Package Insert: Information for the User

Zonisamide Tarbis 25 mg Hard Capsules EFG

(zonisamide)

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

-Keep this package insert, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What Zonisamide Tarbis is and what it is used for

2. What you need to know before starting to take Zonisamide Tarbis

3. How to take Zonisamide Tarbis

4. Possible side effects

5. Storage of Zonisamide Tarbis

6. Contents of the pack and additional information

Zonisamida Tarbiscontains 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 convulsive seizures in adults.
• With other antiepileptic drugs to treat convulsive seizures in adults, adolescents, and children 6 years and older.

Do not take Zonisamida Tarbis:

-if you are allergic to the active principle(s) or to any of the components of this medication (including those 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 rashes, and blood disorders, which very rarely may cause death (see section 4. Possible side effects).

There have been cases of severe 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 have a higher risk of presentingdecreased sweating, sunstroke, pneumonia, and liver problems. Zonisamida is not recommended for use in children under 6 years old.
• if you are elderly, as you may need to adjust the dose of zonisamida, and you may have a higher risk of developing an allergic reaction, severe rash, swelling of the 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 the dose of zonisamida.
• if you have kidney problems, as you may need to adjust the dose of zonisamida.
• if you have previously had kidney stones, as you may be at a higher risk of having more kidney stones.Reduce the risk of 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 cause your body temperature to rise.Reduce the risk of overheating by drinking enough water and staying cool.
• if you are pregnant or could become pregnant (for more information, see section “Pregnancy, breastfeeding, and fertility).
• 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 have eye problems such as glaucoma.
• The use of Zonisamida Tarbis may cause high levels of ammonia in the blood, which could change 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 generated 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 making sure 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 it is not known whether the potential benefits outweigh the risks in this age group.

Taking Zonisamida Tarbis with other medications

Inform your doctor or pharmacist if you are using or have recently used 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 in the dose of zonisamida.

Taking Zonisamida Tarbis 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 intendto 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 think you 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 pregnancyis unknown. A study showed that children whose mothers used zonisamida 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 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 cause symptoms such as drowsiness, dizziness, or visual disturbances, and may impair your ability to react. These effects, as well as the underlying condition, 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 medication.

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

Usual dose in adults

If taking Zonisamida alone:

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

If taking Zonisamida 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 intervals of one to two weeks.
• The usual 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 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 intervals of one to two weeks.
• The usual daily dose is between 6 mg and 8 mg 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 Zonisamida is too strong or too weak, inform your doctor or pharmacist.

• Zonisamida capsules should be swallowed whole with water.
• Do not chew the capsules.
• Zonisamida can be taken once or twice a day, as instructed by your doctor.
• If taking Zonisamida twice a day, take half the daily dose in the morning and the other half at night.

If taking more Zonisamida Tarbis 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 drive.

If you forgot to take Zonisamida Tarbis

• 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 Zonisamida Tarbis

• Zonisamida 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 may cause side effects, although not everyone will experience them.

Zonisamide belongs to a group of medicines (sulfonamides) that may cause severe allergic reactions, severe rashes, and blood disorders, which very rarely may 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 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 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 may lead to kidney problems.
• you have sudden pain in the back or stomach, painful urination, or notice 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 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 that you have 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 frequently 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 the following, except for the following exceptions: 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, 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.
• bruising (a small hematoma caused by blood from a broken skin 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, attempted suicide.
• vomiting.
• inflammation of the gallbladder or gallstones.
• kidney stones.
• pulmonary infection/inflammation, urinary tract infections.
• low potassium levels in the blood and seizures/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 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).
• severe rashes or skin peeling (you may feel unwell and have a fever).
• abnormal muscle breakdown (you may have muscle pain or weakness) that may 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 that causes an increase in the eye's internal 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 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 you no longer need at the SIGRE point of the pharmacy.Ask your pharmacist if you are unsure how to dispose of the packaging and medications you no longer need.By doing so, you will help protect the environment.

Composition of Zonisamida Tarbis

The active ingredient inZonisamida Tarbisis zonisamida.

ZonisamidaTarbis25 mg hard capsules contain 25 mg of zonisamida. 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), and potassium hydroxide

Appearance of the product and content of the container

ZonisamidaTarbis25 mg hard capsules have a white opaque body and a white opaque closure capsule. Capsule size #4, 14.4 mm, marked with “Z25” in black.

The ZonisamidaTarbis 25 mgcapsules are packaged in blisters that are further packaged in boxes containing:

14 and 28 capsules

Only some package sizes may be commercially available.

Marketing authorization holder

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

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