Ondansetron Fresenius Kabi 2 mg/ml solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ondansetron Fresenius Kabi 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.
• If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What Ondansetron Fresenius Kabi is and what it is used for

Ondansetron Fresenius Kabi belongs to a group of medicines known as antiemetics, drugs used to prevent or treat nausea and vomiting. Certain medical treatments for cancer (chemotherapy) or radiotherapy may cause nausea or vomiting. You may also experience nausea or vomiting after surgery. Ondansetron Fresenius Kabi can help prevent or stop these effects.

2. What you need to know before starting to use Ondansetron Fresenius Kabi

Do not use Ondansetron Fresenius Kabi

• if you are allergic to ondansetron, to other selective 5HT3 receptor antagonists (e.g. granisetron, dolasetron), or to any of the other ingredients of this medicine (listed in section 6).
• if you are being treated with apomorphine (a medicine used to treat Parkinson's disease)

Warnings and precautions

Consult your doctor, nurse, or pharmacist before starting to use Ondansetron Fresenius Kabi

• if you have had hypersensitivity to other medicines for nausea or vomiting, such as granisetron or palonosetron.
• if you have had a blockage in your intestine or suffer from severe constipation. Ondansetron may impair motility of the small intestine.
• if you have any liver damage.
• if you are undergoing surgery to remove your adenoids and tonsils located at the back of the nose (adenotonsillar surgery).
• if you have ever had heart problems, including irregular heartbeats (arrhythmias).
• ondansetron prolongs the QT interval in a dose-dependent manner (an electrocardiogram signal of delayed cardiac repolarization after a heartbeat, with risk of life-threatening arrhythmias).
• if you have problems with electrolyte levels in your blood, such as potassium, sodium, and magnesium.

Use of Ondansetron Fresenius Kabi with other medicines

Inform your doctor, nurse or pharmacist if you are taking, have recently taken or might have to take any other medicines, including those obtained without a prescription.

If you are taking tramadol (a painkiller): ondansetron may reduce the analgesic effect of tramadol.

If you are taking phenytoin, carbamazepine (antiepileptic) or rifampicin (an antibiotic for tuberculosis): these decrease blood concentrations of ondansetron.

If you are taking cardiotoxic medicines (for example, anthracyclines (anticancer antibiotics such as doxorubicin, daunorubicin) or trastuzumab, a cancer medicine), antibiotics (such as erythromycin), antifungals (such as ketoconazole), antiarrhythmics (for example, amiodarone) and beta-blockers (medicines that slow the heart rate, such as atenolol or timolol): the use of ondansetron together with other drugs that prolong the QT interval may result in additional QT interval prolongation, i.e., increased risk of arrhythmias.

If you are taking other serotonergic medicines such as selective serotonin reuptake inhibitors (SSRIs) or serotonin and noradrenaline reuptake inhibitors (SNRIs) like sertraline or duloxetine (both are antidepressants): cases of patients developing serotonin syndrome (e.g., excessive alertness and agitation, increased heart rate and blood pressure, tremors and involuntary movements) have been reported following concomitant use of ondansetron with other serotonergic drugs.

If you are taking apomorphine (a medicine used to treat Parkinson's disease): apomorphine must not be used together with ondansetron, as cases of profound hypotension (low blood pressure) and loss of consciousness have been reported when both medicines are administered together.

Pregnancy and breastfeeding

Ondansetron should not be used during the first trimester of pregnancy. This is because ondansetron 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 ondansetron. If you are a woman of childbearing age, you are advised to use an effective method of contraception.

Ondansetron passes into breast milk. Therefore, mothers receiving ondansetron should not breastfeed.

Consult your doctor before taking any medication.

Driving and Use of Machinery

Ondansetron does not affect the ability to drive or operate machinery.

Ondansetron Fresenius Kabi contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per ampoule, therefore it is considered essentially "sodium-free".

3. How to use Ondansetron Fresenius Kabi

Method of administration

Ondansetron Fresenius Kabi is administered as an intravenous injection (into the vein) or, after dilution, as an intravenous infusion (over a longer period). Administration is usually performed by a doctor or nurse.

Dosage

Adults (under 75 years of age)

Your doctor will determine the correct ondansetron dosage for you. The dosage varies depending on your medical treatment (chemotherapy or surgery), liver function, and whether it has been administered by injection or infusion.

In cases of chemotherapy or radiotherapy, the usual adult dosage 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 given. For the prevention of postoperative nausea and vomiting, a single dose of 4 mg of ondansetron is usually administered.

Children over 6 months of age and adolescents

In cases of chemotherapy, the usual dosage is a single intravenous dose of 5 mg/m² (body surface area) given immediately before chemotherapy. The intravenous dose must not exceed 8 mg.

Children over 1 month of age and adolescents

For the treatment of postoperative nausea and vomiting, the usual dosage is 0.1 mg/kg (body weight). The maximum dose as an intravenous injection is 4 mg.

For the prevention of postoperative nausea and vomiting, the usual dosage is 0.1 mg/kg (body weight). The maximum dose as an intravenous injection is 4 mg. This dose should be administered just before the procedure.

Dosage Adjustment

Elderly patients

In the case of chemotherapy, initial doses should not exceed 8 mg in patients aged 75 years or older.

Patients with hepatic impairment:

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

Patients with renal impairment or slow metabolizers of sparteine/debrisoquine:

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

Duration of treatment

Your doctor will decide the duration of your treatment with ondansetron.

After an intravenous administration of Ondansetrón Fresenius Kabi, treatment should continue with ondansetron tablets or suppositories for 5 days.

If you have received more Ondansetron Fresenius Kabi than you should

Currently, little is known about overdose with ondansetron. Overdose increases the likelihood of experiencing the adverse effects described in section 4. In a limited number of patients, the following effects have been observed after overdose: visual disturbances, severe constipation, low blood pressure, changes in heart rhythm, and fainting. In all cases, symptoms resolved completely.

Your doctor or nurse will administer Ondansetron Fresenius Kabi to you or your child, making it unlikely that you or your child will receive an excessive amount. If you think that you or your child have received too much or have missed a dose, inform your doctor or nurse immediately.

There is no specific antidote for ondansetron; therefore, in case of suspected overdose, only symptomatic treatment should be provided.

If any of these symptoms occur, tell your doctor.

4. Possible adverse effects

Like all medicines, Ondansetrón Fresenius Kabi may produce adverse effects, although not everyone experiences them.

Inform your doctor or nurse immediately if you notice any of the following symptoms:

Uncommon: may affect up to 1 in 100 people.

• Chest pain, slow or irregular heartbeat

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

• Immediate allergic reactions such as itchy rash, swelling of the eyelids, face, lips, mouth and tongue.

Not known

• 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

• Constipation
• Feeling of warmth or flushing
• Irritation and redness at the injection site

Uncommon: may affect up to 1 in 100 people

• Low blood pressure, which may make you feel weak or dizzy
• Slow or irregular heartbeat
• Chest pain
• Seizures
• Unusual body movements or restlessness
• Hiccups
• Abnormalities in liver function tests

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

• Feeling dizzy or lightheaded
• Blurred vision
• Hypersensitivity reactions such as rash, itching, swelling of the eyelids, face, lips, mouth and tongue
• Changes in heart rhythm (sometimes leading to sudden loss of consciousness)

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

• Transient blindness, which usually resolves within 20 minutes
  • Skin rash, e.g., red spots or lumps under the skin (urticaria) anywhere on the body, which may develop into large blisters

Children and adolescents

Adverse effects observed in children and adolescents were comparable to those observed in adults.

Reporting of adverse reactions:

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

5. Storage of Ondansetron Fresenius Kabi.

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

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

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

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

6. Contents of the container and additional information

Composition of Ondansetron Fresenius Kabi

The active substance is ondansetron.

Each 2 ml vial contains 4 mg of ondansetron.

Each 4 ml vial contains 8 mg of ondansetron.

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

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

Appearance of Ondansetron Fresenius Kabi and contents of the pack

Ondansetron Fresenius Kabi is a clear, colourless solution in colourless glass ampoules containing 2 or 4 ml of injectable solution.

Pack sizes: 1, 5 and 10 ampoules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturing Responsible Party

Marketing Authorization Holder:

Fresenius Kabi España, S.A.U.

C/ Marina 16-18

08005 Barcelona, Spain

Manufacturing Responsible Party:

Labesfal Laboratorios Almiro S.A.,

Lagedo, 3465-157 Santiago de Besterios, Portugal.

This medicinal product is authorized in the European Economic Area member states with the following names:

Date of the most recent review of this leaflet: September 2020

Up-to-date 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 for healthcare professionals only:

Use only clear and transparent solutions.

For single use only. Any unused solution and the ampoule must be properly disposed of according to local requirements.

For immediate use once the ampoule is opened.

Ondansetron Fresenius Kabi may be diluted with infusion solutions containing: Sodium chloride solution 9 mg/ml (0.9% w/v)

Glucose solution 50 mg/ml (5% w/v)

Mannitol solution 100 mg/ml (10% w/v) Lactated Ringer's solution

Chemical and physical in-use stability has been demonstrated for 48 hours at 25°C with these solutions. Although compatibility has been shown, the infusion solution should always be administered separately.

Diluted solutions must be protected from light.