Yatrox 8 mg comprimidos recubiertos con pelicula
Introduction
Package Insert: Information for the Patient
Yatrox 8 mg Film-Coated Tablets
Ondansetron
Read this package insert carefully before you start taking this medicine because it contains important information for you.
- Keep this package insert, 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, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.
1. What is Yatrox and what is it used for
Yatrox belongs to a group of medications called antiemetics. Yatrox is used for:
- preventing nausea and vomiting caused by:
- chemotherapy in the treatment of cancer in adults and children over 6 months of age.
- radiation therapy in the treatment of cancer 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 any of the components of Yatrox (including those listed in section 6).
- If you have or have had anyallergic reaction(hypersensitivity) with other anti-nausea or anti-vomiting medications (for example, granisetron or dolasetron).
- If you are taking apomorphine (a medication used to treat Parkinson's disease).
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 have ablockage in the intestineor if you suffer fromsevere constipation. Yatrox may increase the blockage or constipation.
- if you have ever hadheart problems, including irregular heart rhythm (arrhythmia).
- if you are undergoing an operation to remove your tonsils.
- if you haveliver problems.
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:
- rifampicin(an antibiotic used to treat infections such astuberculosis).
- tramadol(a medication used to treatpain).
- phenytoinorcarbamazepine(medications used to treatepilepsy).
- medications used to treatheart problemssuch as arrhythmias (antiarrhythmics) and/or to treathigh blood pressure(beta-blockers).
- haloperidolormethadone(medications that can affect theheart).
- anthracyclinesandtrastuzumab(medications used to treatcancer).
- fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram(Selective serotonin reuptake inhibitors, used to treatdepressionand/oranxiety)
- venlafaxine, duloxetine(Inhibitors of serotonin and noradrenaline reuptake, used to treatdepressionand/oranxiety).
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 a cleft lip and/or palate (openings or fissures 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.
3. How to Take Yatrox
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
One tablet (8 mg) orally, 1-2 hours before the potentially nausea-causing medical treatment, and then one tablet (8 mg) 12 hours later.
To prevent nausea and vomiting on subsequent days, continue taking one tablet (8 mg) every 12 hours for five days.
Nausea and vomiting caused by chemotherapy
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, two 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 action 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.
4. Possible Adverse Effects
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:
- headache
Common side effects
They may affectup to 1 in 10 patientswho take Yatrox:
- sensation of heat or flushing
- constipation
Rare side effects
They may affectup to 1 in 100 patientswho take Yatrox:
- rotating eye movements, abnormal muscle stiffness, body movements, tremor
- seizures
- slow or irregular heartbeats
- low blood pressure (hypotension)
- hypo
- increase in liver function test results
Very rare side effects
They may affectless than 1 in 1,000 patientswho take Yatrox:
- sudden onset of wheezing and chest pain or tightness
- swelling of eyelids, face, lips, mouth, or tongue
- skin rash or urticaria anywhere on the body
- alteration in heart rhythm (in some cases, it may cause sudden loss of consciousness)
- blurred vision.
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:
- transient blindness, which usually resolves in 20 minutes
- electrocardiogram alterations
- widespread skin rash with blisters and peeling, affecting a large part of the body (toxic epidermal necrolysis).
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.
5. Conservation of Yatrox
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.
6. Contents of the packaging and additional information
Composition of Yatrox
The active principle is ondansetron hydrochloride dihydrate. Each coated tablet of Yatrox contains 8 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 contents of the packaging
Yatrox 8 mg are white, film-coated, oblong, and biconvex tablets with the inscription “8” on one face.
Yatrox is available in packaging of 6, 15, or 500 tablets.
Only some packaging sizes may be marketed.
Holder of the marketing authorization and manufacturer responsible
Holder
Dari Pharma, S.L.U.
Gran Via Carles III, 98, 10th floor
08028 Barcelona
Spain
Manufacturer responsible
Neuraxpharm Pharmaceuticals, S.L.
Avda.Barcelona, 69
08970 Sant Joan Despí – Barcelona
Spain
Last review date of this leaflet:February 2022
The detailed information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS):http://www.aemps.gob.es/
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