Leaflet: information for the user

Zonesme 200 mg hard capsules

zonisamide

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Zonesme and what it is used for

2. What you need to know before you start taking Zonesme

3. How to take Zonesme

4. Possible side effects

5. Storage of Zonesme

6. Contents of the pack and additional information

Zonesme contains the active ingredient zonisamide, and is used as an antiepileptic.

Zonesme 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).

Zonesme may be used:

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

Do not take Zonesme:

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

Warnings and precautions

Zonesme belongs to a group of medications (sulfonamides) that may cause severe allergic reactions, severe rashes, and blood disorders, which very rarely may cause death (see section 4. Possible side effects).

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

• if you are under 12 years old, as you may have a higher risk of developingdecreased sweating, sunstroke, pneumonia, and liver problems.Zonisamide 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 have a higher risk of developing an allergic reaction, severe rash, swelling of the legs and feet, and itching when taking this medication (see section 4. Possible side effects).
• if you have liver problems, as you may need to adjust the dose of zonisamide.
• if you have eye problems such as glaucoma.
• 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 developing more kidney stones.Reduce the risk of developing kidney stones by drinking enough water.
• if you live in a hot place or are going on vacation to a hot place. Zonisamide may cause you to sweat less, which can lead to a higher body temperature.Reduce the risk of overheating by drinking enough water and staying cool.
• if you are underweight or have lost a lot of weight, as this medication may cause you to lose more weight. Inform your doctor, as they may need to monitor you.
• if you are pregnant or could become pregnant (for more information, see the section “Pregnancy, breastfeeding, and fertility”)

If any of these statements apply to you, inform your doctor before taking zonisamide.

The use of Zonesme may cause high levels of ammonia in the blood, which could affect 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 too much ammonia to be produced in the body (urea cycle disorder), or if you have liver problems. Inform your doctor immediately if you feel drowsy or confused in an unusual way.

Children and adolescents

Consult your doctor about the following risks:

• Weight:you must 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 use in children who are underweight or have a poor appetite, and should be used with caution in children with a weight under 20 kg.
• Increased blood acidity and kidney stones: reduce these risks by ensuring 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 the potential benefits may not outweigh the risks in this age group.

Use of zonisamide 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 need to be reduced.
• 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 zonisamide.

Taking Zonesme 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 zonisamide treatment and for one month after stopping zonisamide.

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.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 has shown 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 took zonisamide during pregnancy were smaller than expected for their age at birth, compared to children whose mothers were treated with lamotrigine monotherapy. Make sure they inform you 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 zonisamide.

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 cause symptoms such as drowsiness, dizziness, or visual disturbances, and may impair your ability to react. These effects, as well as the underlying condition, 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 medication.

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

In the initial phases of dose adjustment, the 25 mg, 50 mg, and 100 mg Zonesme capsules should be used. These presentations can also be used in conjunction with the 200 mg capsule to achieve the necessary maintenance doses.Take the number of capsules as instructed by your doctor.

Recommended dose in adults

If taking Zonesme alone:

• The initial dose is 100 mg once a day.
• It can be increased by 100 mg in intervals of two weeks.
• The recommended dose is 300 mg once a day.

If taking Zonesme with other antiepileptic medications:

• The initial dose is 50 mg per day, divided into two equal doses of 25 mg.
• It can be increased by 100 mg in intervals of one to two weeks.
• The recommended 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, are elderly, 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 recommended 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 the daily dose of 150 to 200 mg is reached.

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 taking zonisamide twice a day, take half the daily dose in the morning and the other half at night.

If taking more Zonesme than you should

In case of overdose or accidental ingestion,consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.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 rate and renal function. Do not attempt to drive.

If you forgot to take Zonesme

• If you forgot 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.

If interrupting treatment with Zonesme

• Zonisamide is intended to be taken as long-term medication. Do not reduce the dose or stop taking the medication unless your doctor instructs you to.
• If your doctor advises you to stop treatment, the dose will be gradually reduced to minimize the risk of seizures.

If you have any other questions 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 rapid breathing, muscle cramps, and confusion.
• you have had thoughts of self-harm or suicide. A small number of people taking antiepileptic medications, 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 experience 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 increased blood acidity: headaches, drowsiness, difficulty breathing, and loss of appetite. Medical control or treatment may be necessary.

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

The most commonly 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, the side effects were consistent with the following, except for the following exceptions: pneumonia, dehydration, decreased sweating (frequent), and abnormal liver enzymes (infrequent).

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

• agitation, irritability, confusion, depression.
• muscle coordination problems, 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, unusual or strange thoughts, feeling anxious or unstable emotionally.
• 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.
• bruising (small hematoma caused by blood from a broken skin vessel).
• weight loss.
• nausea, indigestion, stomach pain, diarrhea (loose stools), constipation.
• swelling of the legs and feet.

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

• rage, aggression, suicidal thoughts, suicide attempt.
• vomiting.
• inflammation of the gallbladder or gallstones.
• kidney stones.
• pulmonary infection/inflammation, urinary tract infections.
• low potassium levels in the blood and convulsions/epileptic attacks.

Very 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), status epilepticus (prolonged or repeated convulsions).
• 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 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 increased eye pressure. May cause eye pain, blurred vision, or decreased vision and may be signs of glaucoma

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist. Even if it's possible side effects that don't appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products 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.

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

Aluminum/aluminum-polyamide-PVC blister: no special storage conditions are required.

Aluminum/PVC-PVDC blister (60): Do not store at a temperature above 30°C.

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 medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Zonesme

The active principle is zonisamide.

Zonesme 200 mg hard capsules contain 200 mg of zonisamide.

The other components present in the capsule content are: microcrystalline cellulose, anhydrous colloidal silica, hydrogenated vegetable oil from cottonseed and sodium lauryl sulfate.

The capsule coating contains: Gelatin, Titanium dioxide (E171), Iron oxide black (E172), Erythrosine (E127) and Indigo carmine (E132).

Appearance of the product and contents of the packaging

Zonisamide 200 mg hard capsules have a grey body and a red-coloured closure. They are available in packs of 28 capsules.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Adamed Laboratories, S.L.U.

c/ de las Rosas de Aravaca, 31 – 2nd floor

28023 Aravaca – Madrid, Spain

Tel.: +34 91 357 11 25

Fax: +34 91 307 09 70

e-mail:[email protected]

Responsible for manufacturing

Normon Laboratories, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos

Madrid, Spain

Review date of this leaflet: February 2023

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Deviceshttp://www.aemps.gob.es