ONDANSETRON SERRACLINICS 8 mg/4 ml INJECTABLE SOLUTION

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

Ondansetron belongs to a group of medicines called antiemetics. Ondansetron is a 5HT3 receptor antagonist. It works by blocking 5HT3 receptors in the central and peripheral nervous system.

It is used to prevent nausea and vomiting caused by:

• chemotherapy in the treatment of cancer in adults and children over 6 months of age.
• radiotherapy in the treatment of cancer in adults.
• preventing and treating postoperative nausea and vomiting in adults and children over 1 month of age.

2. What you need to know before you use Ondansetron Serraclinics

Do not useOndansetron Serraclinics

• If you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• If you have had an allergic reaction (hypersensitivity) to other antiemetics (e.g., granisetron or dolasetron).
• If you are taking apomorphine (a medicine used to treat Parkinson's disease).

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

Warnings and precautions

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

• If you are allergic to other antiemetic medicines.
• If you have intestinal obstruction, suffer from severe constipation, Ondansetron Serraclinics may increase blockage or constipation.
• If you have ever had heart problems, including irregular heartbeat (arrhythmia).
• If you are undergoing tonsil surgery.
• If you have liver disease.

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

Other medicines andOndansetron Serraclinics

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

• Phenytoin, carbamazepine (to treat epilepsy), as they decrease ondansetron blood levels.
• Rifampicin (to treat certain infections such as tuberculosis), as it decreases ondansetron blood levels.
• Tramadol (to treat pain), as ondansetron may reduce the analgesic effect of tramadol.
• Medicines used to treat heart problems such as irregular heartbeat (antiarrhythmics) and/or to treat high blood pressure (beta-blockers).
• Haloperidol or methadone (medicines that may affect the heart).
• Anthracyclines and trastuzumab (medicines 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 medicines.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Ondansetron Serraclinics should not be used during the first trimester of pregnancy. This is because Ondansetron Serraclinics may slightly increase the risk of a baby being born with a cleft lip and/or cleft palate. If you are already pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using Ondansetron Serraclinics, as Ondansetron Serraclinics may harm the fetus. If you are a woman of childbearing age, you are advised to use an effective method of contraception.

If you are a woman of childbearing age, your doctor or nurse should check if you are pregnant and perform a pregnancy test before starting treatment with Ondansetron Serraclinics.

Women of childbearing age should use an effective method of contraception during treatment with Ondansetron Serraclinics. Ask your doctor about the options for contraceptive methods.

It is likely that ondansetron from the ampoules may pass into breast milk. Therefore, it is recommended that breastfeeding mothers do not breastfeed their babies if they are using Ondansetron.

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

Driving and using machines

Ondansetron 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.

Ondansetron Serraclinics contains sodium:This medicine contains less than 23 mg of sodium (1 mmol) per ampoule, i.e., it is essentially “sodium-free”.

This medicine contains 2.5 mmol (57.9 mg) of sodium per maximum daily dose of 32 mg of ondansetron, which should be taken into account in the treatment of patients on low-sodium diets.

3. How to use Ondansetron Serraclinics

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

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

Dose

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

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

If you think the effect of Ondansetron Serraclinics is too strong or too weak, tell your doctor or pharmacist.

The recommended dose and administration schedule used is:

CHEMOTHERAPY- OR RADIOTHERAPY-INDUCED NAUSEA AND VOMITING

Adults

On the day of chemotherapy or radiotherapy, you will be given a single dose of 8 mg (4 ml) as 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 start 12 hours after chemotherapy or radiotherapy and may continue for 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 intravenously, immediately before chemotherapy. Doses greater than 8 mg of ondansetron should be diluted in 50-100 ml of saline or other compatible infusion fluid and administered by infusion over at least 15 minutes. A single dose greater than 16 mg should not be administered due to the increased risk of QT interval prolongation.
• 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 may be enhanced by adding a single intravenous dose of 20 mg of dexamethasone sodium phosphate 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.

CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING

Children over 6 months and adolescents

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

On the day of chemotherapy: the first dose will be administered by intravenous injection immediately before treatment.

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

POSTOPERATIVE NAUSEA AND VOMITING

To prevent nausea and vomiting after surgery

Adults

A single dose of 4 mg intramuscularly or by slow intravenous injection when anesthesia is induced.

Children over 1 month of age and adolescents

Your doctor will decide on the dose. The maximum dose is 4 mg, administered by intravenous injection. This dose will be administered immediately before surgery.

To treat nausea and vomiting after surgery

Adults

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

Children over 1 month of age and adolescents

Your doctor will decide on the dose. A single dose of ondansetron may be administered by slow intravenous injection (not less than 30 seconds) with a dose of 0.1 mg/kg up to a maximum of 4 mg before, during, or after induction of anesthesia.

Dose adjustments

Patient with hepatic impairment

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

Elderly patients, patients with renal impairment, or poor metabolizers of sparteine/debrisoquine

No dose adjustment is necessary.

Duration of treatment

Your doctor will decide on the duration of your treatment with Ondansetron Serraclinics. Do not stop treatment early. If you think the effect of Ondansetron Serraclinics is too strong or too weak, tell your doctor or pharmacist.

If you use more Ondansetron Serraclinics than you should

This medicine 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 amount. If you think you or your child have been given too much ondansetron, tell 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 (telephone 91.562.04.20) stating the medicine and the amount administered.

If you forget to use Ondansetron Serraclinics

Do not take a double dose to make up for forgotten doses.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common side effects

May affect more than 1 in 10 people using Ondansetron:

• Headache.

Common side effects

May affect up to 1 in 10 people using Ondansetron:

• Feeling of warmth or flushing.

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

Uncommon side effects

May affect up to 1 in 100 people using Ondansetron, but if you experience any of them, tell your doctor immediately:

• Rolling eye movements, abnormal muscle stiffness/movements of the body/tremor.
• Seizures.
• Slow or irregular heartbeat.
• Low blood pressure (hypotension).
• Dizziness or lightheadedness.
• Hiccup.
• This medicine may affect the results of liver function blood tests.

Rare side effects

May affect up to 1 in 1,000 people using Ondansetron. If you experience any of the following symptoms soon after using Ondansetron Serraclinics, tell your doctor immediately.

• Blurred vision.
• Dizziness.
• Abnormal heart rhythm (which can sometimes cause sudden loss of consciousness).

Allergic reactions (sometimes severe): Sudden onset of wheezing, chest pain or tightness.

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

Rash on the skin or hives anywhere on the body.

Very rare side effects

May affect up to 1 in 10,000 people using Ondansetron. Tell your doctor as soon as possible if you have had any of the following symptoms:

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

Side effects of unknown frequency

Cannot be estimated from the available data:

Myocardial ischemia. Signs include sudden chest pain or tightness.

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet or package insert. See section 4.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet or package insert. You can also report side effects directly to the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ondansetron Serraclinics

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

Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date is the last day of the month indicated.

Do not use this medicine if you notice that the ampoules are broken or damaged.

Store in the original packaging.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for proper disposal. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Ondansetrón Serraclinics

The active ingredient is Ondansetrón. Each ampoule contains 8 mg of ondansetrón (as ondansetrón dihydrochloride dihydrate).

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

Appearance of the product and packaging content

Ondansetrón Serraclinics is presented as a transparent and colorless injectable solution, packaged in colorless or amber glass ampoules.

Each package contains 5 or 50 ampoules.

The ampoules are arranged on a tray that may be covered with an aluminum sheet, depending on the type of ampoule. Each tray contains 5 or 10 ampoules.

Marketing authorization holder and manufacturer

Laboratorios SERRA PAMIES S.A.

Ctra. Castellvell, 24

43206 Reus (Tarragona)

Date of the last revision of this prospectus: February2022

Detailed information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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

This information is intended only for doctors or healthcare professionals:

Use only clear solutions free of particles.

For single use. Any remaining unused solution must be discarded.

For immediate use once the ampoule is opened.

Ondansetrón Serraclinics should only be administered with the recommended infusion solutions: 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 stable from a physical and chemical point of view 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 it is 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 under controlled and validated aseptic conditions.