Package Insert: Information for the User

Ondansetron B. Braun 2 mg/ml Injectable Solution EFG

Read this 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.
• This medication has been prescribed for you only, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• 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 2 mg/ml and for what it is used

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

3. How to use Ondansetron 2 mg/ml

4. Possible adverse effects

5. Storage of Ondansetron 2 mg/ml

6. Contents of the package and additional information

Ondansetrón2mg/ml 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 cause you to feel nausea or vomiting. You may also feel nausea or vomiting after a surgical treatment.

Ondansetrón2mg/ml may help reduce these effects:

In adults andin children aged 6 months or older:

• Totreat nausea and vomiting after cancer treatment.

In children aged 1month or older:

• To prevent and treat nausea and vomiting after a surgical intervention.

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

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Ondansetrón 2 mg/ml.

You should be especially careful with this medication:

• If you are allergic to other medications for nausea or vomiting, as you may also develop an allergy to this medication.
• If you have a blockage in your intestine or if you suffer from severe constipation. Ondansetrón may increase the blockage 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, or 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 receives this medication and also, cancer medications that affect the liver, your doctor will need to monitor your child's liver function.

Use of Ondansetrón 2mg/ml with other medications

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

In particular, it is essential that your doctor knows if you take:

• Certain medications for treating epilepsy (e.g., phenitoína, carbamazepina),
• An antibiotic called rifampicina,
• A potent analgesic called tramadol,
• Medications used to treat depressed mood (such as fluoxetin, sertralina, duloxetina, venlafaxina),
• Apomorfina (medication used to treat Parkinson's disease), as there has been a reported pronounced decrease in blood pressure and loss of consciousness with concomitant administration,
• Medications that affect your heart rhythm or heart, such as:
• • Medications for cancer, such as anthracyclines (e.g., doxorrubicina, daunorrubicina, or trastuzumab),
  • Antibiotics (e.g., eritromicina, ketoconazol),
  • Beta blockers (e.g., atenolol, timolol),
  • Antiarrhythmics (such as amiodarona).

Pregnancy and breastfeeding

Ondansetrón 2 mg/ml should not be used during the first trimester of pregnancy. This is because Ondansetrón 2 mg/ml 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 Ondansetrón 2 mg/ml.

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

Ondansetrón passes into the breast milk of animals. Therefore, mothers who receive ondansetrón should not breastfeed.

Driving and operating machinery

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

Ondansetrón 2mg/ml contains sodium

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

Administration Form

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

Dose

Your doctor will decide on the correct dose of ondansetrón 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 8‑32mg of ondansetrón per day. For the treatment of postoperative nausea and vomiting, a single dose of 4mg of ondansetrón is usually administered.

Use in children over 1 month of age and adolescents

Your doctor will decide on 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 8mg of ondansetrón.

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

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

>74years: special dosing requirements apply. Your doctor knows these and will take precautions to administer a lower dose than recommended for younger patients as the first dose. Additionally, this medication will only be administered to you if it is diluted in another solution.

Treatment duration

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

After intravenous administration of Ondansetrón 2mg/ml, therapy may be continued with other routes of administration.

If you use more Ondansetrón 2mg/ml 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 too much. If you think you or your child have been given too much or not given a dose, inform your doctor or nurse.

At present, very little is known about the effects of an overdose with ondansetrón. In most patients, the symptoms were similar to those reported in patients who received the recommended doses of this medication (see section«Adverse reactions»).In some patients, the following effects were observed after an overdose: visual disturbances, severe constipation, low blood pressure, and loss of consciousness. In all cases, the symptoms disappeared completely.

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

There is no specific antidote for ondansetrón; 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 other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines,this medicinecan 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:

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

• Chest pain, irregular heartbeat (arrhythmia that can be fatal in individual cases) and slow heartbeat (bradycardia).

Very rare (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):

• Warmth or flushing sensations.
• Constipation.
• Local reactions at the site of intravenous injection.

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

• Muscle spasms, p.eg. eye spasms, abnormal muscle contractions that can cause involuntary body movements or convulsions (p.eg. epileptic seizures).
• Low blood pressure.
• Hypophosphatemia.
• Asymptomatic increases in liver function. Especially, these reactions were observed in cancer patients treated with cisplatin.

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

• Dizziness during rapid intravenous administration.
• Transient changes in the electrocardiogram (instrumental measurement of processes that normally occur when the heart beats) mainly after intravenous administration of ondansetron (prolonged QTc interval that includesTorsade de Pointes).
• Transient visual disturbances (p.eg., blurred vision during rapid intravenous administration.
• May occur hypersensitivity reactions around the injection site (p.eg., skin rash, urticaria, itching), which sometimes extend along the vein in which the drug is administered.

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

• Depression.
• Transient blindness has been described in individual cases 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 theSpanish System for Pharmacovigilance of Medicines for Human Use: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, which appears on the ampule label and box. The expiration date is the last day of the month indicated.

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

Polyethylene terephthalate (PEBD) ampules: do not store at a temperature above 25°C.

Glass ampules: no special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition ofOndansetrón 2mg/ml

The active ingredient is ondansetrón.

Each ampoule with 2ml contains 4mg of ondansetrón.

Each ampoule with 4ml contains 8mg of ondansetrón.

Each milliliter contains 2mg of ondansetrón as ondansetrón hydrochloride dihydrate.

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

Appearance of the product and contents of the package

Ondansetrón 2mg/ml is a transparent and colorless solution. It is available in:

• Ampoules of colorless glass containing 2ml or 4ml of injectable solution.

Package sizes: 5 and 10 ampoules.

• Ampoules of plastic containing 4ml of injectable solution.

Package size: 20 ampoules.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

B. 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 with the following names:

Last review date of thisleaflet: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

--------------------------------------------------------------------------------------------------------------------

This information is intended solely for medical professionals or healthcare professionals:

Prolongation of the QT interval

Rarely and predominantly with intravenous ondansetrón, transient changes in the ECG have been described, includingprolongation of the QT interval. In addition, cases of Torsade de pointes have been described in patients using ondansetrón. 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 cardiac 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 ofondansetrón and other serotoninergic drugs(including selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs). If clinically justified, concomitant treatment of ondansetrón with other serotoninergic drugs is recommended, with appropriate patient monitoring.