Zonesme 25 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Zonesme 25 mg hard capsules EFG

zonisamide

Read this entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Zonesme is and what it is used for
2. What you need to know before taking Zonesme
3. How to take Zonesme
4. Possible side effects
5. How to store Zonesme
6. Contents of the pack and other information

1. What Zonesme is and what it is used for

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

Zonesme 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).

Zonesme can be used:

• As monotherapy to treat convulsive seizures in adults.
• In combination with other antiepileptic medicines to treat convulsive seizures in adults, adolescents, and children aged 6 years and older.

2. What you need to know before starting Zonesme

Do not take Zonesme:

• if you are allergic to zonisamide or to any of the 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

Zonesme 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. Possible side effects).

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 reduced sweating, heat stroke, pneumonia, and liver problems. The use of zonisamide 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 chance of developing an allergic reaction, severe rash, swelling of the legs and feet, or itching while taking this medicine (see section 4. Possible side effects).
• if you have liver problems, as the dose of zonisamide may need to be adjusted.
• if you have eye problems such as glaucoma.
• 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 developing kidney stones by drinking enough water.
• if you live in or are traveling to a hot climate. Zonisamide may reduce sweating, which could lead to an increase in 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 this medicine may cause further weight loss. Inform your doctor, as monitoring may be necessary.
• 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 zonisamide.

The use of Zonesme may lead to high levels of ammonia in the blood, which could affect brain function, especially if you are also taking other medicines that can 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 experience unusual drowsiness or confusion.

Children and adolescents

Consult your doctor regarding the following risks:

• Weight: You should monitor your child's weight monthly and contact your 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 blood acid levels 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 medicines). 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 zonisamide with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines, including those obtained without a prescription.

• Zonisamide should be used with caution in adults when taken with medications that may cause kidney stones, such as topiramate or acetazolamide. This combination is not recommended in children.
• Zonisamide may possibly increase blood levels of medications 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 zonisamide dose.

Taking Zonesme with food and drinks

Zonisamide may be taken with or without food.

Pregnancy, breastfeeding, and fertility

Women of childbearing potential must use effective contraceptive measures during treatment with zonisamide 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 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 appropriate treatments. If you are or think you may be pregnant, inform your doctor immediately. Do not stop treatment without discussing it with your doctor.

Zonisamide should only be taken during pregnancy if specifically prescribed by your doctor. Research shows an increased risk of birth defects in children of women taking 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 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 the 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 using machines

Zonisamide may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may reduce reaction ability. These effects, as well as the underlying disease itself, may impair your ability to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities requiring special attention until your doctor has assessed your response to this medicine.

3. How to take Zonesme

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

The usual dose in adults

If you are taking Zonesme alone:

• The starting 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 Zonesme with other antiepileptic medicines:

• The starting dose is 50 mg per day, 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 starting 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 of up to 55 kg, or between 300 mg and 500 mg for a child with a body weight above 55 kg (whichever dose is lower), taken 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 that the effect of this medicine is too strong or too weak, tell 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 Zonesme than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

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 Zonesme

• 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 Zonesme

• Zonisamide 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 stop treatment, they will gradually reduce the dose 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 experiences them.

Zonisamide belongs to a group of medicines (sulfonamides) that can cause serious 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 you are experiencing a serious allergic reaction.
• you show signs of overheating: 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 taking antiepileptic medicines such as zonisamide have had thoughts about self-harm or suicide.
• you have muscle pain or feel weak, as this may be a sign of abnormal muscle breakdown which can lead to kidney problems.
• you suddenly have back or stomach pain, painful urination, or notice blood in your urine, as this may be a sign of kidney stones.
• you develop vision 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 may progress to a more severe 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 mean you have 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 this medicine.

The adverse effects most commonly reported with zonisamide are generally mild. They occur during the first month of treatment and often decrease with continued use. 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 levels of bicarbonate (a substance that prevents blood from becoming too acidic) in the blood.

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

• difficulty sleeping, unusual or strange thoughts, 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, diarrhoea (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 potassium levels in blood and seizures/convulsive 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).
• breathing disorders, difficulty breathing, lung inflammation.
• pancreatitis (severe stomach or back pain).
• liver problems, kidney failure, increased creatinine levels (a waste product normally eliminated by the kidneys).
• severe rashes or skin peeling (you may also feel unwell and have a fever).
• abnormal muscle breakdown (you may have muscle pain or weakness) which can lead to kidney problems.
• swollen glands, blood disorders (reduction in blood cell count, 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 vision loss may occur and could be signs of glaucoma.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist. This includes any possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Zonesme

Keep this medicinal product out of the sight and reach of children.

Do not use this medicinal product after the expiry date stated on the blister and on the carton after EXP. The expiry date refers to the last day of the month indicated.

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

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

Do not use this medicinal product if you notice any signs of deterioration in the capsules, blister, or carton, or any visible signs of damage to the medicine. Return the pack to your pharmacist.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Zonesme

The active substance is zonisamide.

Zonesme 25 mg hard capsules contain 25 mg of zonisamide.

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

The capsule shell contains: gelatin, titanium dioxide (E171), and yellow iron oxide (E172).

Appearance of the product and contents of the pack

Zonisamide 25 mg hard capsules have a yellow body and a yellow cap. They are available in packs of 14 and 28 capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Adamed Laboratorios, S.L.U.
C/ de las Rosas de Aravaca, 31 – 2nd floor
28023 Aravaca – Madrid, Spain
Phone: +34 91 357 11 25
Fax: +34 91 307 09 70
e-mail: [email protected]

Manufacturer

Laboratorios Normon, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos –
Madrid, Spain

Date of revision of this leaflet: February 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices http://www.aemps.gob.es