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ZOFRAN ZYDIS 8 mg ORAL LYOPHILIZED

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About the medicine

How to use ZOFRAN ZYDIS 8 mg ORAL LYOPHILIZED

Translated with AI

This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the Patient

Zofran Zydis 8 mg Oral Lyophilisate

ondansetron

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet, you may need to read it again. If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

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

Ondansetron is used to:

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

and

  • radiotherapy in the treatment of cancer in adults.
  • prevent post-operative nausea and vomiting in adults.
Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

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).

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

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.

Hands holding and manipulating a blister pack with circular divisions and empty spaces

Two hands holding a round white tablet with a light blue edge between the fingersDo 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.

Upper and lower teeth open with a white tablet placed between them held by a finger

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/

Online doctors for ZOFRAN ZYDIS 8 mg ORAL LYOPHILIZED

Discuss questions about ZOFRAN ZYDIS 8 mg ORAL LYOPHILIZED, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Doctor

Daniel Cichi

Family medicine 24 years exp.

Dr Daniel Cichi is a family medicine doctor with over 20 years of clinical experience. He provides online consultations for adults, supporting patients with acute symptoms, chronic conditions, and everyday health concerns that require timely medical guidance.

His background includes work in emergency care, ambulance services, and family medicine, which allows him to assess symptoms quickly, identify warning signs, and help patients choose the safest next steps – whether that means home care, treatment adjustment, or in-person evaluation.

Patients commonly consult Dr Daniel Cichi for:

  • acute symptoms: fever, infections, flu-like illness, cough, sore throat, shortness of breath;
  • chest discomfort, palpitations, dizziness, fatigue, and blood pressure concerns;
  • digestive problems: abdominal pain, nausea, diarrhoea, constipation, reflux;
  • muscle, joint, and back pain, minor injuries, post-traumatic symptoms;
  • chronic conditions: hypertension, diabetes, high cholesterol, thyroid disorders;
  • review and interpretation of lab tests, imaging reports, and medical documents;
  • medication review and treatment adjustment;
  • medical advice while travelling or living abroad;
  • second opinions and guidance on whether in-person care is needed.
Dr Cichi’s consultations are structured and practical. He focuses on clear explanations, risk assessment, and actionable recommendations, helping patients understand their symptoms and make informed decisions about their health.
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Doctor

Hocine Lokchiri

General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

  • fever, chills, fatigue and viral symptoms
  • cough, sore throat, nasal congestion, breathing discomfort
  • bronchitis and mild asthma flare-ups
  • nausea, diarrhoea, abdominal pain, digestive infections
  • rashes, allergic reactions, redness, insect bites
  • muscle or joint pain, mild injuries, sprains
  • headache, dizziness, migraine symptoms
  • stress-related symptoms, sleep disturbances
  • questions about test results and treatment plans
  • management of chronic conditions in stable phases
Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

Some situations are not suitable for online care. If a patient has loss of consciousness, severe chest pain, uncontrolled bleeding, seizures, major trauma or symptoms suggesting a stroke or heart attack, he will advise seeking immediate local emergency services. This improves safety and ensures patients receive the right level of care.

Dr. Lokchiri’s professional training includes:

  • Advanced Trauma Life Support (ATLS)
  • Basic and Advanced Cardiac Life Support (BLS/ACLS)
  • Pediatric Advanced Life Support (PALS)
  • Prehospital Trauma Life Support (PHTLS)
  • eFAST and critical care transthoracic echocardiography
  • aviation medicine
He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.
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Doctor

Lina Travkina

Family medicine 13 years exp.

Dr. Lina Travkina is a licensed family and preventive medicine doctor based in Italy. She provides online consultations for adults and children, supporting patients across all stages of care – from acute symptom management to long-term health monitoring and prevention.

Areas of medical care include:

  • Respiratory conditions: colds, flu, acute and chronic bronchitis, mild to moderate pneumonia, bronchial asthma.
  • ENT and eye conditions: sinusitis, tonsillitis, pharyngitis, otitis, infectious and allergic conjunctivitis.
  • Digestive issues: gastritis, acid reflux (GERD), IBS, dyspepsia, bloating, constipation, diarrhoea, functional bowel symptoms, intestinal infections.
  • Urological and infectious diseases: acute and recurrent cystitis, bladder and kidney infections, prevention of recurrent UTIs, asymptomatic bacteriuria.
  • Chronic conditions: hypertension, diabetes, hypercholesterolemia, metabolic syndrome, thyroid disorders, excess weight.
  • Neurological and general symptoms: headache, migraine, dizziness, fatigue, sleep disturbances, reduced concentration, anxiety, asthenia.
  • Chronic pain support: back, neck, joint, and muscle pain, tension syndromes, pain associated with osteochondrosis and chronic conditions.

Additional care areas:

  • Preventive consultations and check-up planning.
  • Medical advice and follow-up consultations.
  • Test interpretation and diagnostic guidance.
  • Structured support for undiagnosed complaints.
  • Second opinion on diagnoses and treatment plans.
  • Nutritional and lifestyle support for vitamin deficiencies, anaemia, metabolic issues.
  • Post-operative recovery support and pain management.
  • Preconception counselling and postpartum support.
  • Immunity support and strategies to reduce frequency of infections.

Dr. Travkina combines evidence-based medicine with an attentive, personalised approach. Her consultations focus not only on treatment, but also on prevention, recovery, and long-term wellbeing.

If during the consultation it becomes clear that your case requires in-person assessment or specialised care outside of her scope, the session will be terminated and the payment fully refunded.

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Doctor

Alina Tsurkan

Family medicine 13 years exp.

Dr. Alina Tsurkan is a licensed family medicine physician based in Portugal, offering online consultations for adults and children. She provides professional primary care, with a focus on prevention, accurate diagnosis, and long-term management of acute and chronic conditions.

Dr. Tsurkan supports patients with a wide range of health issues, including:

  • Respiratory infections: cold, flu, bronchitis, pneumonia, and lingering coughs.
  • ENT conditions: sinusitis, tonsillitis, otitis (ear infections), sore throat, allergic rhinitis.
  • Eye conditions: allergic or infectious conjunctivitis, red eyes, irritation.
  • Digestive issues: acid reflux (GERD), gastritis, irritable bowel syndrome (IBS), constipation, bloating, nausea.
  • Urinary and reproductive health: urinary tract infections (UTIs), cystitis, prevention of recurrent infections.
  • Chronic diseases: hypertension, elevated cholesterol, weight management.
  • Neurological complaints: headaches, migraines, sleep disturbances, fatigue, general weakness.
  • Children’s health: fever, infections, digestive issues, follow-ups, vaccination guidance.

She also provides:

  • IMT medical certificates for driving licence exchange in Portugal.
  • Personalised preventive care and wellness consultations.
  • Interpretation of test results and medical reports.
  • Follow-up care and medication review.
  • Support in managing multiple coexisting conditions.
  • Remote prescription management and medical documentation.

Dr. Tsurkan’s approach is evidence-based and holistic. She works closely with each patient to develop an individualised care plan that addresses both symptoms and root causes. Her goal is to empower patients to take control of their health and maintain well-being through lifestyle adjustments, routine check-ups, and early intervention.

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€55

Frequently Asked Questions

Is a prescription required for ZOFRAN ZYDIS 8 mg ORAL LYOPHILIZED?
ZOFRAN ZYDIS 8 mg ORAL LYOPHILIZED requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in ZOFRAN ZYDIS 8 mg ORAL LYOPHILIZED?
The active ingredient in ZOFRAN ZYDIS 8 mg ORAL LYOPHILIZED is ondansetron. This information helps identify medicines with the same composition but different brand names.
Who manufactures ZOFRAN ZYDIS 8 mg ORAL LYOPHILIZED?
ZOFRAN ZYDIS 8 mg ORAL LYOPHILIZED is manufactured by Bexal Farmaceutica S.A.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of ZOFRAN ZYDIS 8 mg ORAL LYOPHILIZED online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether ZOFRAN ZYDIS 8 mg ORAL LYOPHILIZED is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to ZOFRAN ZYDIS 8 mg ORAL LYOPHILIZED?
Other medicines with the same active substance (ondansetron) include ONDANSETRON ACCORD 2 mg/ml INJECTABLE SOLUTION, ONDANSETRON ARISTO 4 mg ORALLY DISINTEGRATING TABLETS, ONDANSETRON ARISTO 8 mg ORALLY DISINTEGRATING TABLETS. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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