Leaflet: information for the user

Zonisamide Teva 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, and you must 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 Zonisamide Teva is and what it is used for

2. What you need to know before you start taking Zonisamide Teva

3. How to take Zonisamide Teva

4. Possible side effects

5. Storage of Zonisamide Teva

6. Contents of the pack and additional information

Zonisamida Teva contains the active ingredient zonisamida, and is used as an antiepileptic.

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

Zonisamida may be used:

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

Do not take Zonisamida Teva:

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

Warnings and precautions

Zonisamida belongs to a group of medications (sulfonamides) that may cause severe allergic reactions, severe rashes, and blood disorders, which very rarely may causedeath(see section 4. Possible side effects).

The use of zonisamida may cause high levels of ammonia in the blood, which could change brain function, especially if you are also taking other medications that may increase ammonia levels (e.g., valproate), if you have a genetic disorder that causes excessive ammonia production 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 take Zonisamida Teva if you:

• areunder 12 years old, as you may be at greater risk of developingdecreased sweating, heatstroke, pneumonia, and liver problems.Zonisamida is not recommended forchildren under 6 years old.
• areelderly, as you may need to adjust the zonisamida dose, and you may be at greater risk of developing an allergic reaction, severe rash, swelling of the legs and feet, and itching when taking zonisamida (see section 4. Possible side effects).
• haveliver problems, as you may need to adjust the zonisamida dose.
• have eye problems such as glaucoma
• havekidney problems, as you may need to adjust the zonisamida dose.
• have previously hadkidney stones, as you may be at greater risk of developing more kidney stones.Reduce the risk of kidney stones by drinking enough water.
• live in a hot place or are going on vacation to a hot place. Zonisamida may cause you to sweat less, which can lead to a higher body temperature.Reduce the risk of heatstroke by drinking enough water and staying cool.
• areunderweightor have lost a lot of weight, as zonisamida may cause you to lose weight more. Inform your doctor, as you may need to be monitored.
• are pregnant or may be pregnant (see section “Pregnancy, breastfeeding, and fertility” for more information)

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

Children and adolescents

Consult your doctor about the following risks:

• Weight:you should monitor your child's weight monthly and see your doctor as soon as possible if they are not gaining enough weight.Zonisamida is 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 blood acidity 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 Use of Zonisamida Teva with other medications). Your doctor will monitor your child's blood bicarbonate levels and kidneys (see also section 4).

Do not administer this medication to childrenunder 6 years oldas it is not known if the potential benefits outweigh the risks in this age group.

Use of Zonisamida Teva with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

• Zonisamida should be used with caution in adults if taken with medications that may cause kidney stones, such astopiramateoracetazolamide. In children, this combination is not recommended.
• Zonisamida may increase the levels of medications such asdigoxinandquinidinein the blood, and therefore may need to be reduced.
• Other medications such asphenytoin, carbamazepine, phenobarbitalandrifampicinmay decrease the levels of zonisamida in the blood, which may require an adjustment of the Zonisamida Teva dose.

Taking Zonisamida Teva with food and drinks

Zonisamida Teva can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Women of childbearing age should use effective contraceptive measures during zonisamida treatment and for one month after stopping zonisamida.

If you intend to become pregnant, talk to your doctor before stopping your contraceptives 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 or pharmacist immediately. Do not stop your treatment without consulting your doctor.

You should only take zonisamida during pregnancy if your doctor advises it. Research has shown a higher risk of birth defects in children of women taking antiepileptic medications. The risk of birth defects or neurological developmental disorders (brain development problems) for your child after taking zonisamida during pregnancy is unknown. A study showed that children whose mothers used zonisamida 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 zonisamida for epilepsy during pregnancy.

Do not breastfeed while taking zonisamida or for one month after stopping zonisamida.

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

Driving and operating machinery

Zonisamida may affect your concentration, reaction time, and may cause drowsiness, especially at the beginning of treatment or after increasing the dose. If zonisamida affects you in this way, be extra careful when driving or operating machinery.

Sodium

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

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

The recommended dose in adults is

When taking Zonisamida Teva alone:

• The initial dose is 100 mg once a day.
• It can be increased up to 100 mg in two-week intervals.
• The recommended dose is 300 mg once a day.

When taking Zonisamida Teva with other antiepileptic medications:

• The initial dose is 50 mg per day divided into two equal doses of 25 mg.
• It can be increased up to 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, if you are an elderly patient or if you have kidney or liver problems.

Use in children (6 to 11 years old) and adolescents (12 to 17 years old) who weigh 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 6 mg to 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 reaching a daily dose of 150 to 200 mg.

If you estimate that the action of Zonisamida Teva is too strong or too weak, inform your doctor or pharmacist.

• Zonisamida Teva capsules should be swallowed whole with water.
• Do not chew the capsules.
• Zonisamida Teva can be taken once or twice a day, as instructed by your doctor.
• If you take Zonisamida Teva twice a day, take half of the daily dose in the morning and the other half at night.

If you take more Zonisamida Teva than you should

Go to the doctor immediately. Bring the medication packaging with you. You can also call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount taken. You may feel drowsy and may lose consciousness. You may also feel like vomiting, have stomach pain, muscle spasms, eye movement, feel like fainting, have a slow heart rate and decreased respiratory rate and renal function. Do not drive.

If you forgot to take Zonisamida Teva

• If you forgot 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.

If you interrupt treatment with Zonisamida Teva

• Zonisamida Teva is intended to be taken as a 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 taking Zonisamida Teva, the dose will be gradually reduced to minimize the risk of 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.

Immediately contact your doctor if you:

• have difficulty breathing, swelling of the face, lips, or tongue, or a severe rash, as these symptoms may indicate that you are having asevere allergic reaction.
• have signs ofexcessive heat - high body temperature with little or no sweating, rapid heartbeat, and rapid breathing, muscle cramps, and confusion.
• havethoughts of self-harm or suicide. A small number of people receiving treatment with antiepileptic drugs such as Zonisamide Teva have had thoughts of self-harm or suicide.
• havemuscle painor feel weak, as this may be a sign of abnormal muscle breakdown that can lead to kidney problems.
• have asudden pain in the back or stomach, painful urination, or notice blood in the urine, as this may be a sign of kidney stones.
• experience visual problems such as eye pain or blurred vision while taking Zonisamide Teva.

Immediately contact your doctor as soon as possible if you:

• have unexplained rashes, as it may become a more severe rash or skin peeling.
• feel extremely tired or feverish, have a sore throat, swollen glands, or notice that you bruise easily, as this may indicate that you have a blood disorder.
• have signs of increased blood acidity: headaches, drowsiness, difficulty breathing, and loss of appetite. It may be necessary to monitor or treat the condition medically.

Your doctor may decide that you should stop taking Zonisamide Teva.

The side effects of zonisamide reported most frequently are all mild in nature. 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 (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 emotionally unstable.
• 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.
• bruising (a small hematoma 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.

Rare 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 infection/inflammation, urinary tract infections.
• low potassium levels in the blood and seizures/attacks.

Very 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), epileptic state (prolonged or repeated seizures).
• respiratory disorders, difficulty breathing, lung inflammation.
• pancreatitis (severe stomach or back pain)
• liver problems, kidney failure, increased creatinine levels (a waste product that the kidneys should normally eliminate).
• severe rashes or skin peeling (may also feel unwell and have a fever).
• abnormal muscle breakdown (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 an increase in the eye's internal pressure. You may experience eye pain, blurred vision, or decreased vision, which 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 prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about 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 blister pack and on the outer packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Do not use this medication if you observe any sign of deterioration in the capsules, blister pack, or box, or any visible sign of deterioration in the medication. Return the packaging to your pharmacist.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications that you do not need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications that you do not need. By doing so, you will help protect the environment.

Composition of Zonisamida Teva

• The active ingredient is zonisamida.

Zonisamida Teva 100 mg hard capsules EFG contain 100 mg of zonisamida.

• The other components present in the capsule content are: microcrystalline cellulose, sodium laurilsulfate, hydrated colloidal silica, and hydrogenated vegetable oil type I.
• The capsule coating contains: titanium dioxide (E171), gelatin, and iron oxide red (E 172).
• The printing ink contains: shellac, propylene glycol, strong ammonia solution, iron oxide black (E 172), and potassium hydroxide.

Appearance of the product and contents of the package

Zonisamida Teva 100 mg hard capsules: hard gelatin capsule size No. 1, approximately 19 mm x 7 mm, with an orange cap and a white body, filled with a white or off-white granulate, printed with “100” on the body.

The hard capsules of Zonisamida Teva 100 mg are packaged in blisters of 7, 14, 28, 30, 56, 60, 84, 98, 100, or 196 (2 x 98 – multipack) hard capsules.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma S.L.U.

C/Anabel Segura, 11 Edificio Albatros B, 1st Floor

28108 Alcobendas, Madrid

Responsible for manufacturing

TEVA Gyógyszergyár Zrt.

Pallagi út 13

4042 Debrecen

Hungary

or

Teva Operations Poland Sp. z.o.o

ul. Mogilska 80, Krakow

31-546

Poland

or

Merckle GmbH

Ludwig-Merckle-Straße 3,

89143 Blaubeuren

Germany

or

Teva Pharma B.V.

Swensweg 5, Haarlem

2031 GA

Netherlands

This medicine is authorized in the Member States with the following names:

Germany: Zonisamid-ratiopharm 100 mg Hartkapseln

Denmark: Zonisamide Teva

Spain: Zonisamida Teva 100 mg hard capsules EFG

France: Zonisamide Teva 100 mg gélule

Netherlands: Zonisamide Teva 100mg harde capsules

Portugal: Zonisamida Ratiopharm

Sweden: Zonisamide Teva

United Kingdom: Zonisamide Ratiopharm 100 mg Capsules, Hard

Last review date of this leaflet:May 2023

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

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/80450/P_80450.html

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