Prospecto: information for the patient

Ondansetrón Fresenius Kabi 2 mg/ml injectable solution EFG

Read this prospect carefully before starting to use this medicine, because it contains important information for you:

-Keep this prospect, as you may have to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-If you experience adverse effects, consult your doctor, nurse or pharmacist, even if they are not listed in this prospect. See section 4.

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

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

3.How to use Ondansetrón Fresenius Kabi.

4.Possible adverse effects

5.Storage of Ondansetrón Fresenius Kabi.

6.Contents of the package and additional information.

Ondansetrón Fresenius Kabi belongs to a group of medicines called anti-emetics, drugs against the feeling of dizziness or against dizziness. Some medical treatments with medicines for cancer treatment (chemotherapy) or radiation therapy may make you feel dizzy (nausea) or dizzy (vomiting). You may also feel dizzy (nausea) or dizzy (vomiting) after a surgical treatment. Ondansetrón Fresenius Kabi may help you prevent or stop these effects.

Do not use Ondansetrón Fresenius Kabi

• If you are allergic to ondansetrón, other selective 5HT3 receptor antagonists (e.g. granisetrón, dolastrón), or any of the other components of this medication (listed in section 6).
• If you are being treated with apomorfina (a medication used to treat Parkinson's disease)

Warnings and precautions

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

• If you have experienced hypersensitivity to other nausea or vomiting medications, such as granisetrón or palonosetrón.
• If you have experienced a blockage in your intestine or have severe constipation.Ondansetrón may prevent the movement of the small intestine.
• If you have any liver damage.
• If you are to undergo surgery to remove your tonsils located at the back of your nose (adenoidectomy).
• If you have had any heart problems, including irregular heartbeats (arrhythmias).
• Ondansetrón prolongs the QT interval in a dose-dependent manner (ECG signal of delayed heart repolarization, with a risk of life-threatening arrhythmias).
• If you have problems with the levels of salts in your blood, such as potassium, sodium and magnesium.

Use of Ondansetrón Fresenius Kabi with other medications

Inform your doctor, nurse or pharmacist if you are taking, have taken recently or may need to take any other medication, including those purchased without a prescription.

If you are taking tramadol (analgesic): ondansetrón may reduce the analgesic effect of tramadol.

If you are taking phenytoin, carbamazepine (antiepileptic) or rifampicin (antibiotic for tuberculosis): they decrease the blood concentrations of ondansetrón.

If you are taking cardiotoxic medications (e.g. anthracyclines (antibiotics against cancer such as doxorubicin, daunorubicin) or trastuzumab, a cancer medication), antibiotics (such as erythromycin), antifungals (such as ketoconazole), antiarrhythmics (e.g. amiodarone) and beta-blockers (medications that slow the heart rate, such as atenolol or timolol): the use of ondansetrón with other medications that prolong the QT interval may lead to additional QT interval prolongation, i.e. increase the risk of arrhythmias.

If you are taking other serotoninergic medications such as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) such as sertraline or duloxetine (both are antidepressants): cases of patients with the so-called serotonin syndrome (e.g. excessive state of alertness and agitation, increased heart rate and blood pressure, tremors and involuntary movements) have been reported after concomitant use of ondansetrón with other serotoninergic medications.

If you are taking apomorfina (a medication for treating Parkinson's disease): apomorfina should not be used with ondansetrón, as cases of deep hypotension (low blood pressure) and loss of consciousness have been reported when both medications are administered together.

Pregnancy and breastfeeding

Ondansetrón should not be used during the first trimester of pregnancy. This is because Ondansetrón 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 intend to become pregnant, consult your doctor or pharmacist before using ondansetrón. If you are a fertile woman, it is recommended that you use an effective contraceptive method.

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

Consult your doctor before taking any medication.

Driving and operating machinery

Ondansetrón does not affect the ability to drive and operate machinery.

Ondansetrón Fresenius Kabi contains sodium

This medication contains less than 1 mmol (23 mg) of sodium per vial, so it is essentially "sodium-free".

Administration Method

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.

Dose

Adults (under 75 years of age)

Your doctor will decide on the correct dose of ondansetron treatment for you. The dose varies depending 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 8-32 mg of ondansetron per day. For post-operative nausea and vomiting, a single dose of 4 mg of ondansetron is usually administered. For the prevention of post-operative nausea and vomiting, a single dose of 4 mg of ondansetron is usually administered.

Children over 6 months and adolescents

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

Children over 1 month and adolescents

The usual dose for post-operative nausea and vomiting is 0.1 mg/kg (body weight). The maximum dose as a venous injection is 4 mg.

The usual dose for the prevention of post-operative nausea and vomiting is 0.1 mg/kg (body weight). The maximum dose as a venous injection is 4 mg. This dose should be administered just before the procedure.

Dose Adjustment

Older adults

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

Patients with liver insufficiency:

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

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

No dose adjustment is required.

Treatment Duration

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

After an intravenous administration of Ondansetron Fresenius Kabi, treatment should be continued with ondansetron tablets or suppositories for 5 days.

If you have received more Ondansetron Fresenius Kabi than you should

Little is currently known about ondansetron overdose. Overdose increases the likelihood of the adverse effects described in section 4. In a limited number of patients, the following effects were observed after an overdose: visual disturbances, severe constipation, low blood pressure, cardiac rhythm disturbances, and dizziness. In all cases, symptoms disappeared completely.

Your doctor or nurse will administer Ondansetron Fresenius Kabi 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 received too much or not received a dose, inform your doctor or nurse.

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

If any of these symptoms appear, tell your doctor.

Like all medicines, Ondansetron Fresenius Kabi can cause side effects, although not everyone will experience 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 heartbeats

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

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

Not known

• Myocardial ischemia

The signs include:

• sudden chest pain or

• chest tightness

Other side effects include:

Very common:s:may affect more than 1 in 10 people

Common:es:may affect up to 1 in 10 people

Uncommon:may affect up to 1 in 100 people

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

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

-transient blindness, which usually resolves in 20 minutes.

Children and adolescents

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

Reporting of side effects:

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly to the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date indicated on the ampoule label and on the box. The expiration date refers to the last day of the month.

Keep the ampoules in the outer box, to protect them from light.

Medicines should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need.By doing so, you will help protect the environment.

Composition of Ondansetron Fresenius Kabi

The active ingredient is ondansetron.

Each ampoule with 2 ml contains 4 mg of ondansetron.

Each ampoule with 4 ml contains 8 mg of ondansetron.

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

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

Appearance of Ondansetron Fresenius Kabi and packaging contents

Ondansetron Fresenius Kabi is a transparent and colorless solution in colorless glass ampoules containing 2 or 4 ml of injectable solution.

Packaging sizes: 1, 5, and 10 ampoules.

Only some packaging sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder:

Fresenius Kabi España, S.A.U.

C/ Marina 16-18

08005 Barcelona

Responsible Manufacturer:

Labesfal Laboratorios Almiro S.A.,

Lagedo, 3465-157 Santiago de Besterios, Portugal.

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

Last review date of this leaflet: September 2020

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

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

Use only clear and transparent solutions.

For single use only. Any unused solution and the ampoule must be disposed of properly, in accordance with local requirements.

For immediate use once the ampoule is opened.

Ondansetron Fresenius Kabi can be diluted with infusion solutions containing:

Sodium chloride 9 mg/ml (0.9% w/v)

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

Manitol 100 mg/ml (10% w/v)

Lactate Ringer solution

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

Diluted solutions should be protected from light.