Nyzol 25 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Nyzol 25 mg tablets EFG

zonisamide

Read the entire 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Nyzol is and what it is used for

This medicinal product contains the active substance zonisamide and is used as an antiepileptic.

This medicinal product 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).

This medicinal product may be used:

• As monotherapy for the treatment of seizures in adults.
• In combination with other antiepileptic medicines for the treatment of seizures in adults, adolescents, and children aged 6 years and older.

2. What you need to know before starting to take Nyzol

Do not take Nyzol:

• if you are allergic to zonisamide or to 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 serious allergic reactions, severe skin rashes, and blood disorders, which very rarely may lead to death (see section 4. Possible side effects).

The use of this medicine may cause high levels of ammonia in the blood, which could alter 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 in the body (urea cycle disorder), or if you have liver problems. Inform your doctor immediately if you become unusually drowsy or confused.

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

• if you are under 12 years of age, as you may have an increased risk of reduced sweating, heat stroke, pneumonia, and liver problems. The use of this medicine is not recommended in children under 6 years of age.
• if you are elderly, as a dose adjustment of this medicine may be necessary, and you may have a higher risk of developing an allergic reaction, severe rash, swelling of the legs and feet, or itching when taking zonisamide (see section 4. Possible adverse effects).
• if you have liver problems, as a dose adjustment of this medicine may be necessary.
• if you have eye problems such as glaucoma.
• if you have kidney problems, as a dose adjustment of this medicine may be necessary.
• if you have previously had kidney stones, as you may be at higher 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. This medicine may reduce sweating, which could lead to an increase in your body temperature. Reduce the risk of overheating by drinking enough water and keeping cool.
• if you are underweight or have lost a significant amount of weight, as this medicine may cause further weight loss. Inform your doctor, as monitoring may be necessary.
• if you are pregnant or could become pregnant (for further information, see section “Pregnancy, breastfeeding and fertility”).

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

Children and adolescents

Consult your doctor regarding the following risks:

• Weight: You should monitor your child's weight monthly and consult a doctor as soon as possible if they are not gaining sufficient weight. This medicine is not recommended for 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 other medicines 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.

Other medicines and Nyzol

Inform 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 when taken 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 a dose reduction of these medicines may be necessary.
• Other medicines such as phenytoin, carbamazepine, phenobarbitone, and rifampicin may decrease blood levels of this medicine, which might require adjustment of its dose.

Pregnancy, breastfeeding, and fertility

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

If you are planning to become pregnant, speak with 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, inform your doctor immediately. Do not discontinue treatment without consulting your doctor.

This medicine should only be taken during pregnancy if specifically prescribed by your doctor. Research shows an increased risk of birth defects in children born to women taking antiepileptic medicines. The risk of birth defects or neurodevelopmental disorders (problems in brain development) for your child after taking this medicine 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 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 use of machines

Zonisamide may affect concentration and reaction capacity, and may cause drowsiness, especially at the beginning of treatment or after a dose increase. If this medicine affects you in this way, take special care when driving or operating machinery.

Nyzol contains lactose and sodium

If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take Nyzol

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

Recommended dose in adults

If you are taking Nyzol alone:

• The initial dose is 100 mg once daily.
• It may be increased by 100 mg at intervals of two weeks.
• The recommended dose is 300 mg once daily.

If you are taking Nyzol with other antiepileptic medicines:

• The initial dose is 50 mg daily, divided into two equal doses of 25 mg.
• It may 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 adverse effects, are elderly, or 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.
• It may 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 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), 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 this medicine 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 may be taken once or twice daily, according to your doctor's instructions.
• If you take Nyzol twice daily, take half of the daily dose in the morning and the other half at night.

The tablet may be divided into equal doses.

If you take more Nyzol than you should

If you have taken more Nyzol than you should, inform immediately the person caring for you (family member or friend), your doctor or pharmacist, or contact the nearest hospital emergency department, and bring the medicine with you. You may feel drowsy and could lose consciousness. You may also feel nauseous, have stomach pain, muscle spasms, eye movements, feel faint, have a slow heartbeat, and experience reduced respiratory and kidney function. Do not attempt 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 medicine unless instructed by your doctor.
• If your doctor advises you to stop treatment, they will gradually reduce the dose to decrease the risk of having more 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 will experience them.

Zonisamide belongs to a group of medicines (sulfonamides) that may cause serious 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 you are experiencing a serious 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 receiving treatment with 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 which can lead to kidney problems.
• you suddenly have back or stomach pain, pain when urinating, 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 this medicine.

Contact your doctor as soon as possible if:

• you develop an unexplained rash, as it could progress to a more severe rash or skin peeling.
• you feel unusually tired or feverish, have a sore throat, swollen glands, or notice you bruise more easily, as this may indicate you have 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 this medicine.

The adverse effects of zonisamide reported most frequently 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 exceptions: 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 blood

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

• difficulty sleeping, unusual or strange thoughts, feeling anxious or emotionally unstable
• 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 (a small bruise caused by blood from a broken blood vessel in 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 blood potassium levels and seizures

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), status epilepticus (prolonged or repeated seizures)
• breathing disorders, difficulty breathing, lung inflammation
• pancreatitis (severe stomach or back pain)
• liver problems, kidney failure, increased levels of creatinine (a waste product normally eliminated by the kidneys) in blood
• severe rashes or skin peeling (you may also feel unwell and have a fever)
• abnormal muscle breakdown (you may have muscle pain or weakness) which can lead to kidney problems
• swollen glands, blood disorders (reduction in blood cell count, which may make you more prone to infections, look pale, feel 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 can be signs of glaucoma.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Nyzol

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

Do not use this medicine after the expiry date stated on the blister and 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 tablets, blister, 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 Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Nyzol

The active substance is zonisamide.

Each tablet contains 25 mg of zonisamide.

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

Appearance of the product and contents of the pack

• Nyzol 25 mg are white, round, biconvex, scored tablets, with the inscription “N” engraved on one side. Diameter: 5 mm.

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

Only certain pack 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 medicinal product is authorized in EEA Member States under the following names:

Germany: Zonisamid neuraxpharm 25 mg Tabletten

Spain: Nyzol 25 mg comprimidos EFG

Date of the most recent review 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.gob.es