ONDANSETRON B. BRAUN 0.16 mg/ml SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the Patient

Ondansetron B.Braun 0.16mg/ml solution for infusion

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Ondansetron B. Braun is and what it is used for
2. What you need to know before you use Ondansetron B. Braun
3. How to use Ondansetron B. Braun
4. Possible side effects
5. Storage of 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 medicines for cancer treatment (chemotherapy) or radiation therapy may make you feel nauseous or vomit. You may also feel nauseous or vomit after surgical treatment. Ondansetron can help reduce these effects in adults.

In addition, Ondansetron can be used in children:

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

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

Do not use Ondansetron B.Braun

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

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

Warnings and precautions

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

Be particularly careful with this medicine:

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

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

Using Ondansetron B. Braun with other medicines

Tell your doctor if you are taking/using, have recently taken/used, or might take/use any other medicines.

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

• certain medicines for treating epilepsy (e.g., phenytoin, carbamazepine),
• an antibiotic called rifampicin,
• a powerful pain reliever called tramadol,
• medicines used to treat a depressed mood (such as fluoxetine, sertraline, duloxetine, venlafaxine),
• apomorphine (a drug used to treat Parkinson's disease), as a pronounced drop in blood pressure and loss of consciousness have been reported with concomitant administration,
• medicines that affect your heart rhythm or heart, 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

Ondansetron B. Braun must 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 a cleft lip and/or cleft 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 woman of childbearing age, you are advised to use an effective method of birth control.

It has been shown that ondansetron passes into the breast milk of animals. Therefore, mothers who receive ondansetron MUST NOT breastfeed.

Driving and using machines

Ondansetron has no or negligible influence on the ability to drive and use machines.

Ondansetron 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 is equivalent to 8.9% of the maximum recommended daily intake of sodium for an adult.

3. How to use Ondansetron B. Braun

Dose

Your doctor will decide 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 radiation therapy, 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 usually administered.

Use in children over 1 month of age and adolescents

The doctor will decide the dose on an individual basis.

Dose adjustment

Patients with liver insufficiency

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

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

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

Elderly patients

65-74 years: the individual dosage regimen for adults should be followed.

> 74 years: they have special dosage requirements. Your doctor is aware of them and will take the precaution of administering a lower amount of this medicine than 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 be continued with other routes of administration.

Method of administration

Ondansetron B. Braun is administered as a short-term intravenous infusion into 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 medicine to you or your child, so it is unlikely that you or your child will receive more than the prescribed amount. If you think you or your child have been given too much, tell your doctor or nurse.

Currently, very little is known about the effects of overdose. In most patients, the symptoms were similar to those reported in patients who received 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, the symptoms disappeared completely.

This medicine may affect your heart rhythm, especially in case of overdose. In this case, your doctor should monitor your heartbeat afterwards.

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

Tell your doctor if you experience any of these symptoms.

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

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

4. Possible side effects

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

The following side effects may be serious. If you experience any of the following side effects, contact your doctor immediately, as you may need to stop using this medicine:

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

• Chest pain, irregular heartbeat (arrhythmia that can be life-threatening 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 can be: swelling of hands, feet, ankles, face, lips, mouth, or throat that cause difficulty swallowing or breathing. Additionally, rash or itching and hives.

Frequency not known (frequency cannot be estimated from the available data):

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

Other side effects include:

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

• Headache

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

• Feelings of flushing or warmth.
• Constipation
• Local reactions at the injection site.

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

• Disorders of involuntary movements, e.g., spasmodic movements of the eyeball, abnormal muscle contractions that can cause twisting or shaking body movements, convulsions (e.g., epileptic spasms)
• Low blood pressure (hypotension)
• Hiccup
• Asymptomatic increases in liver function. In particular, these reactions were observed in patients with cancer treatments, for example, with cisplatin.
• Hypersensitivity reactions may occur around the injection site (e.g., skin rash, hives, itching).

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

• Dizziness during rapid intravenous administration
• Transient changes in the electrocardiogram (instrumental measurement of electronic 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 described in patients receiving chemotherapeutic agents, including cisplatin. Most reported cases resolved within 20 minutes.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side 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 which is stated on the vial label and carton after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage temperature.

Keep the bottle 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 dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

The active substance is ondansetron.

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

Each 50 ml vial contains 8 mg of ondansetron.

The other ingredients are sodium chloride, sodium citrate dihydrate, citric acid monohydrate, and water for injections.

Appearance and packaging

Ondansetron B. Braun is a clear and colorless solution.

It is available in LDPE plastic vials.

Each vial contains 50 ml of solution for infusion.

Package 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, SA

Carretera de Terrassa, 121

08191 – Rubí (Barcelona) – Spain

This medicine 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 last revision of this leaflet:04/2022

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

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This information is intended only for healthcare professionals:

QT interval prolongation

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

Serotonin syndrome

Pharmacovigilance reports have been received describing patients with serotonin syndrome (including altered mental status, autonomic instability, and neuromuscular abnormalities) after concomitant use of ondansetron and other serotonergic agents (including selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs)). If concomitant treatment with ondansetron and other serotonergic agents is clinically justified, appropriate observation of the patient is recommended.

Compatibility with other medicines:

The following drugs can be administered simultaneously with Ondansetron B. Braun through the Y-connector of the ondansetron administration equipment. Although compatibility has been demonstrated in general for up to 1 hour, the recommendations indicated by the manufacturer for the drug to be administered simultaneously should 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 liter).

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 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 medicine, consult the Summary of Product Characteristics or Package Leaflet.