Prospect: information for the user

Ondansetrón Serraclinics8 mg/4 mlinjectable solutionEFG

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

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you, and you must not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects,consult your doctor, pharmacist, or nurse, evenifthey are not listed in this prospector package insert. See section 4.

1.What is Ondansetrón Serraclinics and for what it is used

2.What you need to know before starting to use Ondansetrón Serraclinics

3.How to use Ondansetrón Serraclinics

4.Possible adverse effects

5.Storage of Ondansetrón Serraclinics

6.Contents of the package and additional information

Ondansetrón belongs to a group of medicines known as antiemetics. Ondansetrón is a 5HT3 receptor antagonist. It acts by inhibiting 5HT3 receptors on neurons located in the central and peripheral nervous systems.

It is used to prevent vomiting and nausea caused by:

Do not useOndansetrón Serraclinics

• If you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).
• If you have or have had an allergic reaction (hypersensitivity) to other antiemetics (for example, granisetron or dolasetron).
• If you are taking apomorphine (a medication used to treat Parkinson's disease).

→ If you consider this applies to you, do not use Ondansetrón Serraclinics and consult your doctor.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Ondansetrón Serraclinics:

• If you are allergic to other antiemetics.
• If you have intestinal obstruction, severe constipation, Ondansetrón Serraclinics may increase the blockage or constipation.
• If you have ever had heart problems, including irregular heart rhythm (arrhythmia).
• If you are undergoing a tonsillectomy.
• If you have any liver disease.

If you are to undergo any diagnostic tests (including blood, urine, skin tests using allergens, etc.) inform your doctor that you are taking this medication, as it may alter the results.

Other medications and Ondansetrón Serraclinics

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

Especially, inform your doctor if you are using the following medications, as it may be necessary to interrupt treatment or adjust the dose of one of them:

• Fenitoin, carbamazepine (to treat epilepsy), as they decrease the blood concentrations of ondansetron.
• Rifampicin (to treat certain infections such as tuberculosis), as they decrease the blood concentrations of ondansetron.
• Tramadol (to treat pain), as ondansetron may reduce the analgesic effect of tramadol.
• Medications used to treat heart problems such as arrhythmias (antiarrhythmics) and/or to treat high blood pressure (beta-blockers).
• Haloperidol or methadone (medications that can affect the heart).
• Anthracyclines and trastuzumab (medications used to treat cancer).
• Fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram (selective serotonin reuptake inhibitors, used to treat depression and/or anxiety).
• Venlafaxine, duloxetine (serotonin and noradrenaline reuptake inhibitors, used to treat depression and/or anxiety).

→ Inform your doctor or pharmacist if you are taking any of these medications.

Ondansetrón Serraclinics injectable solution should not be administered in the same syringe or infusion as other medications. Ondansetrón should only be mixed with the recommended infusion solutions.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Ondansetrón Serraclinics should not be used during the first trimester of pregnancy. This is because Ondansetrón Serraclinics 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 or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using Ondansetrón Serraclinics, as Ondansetrón Serraclinics may cause harm to the fetus. If you are a fertile woman, your doctor or nurse should check if you are pregnant and perform a pregnancy test before starting treatment with Ondansetrón Serraclinics.

Fertile women should use an effective contraceptive method during treatment with Ondansetrón Serraclinics. Consult your doctor about the options for contraceptive methods.

It is likely that the ondansetron from the ampoules may pass into breast milk. Therefore, mothers who are breastfeeding should not breastfeed their children if they are using Ondansetrón.

If you become pregnant during treatment with Ondansetrón Serraclinics, inform your doctor.

Driving and operating machinery

Ondansetrón does not affect the ability to drive and use machines. However, if you experience side effects such as dizziness or blurred vision, your ability to drive and use machines may be affected.

Ondansetrón Serraclinics contains sodium:This medication contains less than 23 mg of sodium (1 mmol)per ampoule, which is essentially "sodium-free".

This medication contains 2.5 mmol (57.9 mg) of sodiumper maximum daily doseof 32 mg of ondansetron, which should be taken into account in the treatment of patients with low-sodium diets.

Ondansetron Serraclinics should be administered always by a qualified healthcare professional and never by oneself.

Ondansetron Serraclinics is administered as an intravenous injection or after its dilution, as an intravenous infusion (for a longer period of time).

Dose

Your doctor will decide on the correct treatment dose with Ondansetron Serraclinics.

The dose varies depending on your medical treatment (chemotherapy or surgery), liver function, and whether the administration is by intravenous injection or infusion.

If you estimate that the action of Ondansetron Serraclinics is too strong or too weak, inform your doctor or pharmacist.

The recommended dose and administration schedule used is:

NAUSEA AND VOMITING INDUCED BY CHEMOTHERAPY OR RADIOTHERAPY

Adults

On the day you undergo chemotherapy or radiotherapy, they will administer a single dose of 8 mg (4 ml) in the form of a slow intravenous injection immediately before chemotherapy or radiotherapy, and another 8 mg 12 hours later.

In the following days:

-The usual intravenous dose in adults will not exceed 8 mg.

-Oral administration may begin 12 hours after chemotherapy or radiotherapy and may continue for a period of up to 5 days. The usual dose is 8 mg twice a day.

Highly emetogenic chemotherapy: one of the following dosing regimens:

• A single dose of 8-16 mg by intravenous route, immediately before chemotherapy. Doses greater than 8 mg of ondansetron should be diluted in 50-100 ml of saline solution or another compatible infusion fluid and administered via infusion for no less than 15 minutes. A single dose of more than 16 mg should not be administered due to the increased risk of dose-dependent prolongation of the QT interval.
• A dose of 8 mg by slow intravenous injection immediately before chemotherapy, followed by two additional intravenous doses of 8 mg spaced 2 to 4 hours apart, or by a continuous infusion of 1 mg/hour for 24 hours.

The efficacy of ondansetron in highly emetogenic chemotherapy can be potentiated by adding a single intravenous dose of 20 mg of sodium phosphate dexamethasone before chemotherapy.

To protect against delayed or prolonged emesis after the first 24 hours, continue administering ondansetron orally, 8 mg twice a day, for 5 days after a treatment cycle.

NAUSEA AND VOMITING INDUCED BY CHEMOTHERAPY

Children over 6 months and adolescents

Your doctor will decide the dose based on your child's weight or body surface area.

On the day of chemotherapy: the first dose is administered via injection into a vein immediately before your child's treatment.

Normally, 12 hours after chemotherapy, your child will receive ondansetron orally. The usual dose is 4 mg twice a day and may continue for a period of up to 5 days.

POSTOPERATIVE NAUSEA AND VOMITING

To prevent nausea and vomiting after surgery

Adults

A single dose of 4 mg by intramuscular injection or slow intravenous injection at the time of anesthesia induction.

Children over 1 month of age and adolescents

Your doctor will decide the dose. The maximum dose is 4 mg, administered via injection into a vein. This dose will be administered to you immediately before the procedure.

To treat nausea and vomiting after surgery

Adults

The usual dose in adults is 4 mg, administered via intramuscular or intravenous injection.

Children over 1 month of age and adolescents

Your doctor will decide the dose. A single dose of ondansetron may be administered via slow intravenous injection (no less than 30 seconds) with doses of 0.1 mg/kg up to a maximum of 4 mg before, during, or after anesthesia induction.

Dose adjustments

Patients with liver insufficiency

In patients with liver problems, the dose should be adjusted to a maximum of 8 mg per day of Ondansetron Serraclinics.

Older patients, patients with renal insufficiency, or slow metabolizers of sparteine/debrisoquine

No adjustment of the daily dose or frequency of the dose or route of administration is necessary.

Treatment duration

Your doctor will decide the duration of your treatment with Ondansetron Serraclinics. Do not discontinue treatment prematurely. If you estimate that the action of Ondansetron Serraclinics is too strong or too weak, inform your doctor or pharmacist.

If you use more Ondansetron Serraclinics than you should

This medication will be administered to you in the hospital.

Your doctor or nurse will administer Ondansetron Serraclinics to you or your child, so it is unlikely that you or your child will receive more than the prescribed dose. If you believe that you or your child have received more than the prescribed dose, inform your doctor or nurse.

If, for any reason, you receive more ondansetron than you should, consult your doctor or pharmacist immediately, go to the nearest hospital, or contact the Toxicology Information Service (phone 91.562.04.20) indicating the medication and the amount administered.

If you forgot to use Ondansetron Serraclinics

Do not take a double dose to compensate for the missed doses.

Like all medications, this medicationmay have side effects, although not everyone will experience them.

Very common side effects

May affect more than 1 in 10 people who use Ondansetrón:

• Headache.

Common side effects

May affect up to 1 in 10 people who use Ondansetrón:

• Sensation of heat or flushing.

• Irritation at the site where the injection was administered, as well as pain, burning sensation, swelling, redness, or itching.
• Constipation.

Uncommon side effects

May affect up to 1 in 100 people who use Ondansetrón, but if any of them appear, report them to the doctor immediately:

• Eye movements that ascend in a circular motion, abnormal muscle stiffness/muscle movements/tremor.
• Seizures.
• Slow or irregular heartbeats.
• Low blood pressure (hypotension).
• Dizziness or drowsiness.
• Hiccups.
• This medicine may affect the results of liver function blood tests.

Rare side effects

May affect up to 1 in 1,000 people who use Ondansetrón. If any of the following symptoms appear shortly after usingOndansetrón Serraclinics,inform the doctor immediately.

• Blurred vision.
• Dizziness.
• Alteration of heart rhythm (in some cases, it may cause sudden loss of consciousness).

Allergic reactions (sometimes severe):Sudden appearance of "pops" and chest pain or oppression.

Swelling of eyelids, face, lips, mouth, or tongue.

Rash or urticaria on any part of the body.

Very rare side effects

May affect up to 1 in 10,000 people who use Ondansetrón. Inform the doctor as soon as possible if any of the following symptoms have occurred:

• Transient blindness, which usually resolves in 20 minutes.
• Alterations in the electrocardiogram.
• Extensive skin rash with blisters and peeling, affecting a large part of the body surface (toxic epidermal necrolysis).

Side effects of unknown frequency

Cannot be estimated:

Myocardial ischemia. Symptoms include sudden chest pain or oppression.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish 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 medication.

Keepthis medicationout of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you observe that the ampoules are broken or damaged.

Store in the original packaging.

Medicines should not be disposed of through drains or inthe trash. Disposeof the packaging and unused medications at the SIGREcollection pointof the pharmacy. Incase of doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Ondansetron Serraclinics Composition

The active ingredient is Ondansetron. Each ampule contains 8 mg of ondansetron (as ondansetron dihydrochloride dihydrate).

- The other components (excipients) are: citric acid, sodium citrate, sodium chloride, and water for injection preparations.

Appearance of the product and contents of the package

Ondansetron Serraclinics is presented in the form of a transparent and colorless injectable solution, packaged in colorless or amber glass ampules.

Each package contains 5 or 50 ampules.

The ampules are arranged in a tray that may be coated with an aluminum sheet, depending on the type of ampule. In each tray, 5 or 10 ampules are arranged.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios SERRA PAMIES S.A.

Ctra. Castellvell, 24

43206 Reus (Tarragona)

Date of the last review of this leaflet: February2022

The detailed information of this medication 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 only for doctors or healthcare professionals:

Use only transparent solutions free of particles.

For single use only. Any remaining solution not used must be discarded.

For immediate use once the ampule is opened.

Ondansetron Serraclinics should be administered only with those infusion solutions that are recommended: sodium chloride 0.9% w/v, glucose 5% w/v, mannitol 10% w/v, Ringer's solution, potassium chloride 0.3% w/v in sodium chloride 0.9% w/v, and potassium chloride 0.3% w/v in glucose 5% w/v.

Compatibility studies have shown that these mixtures are physically and chemically stable for up to 7 days when stored at a temperature of 4-25°C.

From a microbiological point of view, the medication should be used immediately. If not used immediately, the storage time and conditions before use are the responsibility of the user and should not normally exceed 24 hours at 2-8°C, unless the dilution has occurred in controlled and validated aseptic conditions.