Package Insert: Information for the Patient

Zofran 4mg Injectable Solution

ondansetron hydrochloride dihydrate

Read this entire 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, pharmacist, or nurse.
• This medication has been prescribed only for you, 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, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

1. What is Zofran and how is it used

2. What you need to know before Zofran is administered

3. How to administer Zofran

4. Possible adverse effects

5. Storage of Zofran

6. Contents of the package and additional information

Zofran belongs to a group of medications called antiemetics. Ondansetron is a 5HT3 receptor antagonist. It acts by inhibiting 5HT3 receptors on neurons located in the central and peripheral nervous systems.

Ondansetron is used for:

- preventing nausea and vomiting caused by:

- chemotherapy in the treatment of cancer in adults and children over 6 months of age.

- radiation therapy in the treatment of cancer in adults.

- preventing and treating postoperative nausea and vomiting in adults and children over 1 month of age.

• No useZofran
• If you areallergic(hypersensitive) to ondansetron or any of the other components of this medication (listed in section6).
• If you have or have had anyallergic 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 Zofran and consult your doctor.

Warnings and precautions

• Consult your doctor, pharmacist, or healthcare provider before starting to use Zofran if you have a blockage in the intestine or severe constipation. Zofran may increase the blockage or constipation.
• If you have ever had a heart problem, including irregular heart rhythm (arrhythmia).
• If you are undergoing an operation to remove your tonsils.
• If you have liver problems.

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

Other medications and Zofran

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

• Rifampicin(an antibiotic used to treat infections such astuberculosis),
• Tramadolor buprenorphine(medications used to treat severe pain),
• Phenytoinorcarbamazepine(medications used to treatepilepsy),
• Medications used to treatheart problemssuch as arrhythmias (antiarrhythmics) and/or to treathigh blood pressure(beta-blockers),
• Haloperidolormethadone(medications that can affect theheart),
• Anthracyclinesandtrastuzumab(medications used to treatcancer),
• Fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopramInhibitors of selective serotonin reuptake, used to treat depression and/or anxiety),
• Venlafaxine, duloxetine(Inhibitors of serotonin and noradrenaline reuptake, used to treat depression and/or anxiety).

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

Inform your doctor or pharmacist immediately if you notice any of these symptoms during or after treatment

• If you experience sudden chest pain or pressure (myocardial ischemia).

Zofran injectable solution should not be administered in the same syringe or infusion as other medications.

Ondansetron should only be mixed with the recommended infusion solutions.

Pregnancy, breastfeeding, and fertility

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

Zofran should not be used during the first trimester of pregnancy. This is because Zofran may slightly increase the risk of a baby being born with a cleft lip and/or palate (openings or clefts in the upper lip or palate). If you are already pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using Zofran, as it may cause harm to the fetus.

If you are a woman of childbearing age, your doctor or healthcare provider will check if you are pregnant and perform a pregnancy test before starting treatment with Zofran.

Women of childbearing age should use an effective contraceptive method during treatment with Zofran. Consult your doctor about the options for contraceptive methods.

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

It is not recommended to breastfeed during treatment with Zofran. The ingredients in Zofran (ondansetron) may pass into breast milk and affect your baby.

Driving and operating machinery

It is unlikely that Zofran will affect your ability to drive and operate machinery.

Zofran contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per ampoule, which is essentially "sodium-free". If your doctor uses a saline solution to dilute Zofran, then the amount of sodium received would be higher.

Zofran must be administered by a qualified healthcare professional and never by oneself.

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

Dosage

Your doctor will decide on the correct dosage of Zofran treatment.

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

Nausea and vomiting induced by chemotherapy or radiation therapy

Adults

On the day you undergo chemotherapy or radiation therapy, they will administer the usual adult dose of 8 mg via an injection into a vein immediately before your treatment, and another 8 mg 12 hours later.

On the following days:

- the usual intravenous or intramuscular adult dose will not exceed 8 mg.

- oral administration can begin 12 hours after chemotherapy or radiation therapy and can continue for up to 5 days. The usual dose is 8 mg twice a day.

If it is likely that your chemotherapy or radiation therapy will cause intense nausea and vomiting, they may administer a higher dose of Zofran than usual. Your doctor will decide what to do. Do not administer a single dose of more than 16 mg due to the dose-dependent risk of prolonging the QT interval.

Nausea and vomiting induced by chemotherapy

Children over 6 months and adolescents

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

On the day of chemotherapy: the first dose is administered via an 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 can continue for up to 5 days.

Postoperative nausea and vomiting

To prevent nausea and vomiting after surgery

Adults

The usual dose is 4 mg, administered via an injection into a vein or intramuscular injection. This dose will be administered to you immediately before the procedure.

Children over 1 month of age and adolescents

Your doctor will decide the dosage. The maximum dose is 4 mg, administered via an 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 adult dose is 4 mg, administered via an injection into a vein or intramuscular injection

Children over 1 month of age and adolescents.

Your doctor will decide the dosage. A single dose of ondansetron can be administered via slow intravenous injection (not 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

Liver insufficiency

In patients with liver problems, the dose must be adjusted to a maximum of 8 mg of Zofran per day.

Advanced age, renal insufficiency, or slow metabolizers of sparteine/debrisoquine

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

Treatment duration

Your doctor will decide on the duration of your Zofran treatment. Do not stop treatment prematurely.

If you think the action of Zofran is too strong or too weak,inform your doctor or pharmacist.

If you are given more Zofran than you should

This medication will be administered to you in the hospital. Your doctor or nurse will administer Zofran 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 have not received a dose, inform your doctor or nurse. Symptoms of overdose may include vision problems, low blood pressure (which can cause dizziness or fainting) and palpitations (irregular heartbeat). In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service (Phone: 91 5620420) indicating the medication and the amount administered.

If you have any doubts about the administration of Zofran,consult with the doctor administering it to you.

Like all medications, Zofran can cause side effects, although not everyone will experience them.

Very common side effects

May affect more than 1 in 10 patients

• headache.

Common side effects

May affect up to 1 in 10 patients

• feeling of heat or flush,
• irritation at the site where the injection was administered, as well as pain, burning sensation, swelling, redness, or itching,
• constipation.

Rare side effects

May affect up to 1 in 100 patients

• eye movements, abnormal muscle stiffness, body movements, tremor,
• seizures,
• slow or irregular heartbeats,
• low blood pressure (hypotension),
• hypothermia,
• increased levels in liver function test results.

• Inform your doctor or pharmacist immediatelyif you experience any of these symptoms.

Very rare side effects

May affect fewer than 1 in 1,000 patients

• blurred vision,
• dizziness,
• alteration of heart rhythm (in some cases may cause sudden loss of consciousness),
• allergic reactions (sometimes severe):
• • sudden onset of ringing and chest pain or pressure,
  • swelling of eyelids, face, lips, mouth, or tongue,
  • skin rash or urticaria anywhere on the body.

• If you experience any of these symptoms,stop taking the medication immediately and inform your doctor.

Very rare side effects

May affect fewer than 1 in 10,000 patients

• transient blindness, which usually resolves in 20 minutes,
• electrocardiogram alterations,
• widespread skin rash with blisters and peeling, affecting a large area of the body (toxic epidermal necrolysis).

• Inform your doctor immediatelyif you experience any of these symptoms.

Side effects of unknown frequency

Cannot be estimated

• myocardial ischemia
• • sudden onset of chest pain or,
  • chest pressure.

• If you experience any of these symptoms,stop taking the medication immediately and inform your doctor.

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 not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Store in the original packaging to protect it from light. Do not store at a temperature above 30 °C.

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

Medications should not be disposed of through drains or trash. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. This will help protect the environment.

Composition of Zofran 4mg injectable solution

Appearance of the product and contents of the package

Zofran 4 mg injectable solution is presented as a transparent and colorless injectable solution, packaged in sterile ampoules of 2ml. Each package contains 5, 10 or 50ampoules.

Only some package sizes may be commercially available.

Marketing Authorization Holder

BEXAL FARMACÉUTICA, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/Serrano Galvache 56,

28033 Madrid

Spain

Responsible for manufacturing

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Germany

or

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

or

LEK Pharmaceuticals d.d.,

Verovškova ulica 57,

1526 Ljubljana,

Slovenia

Last review date of this leaflet:May 2024

The detailed information of this medicine 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 healthcare professionals:

Instructions for use

For intravenous or intramuscular injection or for intravenous infusion after dilution.

The injection solution does not contain preservatives and must be used immediately after opening. Unused solution must be discarded.

The injection solution must not be sterilized in an autoclave.

Compatibility with intravenous fluids

Compatibility studies have shown that Zofran injectable solution is stable for seven days at a temperature below 25 °C under fluorescent light or stored in a refrigerator, with the following recommended intravenous infusion solutions:

• Sodium chloride 0.9% w/v intravenous infusion solution BP.
• Glucose 5% w/v intravenous infusion solution BP.
• Manitol 10% w/v intravenous infusion solution BP.
• Ringer's solution for intravenous infusion.
• Potassium chloride 0.3% w/v and sodium chloride 0.9% w/v intravenous infusion solution BP.
• Potassium chloride 0.3% w/v and glucose 5% w/v intravenous infusion solution BP.

Compatibility with other drugs

The following drugs may be administered through the Y-connector of the intravenous administration equipment for ondansetron, in order to provide fluids with concentrations of 16-160?g/ml (8mg/500ml, 8mg/50ml):