Ondansetron Aristo 8 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ondansetron Aristo 8 mg film-coated tablets EFG

Read all of this 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 other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Ondansetron Aristo is and what it is used for

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

Ondansetron Aristo is used to treat nausea and vomiting caused by cytotoxic agents (medicines used to treat cancer) and radiotherapy. It is also used to prevent nausea and vomiting after surgery.

2. What you need to know before taking Ondansetrón Aristo

Do not take Ondansetrón Aristo

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

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Ondansetrón Aristo if:

• you are allergic (hypersensitive) to medicines (5-HT3 receptor antagonists) similar to ondansetron,
• you have heart problems, including irregular heartbeat (arrhythmia),
• you are taking certain medicines for depression and/or anxiety (selective serotonin reuptake inhibitors [SSRIs] such as fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, and escitalopram or serotonin-noradrenaline reuptake inhibitors [SNRIs] such as venlafaxine or duloxetine), or if you are taking buprenorphine, a medicine used to treat pain. Using these medicines together with Ondansetrón Aristo may cause serotonin syndrome, a potentially life-threatening condition. You may experience symptoms such as involuntary rhythmic muscle contractions, including muscles controlling eye movements, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tone, body temperature above 38°C. Contact your doctor if you experience these symptoms,
• you have gastrointestinal disorders,
• you have liver problems, in which case your doctor may reduce your dose of ondansetron,
• you have problems with your blood salt levels (electrolyte disorders), for example potassium and magnesium.
• you are scheduled for tonsillectomy

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

Other medicines and Ondansetrón Aristo

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

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 certain medicines. These include:

• apomorphine (a medicine used to treat Parkinson’s disease), as a marked drop in blood pressure and loss of consciousness have been reported when ondansetron is given with apomorphine,
• carbamazepine, phenytoin (medicines used to treat epilepsy),
• rifampicin, an antibiotic used 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 ECG, with a risk of potentially life-threatening heart rhythm disorders),
• tramadol or buprenorphine, medicines used to treat pain (see section “Warnings and precautions”),
• serotonin reuptake inhibitors (SSRIs) used to treat depression and/or anxiety, such as fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, or escitalopram; serotonin-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 cleft palate (openings or splits in the upper lip or the roof of the mouth). If you are already pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using Ondansetrón Aristo. If you are a woman of childbearing age, you are advised to use an effective method of contraception.

You must not breastfeed while taking Ondansetrón Aristo.

Driving and using machines

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

Ondansetrón Aristo contains lactose

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

3. How to take Ondansetrón Aristo

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

The recommended dose is:

To protect you from nausea and vomiting during and after cancer treatment with cytostatic agents (chemotherapy) or radiotherapy:

Adults

On the day of chemotherapy or radiotherapy:

The recommended dose of Ondansetrón Aristo is 8 mg of ondansetron one or two hours before treatment, followed by another 8 mg of ondansetron twelve hours later.

On the following days:

On the following days, you will receive ondansetron in the form of film-coated tablets, orodispersible tablets (which dissolve in the mouth), or as a solution. Always use this medicine exactly as described in this leaflet or as directed by your doctor or nurse.

The recommended dose is 8 mg of ondansetron twice daily every 12 hours for 5 days.

Use in children (6 months of age and older) and adolescents

On the day of chemotherapy:

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

On the following days, ondansetron is administered as film-coated tablets, orodispersible tablets, or as a solution:

Your doctor will decide the appropriate ondansetron dose for your child, which will depend on the child's size (body surface area) and weight. The maximum dose is 8 mg of ondansetron twice daily every 12 hours for 5 days.

Ondansetrón Aristo 8 mg film-coated tablets should not be used in children. For this patient group, more suitable dosage forms with a lower level of active substance are available.

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

Elderly patients

No dose adjustment or change in dosing frequency is required.

Prevention of discomfort (nausea and vomiting) after surgery:

Adults

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

Use in children and adolescents

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

Elderly patients

Experience with ondansetron in the prevention of nausea and vomiting after surgery in elderly patients is limited.

Patients with hepatic impairment

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

Method of administration

Film-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, speak to your doctor or go immediately to the nearest hospital or call the Toxicology Information Service at 91 562 04 20 (indicating the medicine and the amount ingested). Take the medicine with you.

If you forget to take Ondansetrón Aristo

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

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

If you stop taking Ondansetrón Aristo

Take Ondansetrón Aristo for as long as your doctor recommends. Do not stop treatment unless instructed by your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Severe allergic reactions

If you experience any of the following adverse effects, stop taking the tablets and inform your doctor immediately:

• rash or itching (urticaria)
• swelling, sometimes of the face or mouth (angioedema), which may cause difficulty breathing
• collapse

Severe skin reactions

If you experience any of the following adverse effects, stop taking the tablets and inform your doctor immediately:

• widespread skin rash with blisters and peeling affecting a large part of the body surface (toxic epidermal necrolysis)

Myocardial ischemia

If you experience any of the following adverse effects, stop taking the tablets and inform your doctor immediately:

• sudden chest pain or
• chest tightness

Other adverse effects:

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

• headache

Common: may affect up to 1 in 10 treated patients

• sensation of flushing, hot flushes with reddening of the skin
• constipation

Uncommon: may affect up to 1 in 100 treated patients

• seizures
• movement disorders or spasms (including extrapyramidal reactions, such as disturbances in muscle tone, eye muscle disorders [oculogyric crisis], and motor disorders), although these have been shown not to have long-term clinical consequences
• chest pain (with or without ST-segment depression on ECG)
• irregular or slow heartbeats (cardiac rhythm disorders, bradycardia)
• low blood pressure (hypotension)
• hiccups
• increase in substances (enzymes) produced by the liver (elevated liver function tests)

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

• allergic reactions
• cardiac rhythm disorders (prolongation of the QT interval, including torsade de pointes, which may cause sudden loss of consciousness)
• temporary visual disturbances (e.g., blurred vision), mainly with i.v. administration, particularly with rapid intravenous administration
• dizziness, mainly with rapid i.v. administration

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

• transient blindness, mainly with i.v. administration

Not known: frequency cannot be estimated from available data

• myocardial ischemia

Adverse effects in children and adolescents

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ondansetron Aristo

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

This medicine does not require special storage conditions.

Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of OndansetrónAristo

The active substance 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 corn starch
Magnesium stearate (Ph. Eur.)

Film coating of the tablet:

Hypromellose
Triacetin
Titanium dioxide (E 171)
Yellow iron oxide

Appearance of the product and contents of the pack

Film-coated tablets.

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and 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 medicinal product is authorized in the European Economic Area member states under the following names:

Date of the most recent review of this leaflet: June 2022

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