Yatrox 4 mg comprimidos recubiertos con pelicula

Product Information for the Patient

Yatrox 4 mg Film-Coated Tablets

Ondansetron

Read this 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 or pharmacist.

• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Yatrox belongs to a group of medications called antiemetics. Yatrox is used for:

Do not take Yatrox:

If you consider this applies to you, consult your doctor before taking Yatrox

Warnings and precautions

Consult your doctor or pharmacist before starting to use Yatrox.

If you are to undergo any diagnostic tests (including blood, urine, skin tests that use allergens, etc.) inform your doctor that you are taking this medication, as it may alter the results.

Use of Yatrox with other medications

Inform your doctor or pharmacist if you are using or have used recently or may have to use any other medication.

Particularly, it is essential to inform the doctor if you are taking any of the following medications, as it may be necessary to interrupt treatment or adjust the dose of one of them:

Inform your doctor or pharmacistif you are taking any of these medications.

Pregnancy and breastfeeding

Yatrox should not be used during the first trimester of pregnancy. This is because Yatrox 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). If you are already pregnant, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using Yatrox. If you are a fertile woman, it is recommended that you use an effective contraceptive method.

Driving and operating machinery

It is unlikely that Yatrox will affect your ability to drive and operate machinery.

Yatrox contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication. Swallow the whole tablets with a little water. Your doctor will indicate the duration of your treatment with Yatrox. Do not discontinue treatment before.

Nausea and vomiting caused by chemotherapy or radiation therapy

Adults

Two tablets (8 mg) orally, 1-2 hours before the potentially nausea-causing medical treatment, and then 2 tablets (8 mg) 12 hours later.

To prevent nausea and vomiting on subsequent days, continue taking 2 tablets (8 mg) every 12 hours for five days.

Children over 6 months and adolescents

Your doctor will decide the dose based on your child's weight or body surface area.

Normally, 12 hours after chemotherapy, your child will receive ondansetron orally. The usual dose is 4 mg twice a day and may continue for up to 5 days.

Postoperative nausea and vomiting

Adults

To prevent nausea and vomiting after surgery, 4 tablets (16 mg) orally, 1 hour before anesthesia.

Children

No data are available on the oral administration of ondansetron for the prevention of postoperative nausea and vomiting in children.

Dose adjustments

Patients with liver insufficiency

In patients with liver problems, the dose should be adjusted to a maximum of 8 mg of ondansetron per day.

Older patients, patients with renal insufficiency or slow metabolizers ofsparteine/debrisoquine

No dose adjustment or frequency of dose or route of administration is necessary.

Treatment duration

Your doctor will decide the duration of your treatment with Yatrox. Do not discontinue treatment before.

If you estimate that the effect of this medication is too strong or too weak, inform your doctor or pharmacist.

If you take more Yatrox than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, Teléfono 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Yatrox

Do not take a double dose to compensate for the missed doses. Do not increase or decrease the dose without your doctor's authorization.

If you forget to take a dose and experience discomfort or vomiting, take another dose as soon as possible. Then, continue taking the medication as indicated.

If you forget to take a dose and do not experience discomfort, wait for the next dose and continue taking the medication as indicated.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medicines, Yatrox can cause side effects, although not everyone will experience them.

Very common side effects

They may affectmore than 1 in 10 patientswho take Yatrox:

Common side effects

They may affectup to 1 in 10 patientswho take Yatrox:

Rare side effects

They may affectup to 1 in 100 patientswho take Yatrox:

Very rare side effects

They may affectless than 1 in 1,000 patientswho take Yatrox:

If you experience any of these symptoms,stop taking the medicine immediately and inform your doctor.

Very rare side effects

They may affectless than 1 in 10,000 patientswho take Yatrox:

Inform your doctor immediatelyif you experience any of these symptoms.

Side effects of unknown frequency: cannot be estimated

• myocardial ischemia

The signs include:

• sudden chest pain or
• chest tightness

If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospectus.

Adverse event reporting

If you experience any type of adverse event, consult your doctor or pharmacist, even if it is a possible adverse event not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse events, 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 use this medication after the expiration date that appears on the blister pack and on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Yatrox

The active principle is ondansetron hydrochloride dihydrate. Each film-coated Yatrox tablet contains 4 mg of ondansetron (as hydrochloride dihydrate).

The other components are: lactose monohydrate, microcrystalline cellulose (E460), pregelatinized cornstarch, magnesium stearate (E470b), hypromellose (E464), titanium dioxide (E171), and polyethylene glycol 400 (E1521).

Appearance of the product and content of the packaging

Yatrox 4 mg are white, oblong, biconvex film-coated tablets with the inscription “4” on one face.

Yatrox is available in packaging of 6, 15, or 500 tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Dari Pharma, S.L.U.

Gran Via Carles III, 98, 10th floor

08028 Barcelona

Spain

Responsible manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda.Barcelona, 69

08970 Sant Joan Despí – Barcelona

Spain

Last review date of this leaflet:February 2022

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