ONDANSETRON NORMON 8mg/4 ml INJECTABLE SOLUTION

2. What you need to know before you use Ondansetron Normon

Do not use Ondansetron Normon:

• If you are allergic (hypersensitive) to ondansetron or any of the other ingredients of this medicine (listed in section 6).
• If you have had 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 you think any of these apply to you, do not use ondansetron and consult your doctor.

Warnings and precautions

Tell your doctor or pharmacist before starting ondansetron:

• If you have a blockage in your intestine or if you have severe constipation. Ondansetron may make the blockage or constipation worse.
• If you have ever had heart problems, including an irregular heartbeat (arrhythmia).
• If you are having a tonsillectomy.
• If you have liver problems.

If you are going to have any diagnostic tests (including blood tests, urine tests, skin tests that use allergens, etc.), tell your doctor that you are taking this medicine, as it may affect the results.

Other medicines and Ondansetron Normon

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

In particular, it is important to tell your doctor if you are taking any of the following medicines, as it may be necessary to stop treatment or adjust the dose of one 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 heartbeats (antiarrhythmics) and/or high blood pressure (beta-blockers).
• Haloperidol or methadone (medicines that can 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 noradrenaline reuptake inhibitors, used to treat depression and/or anxiety).

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

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

If you notice a sudden pain or pressure in the chest (myocardial ischemia)

Ondansetron solution for injection should not be given in the same syringe or infusion as other medicines. Ondansetron should only be mixed with those infusion solutions recommended.

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 a cleft lip and/or cleft palate ( openings or gaps in the upper lip or palate). If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking 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 if 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. Ask your doctor about the options for contraceptive methods.

If you become pregnant during treatment with ondansetron, tell your doctor.

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

Driving and using machines

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

Ondansetron Normon contains sodium

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

3. How to use Ondansetron Normon

Ondansetron should always be given by a qualified healthcare professional and never by yourself.

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

Dose

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

Nausea and vomiting caused by chemotherapy and radiotherapy.

Adults:

On the day you have chemotherapy or radiotherapy, you will be given the usual adult dose of 8 mg by injection into a vein or muscle, immediately before your treatment, and another 8 mg 12 hours later.

On subsequent days:

• the usual adult dose by injection into a vein or muscle will not exceed 8 mg.
• oral administration may start 12 hours after chemotherapy or radiotherapy and may continue for up to 5 days. The usual dose is 8 mg twice a day.

If it is likely that your chemotherapy or radiotherapy will cause severe 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 given due to the dose-dependent increase in the risk of QT interval prolongation.

Nausea and vomiting caused by chemotherapy

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 will be given by injection into a vein, immediately before your child's treatment.

Usually, 12 hours after chemotherapy, your child will be given ondansetron by mouth. The usual dose is 4 mg twice a day and may continue for up to 5 days.

Post-operative nausea and vomiting.

To prevent nausea and vomiting after surgery

Adults

The usual dose is 4 mg, given by injection into a vein or muscle. This dose will be given immediately before surgery.

Children over 1 month of age and adolescents

Your doctor will decide on the dose. The maximum dose is 4 mg, given by injection into a vein. This dose will be given immediately before surgery.

To treat nausea and vomiting after surgery

Adults

The usual dose is 4 mg, given by injection into a vein or muscle.

Children over 1 month of age and adolescents

Your doctor will decide on the dose. A single dose of ondansetron may be given by slow intravenous injection (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

Patient with liver impairment

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

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

No dose adjustment is necessary.

Duration of treatment

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

If you are given too much Ondansetron Normon

This medicine will be given to you in hospital. Your doctor or nurse will give you ondansetron, so it is unlikely that you will be given too much. If you think you have been given too much or have not been given a dose, tell 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) stating the medicine and the amount taken.

If you have any doubts about the administration of this medicine, ask the doctor who is administering it to you.

4. Possible side effects

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

Very common side effects

May affect more than 1 in 10 people

• headache

Common side effects

May affect up to 1 in 10 people

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

Uncommon side effects

May affect up to 1 in 100 people

• rotating upward movements of the eyes, abnormal muscle stiffness, body movements, tremor
• seizures
• slow or irregular heartbeat
• low blood pressure (hypotension)
• hypotension
• increased levels in blood test results for liver function.

Tell your doctor or pharmacist immediately if you get any of these symptoms.

Rare side effects

May affect up to 1 in 1,000 people

• blurred vision
• dizziness
• abnormal heart rhythm (which can sometimes cause sudden loss of consciousness)
• allergic reactions (sometimes severe):

• sudden onset of wheezing, pain or pressure in the chest
• swelling of the eyelids, face, lips, mouth or tongue
• skin rash or hives anywhere on the body

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

Very rare side effects

May affect up to 1 in 10,000 people

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

Tell your doctor immediately if you get any of these symptoms.

Frequency not known

• myocardial ischemia: signs include sudden chest pain or pressure in the chest.

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

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring 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 Normon

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

Store in the original package to protect from light. Once diluted, it can be stored at 2-8°C for no more than 24 hours.

Do not use Ondansetron Normon after the expiry date which is stated on the carton after EXP. The expiry date refers to 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 to protect the environment.

6. Container Content and Additional Information

Composition of Ondansetron Normon 8 mg/4 ml injectable solution

• The active ingredient 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 Container Content.

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

Each container contains 5 ampoules.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the Last Revision of this Prospectus: June 2023

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

You can access detailed and updated information about this medication by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). 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. The unused solution must be rejected. Before use, the solution must be visually inspected. Only those solutions that are practically free of particles and transparent 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 ºC. Ondansetron Normon Injectable Solution should only be mixed with those infusion solutions that are recommended:

• 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 medicinal product should be used immediately. If it is not used immediately, the storage time and conditions before use are the responsibility of the user and normally should not exceed 24 hours at 2 – 8 ºC, unless the dilution has occurred under controlled and validated aseptic conditions.

Compatibility with Other Medicinal Products

The following medicinal products can be administered through the Y-connector of the intravenous administration equipment of ondansetron, in order 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 following the instructions in the prospectus (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) following the instructions in the prospectus. 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) following the instructions in the prospectus. Administration time approximately 5 minutes.

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