Patient Information

Zonisamide Aristo 100 mg Hard Capsules EFG

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

-Keep this leaflet, as 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 others even if they have similar symptoms to you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you start taking Zonisamide Aristo

3.How to take Zonisamide Aristo

4.Possible side effects

5.Storage of Zonisamide Aristo

6.Contents of the pack and additional information

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

Zonisamida is used to treat seizures that 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 may be used:

??Alone to treat seizures in adults.

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

Do not take Zonisamida Aristo:

??if you are allergic to zonisamida 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 anti-diabetics.

Warnings and precautions

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

The use of Zonisamida Aristo may cause high levels of ammonia in the blood, which could change brain function, especially if you are also taking other medications that may increase ammonia levels (e.g., valproate), if you have a genetic disorder that causes too much ammonia in the body (urea cycle disorder), or if you have liver disorders. Inform your doctor immediately if you feel drowsy or confused.

Consult your doctor or pharmacist before starting to take zonisamida:

• if you are under 12 years old, as you may be at higher risk of developingdecreased sweating, heatstroke, pneumonia, and liver problems. Zonisamida is not recommended for children under 6 years old.
• if you are elderly, as you may need to adjust the zonisamida dose, and you may be at higher risk of developing an allergic reaction, severe rash, swelling of the legs and feet, and itching when taking Zonisamida Aristo (see section 4. Possible side effects).
• if you have liver problems, as you may need to adjust the zonisamida dose.
• if you have eye problems such as glaucoma.
• if you have kidney problems, as you may need to adjust the zonisamida dose.
• if you have previously had kidney stones, as you may be at higher risk of developing 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. Zonisamida may cause you to sweat less, which can lead to a higher body temperature.Reduce the risk of heatstroke by drinking enough water and staying cool.
• if you are underweight or have lost a lot of weight, as zonisamida 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 (for more information, see the section “Pregnancy, breastfeeding, and fertility).

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

Children and adolescents

Consult your doctor about the following risks:

??Weight:you should monitor your child's weight monthly and see your doctor as soon as possible if they are not gaining enough weight. Zonisamida 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 levels of acid in the blood and kidney stones: reduce these risks by ensuring your child drinks enough water and does not take any other medication that may 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 the potential benefits may not outweigh the risks in this age group.

Other medications and Zonisamida Aristo

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

?Zonisamida should be used with caution in adults if taken with medications that mayproduce kidney stones, such as topiramate or acetazolamide. In children, this combination is not recommended.

?Zonisamida may increase the levels of medications such as digoxin and quinidine in the blood, andmay require a reduction in the dose of these.

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

Administration of Zonisamida Aristo with food and drinks

Zonisamida can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Women of childbearing age should use effective contraceptive measures during zonisamida treatment and for one month after stopping zonisamida.

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 zonisamida 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 zonisamida during pregnancyis unknown. A study showed that children whose mothers used zonisamida 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 informed in detail about the risks and benefits of using zonisamida for epilepsy during pregnancy.

Do not breastfeed while taking zonisamida or for one month after stopping zonisamida.

There are no clinical data on the effects of zonisamida on human fertility. Animal studies have shown changes in fertility parameters.

Driving and operating machinery

Zonisamida may affect concentration, reaction time, and cause drowsiness, especially at the beginning of treatment or after increasing the dose. If zonisamida affects you in this way, be extra careful when driving or operating machinery.

Important information about some of the components of Zonisamida Aristo

This medication may cause stomach discomfort and diarrhea because it contains hydroxyestearate of macrogolglycerol and ricin oil.

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

It may cause asthma, especially in patients allergic to aspirin.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Recommended dose in adults

When taking zonisamide alone:

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

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

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

When taking zonisamide with other antiepileptic drugs:

??The initial dose is 50 mg per day divided into two equal doses of 25 mg.

??It can be increased up to 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, are elderly, or have kidney or liver problems.

Use in children (6 to 11 years old) and adolescents (12 to 17 years old) 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 in 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 dose) 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 beginning of each week until the daily dose of 150 to 200 mg is reached.

If you estimate that the action 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 of the daily dose in the morning and the other half at night.

When taking more Zonisamide Aristo than you should

If you have taken more zonisamide than you should, inform the person who takes care of you (family member or friend), your doctor or pharmacist, or contact the nearest hospital emergency service and bring the medication with you. You may feel drowsy and may lose consciousness. You may also feel like vomiting, have stomach pain, muscle spasms, eye movement, feel like you are fainting, have a slow heart rate, and decreased respiratory and renal function. Do not drive.

For cases of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91562 04 20 indicating the medication and the amount used.

When 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 compensate for the missed doses.

When interrupting 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 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, this medicine 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 experience difficulty breathing, facial swelling, lip or tongue swelling, or severe rash, as these symptoms may indicate a severe allergic reaction.

??you experience signs of excessive heat: 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 taking antiepileptic medicines, such as zonisamide, have had thoughts of self-harm or suicide.

??you experience muscle pain or weakness, as this may be a sign of abnormal muscle breakdown that can lead to kidney problems.

??you experience 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:if:

??you experience unexplained rash, as it may become a more severe rash or skin peeling.

??you feel extremely tired or feverish, experience sore throat, swollen glands, or notice that you bruise easily, as this may indicate a blood disorder.

??you experience signs of high acid levels in your blood: 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, side effects were consistent with those described below, except for the following: pneumonia, dehydration, decreased sweating (frequent), and abnormal liver enzymes (infrequent).

Very common side effects(may affect more than 1 in 10 people):

??agitation, irritability, confusion, depression

??muscle coordination problems, dizziness, poor memory, drowsiness, double vision

??loss of appetite, decreased bicarbonate levels in blood

Common side effects(may affect up to 1 in 10 people):

??difficulty sleeping, unusual or strange thoughts, anxiety, or mood instability.

??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.

??petechiae (small bruises caused by blood from a broken blood vessel in the skin).

?weight loss.

?nausea, indigestion, stomach pain, diarrhea (loose stools), constipation.

?swelling of legs and feet.

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

??rage, aggression, suicidal thoughts, suicide attempt.

??vomiting.

??inflammation of the gallbladder or gallstones.

??urinary stones.

??pulmonary infections or inflammation, urinary tract infections.

??low potassium levels in blood and convulsions.

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 seizures).

??respiratory disorders, difficulty breathing, lung inflammation.

??pancreatitis (severe stomach or back pain).

??liver problems, kidney failure, increased creatinine levels in blood.

??severe rashes or skin peeling (may be accompanied by fever).

??abnormal muscle breakdown (may cause 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 pale, feel tired and feverish, and bruise easily).

?decreased sweating, excessive body temperature.

?glaucoma, which is a blockage of the eye's drainage system that causes increased eye pressure. Eye pain, blurred vision, or decreased vision may be signs of glaucoma.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is not listed in this leaflet.

You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://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. Deposit the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Zonisamida Aristo

The active ingredient in Zonisamida Aristo is zonisamida.Each capsulecontains 100 mg of zonisamida.

??The other components are: microcrystalline cellulose, hydrogenated vegetable oil andhydroxyestearate of macrogolglycerol

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

Appearance of the product and contents of the packaging

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

It is presented in blisters with 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

Responsible for manufacturing

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 with 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

Last review date of this leaflet: May 2023

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