ZONISAMIDE AUROVITAS 25 mg HARD CAPSULES

2. What you need to know before you take Zonisamide Aurovitas

Do not takeZonisamide Aurovitas

• 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 may cause severe allergic reactions, serious skin rashes, and blood disorders, which can very rarely be life-threatening (see section 4. Possible side effects).

There have been reports of serious skin rashes associated with zonisamide therapy, including cases of Stevens-Johnson syndrome.

The use of zonisamide may result in high blood ammonia levels, which could affect brain function, especially if you are also taking other medicines that may 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 disease. Tell your doctor immediately if you feel unusually drowsy or confused.

Consult your doctor or pharmacist before taking zonisamide if:

• you are under 12 years old, as you may have a higher risk of decreased sweating, heat stroke, pneumonia, and liver problems. Zonisamide is not recommended for use in children under 6 years old.
• you are elderly, as your dose of zonisamide may need to be adjusted, and you may have a higher risk of developing an allergic reaction, serious skin rash, swelling of legs and feet, and itching when taking zonisamide (see section 4. Possible side effects).
• you have liver problems, as your dose of zonisamide may need to be adjusted.
• you have eye problems such as glaucoma.
• you have kidney problems, as your dose of zonisamide may need to be adjusted.
• you have previously had kidney stones, as you may have a higher risk of having more kidney stones. Reduce the risk of having kidney stones by drinking plenty of water.
• you live in a hot place or are going on holiday to a hot place. Zonisamide may make you sweat less, which can result in your body temperature increasing. 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 make you lose more weight. Tell your doctor, as you may need to be monitored.
• if you are pregnant or could become pregnant (for more information, see the section "Pregnancy, breastfeeding, and fertility").

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

Children and adolescents

Consult your doctor about the following risks:

Prevention of heat excess and dehydration in children

Zonisamide may cause your child to sweat less or have heat excess, which can cause brain damage and death if not treated. Children are the most vulnerable population, especially on hot days.

While your child is taking zonisamide:

• Keep them cool, especially on hot days.
• Your child should avoid strenuous exercise, especially when it is hot.
• Give them plenty of cold water to drink.
• Your child should not take these 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, the child feels confused or has muscle cramps, or their heart rate or breathing is fast.

• Take the child to a cool, shaded area.
• Pass a sponge with fresh (not cold) water over the child's skin.
• Give the child cold water to drink.
• Seek urgent medical attention.

• 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 other medicine that may cause kidney stones (see Other medicines). Your doctor will monitor your child's blood bicarbonate levels and kidneys (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.

Other medicines and Zonisamide Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might 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. In children, this combination is not recommended.
• Zonisamide may 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 dose of zonisamide.

Taking Zonisamide Aurovitas 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. 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 your concentration, ability to react/respond, and may make you feel drowsy, especially at the start of treatment or after increasing the dose. If zonisamide affects you in this way, be especially careful when driving or using machines.

Zonisamide Aurovitas contains azo colorants

These medicines contain azo colorants such as brilliant blue FCF (E133) (50 mg dose), orange yellow S (E110) (50 mg and 100 mg doses), and allura red AC (E129) (50 mg and 100 mg doses), which may cause allergic reactions.

3. How to take Zonisamide Aurovitas

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Recommended dose in adults

If you are taking zonisamide on its own:

• The initial dose is 100 mg once a day.
• This can be increased by up to 100 mg at intervals of two weeks.
• The recommended dose is 300 mg once a day.

If you are taking zonisamide with other antiepileptics:

• The initial dose is 50 mg a day divided into two equal doses of 25 mg.
• This can 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 side effects, are elderly, or have kidney or liver 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.
• This can 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 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 the 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 that the action of zonisamide is too strong or too weak, tell your doctor or pharmacist.

• The 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 in the evening.

If you take more Zonisamide Aurovitas than you should

If you have taken more zonisamide than you should, tell the person taking care of you (family or friend), your doctor, or pharmacist, or contact the emergency department of the nearest hospital and take the medicine with you. You may feel drowsy and may lose consciousness. You may also feel sick, have stomach pain, muscle spasms, eye movements, feel faint, have a slow heart rate, and decreased kidney function. Do not try to drive.

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.

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 forgotten doses.

If you stop taking Zonisamide Aurovitas

• Zonisamide is intended to be taken as a long-term medicine. Do not reduce the dose or stop taking the medicine unless your doctor advises you to.
• If your doctor advises you to stop treatment, they will gradually reduce the dose to minimize the risk of you 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, this medicine 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, serious 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 a severe rash, as these symptoms may indicate that you are having a severe allergic reaction.
• you have signs of excessive heating: 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 who were receiving treatment with antiepileptics like 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 destruction 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 vision problems such as eye pain or blurred vision while taking zonisamide.

Contact your doctor as soon as possible if:

• you have an unexplained rash, as it could become a more severe rash or skin peeling.
• you feel especially tired or feverish, have a sore throat, swollen glands, or notice that you bruise more easily, as this may mean that 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 frequent adverse effects of zonisamide are 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, decrease in 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), 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 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 status (prolonged or repeated convulsions).
• respiratory disorders, breathing difficulties, lung inflammation.
• pancreatitis (severe stomach or back pain).
• liver problems, kidney failure, increased creatinine levels (a waste product that the kidneys should normally eliminate) in the blood.
• severe skin rashes or peeling (you may feel unwell and have a fever at the same time).
• abnormal muscle destruction (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 may be signs of glaucoma.

Reporting 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. Conservation of Zonisamida Aurovitas

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging or blister, after "CAD". The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines that you no longer need in the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition ofZonisamida Aurovitas

• The active ingredient 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 content:microcrystalline cellulose (grades 101 and 102), macrogolglycerol hydroxystearate, and hydrogenated vegetable oil.

Capsule shell:titanium dioxide (E171), brilliant blue FCF (E133) (only for 50 mg), allura red AC (E129) (only for 50 mg and 100 mg), orange yellow S (E110) (only for 50 mg and 100 mg), and gelatin.

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

Product Appearance and Package Contents

Zonisamida Aurovitas 25 mg hard capsules EFG[approximate size 14.4 mm]

Hard gelatin capsule of size "4", with the cap of white or off-white opaque color and the body of white or off-white opaque color, with the imprint "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 the cap of gray opaque color and the body of white or off-white opaque color, with the imprint "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 the cap of red opaque color and the body of white or off-white opaque color, with the imprint "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.

Package sizes:

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

Hospital packages:25 mg: 56 hard capsules.

50 mg: 14 hard capsules.

100 mg: 28 hard capsules.

Not all package sizes may be marketed.

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

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

O

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

This medicine is authorized in the Member States of the European Economic Area with the following names:

Germany: Zonisamid PUREN 25 mg/50 mg/100 mg hard capsules

Spain: Zonisamida Aurovitas 25 mg/50 mg/100 mg hard capsules EFG

France: Zonisamide Arrow 25 mg/50 mg/100 mg gelule

Portugal: Zonisamida Generis

Date of the last revision of this prospectus: September 2023

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