Package Insert: Information for the Patient

Ondansetron Viatris 8 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

Ondansetrón Viatris belongs to a group of medications known as antiemetics or anti-nausea medications.

Ondansetrón Viatris is used for:

• Prevention of nausea (urge to vomit) and vomiting caused by chemotherapy or radiation therapy used in cancer treatment (in adults and children over 6 months of age).
• Prevention of postoperative nausea and vomiting (only in adults).

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

Do not take Ondansetrón Viatris:

• If you are allergic to ondansetrón or any of the other components of this medication (listed in section 6).
• If you are allergic to nausea or vomiting medications that belong to the group of selective serotonin 5-HT3 receptor antagonists (for example, granisetrón, dolasetrón), as in this case you may also be allergic to ondansetrón.
• If you are taking apomorfina (used to treat Parkinson's disease).

Consult your doctor, nurse or pharmacist before taking Ondansetrón Viatris if you have any doubts.

Warnings and precautions

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

• If you have ever had heart problems or if you have arrhythmias.
• If you have problems with blood electrolyte levels, such as potassium, sodium or magnesium.
• If you have a bowel obstruction or if you suffer from severe constipation.
• If you are about to undergo surgery or have recently undergone tonsillectomy, as ondansetrón treatment may mask symptoms of internal bleeding.
• If you have liver problems.

Consult your doctor, nurse or pharmacist if you are unsure if any of the above circumstances apply to you before taking Ondansetrón Viatris.

Other medications and Ondansetrón Viatris

Inform your doctor, nurse or pharmacist if you are taking, have taken recently or may need to take any other medication, including those purchased without a prescription and herbal remedies. This is because Ondansetrón Viatris may affect the proper functioning of some medications. Some medications may also affect Ondansetrón Viatris.

Particularly, inform your doctor, nurse or pharmacist if you are taking any of the following medications:

• Apomorfina (medication used to treat Parkinson's disease), as significant reductions in blood pressure and loss of consciousness have been reported when apomorfina and ondansetrón are used together.
• Carbamazepine or phenytoin used to treat epilepsy. These medications may reduce the effect of ondansetrón.
• Rifampicin, used in infections such as tuberculosis (TB). This medication may reduce the effect of ondansetrón.
• Antibiotics such as erythromycin or ketoconazole, used to treat fungal infections.
• Antiarrhythmic medications (such as amiodarone) used to treat irregular heartbeats.
• Beta-blockers (such as atenolol or timolol), medications used to treat certain heart or eye problems, anxiety or prevent migraines.
• Tramadol, a pain reliever. The effect of this medication may be reduced.
• Medications used to treat cancer (especially anthracyclines and trastuzumab).
• Some medications 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 ondansetrón. Symptoms of serotonin syndrome may include a combination of the following: nausea (feeling of discomfort), vomiting, agitation, diarrhea, high fever, increased blood pressure, excessive sweating, tachycardia, hallucinations, loss of coordination, hyperactivity of reflexes, and coma.

Consult your doctor, nurse or pharmacist if you are unsure if any of the above circumstances apply to you 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 palate (openings or clefts in the upper lip or palate).

Consult your doctor before taking Ondansetrón Viatris if you are pregnant, think you may be pregnant or intend to become pregnant.

Women of childbearing age are advised to use an effective contraceptive method.

Do not breastfeed while taking Ondansetrón Viatris, as this medication may pass into breast milk. Consult your doctor, pharmacist or midwife.

Driving and operating machinery

Ondansetrón is not expected to affect your ability to drive. However, if you experience any of the 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 medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor, nurse or pharmacist again. The dose prescribed to you will depend on the treatment you receive.

To prevent nausea and vomiting in patients receiving chemotherapy or radiation therapy

On the day of chemotherapy and radiation therapy:

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

The following days:

• The recommended dose for adults is 8 mg twice a day.
• This treatment can be administered for a maximum of 5 days.

Use in children (over 6 months) and adolescents

Your 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 a day depending on the child's weight.
• This treatment can be administered for a maximum of 5 days.

To prevent nausea and vomiting after surgery

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 8-hour interval.

Use in children (over 1 month) and adolescents

It is recommended to administer ondansetron by injection. Other pharmaceutical forms of this medication are more suitable for children; consult your doctor or pharmacist.

Older patients

The experience of using ondansetron to prevent nausea and vomiting after surgery is limited in older patients. However, ondansetron is well tolerated in patients over 65 years of age who receive chemotherapy. No dose adjustment is required.

Patients with moderate or severe liver problems

The total daily dose should not exceed 8 mg.

Ondansetron Viatris tablets should start to take effect within one to two hours of taking the dose.

Patients with kidney problems or slow metabolizers of sparteine/debrisoquine

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

If you vomit within an hour of taking a dose

• Take the same dose again.
• Do not take more Ondansetron Viatris than indicated in this leaflet.

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

Administration form

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

If you take moreOndansetron Viatristhan you should

If you or your child has taken more ondansetron than you should, talk to a doctor or go immediately to the nearest hospital or call the Toxicology Information Service, phone 91 562 04 20. Bring the packaging and remaining tablets with you.

The information on ondansetron overdose is limited. The symptoms that have been reported after an overdose of the medication are as follows: visual disturbances, severe constipation, low blood pressure, fainting, and heart rhythm disturbances. In children, fever, sweating, dilated pupils, and diarrhea have also been reported.

If you forgot to takeOndansetron Viatris

If you forgot to take a dose and feel nausea or vomiting:

• Take Ondansetron Viatris as soon as possible, then;
• Take the next dose at your usual time (as shown inthis leaflet);
• Do not take a double dose to compensate for the missed doses.

If you forgot to take a dose but do not feel nausea:

• Take the next dose as indicatedin this leaflet.

- Do not take a double dose to compensate for the missed doses.

Like all medicines, this medicine may cause side effects, although not everyone will experience 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 symptoms may include:

• Sudden wheezing and chest pain or pressure.
• Swelling in eyelids, face, lips, mouth, or tongue.
• Rashes on the skin - red patches or lumps under the skin (urticaria) anywhere on your body.
• Collapsing.

Uncommon(may affect up to 1 in 100 people)

• Uncontrolled eye movements (crisis oculógiras).

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

• Severe rash with blisters and peeling that affects a large area of the body, especially around the mouth, nose, eyes, and genitals, which appear to be severe burns.

Other possible side effects

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

• Headache.

Common(may affect up to 1 in 10 people)

• Sensation of flushing or heat (hot flushes).
• Constipation.

Uncommon(may affect up to 1 in 100 people)

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

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

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

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

• Bad vision or temporary loss of vision that usually returns in 20 minutes.

Frequency not known(cannot be estimated from available data)

• Myocardial ischemia: symptoms include sudden chest pain or pressure.

Side effects in children and adolescents

The side effects observed in children and adolescents were similar to those observed in adults, as previously indicated.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above30°C.

Do not use this medication after the expiration date that appears on the packaging or in the blister after CAD or EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Ondansetron Viatris

The active ingredient is ondansetron hydrochloride dihydrate.

Each tablet contains 8 mg of the active ingredient ondansetron (in the form of hydrochloride dihydrate).

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

The coating contains: hypromellose (E-464), titanium dioxide (E-171), macrogol (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 package

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

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

Only some package 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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area with the following names:

SpainOndansetron Viatris8 mg film-coated tablets EFG

GreeceOndanserton/Generics F.C. TAB 8 mg/TAB

IrelandEmizof 8 mg Film-Coated Tablets

NetherlandsOndansetron Mylan 8 mg, filmomhulde tabletten

United KingdomOndansetron 8 mg Film coated Tablets

Last review date of this leaflet:February 2022

More detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/