ZONISAMIDE KERN PHARMA 25 mg HARD CAPSULES

2. What you need to know before you take Zonisamide Kern Pharma

Do not take Zonisamide Kern Pharma:

• 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, such as sulfonamide antibiotics, thiazide diuretics, and sulfonylurea antidiabetics.

Warnings and precautions

Zonisamide belongs to a group of medicines (sulfonamides) that can cause severe allergic reactions, severe skin reactions, and blood disorders, which can very rarely be life-threatening (see section 4).

Zonisamide use may result in high blood ammonia levels, which could alter 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 results in excessive ammonia production in the body (urea cycle disorder), or if you have liver disease. 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 old, as you may be at higher risk of developing reduced sweating, heat stroke, pneumonia, and liver problems. This medicine 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, severe skin reaction, swelling of legs and feet, and itching when taking this medicine (see section 4).
• If you have liver problems, as your dose of zonisamide may need to be adjusted.
• If you have kidney problems, as your dose of zonisamide may need to be adjusted.
• If you have previously had kidney stones, as you may be at higher 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 go on holiday to a hot place, this medicine can make you sweat less, which can result in your body temperature rising. Reduce the risk of overheating by drinking plenty of water and staying cool.
• If you are underweight or have lost a lot of weight, as zonisamide can make you lose more weight. Inform your doctor, as you may need to be monitored.
• If you have eye problems such as glaucoma.
• 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, inform your doctor before taking this medicine.

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 ensuring your child drinks plenty of water and does not take any medicine 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 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.

Using Zonisamide Kern Pharma with other medicines

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 can cause kidney stones, such as topiramate or acetazolamide. In children, this combination is not recommended.
• Zonisamide may increase the blood levels of medicines such as digoxin and quinidine, and therefore may require a dose reduction of these medicines.
• Other medicines such as phenytoin, carbamazepine, phenobarbital, and rifampicin may decrease the blood levels of zonisamide, which may require a dose adjustment of this medicine.

Taking Zonisamide Kern Pharma with food and drinks

Zonisamide can be taken with or without food.

Pregnancy, breastfeeding, and fertility

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

If you plan to become pregnant, talk to your doctor before stopping contraception and before becoming pregnant about the possibility of switching 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 zonisamide during pregnancy if your doctor advises it. Research shows a higher risk of birth defects in children of women who take antiepileptics. The risk of birth defects or developmental neurological disorders (brain development problems) for your child after taking zonisamide 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 this medicine.

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 can affect concentration, reaction time, and may cause drowsiness, especially at the start of treatment or after a dose increase. If zonisamide affects you in this way, be especially careful when driving or using machines.

3. How to take Zonisamide Kern Pharma

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

The usual dose in adults:

If you take Zonisamide Kern Pharma 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 take Zonisamide Kern Pharma 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 kilogram of body weight once a day.
• This can be increased by 1 mg per kilogram of body weight at intervals of one to two weeks.
• The usual daily dose is between 6 mg and 8 mg per kilogram of body weight 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 over 55 kg (the lower of the two doses) once a day.

Example: a child who weighs 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 zonisamide 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 of the daily dose in the morning and the other half in the evening.

If you take more Zonisamida Kern Pharma than you should

If you have taken more zonisamide than you should, tell the person taking care of you (family or friend), your doctor, or pharmacist, or contact the emergency department of the nearest hospital and take the medicine with you. 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 kidney function. Do not try to drive.

If you forget to take Zonisamida Kern Pharma

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 Zonisamida Kern Pharma

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 gradually reduce the dose to minimize the risk of you having more seizures.

If you have any other questions about 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 can cause severe allergic reactions, severe skin reactions, and blood disorders, which can very rarely be life-threatening.

Contact your doctor immediately if:

• You have difficulty breathing, swelling of the face, lips, or tongue, or a severe skin reaction, as these symptoms can indicate that you are having a severe allergic reaction.
• You have signs of overheating: high body temperature with little or no sweating, rapid heart rate 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 can be a sign of abnormal muscle breakdown that can lead to kidney problems.
• You have sudden back or stomach pain, pain when urinating, or blood in your urine, as this can 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 reaction, as it can become a more severe skin reaction or skin peeling.
• You feel especially tired or feverish, have a sore throat, swollen glands, or bruise more easily, as this can mean you have a blood disorder.
• You have signs of increased acid levels in the blood: headaches, drowsiness, difficulty breathing, and loss of appetite. Medical monitoring or treatment may be necessary.

Your doctor may decide that you should stop taking zonisamide.

The most common 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, reduced 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 abnormal thoughts, feeling anxious or emotionally unstable.
• Slow thinking, loss of concentration, speech disorders, abnormal sensation in the skin (tingling), tremors, involuntary eye movements.
• Kidney stones.
• Skin reactions, 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, diarrhea (loose stools), constipation.
• Swelling of legs and feet.

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

• Anger, 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/attacks.

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 status (prolonged or repeated seizures).
• Respiratory disorders, breathing difficulties, lung inflammation.
• Pancreatitis (severe stomach or back pain).
• Liver problems, kidney failure, increased creatinine levels (a waste product that the kidneys should normally remove).
• Severe skin reactions or skin 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).
• Reduced sweating, high body temperature.
• Glaucoma, which is a blockage of the drainage of fluid from the eye that causes increased pressure inside the eye. Symptoms can include eye pain, blurred vision, or decreased vision and can be signs of glaucoma.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Zonisamida Kern Pharma

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after CAD. The expiry date is the last day of the month indicated.

Do not use this medicine if you notice any signs of deterioration in the capsules, blisters, or box, or any visible signs of deterioration in the medicine. Return the packaging to your pharmacist.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the pharmacy's SIGRE Point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Packaging contents and additional information

Composition of Zonisamida Kern Pharma

• The active ingredient is zonisamide. Each capsule contains 25 mg of zonisamide.
• The other components present in the capsule are: microcrystalline cellulose, sodium lauryl sulfate, and hydrogenated vegetable oil Type I.

The capsule shell contains: titanium dioxide and gelatin.

The printing ink contains: Shellac, black iron oxide (E-172), and traces of potassium hydroxide.

Appearance of the product and packaging contents

Hard white capsules marked with "Z 25".

Packaging sizes:

Blisters of 14 and 28 capsules.

Only some packaging sizes may be marketed.

Marketing authorization holder

Kern Pharma S.L

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

NOUCOR HEALTH, S.A.

Av. Camí Reial, 51-57

08184 – Palau-solità i Plegamans

Barcelona

Spain

Date of the last revision of this leaflet:March 2023

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