ZONISAMIDE ARISTO 100 mg HARD CAPSULES

Introduction

Prospective: Information for the User

Zonisamide Aristo 100 mg Hard Capsules EFG

Read the entire prospectus carefully before starting to take this medication, as it contains important information for you.

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

Contents of the Prospectus:

1. What Zonisamide Aristo is and what it is used for
2. What you need to know before taking Zonisamide Aristo
3. How to take Zonisamide Aristo
4. Possible adverse effects
5. Storage of Zonisamide Aristo
6. Package contents and additional information

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

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

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

Zonisamide may be used:

?? Alone to treat seizures in adults.

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

2. What you need to know before taking Zonisamide Aristo

Do not take Zonisamide Aristo:

?? 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, such as sulfonamide antibiotics, thiazide diuretics, and sulfonylurea antidiabetics.

Warnings and precautions

Zonisamide belongs to a group of medications (sulfonamides) that can cause severe allergic reactions, serious skin rashes, and blood disorders, which can very rarely be fatal (see section 4. Possible adverse 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 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 disease. Inform your doctor immediately if you feel unusually drowsy or confused.

Consult your doctor or pharmacist before starting to take zonisamide:

• if you are under 12 years old, as you may be at higher risk of decreased sweating, heat stroke, pneumonia, and liver problems. Zonisamide is not recommended for children under 6 years old.
• if you are elderly, as it may be necessary to adjust the dose of zonisamide, and you may be more likely to develop an allergic reaction, serious skin rash, swelling of the legs and feet, and itching when taking Zonisamide Aristo (see section 4. Possible adverse 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 be at higher risk of having more kidney stones. Reduce the risk of kidney stones by drinking enough water.
• if you live in a hot place or are going on vacation to a hot place. Zonisamide can make you sweat less, which can result in your body temperature rising. 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 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 "Pregnancy, breastfeeding, and fertility" section).

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 consult the 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 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 medication that can cause kidney stones (see Other medications). Your doctor will monitor your child's blood bicarbonate levels and kidney function (see also section 4).

Do not give this medication to children under 6 years old, as it is not known whether the potential benefits outweigh the risks in this age group.

Other medications and Zonisamide Aristo

Inform your doctor or pharmacist if you are using, have recently used, or may need to use 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 blood levels of medications such as digoxin and quinidine, and it may be necessary to reduce the dose of these medications.

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

Taking Zonisamide Aristo 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 plan to become pregnant, consult 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.

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 neurodevelopmental disorders (brain development problems) for your child after taking zonisamide 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 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 can affect concentration, reaction capacity, and may cause drowsiness, 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.

Important information about some of the components of Zonisamide Aristo

This medication can cause stomach upset and diarrhea because it contains macrogolglycerol hydroxystearate and castor oil.

This medication can cause allergic reactions because it contains a red dye called Ponceau 4R (E124).

It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Zonisamide Aristo

Follow the administration instructions for this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Recommended dose in adults

If you take zonisamide alone:

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

?? It can be increased by up to 100 mg at two-week intervals.

?? 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 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 kidney or liver problems.

Use in children (6-11 years) and adolescents (12-17 years) 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 at one- to two-week intervals.

?? The recommended daily dose is between 6 mg and 8 mg per kg for a child weighing up to 55 kg or between 300 mg and 500 mg for a child weighing over 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 start of each week until the daily dose of 150-200 mg is reached.

If you think the effect of zonisamide is too strong or too weak, inform your doctor or pharmacist.

?? 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 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, inform the person caring for you (family or friend), your doctor, or pharmacist immediately, or contact the emergency department of the nearest hospital and take the medication 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 respiratory and kidney function. Do not attempt to drive.

In case of overdose or accidental ingestion, consult the Toxicology Information Service, telephone 91562 04 20, indicating the medication 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 treatment with Zonisamide Aristo

?? Zonisamide is intended to be taken as a long-term medication. Do not reduce the dose or stop taking the medication unless your doctor advises it.

?? 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 other questions about the use of this medication, 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 who were 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 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 adverse effects of zonisamide that are most frequently reported 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, strange or unusual thoughts, feeling anxious or emotionally unstable.

?? slow thinking, loss of concentration, speech abnormalities, 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 stools), constipation.

? swelling of the legs and feet.

Uncommon adverse effects(may affect up to 1 in 100 people):

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

?? vomiting.

?? inflammation of the gallbladder 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 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 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 it more likely that you will have infections and that you will 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 that causes 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 is not listed 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 carton 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 notice any signs of deterioration in the capsules, blister pack, or carton, or any visible signs of deterioration in the medicine. Return the packaging to your pharmacist.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines that you no longer need at the SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This 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 100 mg of zonisamide.

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

?? The capsule shell contains: gelatin, titanium dioxide (E171), Ponceau 4R red dye (E124), and quinoline yellow (E104).

Appearance of the Product and Package Contents

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

They are available in blister packs of 28, 56, and 98 hard capsules.

Only some package 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 100 mg hard capsules

Austria: Zonisamid Aristo 100 mg Hartkapseln

Netherlands: Zonisamide Aristo 100 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/