Zonisamide Tarbis 25 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Zonisamida Tarbis 25 mg hard capsules EFG

(zonisamide)

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 give it to other people, even if they have the same symptoms as you, because it could harm them.

• If you experience any adverse reactions, talk to your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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

Zonisamida Tarbis contains the active substance zonisamida, and is used as an antiepileptic.

Zonisamida 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).

Zonisamida may be used:

• Alone to treat epileptic seizures in adults.
• In combination with other antiepileptics to treat epileptic seizures in adults, adolescents, and children aged 6 years and older.

2. What you need to know before starting Zonisamide Tarbis

Do not take Zonisamide Tarbis:

• if you are allergic to the active substance(s) or to any of the components of this medicine (listed in section 6),
• if you are allergic to other sulfonamides, for example: sulfonamide antibiotics, thiazide diuretics, or 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).

Cases of severe rashes associated with zonisamide therapy have been reported, including cases of Stevens-Johnson syndrome.

Consult your doctor or pharmacist before starting Zonisamide:

• if you are under 12 years of age, as you may have an increased risk of experiencing reduced sweating, heatstroke, 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 required, 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 necessary.
• if you have kidney problems, as a dose adjustment of zonisamide may be necessary.
• if you have previously had kidney stones, as you may be at increased risk of developing further kidney stones. Reduce the risk of kidney stones by drinking enough water.
• if you live in or are traveling to a hot climate. Zonisamide may reduce sweating, which could lead to an increase in body temperature. Reduce the risk of overheating by drinking enough water and keeping cool.
• if you are pregnant or could become pregnant (for further information, see section “Pregnancy, breastfeeding and fertility”).
• if you are underweight or have lost a lot of weight, as zonisamide may cause further weight loss. Inform your doctor, as monitoring may be necessary.
• if you have eye problems such as glaucoma.
• The use of Zonisamide Tarbis may lead to high levels of ammonia in the blood, which could affect brain function, especially if you are also taking other medicines that may increase ammonia levels (e.g., valproate), if you have a genetic disorder causing excessive ammonia production (urea cycle disorder), or if you have liver problems. Inform your doctor immediately if you experience unusual drowsiness or confusion.

If any of these situations apply to you, inform your doctor before taking Zonisamide.

Children and adolescents

Discuss the following risks with your doctor:

• Weight: You should monitor your child's weight monthly and consult 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 medication that may cause kidney stones (see Other medicines). 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 not known whether the potential benefits outweigh the risks in this age group.

Taking Zonisamida Tarbis with other medicines

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

• 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 may 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 might require adjustment of the zonisamide dose.

Taking Zonisamida Tarbis with food and drinks

Zonisamide can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Women of childbearing potential must use effective contraceptive measures during treatment with zonisamide and for one month after stopping zonisamide.

If you plan to become pregnant, talk to your doctor before stopping contraceptives and before attempting pregnancy about the possibility of switching to other appropriate treatments. If you are pregnant or think you may be pregnant, inform your doctor immediately. You must not stop treatment without consulting your doctor.

You should only take zonisamide during pregnancy if specifically instructed by your doctor. Research shows an increased risk of birth defects in children of women who take antiepileptic medicines. The risk of birth defects or neurodevelopmental disorders (problems with 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 visual disturbances, and may reduce reaction ability. These effects, as well as the underlying 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.

3. How to take Zonisamide Tarbis

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Usual dose in adults

If you are taking Zonisamide alone:

• The initial dose is 100 mg once daily.
• This dose may be increased by up to 100 mg at two-week intervals.
• The usual dose is 300 mg once daily.

If you are taking Zonisamide with other antiepileptic medicines:

• The initial dose is 50 mg per day, divided into two equal 25 mg doses.
• The dose may be increased by up to 100 mg every one to two weeks.
• The usual 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 or if you have renal or hepatic impairment.

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 daily.
• This may be increased by 1 mg per kg of body weight every one to two weeks.
• The usual 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 is lower), taken 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, inform 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 Tarbis than you should

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

You may feel drowsy and could lose consciousness. You may also experience nausea, vomiting, stomach pain, muscle spasms, eye movements, feeling faint, slow heartbeat, reduced breathing rate, and impaired kidney function. Do not attempt to drive.

If you forget to take Zonisamide Tarbis

• If you forget to take a dose, do not worry; take the next dose at your usual time.
• Do not take a double dose to make up for forgotten doses.

If you stop taking Zonisamide Tarbis

• Zonisamide is intended for long-term treatment. Do not reduce the dose or stop taking the medicine unless instructed by your doctor.
• If your doctor advises you to discontinue treatment, they will gradually reduce your dose to minimize the risk of increased 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 experiences them.

Zonisamide belongs to a group of medicines (sulfonamides) that may cause severe allergic reactions, severe rashes, and blood disorders, which very rarely can be fatal.

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 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 that could 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 could progress to a more serious rash or skin peeling.
• you feel unusually tired or feverish, have a sore throat, swollen glands, or notice you are bruising more easily, as this may indicate 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 most commonly reported 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: 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 too acidic) in the blood

Common adverse effects: may affect up to 1 in 10 people

• difficulty sleeping, unusual or strange thoughts, feeling anxious or mood instability
• 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 (small bruises caused by blood from broken blood vessels under the skin)
• weight loss
• nausea, indigestion, stomach pain, diarrhea, 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 potassium levels in blood and seizures/attacks

Very 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), epileptic status (prolonged or repeated seizures)
• breathing disorders, difficulty breathing, lung inflammation
• pancreatitis (severe stomach or back pain)
• liver problems, kidney failure, increased creatinine levels (a waste product normally eliminated by the kidneys)
• severe rashes or skin peeling (you may also feel unwell and have fever)
• abnormal muscle breakdown (you may have muscle pain or weakness) which could lead to kidney problems
• swollen glands, blood disorders (reduction in blood cells, which may make you more prone to infections, feel pale, tired, and feverish, and bruise more easily)
• decreased sweating, excessive body temperature
• glaucoma, which is a blockage in the drainage of fluid from the eye leading to increased internal eye pressure. Eye pain, blurred vision, or vision loss may occur and could be signs of glau combust.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects 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 Tarbis

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

Do not use this medicine after the expiry date stated on the blister pack and on the carton following 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 deterioration in the capsules, blister pack, or carton, or any visible signs of degradation in the medicine. Return the pack to your pharmacist.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Zonisamida Tarbis

The active substance in Zonisamida Tarbis is zonisamide.

Zonisamida Tarbis 25 mg hard capsules contain 25 mg of zonisamide. The other components present in the capsule contents are:

• capsule contents: microcrystalline cellulose, hydrogenated vegetable oil, and sodium lauryl sulfate
• capsule shell: gelatin and titanium dioxide (E171)
• printing ink: shellac, black iron oxide (E172), and potassium hydroxide

Appearance of the product and contents of the pack

Zonisamida Tarbis 25 mg hard capsules have an opaque white body and an opaque white cap. Size 4 capsules, 14.4 mm long, printed with "Z25" in black.

Zonisamida Tarbis 25 mg capsules are packed in blisters, which are placed in cardboard boxes containing:

14 and 28 capsules

Only some pack sizes may be marketed.

Marketing Authorization Holder

Tarbis Farma, S.L.
Gran Vía Carlos III, 94
08028 Barcelona
Spain

Manufacturer

Noucor Health, S.A.
Av. Camí Reial 51-57
08184 Palau-solità i Plegamans
(Barcelona – Spain)

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

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/