Zonisamide Kern Pharma 25 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Zonisamide Kern Pharma 25 mg hard capsules EFG

Read all of this 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. Do not pass it on to others, even if they have the same symptoms as you, because it may harm them.

  • If you experience any adverse reactions, talk to your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Zonisamide Kern Pharma is and what it is used for

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

3. How to take Zonisamide Kern Pharma

4. Possible side effects

   1. Storage of Zonisamide Kern Pharma

5. Contents of the pack and other information

1. What is Zonisamida Kern Pharma and what is it used for?

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

Zonisamide 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).

Zonisamide 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 Zonisamide Kern Pharma

Do not take Zonisamide Kern Pharma:

• 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 rashes, and blood disorders, which very rarely may lead to death (see section 4).

The use of Zonisamide may cause high levels of ammonia in the blood, which could alter brain function, especially if you are also taking other medications 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 disorders. 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 experiencing decreased 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 the dose of zonisamide may need to be adjusted, and you may have a higher risk of developing allergic reactions, severe rash, swelling of legs and feet, and itching while taking this medicine (see section 4).
• If you have liver problems, as the dose of zonisamide may need to be adjusted.
• 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, this medicine may cause you to sweat less, which could result in 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 zonisamide may cause further weight loss. Inform your doctor, as monitoring may be necessary.
• If you have eye problems such as glaucoma.
• 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 must monitor your child's weight monthly and consult the doctor as soon as possible if they do not gain 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 acid levels in the blood 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 Medications). 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.

Use of Zonisamida Kern Pharma with other medicines

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 if taken together 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 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 an adjustment of the dose of this medicine.

Taking Zonisamida Kern Pharma with food and drinks

Zonisamide may 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 intend to become pregnant, speak with your doctor before stopping contraceptives and before attempting pregnancy about the possibility of switching to other appropriate treatments. If you are or think you may be pregnant, inform your doctor immediately. Do not discontinue treatment without consulting your doctor.

You should take zonisamide during pregnancy only if specifically instructed by your doctor. Research shows an increased risk of birth defects in children of women who take antiepileptic medicines. The risk of birth defects or neurodevelopmental disorders (problems in brain development) for your child after taking zonisamide during pregnancy is unknown. One study showed that children whose mothers used zonisamide during pregnancy were smaller than expected for their gestational 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 zonisamide or during 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 may affect concentration and reaction/response ability, and may cause drowsiness, especially at the beginning of treatment or after a dose increase. If zonisamide affects you in this way, take special care when driving or using machines.

3. How to take Zonisamida Kern Pharma

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

The usual dose in adults:

If you are taking Zonisamida Kern Pharma 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 you are taking Zonisamida Kern Pharma 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 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 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 the effect of zonisamide 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, according to your doctor's instructions.
• 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 Zonisamida Kern Pharma than you should

If you have taken more zonisamide 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, reduced breathing rate, and decreased kidney function. Do not attempt 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 your usual time.

Do not take a double dose to make up for forgotten doses.

If you stop taking Zonisamida Kern Pharma

Zonisamida 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 discontinue treatment, they will gradually reduce the dose in order 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 can cause severe 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 that you are experiencing a severe 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 harming yourself or of 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 that could lead to kidney problems.
• You suddenly have pain in your back or stomach, experience pain when urinating, or notice blood in your urine, as this may be a sign of kidney stones.
• You experience 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 could progress to a more serious 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 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 zonisamide.

The adverse effects of zonisamide most commonly reported are generally mild. 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 blood bicarbonate levels (a substance that prevents blood from becoming too acidic).

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

• Difficulty sleeping, unusual or strange thoughts, feeling of anxiety or mood instability.
• 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 under 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, seizures/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).
• 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 normally eliminate).
• Severe rashes or skin peeling (you may also feel unwell and have a fever).
• Abnormal muscle breakdown (you may have muscle pain or weakness) that may lead to kidney problems.
• Swollen glands, blood disorders (reduction in blood cells, 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 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, even if it is not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Zonisamide 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 EXP. 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, blister pack, or container, or any visible signs of degradation in the medicine. Return the package 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 you are unsure, 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 Zonisamide Kern Pharma

• The active substance 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 contents of the pack

White hard capsules marked with “Z 25”.

Pack sizes:

Blister packs of 14 and 28 capsules.

Only certain pack 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 most recent revision 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/