Ondansetron Normon 8 mg/4 ml solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ondansetron Normon 8 mg/4 ml injection solutionEFG

Read all of this leaflet carefully before you start using 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, and you should 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 the effects are not listed in this leaflet. See section 4.

Contents of this leaflet

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

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

Ondansetron belongs to a group of medicines called antiemetics. Ondansetron is a 5HT3 receptor antagonist. It works by blocking 5HT3 receptors on neurons located in the central and peripheral nervous system.

Ondansetron is used to:

• Prevent 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.
• Prevent and treat postoperative nausea and vomiting in adults and children over 1 month of age.

2. What you need to know before using Ondansetron Normon

Do not use Ondansetron Normon:

• If you are allergic (hypersensitive) to ondansetron or to any of the other components of this medicine (listed in section 6).
• If you have had or currently have an allergic reaction (hypersensitivity) to other antiemetics (e.g., granisetron or dolasetron).
• If you are taking apomorphine (a medicine used to treat Parkinson's disease).

If any of the above apply to you, do not use ondansetron and consult your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before starting ondansetron:

• If you have intestinal blockage or suffer from severe constipation. Ondansetron may worsen the blockage or constipation.
• If you have ever had heart problems, including irregular heartbeat (arrhythmia).
• If you are undergoing tonsillectomy surgery.
• If you have liver problems.

If you are due to have any diagnostic tests (including blood or urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may affect test results.

Other medicines and Ondansetron Normon

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

In particular, it is important to inform your doctor if you are taking any of the following medicines, as it may be necessary to interrupt treatment or adjust the dose of one or more of them:

• Rifampicin (an antibiotic used to treat infections such as tuberculosis).
• Tramadol (a medicine used to treat pain).
• Phenytoin or carbamazepine (medicines used to treat epilepsy).
• Medicines used to treat heart problems such as irregular heartbeat (antiarrhythmics) and/or high blood pressure (beta-blockers).
• Haloperidol or methadone (medicines that may affect the heart).
• Anthracyclines and trastuzumab (medicines used to treat cancer).
• Fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram (Selective Serotonin Reuptake Inhibitors, used to treat depression and/or anxiety).
• Venlafaxine, duloxetine (Serotonin and Norepinephrine Reuptake Inhibitors, used to treat depression and/or anxiety).

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

Inform your doctor or pharmacist immediately if you notice any of the following symptoms during or after treatment:

??if you experience sudden pain or tightness in the chest (myocardial ischemia)

Ondansetron injectable solution must not be administered in the same syringe or infusion as other medicines. Ondansetron should only be mixed with infusion solutions recommended for use.

Pregnancy and breastfeeding

Ondansetron should not be used during the first trimester of pregnancy. This is because ondansetron 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 roof of the mouth). If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using ondansetron, as this medicine may harm the fetus.

If you are a woman of childbearing age, you are advised to use an effective method of contraception.

If you are a woman of childbearing age, your doctor or nurse should check whether you are pregnant and perform a pregnancy test before starting treatment with ondansetron.

Women of childbearing age must use an effective method of contraception during treatment with ondansetron. Consult your doctor about suitable contraceptive options.

If you become pregnant while being treated with ondansetron, inform your doctor.

Breastfeeding is not recommended during treatment with ondansetron. This medicine may pass into breast milk and may affect your baby.

Driving and using machines

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

Ondansetron Normon contains sodium

This medicine contains 14.4 mg of sodium (the main component of table/cooking salt) per vial. This is equivalent to 0.72% of the maximum daily recommended sodium intake for an adult.

3. How to use Ondansetron Normon

Ondansetron must always be administered by a qualified healthcare professional and should never be self-administered.

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

Dosage

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

Nausea and vomiting induced by chemotherapy and radiotherapy

Adults:

On the day of your chemotherapy or radiotherapy treatment, you will receive the standard adult dose of 8 mg as an intravenous or intramuscular injection immediately before treatment, followed by another 8 mg 12 hours later.

On subsequent days:

• The standard intravenous or intramuscular dose in adults should not exceed 8 mg.
• Oral administration may begin 12 hours after chemotherapy or radiotherapy and may continue for up to 5 days. The usual dose is 8 mg twice daily.

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

Nausea and vomiting induced by chemotherapy

Children over 6 months of age and adolescents

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

Typically, 12 hours after chemotherapy, your child will receive ondansetron orally. The usual dose is 4 mg twice daily, which may continue for up to 5 days.

Postoperative nausea and vomiting

To prevent nausea and vomiting after surgery

Adults

The standard dose is 4 mg, administered as an intravenous or intramuscular injection. This dose will be given immediately before surgery.

Children over 1 month of age and adolescents

The doctor will determine the dose. The maximum dose is 4 mg, administered as an intravenous injection. This dose will be given immediately before surgery.

To treat nausea and vomiting after surgery

Adults

The standard adult dose is 4 mg, administered as an intravenous or intramuscular injection.

Children over 1 month of age and adolescents

The doctor will determine the dose. A single dose of ondansetron may be administered by slow intravenous injection (over no less than 30 seconds) at a dose of 0.1 mg/kg, up to a maximum of 4 mg, before, during, or after induction of anesthesia.

Dose adjustments

Patients with hepatic impairment

In patients with hepatic impairment, the dose should be adjusted to a maximum of 8 mg of ondansetron per day.

Elderly patients, patients with renal impairment, or slow metabolizers of sparteine/debrisoquine

No adjustment of the daily dose, dosing frequency, or route of administration is necessary.

Duration of treatment

Your doctor will decide the duration of your treatment with ondansetron. Do not discontinue treatment prematurely. If you feel that 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 medicine will be administered in a hospital setting. Your doctor or nurse will administer ondansetron to you or your child, making it unlikely that an overdose will occur. If you believe that you or your child has received too much, or if a dose has been missed, inform your doctor or nurse immediately. Symptoms of overdose may include vision problems, low blood pressure (which may cause dizziness or fainting), and palpitations (irregular heartbeat). In case of overdose or accidental ingestion, contact 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 questions about the administration of this medicine, consult the doctor administering it.

4. Possible adverse effects

Like all medicines, ondansetron may have adverse effects, although not everyone experiences them.

Very common adverse effects

May affect more than 1 in 10 patients

• headache

Common adverse effects

May affect up to 1 in 10 patients

• feeling of warmth or flushing
• irritation at the injection site, including pain, burning sensation, swelling, redness, or itching
• constipation

Uncommon adverse effects

May affect up to 1 in 100 patients

• upward rolling eye movements, abnormal muscle stiffness, body movements, tremor
• seizures
• slow or irregular heartbeat
• lower than normal blood pressure (hypotension)
• hiccups
• increased levels in blood test results indicating liver function

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

Rare adverse effects

May affect up to 1 in 1,000 patients

• blurred vision

• dizziness

• changes in heart rhythm (sometimes may cause sudden loss of consciousness)

• allergic reactions (sometimes severe):

• sudden onset of wheezing and chest pain or tightness

• swelling of the eyelids, face, lips, mouth, or tongue

• skin rash or hives anywhere on the body

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

Very rare adverse effects

May affect up to 1 in 10,000 patients

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

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

Frequency not known

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

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through 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. Ondansetron Normon Storage

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

Store in the original packaging to protect from light. After dilution, it may be stored at 2º-8ºC for no more than 24 hours.

Do not use Ondansetron Normon after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. If you are unsure how to dispose of unused medicines or their packaging, please consult your pharmacist. This will help protect the environment.

6. Contents of the container and additional information

Composition of Ondansetron Normon 8 mg/4 ml injectable solution

• The active substance is ondansetron. Each ampoule contains 8 mg of ondansetron (as dihydrochloride dihydrate).
• The other components are citric acid monohydrate, sodium citrate, sodium chloride, and water for injectable preparations.

Appearance of the product and contents of the pack

Ondansetron Normon 8 mg/4 ml injectable solution is an injectable solution supplied in sterile 4 ml ampoules.

Each pack contains 5 ampoules.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos, Madrid (SPAIN)

Date of the most recent review of this leaflet: June 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es

You can access detailed and updated information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and carton. You may also access this information at the following internet address:

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

This information is intended exclusively for healthcare professionals:

Instructions for use

For intravenous or intramuscular injection or for intravenous infusion after dilution. For single use only. Any unused solution must be discarded. Before use, the solution should be inspected visually. Only clear solutions practically free from 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 at 2–8°C. Ondansetron Normon injectable solution should only be mixed with infusion solutions that are recommended:

• Sodium chloride 0.9%.
• Glucose 5% w/v.
• Mannitol 10% w/v.
• Ringer's solution.
• Potassium chloride 0.3% w/v in sodium chloride 0.9% w/v.
• Potassium chloride 0.3% w/v in glucose 5% w/v.

From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage time and conditions prior to use are the responsibility of the user and should normally not exceed 24 hours at 2–8°C, unless the dilution has been carried out under controlled, aseptic, and validated conditions.

Compatibility with other drugs

The following drugs may be administered via a Y-connector in the intravenous administration set of ondansetron to provide fluids with concentrations of 16–160 μg/mL (8 mg/500 mL, 8 mg/50 mL):

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

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

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

Ceftazidime: administer intravenously doses of 250 mg–2000 mg reconstituted with water for injection according to the instructions in the leaflet (2.5 mL for 250 mg and 10 mL for 2 g of ceftazidime). Administration time approximately 5 minutes.

Cyclophosphamide: administer intravenously doses of 100 mg–1 g reconstituted with water for injection (5 mL per 100 mg of cyclophosphamide) according to the instructions in the leaflet. Administration time approximately 5 minutes.

Doxorubicin: administer intravenously doses of 10 mg–100 mg reconstituted with water for injection (5 mL per 10 mg of doxorubicin) according to the instructions in the leaflet. Administration time approximately 5 minutes.

Dexamethasone: 20 mg of dexamethasone sodium phosphate may be administered as a slow intravenous injection over 2–5 minutes via the Y-connector of an infusion set delivering 8 or 16 mg of ondansetron diluted in 50–100 mL of a compatible infusion fluid over approximately 15 minutes. Compatibility between dexamethasone sodium phosphate and ondansetron has been demonstrated, supporting the administration of these drugs using the same administration set, resulting in concentrations in the administered fluid of 32 μg–2.5 mg/mL of dexamethasone sodium phosphate and 8 μg–1 mg/mL of ondansetron.