NYZOL 100 mg TABLETS

Introduction

Package Leaflet: Information for the User

Nyzol 100 mg Tablets EFG

zonisamide

Read the package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

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

1. What is Nyzol and what is it used for

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

This medication is used to treat partial seizures that affect only a part of the brain, which may or may not be followed by a generalized seizure.

This medication may be used:

• Alone to treat seizures in adults.
• With other antiepileptics to treat seizures in adults, adolescents, and children aged 6 and older.

2. What you need to know before taking Nyzol

Do not take Nyzol:

• if you are allergic to zonisamide or any of the other ingredients of this medication (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 medications (sulfonamides) that can cause severe allergic reactions, serious skin rashes, and blood disorders, which can very rarely be fatal (see section 4. Possible side effects).

The use of this medication 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 excessive ammonia production in the body (urea cycle disorder), or if you have liver disease. Inform your doctor immediately if you feel unusually drowsy or confused.

Consult your doctor or pharmacist before starting to take this medication:

• if you are under 12 years old, as you may be at higher risk of decreased sweating, heat stroke, pneumonia, and liver problems. This medication is not recommended for children under 6 years old.
• if you are elderly, as your doctor may need to adjust the dose of this medication, and you may be more likely to develop an allergic reaction, serious skin rash, swelling of legs and feet, and itching when taking zonisamide (see section 4. Possible side effects).
• if you have liver problems, as your doctor may need to adjust the dose of this medication.
• if you have eye problems such as glaucoma.
• if you have kidney problems, as your doctor may need to adjust the dose of this medication.
• if you have had kidney stones before, as you may be at higher risk of having more kidney stones. Reduce the risk of kidney stones by drinking plenty of water.
• if you live in a hot place or are going on vacation to a hot place. This medication can make you sweat less, which can cause your body temperature to rise. Reduce the risk of overheating by drinking plenty of water and staying cool.
• if you are underweight or have lost a lot of weight, as this medication can cause you to lose more weight. Inform your doctor, as they may need to monitor you.
• if you are pregnant or could become pregnant (for more information, see the section on "Pregnancy, breastfeeding, and fertility").

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

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. This medication is not recommended for 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 ensuring your child drinks plenty of water and does not take any other medication that can cause kidney stones (see "Other medications"). Your doctor will monitor your child's blood bicarbonate levels and kidney function (see also section 4).

Do not give this medication to children under 6 years old, as it is not known whether the potential benefits outweigh the risks in this age group.

Other medications and Nyzol

Tell your doctor or pharmacist if you are using or have recently used any other medications, including those bought without a prescription.

• Zonisamide 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.
• Zonisamide may increase the blood levels of medications such as digoxin and quinidine, and therefore may require a dose reduction of these medications.
• Other medications such as phenytoin, carbamazepine, phenobarbital, and rifampicin may decrease the blood levels of this medication, which may require a dose adjustment of this medication.

Pregnancy, breastfeeding, and fertility

Women of childbearing age must use effective contraceptive measures during treatment with this medication and for one month after stopping it.

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 or think you may be pregnant, inform your doctor immediately. Do not stop treatment without consulting your doctor.

You should only take this medication during pregnancy if your doctor advises it. Research shows a higher risk of birth defects in children of women who take antiepileptics. The risk of birth defects or developmental neurological disorders (brain development problems) for your child after taking this medication during pregnancy is unknown. A 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 breastfeed while taking this medication or for one month after stopping it.

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 affect concentration, reaction time, and may cause drowsiness, especially at the start of treatment or after increasing the dose. If this medication affects you in this way, be extra careful when driving or using machines.

Nyzol contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per dose; this is essentially "sodium-free".

3. How to take Nyzol

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

Recommended dose in adults

If you take Nyzol alone:

• The initial dose is 100 mg once a day.
• It can be increased by up to 100 mg at intervals of two weeks.
• The recommended dose is 300 mg once a day.

If you take Nyzol with other antiepileptics:

• The initial dose is 50 mg per day, divided into two equal doses of 25 mg.
• It can be increased by up to 100 mg at intervals of one to two weeks.
• 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 (6-11 years) and adolescents (12-17 years) 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 at intervals of one to two weeks.
• 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 over 55 kg (the lower dose).

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 a daily dose of 150-200 mg is reached.

If you think the effect of this medication is too strong or too weak, tell your doctor or pharmacist.

• Nyzol tablets should be swallowed whole with water.
• Do not chew the tablets.
• Nyzol can be taken once or twice a day, as instructed by your doctor.
• If you take Nyzol twice a day, take half the daily dose in the morning and the other half in the evening.

The tablet can be divided into equal doses

If you take more Nyzol than you should

If you have taken more Nyzol than you should, tell the person taking care of you (family or friend), your doctor, or pharmacist immediately, or contact the emergency department of the nearest hospital and take 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 you are going to faint, have a slow heart rate, and decreased kidney function. Do not try to drive.

If you forget to take Nyzol

• 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 Nyzol

• Nyzol is intended to be taken as a long-term medication. Do not reduce the dose or stop taking the medication unless your doctor advises you to.
• If your doctor advises you to stop treatment, they will gradually reduce the dose 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.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

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

Contact your doctor immediately if:

• you have difficulty breathing, swelling of the face, lips, or tongue, or a severe skin rash, as these symptoms may indicate a severe allergic reaction.
• you have signs of overheating: 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 may be a sign of abnormal muscle breakdown, which can lead to kidney problems.
• you have sudden back or stomach pain, pain when urinating, or blood in your urine, as this may be a sign of kidney stones.
• you have vision problems such as eye pain or blurred vision while taking this medication.

Contact your doctor as soon as possible if:

• you have an unexplained skin rash, as it may become a more serious skin rash or skin peeling.
• you feel especially tired or feverish, have a sore throat, swollen glands, or bruise more easily, as this may indicate 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 this medication.

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 6-17 years, the side effects were consistent with those described below, except for the following: 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 uncommon thoughts, feeling anxious or emotionally unstable.
• slow thinking, loss of concentration, speech disorders, abnormal sensation in the skin (tingling), tremor, involuntary eye movement.
• kidney stones.
• skin rashes, itching, allergic reactions, fever, fatigue, 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, diarrhea (loose stools), constipation.
• swelling of legs and feet.

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

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

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 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) in the blood.
• serious skin rashes or skin peeling (you may also 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 (reduced number of blood cells, which can make you more likely to get infections and feel pale, tired, and feverish, and bruise more easily).
• decreased sweating, high body temperature.
• glaucoma, which is a blockage of the drainage of fluid from the eye, causing increased pressure inside the eye. Symptoms can include eye pain, blurred vision, or decreased vision, and may be signs of glaucoma.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use www.notificaRAM.es By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Nyzol

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 on the carton after EXP. 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 tablets, 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 medicines you no longer need at the pharmacy's SIGRE Point. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Nyzol

The active ingredient is zonisamide.

Each tablet contains 100 mg of zonisamide.

The other ingredients are: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, povidone K-25, sodium lauryl sulfate, anhydrous colloidal silica, magnesium stearate.

Appearance of the Product and Package Contents

• Nyzol 100 mg are white, round, biconvex, and scored tablets, with the inscription "N2" engraved on one face. Diameter: 9 mm.

Nyzol is packaged in blister packs containing 7, 14, 28, 56, 98, or 196 tablets, or in a multi-pack containing 196 tablets (2 packs of 98 tablets).

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí – Barcelona

Spain

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

or

Neuraxpharm Arzneimittel GmbH

Elisabeth-Selbert Str. 23

40764 Langenfeld

Germany

This medicine is authorized in the EEA member states under the following names:

Germany: Zonisamid neuraxpharm 100 mg Tabletten

Spain: Nyzol 100 mg comprimidos EFG

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.gob.es