Leaflet: information for the user

Zonisamida Aurovitas 25 mg hard capsules EFG

Zonisamida Aurovitas 50 mg hard capsules EFG

Zonisamida Aurovitas 100 mg hard capsules EFG

Read this 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, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before starting to take Zonisamida Aurovitas

3.How to take Zonisamida Aurovitas

4.Possible side effects

5.Storage of Zonisamida Aurovitas

6.Contents of the pack and additional information

Zonisamida Aurovitascontains the active ingredient zonisamida and is used as an antiepileptic.

Zonisamidais used to treat seizures that affect a part of the brain (partial seizures), which may or may not be followed by a seizure that affects the entire brain (secondary generalization).

Zonisamidamay be used:

•Alone to treat seizures in adults.

•With other antiepileptics to treat seizures in adults, adolescents, and children 6 years of age and older.

Do not takeZonisamide Aurovitas

•if you are allergic to zonisamide or any of the other ingredients in this medicine (listed in section 6).

•if you are allergic to other sulfonamides, for example: sulfonamide antibiotics, thiazide diuretics, and sulfonylurea antidiabetic drugs.

Warnings and precautions

Zonisamidebelongs to a group of medicines (sulfonamides) that can cause severe allergic reactions, severe rashes, and blood disorders, which very rarely can cause death (see section 4. Possible side effects).

There have been cases of severe rashes associated with zonisamide therapy, including cases of Stevens-Johnson syndrome.

The use of zonisamide 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 drowsy or confused in an unusual way.

Consult your doctor or pharmacist before starting to takezonisamide if:

•you are under 12 years old, as you may be at higher risk of developingdecreased sweating, heatstroke, pneumonia, and liver problems. Zonisamide is not recommended for children under 6 years old.

•you are elderly, as you may need to adjust the dose ofzonisamide, and you may be at higher risk of developing an allergic reaction, severe rash, swelling of the legs and feet, and itching when takingzonisamide(see section 4. Possible side effects).

•you have liver problems, as you may need to adjust the dose ofzonisamide.

•you have eye problems such as glaucoma.

•you have kidney problems, as you may need to adjust the dose ofzonisamide.

•you have previously had kidney stones, as you may be at higher risk of developing more kidney stones.Reduce the risk of kidney stones by drinking enough water.

•you live in a hot place or are going on holiday to a hot place.Zonisamidecan make you sweat less, which can cause your body temperature to rise.Reduce the risk of overheating by drinking enough water and staying cool.

•you are underweight or have lost a lot of weight, aszonisamidecan make you lose weight more easily. Inform your doctor, as you may need to be monitored.

•if you are pregnant or could become pregnant (for more information, see the section “Pregnancy, breastfeeding and fertility).

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

Children and adolescents

Consult your doctor about the following risks:

•Weight:you must monitor your child's weight monthly and see your doctor as soon as possible if they are not gaining enough weight.Zonisamideis not recommended for children who are underweight or have a poor appetite, and should be used with caution in children with a weight under 20 kg.

•Increased levels of acid in the blood and kidney stones: reduce these risks by making sure your child drinks enough water and does not take any other medicines that can cause kidney stones (see Other medicines). Your doctor will monitor your child's blood bicarbonate levels and kidneys (see also section 4).

Do not administer this medicine to children under 6 years old as the potential benefits may not outweigh the risks in this age group.

Other medicines andZonisamide Aurovitas

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine, including those bought without a prescription.

•Zonisamideshould 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.

•Zonisamidemay increase the levels of medicines such as digoxin and quinidine in the blood, and therefore may need to reduce the dose of these.

•Other medicines such as phenytoin, carbamazepine, phenobarbital, and rifampicin may decrease the levels ofzonisamidein the blood, which may require an adjustment of the dose ofzonisamide.

Taking Zonisamide Aurovitas with food and drinks

Zonisamidecan be taken with or without food.

Pregnancy, breastfeeding and fertility

Women of childbearing age must use effective contraceptive measures during treatment withzonisamideand for one month after stoppingzonisamide.

Si intend to become pregnant, talk to your doctor before stopping contraception and before becoming pregnant about the possibility of changing 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 takezonisamideduring pregnancy if your doctor advises it. Research has shown a higher risk of birth defects in children of women taking antiepileptic drugs. The risk of birth defects or neurological developmental disorders (brain development problems) for your child after takingzonisamideduring pregnancy is unknown. 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 informed in detail about the risks and benefits of using zonisamide for epilepsy during pregnancy.

Do not breastfeed while takingzonisamideor for one month after stoppingzonisamide.

There are no clinical data on the effects of zonisamide on human fertility. Animal studies have shown changes in fertility parameters.

Driving and operating machines

Zonisamidecan affect concentration, reaction time, and may cause drowsiness, especially at the beginning of treatment or after increasing the dose. Ifzonisamideaffects you in this way, you should be especially careful when driving or operating machines.

Zonisamide Aurovitas contains azo dyes

This medicine contains azo dyes such as Brilliant Blue FCF (E133) (50 mg dose), Sunset Yellow FCF (E110) (50 mg and 100 mg doses), and Allura Red AC (E129) (50 mg and 100 mg doses), which can cause allergic reactions.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Recommended dose in adults

When taking zonisamide alone:

•The initial dose is 100 mg once a day.

•It can be increased by 100 mg in intervals of two weeks.

•The recommended dose is 300 mg once a day.

When taking zonisamide with other antiepileptic drugs:

•The initial dose is 50 mg per day divided into two equal doses of 25 mg.

•It can be increased by 100 mg in 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 could be increased more slowly if you experience side effects, are elderly, or have kidney or liver problems.

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

•The initial dose is 1 mg per kg of body weight once a day.

•It can be increased by 1 mg per kg of body weight in intervals of one to two weeks.

•The recommended daily dose is between 6 mg and 8 mg per kg 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 dose) 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 beginning of each week until the daily dose of 150 to 200 mg is reached.

If you estimate that the action ofzonisamideis too strong or too weak, inform your doctor or pharmacist.

•Zonisamidecapsules should be swallowed whole with water.

•Do not chew the capsules.

•Zonisamidecan be taken once or twice a day, as instructed by your doctor.

•If you takezonisamidetwice a day, take half of the daily dose in the morning and the other half at night.

When taking moreZonisamideAurovitas than you should

If you have taken morezonisamidethan you should, inform the person who takes care of you (family member or friend), your doctor or pharmacist, or contact the nearest hospital emergency service and bring the medication with you. You may feel drowsy and may lose consciousness. You may also feel like vomiting, have stomach pain, muscle spasms, eye movement, feel like you are fainting, have a slow heart rate, and decreased respiratory and renal function. Do not drive.

For overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

When you forget to takeZonisamideAurovitas

•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 compensate for the missed doses.

When interrupting treatment withZonisamideAurovitas

•Zonisamideis intended to be taken as long-term medication. Do not reduce the dose or stop taking the medication unless your doctor tells you to.

•If your doctor advises you to stop treatment, the dose will be gradually reduced to minimize the risk of having more seizures.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

Get in touch with your doctor immediately if:

•you have difficulty breathing, swelling of the face, lips, or tongue, or a severe rash, as these symptoms may indicate 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 taking antiepileptic medicines likezonisamidehave had thoughts of self-harm or suicide.

•you have muscle pain or feel weak, as this may be a sign of abnormal muscle destruction that can lead to kidney problems.

•you have sudden back or stomach pain, painful urination, or notice 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 takingzonisamide.

Get in touch with your doctor as soon as possible if:

•you have an unexplained rash, as it could become a more severe rash or skin peeling.

•you feel extremely tired or feverish, have a sore throat, swollen glands, or notice that you bruise easily, as this may indicate a blood disorder.

•you have signs of high levels of acid in the blood: headaches, drowsiness, difficulty breathing, and loss of appetite. Medical control or treatment may be necessary.

Your doctor may decide that you should stop takingzonisamide.

The most common side effects ofzonisamideare mild in nature. They occur during the first month of treatment and often decrease as treatment continues. In children aged 6 to 17 years, side effects were consistent with the following, except for the following exceptions: pneumonia, dehydration, decreased sweating (frequent), and abnormal liver enzymes (infrequent).

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 in the blood.

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

•difficulty sleeping, unusual or strange thoughts, feeling anxious or unstable emotionally.

•slow thinking, loss of concentration, speech abnormalities, abnormal skin sensations (tingling), tremors, involuntary eye movements.

•kidney stones.

•rashes, itching, allergic reactions, fever, fatigue, flu-like symptoms, hair loss.

•ecchymosis (a small bruise caused by blood from a broken skin blood vessel).

•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):

•rage, aggression, suicidal thoughts, attempted suicide.

•vomiting.

•inflammation of the gallbladder or gallstones.

•kidney stones.

•pulmonary infections/inflammation, urinary tract infections.

•low potassium levels in the blood and convulsions/epileptic attacks.

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

•hallucinations, memory loss, coma, malignant neuroleptic syndrome (inability to move, sweating, fever, incontinence), status epilepticus (prolonged or repeated convulsions).

•respiratory disorders, difficulty breathing, inflammation of the lungs.

•pancreatitis (severe stomach or back pain).

•liver problems, kidney failure, increased creatinine levels in the blood.

•severe rashes or skin peeling (may also feel unwell and have a fever).

•abnormal muscle destruction (may have muscle pain or weakness) that can lead to kidney problems.

•swollen glands, blood disorders (reduced number of blood cells, which may make you more prone to infections and feel pale, tired, and feverish, and may bruise easily).

•decreased sweating, excessive body temperature.

•glaucoma, which is a blockage of the eye's drainage that causes increased eye pressure. It may cause eye pain, blurred vision, or decreased vision and may be signs of glaucoma.

Reporting side effects

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

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

Do not use this medication after the expiration date that appears on the packaging or blister, after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Dispose of containers and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of containers and medications you no longer need. This will help protect the environment.

Composition ofZonisamide Aurovitas

-The active ingredient is zonisamide.

Each hard capsule contains 25 mg ofzonisamide.

Each hard capsule contains 50 mg of zonisamide.

Each hard capsule contains 100 mg of zonisamide.

-The other components are:

Capule content:microcrystalline cellulose (grades 101 and 102), macrogolglycerol hydroxystearate and hydrogenated vegetable oil.

Capule coating:titanium dioxide (E171), brilliant blue FCF (E133) (only for 50 mg), allura red AC (E129)(only for 50 mg and 100 mg),yellow orange S (E110)(only for 50 mg and 100 mg) and gelatin.

Printing ink:Shellac lacquer (E904), iron oxide black (E172) and potassium hydroxide (E525).

Appearance of the product and contents of the package

Zonisamide Aurovitas 25 mg hard capsules EFG[approximate size 14.4 mm]

Hard gelatin capsule size “4”, with a white or off-white opaque cap and a white or off-white opaque body, with the imprint “ZN” on the cap and “25” on the body, filled with a white or off-white powder.

Zonisamide Aurovitas 50 mg hard capsules EFG[approximate size 15.8 mm]

Hard gelatin capsule size “3”, with a grey opaque cap and a white or off-white opaque body, with the imprint “ZN” on the cap and “50” on the body, filled with a white or off-white powder.

Zonisamide Aurovitas 100 mg hard capsules EFG[approximate size 19.3 mm]

Hard gelatin capsule size “1”, with a red opaque cap and a white or off-white opaque body, with the imprint “ZN” on the cap and “100” on the body, filled with a white or off-white powder.

Zonisamide Aurovitas hard capsulesare available in blister packs.

Pack sizes:

Blister pack:14, 20, 28, 30, 56, 60, 84, 90, 98, 100 and 196 hard capsules.

Hospital packs:25 mg: 56 hard capsules.

50 mg: 14 hard capsules.

100 mg: 28 hard capsules.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer responsible

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

O

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Germany:Zonisamide PUREN 25 mg/50 mg/100 mg hard capsules

Spain:Zonisamide Aurovitas 25 mg/50 mg/100 mg hard capsules EFG

France:Zonisamide Arrow 25 mg/50 mg/100 mg gelatin

Portugal:Zonisamide Generis

Last review date of this leaflet: September 2023

The detailed information of this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).