels of zonisamide in the blood, which may require an adjustment in the dose of zonisamide.

Taking Zonisamida Viso Farmacéutica 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 intend 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 treatment without consulting your doctor.

You should only take zonisamide during pregnancy if your doctor advises it. Research has shown 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 Zonegran during pregnancy is unknown. 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. Ensure that you are informed in detail 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 operating machinery

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

Follow exactly the administration instructions for Zonisamide Viso Farmacéutica as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Recommended dose in adults

When taking Zonisamide Viso Farmacéutica alone

• The initial dose is 100 mg once a day.
• It can be increased by 100 mg in intervals of two weeks.
• The recommended dose is 300 mg once a day.

When taking Zonisamide Viso Farmacéutica with other antiepileptic drugs

• The initial dose is 50 mg per day divided into two equal doses of 25 mg.
• It can be increased by 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 could 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) weighing 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 mg and 8 mg for a child weighing up to 55 kg or between 300 mg and 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 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 can be taken once or twice a day, as instructed by your doctor.
• If you take Zonisamide Viso Farmacéutica twice a day, take half the daily dose in the morning and the other half at night.

When taking more Zonisamide Viso Farmacéutica than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. 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.

When 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 compensate for the missed doses.

When interrupting treatment with Zonisamide Viso Farmacéutica

• 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, the dose will be gradually reduced to minimize the risk of having more seizures.

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

Like all medicines, zonisamide can cause side effects, although not everyone will experience them.

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

Immediately contact your doctor if:

• you havedifficulty breathing, facial swelling, lip or tongue swelling, orsevere rashas these symptoms may indicate a severe allergic reaction.
• you haveexcessive heat signs: high body temperature with little or no sweating, rapid heartbeat, rapid breathing, muscle cramps, and confusion.
• you have hadthoughts 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 havemuscle painor feel weak, as this may be a sign of abnormal muscle breakdown that can lead to kidney problems.
• you have a sudden back or stomach pain, painful urination, 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 haveunexplained rash, as it may become a more severe rash or skin peeling.
• you feelespecially 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 commonly reported side effects of zonisamide are all 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 those listed below, except for the following: pneumonia, dehydration, decreased sweating (frequent), and abnormal liver enzymes (rare).

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 unstable emotionally.
• slow thinking, loss of concentration, speech abnormalities, abnormal skin sensations (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 skin blood vessel).
• weight loss.
• nausea, indigestion, stomach pain, diarrhea (loose stools), constipation.
• swelling of 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.
• pulmonary infection/inflammation, urinary tract infections.
• low potassium levels in the blood and convulsions/epileptic attacks.

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 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 rashes or skin peeling (may also feel unwell and have a fever).
• abnormal muscle breakdown (may have muscle pain or weakness) that can 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 may bruise easily).
• decreased sweating, high body temperature.
• glaucoma, which is a blockage of the eye's drainage that causes increased eye pressure. May cause eye pain, blurred vision, or decreased vision and may be signs of glaucoma

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist. Even if it's possible side effects that don't appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaram.es

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

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and on the box after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Do not use this medication if you observe any sign of deterioration in the capsules, blister pack, or box, 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. Dispose of the packaging and medications you no longer need at thepharmacy. 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 Viso Farmacéutica

The active ingredient ofZonisamida Viso Farmacéuticais zonisamida.

Zonisamida Viso Farmacéutica 50 mg hard capsules contain 50 mg of zonisamida.

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

• The capsule coating contains: gelatin and titanium dioxide (E171). Additionally, the coating of the 50 mg capsules contains iron oxide black (E172).

Appearance of the product and content of the packaging

Zonisamida Viso Farmacéutica 50 mg hard capsules have a grey opaque cap and a white opaque body, with a “G” and a “743”, approximately 15.80± 0.5 mm in size.

Zonisamida Viso Farmacéutica is available in blisters with packaging that contains: 28 and 56 capsules.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Glenmark Arzneimittel GmbH

Industriestr. 31,

82194 Gröbenzell,

Germany

Responsible for manufacturing:

Glenmark Pharmaceuticals sro

Fibíchova 143,

566 17 Vysoké Mýto,

Czech Republic

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Viso Farmacéutica, S.L.U.

c/ Retama 7, 7th Floor,

28045 Madrid,

Spain

Date of review of this leaflet:May 2023

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