Nyzol 100 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Nyzol 100 mg hard capsules EFG

zonisamide

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, 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 other people, 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 effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Nyzol is used to treat seizures affecting one part of the brain (partial seizures), which may or may not progress to seizures involving the entire brain (secondary generalization).

Nyzol can be used:

• Alone to treat epileptic seizures in adults.
• In combination with other antiepileptic medicines to treat epileptic 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 components 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

Nyzol 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).

The use of Nyzol may lead to high levels of ammonia in the blood, which could alter brain function, especially if you are also taking other medications that can 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 disorders. Inform your doctor immediately if you feel 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, heatstroke, pneumonia, and liver problems*. The use of zonisamide is not recommended in children under 6 years of age.
• if you are elderly, as the dose of zonisamide may need to be adjusted, and you may have a higher risk of developing an allergic reaction, severe rash, swelling of the legs and feet, and itching while taking this medicine (see section 4. Possible adverse effects).
• if you have liver problems, as the dose of zonisamide may need to be adjusted.
• if you have eye problems such as glaucoma.
• if you have kidney problems, as the dose of zonisamide may need to be adjusted.
• 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 cause your body temperature to rise. Reduce the risk of overheating by drinking enough water and keeping cool.
• if you are underweight or have lost a lot 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 zonisamide.

Children and adolescents

Consult your doctor regarding the following risks:

• Weight: You should monitor your child's weight monthly and consult your doctor as soon as possible if they are not gaining 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.

Other medicines and Nyzol

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

• Zonisamide should be used with caution in adults when taken with medications that may cause kidney stones, such as topiramate or acetazolamide. This combination is not recommended in children.
• Zonisamide may possibly increase blood levels of medications 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 could require adjustment of the zonisamide dose.

Taking Nyzol with food and drinks

Zonisamide may be taken with or without food.

Pregnancy, breastfeeding, and fertility

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

If you intend 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 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 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 babies born to mothers who used zonisamide during pregnancy were smaller than expected for their age at birth, compared to babies 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 impair reaction ability. These effects, as well as the underlying condition itself, may affect your ability to drive vehicles 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.

Nyzol contains Macrogol glycerol hydroxystearate

Macrogol glycerol hydroxystearate may cause stomach discomfort and diarrhea.

Nyzol 100 mg contains Ponceau 4R (E124)

Ponceau 4R (E124) may cause allergic reactions.

3. How to take Nyzol

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

Recommended dose in adults

If taking Nyzol alone:

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

If taking Nyzol with other antiepileptic medicines:

• The initial dose is 50 mg per day, 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 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 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 daily.
• It may 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 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.

• Zonisamide capsules must be swallowed whole with water.
• Do not chew the capsules.
• Zonisamide may be taken once or twice daily, as instructed by your doctor.
• 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 Nyzol 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 feel nauseous, have stomach pain, muscle spasms, eye movements, feel faint, have a slow heartbeat, and experience reduced respiratory rate 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

• Zonisamide is intended to be taken as a long-term medicine. 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 in order to decrease the risk of having further 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 can cause serious allergic reactions, severe rashes, and blood disorders, which very rarely may lead to death.

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 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 which can lead to kidney problems.
• you suddenly develop back or stomach pain, experience pain when urinating, or notice blood in your urine, as this may be a sign of kidney stones.
• you develop visual 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 may progress to a more severe 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 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 most commonly reported are generally 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 mood instability.
• slowed thinking, difficulty concentrating, speech abnormalities, abnormal sensation in the skin (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 (loose stools), 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/convulsive attacks.

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 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, 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 reduced vision may occur and could be signs of glaucoma.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist. This includes any possible adverse effects 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 outer 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 your pharmacy. If you are unsure, please ask your pharmacist how to properly 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.

Nyzol 100 mg hard capsules contain 100 mg of zonisamide.

The other components present in the capsule contents are: microcrystalline cellulose, hydrogenated cottonseed vegetable oil, and macrogol glycerol hydroxystearate.

The capsule shell contains:

Gelatin, titanium dioxide (E171), ponceau 4R (E124), and quinoline yellow (E104).

Appearance of the product and contents of the pack

Nyzol 100 mg hard capsules EFG: are hard gelatin capsules with an opaque red cap and an opaque white body (size 1; 19.3 mm ± 0.4 mm), containing white to off-white granules.

Nyzol is available in packs of 14, 28, 56, 98 and 196 capsules, packed in blisters.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona

Manufacturer

Neuraxpharm Arzneimittel GmbH

Elisabeth-Selbert-Strase 23

40764 – Langenfeld

Germany

Date of latest revision of this leaflet: April 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products http://www.aemps.gob.es