ONDANSETRON ARISTO 8 mg FILM-COATED TABLETS

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

Do not take Ondansetron Aristo

• if you are allergic to ondansetron or any of the other ingredients of this medicine (listed in section 6).
• if you are taking apomorphine (a medicine used to treat Parkinson's disease).

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ondansetron 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 treating 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 Ondansetron Aristo may cause serotonin syndrome, a potentially life-threatening disease. You may experience symptoms such as involuntary rhythmic contractions of muscles, including the muscles that control eye movements, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, body temperature above 38 °C. Contact your doctor if you suffer from these symptoms,
• you have digestive disorders,
• you have liver problems, in which case your doctor may reduce your dose of ondansetron,
• you have problems with salt levels in the blood (electrolyte disorders), such as potassium and magnesium.
• you are going to have your tonsils removed

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

Other medicines and Ondansetron Aristo

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

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

• apomorphine (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 ondansetron with apomorphine
• 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 the 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

Ondansetron Aristo should not be used during the first trimester of pregnancy. This is because Ondansetron Aristo may slightly increase the risk of a baby being born with a cleft lip and/or cleft palate (openings or fissures in the upper lip or palate). If you are already pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using Ondansetron Aristo. If you are a woman of childbearing age, you are advised to use an effective method of contraception.

Do not breastfeed your child while taking Ondansetron Aristo.

Driving and using machines

Ondansetron Aristo is unlikely to affect your ability to drive or use machines.

Ondansetron Aristo contains lactose

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

3. How to take Ondansetron Aristo

Follow exactly the instructions for administration of this medicine given by your doctor. In case of 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 Ondansetron Aristo is 8 mg of ondansetron one or two hours before treatment, and then 8 mg of ondansetron twelve hours later.

In the following days:

In 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 your doctor or nurse has told you.

The recommended dose is 8 mg of ondansetron 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, ondansetron is available as an injectable solution for correct intravenous dosing as a slow injection into a vein for at least 30 seconds before treatment.

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

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

Ondansetron Aristo 8 mg film-coated tablets should not be used in children. For this group of patients, there are other dosage forms available with a lower level of active substance.

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 nausea and vomiting (post-operative nausea and vomiting):

Adults

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

Use in children and adolescents

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

Elderly patients

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

Patient with hepatic impairment

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

Method of administration

Oral use.

If you take more Ondansetron Aristo than you should

If you or your child take more Ondansetron Aristo than you should, talk to your doctor or go immediately to the nearest hospital or call the Toxicology Information Service, telephone 91 562 04 20 (indicating the medicine and the amount taken). Bring the medicine with you.

If you forget to take Ondansetron Aristo

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

If you are not sure what to do, consult your doctor or pharmacist.

If you stop taking Ondansetron Aristo

Take Ondansetron Aristo for as long as your doctor recommends. Do not stop treatment unless your doctor tells you to.

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

4. Possible side effects

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

Severe allergic reactions

If you get any of the following side effects, stop taking the tablets and tell your doctor immediately:

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

Severe skin reactions

If you get any of the following side effects, stop taking the tablets and tell your doctor immediately:

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

Myocardial ischemia

If you get any of the following side effects, stop taking the tablets and tell your doctor immediately:

• sudden chest pain or
• chest tightness

Other side effects:

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

• headache

Common:may affect up to 1 in 10 people treated

• feeling of flushing, hot flushes with skin reddening
• constipation

Uncommon:may affect up to 1 in 100 people treated

• seizures
• movement disorders or spasms (including extrapyramidal reactions, such as muscle tone disorders, eye muscle disorders [oculogyric crisis], and motor disorders), but it has been shown that these have no long-term clinical consequences
• chest pain (with or without ST segment depression on the ECG)
• irregular or slow heartbeats (heart rhythm disorders, bradycardia)
• low blood pressure (hypotension)
• hypokalemia
• increased liver enzymes (increased liver function tests)

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

• allergic reactions
• heart rhythm disorders (prolongation of the QT interval, including torsades de pointes, which can cause sudden loss of consciousness)
• temporary visual disturbances (e.g., blurred vision), mainly with intravenous administration, mainly with rapid intravenous administration
• drowsiness, mainly with rapid intravenous administration

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

• transient blindness, mainly with intravenous administration

Not known:frequency cannot be estimated from the available data

• myocardial ischemia

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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use: www.notificaRAM.es. By reporting side 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 any special storage conditions.

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

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 protect the environment.

6. Contents of the pack and other information

Composition of Ondansetron Aristo

The active substance is ondansetron hydrochloride dihydrate.

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

The other ingredients are:

Core of the tablet:

Lactose

Microcrystalline cellulose

Pregelatinized corn starch

Magnesium stearate (Ph. Eur.)

Tablet film coating:

Hypromellose

Triacetin

Titanium dioxide (E 171)

Yellow iron oxide

Appearance and packaging

Film-coated tablets.

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

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

Not all pack sizes may be marketed.

Marketing authorisation 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 medicine is authorised in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet: June 2022

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