Package Insert: Information for the Patient

Ondansetron B.Braun 0.16mg/mL Solution for Infusion

Read this entire 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.
• 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 Ondansetron B. Braun and for what it is used

2. What you need to know before starting to use Ondansetron B. Braun

3. How to use Ondansetron B. Braun

4. Possible adverse effects

5. Storage of Ondansetron B. Braun

6. Contents of the package and additional information

Ondansetrónbelongs to a group of medications called antiemetics, which act against nausea or vomiting. Some medical treatments with medications for cancer treatment (chemotherapy) or radiation therapy may cause you to feel nausea or vomiting. Also, after a surgical treatment, you may feel nausea or vomiting. Ondansetrónmay help reduce these effectsin adults.

In addition, Ondansetrónmay be usedin children:

• from 6months of age: totreat nausea and vomiting after cancer treatment,
• from 1month of age:to prevent and treat nausea and vomiting after a surgical intervention.

No use Ondansetrón B.Braun

This medication should not be administered (please inform your doctor)

• If you are allergic to ondansetron or any of the other components of this medication (listed in section 6).
• If you are receiving apomorphine (medication for Parkinson's disease treatment).

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medication.

Be especially careful with this medication:

• If you are allergic to other anti-nausea or anti-vomiting medications: you may also develop an allergy to this medication.
• If you have a bowel obstruction or severe constipation. Ondansetron may increase the obstruction or constipation.
• If you have received medications that affect your heart.
• If you have ever had heart problems.
• If you have problems with the levels of salts in your blood, such as potassium, sodium, and magnesium.
• If your heart has an irregular heartbeat (arrhythmia).
• If you are undergoing a tonsillectomy operation.
• If your liver does not function as it should.

If your child is receiving this medication and also cancer medications that affect the liver, your doctor will need to monitor your child's liver function.

Use of Ondansetrón B.Braun with other medications

Inform your doctor if you are taking/using, have taken/used recently or may need to take/use any other medication.

In particular, it is essential that your doctor knows if you are taking/using:

• Certain medications for treating epilepsy (e.g., phenytoin, carbamazepine),
• An antibiotic called rifampicin,
• A potent analgesic called tramadol,
• Medications used to treat depressed mood (such as fluoxetine, sertraline, duloxetine, venlafaxine),
• Apomorphine (medication used to treat Parkinson's disease), as a pronounced decrease in blood pressure and loss of consciousness have been reported with concomitant administration,
• Medications that affect your heart rhythm or heart, such as:
• • Medications for cancer, such as anthracyclines (e.g., doxorubicin, daunorubicin, or trastuzumab),
  • Antibiotics (e.g., erythromycin, ketoconazole),
  • Beta blockers (e.g., atenolol, timolol),
  • Antiarrhythmics (such as amiodarone)

Pregnancy and breastfeeding

Ondansetron B. Braun should not be used during the first trimester of pregnancy. This is because Ondansetron B. Braun 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 plan to become pregnant, consult your doctor or pharmacist before using Ondansetron B. Braun.

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

It has been demonstrated that ondansetron passes into the milk of animals. Therefore, mothers receiving ondansetron should not breastfeed.

Driving and operating machinery

Ondansetron has no effects or they are insignificant on the ability to drive or operate machinery.

Ondansetrón B.Braun contains sodium

This medication contains 178.5 mg of sodium (main component of table salt/for cooking) in each 100 ml bottle. This is equivalent to 8.9% of the maximum daily sodium intake recommended for an adult.

Dose

Your doctor will decide on the correct dose of ondansetron therapy for you.

The dose depends on your medical treatment (chemotherapy or surgery), liver function, and whether it is administered by injection or infusion.

In the case of chemotherapy or radiation therapy, the usual dose in adults is 8-32 mg of ondansetron per day. For postoperative nausea and vomiting treatment, a single dose of 4 mg of ondansetron is usually administered.

Use in children over 1 month of age and adolescents

Your doctor will decide on the dose individually.

Dose adjustment

Patients with liver insufficiency

In patients with liver problems, the dose needs to be adjusted to a maximum daily dose of 8 mg of ondansetron.

Patients with renal insufficiency or patients with deficient metabolism of sparteine and debrisoquine

No dose adjustment or frequency of dosing or route of administration is required.

Geriatric patients

65-74 years: follow the individual dosing regimen for adults.

> 74 years: have special dosing requirements. Your doctor knows this and will take precautions to administer a lower dose than recommended for younger patients as the first dose.

Treatment duration

Your doctor will decide on the duration of ondansetron therapy for you.

After intravenous administration of Ondansetron B. Braun, therapy may be continued with other routes of administration.

Administration form

Ondansetron B. Braun is administered as a short-term intravenous infusion in a vein. It is usually administered by a doctor or nurse.

If you use more Ondansetron B. Braun than you should

Your doctor or nurse will administer this medication to you or your child, so it is unlikely that you or your child will receive more than the prescribed dose. If you think you or your child have received more than the prescribed dose or have not received a dose, inform your doctor or nurse.

Currently, very little is known about the effects of overdose. In most patients, symptoms were similar to those reported in patients who received the recommended doses of this medication (see section "Possible adverse effects").

In some patients, the following effects were observed after overdose: visual disturbances, severe constipation, low blood pressure, and loss of consciousness. In all cases, symptoms disappeared completely.

This medication may alter your heart rhythm, especially in the case of overdose. In this case, your doctor will monitor your heart rate afterwards.

There is no specific antidote for ondansetron; therefore, if an overdose is suspected, only symptomatic treatment should be performed.

Inform your doctor if you experience any of these symptoms.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

In case of accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 915620420, indicating the medication and the amount ingested.

Like all medicines,this medicinemay cause side effects, although not everyone will experience them.

The following side effects could be serious. If any of the following side effects occur, consult your doctor immediately, as you may need to stop taking this medicine:

Rare (may affect up to 1 in 100people):

• Chest pain, arrhythmic heartbeat (arrhythmia that may be fatal in individual cases) and slow heartbeat (bradycardia)

Uncommon (may affect up to 1 in 1,000people):

• Immediate allergic reactions, including life-threatening allergic reaction (anaphylaxis). These reactions may include: swelling of hands, feet, ankles, face, lips, mouth, or throat that causes difficulty swallowing or breathing. Additionally, rash or itching and urticaria.

Side effects of unknown frequency (frequency cannot be estimated from available data):

• Myocardial ischemia: symptoms include sudden chest pain or chest pressure

Otherside effectsinclude:

Very common(may affect more than 1 in 10people):

• Headache

Common (may affect up to 1 in 10people):

• Sensations of warmth or redness.
• Constipation
• Local reactions at the site of intravenous injection.

Rare (may affect up to 1 in 100people):

• Involuntary movement disorders, p.eg. spasmodic eye movements, abnormal muscle contractions that can cause body movements of twisting or shaking, convulsions (p.eg. epileptic seizures)
• Hypotension (low blood pressure)
• Hypophosphatemia
• Asymptomatic increases in liver function. In particular, these reactions were observed in cancer patients treated with, for example, cisplatin.
• Reactions of hypersensitivity around the injection site (p.eg., skin rash, urticaria, itching).

Rare (may affect up to 1 in 1,000people):

• Dizziness during rapid intravenous administration
• Transient changes in the electrocardiogram (instrumental measurement of the normal processes that occur when the heart beats) mainly after intravenous administration of ondansetron (prolonged QTc interval includingTorsade de Pointes)
• Transient visual disturbances (p.eg., blurred vision during rapid intravenous administration

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

• Depression
• In individual cases, transient blindness has been described in patients receiving chemotherapy agents, including cisplatin. Most reported cases resolved in 20 minutes.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de medicamentos de Uso Humano: https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the label of the bottle and the box after CAD. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature.

Store the bottle in the outer packaging to protect it from light.

Medications should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

The active principle is ondansetron.

1 ml of infusion solution contains 0.16 mg of ondansetron as ondansetron hydrochloride dihydrate.

Each 50 ml vial contains 8 mg of ondansetron.

The other components are sodium chloride, sodium citrate dihydrate, citric acid monohydrate, and water for injectable preparations.

Product appearance and packaging content

Ondansetron B. Braun is a clear and colorless solution.

It is available in LDPE plastic vials.

Each vial contains 50 ml of infusion solution.

Packaging sizes: 10 x 50 ml.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

B. Braun Melsungen AG

Carl-Braun Strasse, 1

D-34212 Melsungen, Germany

Manufacturer responsible:

B. Braun Medical, SA

Carretera de Terrassa, 121

08191 – Rubí (Barcelona) – Spain

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

Germany: Ondansetron B. Braun 0.16 mg/ml Infusionslösung

Belgium: Ondansetron B. Braun 0.16 mg/ml, oplossing voor infusie

Spain: Ondansetron B. Braun 0.16 mg/ml solución para perfusión

Finland: Ondansetron B. Braun 0.16 mg/ml infuusioneste, liuos

Italy: Ondansetron B. Braun 0.16 mg/ml soluzione per infusione

Netherlands: Ondansetron B. Braun 0.16 mg/ml, oplossing voor infusie

Poland: Ondansetron B. Braun 0.16 mg/ml, roztwór do infuzji

Sweden: Ondansetron B. Braun 0.16 mg/ml infusionsvätska, lösning

Last review date of this prospectus:04/2022

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

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This information is intended solely for healthcare professionals:

Prolongation of the QT interval

Rarely and predominantly with intravenous ondansetron, transient changes in the ECG have been described, including prolongation of the QT interval. In addition, cases of Torsade de Pointes have been described in patients using ondansetron. Caution is advised in patients with or who may develop QTc prolongation. These disorders include patients with electrolyte imbalances, with congenital long QT syndrome, or patients taking other medications that lead to QT interval prolongation. Therefore, caution should be exercised in patients with conduction or rhythm disorders, in patients treated with antiarrhythmics or beta-blockers, and in patients with significant electrolyte imbalances.

Serotonin syndrome

Reports of pharmacovigilance have described patients with serotonin syndrome (including altered mental status, autonomic instability, and neuromuscular abnormalities) after concomitant use of ondansetron and other serotonin-active principles (including selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs)). If clinically justified, concomitant treatment with ondansetron and other serotonin-active principles is recommended with appropriate patient monitoring.

Compatibility with other medications:

The following medications can be administered simultaneously with Ondansetron B. Braun through the Y-connector of the administration equipment. Although general compatibility has been demonstrated for up to 1 hour, the recommendations indicated by the manufacturer for the medication to be administered simultaneously should be taken into account.

Cisplatin:Concentrations of up to 0.48 mg/ml (e.g., 240 mg in 500 ml).

Carboplatin:Concentrations between 0.18 mg/ml and 9.9 mg/ml (e.g., between 90 mg in 500 ml and 990 mg in 100 ml).

Etoposide:Concentrations between 0.14 mg/ml and 0.25 mg/ml (e.g., between 72 mg in 500 ml and 250 mg in 1 liter).

Ceftazidima:Compatibility has been demonstrated for 2,000 mg reconstituted with 20 ml of 0.9% NaCl and for 2,000 mg reconstituted with 10 ml of water for injectable preparations.

Cyclophosphamide:Compatibility has been demonstrated for 1,000 mg reconstituted with 50 ml of 0.9% NaCl.

Doxorubicin:Concentrations of up to 2 mg/ml (e.g., 10 mg in 5 ml or 100 mg in 200 ml).

Dexamethasone:Compatibility has been demonstrated between sodium phosphate dexamethasone and ondansetron through the same administration equipment, with resulting concentrations in the line of 32 micrograms – 2.5 mg/ml for sodium phosphate dexamethasone and 8 micrograms – 0.75 mg/ml for ondansetron.

To see the complete information about this medicinal product, consult the Technical Dossier or Summary of Product Characteristics.