Leaflet: information for the user

Zonisamide STADA 25 mg hard capsules EFG

Zonisamide STADA 50 mg hard capsules EFG

Zonisamide STADA 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 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 Zonisamide Stada is and what it is used for

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

3.How to take Zonisamide Stada

4.Possible side effects

5.Storage of Zonisamide Stada

6.Contents of the pack and additional information

This medication 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 antiepileptic medications to treat seizures in adults, adolescents, and children 6 years and older.

Do not take Zonisamida Stada:

-if you are allergic to zonisamida or any of the other ingredients of this medication (listed in section 6).

-if you are allergic to other sulfonamides, for example: sulfonamide antibiotics, thiazide diuretics, and sulfonylurea antidiabetics.

Warnings and precautions

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

There have been cases of severe skin rashes associated with zonisamida therapy, including cases of Stevens-Johnson syndrome.

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 your zonisamida dose, and you may be at higher risk of developing an allergic reaction, severe skin rash, swelling of legs and feet, and itching when taking zonisamida (see section 4. Possible side effects).
• if you have liver problems, as you may need to adjust your zonisamida dose.
• if you have eye problems such as glaucoma.
• if you have kidney problems, as you may need to adjust your 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 developing 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 overheating 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).

The use of zonisamida may cause 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 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.

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 must 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 blood acidity and kidney stones: reduce these risks by ensuring your child drinks enough water and does not take any medication that can 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 Stada

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 can cause 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, and therefore may need to be reduced.
• 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.

Taking Zonisamida Stada with food and drinks

Zonisamida can be taken with or without food.

Pregnancy, breastfeeding, and fertility

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

If you plan 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 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 pregnancy is unknown. A study showed that children whose mothers took zonisamida during pregnancy were smaller than expected for their age at birth, compared to children whose mothers were treated with lamotrigine monotherapy. Ensure that 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 may 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.

Zonisamida Stada contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per capsule; it is essentially “sodium-free”.

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

The recommended dose in adults is:

If you are taking only zonisamide:

• 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 you are 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 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 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 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 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.

If you take more Zonisamide Stada 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.

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 rate and renal function. Do not attempt to drive.

If you forgot to take Zonisamide Stada

• 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 you interrupt treatment with Zonisamide Stada

• 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 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 a 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 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 that can lead to kidney problems.
• you have sudden back or stomach pain, painful urination, or blood in the 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 experience unexplained rashes, as they may become more severe or lead to 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):

• agitation, irritability, confusion, depression
• muscle coordination problems, dizziness, poor memory, drowsiness, double vision
• loss of appetite, decreased bicarbonate levels in the 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.
• bruising (a small hematoma caused by blood from a broken skin blood vessel).
• weight loss.
• nausea, indigestion, stomach pain, diarrhea (loose stools), constipation.
• swelling of the legs and feet.

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

• rage, aggression, suicidal thoughts, suicide attempt.
• vomiting.
• inflammation of the gallbladder or gallstones.
• kidney stones.
• pulmonary infections or inflammation, urinary tract infections.
• low potassium levels in the 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 convulsions).
• respiratory disorders, difficulty breathing, lung inflammation.
• pancreatitis (severe stomach or back pain)
• liver problems, kidney failure, increased creatinine levels in the 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 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 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 medications that you no longer need at the SIGRE point of the pharmacy.In case of doubt, ask your pharmacist how to dispose of the packaging and medications that you no longer need.By doing so, you will help protect the environment.

Composition of Zonisamida Stada

The active ingredient is zonisamide. Zonisamida Stada 25 mg hard capsules contain 25 mg of zonisamide. Zonisamida Stada 50 mg hard capsules contain 50 mg of zonisamide. Zonisamida Stada 100 mg hard capsules contain 100 mg of zonisamide.

The other components present in the capsule content are:

• capsule content: microcrystalline cellulose, hydrogenated vegetable oil, and sodium lauryl sulfate
• capsule coating: gelatin and titanium dioxide (E171)
• printing ink: shellac, iron oxide black (E172) (dose of 25 mg and 100 mg), iron oxide red (E172) (dose of 50 mg), and potassium hydroxide (dose of 25 mg and 100 mg).

Appearance of the product and contents of the packaging

Zonisamida Stada 25 mg hard capsules are size 4 capsules, with a white opaque body and a white opaque closure, 14.4 mm in size, and marked with “Z25” in black.

Zonisamida Stada 50 mg hard capsules are size 3 capsules, with a white opaque body and a white opaque closure, 15.8 mm in size, and marked with “Z50” in red.

Zonisamida Stada 100 mg hard capsules are size 1 capsules, with a white opaque body and a white opaque closure, 19.3 mm in size, and marked with “Z100” in black.

Zonisamida Stada capsules are packaged in blisters, which are then packaged in boxes. The 25 mg packaging contains: 14 or 28 capsules, the 50 mg packaging contains 28 or 56 capsules, and the 100 mg packaging contains 56 capsules.

Only some packaging sizes may be commercially available.

Marketing Authorization Holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for Manufacturing

Noucor Health S.A.

Av. Camí Reial 51-57

08184 Palau-Solità i Plegamans (Barcelona)

Spain

Last review date of this leaflet: March 2023

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