Zonisamide Aristo 100 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Zonisamida Aristo 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 pass it on to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, talk to your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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

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

Zonisamida 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).

Zonisamida may 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 starting to take Zonisamida Aristo

Do not take Zonisamida Aristo:

?? 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 antidiabetic agents.

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 lead to death (see section 4. Possible side effects).

Serious rashes have been reported in association with zonisamide therapy, including cases of Stevens-Johnson syndrome.

The use of Zonisamide Aristo may cause high levels of ammonia in the blood, 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 causing excessive ammonia production in the body (urea cycle disorder), or if you have liver disorders. 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 experiencing reduced sweating, heat stroke, pneumonia, and liver problems. The use of zonisamide is not recommended in children under 6 years of age.
• if you are elderly, as the dose of zonisamide may need to be adjusted, and you may have a higher risk of developing allergic reactions, severe rash, swelling of the legs and feet, and itching while taking Zonisamide Aristo (see section 4. Possible side effects).
• if you have liver problems, as the dose of zonisamide may need to be adjusted.
• if you have eye problems such as glaucoma.
• if you have kidney problems, as the dose of zonisamide may need to be adjusted.
• if you have previously had kidney stones, as you may be at increased risk of developing further kidney stones. Reduce the risk of kidney stones by drinking enough water.
• if you live in or are traveling to a hot climate. Zonisamide may reduce sweating, which could lead to an increase in body temperature. Reduce the risk of overheating by drinking enough water and keeping cool.
• if you are underweight or have lost a significant amount of weight, as zonisamide may cause further weight loss. Inform your doctor, as monitoring may be necessary.
• if you are pregnant or could become pregnant (for more information, see section “Pregnancy, breastfeeding and fertility”).

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

Children and adolescents

Discuss the following risks with your doctor:

Preventing overheating and dehydration in children Zonisamide may cause your child to sweat less or develop excessive heat; this could lead to brain damage or death if not treated. Children are the most vulnerable population, 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 should not take the following medications: 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 the child is confused or has muscle cramps, or if 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: You must monitor your child's weight monthly and consult your doctor as soon as possible if your child does not gain sufficient weight. Zonisamide is not recommended in children who are underweight or have poor appetite, and it 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 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 administer 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 Zonisamida Aristo

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 together 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 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 could require adjustment of the zonisamide dose.

Taking Zonisamida Aristo with food and drink

Zonisamide may 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 intend to become pregnant, speak with your doctor before stopping contraception and before becoming pregnant about the possibility of switching to other suitable treatments. If you are pregnant or think you may be pregnant, inform your doctor immediately. Do not discontinue treatment without consulting your doctor.

Zonisamide should only be taken during pregnancy if specifically instructed by your doctor. Research shows an increased risk of birth defects in children of women who take antiepileptic medicines. The risk of birth defects or neurological developmental disorders (problems in brain development) for 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. Ensure you receive detailed information about the risks and benefits of using zonisamide for epilepsy during pregnancy.

Do not breastfeed while taking zonisamide or during the month following discontinuation of zonisamide.

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

Driving and use of machines

Zonisamide may affect concentration and reaction/response ability, and may cause drowsiness, especially at the beginning of treatment or after increasing the dose. If zonisamide affects you in this way, take special care when driving or operating machinery.

Important information about some of the components of Zonisamida Aristo

This medicine may cause stomach discomfort and diarrhoea because it contains macrogol glycerol hydroxystearate and castor oil.

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

It may provoke asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Zonisamide Aristo

Follow exactly the instructions given by your doctor for this medicine. 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.

?? It may be increased by up to 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 daily, divided into two equal doses of 25 mg.

?? It 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.

?? It 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), 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 Aristo than you should

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

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone 91562 04 20, indicating the medicine and the amount taken.

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 instructed by your doctor.

?? If your doctor advises you to discontinue treatment, they will gradually reduce the dose in order to decrease the risk of having more 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 may cause adverse effects, although not everyone will experience 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 having 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 taking 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 can lead to kidney problems.

?? you suddenly have pain in your back or stomach, have painful urination, or notice 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 develop an unexplained rash, as it may 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 mean 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 adverse effects of zonisamide most commonly reported are generally mild. 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: 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 too acidic) in the blood

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

?? difficulty sleeping, unusual or strange thoughts, feeling anxious or emotionally unstable

?? 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 (small bruises caused by blood from broken blood vessels under the skin)

?? weight loss

?? nausea, indigestion, stomach pain, diarrhoea, 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

Rare adverse effects (may affect up to 1 in 1,000 people):

?? hallucinations, memory loss, coma, neuroleptic malignant syndrome (inability to move, sweating, fever, incontinence), status epilepticus (prolonged or repeated seizures)

?? breathing problems, difficulty breathing, lung inflammation

?? pancreatitis (severe stomach or back pain)

?? liver problems, kidney failure, increased levels of creatinine (a waste product normally removed by the kidneys) in blood

?? severe rashes or skin peeling (you may also feel unwell and have a fever)

?? abnormal muscle breakdown (you may have muscle pain or weakness) which can lead to kidney problems

?? swollen glands, blood disorders (reduction in blood cell counts, which may increase your risk of infections, make you 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. Eye pain, blurred vision, or vision loss may occur and can be signs of glaucoma.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is an effect not listed in this leaflet.

You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the blister and the carton after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any 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 degradation in the medicine. Return the pack to your pharmacist.

Medicines must not be disposed of via wastewater or household waste. Instead, dispose of unused medicines and their packaging at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Zonisamida Aristo

The active substance in Zonisamida Aristo is zonisamide. Each capsule contains 100 mg of zonisamide.

?? The other components are: microcrystalline cellulose, hydrogenated vegetable oil, and macrogol glycerol hydroxystearate.

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

Appearance of the product and contents of the pack

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

Available in blister packs containing 28, 56, and 98 hard capsules.

Only certain 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 medicinal product 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 most recent review of this summary: May 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS) http://www.aemps.gob.es/