Package Insert: Information for the User

Ondansetrón Normon 8 mg/4 ml Injectable SolutionEFG

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to 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 Ondansetrón Normon and how is it used

2. What you need to know before starting to use Ondansetrón Normon

3. How to use Ondansetrón Normon

4. Possible adverse effects

5. Storage of Ondansetrón Normon

6. Contents of the package and additional information

Ondansetrón belongs to a group of medicines called antiemetics. Ondansetrón is a 5HT3 receptor antagonist. It acts by inhibiting 5HT3 receptors on neurons located in the central and peripheral nervous systems.

Ondansetrón 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 and treating postoperative nausea and vomiting in adults and children over 1 month of age.

Do not use Ondansetrón Normon:

- If you are allergic (hypersensitive) 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).

- If you are taking apomorfina (medication used to treat Parkinson's disease).

If you consider this applies to you, do not use ondansetrón and consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to use ondansetrón:

• If you have a blockage in the intestine or if you suffer from severe constipation. Ondansetrón may increase the blockage or constipation.
• If you have ever had heart problems, including irregular heart rhythm (arrhythmia).
• If you are undergoing an operation for tonsils.
• If you have liver 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.

Other medications and Ondansetrón Normon

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 your doctor if you are taking any of the following medications, as it may be necessary to interrupt treatment or adjust the dose of any of them:

• Rifampicina (antibiotic used to treat infections such as tuberculosis).
• Tramadol (medication used to treat pain).
• Fenitoína or carbamacepina (medications used to treat epilepsy).
• Medications used to treat heart problems such as irregular heartbeats (antiarrhythmics) and/or to treat high blood pressure (beta-blockers).
• Haloperidol or metadona (medications that may affect the heart).
• Antraciclinas and trastuzumab (medications used to treat cancer).
• Fluoxetina, paroxetina, sertralina, fluvoxamina, citalopram, escitalopram (Selective serotonin reuptake inhibitors, used to treat depression and/or anxiety).
• Venlafaxina, duloxetina (Inhibitors of serotonin and noradrenaline reuptake, used to treat depression and/or anxiety).

Inform your doctor or pharmacist if you are taking any of these medications.

Inform your doctor or pharmacist immediately if you notice any of these symptoms during or after treatment

??if you notice sudden chest pain or oppression (myocardial ischemia)

Ondansetrón injectable solution should not be administered in the same syringe or infusion as other medications. Ondansetrón should only be mixed with those infusion solutionsrecommended.

Pregnancy and breastfeeding

Ondansetrón should not be used during the first trimester of pregnancy. This is because ondansetrón may slightly increase the risk of a baby being born with cleft lip and/or palate (openings or fissures in the upper lip or palate). If you are pregnant or breastfeeding, consult your doctor or pharmacist before using ondansetrón as this medication may cause damage to the fetus.

If you are a fertile woman, it is recommended that you use an effective contraceptive method.

If you are a fertile woman, your doctor or nurse should check if you are pregnant and perform a pregnancy test before starting treatment with ondansetrón.

Fertile women should use an effective contraceptive method during treatment with ondansetrón. Consult your doctor about the options for contraceptive methods.

If you become pregnant during treatment with ondansetrón, inform your doctor.

It is not recommended to breastfeed during treatment with ondansetrón. This medication may pass into breast milk and may affect your baby.

Driving and operating machines

It is unlikely thatondansetrónwill affect your ability to drive and use machines.

Ondansetrón Normon contains sodium

Thismedication contains14.4 mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 0.72% of the maximum daily sodium intake recommended for an adult.

Ondansetronmust be administered by a qualified professional and never by oneself.

Ondansetron is administered as an intravenous injection (into a vein) or intramuscular injection, or, after dilution, as an intravenous infusion (over a longer period of time).

Dose

Your doctor will decide on the correct treatment dose of ondansetron. The dose varies depending on your medical treatment (chemotherapy or surgery), liver function, and whether the administration is by injection or infusion.

Chemotherapy and radiation-induced nausea and vomiting.

Adults:

On the day you undergo chemotherapy or radiation therapy, you will be given the usual adult dose of 8 mg via intravenous or intramuscular injection immediately before your treatment, and another 8 mg 12 hours later.

On subsequent days:

- the usual adult intravenous or intramuscular dose will not exceed 8 mg.

- oral administration can begin 12 hours after chemotherapy or radiation therapy and can continue for up to 5 days. The usual dose is 8 mg twice a day.

If your chemotherapy or radiation therapy is likely to cause intense nausea and vomiting, you may be given a higher dose of ondansetron than usual. Your doctor will decide what to do. A single dose of more than 16 mg should not be administered due to the increased risk of dose-dependent prolongation of the QT interval.

Chemotherapy-induced nausea and vomiting

Children over 6 months and adolescents

Your doctor will decide on the dose based on your child's weight or body surface area. On the day of chemotherapy: the first dose is administered via intravenous injection immediately before your child's treatment.

Normally, 12 hours after chemotherapy, your child will receive ondansetron orally. The usual dose is 4 mg twice a day and can continue for up to 5 days.

Postoperative nausea and vomiting.

To prevent nausea and vomiting after surgery

Adults

The usual dose is 4 mg, administered via intravenous or intramuscular injection. This dose will be administered to you immediately before the procedure.

Children over 1 month of age and adolescents

Your doctor will decide on the dose. The maximum dose is 4 mg, administered via intravenous injection. This dose will be administered to you immediately before the procedure.

To treat nausea and vomiting after surgery

Adults

The usual adult dose is 4 mg, administered via intravenous or intramuscular injection.

Children over 1 month of age and adolescents

Your doctor will decide on the dose. A single dose of ondansetron can be administered via slow intravenous injection (not less than 30 seconds) with doses of 0.1 mg/kg up to a maximum of 4 mg before, during, or after anesthesia induction.

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 of sparteine/debrisoquine

No dose adjustment is necessary.

Treatment duration

Your doctor will decide on the duration of your ondansetron treatment. Do not stop treatment prematurely. If you think the effect of ondansetron is too strong or too weak, inform your doctor or pharmacist.

If you are given more Ondansetron Normon than you should

This medication will be administered to you in the hospital. Your doctor or nurse will administer ondansetron to you or your child, so it is unlikely that you or your child will receive too much. If you think you or your child have been given too much or not enough, inform your doctor or nurse. Symptoms of overdose may include vision problems, low blood pressure (which can 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 (Telephone: 91 5620420) indicating the medication and the amount administered.

If you have any doubts about the administration of this medication, consult the doctor administering it to you.

Like all medications, ondansetron may have side effects, although not everyone will experience them.

Very common side effects

May affect more than 1 in 10 patients

• headache

Common side effects

May affect up to 1 in 10 patients

• sensation of heat or flushing
• irritation at the site where the injection was administered, as well as pain, burning sensation, swelling, redness, or itching
• constipation

Rare side effects

May affect up to 1 in 100 patients

• eye movements, abnormal muscle stiffness, body movements, tremors
• seizures
• slow or irregular heartbeats
• low blood pressure (hypotension)
• hypothermia
• increased levels in liver function test results

Inform your doctor or pharmacist immediately if you experience any of these symptoms.

Rare side effects

May affect fewer than 1 in 1,000 patients

• blurred vision
• dizziness
• alteration of heart rhythm (in some cases, it may cause sudden loss of consciousness)
• allergic reactions (sometimes severe):

- 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

If you experience any of these symptoms, stop using the medication immediately and inform your doctor.

Very rare side effects

May affect fewer than 1 in 10,000 patients

• transient blindness, which usually resolves in 20 minutes
• electrocardiogram alterations
• widespread skin rash with blisters and peeling, affecting a large area of the body (toxic epidermal necrolysis)

Inform your doctor immediately if you experience any of these symptoms.

Unknown frequency

• myocardial ischemia: symptoms include sudden chest pain or tightness.

If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospectus.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Store in the original packaging to protect it from light. Once it is diluted, it can be stored at 2º-8ºC for no more than 24 hours.

Do not use Ondansetrón Normon after the expiration date that appears on the packaging after CAD.. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. If in doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. In this way, you will help protect the environment.

Ondansetron Normon 8 mg/4 ml Injectable Solution Composition

• The active ingredient is ondansetron. Each ampule contains 8 mg of ondansetron (as dihydrochloride hydrate).
• The other components are citric acid monohydrate, sodium citrate, sodium chloride, and water for injection preparations.

Product Appearance and Packaging Contents

Ondansetron Normon 8 mg/4 ml Injectable Solution is an injectable solution presented in sterile ampules of 4 ml.

Each package contains 5 ampules.

Marketing Authorization Holder and Responsible Manufacturer

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos, Madrid (SPAIN)

Last Review Date of this Leaflet: June 2023

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

You can access detailed and updated information about this medicine by scanning with your smartphone the QR code included in the leaflet and packaging. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/69381/P_69381.html

This information is intended solely for healthcare professionals:

Instructions for Use

For intravenous or intramuscular injection or for intravenous infusion after dilution. For single use only. The unused solution must be discarded.Before use, the solution must be visually inspected. Only solutions that are transparent and practically free of particles should be used.

Compatibility with Intravenous Fluids

Compatibility studies have shown that these mixtures are stable for up to 7 days when stored at room temperature or 2-8 °C. Ondansetron Normon Injectable Solution should only be mixed with the recommended infusion solutions:

•Sodium chloride 0.9%.

•Glucose 5% p/v.

•Mannitol 10% p/v.

•Ringer's solution.

•Potassium chloride 0.3% p/v in sodium chloride 0.9% p/v.

•Potassium chloride 0.3% p/v in glucose 5% p/v.

From a microbiological point of view,the medicine should be used immediately. If not used immediately, the storage time and conditions before use are the responsibility of the user and should not normally exceed 24 hours at 2-8 °C, unless the dilution has occurred in controlled and validated aseptic conditions.

Compatibility with Other Medicines

The following medicines can be administered through the Y-connector of the intravenous administration equipment of ondansetron, in order to provide fluids with concentrations of 16-160μg/mL (8mg/500 mL, 8mg/50mL):

Cisplatin:at concentrations of up to 0.48mg/mL (240mg in 500 mL). Administration time of 1 to 8 hours.

Carboplatin: at concentrations of 0.18mg/mL - 9.9mg/mL (90mg in 500mL to 990mg in 100mL). Administration time 10-60 minutes.

Etoposide: at concentrations of 0.144mg/mL - 0.25mg/mL (72mg in 500mL to 250mg in 1L). Administration time 30-60 minutes.

Ceftazidima: administer by intravenous route doses of 250 mg-2000mg reconstituted with water for injection following the instructions of the leaflet (2.5mL for 250mg and 10mL for 2g of ceftazidima). Administration time about 5 minutes.

Cyclophosphamide: administer by intravenous route doses of 100mg-1g reconstituted with water for injection (5mL for each 100mg of cyclophosphamide) following the instructions of the leaflet. Administration time about 5 minutes.

Doxorubicin: administer by intravenous route doses of 10mg-100mg reconstituted with water for injection (5mL for each 10mg of doxorubicin) following the instructions of the leaflet. Administration time about 5 minutes.

Dexamethasone:can be administered 20mg of sodium phosphate of dexamethasone in the form of intravenous injection slowly over 2-5 minutes of duration, through the Y-connector of an infusion device that provides 8 or 16 mg of ondansetron diluted in 50-100mL of a compatible infusion fluid over 15 minutes. Compatibility between sodium phosphate of dexamethasone and ondansetron has been demonstrated, supporting the administration of these drugs using the same administration equipment, producing concentrations in the administered fluid of 32μg - 2.5mg/mL of sodium phosphate of dexamethasone and 8μg - 1mg/mL of ondansetron.