Yatrox 8 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Patient Information Leaflet

Yatrox 8 mg film-coated tablets

ondansetron

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.

If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Yatrox is and what it is used for

Yatrox is a medicine that contains the active substance sodium fusidate. It belongs to a group of medicines called antibiotics. Yatrox is used to treat infections caused by certain bacteria. It is mainly used for skin infections (such as infected wounds or cuts, boils), bone infections (osteomyelitis), joint infections (arthritis), and infections that occur in people with reduced immune defenses (such as those with HIV infection). Yatrox can also be used in combination with other antibiotics to treat serious infections such as endocarditis (infection of the inner lining of the heart).

Yatrox belongs to a group of medicines known as antiemetics. Yatrox is used for:

• preventing nausea and vomiting caused by:
  • chemotherapy in cancer treatment in adults and children over 6 months of age.
  • radiotherapy in cancer treatment in adults.
• preventing postoperative nausea and vomiting in adults.

2. What you need to know before starting to take Yatrox

Do not take Yatrox:

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

If you think 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 have a bowel obstruction or suffer from severe constipation. Yatrox may worsen the obstruction or constipation.
• if you have ever had heart problems, including irregular heartbeat (arrhythmia).
• if you are undergoing a tonsillectomy.
• if you have liver problems.

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

Use of Yatrox with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to 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 interrupt treatment or adjust the dose of one or more 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 heartbeats (antiarrhythmics) and/or high blood pressure (beta-blockers).
• haloperidol or methadone (medicines that may 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 must 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 cleft palate (openings or splits in the upper lip or in the palate). If you are already pregnant, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using Yatrox. If you are a woman of childbearing age, you are advised to use an effective method of contraception.

Driving and operating machinery

It is unlikely that Yatrox will affect the ability to drive or operate machinery.

Yatrox contains lactose

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

3. How to take Yatrox

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine. Swallow the tablets whole, with some water. Your doctor will tell you how long your treatment with Yatrox should last. Do not stop treatment prematurely.

Nausea and vomiting caused by chemotherapy or radiotherapy

Adults

One tablet (8 mg) taken orally, 1–2 hours before medical treatment that may cause nausea and vomiting, followed by 1 tablet (8 mg) 12 hours later.

To prevent nausea and vomiting on subsequent days, continue taking 1 tablet (8 mg) every 12 hours for five days.

Nausea and vomiting caused by chemotherapy

Children over 6 months of age and adolescents

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

Usually, twelve hours after chemotherapy, your child will receive oral ondansetron. The usual dose is 4 mg twice daily and may continue for up to 5 days.

Postoperative nausea and vomiting

Adults

To prevent nausea and vomiting after surgery, 2 tablets (16 mg) orally, 1 hour before anesthesia.

Children

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

Dosage adjustments

Patients with hepatic impairment

In patients with hepatic problems, the dose should be adjusted to a maximum of 8 mg daily of ondansetron.

Elderly patients, patients with renal impairment, or slow metabolizers of sparteine/debrisoquine

It is not necessary to modify the daily dose, dosing frequency, or route of administration.

Duration of treatment

Your doctor will determine the duration of your treatment with Yatrox. Do not stop the treatment prematurely.

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

If you take more Yatrox than you should

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

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

If you forget to take Yatrox

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

If you forget to take a dose and experience discomfort 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 experience discomfort, wait until your next scheduled dose and continue taking the medicine as directed.

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

4. Possible adverse effects

Like all medicines, Yatrox may cause adverse effects, although not everyone will experience them.

Very common adverse effects

May affect more than 1 in 10 people taking Yatrox:

• headache

Frequent adverse effects

May affect up to 1 in 10 patients taking Yatrox:

• sensation of heat or flushing
• constipation

Uncommon adverse effects

These may affect up to 1 in 100 patients taking Yatrox:

• upward rolling eye movements, abnormal muscle rigidity, body movements, tremor
• seizures
• slow or irregular heartbeat
• lower than normal blood pressure (hypotension)
• hiccups
• increased levels in blood test results used to monitor liver function.

Rare adverse effects

These may affect fewer than 1 in 1,000 patients taking Yatrox:

• sudden onset of whistling sounds and chest pain or tightness
• swelling of the eyelids, face, lips, mouth, or tongue
• skin rash or hives anywhere on the body
• changes in heart rhythm (sometimes may 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 adverse effects

May affect fewer than 1 in 10,000 patients taking Yatrox:

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

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

Adverse effects with unknown frequency: frequency cannot be estimated

• Myocardial ischemia

Signs include:

• sudden chest pain or
• chest tightness

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

Reporting of adverse effects

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Yatrox

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

Do not use this medicine after the expiry date stated on the blister and outer packaging following EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to a SIGRE point at your pharmacy. If you are unsure how to dispose of unused medicines or their packaging, please consult your pharmacist. This will help protect the environment.

6. Contents of the pack and other information

Composition of Yatrox

The active substance is ondansetron hydrochloride dihydrate. Each Yatrox film-coated tablet contains 8 mg of ondansetron (as hydrochloride dihydrate).

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

Appearance of the product and contents of the pack

Yatrox 8 mg are white, oblong, biconvex film-coated tablets with the inscription “8” on one side.

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

Only certain 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 the most recent revision of this leaflet: February 2022

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