ZONISAMIDE NORMON 200 mg HARD CAPSULES

2. What you need to know before you take Zonisamide Normon

Do not take Zonisamide Normon:

if you are allergic to the active substance 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

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

Taking this medicine may cause 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 causes too much ammonia in the body (urea cycle disorder), or if you have liver disease. Tell your doctor immediately if you feel unusually drowsy or confused.

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

• if you are under 12 years old, as you may be at 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 be more likely to develop an allergic reaction, severe skin reaction, swelling of the legs and feet, and itching when taking zonisamide (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 had kidney stones before, as you may be at 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 your body temperature rising. 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 zonisamide can make you lose more weight. Tell your doctor, as you may need to be monitored.
• if you are pregnant or think you may be pregnant (see section "Pregnancy, breastfeeding, and fertility")

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

Children and adolescents

Talk to your doctor about the following risks:

• Weight: your child's weight should be checked monthly, and you should see a doctor as soon as possible if they are not gaining enough weight. Zonisamide is not recommended for children who are underweight or have a poor appetite, and should be used with caution in children who weigh less than 20 kg.
• Increased acid levels in the blood and kidney stones: reduce these risks by making sure your child drinks plenty of water and does not take any medicines that can cause kidney stones (see Other medicines). Your doctor will check 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.

Other medicines and Zonisamide Normon

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 certain medicines in the blood, such as digoxin and quinidine, and may need to be reduced.
• Other medicines, such as phenytoin, carbamazepine, phenobarbital, and rifampicin, may decrease the levels of zonisamide in the blood, which may require a dose adjustment of zonisamide.

Taking Zonisamide Normon with food and drink

Zonisamide can 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, 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, tell your doctor immediately. Do not stop treatment without talking to your doctor.

You should only take zonisamide during pregnancy if your doctor advises it. 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 may affect your concentration, reaction time, and may make you feel drowsy, especially at the start of treatment or after a dose increase. If zonisamide affects you in this way, be extra careful when driving or using machines.

Zonisamide Normon contains sodium

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

3. How to take Zonisamide Normon

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 dose adjustment phases, zonisamide 25 mg, 50 mg, and 100 mg capsules should be used. These presentations may also be used in combination 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 are taking Zonisamide Normon 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 are taking Zonisamide Normon with other antiepileptics:

• The initial dose is 50 mg a 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 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 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.

• 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 the daily dose in the morning and the other half in the evening.

If you take more Zonisamide Normon than you should

In case of overdose or accidental ingestion, talk to your doctor, pharmacist, or call the Toxicology Information Service, telephone: 91 562 04 20, stating the medicine and the amount used. 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 heartbeat, and decreased kidney function. Do not try to drive.

If you forget to take Zonisamide Normon

• 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 Zonisamide Normon

• 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, the dose will be reduced gradually 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.

Zonisamide belongs to a group of medicines (sulfonamides) that may cause severe allergic reactions, severe skin reactions, 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 severe skin rash, as these symptoms can be signs of a severe allergic reaction.
• you have signs of overheating: high body temperature with little or no sweating, fast heartbeat 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 these can be signs of kidney stones.
• you have vision problems, such as eye pain or blurred vision, while taking zonisamide.

Talk to your doctor as soon as possible if:

• you have unexplained skin rash, as it can become a more severe skin rash or skin peeling.
• you feel especially tired or feverish, have a sore throat, swollen glands, or bruise more easily, as these can be signs of a blood disorder.
• you have signs of increased acid levels in the blood: headaches, drowsiness, difficulty breathing, and loss of appetite. Medical treatment or monitoring may be necessary.

Your doctor may decide that you should stop taking zonisamide.

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: 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 disturbances, abnormal sensation in the skin (tingling), tremor, involuntary eye movements.
• kidney stones.
• skin rashes, itching, allergic reactions, fever, tiredness, 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 the legs and feet.

Uncommon side effects:may affect up to 1 in 100 people

• anger, 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) in the blood.
• severe skin reactions or skin peeling (you may also 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, high body temperature.
• glaucoma, which is a blockage of the drainage of fluid from the eye, leading to increased pressure inside the eye. Symptoms can include eye pain, blurred vision, or decreased vision, and can 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 via the Spanish Pharmacovigilance System for Human Use Website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Zonisamide Normon

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 carton after EXP. The expiry date is the last day of the month shown.

Aluminum/aluminum-polyamide-PVC blister: no special storage conditions are required. Aluminum/PVC-PVDC (60) blister: 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 deterioration in the medicine. Return the pack to your pharmacist.

Medicines should not be disposed of via wastewater or household waste. Return the pack to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Packaging Content and Additional Information

Zonisamide Normon Composition

The active ingredient is zonisamide.

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

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

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

Product Appearance and Packaging Content

Zonisamide 200 mg hard capsules have a gray body and a red closure capsule, containing white or almost white powder without agglomerates. 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 updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products http://www.aemps.gob.es