ONDANSETRON VIATRIS 8 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Ondansetron Viatris 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, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

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

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

Ondansetron Viatris is used to:

• Prevent nausea (feeling sick) and vomiting caused by chemotherapy or radiotherapy used to treat cancer (in adults and children over 6 months of age).
• Prevent nausea and vomiting after surgery (only in adults).

Ask your doctor, nurse, or pharmacist if you want an explanation of these uses.

2. What you need to know before you take Ondansetron Viatris

Do not take Ondansetron Viatris:

• If you are allergic to ondansetron or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to medicines for nausea and vomiting that belong to the group of selective receptor antagonists (5-HT3) (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 are not sure, ask your doctor, nurse, or pharmacist before taking Ondansetron Viatris.

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to take Ondansetron Viatris:

• If you have ever had heart problems or if you have changes in heart rhythm (arrhythmias).
• If you have problems with salt levels in your blood, such as potassium, sodium, or magnesium.
• If you have a blockage in your intestine or if you suffer from severe constipation.
• If you are going to have surgery or have recently had surgery on your tonsils, because treatment with ondansetron may hide the symptoms of internal bleeding.
• If you have liver problems.

If you are not sure if any of the above applies to you, consult with your doctor, nurse, or pharmacist before taking Ondansetron Viatris.

Other Medicines and Ondansetron Viatris

Tell your doctor, nurse, or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription and herbal remedies. This is because Ondansetron Viatris may affect the proper functioning of some medicines. Also, some medicines may affect Ondansetron 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 lowering of blood pressure and loss of consciousness have been reported when apomorphine and ondansetron are used at the same time.
• Carbamazepine or phenytoin used to treat epilepsy. These medicines may reduce the effect of ondansetron.
• Rifampicin, used in infections such as tuberculosis (TB). This medicine may reduce the effect of ondansetron.
• Antibiotics such as erythromycin or ketoconazole, used to treat fungal infections.
• Anti-arrhythmic medicines (such as amiodarone) used to treat irregular heartbeats.
• Beta-blocker medicines (such as atenolol or timolol), medicines used to treat certain heart problems or eye problems, 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) may cause serotonin syndrome, a reaction that can put your life at risk when used with ondansetron. The symptoms of serotonin syndrome may include a combination of the following: nausea (feeling unwell), vomiting, agitation, diarrhea, high fever, increased blood pressure, excessive sweating, rapid heartbeat, hallucinations, loss of coordination, hyperactivity of the reflexes, and coma.

If you are not sure if any of the above applies to you, consult with your doctor, nurse, or pharmacist before taking Ondansetron Viatris.

Pregnancy and Breastfeeding

Ondansetron Viatris should not be used during the first trimester of pregnancy. This is because Ondansetron Viatris may slightly increase the risk of a baby being born with a cleft lip and/or cleft palate.

Consult your doctor or pharmacist before taking Ondansetron Viatris if you are already pregnant, think you may 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 if you are taking Ondansetron Viatris, as this medicine may pass into breast milk. Ask your doctor, pharmacist, or midwife for advice.

Driving and Using Machines

Ondansetron is not expected to affect your ability to drive. However, if you experience any of the side 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.

Ondansetron Viatris contains Lactose

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

3. How to take Ondansetron Viatris

Follow the instructions for administration of this medicine exactly as indicated by your doctor. In case of doubt, consult your doctor, nurse, or pharmacist again. The dose that has been 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 1 to 2 hours before treatment and another 8 mg 12 hours later.

On subsequent days:

• The recommended dose for adults is 8 mg twice a day.
• This treatment may be administered 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 dose than usual. Your doctor will decide.

Use in children (over 6 months) and adolescents

To prevent nausea and vomiting caused by chemotherapy only

Your doctor will decide the dose. Look in this leaflet for more information.

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

Children under 6 months

Ondansetron is not recommended in children under 6 months for the treatment of nausea and vomiting caused by 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 and then
• 8 mg after an interval of 8 hours.

Use in children (over 1 month) and adolescents

Children over 2 years of age

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

Children under 2 years

There is limited information on the correct dose of ondansetron to prevent nausea and vomiting after surgery in children under 2 years of age. Your 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 who receive chemotherapy. No dose adjustment is required.

Patient with moderate or severe liver problems

The total daily dose should not exceed 8 mg.

Ondansetron Viatris tablets should start to work within 1 to 2 hours of taking the dose. If you have blood tests to check how your liver is working, this medicine may alter the results.

Patient with kidney problems or slow metabolizers of sparteine/debrisoquine

Patient 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 1 hour of taking a dose

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

If you continue to feel nauseous, tell your doctor or nurse.

Method of administration

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

If you take more Ondansetron Viatris than you should

If you or your child have taken more ondansetron than you should, talk to a doctor or go to the nearest hospital casualty department or call the Poisons Information Service on 91 562 04 20. Take the package and any remaining tablets with you.

Information on overdose with ondansetron is limited. The signs that have been reported after an overdose of the medicine are as follows: changes in vision, severe constipation, low blood pressure, fainting, and changes in heart rhythm. In children, fever, sweating, dilation of the pupils, and diarrhea have also been reported.

If you forget to take Ondansetron Viatris

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

• Take ondansetron as soon as possible after;
• Take the next dose at the usual time (as shown in this leaflet);
• Do not take a double dose to make up for forgotten 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 forgotten doses.
• Important: a minimum interval of 12 hours must be allowed between doses.

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

4. Possible Side Effects

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

The following serious side 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, the signs may include:

• Sudden wheezing, chest pain or tightness.
• Swelling of the eyelids, face, lips, mouth, or tongue.
• Redness or lumps on the skin in any part of your body (urticaria) or itchy, raised patches of skin (hives).
• Fainting or 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 skin reactions with blistering and peeling, especially on the mouth, nose, eyes, and genitals, which may be life-threatening.

Other Possible Side Effects

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

• Headache.

Common(may affect up to 1 in 10 people)

• Feeling of warmth or flushing.
• 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 heartbeat.
• Chest pain with or without changes in the electrocardiogram.
• Seizures, unusual movements of the body, or jerks.
• Changes in blood tests that show how your liver is working (more commonly in patients receiving chemotherapy with cisplatin).

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

• Temporary blurred vision.
• Changes in heart rhythm, such as prolongation of the QT interval (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” and this condition can cause 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 the available data)

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

Side Effects in Children and Adolescents

The side effects seen in children and adolescents were similar to those seen in adults, as described above.

Reporting of Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side 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 which is stated on the carton or blister after EXP. The expiry date refers to the last day of that month.

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 Viatris

The active substance is ondansetron hydrochloride dihydrate.

Each tablet contains 8 mg of the active substance ondansetron (as hydrochloride dihydrate).

The other ingredients are: lactose monohydrate (see section 2 “Ondansetron Viatris contains lactose”), microcrystalline cellulose (E-460), pregelatinized maize 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 Ondansetron Viatris and Contents of the Pack

Ondansetron tablets are round, pale yellow, and film-coated. The 8 mg tablets are marked with “42” on one side.

Ondansetron Viatris 8 mg film-coated tablets are available in packs of 3, 6, 10, 14, 15, 20, 30, 40, 50, 60, 90, 100, 200, 300, and 500 tablets, packaged in blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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

You can request more information about this medicine from the local representative of the Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

Spain Ondansetron Viatris 8 mg film-coated tablets EFG

Ireland Emizof 8 mg Film-Coated Tablets

United Kingdom (Northern Ireland) Ondansetron 8 mg Film coated Tablets

Date of Last Revision of this Leaflet:January 2025

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