ZONISAMIDE CINFAMED 50 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

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

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

This medicine 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, with or without secondary generalisation.

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 above.

2. What you need to know before you take zonisamide cinfamed

Do not take zonisamide cinfamed

• 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, e.g. sulfonamide antibiotics, thiazide diuretics and sulfonylurea antidiabetics.

Warnings and precautions

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

Consult your doctor or pharmacist before taking zonisamide cinfamed:

• If you are under 12 years old, as you may be at a higher risk of decreased sweating, heat stroke, pneumonia and liver problems. Zonisamide is not recommended in children under 6 years old.
• If you are elderly, as your dose of zonisamide may need to be adjusted, and you may be more likely to develop an allergic reaction, serious skin rash, swelling of legs and feet and itching when taking zonisamide (see section 4. Possible side effects).
• If you have liver problems, as your dose of zonisamide may need to be adjusted.
• If you have eye problems such as glaucoma.
• If you have kidney problems, as your dose of zonisamide may need to be adjusted.
• If you have previously had kidney stones, as you may be at 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 are going on holiday to a hot place. Zonisamide can make you sweat less, which can cause your body temperature to rise. Reduce the risk of overheating by drinking plenty of water and staying cool.
• If you are underweightor have lost a lot of weight, as zonisamide can make you lose more weight. Tell your doctor, as they may need to monitor you.
• If you are pregnant or think you may be pregnant (for more information, see section “Pregnancy, breast-feeding and fertility”).

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

Taking zonisamide may cause high levels of ammonia in the blood, which could affect 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 causes too much ammonia to be produced in the body (urea cycle disorder), or if you have liver disease. Tell your doctor immediately if you feel unusually drowsy or confused.

Children and adolescents

Talk to 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 weighing less than 20 kg.
• Increased acid levels in the blood and kidney stones: reduce these risks by making sure your child drinks plenty of water and does not take any other medicine that may cause kidney stones (see Other medicines and zonisamide cinfamed). 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 oldas it is not known if the potential benefits are greater than the risks in this age group.

Other medicines and zonisamide cinfamed

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

• Zonisamide should be used with caution in adults if taken with medicines that can cause kidney stones, such as topiramateor acetazolamide. In children, this combination is not recommended.
• Zonisamide may possibly increase blood levels of medicines such as digoxinand quinidine, and it may be necessary to reduce the dose of these medicines.
• Other medicines such as phenytoin, carbamazepine, phenobarbitoneand rifampicinmay decrease blood levels of zonisamide, which may require a dose adjustment of the medicine.

Taking zonisamide cinfamed with food and drinks

Zonisamide can be taken with or without food.

Pregnancy, breast-feeding 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 discussing it with 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 taking antiepileptics. It is not known what the risk of birth defects or developmental neurological disorders (problems with brain development) is for your child after taking zonisamide during pregnancy. 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 are fully informed about the risks and benefits of using zonisamide for epilepsy during pregnancy.

Do not breast-feed 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 may cause symptoms such as drowsiness, dizziness or changes in vision, and may affect your ability to react. These effects, as well as your condition itself, may impair your ability to drive or operate machinery. Therefore, do not drive, operate machinery or engage in other activities that require special attention until your doctor has assessed your response to this medicine.

zonisamide cinfamed contains sodiumThis medicine contains less than 23 mg of sodium (1 mmol) per capsule; this is essentially “sodium-free”.

3. How to take zonisamide cinfamed

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Recommended dose in adults

If you are taking zonisamide alone:

• The initial dose is 100 mg once a day.
• This can be increased by up to 100 mg at intervals of two weeks.
• The recommended dose is 300 mg once a day.

If you are taking zonisamide with other antiepileptics:

• The initial dose is 50 mg a day divided into two equal doses of 25 mg.
• This 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) weighing at least 20 kg:

• The initial dose is 1 mg per kg of body weight once a day.
• This 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 weighing up to 55 kg or between 300 mg and 500 mg for a child weighing over 55 kg (the lower of the two doses) 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 a daily dose of 150 to 200 mg is reached.

If you think that the action of zonisamide is too strong or too weak, tell 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 the daily dose in the morning and the other half in the evening.

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, telephone 91 562 04 20, stating the medicine and the amount taken.

If you have taken more zonisamide than you should, tell the person taking care of you (family member 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 sick, have stomach pain, muscle spasms, eye movements, feel faint, have a slow heart rate and decreased respiratory and kidney function. Do not try 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 forgotten doses.

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 your doctor tells you to.
• If your doctor advises you to stop treatment, they will reduce the dose gradually to decrease the risk of you 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 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 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 vision 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 most frequently reported adverse effects of zonisamide are all mild. They occur during the first month of treatment and often decrease as treatment continues. In children aged 6 to 17 years, 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 anxious or emotionally unstable.
• slow thinking, loss of concentration, speech anomalies, 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)

• rage, aggression, suicidal thoughts, attempted suicide.
• vomiting.
• inflammation of the gallbladder or gallstones.
• urinary stones.
• pulmonary 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 seizures).
• respiratory disorders, difficulty breathing, 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 (at the same time, you may 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 feel pale, 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, causing an increase in the internal pressure of the eye. It can cause eye pain, blurred vision, or decreased vision and may be signs of glaucoma.

• Reporting Adverse Effects
• If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible 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 Cinfamed

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

Do not use this medicine after the expiration date that appears on the label and packaging 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, blisters, 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 will help protect the environment.

6. Package Contents and Additional Information

Composition of Zonisamide Cinfamed

• The active ingredient is zonisamide. Each hard capsule contains 50 mg of zonisamide.
• The other ingredients present in the capsule content are: microcrystalline cellulose, sodium lauryl sulfate, colloidal hydrated silica, and hydrogenated vegetable oil type 1.

Capsule shell:gelatin, titanium dioxide (E-171), and black iron oxide (E-172).

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

Appearance of the Product and Package Contents

Hard gelatin capsule, size 3, with a gray cap and a white body, containing a white or off-white granulate, with "50" printed on the body.

Zonisamide Cinfamed is presented in PVC/ACLAR/PVC/ALU, PVC/PE/PVDC/ALU, and OPA/ALU/PVC/ALU (aluminum-aluminum) blisters. Each package contains 28 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 Krakow

Poland

or

Merckle GmbH

Ludwig-Merckle-Straße 3,

89143 Blaubeuren

Germany

Date of the Last Revision of this Leaflet:March 2023

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/80881/P_80881.html

QR code to: https://cima.aemps.es/cima/dochtml/p/80881/P_80881.html