Zonisamide Aurovitas 50 mg hard capsules EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Zonisamide Aurovitas 25 mg Hard Capsules EFG

Zonisamide Aurovitas 50 mg Hard Capsules EFG

Zonisamide Aurovitas 100 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do 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 effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

Zonisamide 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).

Zonisamide can be used:

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

2. What you need to know before taking Zonisamide Aurovitas

Do not take Zonisamide Aurovitas

• 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 skin rashes, and blood disorders, which very rarely may be fatal (see section 4. Possible side effects).

Severe skin rashes have been reported with zonisamide therapy, including cases of Stevens-Johnson syndrome.

Zonisamide use may lead to high levels of ammonia in the blood, which could alter brain function, especially if you are also taking other medicines that may 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 problems. Inform your doctor immediately if you become unusually drowsy or confused.

Consult your doctor or pharmacist before starting zonisamide if:

• you are under 12 years of age, as you may have an increased risk of reduced sweating, heat stroke, pneumonia, and liver problems. The use of zonisamide is not recommended in children under 6 years of age.
• you are elderly, as the dose of zonisamide may need to be adjusted, and you may have a higher risk of developing an allergic reaction, severe rash, swelling of legs and feet, or itching while taking zonisamide (see section 4. Possible side effects).
• you have liver problems, as the dose of zonisamide may need to be adjusted.
• you have eye problems such as glaucoma.
• you have kidney problems, as the dose of zonisamide may need to be adjusted.
• you have previously had kidney stones, as you may be at higher risk of developing further kidney stones. Reduce your risk of kidney stones by drinking enough water.
• you live in or are travelling to a hot climate. Zonisamide may reduce sweating, which could lead to an increase in body temperature. 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 may cause further weight loss. Inform your doctor, as monitoring may be needed.
• you are pregnant or could become pregnant (for more information, see section “Pregnancy, breastfeeding and fertility”).

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

Children and adolescents

Discuss the following risks with your doctor:

Prevention of overheating and dehydration in children

Zonisamide may cause your child to sweat less or experience excessive heat, which could lead to brain damage or death if not treated. Children are the most vulnerable population group, especially on hot days.

While your child is taking zonisamide:

• Keep your child cool, especially on hot days.
• Your child should avoid strenuous exercise, particularly in hot weather.
• Give your child plenty of cold water to drink.
• Your child must not take the following medicines:

carbonic anhydrase inhibitors (e.g., topiramate and acetazolamide) and anticholinergics (e.g., clomipramine, hydroxyzine, diphenhydramine, haloperidol, imipramine, and oxybutynin).

If your child’s skin is very hot with little or no sweating, if your child is confused or has muscle cramps, or if their heartbeat or breathing is rapid:

• Move the child to a cool, shaded place.

• Sponge the child’s skin with cool (not cold) water.

• Give the child cold water to drink.

• Seek urgent medical help.

• Weight: Monitor your child’s weight monthly and see your doctor as soon as possible if your child does not gain adequate weight. Zonisamide is not recommended in children who are underweight or have poor appetite, and should be used with caution in children weighing less than 20 kg.

• Increased blood acid levels and kidney stones: Reduce these risks by ensuring your child drinks enough water and does not take any other medicines 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 give 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.

Other medicines and Zonisamide Aurovitas

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take 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 a dose reduction of these medicines may be necessary.
• Other medicines such as phenytoin, carbamazepine, phenobarbital, and rifampicin may reduce blood levels of zonisamide, which may require a dose adjustment of zonisamide.

Taking Zonisamide Aurovitas with food and drinks

Zonisamide may be taken with or without food.

Pregnancy, breastfeeding and fertility

Women of childbearing age must use effective contraception 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, inform your doctor immediately. Do not stop treatment without consulting your doctor.

Zonisamide should only be taken during pregnancy if prescribed by your doctor. Research shows an increased risk of birth defects in children of women taking antiepileptic medicines. The risk of birth defects or neurodevelopmental disorders (problems in brain development) in your child after taking zonisamide 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 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 and reaction/responsiveness, and may cause drowsiness, especially at the beginning of treatment or after a dose increase. If zonisamide affects you in this way, take special care when driving or operating machinery.

Zonisamide Aurovitas contains macrogolglycerol hydroxystearate (polyoxyl hydrogenated castor oil)

Macrogolglycerol hydroxystearate (polyoxyl hydrogenated castor oil) may cause stomach discomfort and diarrhoea.

3. How to take Zonisamide Aurovitas

Follow exactly the dosing instructions for this medicine as prescribed by your doctor. If in doubt, consult your doctor or pharmacist again.

Recommended dose in adults

If you are taking zonisamide alone:

• The initial dose is 100 mg once daily.
• This dose may be increased by 100 mg at two-week intervals.
• The recommended dose is 300 mg once daily.

If you are taking zonisamide with other antiepileptic medicines:

• The initial dose is 50 mg per day, divided into two equal doses of 25 mg.
• The dose may be increased by up to 100 mg at one- to two-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 adverse effects, are elderly, or have renal or hepatic impairment.

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.
• This may be increased by 1 mg per kg of body weight at one- to two-week intervals.
• 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 is too strong or too weak, inform your doctor or pharmacist.

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

If you take more Zonisamide Aurovitas than you should

If you have taken more zonisamide than prescribed, inform your caregiver (family member or friend), your doctor or pharmacist immediately, or contact the nearest hospital emergency department and bring the medicine with you. You may feel drowsy and could lose consciousness. You may also experience nausea, stomach pain, muscle spasms, eye movements, feel faint, have a slow heartbeat, and reduced respiratory and kidney function. Do not attempt to drive.

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, stating the medicine and the amount ingested.

If you forget to take Zonisamide Aurovitas

• 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 missed doses.

If you stop taking Zonisamide Aurovitas

• 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 minimize the risk of increased 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, this medicine can cause adverse effects, although not everyone experiences them.

Zonisamide 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 that 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 receiving treatment with 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 may lead to kidney problems.
• you have sudden pain in your back or stomach, pain when urinating, or notice blood in your urine, as this may be a sign of kidney stones.
• you develop 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 could progress to a more severe rash or skin peeling.
• you feel unusually tired or feverish, have a sore throat, swollen glands, or notice you are bruising more easily, as this may indicate you have 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 common adverse effects of zonisamide are 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 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 (a small bruise caused by blood from a broken blood vessel in the skin).
• weight loss, nausea, indigestion, stomach pain, diarrhoea (loose stools), 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 potassium levels in blood and seizures/convulsive attacks.

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).
• respiratory disorders, difficulty breathing, lung inflammation.
• pancreatitis (severe stomach or back pain).
• liver problems, kidney failure, increased levels of creatinine (a waste product normally eliminated by the kidneys) in the blood.
• severe rashes or skin peeling (you may also feel unwell and have a fever at the same time).
• abnormal muscle breakdown (you may have muscle pain or weakness) which may lead to kidney problems.
• swollen glands, blood disorders (reduction in blood cell counts, which may make you more prone to infections, look 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 leading to increased internal eye pressure. This may cause eye pain, blurred vision or loss of vision, and may be signs of glaucoma.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect 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. Zonisamide Aurovitas Storage

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

Do not use this medicine after the expiry date stated on the outer packaging or blister, after “EXP”. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point located at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Zonisamida Aurovitas

• The active substance is zonisamide.

Each hard capsule contains 25 mg of zonisamide.

Each hard capsule contains 50 mg of zonisamide.

Each hard capsule contains 100 mg of zonisamide.

• The other components are:

Capsule contents: microcrystalline cellulose (grades 101 and 102), macrogol glycerol hydroxystearate (polyoxyl hydrogenated castor oil) and hydrogenated vegetable oil.

Capsule shell: titanium dioxide (E171), black iron oxide (E172) (only for 50 mg), red iron oxide (E172) (only for 100 mg) and gelatin.

Printing ink: shellac glaze (E904), black iron oxide (E172) and potassium hydroxide (E525).

Description of the product and contents of the pack

Zonisamida Aurovitas 25 mg hard capsules EFG [approximate size 14.4 mm]
Hard gelatin capsule of size "4", with an opaque white or off-white cap and an opaque white or off-white body, printed with “ZN” on the cap and “25” on the body, filled with a white or off-white powder.

Zonisamida Aurovitas 50 mg hard capsules EFG [approximate size 15.8 mm]
Hard gelatin capsule of size "3", with an opaque grey cap and an opaque white or off-white body, printed with “ZN” on the cap and “50” on the body, filled with a white or off-white powder.

Zonisamida Aurovitas 100 mg hard capsules EFG [approximate size 19.3 mm]
Hard gelatin capsule of size "1", with an opaque red cap and an opaque white or off-white body, printed with “ZN” on the cap and “100” on the body, filled with a white or off-white powder.

Zonisamida Aurovitas hard capsules are available in blister packs.

Pack sizes:

Blister packs: 14, 20, 28, 30, 56, 60, 84, 90, 98, 100 and 196 hard capsules.

Hospital packs: 25 mg: 56 hard capsules.
50 mg: 14 hard capsules.
100 mg: 28 hard capsules.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.
Avda. de Burgos, 16-D
28036 Madrid
Spain

Manufacturer

APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta

Or

Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal

Or

Arrow Génériques
26 Avenue Tony Garnier
69007 Lyon
France

This medicinal product is authorised in the European Economic Area member states under the following names:

Germany: Zonisamid PUREN 25 mg/50 mg/100 mg Hartkapseln
Spain: Zonisamida Aurovitas 25 mg/50 mg/100 mg hard capsules EFG
France: Zonisamide Arrow 25 mg/50 mg/100 mg gélules
Portugal: Zonisamida Generis

Date of the most recent revision of this leaflet: January 2026

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