Ondansetron Aristo 8 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ondansetron Aristo 8 mg orodispersible tablets EFG

Read the entire leaflet carefully before you start using the medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet.

Leaflet contents:

1 What Ondansetron Aristo is and what it is used for

2 What you need to know before taking Ondansetron Aristo

3 How to take Ondansetron Aristo

4 Possible adverse effects

5 How to store Ondansetron Aristo

6 Contents of the pack and other information

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

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

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

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

2. Before taking Ondansetron Aristo

Do not take Ondansetron Aristo:

If you are allergic to ondansetron or to any of the other ingredients of this medicine (listed in section 6).

If you have or have had an allergic (hypersensitivity) reaction to other antiemetics (for example,

granisetron or dolasetron).

Warnings and precautions:

Take special care with Ondansetron Aristo:

• If you have intestinal obstruction or suffer from severe constipation.
• If you are undergoing tonsillectomy.
• If you have a heart condition.
• If you have a liver problem.

IF YOU ARE UNDERGOING ANY DIAGNOSTIC TESTS (INCLUDING BLOOD AND URINE ANALYSES, SKIN TESTS USING ALLERGENS, ETC.), INFORM YOUR DOCTOR THAT YOU ARE TAKING THIS MEDICINE, AS IT MAY ALTER TEST RESULTS.

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

Use of Ondansetron Aristo with other medicines:

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

Inform your doctor or pharmacist if you are taking, or have recently taken, 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 dose adjustment may be necessary:

• Rifampicin (an antibiotic used to treat infections such as tuberculosis).
• Tramadol (a medicine used to treat pain).
• Phenytoin or carbamazepine (medicines used to treat epilepsy).
• Medicines used to treat heart problems, such as irregular heartbeats (antiarrhythmics) and/or to treat high blood pressure (beta-blockers).
• Haloperidol or methadone (medicines that may affect the heart).
• Anthracyclines and trastuzumab (medicines used to treat cancer).
• Buprenorphine: may interact with ondansetron and you may experience symptoms such as involuntary rhythmic muscle contractions, including muscles controlling eye movements, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, and body temperature above 38°C. Contact your doctor if you experience these symptoms.

Pregnancy and breast-feeding

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 cleft lip and/or cleft palate (openings or splits in the upper lip or the roof of the mouth). If you are already pregnant, think you might 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.

Breast-feeding:

You should not breast-feed while being treated with ondansetron.

Consult your doctor or pharmacist before using any medicine.

Driving and use of machines

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

Important information about some of the ingredients of Ondansetron Aristo:

This medicine contains sorbitol. If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

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

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

3. How to take Ondansetrón Aristo

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

Peel back the blister pack to open it as shown on the aluminum foil. Do not push the tablet through the aluminum foil.

Ondansetrón orodispersible tablets must be taken by mouth. The tablet dissolves rapidly in the mouth and can then be swallowed in the usual way. Drink a glass of water afterwards.

Important: Do not remove the orodispersible tablet of Ondansetrón from the blister or aluminum foil until you are ready to take it.

Treatment of nausea and vomiting in patients undergoing chemotherapy or radiotherapy:

Adults (including elderly)

The usual dose is 8 mg of Ondansetrón 1-2 hours before chemotherapy or radiotherapy, followed by 8 mg of ondansetrón 12 hours later. To protect against delayed or additional nausea and vomiting, treatment may be continued with 8 mg of Ondansetrón twice daily for 5 days after treatment.

Treatment of nausea and vomiting in patients undergoing chemotherapy:

Children (6 months of age and older) and adolescents (under 18 years):

Your doctor will decide the appropriate dose of Ondansetrón. This will depend on the child's size and weight.

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, followed by another 8 mg tablet eight hours after the first dose, and another 8 mg tablet eight hours after the second dose.

The effect of ondansetrón orodispersible tablets begins within one to two hours after taking the dose.

If you vomit within one hour after taking the 8 mg dose: take another 8 mg tablet, but do not take more Ondansetrón orodispersible tablets than indicated in this leaflet.

Patients with liver problems: The total daily dose should not exceed 8 mg.

If you take more Ondansetrón Aristo than you should:

If you or your child take more ondansetrón than you should, speak to a doctor or go immediately to the nearest hospital. Take the medicine with you.

If you have taken more Ondansetrón Aristo than recommended, contact your doctor or pharmacist or the Toxicology Information Service immediately, telephone 915620420, indicating the medicine and the amount ingested.

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

If you forget to take Ondansetrón Aristo:

If you miss a dose, take it as soon as you remember, unless it is almost time for the next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Ondansetrón Aristo:

Do not stop treatment with ondansetrón without consulting your doctor, even if you feel better. If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Ondansetrón Aristo may cause adverse effects, although not everyone experiences them.

If any of the following symptoms occur shortly after taking Ondansetrón Aristo, stop taking the medicine and inform your doctor immediately:

• Sudden whistling sound when breathing and chest pain or tightness.
• Swelling of the eyelids, face, lips, mouth, tongue, and throat.
• Difficulty breathing.
• Collapse.
• Skin rash.
• Seizures.
• Chest pain.
• Temporary loss of vision, usually returning within 20 minutes.

Adverse effects of Ondansetrón:

If you have any doubts about adverse effects, speak with your doctor. If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

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

• Headache.

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

• Feeling of warmth or flushing.
• Constipation.

Uncommon adverse effects: in up to 1 in 100 patients treated

• Involuntary body movements, including upward rolling eye movements.
• Seizures. If this occurs, seek immediate medical attention.
• Palpitations (irregular or rapid heartbeat) or slow heartbeat.
• Chest pain. If this occurs, seek immediate medical attention.
• Low blood pressure.
• Hiccups.
• Increased liver function test results (more often observed in patients treated with cisplatin chemotherapy).

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

• Immediate allergic reaction, which may be severe and include symptoms such as generalized swelling, chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue, and throat, difficulty breathing, collapse, skin rash. If this occurs, seek immediate medical attention.
• Vision problems, for example blurred vision (although this has been more frequently associated with injectable ondansetron than with tablets).

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

• Temporary loss of vision, usually returning within 20 minutes. If this occurs, seek immediate medical attention. Temporary vision loss has almost always been reported with injectable ondansetron rather than tablets, and usually in association with cisplatin-containing chemotherapy.
• Changes in heart rhythm detectable on an ECG (electrocardiogram, which records the electrical activity of the heart). Symptoms may include dizziness or loss of consciousness.

Frequency not known: cannot be estimated from available data

• Myocardial ischemia. Signs include sudden chest pain or chest tightness.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of Ondansetron Aristo

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

Store in the original packaging.

Do not use this medicine after the expiry date stated on the container. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the Sigre Collection Point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ondansetron Aristo

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

The other components are: PharmaburstTM C1 (composed of mannitol, sorbitol, crospovidone and colloidal silicon dioxide), microcrystalline cellulose, crospovidone type B, aspartame, strawberry flavour (composed of flavouring substances identical to natural ones, natural flavouring substances, natural flavouring preparations, corn starch dextrose, maltodextrin, gum arabic E414, sulphur dioxide E220, flavour), sodium fumarate and magnesium stearate.

Presentation of the product and contents of the pack

Ondansetron Aristo are white, flat, round, bevelled orodispersible tablets.

Ondansetron Aristo 8 mg is available in aluminium/aluminium blisters. Pack sizes contain 10 and 500 orodispersible tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 the most recent review of this leaflet: February 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/