ZOFRAN ZYDIS 8 mg ORAL LYOPHILIZED

2. What you need to know before you take Zofran Zydis

Do not take Zofran Zydis

• If you are allergic (hypersensitive) to ondansetron or any of the other ingredients of Zofran Zydis (listed in section 6).
• If you have had an allergic reaction to other medicines for nausea or vomiting (e.g. granisetron or dolasetron).
• If you are taking apomorphine (a medicine used to treat Parkinson's disease).

If you think any of these apply to you, do not take Zofran Zydis and talk to your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Zofran Zydis.

• If you have a blockage in your intestine or if you suffer from severe constipation. Zofran Zydis may make the blockage or constipation worse.
• If you have ever had heart problems, including an irregular heart rhythm (arrhythmia).
• If you are having an operation on your tonsils.
• If you have liver problems.

If you are going to have any diagnostic tests (including blood, urine, skin tests that use allergens, etc.), tell your doctor that you are taking this medicine, as it may affect the results.

Other medicines and Zofran Zydis

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, it is important to tell your doctor if you are taking any of the following medicines, as your treatment may need to be stopped or the dose of one of them may need to be adjusted:

• rifampicin(an antibiotic used to treat infections such as tuberculosis).
• tramadoland buprenorphine(medicines used to treat severe pain).
• phenytoinor carbamazepine(medicines used to treat epilepsy).
• medicines used to treat heart problems such as irregular heartbeat (antiarrhythmics) and/or high blood pressure (beta-blockers).
• haloperidolor methadone(medicines that can affect the heart).
• anthracyclinesand trastuzumab(medicines used to treat cancer).
• fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram(Selective serotonin reuptake inhibitors, used to treat depression and/or anxiety)
• venlafaxine, duloxetine(Serotonin and noradrenaline reuptake inhibitors, used to treat depression and/or anxiety).

Tell your doctor or pharmacistif you are taking any of these medicines.

Tell your doctor or pharmacist immediatelyif you notice any of these symptoms during or after treatment.

• if you notice sudden pain or pressure in the chest (myocardial ischemia).

Pregnancy, Breast-feeding and Fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Zofran Zydis should not be used during the first trimester of pregnancy. This is because Zofran Zydis may slightly increase the risk of a baby being born with a cleft lip and/or cleft palate. If you are already pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking Zofran Zydis, as Zofran Zydis may harm the fetus. If you are a woman of childbearing age, you are advised to use an effective method of contraception.

If you are a woman of childbearing age, your doctor or nurse will check if you are pregnant and will perform a pregnancy test before you start treatment with Zofran Zydis.

Women of childbearing age must use an effective method of contraception during treatment with Zofran Zydis. Ask your doctor about the options for contraceptive methods.

If you become pregnant during treatment with Zofran Zydis, tell your doctor.

It is not recommended to breast-feed during treatment with Zofran Zydis, as the ingredients of Zofran Zydis (ondansetron) may pass into breast milk and may affect your baby.

Driving and using machines

Zofran Zydis is unlikely to affect your ability to drive or use machines.

Zofran Zydis contains aspartame (E951), sodium methyl parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate and benzyl alcohol (E1519)

This medicine contains 1.25 mg of aspartame per oral lyophilisate. Aspartame is a source of phenylalanine, which may be harmful for people with phenylketonuria (a rare genetic disorder in which phenylalanine accumulates in the body because it cannot be eliminated properly).

This medicine may cause allergic reactions (which may be delayed) because it contains sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate.

This medicine contains less than 1 mmol of sodium (23 mg) per oral lyophilisate, which is essentially "sodium-free".

This medicine contains 0.00005 mg of benzyl alcohol in each oral lyophilisate.

Benzyl alcohol may cause allergic reactions. Benzyl alcohol has been associated with a risk of serious side effects that include breathing problems ("gasping syndrome") in children. Do not give this medicine to your newborn (up to 4 weeks of age) unless your doctor has told you to. This product should not be used for more than a week in children under 3 years of age unless your doctor or pharmacist has told you to. Ask your doctor or pharmacist for advice if you are pregnant or breast-feeding, or if you have liver or kidney disease. This is because large amounts of benzyl alcohol may build up in your body and cause side effects (metabolic acidosis).

3. How to take Zofran Zydis

Your doctor will tell you exactly how much Zofran Zydis to take.If you are unsure, ask your doctor or pharmacist again.

Remember to take your medicine. Your doctor will tell you how long to take Zofran Zydis for. Do not stop treatment early.

Nausea and vomiting caused by chemotherapy or radiotherapy

Adults

One 8 mg oral lyophilisate 1-2 hours before the medical treatment that is likely to cause nausea and vomiting, and then one 8 mg oral lyophilisate 12 hours later.

To prevent nausea and vomiting on subsequent days, continue taking one 8 mg oral lyophilisate every 12 hours for 5 days.

Nausea and vomiting caused by chemotherapy

Children over 6 months of age and adolescents

Your doctor will decide the dose based on your child's weight or body surface area.

Normally, 12 hours after chemotherapy, your child will receive ondansetron by mouth. The usual dose is 4 mg twice a day and may continue for up to 5 days.

Post-operative nausea and vomiting

Adults

To prevent nausea and vomiting after surgery, 2 oral lyophilisates (16 mg) 1 hour before anesthesia.

Children

There is no data available on the oral administration of Zofran Zydis in the prevention of post-operative nausea and vomiting in children.

Dose adjustments

Patient with liver impairment

In patients with liver problems, the dose should be adjusted to a maximum of 8 mg daily of Zofran Zydis.

Patients with advanced age, patients with renal impairment or slow metabolizers of sparteine/debrisoquine

No dose adjustment is necessary.

Duration of treatment

Your doctor will decide the duration of your treatment with Zofran Zydis. Do not stop treatment early.

If you think the effect of Zofran Zydis is too strong or too weak, tell your doctor or pharmacist.

Zofran Zydis is a type of oral lyophilisate that disappears very quickly when placed on the top of the tongue.

Separate the top aluminum foil from a blister and carefully removethe Zofran Zydis oral lyophilisate unit.

Do not try to remove the oral lyophilisate from the blister pack by breaking the top aluminum foil, as the oral lyophilisate unit is fragile and will break inside

Place the oral lyophilisate on the top of the tongue; it will disappear very quickly; then swallow it in the usual way.

If you take more Zofran Zydis than you should

If you take more Zofran Zydis than you should, the symptoms that may appear are: vision problems, low blood pressure (which can cause dizziness or fainting) and palpitations (irregular heartbeat).

If you or your child take more Zofran Zydis than you should, talk to a doctor or go to the nearest hospital or call the Toxicology Information Service, phone: 91 5620420, indicating the medicine and the amount taken. Bring the medicine with you.

If you forget to take Zofran Zydis

Do not take a double dose to make up for forgotten doses. Do not increase or decrease the dose without your doctor's authorization.

If you forget to take a dose of Zofran Zydis and you are feeling unwell or vomiting, take another dose as soon as possible. Then, continue taking the medicine as directed.

If you forget to take a dose of Zofran Zydis and you are not feeling unwell, wait for the next dose and continue taking the medicine as directed.

If you have any other questions about 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.

Very common side effects

May affect more than 1 in 10 people

• headache.

Common side effects

May affect up to 1 in 10 people

• feeling of warmth or flushing,
• constipation.

Uncommon side effects

May affect up to 1 in 100 people

• rotating upward movements of the eyes, abnormal muscle stiffness, body movements, tremor,
• seizures,
• slow or irregular heartbeat,
• low blood pressure,
• hypo,
• increased levels in blood test results for liver function.

Rare side effects

May affect up to 1 in 1,000 people

• sudden onset of ringing in the ears and pain or pressure in the chest,
• swelling of the eyelids, face, lips, mouth or tongue,
• skin rash or hives on any part of the body,
• abnormal heart rhythm (which may sometimes cause sudden loss of consciousness),
• blurred vision.

If you experience any of these symptoms, stop taking the medicine immediately and tell your doctor.

Very rare side effects

May affect less than 1 in 10,000 people

• temporary blindness, which usually resolves within 20 minutes,
• abnormalities in the electrocardiogram,
• widespread skin rash with blisters and peeling, affecting a large part of the body surface (toxic epidermal necrolysis),

Inform your doctor immediately if you experience any of these symptoms.

Side effects with unknown frequency

Cannot be estimated from the available data

myocardial ischemia

• sudden onset of severe chest pain or pressure (myocardial ischemia).

If you experience any of these symptoms, stop taking the medicine immediately and tell your doctor.

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting of side effects

If you get 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 Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Zofran Zydis

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

Do not store above 30°C.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

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

6. Contents of the pack and other information

Composition of Zofran Zydis 8 mg oral lyophilisate

The active substance is ondansetron. Each oral lyophilisate contains 8 mg of ondansetron.

The other ingredients (excipients) are: gelatin, mannitol (E421), aspartame (E951), sodium methyl parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate and strawberry flavor (contains strawberry flavor, propylene glycol (E1520), benzyl alcohol (E1519) and sodium).

Appearance of the product and pack contents

Zofran Zydis 8 mg is presented as round, white, flat-convex oral lyophilisates that disintegrate quickly. Each pack contains 10 or 500 oral lyophilisates.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

BEXAL FARMACÉUTICA, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Aspen Bad Oldesloe GmbH

Industriestrasse 32-36

23843 Bad Oldesloe

Germany

or

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona – Spain

or

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Germany

or

LEK Pharmaceuticals d.d.,

Verovškova ulica 57,

1526 Ljubljana,

Slovenia

Date of last revision of this leaflet:July 2024.

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

//www.aemps.gob.es/