NYZOL 100 mg HARD CAPSULES

2. What you need to know before you take Nyzol

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, e.g. sulfonamide antibiotics, thiazide diuretics and sulfonylurea antidiabetics.

Warnings and precautions

Nyzol belongs to a group of medicines (sulfonamides) that may 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 Nyzol may lead to high levels of ammonia in the blood, which could affect brain function, especially if you are also taking other medicines that may 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 disease. Tell 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 old, as you may be at greater risk of developing 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, serious skin rash, swelling of legs and feet and itching when taking this medicine (see section 4. Possible side effects).
• if you have liver problems, as your dose of zonisamide may need to be adjusted.
• if you have eye problems such as glaucoma.
• if you have kidney problems, as your dose of zonisamide may need to be adjusted.
• if you have had kidney stones before, 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 lead to your body temperature rising. Reduce the risk of overheating by drinking plenty of water and keeping cool.
• if you are underweight or have lost a lot of weight, as this medicine may make you lose more weight. Tell your doctor, as you may need to be monitored.
• if you are pregnant or could become pregnant (for more information, see section "Pregnancy, breastfeeding and fertility").

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 with a weight below 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 medicine that may cause kidney stones (see Other medicines). Your doctor will check your child's blood bicarbonate levels and kidneys (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.

Other medicines and Nyzol

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

• Zonisamide should be used with caution in adults if taken with medicines that may cause kidney stones, such as topiramate or acetazolamide. In children, this combination is not recommended.
• Zonisamide may possibly increase the levels of medicines such as digoxin and quinidine in the blood, and therefore may need to have their dose reduced.
• 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 Nyzol with food and drink

Zonisamide can be taken with or without food.

Pregnancy, breastfeeding and fertility

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

If you plan to become pregnant, consult 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 shows a higher risk of birth defects in children of women taking antiepileptics. The risk of birth defects or developmental neurological disorders (brain development problems) for your child after taking this medicine during pregnancy is not known.

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 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 may cause symptoms such as drowsiness, dizziness or changes in vision, and may reduce your reaction speed. These effects, as well as your condition itself, may 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 assesses your response to this medicine.

Nyzol contains Macrogol glycerol hydroxystearate

Macrogol glycerol hydroxystearate may cause stomach upset and diarrhoea.

Nyzol 100 mg contains Ponceau 4R (E124)

Ponceau 4R (E124) may cause allergic reactions.

3. How to take Nyzol

Follow exactly the instructions for administration of this medicine given by your doctor. If you are unsure, consult your doctor again.

Recommended dose in adults

If you are taking Nyzol 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 Nyzol 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) who weigh 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 these two doses) 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 start of each week until a daily dose of 150 to 200 mg is reached.

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

• The 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 Nyzol 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 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 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, 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 that you are having a severe allergic reaction.
• you have signs of overheating: high body temperature with little or no sweating, fast 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 the urine, as this may 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 an unexplained skin rash, as it may become a more serious skin rash or peeling.
• you feel especially tired or feverish, have a sore throat, swollen glands or notice that you bruise more easily, as this may mean you have a blood disorder.
• you have signs of increased acid levels in the blood: headaches, drowsiness, difficulty breathing and loss of appetite. You may need medical attention or treatment.

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

The most frequently reported 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: 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 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 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, neuroleptic malignant syndrome (inability to move, sweating, fever, incontinence), status epilepticus (prolonged or repeated seizures).
• respiratory disorders, difficulty breathing, lung inflammation.
• pancreatitis (severe stomach or back pain)
• liver problems, kidney failure, increased creatinine levels (a waste product that the kidneys should normally remove).
• serious skin rashes or 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, high body temperature.
• glaucoma, which is a blockage of the drainage of fluid from the eye, leading to increased pressure inside the eye. It can cause eye pain, blurred vision or decreased vision, and may 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 Medicines Monitoring System for Human Use: www.notificaram.es

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Nyzol

Keep this medication out of sight and reach of children.

Do not use this medication 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 medication does not require special storage conditions.

Do not use this medication if you observe any signs of deterioration in the capsules, blister pack, or carton, or any visible signs of deterioration in the medication. Return the packaging to your pharmacist.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medications at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Nyzol

The active ingredient is zonisamide.

Nyzol 100 mg hard capsules contain 100 mg of zonisamide.

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

The capsule shell contains:

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

Appearance of the Product and Package Contents

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

Nyzol is available in packages of 14, 28, 56, 98, and 196 capsules, packaged in blister packs.

Only some package 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 Revision of this Leaflet: April 2023

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