ZONESME 25 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Zonesme 25 mg Hard Capsules EFG

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 is Zonesme and what is it 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 is Zonesme and what is it 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:

• Alone 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 life-threatening (see section 4. Possible side effects).

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

• if you are under 12 years old, as you may be at greater 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 be more likely to develop 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 be at greater 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 cause your body temperature to rise. 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 you may need to be monitored.
• if you are pregnant or think you may be pregnant (for more information, see 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 change 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 causes too much ammonia to be produced 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 medicine 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.

Use of zonisamide with other medicines

Tell your doctor or pharmacist if you are using or have recently used 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 therefore may require a reduction in 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, breastfeeding and fertility

Women of childbearing age 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 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 you to. Research shows a higher risk of birth defects in children of women who take antiepileptics. The risk of birth defects or developmental neurological disorders (brain development problems) 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 about the risks and benefits of using zonisamide for epilepsy during pregnancy.

Do not breastfeed 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 vision changes, and can reduce your reaction speed. These effects, as well as the underlying disease, can 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 medicine.

3. How to take Zonesme

Follow the instructions for taking this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist again.

The usual dose in adults

If you take Zonesme alone:

• The initial dose is 100 mg once a day.
• It can be increased by up to 100 mg at intervals of two weeks.
• The usual 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.
• It can 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 side effects 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 kilogram of body weight once a day.
• It can be increased by 1 mg per kilogram of body weight at intervals of one to two weeks.
• The usual daily dose is between 6 mg and 8 mg per kilogram of body weight 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 over 55 kg (the lower of the two doses) once a day.

Example: a child who weighs 25 kg should take 25 mg once a day for the first week, and then the daily dose should be increased by 25 mg at the start of each week until the daily dose of 150 to 200 mg is reached.

If you think the effect of this medicine 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 or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

You may feel drowsy and may lose consciousness. You may also feel like vomiting, have stomach pain, muscle spasms, eye movements, feel like you are going to 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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 life-threatening.

Get medical help immediately if:

• you have difficulty breathing, swelling of the face, lips, or tongue, or a severe skin rash, as these symptoms can indicate a severe allergic reaction.
• you have signs of excessive heat: high body temperature with little or no sweating, rapid heart rate and breathing, muscle cramps, and confusion.
• you have had thoughts of self-harm or suicide. A small number of people taking antiepileptics such as zonisamide have had thoughts of self-harm or suicide.
• you have muscle pain or feel weak, as this can be a sign of abnormal muscle breakdown, which can lead to kidney problems.
• you have sudden back or stomach pain, pain when urinating, or blood in your urine, as this can be a sign of kidney stones.
• you have vision problems such as eye pain or blurred vision while taking zonisamide.

Get medical help as soon as possible if:

• you have an unexplained skin rash, as it can become a more serious skin rash or skin peeling.
• you feel especially tired or feverish, have a sore throat, swollen glands, or bruise more easily, as this can mean 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 most common side effects of zonisamide are all mild. 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 those described below, except for the following exceptions: pneumonia, dehydration, decreased sweating (frequent), and abnormal liver enzymes (uncommon).

Very common side 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 side 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 disorders, abnormal sensation in the skin (tingling), tremors, involuntary eye movements.
• kidney stones.
• skin rashes, itching, allergic reactions, fever, fatigue, flu-like symptoms, hair loss.
• bruising (a small bruise 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 side effects:may affect up to 1 in 100 people

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

Rare side effects:may affect up to 1 in 10,000 people

• hallucinations, memory loss, coma, neuroleptic malignant syndrome (inability to move, sweating, fever, incontinence), status epilepticus (prolonged or repeated seizures).
• respiratory disorders, breathing difficulties, lung inflammation.
• pancreatitis (severe stomach or back pain)
• liver problems, kidney failure, increased creatinine levels (a waste product that the kidneys should normally remove).
• serious 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 get 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 fluid from the eye, causing increased pressure inside the eye. It can cause eye pain, blurred vision, or decreased vision, and may be signs of glaucoma.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: www.notificaram.es. By reporting side effects, you can help provide 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 expiry date which is stated on the blister and on the carton after CAD. The expiry date is 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 are required.

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Zonesme Composition

The active ingredient is zonisamide.

Zonesme 25 mg hard capsules contain 25 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), and yellow iron oxide (E172).

Product Appearance and Package Contents

Zonisamide 25 mg hard capsules have a yellow body and a yellow capsule 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 – 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 Leaflet: February 2023

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