ZONISAMIDE TARBIS 100 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Zonisamide Tarbis 100 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 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 Tarbis and what is it used for
2. What you need to know before you take Zonisamide Tarbis
3. How to take Zonisamide Tarbis
4. Possible side effects
5. Storing Zonisamide Tarbis
6. Contents of the pack and other information

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

Zonisamide Tarbis contains the active substance zonisamide and is used as an antiepileptic.

Zonisamide is used to treat seizures that affect only a part of the brain (partial seizures), which may or may not be followed by a seizure that affects the whole brain (secondary generalisation).

Zonisamide may be used:

• On its own to treat convulsive seizures in adults.
• With other antiepileptics to treat convulsive seizures in adults, adolescents and children aged 6 years and above.

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

Do not take Zonisamide Tarbis:

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6),
• if you are allergic to other sulfonamides, such as sulfonamide antibiotics, thiazide diuretics and sulfonylurea antidiabetics.

Warnings and precautions

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

There have been reports of severe skin reactions associated with zonisamide therapy, including cases of Stevens-Johnson syndrome.

Consult your doctor or pharmacist before taking Zonisamide:

• if you are under 12 years old, as you may be at greater risk of decreased sweating, heat stroke, pneumonia and liver problems. Zonisamide is not recommended for use 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, severe skin reaction, swelling of the 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 kidney problems, as your dose of zonisamide may need to be adjusted.
• if you have previously had kidney stones, as you may be at greater 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 result in your body temperature rising. Reduce the risk of overheating by drinking plenty of water and keeping cool.
• if you are pregnant or think you may be pregnant (see section "Pregnancy, breast-feeding and fertility").
• if you are underweight or 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 have eye problems such as glaucoma.
• Zonisamide Tarbis may cause high levels of ammonia in the blood, which could change 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 disorders. Tell your doctor immediately if you feel unusually sleepy or confused.

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

Children and adolescents

Consult 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 medicines that can cause kidney stones (see Other medicines). Your doctor will check your child's blood bicarbonate levels and kidney function (see also section 4).

Do not give this medicine to children under 6 years old as it is not known if the potential benefits are greater than the risks in this age group.

Taking Zonisamide Tarbis with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

• Zonisamide should be used with caution in adults if taken with medicines that can cause kidney stones, such as topiramate or acetazolamide. This combination is not recommended in children.
• Zonisamide may increase the levels of medicines such as digoxin and quinidine in the blood, and it may be necessary to reduce the dose of these medicines.
• Other medicines such as phenytoin, carbamazepine, phenobarbital and rifampicin may decrease the levels of zonisamide in the blood, which may require an adjustment of the dose of zonisamide.

Taking Zonisamide Tarbis with food and drink

Zonisamide can be taken with or without food.

Pregnancy, breast-feeding and fertility

Women of childbearing potential must 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 pregnant or think you may be pregnant, tell your doctor immediately. Do not stop treatment without consulting your doctor.

You should only take zonisamide during pregnancy if your doctor advises you to. Research has shown a higher risk of birth defects in children of women who take antiepileptics. The risk of birth defects or developmental neurological disorders (problems with brain development) for your child after taking Zonisamide during pregnancy is not known. 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 can cause symptoms such as drowsiness, dizziness or changes in vision, and can reduce your reaction speed. These effects, as well as the disease itself, can 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 has assessed your response to this medicine.

3. How to take Zonisamide Tarbis

Follow exactly the instructions of administration of this medicine given to you by your doctor. If you are not sure, consult your doctor or pharmacist again.

The usual 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 usual 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 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 side effects 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 usual daily dose is between 6 mg and 8 mg per kg of body weight 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 for the first week, and then the daily dose should be increased by 25 mg at the start of each week until the daily dose of 150 to 200 mg is reached

If you think the effect of Zonisamide is too strong or too weak, talk to 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 the daily dose in the morning and the other half in the evening.

If you take more Zonisamide Tarbis than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, stating the medicine and the amount taken.

You may feel drowsy and may lose consciousness. You may also feel like vomiting, have stomach pain, muscle spasms, eye movements, feel like you are going to faint, have a slow heart rate and decreased respiratory and 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 the usual time.
• Do not take a double dose to make up for forgotten doses.

If you stop taking Zonisamide Tarbis

• 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Contact your doctor immediately if:

• you have difficulty breathing, swelling of the face, lips or tongue or severe skin rash, as these symptoms can indicate that you are having a severe allergic reaction.
• you have signs of excessive heat: high body temperature with little or no sweating, rapid heart rate and breathing, muscle cramps and confusion.
• you have had thoughts of self-harm or suicide. A small number of people taking antiepileptics such as zonisamide have had thoughts of self-harm or suicide.
• you have muscle pain or feel weak, as this can be a sign of abnormal muscle breakdown that can lead to kidney problems.
• you have sudden back or stomach pain, pain when urinating or blood in the urine, as this can be a sign of kidney stones.
• you have vision problems such as eye pain or blurred vision while taking zonisamide.

Contact your doctor as soon as possible if:

• you have unexplained skin rash, as it can become a more severe skin 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 can 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 common side 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 side effects were consistent with those described below, except for the following exceptions: pneumonia, dehydration, decreased sweating (frequent) and abnormal liver enzymes (uncommon).

Very common side 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 side 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 disorders, abnormal sensation in the skin (tingling), tremor, involuntary eye movements.
• kidney stones.
• skin rashes, itching, allergic reactions, fever, tiredness, flu-like symptoms, hair loss.
• bruising (a small bruise caused by blood from a broken blood vessel in the skin).
• weight loss.
• nausea, indigestion, stomach pain, diarrhoea (loose stools), constipation.
• swelling of the legs and feet.

Uncommon side effects: may affect up to 1 in 100 people

• anger, aggression, suicidal thoughts, attempted suicide.
• vomiting.
• inflammation of the gallbladder or gallstones.
• urinary stones.
• lung infection/inflammation, urinary tract infections.
• low potassium levels in the blood and seizures/attacks.

Rare side 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).
• respiratory disorders, breathing difficulties, lung inflammation.
• pancreatitis (severe stomach or back pain)
• liver problems, kidney failure, increased creatinine levels (a waste product that the kidneys should normally remove).
• severe skin reactions or skin 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 get infections and make you pale, feel tired and feverish, and bruise more easily).
• decreased sweating, excessive body temperature.
• glaucoma, which is a blockage of the drainage of fluid from the eye that causes increased pressure inside the eye. There may be eye pain, blurred vision or decreased vision, and these can be signs of glaucoma.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Zonisamida Tarbis

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

Do not use this medicine after the expiration date that appears on the blister pack and carton 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, blister pack, or carton, or any visible signs of deterioration in the medicine. Return the packaging to your pharmacist.

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

6. Package Contents and Additional Information

Composition of Zonisamida Tarbis

The active ingredient in Zonisamida Tarbis is zonisamide.

Zonisamida Tarbis 100 mg hard capsules contain 100 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 Package Contents

Zonisamida Tarbis 100 mg hard capsules have a white opaque body and a white opaque capsule cap. Capsule size No. 1, 19.3 mm, marked with "Z100" in black.

The Zonisamida Tarbis 100 mg capsules are packaged in blister packs, which are then packaged in cartons containing:

56 capsules

Only some package 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 Last Revision of this Leaflet: March 2023

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