ONDANSETRON ARISTO 4 mg ORALLY DISINTEGRATING TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ondansetron Aristo 4 mg oral lyophilisates 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 experience 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).

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 THAT USE ALLERGENS, ETC.), TELL YOUR DOCTOR THAT YOU ARE TAKING THIS MEDICINE, AS IT MAY ALTER THE RESULTS.

Talk to 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(an antibiotic used to treat infections such as tuberculosis).
• Tramadol(a medicine used to treat pain).
• Phenytoinor carbamazepine(medicines used to treat epilepsy).
• Medicines used to treat heart problemssuch as irregular heartbeat (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 upward rolling 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 gaps in the upper lip or palate). If you are already pregnant, think you may be pregnant, or are planning to become pregnant, tell 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.

Ask your doctor or pharmacist for advice before taking 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 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.

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

Important: Do not remove Ondansetron oral lyophilisates from the blister or aluminum until you are ready to take it.

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 (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 lyophilisates starts one to two 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 lyophilisates 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 Aristo than 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 almost 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 talking to your doctor, even if you feel better. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ondansetron Aristo can cause side effects, although not everybody gets them.

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

• Sudden appearance 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.
• Temporary loss of vision that usually returns within 20 minutes.

Ondansetron side effects:

If you are unsure about the side effects, talk to your doctor. If you think any side effect is serious or have noticed any side effects not mentioned in this leaflet, tell 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 upward 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-containing chemotherapy.
• Changes in heart rhythm that can be seen on an ECG (records the electrical activity of the heart). Symptoms may include feeling dizzy or loss of consciousness.

Frequency not known: cannot be estimated from the available data

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

If you think any side effect is serious or have noticed any side effects not mentioned in this leaflet, tell 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 is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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 4 mg of ondansetron.

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

Appearance of the product and contents of the pack

Ondansetron Aristo are white, flat, round, and beveled oral lyophilisates.

Ondansetron Aristo 4 mg is presented in aluminum/aluminum blisters. It is presented in packs containing 10 and 500 oral lyophilisates.

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/