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ONDANSETRON ARISTO 8 mg ORALLY DISINTEGRATING TABLETS

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About the medicine

How to use ONDANSETRON ARISTO 8 mg ORALLY DISINTEGRATING 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 USER

Ondansetron Aristo 8 mg oral lyophilisate tablets EFG

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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.

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 Storing Ondansetron Aristo

6 Contents of the pack and other information

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

This medicine contains ondansetron, which belongs to a group of medicines called antiemetics that help improve the feeling of nausea and vomiting.

Ondansetron is used to treat nausea (feeling of discomfort) and vomiting (discomfort) caused by some medical treatments for cancer, such as chemotherapy (in adults and children) or radiotherapy (adults).

It is also used to prevent nausea and vomiting in patients after an operation (adults).

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. Before taking 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 have had any allergic reaction (hypersensitivity) to other antiemetics (e.g. granisetron or dolasetron).

Warnings and precautions:

Be especially careful with Ondansetron Aristo:

  • If you have a bowel obstruction or suffer from severe constipation.
  • If you are going to have your tonsils removed.
  • If you have a heart problem.
  • If you have a liver problem.

IF YOU ARE GOING TO HAVE ANY DIAGNOSTIC TEST (INCLUDING BLOOD, URINE, SKIN TESTS USING ALLERGENS, ETC.), TELL YOUR DOCTOR THAT YOU ARE TAKING THIS MEDICINE, AS IT MAY ALTER THE RESULTS.

Consult your doctor if any of the above circumstances apply to you before starting treatment with Ondansetron Aristo.

Using Ondansetron Aristo with other medicines:

Ondansetron Aristo may have some effect on other medicines and other medicines may have some effect on ondansetron.

Tell your doctor or pharmacist if you are using, or have recently used, any other medicines, including those obtained without a prescription.

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

  • Rifampicin(antibiotic used to treat infections such as tuberculosis).
  • Tramadol(medicine used to treat 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).
  • Buprenorphine, may interact with ondansetron and you may experience symptoms such as involuntary muscle contractions, including movements of the eyes, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor if you experience these symptoms.

Pregnancy and breastfeeding

Pregnancy:

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 are planning to become pregnant, inform your doctor before taking Ondansetron Aristo. If you are a woman of childbearing age, you are advised to use an effective contraceptive method.

Breastfeeding:

You should not breastfeed your child while being treated with ondansetron.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Important information about some of the ingredients of Ondansetron Aristo:

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

This medicine may be harmful to people with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

This medicine may cause severe allergic reactions and bronchospasm (sudden feeling of suffocation) because it contains sulfur dioxide.

3. How to take Ondansetron Aristo

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If in doubt, ask your doctor or pharmacist.

Open the blister pack by peeling off the aluminum foil as shown. Do not push the tablet through the aluminum foil.

Ondansetron oral lyophilisate tablets should be taken orally. The tablet dissolves quickly in the mouth and can then be swallowed normally. Drink a glass of water afterwards.

Important: Do not remove Ondansetron oral lyophilisate tablets from the blister or aluminum foil until you are ready to take them.

Treatment of nausea and vomiting (nausea and vomiting) in patients who are going to receive chemotherapy or

radiotherapy:

Adults (including elderly)

The usual dose is 8 mg of Ondansetron 1-2 hours before chemotherapy or radiotherapy, followed by 8 mg of ondansetron 12 hours later. In order to protect against delayed nausea, or additional nausea, treatment may be continued with a dose of 8 mg of Ondansetron twice a day for 5 days after treatment.

Treatment of nausea and vomiting (nausea and vomiting) in patients who are going to receive chemotherapy:

Children (from 6 months or older) and adolescents (under 18 years):

Your doctor will decide what dose of Ondansetron is suitable. This will depend on the size and weight of the child.

To prevent nausea and vomiting after surgery:

Adults: The usual dose is 16 mg before surgery or one 8 mg tablet one hour before surgery. And then, another 8 mg tablet eight hours after the first dose and another 8 mg tablet eight hours after the second dose.

The effect of the ondansetron oral lyophilisate tablets starts 1 to 2 hours after taking the corresponding dose.

If you vomit during the hour after taking the 8 mg dose: take another 8 mg tablet, but do not take more ondansetron oral lyophilisate tablets than indicated in this leaflet.

Patients with liver problems: The total daily dose should not be more than 8 mg.

If you take more Ondansetron Aristothan you should:

If you or your child take more ondansetron than you should, talk to a doctor or go to the nearest hospital immediately. Bring the medicine with you.

If you have taken Ondansetron Aristo more than you should, consult your doctor or pharmacist or the Toxicology Information Service, telephone 915620420, indicating the medicine and the amount taken.

In case of overdose, the symptoms that may appear are: vision problems, low blood pressure (which can cause dizziness or fainting) and palpitations (irregular or rapid heartbeat).

If you forget to take Ondansetron Aristo:

If you forget a dose, take it when you remember unless it is close to the time for the next dose. Do not take a double dose to make up for forgotten doses.

If you stop taking Ondansetron Aristo

Do not stop taking ondansetron without consulting your doctor, even if you feel better. If you have any further questions on the use of this product, 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, Ondansetron Aristo can cause side effects, although not everybody gets them.

If you experience any of the following symptoms soon after taking Ondansetron Aristo, stop taking the medicine and inform your doctor immediately.

  • Sudden onset of "wheezing" when breathing and pain or pressure in the chest.
  • Swelling of the eyelids, face, lips, mouth, tongue, and throat.
  • Difficulty breathing.
  • Collapse.
  • Skin rash.
  • Seizures.
  • Chest pain.
  • Transient loss of vision that usually returns within 20 minutes.

Side effects of Ondansetron:

If you are unsure about the side effects, talk to your doctor. If you think any of the side effects you are experiencing are serious, or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Very common side effects: in more than 1 in 10 patients treated

  • Headache.

Common side effects: up to 1 in 10 patients treated:

  • Feeling of heat or flushing.
  • Constipation.

Uncommon side effects: up to 1 in 100 patients treated

  • Involuntary movements of the body, including rolling movements of the eyes.
  • Seizures. If this happens, see a doctor immediately.
  • Palpitations (irregular or rapid heartbeat) or slow heartbeat.
  • Chest pain. If this happens, see a doctor immediately.
  • Low blood pressure.
  • Hiccup.
  • Increased liver test results (more often in patients treated with cisplatin chemotherapy)

Rare side effects: up to 1 in 1,000 patients treated

  • Immediate allergic reaction, which can be severe and include symptoms such as general swelling, pain or pressure in the chest, swelling of the eyelids, face, lips, mouth, tongue, and throat, difficulty breathing, collapse, skin rash. If this happens, see a doctor immediately.
  • Vision problems, for example blurred vision (although this has always been associated with ondansetron injection more than with tablets).

Very rare side effects: less than 1 in 10,000 patients treated

  • Temporary loss of vision that usually returns within 20 minutes. If this happens, see a doctor immediately. Temporary loss of vision has almost always been associated with ondansetron injection more than with tablets, and usually with cisplatin chemotherapy.
  • Changes in heart rhythm that can be seen on an ECG (records the electrical activity of the heart). The symptoms may include a feeling of dizziness or loss of consciousness.

Frequency not known: cannot be estimated from the available data

  • Myocardial ischemia. The signs include sudden chest pain or pressure in the chest.

If you think any of the side effects you are experiencing are serious, or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storing Ondansetron Aristo

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

Store in the original package

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

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ondansetron Aristo

The active substance is Ondansetron. Each tablet contains 8mg of ondansetron.

The other ingredients are: PharmaburstTM C1 (compound of mannitol, sorbitol, crospovidone, and colloidal silicon dioxide), Microcrystalline cellulose, Crospovidone type B, Aspartame, Strawberry flavor (compound of identical natural flavoring substances, natural flavoring substances, natural flavoring preparations, corn starch dextrin, maltodextrin, Gum arabic E414, Sulfur dioxide E220, Flavor), Sodium fumarate, and Magnesium stearate.

Appearance of the product and pack contents

Ondansetron Aristo are white, flat, round, and beveled oral lyophilisate tablets.

Ondansetron Aristo 8mg is presented in aluminum/aluminum blisters. It is presented in packs containing 10 and 500 oral lyophilisate tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid – Spain

Manufacturer:

Sofarimex Industria Química e Farmaceutica Lda

Av. Indústrias, Alto do Colaride, Agualva-2735-213, Cacém

Portugal

or

MPF B.V.

Applehof 13, 8465 RX, Heerenveen (Ouderhaske)

Netherlands

or

Laboratorios de Medicamentos Internacionales, S.A. (Medinsa)

c/ Solana, 26

28850 – Torrejón de Ardoz, Madrid

Spain

Date of last revision of this leaflet: February 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 ORALLY DISINTEGRATING TABLETS

Discuss questions about ONDANSETRON ARISTO 8 mg ORALLY DISINTEGRATING TABLETS, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

5.0 (29)
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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.
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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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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.
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  • 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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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.
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  • 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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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).
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  • Abdominal pain, bloating, changes in bowel habits, nausea, heartburn.
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  • Hyperlipidaemia and elevated cholesterol.
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  • Anaemia, including iron deficiency and related conditions.
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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 ONDANSETRON ARISTO 8 mg ORALLY DISINTEGRATING TABLETS?
ONDANSETRON ARISTO 8 mg ORALLY DISINTEGRATING 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 ORALLY DISINTEGRATING TABLETS?
The active ingredient in ONDANSETRON ARISTO 8 mg ORALLY DISINTEGRATING TABLETS is ondansetron. This information helps identify medicines with the same composition but different brand names.
Who manufactures ONDANSETRON ARISTO 8 mg ORALLY DISINTEGRATING TABLETS?
ONDANSETRON ARISTO 8 mg ORALLY DISINTEGRATING TABLETS is manufactured by Aristo Pharma Iberia S.L.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of ONDANSETRON ARISTO 8 mg ORALLY DISINTEGRATING 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 ORALLY DISINTEGRATING 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 ORALLY DISINTEGRATING 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 FILM-COATED 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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