Ondansetron Viatris 4 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ondansetron Viatris 4 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this 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, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

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

Ondansetron Viatris belongs to a group of medicines known as antiemetics or anti-nausea medicines.

Ondansetron Viatris is used for:

• Prevention of nausea (feeling sick) and vomiting caused by chemotherapy or radiotherapy used in the treatment of cancer (in adults and children over 6 months of age).
• Prevention of postoperative nausea and vomiting (in adults only).

Ask your doctor, nurse, or pharmacist if you would like an explanation about these uses.

2. What you need to know before taking Ondansetrón Viatris

Do not take Ondansetrón Viatris:

• If you are allergic to ondansetron or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to medicines for nausea or vomiting belonging to the group of selective 5-HT3 receptor antagonists (e.g., granisetron, dolasetron), as you may also be allergic to ondansetron.
• If you are taking apomorphine (used to treat Parkinson's disease).

If you have any doubts, ask your doctor, nurse, or pharmacist before taking Ondansetrón Viatris.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting Ondansetrón Viatris:

• If you have ever had heart problems or heart rhythm disorders (arrhythmias).
• If you have problems with blood levels of salts such as potassium, sodium, or magnesium.
• If you have intestinal blockage or suffer from severe constipation.
• If you are going to have surgery or have recently had your tonsils removed, because treatment with ondansetron may mask symptoms of internal bleeding.
• If you have liver problems.

If you are unsure whether any of the above apply to you, consult your doctor, nurse, or pharmacist before taking Ondansetrón Viatris.

Other medicines and Ondansetrón Viatris

Tell your doctor, nurse, or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription and herbal remedies. This is because Ondansetrón Viatris may affect how some medicines work. Likewise, some medicines may affect Ondansetrón Viatris.

In particular, inform your doctor, nurse, or pharmacist if you are taking any of the following medicines:

• Apomorphine (a medicine used to treat Parkinson's disease), as significant drops in blood pressure and loss of consciousness have been reported when apomorphine and ondansetron are used together.
• Carbamazepine or phenytoin, used to treat epilepsy. These medicines may reduce the effect of ondansetron.
• Rifampicin, used for infections such as tuberculosis (TB). This medicine may reduce the effect of ondansetron.
• Antibiotics such as erythromycin or ketoconazole, used to treat fungal infections.
• Antiarrhythmic medicines (such as amiodarone) used to treat irregular heartbeats.
• Beta-blockers (such as atenolol or timolol), medicines used to treat certain heart or eye conditions, anxiety, or to prevent migraines.
• Tramadol, a pain reliever. The effect of this medicine may be reduced.
• Medicines used to treat cancer (especially anthracyclines and trastuzumab).
• Some medicines used to treat depression, known as SSRIs (Selective Serotonin Reuptake Inhibitors) or SNRIs (Serotonin and Norepinephrine Reuptake Inhibitors), which may cause serotonin syndrome—a potentially life-threatening reaction when used together with ondansetron. Symptoms of serotonin syndrome may include a combination of the following: nausea (feeling unwell), vomiting, agitation, diarrhea, high fever, increased blood pressure, excessive sweating, tachycardia, hallucinations, loss of coordination, hyperactive reflexes, and coma.

If you are unsure whether any of the above apply to you, consult your doctor, nurse, or pharmacist before taking Ondansetrón Viatris.

Pregnancy and breastfeeding

Ondansetrón Viatris should not be used during the first trimester of pregnancy. This is because Ondansetrón Viatris 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 roof of the mouth).

Consult your doctor or pharmacist before taking Ondansetrón Viatris if you are already pregnant, think you might be pregnant, or plan to become pregnant.

If you are a woman of childbearing age, you are advised to use an effective method of contraception.

Do not breastfeed while taking Ondansetrón Viatris, as this medicine may pass into breast milk. Seek advice from your doctor, pharmacist, or midwife.

Driving and using machines

Ondansetron is not expected to affect your ability to drive. However, if you experience any adverse effects (listed in section 4), such as dizziness or blurred vision, you are advised to exercise caution. Do not drive or operate machinery if you do not feel well.

Ondansetrón Viatris contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Ondansetron Viatris

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor, nurse, or pharmacist again. The dose prescribed for you will depend on the treatment you are receiving.

To prevent nausea and vomiting caused by chemotherapy or radiotherapy

Adults:

On the day of chemotherapy or radiotherapy:

• The recommended dose for adults is 8 mg taken one or two hours before treatment and another 8 mg twelve hours later.

On the following days:

• The recommended dose for adults is 8 mg twice daily.
• This treatment may be given for up to a maximum of 5 days.

If your chemotherapy or radiotherapy is likely to cause severe nausea and vomiting, you may be given a higher than usual dose. Your doctor will decide.

Use in children (over 6 months of age) and adolescents

To prevent nausea and vomiting caused by chemotherapy only

The doctor will decide the dose. See this leaflet for more information.

• The recommended dose for a child is up to a maximum of 8 mg twice daily, depending on the child's weight.
• This treatment may be administered for up to a maximum of 5 days.

Children under 6 months of age

Ondansetron is not recommended for children under 6 months of age for the treatment of nausea and vomiting due to chemotherapy.

To prevent nausea and vomiting after surgery

Adults

The recommended dose for adults is 16 mg before surgery, or

• 8 mg before surgery and
• 8 mg after surgery, followed by
• 8 mg after an interval of 8 hours.

Use in children (over 1 month of age) and adolescents

Children aged 2 years or older

Ondansetron injection is recommended. Other pharmaceutical forms of this medicine are more suitable for children; consult your doctor or pharmacist.

Children under 2 years of age

There is limited information on the correct dose of ondansetron to prevent nausea and vomiting after surgery in children under 2 years of age. The doctor will decide the correct dose.

Elderly patients

Experience with the use of ondansetron in the prevention of nausea and vomiting after surgery is limited in elderly patients. However, ondansetron is well tolerated in patients over 65 years of age receiving chemotherapy. Dose adjustment is not required.

Patients with moderate or severe hepatic impairment

The total daily dose must not exceed 8 mg.

Ondansetron Viatris tablets should start to take effect within one or two hours after taking the dose. If you have blood tests to check how your liver is functioning, this medicine may alter the results.

Patients with renal impairment or slow metabolizers of sparteine/debrisoquine

Patients with kidney problems or those who cannot metabolize sparteine/debrisoquine properly may take the recommended doses of ondansetron as indicated above.

If you vomit within one hour of taking a dose

• Inform your doctor or nurse.
• Take the same dose again.
• Do not take more Ondansetron than indicated in this leaflet.

If you continue to experience nausea, inform your doctor or nurse.

Method of administration

• Swallow the tablets with a glass of water.
• Ondansetron is also available as an injectable solution.

If you take more Ondansetron Viatris than you should

If you or your child has taken more ondansetron than you should, speak to a doctor or go immediately to the nearest hospital or call the Toxicology Information Service at telephone number 91 562 04 20. Take the packaging and any remaining tablets with you.

Information on overdose with ondansetron is limited. Signs reported following an overdose of the medicine include: visual disturbances, severe constipation, low blood pressure, fainting, and changes in heart rhythm. In children, fever, sweating, dilated pupils, and diarrhea have also been reported.

If you forget to take Ondansetron Viatris

If you forget to take a dose and you feel nauseous or vomit:

• Take ondansetron as soon as possible;
• Take the next dose at your usual time (as shown in this leaflet);
• Do not take a double dose to make up for missed doses.

If you forget to take a dose but do not feel nauseous:

• Take the next dose as indicated in this leaflet.

• Do not take a double dose to make up for missed doses.

• Important: A minimum interval of 12 hours must be allowed between doses.

If you have any further questions about the use of this medicine, consult your doctor, nurse, or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following serious adverse effects may occur when taking this medicine. If you notice any of these, stop taking the medicine and consult a doctor immediately or go to the nearest hospital.

Rare (may affect up to 1 in 1,000 people)

If you have an allergic reaction, signs may include:

• Sudden wheezing and pain or pressure in the chest.
• Swelling of the eyelids, face, lips, mouth or tongue.
• Skin rash – red spots or lumps under the skin (urticaria) anywhere on the body.
• Collapse.

Uncommon (may affect up to 1 in 100 people)

• Involuntary eye movements (oculogyric crisis).

Very rare (may affect up to 1 in 10,000 people)

• Severe rash with blisters and peeling affecting a large part of the body surface, especially around the mouth, nose, eyes and genitals, resembling severe burns.

Other possible adverse effects

Very common (may affect more than 1 in 10 people)

• Headache.

Common (may affect up to 1 in 10 people)

• Feeling of flushing or warmth (hot flushes).
• Constipation.

Uncommon (may affect up to 1 in 100 people)

• Hiccups.
• Low blood pressure, which may make you feel weak or dizzy.
• Slow or irregular heartbeats.
• Chest pain with or without changes in the electrocardiogram.
• Seizures, unusual body movements or jerking.
• Changes in blood tests indicating liver function (more frequently in patients receiving cisplatin chemotherapy).

Rare (may affect up to 1 in 1,000 people)

• Transient blurred vision.
• Heart rhythm disturbances, such as QT interval prolongation (delay in the conduction of electrical signals in the heart). In some people, this may lead to a potentially serious heart condition known as "Torsade de Pointes", which can cause a very rapid heartbeat and sudden loss of consciousness.

Very rare (may affect up to 1 in 10,000 people)

• Poor vision or temporary loss of vision, which usually returns within 20 minutes.

Frequency not known (cannot be estimated from available data)

• Myocardial ischemia: signs include sudden chest pain or chest tightness.

Adverse effects in children and adolescents

Adverse effects observed in children and adolescents were similar to those observed in adults, as described above.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ondansetron Viatris

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 stated on the packaging or blister after EXP or CAD. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point in your pharmacy. If in doubt, 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 Ondansetrón Viatris

The active substance is ondansetron hydrochloride dihydrate.

Each tablet contains 4 mg of the active substance ondansetron (as hydrochloride dihydrate).

The other components are: monohydrate lactose (see section 2 “Ondansetrón Viatris contains lactose”), microcrystalline cellulose (E-460), pregelatinized corn starch, magnesium stearate (E-470b).

The coating contains: hypromellose (E-464), titanium dioxide (E-171), propylene glycol (E-1520), hydroxypropylcellulose (E-463), sorbitan oleate (E-494), sorbic acid (E-200), vanillin, and quinoline yellow (E-104).

Appearance of Ondansetrón Viatris and contents of the pack

Ondansetron tablets are round, pale yellow, film-coated tablets. The 4 mg tablets are marked with “41” on one side.

Ondansetrón Viatris 4 mg tablets are available in boxes of 3, 6, 10, 14, 15, 20, 30, 40, 50, 60, 90, 100, 200, 300 and 500 tablets, packed in blisters.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer

McDermott Laboratories Ltd. t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road (Dublin) – 13
Ireland

or

Mylan Hungary Kft.
Mylan utca 1.
Komárom, H-2900
Hungary

Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Spain: Ondansetrón Viatris 4 mg film-coated tablets EFG
Ireland: Emizof 4 mg Film-Coated Tablets
United Kingdom (Northern Ireland): Ondansetron 4 mg Film Coated Tablets

Date of the most recent revision of this leaflet: January 2025

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