Prospect: Information for the User

Zonisamide Kern Pharma 100 mg Hard Capsules EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist even if they are not listed in this prospect. See section 4.

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

2.What you need to knowbefore starting to take Zonisamide Kern Pharma

3.How to take Zonisamide Kern Pharma

4.Adverse effects

1. Storage of Zonisamide Kern Pharma

6.Contents of the package and additional information

This medication contains the active ingredient zonisamida, and is used as an antiepileptic.

Zonisamida is used to treat seizures that affect a part of the brain (partial seizures), which may or may not be followed by a seizure that affects the entire brain (secondary generalization).

Zonisamida may be used:

• Alone to treat convulsive seizures in adults.
• With other antiepileptic medications to treat convulsive seizures in adults, adolescents, and children 6 years of age and older.

Do not take Zonisamida Kern Pharma:

• If you are allergic to zonisamide or any of the other components of this medication (listed in section 6).
• If you are allergic to other sulfonamides, for example: sulfonamide antibiotics, thiazide diuretics, and sulfonylurea antidiabetic drugs.

Warnings and precautions

Zonisamide belongs to a group of medications (sulfonamides) that may cause severe allergic reactions, severe skin rashes, and blood disorders, which very rarely can be fatal (see section 4).

The use of Zonisamide may cause high levels of ammonia in the blood, which could change brain function, especially if you are also taking other medications that can increase ammonia levels (e.g., valproate), if you have a genetic disorder that causes excessive ammonia production in the body (urea cycle disorder), or if you have liver disorders. Inform your doctor immediately if you feel drowsy or confused in an unusual manner.

Consult your doctor or pharmacist before starting to take this medication:

• If you are under 12 years old, as you may be at a higher risk of presentingdecreased sweating, heatstroke, pneumonia, and liver problems. This medication is not recommended for use in children under 6 years old.
• If you are elderly, as you may need to adjust the dose of zonisamide, and you may be at a higher risk of developing an allergic reaction, severe skin rash, swelling of the legs and feet, and itching when taking this medication (see section 4).
• If you have liver problems, as you may need to adjust the dose of zonisamide.
• If you have kidney problems, as you may need to adjust the dose of zonisamide.
• If you have previously had kidney stones, as you may be at a higher risk of having more kidney stones.Reduce the risk of kidney stones by drinking enough water.
• If you live in a hot place or are going on vacation to a hot place, this medication may cause you to sweat less, which can result in your body temperature increasing.Reduce the risk of overheating by drinking enough water and staying cool.
• If you are underweight or have lost a lot of weight, as zonisamide may cause you to 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 medication.

Children and adolescents

Consult your doctor about the following risks:

• Weight:Monitor your child's weight monthly and see your doctor as soon as possible if they are not gaining enough weight. Zonisamide is not recommended for children who are underweight or have a poor appetite, and it should be used with caution in children with a weight under 20 kg.
• Increased blood acidity and kidney stones: reduce these risks by making sure your child drinks enough water and does not take any medication that can cause kidney stones (see Other medications). Your doctor will monitor your child's blood bicarbonate levels and kidneys (see also section 4).

Do not administer this medication to children under 6 years old, as it is not known if the potential benefits outweigh the risks in this age group.

Use of Zonisamida Kern Pharma with other medications

Inform your doctor or pharmacist if you are using or have recently used any other medication, including those purchased without a prescription.

• Zonisamide should be used with caution in adults if taken with medications that can cause kidney stones, such as topiramate or acetazolamide. In children, this combination is not recommended.
• Zonisamide may increase the levels of medications such as digoxin and quinidine in the blood, and therefore may require a reduction in the dose of these medications.
• Other medications such as phenytoin, carbamazepine, phenobarbital, and rifampicin may decrease the levels of zonisamide in the blood, which may require an adjustment in the dose of this medication.

Taking Zonisamida Kern Pharma with food and drinks

Zonisamide can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Women of childbearing age should use effective contraceptive measures during zonisamide treatment and for one month after stopping this medication.

If you intend to become pregnant, talk to your doctor before stopping contraceptives 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 taking antiepileptic medications.The risk of birth defects or neurological developmental disorders (brain development problems) for your child after taking zonisamide during pregnancy is unknown. 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 informed in detail about the risks and benefits of using zonisamide for epilepsy during pregnancy.

Do not breastfeed while taking zonisamida or for one month after stopping this medication.

There are no clinical data on the effects of zonisamide on human fertility. Animal studies have shown changes in fertility parameters.

Driving and operating machinery

Zonisamide may affect concentration, reaction time, and may cause drowsiness, especially at the beginning of treatment or after increasing the dose. If zonisamide affects you in this way, be extra careful when driving or operating machinery.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Usual dose in adults:

When taking Zonisamida Kern Pharma alone:

-The initial dose is 100 mg once a day.

-It can be increased up to 100 mg in two-week intervals.

-The usual dose is 300 mg once a day.

When taking Zonisamida Kern Pharma with other antiepileptic medications:

-The initial dose is 50 mg per day divided into two equal doses of 25 mg.

-It can be increased up to 100 mg in 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 could be increased more slowly if you experience side effects or have kidney or liver problems.

Use in children (6 to 11 years old) and adolescents (12 to 17 years old) weighing at least 20 kg:

-The initial dose is 1 mg per kg of body weight once a day.

-It can be increased by 1 mg per kg of body weight in intervals of one to two weeks.

-The usual daily dose is between 6 mg and 8 mg for a child weighing up to 55 kg or between 300 mg and 500 mg for a child weighing more than 55 kg (the lower dose) 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 beginning of each week until reaching a daily dose of 150 to 200 mg.

If you estimate that the action of zonisamide is too strong or too weak, inform your doctor or pharmacist.

-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 at night.

When taking more Zonisamida Kern Pharma than you should:

If you have taken more zonisamide than you should, inform the person taking care of you (family member or friend), your doctor or pharmacist, or contact the nearest hospital emergency service and bring the medication with you. You may feel drowsy and may lose consciousness. You may also feel like vomiting, have stomach pain, muscle spasms, eye movement, feel like fainting, have a slow heart rate, and decreased respiratory and renal function. Do not attempt to drive.

When 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 compensate for the missed doses.

When interrupting treatment with Zonisamida Kern Pharma:

Zonisamide is intended to be taken as a long-term medication. Do not reduce the dose or stop taking the medication unless your doctor instructs you to do so.

If your doctor advises you to stop treatment, the dose will be gradually reduced to minimize the risk of having more seizures.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side 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 can cause death.

Immediately contact your doctor if:

• You have difficulty breathing, swelling of the face, lips, or tongue, or severe rash, as these symptoms may indicate a severe allergic reaction.
• You have signs of excessive heat: 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 receiving treatment with antiepileptic drugs 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 can lead to kidney problems.
• You have sudden back or stomach pain, painful urination, 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 have an unexplained rash, as it may become a more severe rash or skin peeling.
• You feel extremely tired or feverish, have a sore throat, swollen glands, or notice that you bruise easily, as this may indicate a blood disorder.
• You have signs of high levels of acid in the blood: headaches, drowsiness, difficulty breathing, and loss of appetite. Medical control or treatment may be necessary.

Your doctor may decide that you should stop taking zonisamide.

The most frequently reported side effects of zonisamide are all mild in nature. They occur during the first month of treatment and often decrease as treatment continues. In children aged 6 to 17 years, side effects were consistent with the following, except for the following exceptions: pneumonia, dehydration, decreased sweating (frequent), and abnormal liver enzymes (rare).

Very common side effects: may affect more than 1 in 10 people

-Restlessness, irritability, confusion, depression.

-Poor muscle coordination, dizziness, poor memory, drowsiness, double vision.

-Loss of appetite, decreased bicarbonate levels in the blood.

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

-Difficulty sleeping, strange or unusual thoughts, feeling anxious or emotionally unstable.

-Slow thinking, loss of concentration, speech abnormalities, abnormal skin sensations (tingling), tremors, involuntary eye movements.

-Kidney stones.

-Rashes, itching, allergic reactions, fever, fatigue, flu-like symptoms, hair loss.

-Ecchymosis (a small bruise caused by blood from a broken skin vessel).

-Weight loss.

-Nausea, indigestion, stomach pain, diarrhea (loose stools), constipation.

-Swelling of the 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.

-Kidney stones.

-Pulmonary infection/inflammation, urinary tract infections.

-Low potassium levels in the blood and seizures.

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 state (prolonged or repeated seizures).

-Respiratory disorders, difficulty breathing, inflammation of the lungs.

-Inflammation of the pancreas (severe stomach or back pain).

-Liver problems, kidney failure, increased creatinine levels (a waste product that the kidneys should normally eliminate).

-Severe rashes or skin peeling (may also feel unwell and have a fever).

-Abnormal muscle breakdown (may have muscle pain or weakness) that can lead to kidney problems.

-Swollen glands, blood disorders (reduced number of blood cells, which may make you more prone to infections and pale, feel tired and feverish, and bruise easily).

-Decreased sweating, excessive body temperature.

• Glaucoma, which is a blockage of the eye's drainage that causes an increase in the eye's internal pressure. Eye pain, blurred vision, or decreased vision may be signs of glaucoma.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is not listed in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

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

Medications should not be disposed of through drains or in the trash. Deposit the packaging and unused medications at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and unused medications.By doing so, you will help protect the environment.

Composition of Zonisamida Kern Pharma

• The active ingredient is zonisamida. Each capsule contains 100 mg of zonisamida.
• The other components present in the capsule are: microcrystalline cellulose, sodium laurilsulfate, and hydrogenated vegetable oil Type I.

The capsule coating contains: titanium dioxide and gelatine.

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

Appearance of the product and content of the packaging

Hard capsules of white color marked with “Z 100”.

Packaging size:

Blister of 56 capsules.

Holder of the marketing authorization

Kern Pharma S.L

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing

NOUCOR HEALTH, S.A.

Av. Camí Reial, 51-57

08184 – Palau-solità i Plegamans

Barcelona

Spain

Last review date of this leaflet: March 2023

The detailed and updated information of this medicine is available on the webpage of the Spanish Agency of Medicaments and Health Products (AEMPS) http:// www.aemps.gob.es /