PATIENT INFORMATION LEAFLET

Ondansetrón Aristo 8 mg buccal tablets EFG

Read this leaflet carefully before you start to take 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 pass it on to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

1What Ondansetrón Aristo is and what it is used for

2What you need to know before you start taking Ondansetrón Aristo

3How to take Ondansetrón Aristo

4Possible side effects

5Storage of Ondansetrón Aristo

6Contents of the pack and additional information

This medication contains ondansetrón, which belongs to a group of medications called antiemetics that help improve the sensation of nausea and vomiting.

Ondansetrón is used to treat nausea (sensation of discomfort) and vomiting (discomfort) caused by some medical treatments for cancer, such as chemotherapy (in adults and children) or radiation therapy (adults).

It is also used to prevent nausea and vomiting in patients after surgery (adults).

Do not take Ondansetrón Aristo:

If you are allergic to Ondansetrón or to any of the other components of this medication (listed in section 6).

If you have or have had any allergic reaction (hypersensitivity) with other antiemetics (for example, granisetrón or dolasetrón).

Warnings and precautions:

Be especially careful with Ondansetrón Aristo:

- If you have an intestinal obstruction or severe constipation.

- If you are about to undergo a tonsillectomy.

- If you have a heart problem.

- If you have a liver problem.

IF YOU ARE ABOUT TO UNDERGO ANY DIAGNOSTIC TEST (INCLUDING BLOOD, URINE, SKIN TESTS THAT USE ALLERGENS, ETC.) INFORM YOUR DOCTOR THAT YOU ARE TAKING THIS MEDICATION, AS IT MAY ALTER THE RESULTS.

Consult your doctor if the above circumstances apply to you before starting treatment with Ondansetrón Aristo.

Use of Ondansetron Aristo with other medications:

Ondansetrón Aristo may have some effect on other medications and other medications may have some effect on ondansetrón.

Inform your doctor or pharmacist if you are using, or have recently used, any other medication, even those acquired without a prescription.

Particularly, it is essential to inform your doctor if you are taking any of the following medications, as it may be necessary to adjust your dose:

• rifampicina(antibiotic used to treat infections such as tuberculosis).
• tramadol(medication used to treat pain).
• fenitoínaorcarbamacepina(medications used to treat epilepsy).
• medications used to treatheart problemssuch as arrhythmias (antiarrhythmics) and/or to treathigh blood pressure(beta-blockers).
• haloperidolormetadona(medications that may affect theheart).
• antraciclinasandtrastuzumab(medications used to treatcancer).
• Buprenorfina, may interact with ondansetron and may experience symptoms such as involuntary 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.

Pregnancy and breastfeeding

Pregnancy:

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 already pregnant, think you may be pregnant, or are planning to become pregnant, inform your doctor before taking Ondansetrón Aristo. If you are a fertile woman, it is recommended that you use an effective contraceptive method.

Breastfeeding::

Do not breastfeed your child while on treatment with ondansetrón.

Consult your doctor or pharmacist before using any medication

Driving and operating machinery

It is unlikely that ondansetrón will affect your ability to drive or operate machinery

Important information about some of the components of Ondansetrón Aristo:

This medication contains sorbitol. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication may be harmful to individuals with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

This medication may cause severe allergic reactions and bronchospasm (sudden feeling of choking) because it contains sulfur dioxide.

Follow exactly the administration instructions of this medication indicated by your doctor. If in doubt, ask your doctor or pharmacist.

Remove the blister pack to open it as shown on the aluminum sheet. Do not push the tablet through the aluminum sheet.

Ondansetron buccal tablets should be taken orally. The tablet dissolves quickly in the mouth and can then be swallowed normally. Drink a glass of water afterwards.

Important: Do not extract Ondansetron buccal tablets from the blister or aluminum until you are ready to take it.

Treatment of discomfort (nausea and vomiting) in patients receiving chemotherapy or

radiation therapy:

Adults (including elderly)

The usual dose is 8 mg of Ondansetron 1-2 hours before chemotherapy or radiation therapy, followed by 8 mg of ondansetron 12 hours later. To protect against delayed or additional discomfort, treatment can be continued with a dose of 8 mg of Ondansetron twice a day for 5 days after treatment.

Treatment of discomfort (nausea and vomiting) in patients receiving chemotherapy:

Children (6 months or older) and adolescents (under 18 years):

Your doctor will decide what is the appropriate dose of Ondansetron. This will depend on the child's size and weight.

To prevent nausea and vomiting after a surgical procedure:

Adults:The usual dose is 16 mg before surgery or a tablet of 8 mg one hour before surgery. And then, another tablet of 8 mg eight hours after the first dose and another tablet of 8 mg eight hours after the second dose.

The effect of Ondansetron buccal tablets begins one to two hours after taking the corresponding dose.

If you vomit within one hour after taking the 8 mg dose: take another 8 mg tablet, but do not take more Ondansetron buccal tablets than indicated in this prospectus.

Patients with liver problems: The total daily dose should not exceed 8 mg.

If you take more OndansetronAristothan you should:

If youor your childtake moreondansetronthan you should, talk to a doctor or go immediately to the nearest hospital. Bring the medication with you.

If you have taken OndansetronAristomore than you should, consult your doctor or pharmacist immediately or the Toxicology Information Service, phone 915620420 indicating the medication and the amount ingested.

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

If you forgot to take Ondansetron Aristo:

If you forget a dose, take it when you remember, unless it is almost time for the next dose.Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Ondansetron Aristo

Do not stop treatment with ondansetron without consulting your doctor, even if you feel better. If

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

Like all medicines, Ondansetrón Aristo may have side effects, although not everyone will experience them.

If any of the following symptoms appear shortly after taking Ondansetrón Aristo, stop taking the medicine and inform your doctor immediately.

- Sudden onset of wheezing while breathing and chest pain or tightness.

- Swelling in the eyelids, face, lips, mouth, tongue, and throat.

- Difficulty breathing.

- Collapse.

- Skin rash.

- Convulsions.

-Chest pain.

- Transient loss of vision that usually returns within 20 minutes.

Ondansetrón side effects:

If you have any doubts about side effects, talk to your doctor. If you consider any of the side effects you are experiencing to be severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Very common side effects: in more than 1 in 10 patients treated

- Headache.

Common side effects:up to 1 in 10 patients treated:

- Feeling of heat or flushing.

- Constipation.

Uncommon side effects: up to 1 in 100 patients treated

- Involuntary body movements, including upward rolling eye movements.

- Convulsions.If this occurs, seek immediate medical attention.

- Palpitations (irregular or rapid heartbeat) or slow heartbeat.

- Chest pain.If this occurs, seek immediate medical attention.

- Low blood pressure.

- Hiccups.

- Increased liver test results (more often in patients treated with cisplatin chemotherapy)

Rare side effects: up to 1 in 1,000 patients treated

- Immediate allergic reaction, which can be severe and include symptoms such as general swelling, chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue, and throat, difficulty breathing, collapse, skin rash.If this occurs, seek immediate medical attention.

- Vision problems, for example, blurred vision (although it has always been associated with injectable ondansetron more than with tablets).

Very rare side effects: less than 1 in 10,000 patients treated

- Transient loss of vision that usually returns within 20 minutes.If this occurs, seek immediate medical attention.Transient vision loss, almost always associated with injectable ondansetron more than with tablets, and usually with cisplatin-containing chemotherapy.

- Alterations in heart rhythm that can be detected on an ECG (records the heart's electrical activity). Symptoms may include feeling dizzy or loss of consciousness.

Frequency not known: cannot be estimated from available data

- Myocardial ischemia. Signs include sudden chest pain or tightness.

If you consider any of the side effects you are experiencing to be severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

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

Store in the original packaging

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

Medications should not be disposed of through drains or in the trash.Deposit empty containers and unused medications at the Sigre Point of your pharmacyAsk your pharmacist how to dispose of empty containers and unused medications. By doing so, you will help protect the environment.

Composition of Ondansetrón Aristo

The active ingredient is Ondansetrón. Each tablet contains 8mg of ondansetrón.

The other components are:PharmaburstTMC1 (compound of mannitol, sorbitol, crospovidone and colloidal silicon dioxide), Microcrystalline cellulose, Crospovidone type B, Aspartame, Strawberry flavor (compound of identical natural flavoring substances, natural flavoring substances, natural flavoring preparations, cornstarch dextrose, maltodextrin, Arabic gum E414, Sulfurous anhydride E220, Aroma), Stearate of fumaric acid and sodium, Magnesium stearate.

Appearance of the product and content of the container

OndansetrónAristoare buccal dispersible tablets of white color, flat, round and beveled.

OndansetrónAristo8mg is presented in aluminum/aluminum blister. It is presented in containers containing 10 and 500 buccal dispersible tablets.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid – Spain

Responsible for manufacturing:

Sofarimex Industria Química e Farmaceutica Lda

Av. Indústrias, Alto do Colaride, Agualva-2735-213, Cacém

Portugal

or

MPF B.V.

Applehof 13, 8465 RX, Heerenveen (Ouderhaske)

Holland

or

Laboratorios de Medicamentos Internacionales, S.A. (Medinsa)

c/ Solana, 26

28850 – Torrejón de Ardoz, Madrid

Spain

Last review date of this leaflet: February 2022

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