Zonisamide Cinfamed 25 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

zonisamide cinfamed 25 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 yours, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What zonisamide cinfamed is and what it is used for

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

Zonisamide 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).

Zonisamide can 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 zonisamide cinfamed

Do not take zonisamide cinfamed

• 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 antidiabetics.

Warnings and precautions

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

Consult your doctor or pharmacist before starting zonisamide cinfamed:

• 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 a dose adjustment of zonisamide may be necessary, and you may have a higher risk of developing an allergic reaction, severe rash, swelling of the legs and feet, or itching while taking zonisamide (see section 4. Possible side effects).
• If you have liver problems, as a dose adjustment of zonisamide may be required.
• If you have eye problems such as glaucoma.
• If you have kidney problems, as a dose adjustment of zonisamide may be required.
• If you have previously had kidney stones, as you may be at increased risk of developing further kidney stones. Reduce the risk of developing kidney stones by drinking enough water.
• If you live in or are traveling to a hot climate. Zonisamide may reduce your ability to sweat, 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 further information, see section “Pregnancy, breastfeeding and fertility”).

If any of the above apply to you, inform your doctor before taking zonisamide.

The use of zonisamide may lead to high levels of ammonia in the blood, which could affect 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 problems. Inform your doctor immediately if you experience unusual drowsiness or confusion.

Children and adolescents

Consult your doctor regarding the following risks:

• Weight: you must monitor your child's weight monthly and see a doctor as soon as possible if they do 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 medicines that may cause kidney stones (see Other medicines and zonisamida cinfamed). 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 unknown whether the potential benefits outweigh the risks in this age group.

Other medicines and zonisamida cinfamed

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

• 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 could 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 dose of this medicine.

Taking zonisamida cinfamed with food and drinks

Zonisamide may be taken with or without food.

Pregnancy, breastfeeding, and fertility

Women of childbearing age must use effective contraception during treatment with zonisamide and for one month after stopping zonisamide.

If you plan to become pregnant, speak with your doctor before stopping contraception and before becoming pregnant about the possibility of switching to other appropriate treatments. If you are or think you may be pregnant, inform your doctor immediately. Do not stop 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 taking antiepileptic medicines. The risk of birth defects or neurodevelopmental 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. Make sure you receive detailed information about the risks and benefits of using zonisamide for epilepsy during pregnancy.

Do not breastfeed while taking zonisamide or during 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 cause symptoms such as drowsiness, dizziness, or vision disturbances, and may reduce reaction ability. These effects, as well as the disease itself, may impair your ability to drive or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities requiring special attention until your doctor has assessed your response to this medicine.

zonisamida cinfamed contains sodium This medicine contains less than 23 mg of sodium (1 mmol) per capsule; thus, it is essentially “sodium-free”.

3. How to take zonisamide cinfamed

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Recommended dose in adults

If you are taking zonisamide alone:

• The starting dose is 100 mg once daily.
• It may be increased by 100 mg at two-week intervals.
• The recommended dose is 300 mg once daily.

If you are taking zonisamide with other antiepileptic medicines:

• The starting dose is 50 mg per day, divided into two equal doses of 25 mg.
• It may 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 adverse effects, are elderly, or have kidney or liver problems.

Use in children (6 to 11 years) and adolescents (12 to 17 years) weighing at least 20 kg:

• The starting dose is 1 mg per kg of body weight once daily.
• It may 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 above 55 kg (whichever dose 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, tell 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 cinfamed than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you have taken more zonisamide than you should, inform your caregiver (family member or friend), your doctor or pharmacist immediately, or contact the nearest hospital emergency service and bring the medicine with you. You may feel drowsy and could lose consciousness. You may also feel nauseous, have stomach pain, muscle spasms, eye movements, feel faint, have a slow heartbeat, and experience reduced breathing rate and kidney function. Do not attempt to drive.

If you forget to take zonisamide cinfamed

• 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 a missed dose.

If you stop taking zonisamide cinfamed

• 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 stop treatment, they will gradually reduce the dose to minimize 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 can cause adverse effects, although not everyone will experience them.

Zonisamide belongs to a group of medicines (sulfonamides) that may cause serious allergic reactions, severe rashes, and blood disorders, which very rarely can 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 back or stomach pain, painful urination, or notice 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 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 bruise 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 reported most frequently are all mild in nature. 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 exceptions: 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 acidic) in 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 (a small bruise caused by blood from a broken blood vessel in the skin)
• weight loss
• nausea, indigestion, stomach pain, diarrhoea (loose stools), 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 blood potassium levels and seizures/convulsive attacks

Rare adverse effects (may affect up to 1 in 10,000 people)

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

• breathing disorders, difficulty breathing, lung inflammation

• pancreatitis (severe stomach or back pain)

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

• severe rashes or skin peeling (you may also feel unwell and have a fever at the same time)

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

• swollen glands, blood disorders (reduction in the number of blood cells, which may make you more likely to get infections, feel pale, tired and feverish, and bruise more easily)

• decreased sweating, excessive body temperature

• glaucoma, which is a blockage of fluid drainage from the eye causing increased internal eye pressure. Eye pain, blurred vision, or loss of vision may occur and can be signs of glaucoma.

• Reporting of adverse effects

• If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse 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 cinfamed

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label and on the packaging 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 damage or deterioration in the capsules, blister pack, or box, or any visible signs of deterioration in the medicine itself. Return the package to your pharmacist.

Medicines must not be disposed of via wastewater or household waste. 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 way, you will help protect the environment.

6. Contents of the pack and other information

Composition of zonisamide cinfamed

• The active substance is zonisamide. Each hard capsule contains 25 mg of zonisamide.
• The other components present in the capsule contents are: microcrystalline cellulose, sodium lauryl sulfate, colloidal hydrated silica, and hydrogenated vegetable oil type 1.

Capsule shell: titanium dioxide (E-171) and gelatin.

Printing ink: shellac, propylene glycol, concentrated ammonium solution (E-527), black iron oxide (E-172), and potassium hydroxide.

Appearance of the product and contents of the pack

Hard gelatin capsule of size number 4, with white cap and body, containing white or almost white granules, with "25" printed on the body.

Zonisamide cinfamed is available in PVC/ACLAR/PVC/ALU, PVC/PE/PVDC/ALU, and OPA/ALU/PVC/ALU (aluminum-aluminum) blisters. Each pack contains 14 hard capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13

4042 Debrecen

Hungary

or

Teva Operations Poland Sp. z o.o.

ul. Mogilska 80,

31-546 Kraków

Poland

or

Merckle GmbH

Ludwig-Merckle-Straße 3,

89143 Blaubeuren

Germany

Date of the most recent revision of this leaflet: March 2023

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/80880/P_80880.html

QR code: https://cima.aemps.es/cima/dochtml/p/80880/P_80880.html