Zofran Zydis 8 mg oral lyophilisate

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Zofran Zydis 8 mg orodispersible lyophilisate

ondansetron

Read the entire 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, consult 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, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Zofran Zydis is and what it is used for

Zofran Zydis belongs to a group of medicines called antiemetics. Ondansetron is a 5HT3 receptor antagonist. It works by blocking 5HT3 receptors located on neurons in the central and peripheral nervous systems.

Ondansetron is used to:

• prevent nausea and vomiting caused by:
• chemotherapy in the treatment of cancer in adults and children older than 6 months of age.
• radiotherapy in the treatment of cancer in adults.
• prevent postoperative nausea and vomiting in adults.

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

Do not take Zofran Zydis

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

→ If you think this applies to you, do not take Zofran Zydis and consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Zofran Zydis.

• If you have intestinal blockage or suffer from severe constipation. Zofran Zydis may worsen the blockage or constipation.
• If you have ever had heart problems, including irregular heartbeat (arrhythmia).
• If you are undergoing tonsil surgery.
• If you have liver problems.

If you are due to have any diagnostic tests (including blood or urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter test results.

Other medicines and Zofran Zydis

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

In particular, it is important to inform your doctor if you are taking any of the following medicines, as it may be necessary to stop treatment or adjust the dose of one or more of them:

• Rifampicin (an antibiotic used to treat infections such as tuberculosis).
• Tramadol and buprenorphine (medicines used to treat severe pain).
• Phenytoin or carbamazepine (medicines used to treat epilepsy).
• Medicines used to treat heart problems, such as irregular heartbeats (antiarrhythmics) and/or to treat high blood pressure (beta-blockers).
• Haloperidol or methadone (medicines that may affect the heart).
• Anthracyclines and 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 pharmacist if you are taking any of these medicines.

Tell your doctor or pharmacist immediately if you notice any of the following symptoms during or after treatment

• If you experience sudden pain or tightness in the chest (myocardial ischemia)

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Zofran Zydis must 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 cleft lip and/or cleft palate (openings or splits in the upper lip or in the palate). If you are already pregnant or breastfeeding, think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using Zofran Zydis, as Zofran Zydis may cause harm to the fetus. If you are a woman of childbearing potential, you are advised to use an effective contraceptive method.

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

Women of childbearing potential must use an effective contraceptive method during treatment with Zofran Zydis. Please consult your doctor regarding contraceptive options.

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

Breastfeeding is not recommended during treatment with Zofran Zydis, as the active ingredient in Zofran Zydis (ondansetron) may pass into breast milk and may affect your baby.

Driving and use of machines

It is unlikely that Zofran Zydis will affect your ability to drive or operate machinery.

Zofran Zydis contains aspartame (E951), sodium methylparahydroxybenzoate (E219), sodium propylparahydroxybenzoate and benzyl alcohol (E1519)

This medicine contains 1.25 mg of aspartame per oral lyophilisate. Aspartame contains a source of phenylalanine which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

This medicine may cause allergic reactions (possibly delayed) because it contains sodium methylparahydroxybenzoate and sodium propylparahydroxybenzoate.

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 the risk of serious adverse effects including breathing problems (“gasping syndrome”) in newborn infants. Do not administer this medicine to your newborn (up to 4 weeks of age) unless advised by your doctor. This product should not be used for more than one week in children under 3 years of age unless directed by your doctor or pharmacist. Consult your doctor or pharmacist if you are pregnant or breastfeeding, or if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

3. How to take Zofran Zydis

Your doctor will tell you exactly how much Zofran Zydis to take. If in doubt, consult your doctor or pharmacist again.

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

Nausea and vomiting caused by chemotherapy or radiotherapy

Adults

One orally disintegrating tablet (8 mg) 1–2 hours before the medical treatment that may cause nausea and vomiting, followed by one orally disintegrating tablet (8 mg) 12 hours later.

To prevent nausea and vomiting on subsequent days, continue taking one orally disintegrating tablet (8 mg) every 12 hours for five days.

Nausea and vomiting caused by chemotherapy

Children over 6 months of age and adolescents

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

Normally, twelve hours after chemotherapy, your child will receive ondansetron orally. The usual dose is 4 mg twice daily and may continue for up to 5 days.

Postoperative nausea and vomiting

Adults

To prevent nausea and vomiting after surgery, take 2 orally disintegrating tablets (16 mg) 1 hour before anesthesia.

Children

There are no data available on the oral administration of Zofran Zydis for the prevention of postoperative nausea and vomiting in children.

Dose adjustments

Patients with hepatic impairment

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

Elderly patients, patients with renal impairment, or slow metabolizers of mephenytoin/debrisoquine

No need to modify the daily dose, dosing frequency, or route of administration.

Duration of treatment

Your doctor will decide how long your treatment with Zofran Zydis should last. Do not stop treatment prematurely.

If you feel that the effect of Zofran Zydis is too strong or too weak, inform your doctor or pharmacist.

Zofran Zydis is a type of orally disintegrating tablet that dissolves very rapidly when placed on the top of the tongue.

Peel back the upper aluminum foil from a blister and carefully remove the Zofran Zydis orally disintegrating tablet.

Do not attempt to remove the Zofran Zydis orally disintegrating tablet by breaking through the upper aluminum foil, as the tablet is fragile and may break inside.

Place the orally disintegrating tablet on the top of the tongue; it will dissolve very rapidly; then swallow it in the usual manner.

If you take more Zofran Zydis than you should

In case of overdose, symptoms that may occur include: vision problems, low blood pressure (which may cause dizziness or fainting), and palpitations (irregular heartbeat).

If you or your child takes more Zofran Zydis than prescribed, contact a doctor immediately, go to the nearest hospital, or call the Toxicology Information Service at: 91 5620420, stating the medication and the amount taken. Bring the medication with you.

If you forget to take Zofran Zydis

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

If you forget to take a dose of Zofran Zydis and experience discomfort or vomiting, take the missed dose as soon as possible. Then continue taking the medication as directed.

If you forget to take a dose of Zofran Zydis and do not experience discomfort, wait until the next scheduled dose and continue taking the medication as directed.

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 cause adverse effects, although not everyone experiences them.

Very common adverse effects

May affect more than 1 in 10 patients

• headache.

Common adverse effects

May affect up to 1 in 10 patients

• sensation of warmth or flushing,
• constipation.

Uncommon adverse effects

May affect up to 1 in 100 patients

• upward rolling eye movements, abnormal muscle stiffness, body movements, tremor,
• seizures,
• slow or irregular heartbeat,
• low blood pressure (hypotension),
• hiccups,
• increased levels in blood tests assessing liver function.

Rare adverse effects

May affect up to 1 in 1,000 patients

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

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

Very rare adverse effects

May affect up to 1 in 10,000 patients

• transient blindness, which usually resolves within 20 minutes,

• changes in the electrocardiogram,

• extensive 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.

Adverse effects with unknown frequency

Frequency cannot be estimated from the available data

• myocardial ischemia,
• sudden onset of sudden chest pain or chest tightness (myocardial ischemia).

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

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse 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 stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE E Point located at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This 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 components (excipients) are: gelatin, mannitol (E421), aspartame (E951), sodium methyl parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate, and strawberry flavour (containing strawberry aroma, propylene glycol (E1520), benzyl alcohol (E1519) and sodium).

Appearance of the medicinal product and contents of the pack

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

BEXAL FARMACÉUTICA, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

LEK Pharmaceuticals d.d.,

Verovškova ulica 57,

1526 Ljubljana,

Slovenia

Date of the most recent revision of this leaflet: July 2024.

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http:

//www.aemps.gob.es/