YATROX 4 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Yatrox 4 mg Film-Coated Tablets

ondansetron

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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Yatrox and what is it used for

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

• prevent nausea and vomiting caused by:
• • cancer chemotherapy in adults and children over 6 months of age.
  • radiotherapy in the treatment of cancer in adults.
• prevent post-operative nausea and vomiting in adults.

2. What you need to know before you take Yatrox

Do not take Yatrox:

• If you are allergic (hypersensitive) to ondansetron or any of the other ingredients of Yatrox (listed in section 6).
• If you have ever had an allergic reaction (hypersensitivity) to other medicines for nausea or vomiting (e.g. granisetron or dolasetron).
• If you are taking apomorphine (a medicine used to treat Parkinson's disease).

If you think any of these apply to you, talk to your doctor before taking Yatrox.

Warnings and precautions

Talk to your doctor or pharmacist before taking Yatrox.

• if you have a blockage in your intestine or if you suffer from severe constipation. Yatrox may increase the blockage or constipation.
• if you have ever had heart problems, including an irregular heartbeat (arrhythmia).
• if you are having a tonsillectomy.
• if you have liver problems.

If you are going to have any diagnostic tests (including blood tests, urine tests, skin tests using allergens, etc.), tell your doctor that you are taking this medicine, as it may affect the results.

Using Yatrox with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

In particular, it is important to tell your doctor if you are taking any of the following medicines, as it may be necessary to stop treatment or adjust the dose of one of them:

• rifampicin (an antibiotic used to treat infections such as tuberculosis).
• tramadol (a medicine used to treat pain).
• phenytoin or carbamazepine (medicines used to treat epilepsy).
• medicines used to treat heart problems such as irregular heartbeat (antiarrhythmics) and/or to treat high blood pressure (beta-blockers).
• haloperidol or methadone (medicines that can affect the heart).
• anthracyclines and trastuzumab (medicines used to treat cancer).
• fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram (Selective Serotonin Reuptake Inhibitors, used to treat depression and/or anxiety)
• venlafaxine, duloxetine (Serotonin and Noradrenaline Reuptake Inhibitors, used to treat depression and/or anxiety).

Tell your doctor or pharmacist if you are taking any of these medicines.

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 a cleft lip and/or cleft palate. If you are already pregnant, think you might be pregnant or are planning to become pregnant, talk to your doctor or pharmacist before taking Yatrox. If you are a woman of childbearing age, you are advised to use an effective method of contraception.

Driving and using machines

It is unlikely that Yatrox will affect your ability to drive or use machines.

Yatrox contains lactose

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

3. How to take Yatrox

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Remember to take your medicine. Swallow the tablets whole with a little water. Your doctor will tell you how long to take Yatrox for. Do not stop treatment early.

Nausea and vomiting caused by chemotherapy or radiotherapy

Adults

Two tablets (8 mg) by mouth, 1-2 hours before the medical treatment that is likely to cause nausea and vomiting, 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 5 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 be given ondansetron by mouth. The usual dose is 4 mg twice a day and may continue for up to 5 days.

Post-operative nausea and vomiting

Adults

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

Children

No data are available on the oral administration of ondansetron in the prevention of post-operative nausea and vomiting in children.

Dose adjustments

Patient with liver impairment

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

Patients with advanced age, patients with kidney impairment or slow metabolizers of sparteine/debrisoquine

No dose adjustment is necessary.

Duration of treatment

Your doctor will decide the duration of your treatment with Yatrox. Do not stop treatment early.

If you think the effect of this medicine is too strong or too weak, talk to 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 can 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, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Yatrox

Do not take a double dose to make up for forgotten doses. Do not increase or decrease the dose without consulting your doctor.

If you forget to take a dose and have nausea or vomiting, take another dose as soon as possible. Then, continue taking the medicine as directed.

If you forget to take a dose and do not have nausea or vomiting, wait for the next dose and continue taking the medicine as directed.

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

4. Possible side effects

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

Very common side effects

May affect more than 1 in 10 people taking Yatrox:

• headache

Common side effects

May affect up to 1 in 10 people taking Yatrox:

• feeling of warmth or flushing
• constipation

Uncommon side effects

May affect up to 1 in 100 people taking Yatrox:

• rotating upward movements of the eyes, abnormal muscle stiffness, body movements, tremor
• seizures
• slow or irregular heartbeat
• low blood pressure
• hypoglycemia
• increased levels in blood test results for liver function.

Rare side effects

May affect less than 1 in 1,000 people taking Yatrox:

• sudden onset of wheezing or chest pain or tightness
• swelling of the eyelids, face, lips, mouth or tongue
• skin rash or hives anywhere on the body
• abnormal heart rhythm (which can sometimes cause sudden loss of consciousness)
• blurred vision.

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

Very rare side effects

May affect less than 1 in 10,000 people taking Yatrox:

• transient blindness, which usually resolves within 20 minutes
• changes in the electrocardiogram
• widespread skin rash with blisters and peeling, affecting a large area of the body (toxic epidermal necrolysis).

Inform your doctor immediately if you experience any of these symptoms.

Side effects of unknown frequency: cannot be estimated from the available data

• Myocardial ischemia

The signs include:

• sudden chest pain or
• chest tightness

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Yatrox

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

Do not use this medicine after the expiry date which is stated on the blister and on the carton after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

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 to protect the environment.

6. Contents of the pack and further information

What Yatrox contains

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

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

Appearance and packaging

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

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Dari Pharma, S.L.U.

Gran Via Carles III, 98, 10th floor

08028 Barcelona

Spain

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí – Barcelona

Spain

Date of last revision of this leaflet:February 2022

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