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Package Insert: Information for the Patient

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

1. What is Ondansetron Aristo and how is it used

2. What you need to know before starting to take Ondansetron Aristo

3. How to take Ondansetron Aristo

4. Possible adverse effects

5. Storage of Ondansetron Aristo

6. Contents of the package and additional information

Ondansetrón Aristo belongs to a group of medicines called serotonin receptor antagonists (5-HT3). These have the ability to block the action of a chemical known as serotonin, which can cause nausea and vomiting.

Ondansetrón Aristo is used to treat nausea and vomiting caused by cytostatics (cancer treatment medicines) and radiotherapy. It is also used to prevent nausea and vomiting after surgery.

Do not take OndansetrónAristo

• if you are allergic to ondansetrón or any of the other ingredients of this medicine (listed in section 6 “Contents of the pack and additional information”).
• if you are taking apomorfina (a medicine used to treat Parkinson's disease).

Do not administerOndansetrón Aristo 8 mg film-coated tablets to children.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ondansetrón Aristo ifyou

• are allergic (hypersensitive) to similar medicines (5-HT3 receptor antagonists) to ondansetrón,
• have heart problems, including irregular heart rhythm (arrhythmia),
• are taking certain medicines to treat depression and/or anxiety (selective serotonin reuptake inhibitors [SSRIs] such as fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, and escitalopram or serotonin and noradrenaline reuptake inhibitors [SNRIs] such as venlafaxine or duloxetine) or if you are taking buprenorphine, a medicine used to treat pain. The use of these medicines with Ondansetrón Aristo may cause serotonin syndrome, a potentially fatal disease. You may experience symptoms such as involuntary rhythmic muscle contractions, including those that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, body temperature above 38 °C. Contact your doctor if you experience these symptoms,
• have digestive problems,
• have liver problems, in which case your doctor may reduce your dose of ondansetrón,
• have problems with blood electrolyte levels, for example potassium and magnesium.
• are to undergo tonsillectomy.

If any of the above points apply to you, do not take Ondansetrón Aristo until you have consulted with your doctor.

Other medicines and Ondansetrón Aristo

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

Some medicines may alter the effects and/or side effects of Ondansetrón Aristo, or Ondansetrón Aristo may alter the effects and/or side effects of some medicines. These include:

• apomorfina (a medicine used to treat Parkinson's disease), as a pronounced decrease in blood pressure and loss of consciousness have been reported with the administration of ondansetrón with apomorfina
• carbamazepine, phenytoin (medicines used to treat epilepsy)
• rifampicin, an antibiotic for tuberculosis
• medicines that affect the heart, such as certain cancer medicines (anthracyclines and trastuzumab) or medicines that prolong the QT interval (a delay in the transmission of impulses in the heart muscle, visible on an ECG, with the risk of potentially fatal heart rhythm disorders)
• tramadol or buprenorphine, medicines used to treat pain (see section “Warnings and precautions”)
• selective serotonin reuptake inhibitors (SSRIs) used to treat depression and/or anxiety, such as fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, or escitalopram; serotonin and noradrenaline reuptake inhibitors (SNRIs) used to treat depression and/or anxiety, such as venlafaxine or duloxetine (see section “Warnings and precautions”).

Pregnancy, breastfeeding, and fertility

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

Do not breastfeed your child while taking Ondansetrón Aristo.

Driving and operating machinery

It is unlikely that Ondansetrón Aristo will affect your ability to drive and use machines.

Ondansetrón Aristo contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

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

The recommended dose is:

For protection against nausea and vomiting during and after cancer treatment with cytostatic agents (chemotherapy) or radiation therapy:

Adults

On the day of chemotherapy or radiation therapy:

The recommended dose of Ondansetrón Aristo is 8 mg of ondansetrón one or two hours before treatment, and then 8 mg of ondansetrón twelve hours later.

On the following days:

You will receive ondansetrón in the form of coated tablets, buccal dispersible tablets (which dissolve in the mouth) or as a solution. Always use this medication exactly as described in this leaflet or as your doctor or nurse has instructed you.

The recommended dose is 8 mg of ondansetrón twice a day every 12 hours for 5 days.

Use in children (6 months or older) and adolescents:

On the day of chemotherapy:

For children and adolescents, ondansetrón is available as an injectable solution, for correct intravenous dosing, a slow injection into a vein for at least 30 seconds before treatment.

On the following days, ondansetrón is administered as coated tablets, buccal dispersible tablets or as a solution:

Your doctor will decide what dose of ondansetrón is suitable for your child, this will depend on the child's size (body surface area) and weight. The maximum dose is 8 mg of ondansetrón twice a day every 12 hours for 5 days.

Ondansetrón Aristo 8 mg coated tablets should not be used in children. For this group of patients, there are available forms of dosing that are more suitable with a lower level of active substance.

For the treatment of nausea and vomiting caused by radiation therapy, there are no available data from controlled clinical studies on the use of ondansetrón in children.

Older adults:

No dose adjustment or change in dosing frequency is required.

Prevention of discomfort (nausea and vomiting) after surgery:

Adults

Unless your doctor indicates otherwise, the recommended dose is 16 mg of Ondansetrón Aristo one hour before anesthesia.

Use in children and adolescents:

Your doctor may decide to administer an injection instead of tablets.

Older adults:

The experience with ondansetrón in the prevention of nausea and vomiting after surgery in older adults is limited.

Patients with liver insufficiency:

In patients with moderate to severe liver insufficiency, the total daily dose should not exceed 8 mg.

Administration form:

Coated tablets for oral use.

If you take more Ondansetrón Aristo than you should:

If you or your child takes more Ondansetrón Aristo than you should, talk to your doctor or go immediately to the nearest hospital or call the Toxicology Information Service, phone 91 562 04 20 (indicating the medication and the amount ingested). Bring the medication with you.

If you forget to take Ondansetrón Aristo:

Do not take a double dose to make up for the missed dose. If you forget a dose and experience nausea or vomiting, take another dose as soon as possible. Then, continue taking the medication as instructed.

If you are unsure what to do, consult your doctor or pharmacist.

If you interrupt treatment with Ondansetrón Aristo:

Take Ondansetrón Aristo for the time your doctor recommends. Do not interrupt treatment unless your doctor tells you to.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Severe allergic reactions

If any of the following side effects appear, stop taking the tablets and inform your doctor immediately:

• hives or itching (urticaria)
• swelling, sometimes on the face or mouth (angioedema), which may cause breathing difficulties
• collapse

Severe skin reactions

If any of the following side effects appear, stop taking the tablets and inform your doctor immediately:

• widespread skin rash with blisters and peeling that affects a large area of the body (toxic epidermal necrolysis)

Myocardial ischemia

If any of the following side effects appear, stop taking the tablets and inform your doctor immediately:

• sudden chest pain or
• chest tightness

Other side effects:

Very common:may affect more than 1 in 10 patients treated

Common:may affect up to 1 in 10 patients treated

Uncommon:may affect up to 1 in 100 patients treated

Rare:may affect up to 1 in 1,000 patients treated

Very rare:may affect up to 1 in 10,000 patients treated

Unknown:the frequency cannot be estimated from the available data

Side effects in children and adolescents

The side effect profile in children and adolescents was comparable to the side effect profile observed in adults.

Reporting of 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 the Pharmacovigilance of Medicines for Human Use: 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.

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging and blister after “CAD”. The expiration date is the last day of the month indicated.

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. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of OndansetrónAristo

The active ingredient is ondansetron hydrochloride dihydrate.

Each film-coated tablet contains 8 mg of ondansetron (as ondansetron hydrochloride dihydrate).

The other components are:

Tablet core:

Lactose

Microcrystalline cellulose

Pregelatinized maize starch

Magnesium stearate (Ph. Eur.)

Film coating of the tablet:

Hypromellose

Triacetin

Titanium dioxide (E 171)

Yellow iron oxide

Appearance of the product and content of the container

Film-coated tablets.

Yellow, oval, coated, and printed with an “E” on one side and with “02” on the other.

Ondansetrón Aristo 8 mg film-coated tablets are available in containers of 4, 5, 6, 10, 15, 30, 49, 50, and 100 tablets.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible manufacturer

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Local representative

Aristo Pharma Iberia, S.L.

C/Solana, 26

28850 Torrejón de Ardoz, Madrid

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: June 2022

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