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ONDANSETRON ARISTO 8 mg FILM-COATED TABLETS

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About the medicine

How to use ONDANSETRON ARISTO 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

Ondansetron Aristo 8 mg Film-Coated Tablets EFG

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

1. What is Ondansetron Aristo and what is it used for

Ondansetron Aristo belongs to a group of medicines called serotonin receptor antagonists (5-HT3). These have the ability to block the action of a chemical substance known as serotonin, which can cause nausea and vomiting.

Ondansetron Aristo is used to treat nausea and vomiting caused by cytostatics (cancer treatment medications) and radiotherapy. It is also used to prevent nausea and vomiting after an operation.

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 Ondansetron Aristo

Do not take Ondansetron Aristo

  • if you are allergic to ondansetron or any of the other ingredients of this medicine (listed in section 6).
  • if you are taking apomorphine (a medicine used to treat Parkinson's disease).

Do not giveOndansetron Aristo 8 mg film-coated tablets to children.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ondansetron Aristo if:

  • you are allergic (hypersensitive) to medicines (5-HT3 receptor antagonists) similar to ondansetron,
  • you have heart problems, including irregular heartbeat (arrhythmia),
  • you are taking certain medicines for treating depression and/or anxiety (selective serotonin reuptake inhibitors [SSRIs] such as fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, and escitalopram or serotonin and noradrenaline reuptake inhibitors [SNRIs] such as venlafaxine or duloxetine) or if you are taking buprenorphine, a medicine used to treat pain. The use of these medicines with Ondansetron Aristo may cause serotonin syndrome, a potentially life-threatening disease. You may experience symptoms such as involuntary rhythmic contractions of muscles, including the muscles that control eye movements, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, body temperature above 38 °C. Contact your doctor if you suffer from these symptoms,
  • you have digestive disorders,
  • you have liver problems, in which case your doctor may reduce your dose of ondansetron,
  • you have problems with salt levels in the blood (electrolyte disorders), such as potassium and magnesium.
  • you are going to have your tonsils removed

If you think any of the above applies to you, do not take Ondansetron Aristo until you have consulted your doctor.

Other medicines and Ondansetron Aristo

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

Some medicines may alter the effects and/or side effects of Ondansetron Aristo, or Ondansetron Aristo may alter the effects and/or side effects of some medicines. These include:

  • apomorphine (a medicine used to treat Parkinson's disease), as a pronounced decrease in blood pressure and loss of consciousness have been reported with the administration of ondansetron with apomorphine
  • carbamazepine, phenytoin (medicines used to treat epilepsy)
  • rifampicin, an antibiotic for tuberculosis
  • medicines that affect the heart, such as certain cancer medicines (anthracyclines and trastuzumab) or medicines that prolong the QT interval (a delay in the transmission of impulses in the heart muscle, visible on the ECG, with the risk of potentially fatal heart rhythm disorders)
  • tramadol or buprenorphine, medicines used to treat pain (see section "Warnings and precautions")
  • selective serotonin reuptake inhibitors (SSRIs) used to treat depression and/or anxiety, such as fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, or escitalopram; serotonin and noradrenaline reuptake inhibitors (SNRIs) used to treat depression and/or anxiety, such as venlafaxine or duloxetine (see section "Warnings and precautions").

Pregnancy, breastfeeding, and fertility

Ondansetron Aristo should not be used during the first trimester of pregnancy. This is because Ondansetron Aristo may slightly increase the risk of a baby being born with a cleft lip and/or cleft palate (openings or fissures in the upper lip or palate). If you are already pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using Ondansetron Aristo. If you are a woman of childbearing age, you are advised to use an effective method of contraception.

Do not breastfeed your child while taking Ondansetron Aristo.

Driving and using machines

Ondansetron Aristo is unlikely to affect your ability to drive or use machines.

Ondansetron Aristo contains lactose

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

3. How to take Ondansetron Aristo

Follow exactly the instructions for administration of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

To protect you from nausea and vomiting during and after cancer treatment with cytostatic agents (chemotherapy) or radiotherapy:

Adults

On the day of chemotherapy or radiotherapy:

The recommended dose of Ondansetron Aristo is 8 mg of ondansetron one or two hours before treatment, and then 8 mg of ondansetron twelve hours later.

In the following days:

In the following days, you will receive ondansetron in the form of film-coated tablets, orodispersible tablets (which dissolve in the mouth), or as a solution. Always use this medicine exactly as described in this leaflet or as your doctor or nurse has told you.

The recommended dose is 8 mg of ondansetron twice a day every 12 hours for 5 days.

Use in children (6 months or older) and adolescents

On the day of chemotherapy:

For children and adolescents, ondansetron is available as an injectable solution for correct intravenous dosing as a slow injection into a vein for at least 30 seconds before treatment.

In the following days, ondansetron is administered as film-coated tablets, orodispersible tablets, or as a solution:

Your doctor will decide what dose of ondansetron is suitable for your child, depending on the child's size (body surface area) and weight. The maximum dose is 8 mg of ondansetron twice a day every 12 hours for 5 days.

Ondansetron Aristo 8 mg film-coated tablets should not be used in children. For this group of patients, there are other dosage forms available with a lower level of active substance.

For the treatment of nausea and vomiting caused by radiotherapy, there are no data available from controlled clinical studies on the use of ondansetron in children.

Elderly patients

No dose adjustment or change in dosing frequency is required.

Prevention of nausea and vomiting (post-operative nausea and vomiting):

Adults

Unless your doctor indicates otherwise, the recommended dose is 16 mg of Ondansetron Aristo one hour before anesthesia.

Use in children and adolescents

Your doctor may decide to administer an injection instead of tablets.

Elderly patients

Experience with ondansetron in the prevention of nausea and vomiting after an operation in elderly patients is limited.

Patient with hepatic impairment

In patients with moderate to severe hepatic impairment, the total daily dose should not exceed 8 mg.

Method of administration

Oral use.

If you take more Ondansetron Aristo than you should

If you or your child take more Ondansetron Aristo than you should, talk to your doctor or go immediately to the nearest hospital or call the Toxicology Information Service, telephone 91 562 04 20 (indicating the medicine and the amount taken). Bring the medicine with you.

If you forget to take Ondansetron Aristo

Do not take a double dose to make up for forgotten doses. If you forget a dose and have nausea or vomiting, take another dose as soon as possible. Then, continue taking the medicine as instructed.

If you are not sure what to do, consult your doctor or pharmacist.

If you stop taking Ondansetron Aristo

Take Ondansetron Aristo for as long as your doctor recommends. Do not stop treatment unless your doctor tells you to.

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

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Severe allergic reactions

If you get any of the following side effects, stop taking the tablets and tell your doctor immediately:

  • rash or itching (urticaria)
  • swelling, sometimes in the face or mouth (angioedema), which can cause difficulty breathing
  • collapse

Severe skin reactions

If you get any of the following side effects, stop taking the tablets and tell your doctor immediately:

  • widespread skin rash with blisters and peeling affecting a large area of the body surface (toxic epidermal necrolysis)

Myocardial ischemia

If you get any of the following side effects, stop taking the tablets and tell your doctor immediately:

  • sudden chest pain or
  • chest tightness

Other side effects:

Very common:may affect more than 1 in 10 people treated

  • headache

Common:may affect up to 1 in 10 people treated

  • feeling of flushing, hot flushes with skin reddening
  • constipation

Uncommon:may affect up to 1 in 100 people treated

  • seizures
  • movement disorders or spasms (including extrapyramidal reactions, such as muscle tone disorders, eye muscle disorders [oculogyric crisis], and motor disorders), but it has been shown that these have no long-term clinical consequences
  • chest pain (with or without ST segment depression on the ECG)
  • irregular or slow heartbeats (heart rhythm disorders, bradycardia)
  • low blood pressure (hypotension)
  • hypokalemia
  • increased liver enzymes (increased liver function tests)

Rare:may affect up to 1 in 1,000 people treated

  • allergic reactions
  • heart rhythm disorders (prolongation of the QT interval, including torsades de pointes, which can cause sudden loss of consciousness)
  • temporary visual disturbances (e.g., blurred vision), mainly with intravenous administration, mainly with rapid intravenous administration
  • drowsiness, mainly with rapid intravenous administration

Very rare:may affect up to 1 in 10,000 people treated

  • transient blindness, mainly with intravenous administration

Not known:frequency cannot be estimated from the available data

  • myocardial ischemia

Side effects in children and adolescents

The side effect profile in children and adolescents was comparable to the side effect profile observed in adults.

Reporting of side effects

If you experience 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 Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ondansetron Aristo

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton and blister after "EXP". The expiry date is 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 Ondansetron Aristo

The active substance is ondansetron hydrochloride dihydrate.

Each film-coated tablet contains 8 mg of ondansetron (as ondansetron hydrochloride dihydrate).

The other ingredients are:

Core of the tablet:

Lactose

Microcrystalline cellulose

Pregelatinized corn starch

Magnesium stearate (Ph. Eur.)

Tablet film coating:

Hypromellose

Triacetin

Titanium dioxide (E 171)

Yellow iron oxide

Appearance and packaging

Film-coated tablets.

Yellow, oval, film-coated tablets, printed with an "E" on one side and "02" on the other.

Ondansetron Aristo 8 mg film-coated tablets are available in packs of 4, 5, 6, 10, 15, 30, 49, 50, and 100 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Local representative

Aristo Pharma Iberia, S.L.

C/Solana, 26

28850 Torrejón de Ardoz, Madrid

Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Norway

Ondansetron Aristo 8 mg film-coated tablets

Spain

Ondansetron Aristo 8 mg film-coated tablets EFG

Sweden

Ondansetron Aristo 8 mg film-coated tablets

Date of last revision of this leaflet: June 2022

Detailed and updated 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 ONDANSETRON ARISTO 8 mg FILM-COATED TABLETS

Discuss questions about ONDANSETRON ARISTO 8 mg FILM-COATED TABLETS, 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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€55
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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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€58
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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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€70
5.0 (760)
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 ONDANSETRON ARISTO 8 mg FILM-COATED TABLETS?
ONDANSETRON ARISTO 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 ONDANSETRON ARISTO 8 mg FILM-COATED TABLETS?
The active ingredient in ONDANSETRON ARISTO 8 mg FILM-COATED TABLETS is ondansetron. This information helps identify medicines with the same composition but different brand names.
Who manufactures ONDANSETRON ARISTO 8 mg FILM-COATED TABLETS?
ONDANSETRON ARISTO 8 mg FILM-COATED TABLETS is manufactured by Aristo Pharma Gmbh. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of ONDANSETRON ARISTO 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 ONDANSETRON ARISTO 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 ONDANSETRON ARISTO 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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