Leaflet: information for the user

Zonisamide Cinfamed 50 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, and you must not give it to others even if they have the same symptoms as 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 cinfamed and what it is used for

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

3. How to take zonisamide cinfamed

4. Possible side effects

5. Storage of zonisamide cinfamed

6. Contents of the pack and additional information

This medication contains the active ingredient zonisamide, and is used as an antiepileptic.

Zonisamide 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).

Zonisamide may be used:

• Alone to treat seizures in adults.
• With other antiepileptic medications to treat seizures in adults, adolescents, and children 6 years of age and older.

Do not take zonisamide Cinfa

• 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, for example: sulfonamide antibiotics, thiazide diuretics and sulfonylurea antidiabetics.

Warnings and precautions

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

Consult your doctor or pharmacist before starting to take zonisamide Cinfa:

• If you areunder 12 years, as you may be at greater risk of developingdecreased sweating, sunstroke, pneumonia and liver problems.Zonisamide is not recommended for use inchildren under 6 years.
• If you areelderly, as you may need to adjust your zonisamide dose, and you may be at greater risk of developing an allergic reaction, severe rash, swelling of legs and feet and itching when taking zonisamide (see section 4. Possible side effects).
• If you haveliver problems, as you may need to adjust your zonisamide dose.
• If you have eye problems such as glaucoma.
• If you havekidney problems, as you may need to adjust your zonisamide dose.
• If you have previously hadkidney stones, as you may be at greater risk of developing more kidney stones.Reduce the risk of developing kidney stones by drinking enough 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 enough water and staying cool.
• If you areunderweightor have lost a lot of weight, as zonisamide can make you lose weight more. Inform your doctor, as you may need to be monitored.
• If you are pregnant or could become pregnant (for more information, see section “Pregnancy, breastfeeding and fertility”).

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

The use of 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 problems. Inform your doctor immediately if you feel drowsy or confused in an unusual way.

Children and adolescents

Consult your doctor about the following risks:

• Weight:You must monitor your child's weight monthly and see your doctor as soon as possible if they do not gain enough weight.Zonisamide 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 level of acid in the blood and kidney stones: reduce these risks by ensuring your child drinks enough water and does not take any other medicine that can cause kidney stones (see Other medicines and zonisamide Cinfa). Your doctor will monitor your child's bicarbonate levels in the blood and kidneys (see also section 4).

Do not administer this medicine to childrenunder 6 yearsas there is no knowledge of the possible benefits being greater than the risks in this age group.

Other medicines and zonisamide Cinfa

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medicine.

• Zonisamide should be used with caution in adults if taken with medicines that can cause kidney stones, such astopiramateoracetazolamide. In children, this combination is not recommended.
• Zonisamide may possibly increase the levels of medicines such asdigoxinandquinidinein the blood, and therefore may need to reduce the dose of these.
• Other medicines such asphenytoin, carbamazepine, phenobarbitalandrifampicinmay decrease the levels of zonisamide in the blood, which may require an adjustment of the dose of the medicine.

Taking zonisamide Cinfa with food and drink

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 intend to become pregnant, talk to your doctor before stopping your contraceptives and before becoming pregnant about the possibility of changing 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 zonisamideduring pregnancy if your doctor advises it. Research has shown a higher risk of birth defects in children of women taking antiepileptic medicines. The risk of birth defects or neurological developmental disorders (brain development problems) for your child after taking zonisamide during pregnancy is unknown. A study showed that children whose mothers took 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 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 operating machinery

Zonisamide may cause symptoms such as drowsiness, dizziness or visual disturbances, and may impair your ability to react. These effects, as well as the underlying disease, may make it difficult for you to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention, until your doctor assesses your response to this medicine.

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

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

Recommended dose in adults

If taking zonisamide alone:

• The initial dose is 100 mg once a day.
• It can be increased up to 100 mg in two-week intervals.
• The recommended dose is 300 mg once a day.

If taking zonisamide with other antiepileptic medications:

• 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 one to two-week intervals.
• 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) 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 in 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 more than 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 beginning of each week until reaching a daily dose of 150 to 200 mg.

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 taking zonisamide twice a day, take half the daily dose in the morning and the other half at night.

If taking more zonisamide than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you have taken more zonisamide than you should, inform the person taking care of you (family member or friend), your doctor or pharmacist, or contact the emergency department of the nearest hospital 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 fainting, have a slow heart rate, and decreased respiratory and renal function.Do not attempt to drive.

If you forgot to take zonisamide

• If you forgot 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.

If interrupting treatment with zonisamide

• Zonisamide is intended to be taken as a long-term medication. Do not reduce the dose or stop taking the medication unless your doctor instructs 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 have difficulty breathing, swelling of the face, lips, or tongue, or severe rash, as these symptoms may indicate a severe allergic reaction.
• You have signs of excessive heat: high body temperature with little or no sweating, rapid heartbeat, and rapid breathing, muscle cramps, and confusion.
• You have had thoughts of self-harm or suicide. A small number of people receiving treatment with antiepileptic drugs 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, pain while urinating, 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 have unexplained rash, as it may become a more severe rash or skin peeling.
• You feel extremely tired or feverish, have a sore throat, swollen glands, or notice that you bruise easily, as this may indicate a blood disorder.
• You have signs of increased blood acidity: 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, the 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)

• Restlessness, irritability, confusion, depression
• Bad muscle coordination, 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, feeling anxious or emotionally unstable.
• 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.
• Ecchymosis (a small bruise caused by blood from a broken skin blood vessel).
• Weight loss.
• Nausea, indigestion, stomach pain, diarrhea (loose stools), constipation.
• Swelling of legs and feet.

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

• Anger, aggression, suicidal thoughts, suicide attempt.
• Vomiting.
• Inflammation of the gallbladder or gallstones.
• Kidney stones.
• Pulmonary infection/inflammation, urinary tract infections.
• Low potassium levels in blood and convulsions/epileptic attacks.

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), epileptic state (prolonged or repeated convulsions).
• 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 also feel unwell and have a fever).
• Abnormal muscle breakdown (may have 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 feel pale, tired, and feverish, and may bruise easily).
• Decreased sweating, excessive body temperature.
• Glaucoma, which is a blockage of the eye's drainage that causes increased internal eye pressure. You may experience eye pain, blurred vision, or decreased vision, and these may be signs of glaucoma.

• Reporting side effects
• If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the 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 label and on the packaging 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 medications thatyou do not need in the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications that you do not need. This will help protect the environment.

Zonisamide Cinfa Composition

-The active ingredient is zonisamide. Each hard capsule contains 50 mg of zonisamide.

-The other components present in the capsule content are: microcrystalline cellulose, sodium lauryl sulfate, hydrated colloidal silica, and hydrogenated vegetable oil type 1.

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

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

Appearance of the product and contents of the package

Hard gelatin capsule size No. 3, with a gray-colored cap and a white-colored body, containing white or off-white granules, with "50" printed on the body.

Zonisamide Cinfa 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 responsible for manufacturing

Marketing authorization holder

Cinfa Laboratories, S.A.

Olaz-Chipi Road, 10. Areta Industrial Estate

31620 Huarte (Navarra) – Spain

Responsible for manufacturing

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

Last review date of this leaflet:March 2023

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (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 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