ZONESME 200 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Zonesme 200 mg Hard Capsules

zonisamide

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Zonesme is and what it is used for
2. What you need to know before you take Zonesme
3. How to take Zonesme
4. Possible side effects
5. Storage of 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 that affect only 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:

• On its own to treat convulsive seizures in adults.
• With other antiepileptics to treat convulsive seizures in adults, adolescents, and children aged 6 years and older.

2. What you need to know before you take Zonesme

Do not take Zonesme:

• 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

Zonesme belongs to a group of medicines (sulfonamides) that can cause severe allergic reactions, serious skin rashes, and blood disorders, which can very rarely be fatal (see section 4. Possible side effects).

Consult your doctor or pharmacist before taking this medicine:

• if you are under 12 years old, as you may have a higher risk of decreased sweating, heat stroke, pneumonia, and liver problems. Zonisamide 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 have a higher risk of developing an allergic reaction, serious skin rash, swelling of legs and feet, and itching when taking this medicine (see section 4. Possible side effects).
• if you have liver problems, as your dose of zonisamide may need to be adjusted.
• if you have eye problems such as glaucoma.
• 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 have a 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 are going on holiday to a hot place. Zonisamide can make you sweat less, which can lead to an increase in your body temperature. 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 this medicine can make you lose more weight. Inform your doctor, as they may need to monitor you.
• if you are pregnant or think you may be pregnant (see section "Pregnancy, breast-feeding and fertility")

If any of these statements 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 that leads to excessive ammonia production in the body (urea cycle disorder), or if you have liver disorders. Inform your doctor immediately if you feel unusually drowsy or confused.

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 medicines that can 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 with other medicines

Tell 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 with medicines that can cause kidney stones, such as topiramate or acetazolamide. In children, this combination is not recommended.
• Zonisamide may increase the levels of medicines such as digoxin and quinidine in the blood, and it may be necessary to reduce the dose of these medicines.
• Other medicines such as phenytoin, carbamazepine, phenobarbital, and rifampicin may decrease the levels of zonisamide in the blood, which may require an adjustment of the dose of zonisamide.

Taking Zonesme with food and drink

Zonisamide can be taken with or without food.

Pregnancy, breast-feeding and fertility

Women of childbearing potential have to use effective contraception during treatment with zonisamide and for one month after stopping zonisamide.

If you are pregnant or think you may be pregnant, consult your doctor before taking this medicine. If you are planning to become pregnant, talk to your doctor before stopping your contraceptives and before becoming pregnant about the possibility of switching to other suitable treatments. If you become pregnant, inform your doctor immediately. Do not stop treatment without discussing it with your doctor.

You should only take zonisamide during pregnancy if your doctor advises you to do so. Research has shown a higher risk of birth defects in children of women who take antiepileptics. The risk of birth defects or developmental disorders (problems with brain development) 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 by your doctor about the risks and benefits of using zonisamide for epilepsy during pregnancy.

Do not breast-feed while taking zonisamide 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 using machines

Zonisamide can cause symptoms such as drowsiness, dizziness, or changes in vision, and can reduce your reaction time. These effects, as well as your underlying illness, can make it difficult for you to drive vehicles or operate machines. Therefore, do not drive, operate machines, or engage in other activities that require special attention until your doctor has assessed your response to this medicine.

3. How to take Zonesme

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

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 together with the 200 mg presentation to achieve the necessary maintenance doses. Take the number of capsules as instructed by your doctor.

Recommended dose in adults

If you take Zonesme 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 recommended dose is 300 mg once a day.

If you take Zonesme with other antiepileptics:

• The initial dose is 50 mg per 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 recommended 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, are elderly, 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 kg of body weight once a day.
• This can be increased by 1 mg per kg of body weight at intervals of one to two weeks.
• The recommended daily dose is between 6 mg and 8 mg per kg of body weight 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 of these two doses) 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 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, talk to 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 Zonesme than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service (telephone: 91 562 04 20), stating the medicine and the amount taken. You may feel drowsy and may lose consciousness. You may also feel nauseous, have stomach pain, muscle spasms, eye movements, feel faint, have a slow heart 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 your doctor tells you to.
• If your doctor advises you to stop treatment, they will gradually reduce the dose to minimize the risk of having more seizures.

If you have any further questions on 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 all people suffer from them.

Zonisamide belongs to a group of medicines (sulfonamides) that can cause severe allergic reactions, severe skin rashes, and blood disorders, which can very rarely cause 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 having 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 antiepileptics 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 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 especially tired or feverish, have a sore throat, swollen glands, or notice that you bruise more easily, as this may mean that 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 this medicine.

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

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 bicarbonate levels (a substance that prevents blood from becoming acidic) in the blood.

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

• difficulty sleeping, unusual or unaccustomed thoughts, feeling anxious or emotionally unstable.
• slow thinking, loss of concentration, speech abnormalities, abnormal sensation in the skin (tingling), tremors, involuntary eye movements.
• kidney stones.
• rashes, itching, allergic reactions, fever, fatigue, flu-like symptoms, hair loss.
• bruising (a small hematoma 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 adverse effects:may affect up to 1 in 100 people

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

Very rare adverse 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 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 skin rashes 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 have infections and feel pale, tired, and feverish, and bruise more easily).
• decreased sweating, excessive body temperature.
• glaucoma, which is a blockage of the drainage of the fluid in the eye that produces an increase in the internal pressure of the eye. It can cause eye pain, blurred vision, or decreased vision, and may be signs of glaucoma.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist. Even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Zonesme

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

Do not use this medicine 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 pack: does not require special storage conditions.

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

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

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Zonesme

The active ingredient is zonisamide.

Zonesme 200 mg hard capsules contain 200 mg of zonisamide.

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

The capsule shell contains: Gelatin, Titanium dioxide (E171), Black iron oxide (E172), Erythrosine (E127), and Carmine indigo (E132).

Appearance of the Product and Package Contents

Zonisamide 200 mg hard capsules have a gray body and a red cap. They are available in packages of 28 capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Adamed Laboratorios, S.L.U.

c/ de las Rosas de Aravaca, 31 – 2ª planta

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 Prospectus: February 2023

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