Zonisamidum Neuraxpharm

Package Leaflet: Information for the User

Zonisamidum Neuraxpharm, 25 mg, hard capsules
Zonisamidum Neuraxpharm, 50 mg, hard capsules
Zonisamidum Neuraxpharm, 100 mg, hard capsules
Zonisamidum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

• 1. What is Zonisamidum Neuraxpharm and what is it used for
• 2. Important information before taking Zonisamidum Neuraxpharm
• 3. How to take Zonisamidum Neuraxpharm
• 4. Possible side effects
• 5. How to store Zonisamidum Neuraxpharm
• 6. Contents of the pack and other information

1. What is Zonisamidum Neuraxpharm and what is it used for

Zonisamidum Neuraxpharm contains the active substance zonisamide and is used as an antiepileptic medicine.
Zonisamidum Neuraxpharm is used to treat seizures that start in one part of the brain (partial seizures) and may or may not spread to other parts of the brain (secondary generalized seizures).
Zonisamidum Neuraxpharm can be used:

• as the only medicine to treat seizures in adults.
• with other antiepileptic medicines to treat seizures in adults, children, and adolescents aged 6 years and older.

2. Important information before taking Zonisamidum Neuraxpharm

When not to take Zonisamidum Neuraxpharm:

• If you are allergic to zonisamide or any of the other ingredients of this medicine (listed in section 6);
• If you are allergic to sulfonamides, which include sulfonamide antibiotics, thiazide diuretics, and sulfonylurea antidiabetic medicines.

Warnings and precautions

Zonisamidum Neuraxpharm belongs to a group of medicines known as sulfonamides, which can cause severe allergic reactions, severe skin rashes, and blood disorders, which can very rarely be fatal (see section 4, Possible side effects).

Taking Zonisamidum Neuraxpharm is associated with the occurrence of severe rashes, including Stevens-Johnson syndrome.

Taking Zonisamidum Neuraxpharm may lead to high levels of ammonia in the blood, which can cause changes in brain function, especially if you are also taking other medicines that can increase ammonia levels (such as valproic acid), have a genetic disorder that causes excessive accumulation of ammonia in the body (urea cycle disorder), or have liver problems. If you experience unusual sleepiness or confusion, you should contact your doctor immediately.
Before starting to take Zonisamidum Neuraxpharm, you should discuss it with your doctor or pharmacist if:

• you are under 12 years old, as there is an increased risk of reduced sweating, heat stroke, pneumonia, and liver problemsin children. Zonisamidum Neuraxpharm is not recommended for children under 6 years old;
• you are elderly; the dose of Zonisamidum Neuraxpharm may need to be adjusted, and allergic reactions, severe skin rashes, swelling of the feet and ankles, and itching may occur more frequently in this age group (see section 4, Possible side effects);
• you have liver problems, as the dose of Zonisamidum Neuraxpharm may need to be adjusted;
• you have eye problems, such as glaucoma;
• you have kidney problems, as the dose of Zonisamidum Neuraxpharm may need to be adjusted;
• you have had kidney stones in the past, as there is an increased risk of forming new kidney stones. To reduce the risk of kidney stones, you should drink plenty of water;
• you are constantly or temporarily (on vacation) in a hot climate. Zonisamidum Neuraxpharm may reduce the amount of sweat produced, which can cause an increase in body temperature. To reduce the risk of overheating, you should drink plenty of water and stay in a cool place;
• you are underweight or have lost a lot of weight, as Zonisamidum Neuraxpharm may cause further weight loss. Your condition may need to be monitored, so you should inform your doctor;
• you are pregnant or may become pregnant (see section "Pregnancy, breastfeeding, and fertility").

If any of the above situations apply to you, you should inform your doctor before starting to take Zonisamidum Neuraxpharm.

Children and adolescents

You should discuss the following risks with your doctor:
Preventing overheating and dehydration in children
Zonisamidum Neuraxpharm may limit sweating in children and cause overheating, which, if left untreated, can lead to brain damage and death. The greatest risk to children occurs especially during heatwaves.
When a child takes Zonisamidum Neuraxpharm:

• you should avoid overheating the child, especially during heatwaves
• the child should avoid intense physical exercise, especially during heatwaves
• you should give the child plenty of cold water to drink
• you should not give the child the following medicines: carbonic anhydrase inhibitors (such as topiramate and acetazolamide) and anticholinergic medicines (such as clomipramine, hydroxyzine, diphenhydramine, haloperidol, imipramine, and oxybutynin).

If the child's skin is very hot, and they are sweating little or not at all, or if they have symptoms of confusion and muscle spasms, or if they have rapid heartbeat and rapid breathing:

• you should move the child to a cool, shaded place
• you should cool the child's skin with cool (not cold) water
• you should give the child cold water to drink
• you should seek immediate medical attention.
• weight: you should weigh the child every month and contact the doctor as soon as possible if the child is not gaining enough weight. Zonisamidum Neuraxpharm is not recommended for children who are underweight or have a poor appetite, and the medicine should be used with caution in children with a body weight of less than 20 kg.
• increased blood acidity and kidney stones: the risk can be reduced if the child drinks plenty of water and does not take any other medicines that can cause kidney stones (see Zonisamidum Neuraxpharm and other medicines). The doctor will monitor the child's blood bicarbonate levels and kidney function (see also section 4).

Zonisamidum Neuraxpharm should not be used in children under 6 years old, as it is not known whether the potential benefits outweigh the risks in this age group.

Zonisamidum Neuraxpharm and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines that are available without a prescription.

• You should be cautious when taking Zonisamidum Neuraxpharm with medicines that can cause kidney stones, such as topiramate or acetazolamide. This combination is not recommended for children.
• Zonisamidum Neuraxpharm may increase the levels of certain medicines in the blood, such as digoxin and quinidine, and the dose of these medicines may need to be reduced.
• Other medicines, such as phenytoin, carbamazepine, phenobarbital, and rifampicin, may decrease the levels of Zonisamidum Neuraxpharm in the blood, and the dose of Zonisamidum Neuraxpharm may need to be adjusted.

Taking Zonisamidum Neuraxpharm with food and drink

Zonisamidum Neuraxpharm can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are of childbearing age, you should use adequate contraception during treatment with Zonisamidum Neuraxpharm and for one month after stopping treatment.
If you plan to become pregnant, you should discuss this with your doctor before stopping contraception and becoming pregnant. If you are pregnant or think you may be pregnant, you should tell your doctor immediately. You should not stop treatment without discussing it with your doctor.
Taking Zonisamidum Neuraxpharm during pregnancy is only allowed if your doctor considers it necessary. Studies have shown an increased risk of birth defects in children of mothers taking antiepileptic medicines. The risk of birth defects or developmental disorders (brain development problems) in a child whose mother took Zonisamidum Neuraxpharm during pregnancy is not known. In one study, it was found that children of mothers who took zonisamide during pregnancy were smaller than expected for their age at birth, compared to children of mothers treated with lamotrigine alone (monotherapy). You should get full information about the risks and benefits of treating epilepsy with zonisamide during pregnancy.
You should not breastfeed while taking Zonisamidum Neuraxpharm and for one month after stopping treatment.
There are no clinical data available on the effects of zonisamide on human fertility. Animal studies have shown changes in fertility parameters.

Driving and using machines

Zonisamidum Neuraxpharm may affect your concentration, reaction time, and ability to react, and may also cause drowsiness, especially at the start of treatment or when the dose is increased. If Zonisamidum Neuraxpharm causes these effects, you should be careful when driving or operating machinery.

3. How to take Zonisamidum Neuraxpharm

This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Recommended dose for adults

Taking Zonisamidum Neuraxpharm as the only medicine:

• The starting dose is 100 mg, taken once a day.
• The dose can be increased by a maximum of 100 mg every 2 weeks.
• The recommended dose is 300 mg once a day.

Taking Zonisamidum Neuraxpharm with other antiepileptic medicines:

• The starting dose is 50 mg per day, taken in two equal doses of 25 mg each.
• The dose can be increased by a maximum of 100 mg every 1-2 weeks.
• The recommended daily dose is between 300 mg and 500 mg.
• In some people, lower doses may be effective. If you experience side effects, are elderly, or have kidney or liver problems, the dose may be increased more slowly.

Taking Zonisamidum Neuraxpharm in children (aged 6-11 years) and adolescents (aged 12-17 years) with a body weight of at least 20 kg:

• The starting dose is 1 mg per kilogram of body weight, taken once a day.
• The dose can be increased by 1 mg per kilogram of body weight every 1-2 weeks.
• The recommended daily dose is between 6 and 8 mg per kilogram of body weight in children with a body weight below 55 kg or between 300 and 500 mg in children with a body weight above 55 kg (use the lower dose), taken once a day.

Example: a child with a body weight of 25 kg should receive a dose of 25 mg once a day in the first week, and then the daily dose should be increased by 25 mg at the start of each subsequent week until a daily dose of between 150 mg and 200 mg is reached.
If you think that the effect of Zonisamidum Neuraxpharm is too strong or too weak, you should talk to your doctor or pharmacist.

• Zonisamidum Neuraxpharm capsules should be swallowed whole with water.
• Do not chew the capsules.
• Zonisamidum Neuraxpharm should be taken once or twice a day, as directed by your doctor.
• If you take Zonisamidum Neuraxpharm twice a day, you should take half the daily dose in the morning and half in the evening.

Taking a higher dose of Zonisamidum Neuraxpharm than recommended

If you have taken more Zonisamidum Neuraxpharm than you should, you should immediately inform your caregiver (family member or friend), doctor, or pharmacist, or go to the nearest hospital emergency department. You may become drowsy and lose consciousness. You may also experience nausea, stomach pain, muscle twitching, eye rolling, feel unwell, have low blood pressure, shortness of breath, and decreased kidney function. You should not attempt to drive.

Missing a dose of Zonisamidum Neuraxpharm

• If you forget to take a dose, you should not worry, just take the next dose at the usual time.
• Do not take a double dose to make up for a forgotten dose.

Stopping treatment with Zonisamidum Neuraxpharm

• Zonisamidum Neuraxpharm is intended for long-term use. You should not reduce the dose or stop treatment unless your doctor tells you to.
• If your doctor tells you to stop taking Zonisamidum Neuraxpharm, the dose will be gradually reduced to minimize the risk of further seizures.

If you have any further questions on the use of this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Zonisamidum Neuraxpharm can cause side effects, although not everybody gets them.
Zonisamidum Neuraxpharm belongs to a group of medicines known as sulfonamides, which can cause severe allergic reactions, severe skin rashes, and blood disorders, which can very rarely be fatal.

You should contact your doctor immediately if you:

• have difficulty breathing, face, lip, or tongue swelling, or a severe skin reaction, as these may be signs of a severe allergic reaction;
• have symptoms of overheating - high body temperature with little or no sweating, rapid heartbeat, and rapid breathing, muscle spasms, and confusion;
• have thoughts of self-harm or suicide. A small number of people taking antiepileptic medicines, such as Zonisamidum Neuraxpharm, have had thoughts of self-harm or suicide;
• have muscle pain or weakness, as these may be signs of muscle breakdown, which can lead to kidney problems;
• have sudden back or stomach pain, pain or bleeding when urinating, as these may be signs of kidney stones;
• have vision problems, such as eye pain or blurred vision, while taking Zonisamidum Neuraxpharm.

You should contact your doctor as soon as possible if you:

• have an unexplained rash, as this may be a sign of a severe rash or skin peeling;
• have unusual tiredness, fever, sore throat, swollen lymph nodes, or bruising, as these may be signs of blood disorders;
• have symptoms of high blood acidity - headaches, drowsiness, shortness of breath, and loss of appetite. Your doctor may need to monitor or treat these symptoms.

Your doctor may decide to stop treatment with Zonisamidum Neuraxpharm.
The most common side effects of Zonisamidum Neuraxpharm are usually mild, occur in the first month of treatment, and usually go away during treatment. In children aged 6-17 years, the side effects were similar to those described below, except for: pneumonia, dehydration, reduced sweating (frequent) and abnormal liver enzyme activity (not very frequent).
Very common side effects(may affect more than 1 in 10 people):

• agitation, irritability, disorientation, depression;
• abnormal muscle coordination, dizziness, memory problems, drowsiness, double vision;
• loss of appetite, low blood bicarbonate levels (bicarbonate helps prevent the blood from becoming too acidic).

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

• sleep disorders, strange or unusual thoughts, feeling anxious or emotionally unstable;
• slow thinking, difficulty concentrating, speech problems, abnormal skin sensations (tingling and numbness), muscle twitching, involuntary eye movements;
• kidney stones;
• skin rashes, itching, allergic reactions, fever, tiredness, flu-like symptoms, hair loss;
• bruising (small blood spots under the skin from damaged blood vessels);
• weight loss, nausea, indigestion, stomach pain, diarrhea, constipation;
• swelling of the feet and ankles.

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

• anger, aggression, suicidal thoughts, suicide attempts;
• vomiting;
• gallbladder inflammation, gallstones;
• urinary tract stones;
• lung infection/pneumonia and urinary tract infections;
• low blood potassium levels, seizures/epileptic fits.

Rare side effects(may affect up to 1 in 1,000 people):

• hallucinations, memory loss, coma, malignant neuroleptic syndrome (inability to move, sweating, fever, incontinence), status epilepticus (repeated or prolonged seizures);
• breathing problems, shortness of breath, pneumonia;
• pancreatitis (severe stomach or back pain);
• liver disease, kidney failure, increased blood creatinine levels (creatinine is a waste product that is normally removed by the kidneys);
• severe skin rashes or skin peeling (which may be accompanied by feeling unwell or fever);
• muscle breakdown, which can lead to kidney problems;
• lymph node swelling, blood disorders (reduced blood cell count, which can increase the risk of infection, cause pale skin, tiredness, fever, and easy bruising);
• reduced sweating, overheating;
• glaucoma, related to fluid retention in the eye, which can cause increased pressure in the eye. You may experience eye pain, blurred vision, or decreased vision, which are symptoms of glaucoma.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. You can also report side effects directly to the
Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C, 02-222 Warsaw; phone: +48 22 49 21 301; fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zonisamidum Neuraxpharm

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP" and on the blister after "EXP". The expiry date refers to the last day of the month.
There are no special storage instructions for this medicine.
Do not use this medicine if you notice damage to the capsule, blister, or carton, or any signs of deterioration. You should return the packaging to the pharmacist.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Zonisamidum Neuraxpharm contains

The active substance of Zonisamidum Neuraxpharm is zonisamide.
The hard capsules of Zonisamidum Neuraxpharm contain 25 mg, 50 mg, or 100 mg of zonisamide.

• The other ingredients of the capsules are: microcrystalline cellulose, hydrogenated vegetable oil, and sodium lauryl sulfate. The ink used for printing on the capsule contains shellac (E 904), potassium hydroxide, and iron oxide black (E 172)
• The composition of the capsule shell is: gelatin, titanium dioxide (E 171). In addition, the capsule shell of the 50 mg capsules contains iron oxide black (E 172), and the capsule shell of the 100 mg capsules contains quinoline yellow (E 104) and erythrosine (E 127).

What Zonisamidum Neuraxpharm looks like and contents of the pack

Zonisamidum Neuraxpharm, 25 mg hard capsules have a white cap and body with the imprint "G" and "742", and are 14.4±0.5 mm in length.
Zonisamidum Neuraxpharm, 50 mg hard capsules have a gray cap and white body with the imprint "G" and "743", and are 15.8±0.5 mm in length.
Zonisamidum Neuraxpharm, 100 mg hard capsules have a red cap and white body with the imprint "G" and "744", and are 19.2±0.5 mm in length.
Available pack sizes:
Zonisamidum Neuraxpharm 25 mg is packaged in blisters and cartons containing 14 capsules.
Zonisamidum Neuraxpharm 50 mg is packaged in blisters and cartons containing 56 capsules.
Zonisamidum Neuraxpharm 100 mg is packaged in blisters and cartons containing 56 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder

neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert-Strasse 23
40764 Langenfeld
Germany

Manufacturer/Importer

Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b
140 78 Prague 4
Czech Republic

For further information on this medicine and its authorized names in the European Economic Area, you should contact the representative of the marketing authorization holder:

Neuraxpharm Polska Sp. z o.o.
Domaniewska 37
02-672 Warsaw
Date of last revision of the leaflet:04/2023