Ondansetron B. Braun 2 mg/ml solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ondansetron B. Braun 2 mg/ml injection solution EFG

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Ondansetron 2 mg/ml is and what it is used for

Ondansetron 2 mg/ml belongs to a group of medicines called antiemetics, which act against nausea and vomiting. Some medical treatments with cancer medicines (chemotherapy) or radiotherapy may cause nausea or vomiting. Nausea or vomiting may also occur after surgical procedures.

Ondansetron 2 mg/ml can help reduce these effects:

In adults and children from 6 months of age:

• To treat nausea and vomiting following cancer treatment.

In children from 1 month of age:

• To prevent and treat nausea and vomiting following surgery.

2. What you need to know before using Ondansetron 2 mg/ml

Do not use Ondansetron 2 mg/ml (please inform your doctor)

• If you are allergic to ondansetron 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 starting to use Ondansetron 2 mg/ml.

Take special care with this medicine:

• If you are allergic to other medicines used to treat nausea or vomiting, as you may also develop an allergic reaction to this medicine.
• If you have a blockage in the intestine or suffer from severe constipation. Ondansetron 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 along with anticancer medicines that affect the liver, your doctor should monitor your child's liver function.

Use of Ondansetron 2 mg/ml with other medicines

Tell your doctor or pharmacist 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 has been reported with concomitant administration,
• medicines that affect your heart rhythm or heart function, such as:
  • anticancer medicines, like 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 2 mg/ml should not be used during the first trimester of pregnancy. This is because Ondansetron 2 mg/ml 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 already pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using Ondansetron 2 mg/ml.

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

Ondansetron passes into the milk of animals. Therefore, mothers receiving ondansetron should NOT breastfeed.

Driving and using machines

Ondansetron has no or negligible effects on the ability to drive or operate machinery.

Ondansetron 2 mg/ml contains sodium

This medicine contains 3.34 mg of sodium (the main component of table/cooking salt) in each milliliter. This is equivalent to 0.2% of the maximum daily recommended intake of sodium for an adult.

3. How to use Ondansetron 2 mg/ml

Method of administration

Ondansetron 2 mg/ml is administered as an intravenous or intramuscular injection (into a vein or into a muscle), or, after dilution, as an intravenous infusion (over a longer period of time). It will usually be administered by a doctor or nursing staff.

Dosage

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

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

In cases of chemotherapy or radiotherapy, the usual adult dose 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 hepatic problems, the dose must be adjusted to a maximum daily dose of 8 mg of ondansetron.

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

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

Elderly patients

65–74 years: the standard adult dosing regimen should be followed.

74 years: have special dosing requirements. Your doctor is aware of these and will take precautions by administering an initial dose lower than the recommended dose for younger patients. In addition, this medicine will only be administered to you if it is diluted in another solution.

Duration of treatment

Your doctor will decide the duration of your ondansetron therapy.

After intravenous administration of Ondansetron 2 mg/ml, therapy may continue via other routes of administration.

If you use more Ondansetron 2 mg/ml 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 too much. If you think that you or your child have been given too much, or if a dose has been missed, inform your doctor or nurse.

Currently, very little is known about the effects of ondansetron 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 resolved completely.

This medicine could alter your heart rhythm, especially if you have received an overdose. In such cases, your doctor should monitor your heartbeats afterward.

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

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.

4. Possible adverse effects

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

The following adverse effects could be serious. If you experience any of the following, consult your doctor immediately, as you may need to discontinue 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 hands, feet, ankles, face, lips, mouth or throat causing difficulty in swallowing or breathing. Additionally, rash, itching and hives.

Adverse effects with unknown frequency (frequency cannot be estimated from 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 IV 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 body movements or jerking, 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 cancer treatment with cisplatin.

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

• Dizziness during rapid intravenous administration.
• Transient changes in electrocardiogram (instrumental measurement of electrical processes occurring normally 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).
• Hypersensitivity reactions around the injection site (e.g., skin rash, hives, itching) may occur, which sometimes extend along the vein used for drug administration.

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

• Depression.
• Transient blindness has been reported in individual cases in patients receiving chemotherapy agents including cisplatin. Most reported cases resolved within 20 minutes.

Reporting of adverse effects

If you experience any adverse effect, talk to 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 Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ondansetron 2 mg/ml

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 label of the ampoule and the carton. The expiry date refers to the last day of the month indicated.

Keep the ampoules in the outer packaging to protect them from light.

Polyethylene (PEBD) ampoules: do not store above 25 °C.

Glass ampoules: no special storage conditions required.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ondansetron 2 mg/ml

The active substance is ondansetron.

Each 2 ml ampoule contains 4 mg of ondansetron.

Each 4 ml ampoule contains 8 mg of ondansetron.

Each millilitre contains 2 mg of ondansetron as ondansetron dihydrochloride dihydrate.

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

Appearance of the product and contents of the pack

Ondansetron 2 mg/ml is a clear, colourless solution. It is available in:

• Colourless glass ampoules containing 2 ml or 4 ml of injectable solution.

Pack sizes: 5 and 10 ampoules.

• Plastic ampoules containing 4 ml of injectable solution.

Pack size: 20 ampoules.

Some pack sizes may not be marketed.

Marketing Authorization Holder and Manufacturer

• Braun Melsungen AG

Carl-Braun-Strasse 1

34212 Melsungen

Germany

Postal address:

34209 Melsungen

Germany

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

Date of the most recent review of this product information: 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 exclusively for physicians or healthcare professionals:

QT interval prolongation

Rarely and predominantly with intravenous Ondansetron, transient ECG changes have been reported, including prolongation of the QT interval. 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 may lead to QT interval prolongation. Therefore, caution should be exercised in patients with disturbances in cardiac conduction or rhythm, in patients treated with antiarrhythmics or beta-adrenergic blockers, and in patients with significant electrolyte disturbances.

Serotonin syndrome

Post-marketing surveillance reports have described patients presenting with serotonin syndrome (including mental status changes, autonomic instability, and neuromuscular abnormalities) following concomitant use of ondansetron and other serotonergic drugs (including selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs)). If concomitant treatment with ondansetron and other serotonergic drugs is clinically justified, appropriate patient monitoring is recommended.