Zonisamide Stada 25 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Zonisamida STADA 25 mg hard capsules EFG

Zonisamida STADA 50 mg hard capsules EFG

Zonisamida STADA 100 mg hard capsules EFG

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

Contents of the leaflet

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

1. What Zonisamida Stada is and what it is used for

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

Zonisamide 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).

Zonisamide may be used:

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

2. What you need to know before starting to take Zonisamide Stada

Do not take Zonisamide Stada:

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

Warnings and precautions

Zonisamide 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).

Cases of severe rash associated with zonisamide therapy have been reported, including cases of Stevens-Johnson syndrome.

Consult your doctor or pharmacist before starting zonisamide:

• if you are under 12 years of age, as you may have an increased risk of decreased 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 a dose adjustment of zonisamide may be necessary, and you may have a higher risk of developing an allergic reaction, severe rash, swelling of the legs and feet, or itching while taking zonisamide (see section 4. Possible side effects).
• if you have liver problems, as a dose adjustment of zonisamide may be necessary.
• if you have eye problems such as glaucoma.
• if you have kidney problems, as a dose adjustment of zonisamide may be necessary.
• if you have previously had kidney stones, as you may be at increased risk of developing further kidney stones. Reduce the risk of kidney stones by drinking enough water.
• if you live in or are travelling 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 lot of weight, as zonisamide 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”).

Zonisamide use may lead to high levels of ammonia in the blood, which could affect brain function, especially if you are also taking other medicines that may increase ammonia levels (e.g., valproate), if you have a genetic disorder causing excessive ammonia production (urea cycle disorder), or if you have liver problems. Inform your doctor immediately if you become unusually sleepy or confused.

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

Children and adolescents

Consult your doctor regarding the following risks:

• Weight: You must monitor your child's weight monthly and contact the 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.

Other medicines and Zonisamida Stada

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take 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 medications.
• Other medications such as phenytoin, carbamazepine, phenobarbital, and rifampicin may decrease blood levels of zonisamide, which could require adjustment of the zonisamide dose.

Taking Zonisamida Stada with food and drinks

Zonisamide may be taken with or without food.

Pregnancy, breastfeeding, and fertility

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

If you plan to become pregnant, speak with 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 discontinue treatment without consulting your doctor.

Zonisamide should only be taken during pregnancy if specifically instructed 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 with 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 gestational age at birth, compared to children whose mothers were treated with lamotrigine monotherapy. Ensure you receive detailed information about the risks and benefits of using zonisamide for epilepsy during pregnancy.

Do not breastfeed while taking zonisamide or during 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 use of machines

Zonisamide may affect concentration and reaction/response ability, and may cause drowsiness, especially at the beginning of treatment or after increasing the dose. If zonisamide affects you in this way, take special care when driving or operating machinery.

Zonisamida Stada contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; thus, it is essentially "sodium-free."

3. How to take Zonisamida Stada

Follow exactly the dosage instructions given by your doctor. If in doubt, consult your doctor or pharmacist again.

Recommended dose in adults:

If you are taking zonisamide alone:

• The initial dose is 100 mg once daily.
• It may be increased by up to 100 mg every two weeks.
• The recommended dose is 300 mg once daily.

If you are taking zonisamide with other antiepileptic medicines:

• The initial dose is 50 mg per day, divided into two equal doses of 25 mg.
• It may be increased by up to 100 mg every 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 adverse effects, are elderly, or have renal or hepatic impairment.

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

• The initial dose is 1 mg per kg of body weight once daily.
• It may be increased by 1 mg per kg of body weight every one to two weeks.
• The recommended 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 is lower), 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 zonisamide is too strong or too weak, inform 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 Zonisamida Stada than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 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, and reduced respiratory and kidney function. Do not attempt to drive.

If you forget to take Zonisamida Stada

• 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 Zonisamida Stada

• Zonisamide is intended to be taken as a long-term medication. Do not reduce the dose or stop taking the medicine unless instructed by your doctor.
• If your doctor advises you to discontinue treatment, they will gradually reduce the dose to decrease the risk of having further 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 having a serious allergic reaction.
• you have signs of overheating: high body temperature with little or no sweating, rapid heartbeat and breathing, muscle cramps, and confusion.
• you have had thoughts of harming yourself or of suicide. A small number of people taking antiepileptic medicines 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 which can lead to kidney problems.
• you have sudden pain in your back or stomach, pain when urinating, or notice blood in your urine, as this may be a sign of kidney stones.
• you experience 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 serious rash or skin peeling.
• you feel unusually tired or feverish, have a sore throat, swollen glands, or notice you bruise 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 zonisamide.

The adverse effects of zonisamide reported most frequently are all mild in nature. They occur during the first month of treatment and often decrease with continued treatment. In children aged 6 to 17 years, adverse effects were consistent with those described below, except for the following: 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 acidic) in blood

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

• difficulty sleeping, unusual or strange thoughts, feeling anxious or emotionally unstable
• 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 in 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 levels of creatinine (a waste product normally eliminated by the kidneys) in blood
• 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 the number of blood cells, which may make you more prone to infections, appear pale, feel tired and feverish, and bruise more easily)
• decreased sweating, excessive body temperature
• glaucoma, which is a blockage of fluid drainage from the eye leading to increased internal eye pressure. Eye pain, blurred vision, or vision loss may occur and can be signs of glaucoma.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Zonisamide Stada

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

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

This medicine does not require any special storage conditions.

Do not use this medicine if you notice any signs of deterioration in the capsules, blister pack, 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 containers at the SIGRE point located at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Zonisamida Stada

The active substance is zonisamide. Zonisamida Stada 25 mg hard capsules contain 25 mg of zonisamide. Zonisamida Stada 50 mg hard capsules contain 50 mg of zonisamide. Zonisamida Stada 100 mg hard capsules contain 100 mg of zonisamide.

The other components present in the capsule contents are:

• capsule contents: microcrystalline cellulose, hydrogenated vegetable oil, and sodium lauryl sulfate
• capsule shell: gelatin and titanium dioxide (E171)
• printing ink: shellac, black iron oxide (E172) (25 mg and 100 mg strengths), red iron oxide (E172) (50 mg strength), and potassium hydroxide (25 mg and 100 mg strengths).

Appearance of the product and contents of the pack

Zonisamida Stada 25 mg hard capsules are size 4 capsules, with an opaque white body and an opaque white cap, 14.4 mm in length, marked with "Z25" in black ink.

Zonisamida Stada 50 mg hard capsules are size 3 capsules, with an opaque white body and an opaque white cap, 15.8 mm in length, marked with "Z50" in red ink.

Zonisamida Stada 100 mg hard capsules are size 1 capsules, with an opaque white body and an opaque white cap, 19.3 mm in length, marked with "Z100" in black ink.

Zonisamida Stada capsules are packaged in blisters, which are then placed in cartons. The 25 mg pack sizes contain 14 or 28 capsules, the 50 mg pack sizes contain 28 or 56 capsules, and the 100 mg pack sizes contain 56 capsules.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder

Laboratorio STADA, S.L.
Frederic Mompou, 5
08960 Sant Just Desvern (Barcelona)
Spain
[email protected]

Manufacturer

Noucor Health S.A.
Av. Camí Reial 51-57
08184 Palau-Solità i Plegamans (Barcelona)
Spain

Date of the most recent review of this leaflet: March 2023

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