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ZOFRAN 8 mg FILM-COATED TABLETS

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About the medicine

How to use ZOFRAN 8 mg FILM-COATED TABLETS

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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 8mg Film-Coated Tablets

ondansetron hydrochloride dihydrate

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 symptoms are the same as yours.
  • If you experience 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 Package Leaflet

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

1. What is Zofran and what is it used for

Zofran 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.

Zofran is used to:

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

Do not take Zofran

  • If you are allergic (hypersensitive) to ondansetron hydrochloride dihydrate or any of the other ingredients of this medicine (listed in section 6),
  • If you have had any allergic reaction(hypersensitivity) 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 and talk to your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before starting Zofran:

  • if you have a blockage in your intestine or if you suffer from severe constipation. Zofran may increase the blockage or constipation.
  • if you have ever had heart problems, including an irregular heartbeat (arrhythmia).
  • if you are having a tonsillectomy.
  • if you have liver problems.
  • If you are going to have any diagnostic tests (including blood tests, urine tests, 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

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 it may be necessary to stop treatment or adjust the dose of one of them:

  • rifampicin(an antibiotic used to treat infections such as tuberculosis),
  • tramadolor buprenorphine(a medicine used to treat severe pain),
  • phenytoinor carbamazepine(medicines used to treat epilepsy),
  • medicines used to treat heart problemssuch as irregular heartbeats (antiarrhythmics) and/or to treat 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 depressionand/or anxiety),
  • venlafaxine, duloxetine(serotonin and noradrenaline reuptake inhibitors, used to treat depressionand/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 a sudden pain or pressure in the chest (myocardial ischemia)

Pregnancy and Breast-feeding

Zofran should not be used during the first trimester of pregnancy. This is because Zofran may slightly increase the risk of a baby being born with a cleft lip and/or cleft palate. If you are already pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking Zofran, as Zofran 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 need to check if you are pregnant and will perform a pregnancy test before starting treatment with Zofran.

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

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

It is not recommended to breastfeed during treatment with Zofran. The ingredients of Zofran (ondansetron) may pass into breast milk and may affect your baby.

Driving and using machines

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

Zofran tablets contain lactose

If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

3. How to take Zofran

Your doctor will tell you exactly how much Zofran to take.

Follow the instructions for taking this medicine exactly as your doctor or pharmacist has told you.

If you are unsure, ask your doctor or pharmacist again.

Remember to take your medicine. Swallow the tablets whole with a little water.

Your doctor will decide how long you need to take Zofran. Do not stop treatment before.

Nausea and vomiting caused by chemotherapy or radiotherapy

Adults

One tablet (8 mg) by mouth, 1-2 hours before the medical treatment that is likely to cause nausea and vomiting, and then one tablet (8 mg) 12 hours later.

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

Nausea and vomiting caused by chemotherapy

Children over 6months 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 tablets (16 mg) by mouth, 1 hour before anesthesia.

Children

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

Dose adjustments

Patient with liver insufficiency

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

Older patients, patients with renal insufficiency 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. Do not stop treatment before.

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

If you take more Zofran than you should

In case of overdose, 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 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

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

If you forget to take a dose and have discomfort or vomiting, take another dose as soon as possible. Then, continue taking the medicine as instructed.

If you forget to take a dose and do not have discomfort, wait for the next dose and continue taking the medicine as instructed.

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

4. Possible side effects

Like all medicines, Zofran 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, tremors,
  • seizures,
  • slow or irregular heartbeats,
  • low blood pressure (hypotension),
  • hypotension,
  • increased levels in blood test results checking liver function.

Rare side effects

May affect less than 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 anywhere on the body,
  • abnormal heart rhythm (which can 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
  • changes in the electrocardiogram
  • widespread skin rash with blisters and peeling, affecting a large area of the body (toxic epidermal necrolysis).
  • Tell your doctor immediatelyif you experience any of these symptoms.

Side effects of unknown frequency

Cannot be estimated from the available data,

  • myocardial ischemia
    • sudden onset of chest pain or
    • pressure in the chest.
    • If you experience any of these symptoms, stop taking the medicine immediately and tell your doctor.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible that they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) via their website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Zofran

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 further information

Composition of Zofran 8mg Film-Coated Tablets

The active substance is ondansetron hydrochloride dihydrate. Each film-coated tablet of Zofran contains 8 mg of ondansetron (as hydrochloride dihydrate).

The other ingredients are: lactose, microcrystalline cellulose (E460), pregelatinized starch (from maize), magnesium stearate (E470b), hypromellose (E464), titanium dioxide (E171) and yellow iron oxide (E172).

Appearance of the product and pack contents

Zofran 8 mg film-coated tablets are yellow, oval, and engraved with “GX ET5” on one side. Each pack contains 6, 15 or 500 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

BEXAL FARMACÉUTICA, S.A.

Centro Empresarial Parque Norte

C/Serrano Galvache 56,

Edificio Roble

28033 Madrid

Spain

Manufacturer

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:May 2024

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

Online doctors for ZOFRAN 8 mg FILM-COATED TABLETS

Discuss questions about ZOFRAN 8 mg FILM-COATED TABLETS, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

5.0 (29)
Doctor

Anna Biriukova

General medicine 6 years exp.

Dr Anna Biriukova is an internal medicine doctor with clinical experience in cardiology, endocrinology, and gastroenterology. She provides online consultations for adults, offering expert medical support for heart health, hormonal balance, digestive issues, and general internal medicine.

Cardiology – Diagnosis and treatment of:

  • High blood pressure, blood pressure fluctuations, and cardiovascular risk prevention.
  • Chest pain, shortness of breath, arrhythmias (tachycardia, bradycardia, palpitations).
  • Leg swelling, chronic fatigue, reduced exercise tolerance.
  • EKG interpretation, lipid profile evaluation, cardiovascular risk assessment (heart attack, stroke).
  • Post-COVID-19 cardiac monitoring and care.
Endocrinology – Diabetes, thyroid, metabolism:
  • Diagnosis and management of type 1 and type 2 diabetes, and prediabetes.
  • Individual treatment plans including oral medications and insulin therapy.
  • GLP-1 therapy– modern pharmacological treatment for weight management and diabetes control, including drug selection, monitoring, and safety follow-up.
  • Thyroid disorders – hypothyroidism, hyperthyroidism, autoimmune thyroid diseases (Hashimoto’s, Graves’ disease).
  • Metabolic syndrome – obesity, lipid disorders, insulin resistance.
Gastroenterology – Digestive health:
  • Abdominal pain, nausea, heartburn, gastroesophageal reflux (GERD).
  • Stomach and intestinal conditions: gastritis, irritable bowel syndrome (IBS), indigestion.
  • Management of chronic digestive disorders and interpretation of tests (endoscopy, ultrasound, labs).
General internal medicine and preventive care:
  • Respiratory infections – cough, colds, bronchitis.
  • Lab test analysis, therapy adjustments, medication management.
  • Adult vaccinations – planning, contraindications assessment.
  • Cancer prevention – screening strategies and risk assessment.
  • Holistic approach – symptom relief, complication prevention, and quality of life improvement.
Dr Biriukova combines internal medicine with specialist insight, offering clear explanations, personalised treatment plans, and comprehensive care tailored to each patient.
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Doctor

Dmytro Horobets

Family medicine 7 years exp.

Dr. Dmytro Horobets is a licensed family medicine physician in Poland, specialising in endocrinology, diabetology, obesity management, gastroenterology, pediatrics, general surgery, and pain medicine. He offers online consultations for adults and children, providing personalised medical support for a wide range of acute and chronic health concerns.

Areas of expertise:

  • Endocrinology: diabetes type 1 and type 2, prediabetes, thyroid disorders, metabolic syndrome, hormonal imbalance.
  • Obesity medicine: structured weight management plans, nutritional counselling, obesity-related health risks.
  • Gastroenterology: acid reflux (GERD), gastritis, irritable bowel syndrome (IBS), liver and biliary conditions.
  • Pediatric care: infections, respiratory symptoms, digestive issues, growth and development monitoring.
  • General surgery support: pre- and post-surgical consultations, wound care, rehabilitation.
  • Pain management: chronic and acute pain, back pain, joint pain, post-traumatic pain syndromes.
  • Cardiovascular health: hypertension, cholesterol control, risk assessment for heart disease.
  • Preventive medicine: regular check-ups, health screenings, long-term management of chronic conditions.

Dr. Horobets combines evidence-based medicine with a patient-centred approach. He carefully evaluates each patient’s medical history and symptoms, offering clear explanations and structured treatment plans adapted to individual needs.

Whether you need help managing diabetes, tackling weight-related health issues, interpreting lab results, or receiving general family medicine support, Dr. Horobets provides professional online care tailored to your specific health goals.

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Doctor

Svetlana Kolomeeva

Cardiology 18 years exp.

Dr. Svetlana Kolomeeva is a general practitioner and internal medicine doctor providing online consultations for adults. She helps patients manage acute symptoms, chronic conditions, and preventive care. Her clinical focus includes cardiovascular health, hypertension control, and managing symptoms like fatigue, weakness, sleep issues, and overall low energy.

Patients commonly seek her help for:

  • High blood pressure, headaches, dizziness, swelling, palpitations.
  • Diagnosis and management of hypertension, arrhythmias, and tachycardia.
  • Metabolic syndrome, excess weight, high cholesterol.
  • Chronic fatigue, insomnia, poor concentration, anxiety.
  • Respiratory symptoms: colds, flu, sore throat, cough, fever.
  • Digestive issues: heartburn, bloating, constipation, IBS symptoms.
  • Chronic conditions: diabetes, thyroid disorders.
  • Interpretation of lab tests and medical reports, therapy adjustment.
  • Second opinion and decision-making support.
  • Cardiovascular disease prevention and metabolic risk reduction.
  • Long-term follow-up and dynamic health monitoring.

Dr Kolomeeva combines clinical expertise with personalised care. She clearly explains diagnoses, guides patients through symptoms and treatment options, and provides actionable plans. Her consultations are designed not only to address current complaints but also to stabilise chronic conditions and prevent future complications. She supports patients through every stage of care – from first symptoms to ongoing health management.

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Doctor

Alexander Nazarchuk

Allergology 7 years exp.

Dr. Alexander Nazarchuk is a physician specialising in allergology and internal medicine. He provides online consultations for adults, following the principles of evidence-based medicine — no outdated treatments or unnecessary tests, with clear explanations and a personalised approach. He helps patients with a wide range of allergic and therapeutic conditions, from common day-to-day complaints to complex cases involving allergies, gastrointestinal issues, cardiovascular concerns, respiratory symptoms, and more.

You can consult Dr. Nazarchuk for:

  • Test interpretation and guidance on diagnostic plans.
  • Allergic rhinitis, hay fever, bronchial asthma (including severe cases).
  • Food and drug allergies, skin rashes, angioedema.
  • Atopic dermatitis, urticaria, contact allergies.
  • Allergen-specific immunotherapy (AIT) – initiation and ongoing management.
  • Abdominal pain, bloating, changes in bowel habits, nausea, heartburn.
  • High blood pressure and adjustment of baseline antihypertensive therapy.
  • Hyperlipidaemia and elevated cholesterol.
  • Cough, nasal congestion, fever, sore throat.
  • Anaemia, including iron deficiency and related conditions.
  • Other issues related to allergology and internal medicine.

During consultations, Dr. Nazarchuk takes a thorough, structured approach — analysing symptoms, identifying potential causes, and helping patients make informed decisions. Whether treatment, further investigation, or monitoring is needed, he explains each step clearly so you understand your health and how best to manage it.

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Frequently Asked Questions

Is a prescription required for ZOFRAN 8 mg FILM-COATED TABLETS?
ZOFRAN 8 mg FILM-COATED TABLETS 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 8 mg FILM-COATED TABLETS?
The active ingredient in ZOFRAN 8 mg FILM-COATED TABLETS is ondansetron. This information helps identify medicines with the same composition but different brand names.
Who manufactures ZOFRAN 8 mg FILM-COATED TABLETS?
ZOFRAN 8 mg FILM-COATED TABLETS 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 8 mg FILM-COATED TABLETS 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 8 mg FILM-COATED TABLETS 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 8 mg FILM-COATED TABLETS?
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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