Zonisamide Normon 200 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Zonisamida Normon 200 mg hard capsules

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 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. It may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

This medicine 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 taking Zonisamide Normon

Do not take Zonisamide Normon:

if you are allergic to the active substance or to any of the components 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

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

This medicine may cause high levels of ammonia in the blood, which could alter 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 in the body (urea cycle disorder), or if you have liver problems. Inform your doctor immediately if you feel unusually drowsy or confused.

Consult your doctor or pharmacist before starting this medicine:

• if you are under 12 years of age, as you may have a higher 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 risk of developing an allergic reaction, severe rash, swelling of legs and feet, and itching when taking zonisamide (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 have a higher 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 staying 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”)

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

Children and adolescents

Discuss the following risks with your doctor:

• Weight: You should monitor your child’s weight monthly and see a doctor as soon as possible if they are not gaining sufficient weight. Zonisamide is not recommended in children who are underweight or have poor appetite, and 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 medicines 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 give 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 Zonisamide Normon

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

• Zonisamide should be used with caution in adults if taken with medicines that may cause kidney stones, such as topiramate or acetazolamide. This combination is not recommended in children.
• Zonisamide may possibly increase blood levels of medicines such as digoxin and quinidine, and therefore it may be necessary to reduce their doses.
• Other medicines such as phenytoin, carbamazepine, phenobarbital, and rifampicin may decrease blood levels of zonisamide, which could require adjustment of the zonisamide dose.

Taking Zonisamide Normon with food and drinks

Zonisamide may be taken with or without food.

Pregnancy, breastfeeding and fertility

Women of childbearing age 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 suitable treatments. If you are or think you may be pregnant, inform your doctor immediately. Do not stop treatment without consulting 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 neurological developmental disorders (problems with brain development) in 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 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 may affect concentration and reaction capacity, and may cause drowsiness, especially at the beginning of treatment or after a dose increase. If zonisamide affects you in this way, take special care when driving or operating machinery.

Zonisamide Normon contains sodium

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

3. How to take Zonisamida Normon

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

During the initial dose adjustment phase, zonisamide capsules of 25 mg, 50 mg, and 100 mg should be used. These strengths may also be used together with the 200 mg strength to achieve the required maintenance doses. Take the number of capsules according to the instructions given by your doctor.

Recommended dose in adults

If you are taking Zonisamida Normon alone:

• The starting dose is 100 mg once daily.
• This may be increased by up to 100 mg at two-week intervals.
• The recommended dose is 300 mg once daily.

If you are taking Zonisamida Normon with other antiepileptic medicines:

• The starting dose is 50 mg daily, divided into two equal doses of 25 mg.
• This may be increased by up to 100 mg at one- to two-week intervals.
• The recommended daily dose is between 300 mg and 500 mg.
• Some individuals 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 starting dose is 1 mg per kg of body weight once daily.
• This may be increased by 1 mg per kg of body weight at one- to two-week intervals.
• 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 the effect 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 may be taken once or twice daily, according to your doctor's instructions.
• If you take zonisamide twice daily, take half the daily dose in the morning and the other half at night.

If you take more Zonisamida Normon than you should

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount taken. You may feel drowsy and could lose consciousness. You may also experience nausea, stomach pain, muscle spasms, eye movements, feeling faint, slow heartbeat, reduced breathing rate, and impaired kidney function. Do not attempt to drive.

If you forget to take Zonisamida Normon

• If you miss a dose, do not worry; take the next dose at the usual time.
• Do not take a double dose to make up for a missed dose.

If you stop taking Zonisamida Normon

• Zonisamida 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 experiencing 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 produce adverse effects, although not everyone experiences them.

Zonisamide belongs to a group of medicines (sulfonamides) that can cause severe allergic reactions, serious rashes, and blood disorders, which very rarely may lead to death.

Contact your doctor immediately if:

• you experience difficulty breathing, swelling of the face, lips or tongue, or a severe rash, as these symptoms may indicate that 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 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 pain in your back or stomach, experience pain when urinating, or notice blood in your urine, as this may be a sign of kidney stones.
• you develop visual 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 could progress to a more serious 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 indicate 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 most commonly reported 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 the 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 under the skin).
• weight loss.
• nausea, indigestion, stomach pain, diarrhea, 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 blood potassium levels 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), status epilepticus (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 the blood.
• severe rashes or skin peeling (you may also feel unwell and have a fever at the same time).
• 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, feel pale, 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, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines Website: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Zonisamida Normon

Keep this medicine out of 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.

Aluminum/aluminum-polyamide-PVC blister: no special storage conditions required.
Aluminum/PVC-PVDC blister (60): store below 30°C.

Do not use this medicine if you notice any signs of deterioration in the capsules, blister, or carton, or any visible signs of degradation in 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 collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Zonisamida Normon

The active substance is zonisamide.

Zonisamida Normon 200 mg hard capsules contain 200 mg of zonisamide.

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

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

Appearance of the product and contents of the pack

Zonisamida 200 mg hard capsules have a grey body and a red cap, containing white or almost white powder free from lumps. It is available in packs of 28 capsules.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760

Tres Cantos – Madrid (SPAIN)

Date of revision of this leaflet: March 2023

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