Package Insert: Information for the User

Nyzol 100 mg Tablets EFG

zonisamide

Read this package insert carefully before you start taking this medicine, because 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 for 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 any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

This medication 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).

This medication may be used:

• Alone to treat seizures in adults.
• With other antiepileptic medications to treat seizures in adults, adolescents, and children 6 years of age and older.

Do not take Nyzol:

• if you are allergic to zonisamide or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other sulfonamides, for example: 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 rashes, and blood disorders, which very rarely can cause death (see section 4. Possible side effects).

The use of this medicine 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 in the body (urea cycle disorder), or if you have liver disorders. Inform your doctor immediately if you feel drowsy or confused in an unusual way.

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

• if you are under 12 years old, as you may have a higher risk of developing decreased sweating, heatstroke, pneumonia, and liver problems. This medicine is not recommended for children under 6 years old.
• if you are elderly, as you may need to adjust the dose of this medicine, and you may have a higher risk of developing an allergic reaction, severe rash, swelling of legs and feet, and itching when taking zonisamide (see section 4. Possible side effects).
• if you have liver problems, as you may need to adjust the dose of this medicine.
• if you have eye problems such as glaucoma.
• if you have kidney problems, as you may need to adjust the dose of this medicine.
• if you have previously had kidney stones, as you may be at a higher risk of developing more kidney stones.Reduce the risk of kidney stones by drinking enough water.
• if you live in a hot place or are going on holiday to a hot place. This medicine may make you 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 underweight or have lost a lot of weight, as this medicine 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 (see section “Pregnancy, breastfeeding, and fertility” for more information).

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

Children and adolescents

Consult your doctor about the following risks:

• Weight:you should monitor your child's weight monthly and see your doctor as soon as possible if they are not gaining enough weight.This medicine is not recommended for children who are underweight or have a poor appetite, and should be used with caution in children with a weight of less than 20 kg.

• Increased blood acidity and kidney stones: reduce these risks by ensuring your child drinks enough water and does not take any other medicines that can cause kidney stones (see Other medicines). Your doctor will monitor your child's blood bicarbonate levels and kidneys (see also section 4).

Do not administer this medicine to children under 6 years old as there is no known benefit in this age group.

Other medicines and Nyzol

Inform your doctor or pharmacist if you are using or have recently used any other medicine, including those purchased 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. In children, this combination is not recommended.
• Zonisamide may increase the levels of medicines such as digoxin and quinidine in the blood, and therefore may require a reduction in the dose of these medicines.
• Other medicines such as phenytoin, carbamazepine, phenobarbital, and rifampicin may decrease the levels of this medicine in the blood, which may require an adjustment in the dose of this medicine.

Pregnancy, breastfeeding, and fertility

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

If you intend to become pregnant, talk to your doctor before stopping contraception and before becoming pregnant about the possibility of changing 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 medicine during pregnancy if your doctor advises it. Research has shown a higher risk of birth defects in children of women taking antiepileptic medicines. The risk of birth defects or neurological developmental disorders (brain development problems) for your child after taking this medicine during pregnancy is unknown. A study showed that children whose mothers took zonisamide 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 zonisamide for epilepsy during pregnancy.

Do not breastfeed while taking this medicine 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 operating machinery

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

Nyzol contains lactose and sodium

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

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

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

Recommended dose in adults

When taking Nyzol alone:

• 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.

When taking Nyzol 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 recommended 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, are elderly, 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 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 reaching a daily dose of 150 to 200 mg.

If you estimate that the action of this medication is too strong or too weak, inform 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 at night.

The tablet can be divided into equal doses

When taking more Nyzol than you should

If you have taken more Nyzol than you should, inform the person taking care of you (family member or friend), your doctor or pharmacist, or contact the nearest hospital emergency service and bring 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 fainting, have a slow heart rate, and decreased respiratory and renal function. Do not drive.

When 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 compensate for the missed doses.

When interrupting treatment with Nyzol

• Nyzol is intended to be taken as long-term medication. Do not reduce the dose or stop taking the medication unless your doctor tells 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 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.

Get in touch with your doctor immediately 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, pain while urinating, or notice blood in your urine, as this may be a sign of kidney stones.
• You experience visual problems such as eye pain or blurred vision while taking this medicine.

Get in touch with your doctor as soon as possible if:

• You have an 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 a blood disorder.
• You have signs of increased acid levels in the blood: headaches, drowsiness, difficulty breathing, and loss of appetite. Medical control or treatment may be necessary.

Your doctor may decide that you should stop taking this medicine.

The most common side effects of zonisamide reported 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 unstable emotionally.
• 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, attempted suicide.
• vomiting.
• inflammation of the gallbladder or gallstones.
• kidney stones.
• pulmonary infections/inflammation, urinary tract infections.
• low potassium levels in the blood and convulsions/epileptic 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 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 also feel unwell and have a fever).
• abnormal muscle breakdown (may have 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 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 theSistema Español de Farmacovigilancia de Medicamentos de Uso Humanowww.notificaRAM.esBy 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 tablets, 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 collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Nyzol

The active ingredient is zonisamide.

Each tablet contains 100 mg of zonisamide.

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

Appearance of the product and contents of the packaging

• 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 a blister pack 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 commercially available.

Marketing Authorization Holder and Responsible for Manufacturing

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí – Barcelona

Spain

Responsible for Manufacturing

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 medicinal product is authorized in the Member States of the EEA with the following names:

Germany:Zonisamide neuraxpharm 100 mg Tablets

Spain:Nyzol 100 mg tablets EFG

Last revision date of this leaflet:March 2023

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