ZONISAMIDE ARISTO 50 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Zonisamide Aristo 50 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 Aristo is and what it is used for
2. What you need to know before you take Zonisamide Aristo
3. How to take Zonisamide Aristo
4. Possible side effects
5. Storage of Zonisamide Aristo
6. Contents of the pack and other information

1. What Zonisamide Aristo is and what it is used for

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

Zonisamide is used to treat partial seizures that affect only a part of the brain, which may or may not be followed by a generalized seizure.

Zonisamide can be used:

?? On its own to treat seizures in adults.

?? With other antiepileptics to treat seizures in adults, adolescents, and children aged 6 years and older.

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

Do not take Zonisamide Aristo:

?? 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 Aristo 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 disease. Inform 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.
• if you are elderly, as it may be necessary to adjust the dose of zonisamide, 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 Aristo (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 eye problems such as glaucoma.
• 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 have a 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 go on holiday to a hot place. Zonisamide can 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.
• 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 blood acid levels and kidney stones: reduce these risks by ensuring your child drinks plenty of water and does not take any other medicine that can cause kidney stones (see Other medicines). Your doctor will check 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 Aristo

Tell your doctor or pharmacist if you are using, have recently used, or might use 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.

? Other medicines such as phenytoin, carbamazepine, phenobarbitone, and rifampicin may decrease blood levels of zonisamide, which may require an adjustment of the dose of zonisamide.

Taking Zonisamide Aristo with food and drinks

Zonisamide can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Women of childbearing potential have to 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, 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 Aristo 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 Aristo affects you in this way, be especially careful when driving or using machines.

Important information about some of the ingredients of Zonisamide Aristo

This medicine may cause stomach upset and diarrhea because it contains macrogolglycerol hydroxystearate and castor oil.

3. How to take Zonisamide Aristo

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 take zonisamide on its own:

?? The initial dose is 100 mg once a day.

?? It can be increased by up to 100 mg at intervals of two weeks.

?? The recommended dose is 300 mg once a day.

If you take zonisamide 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 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.

?? It 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 the effect of zonisamide is too strong or too weak, talk to 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 Aristo 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 like vomiting, have stomach pain, muscle spasms, eye movements, feel like you are going to faint, have a slow heart rate, and decreased kidney function. Do not try to drive.

In case of overdose or accidental ingestion, consult the Toxicology Information Service, telephone 91562 04 20, stating the medicine and the amount used.

If you forget to take Zonisamide Aristo

?? 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 Aristo

?? 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 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, 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 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 receiving treatment with antiepileptics 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 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 have an unexplained rash, as it may 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 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 adverse effects of zonisamide reported most frequently 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.

?? rashes, itching, allergic reactions, fever, fatigue, flu-like symptoms, hair loss.

?? ecchymosis (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):

?? fury, aggressiveness, suicidal thoughts, attempted suicide.

?? vomiting.

?? gallbladder inflammation or gallstones.

?? urinary stones.

?? lung 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, breathing difficulties, lung inflammation.

?? pancreas inflammation (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 also feel unwell and have a fever).

?? 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 be pale, feel 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 or that produces an increase in the internal pressure of the eye. You may experience 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, pharmacist, or nurse, even if it is an adverse effect that does not appear in this leaflet.

You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Zonisamide Aristo

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 on the box 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 observe any signs of deterioration in the capsules, blister pack, or box, 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 SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Zonisamide Aristo

The active ingredient in Zonisamide Aristo is zonisamide. Each capsule contains 50 mg of zonisamide.

?? The other components are: microcrystalline cellulose, hydrogenated vegetable oil, and macrogolglycerol hydroxystearate

?? The capsule shell contains: gelatin, titanium dioxide (E171), and black iron oxide (E172).

Appearance of the Product and Package Contents

Hard gelatin capsules with a gray opaque cap and a white opaque body, filled with white to off-white granules.

They are presented in blister packs of 14, 28, and 56 hard capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

Manufacturer

Laboratorios Medicamentos Internacionales, S.A. (Medinsa)

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

or

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

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

Portugal: Zonisamida Aristo

Italy: Zonisamide Aristo

United Kingdom: Zonisamide Aristo 50 mg hard capsules

Austria: Zonisamid Aristo 50 mg Hartkapseln

Netherlands: Zonisamide Aristo 50 mg harde capsules

Date of the Last Revision of this Leaflet: May 2023

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