Ondansetron B. Braun 0.16 mg/ml solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ondansetron B. Braun 0.16 mg/ml solution for infusion

Read the entire 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.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Ondansetron B. Braun is and what it is used for

Ondansetron belongs to a group of medicines called antiemetics, which act against nausea or vomiting. Some medical treatments with cancer medicines (chemotherapy) or radiotherapy may cause you to feel nauseous or vomit. You may also experience nausea or vomiting after surgery. Ondansetron can help reduce these effects in adults.

In addition, Ondansetron may be used in children:

• from 6 months of age: to treat nausea and vomiting following cancer treatment,
• from 1 month of age: to prevent and treat nausea and vomiting following surgical procedures.

2. What you need to know before using Ondansetrón B. Braun

Do not use Ondansetrón B. Braun

This medicine must not be administered (please inform your doctor)

• If you are allergic to ondansetrón or to any of the other ingredients of this medicine (listed in section 6).
• If you are receiving apomorphine (a medicine used to treat Parkinson's disease).

Warnings and precautions

Talk to your doctor or pharmacist before using this medicine.

Take special care with this medicine:

• If you are allergic to other medicines for nausea or vomiting: you may also develop an allergic reaction to this medicine.
• If you have a blockage in the intestine or suffer from severe constipation. Ondansetrón may worsen the blockage or constipation.
• If you are taking medicines that affect your heart.
• If you have ever had heart problems.
• If you have problems with salt levels in your blood, such as potassium, sodium, or magnesium.
• If your heartbeat has an irregular rhythm (arrhythmia).
• If you are undergoing tonsillectomy surgery.
• If your liver is not working properly.

If your child is receiving this medicine and also anticancer medicines that affect the liver, your doctor should monitor your child's liver function.

Use of Ondansetrón B. Braun with other medicines

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

In particular, it is important that your doctor knows if you are taking:

• certain medicines used to treat epilepsy (e.g., phenytoin, carbamazepine),
• an antibiotic called rifampicin,
• a strong painkiller called tramadol,
• medicines used to treat depression (such as fluoxetine, sertraline, duloxetine, venlafaxine),
• apomorphine (a medicine used to treat Parkinson's disease), as a marked drop in blood pressure and loss of consciousness have been reported with concomitant administration,
• medicines that affect your heart rhythm or heart function, such as:
  • anticancer medicines, 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

Ondansetrón B. Braun must not be used during the first trimester of pregnancy. This is because Ondansetrón B. Braun 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 the roof of the mouth).

If you are already pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using Ondansetrón B. Braun.

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

It has been shown that ondansetrón passes into the milk of animals. Therefore, mothers receiving ondansetrón must not breastfeed.

Driving and using machines

Ondansetrón has no effects or the effects are negligible on the ability to drive or use machines.

Ondansetrón B. Braun contains sodium

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

3. How to use Ondansetron B. Braun

Dosage

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

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

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

Use in children over 1 month of age and adolescents

The doctor will determine the dose individually.

Dosage adjustment

Patients with hepatic impairment

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

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

No alteration of the daily dose, dosing frequency, or route of administration is required.

Elderly patients

65–74 years: follow the standard adult dosing regimen.

74 years: have special dosing requirements. Your doctor is aware of these and will take care to administer, as the first dose, a lower amount of this medicine than that recommended for younger patients.

Duration of treatment

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

After intravenous administration of Ondansetron B. Braun, therapy may continue via other routes of administration.

Method of administration

Ondansetron B. Braun is administered as a short-duration intravenous infusion into a vein. It is normally administered by a doctor or nurse.

If you use more Ondansetron B. Braun than you should

Your doctor or nurse will administer this medicine to you or your child, so it is unlikely that you or your child will receive an overdose. If you think that you or your child has received too much, or has missed a dose, inform the doctor or nurse.

Currently, very little is known about the effects of overdose. In most patients, symptoms were similar to those reported in patients receiving the recommended doses of this medicine (see section "Possible side 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 completely resolved.

This medicine could alter your heart rhythm, especially if you have received an overdose. In this case, your doctor should subsequently monitor your heartbeats.

There is no specific antidote for ondansetron; therefore, if an overdose is suspected, only the symptoms should be treated.

Inform your doctor if you experience any of these symptoms.

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

In case of accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 915620420, stating the name of the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

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

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

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

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

Adverse effects with unknown frequency (frequency cannot be estimated from the available data):

• Myocardial ischemia: signs include sudden chest pain or chest tightness

Other adverse effects include:

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

• Headache

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

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

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

• Involuntary movement disorders, e.g. spasmodic eye movements, abnormal muscle contractions that may cause twisting or jerking body movements, seizures (e.g. epileptic spasms)
• Hypotension (low blood pressure)
• Hiccups
• Asymptomatic increases in liver function tests. In particular, these reactions were observed in patients receiving anticancer treatment with, for example, cisplatin.
• Hypersensitivity reactions around the injection site may occur (e.g., skin rash, urticaria, itching)

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

• Dizziness during rapid intravenous administration
• Transient changes in the electrocardiogram (instrumental measurement of electrical processes that normally occur when the heart beats), mainly after intravenous administration of ondansetron (prolonged QTc interval including Torsade de Pointes)
• Transient visual disturbances (e.g., blurred vision during rapid intravenous administration)

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

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ondansetron B. Braun

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

Do not use this medicine after the expiry date stated on the label of the vial and the outer carton after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Package contents and other information

The active substance 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 injections.

Appearance of the product and contents of the container

Ondansetron B. Braun is a clear, colourless solution.

It is available in LDPE plastic vials.

Each vial contains 50 ml of infusion solution.

Pack sizes: 10 x 50 ml.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

• Braun Melsungen AG

Carl-Braun Strasse, 1

D-34212 Melsungen, Germany

Manufacturer:

• Braun Medical, S.A.

Carretera de Terrassa, 121

08191 – Rubí (Barcelona) – Spain

This medicinal product is authorised in the Member States of the European Economic Area under 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

Date of latest revision of the package leaflet: 04/2022

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

This information is intended for healthcare professionals only:

QT interval prolongation

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

Serotonin syndrome

Pharmacovigilance reports have described patients developing serotonin syndrome (including mental status changes, autonomic instability and neuromuscular abnormalities) following concomitant use of ondansetron and other serotonergic active substances (including selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs)). If concomitant treatment with ondansetron and other serotonergic active substances is clinically justified, appropriate patient monitoring is recommended.

Compatibility with other medicinal products:

The following drugs may be administered simultaneously with Ondansetron B. Braun via a Y-site administration set. Although compatibility has generally been demonstrated for up to 1 hour, the manufacturer's recommendations for the drug being co-administered should always be taken into account.

Cisplatin: Concentrations 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 litre).

Ceftazidime: 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 injections.

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

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

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

For complete information on this medicinal product, please refer to the Summary of Product Characteristics or Technical Data Sheet.