Zofran 4 mg solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Zofran 4 mg injection solution

ondansetron dihydrochloride dihydrate

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again. If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Zofran is and what it is used for
2. What you need to know before you are given Zofran
3. How Zofran is administered
4. Possible side effects
5. How to store Zofran
6. Contents of the pack and other information

1. What Zofran is and what it is used for

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

Ondansetron 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.
• prevent and treat postoperative nausea and vomiting in adults and children over 1 month of age.

2. What you need to know before you are given Zofran

• Do not use Zofran
• If you are allergic (hypersensitive) to ondansetron or to any of the other ingredients of this medicine (listed in section 6).
• If you have ever had an allergic reaction (hypersensitivity) to other antiemetics (for example, granisetron or dolasetron).
• If you are taking apomorphine (a medicine used to treat Parkinson's disease).

If any of the above apply to you, do not use Zofran and consult your doctor.

Warnings and precautions

• Talk to your doctor, pharmacist, or nurse before starting Zofran if:
  • You have or have had a blockage in the intestine or suffer from severe constipation. Zofran may worsen the blockage or constipation.
  • You have ever had heart problems, including irregular heartbeat (arrhythmia).
  • You are undergoing tonsil surgery.
  • You have liver problems.

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

Other medicines and Zofran

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, it is important to inform your doctor if you are taking any of the following medicines, as it may be necessary to stop treatment or adjust the dose:

• Rifampicin (an antibiotic used to treat infections such as tuberculosis),
• Tramadol, buprenorphine (medicines used to treat severe pain),
• Phenytoin or carbamazepine (medicines used to treat epilepsy),
• Medicines used to treat heart problems, such as irregular heartbeats (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.

Tell your doctor or pharmacist immediately if you notice any of the following symptoms during or after treatment

• If you experience sudden pain or tightness in the chest (myocardial ischemia).

Zofran injectable solution must 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 become pregnant, consult your doctor or pharmacist before using this medicine.

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 cleft lip and/or cleft palate (openings or splits in the upper lip or in the palate). If you are already pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using Zofran, as Zofran may cause harm to the fetus.

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

Women of childbearing age should use an effective method of contraception during treatment with Zofran. Please consult your doctor regarding suitable contraceptive options.

If you become pregnant while receiving Zofran, inform your doctor.

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

Driving and use of machinery

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

Zofran contains sodium

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

3. How Zofran is administered

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

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

Dosage

Your doctor will determine the appropriate dose of Zofran treatment.

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

Nausea and vomiting induced by chemotherapy or radiotherapy

Adults

On the day you receive chemotherapy or radiotherapy, you will be given the usual adult dose of 8 mg as an intravenous injection immediately before your treatment, followed by another 8 mg twelve hours later.

On the following days:

• The usual intravenous or intramuscular adult dose must not exceed 8 mg.
• Oral administration may begin twelve hours after chemotherapy or radiotherapy and may continue for up to 5 days. The usual dose is 8 mg twice daily.

If your chemotherapy or radiotherapy is likely to cause severe nausea and vomiting, you may be given a higher than usual dose of Zofran. Your doctor will decide what is appropriate. A single dose greater than 16 mg must not be administered due to the dose-dependent risk of QT interval prolongation.

Nausea and vomiting induced by chemotherapy

Children over 6 months of age and adolescents

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

On the day of chemotherapy: the first dose is administered as an intravenous injection immediately before your child's treatment.

Typically, twelve hours after chemotherapy, your child will receive ondansetron orally. The usual dose is 4 mg twice daily, which may 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 as an intravenous or intramuscular injection. This dose will be given immediately before surgery.

Children over 1 month of age and adolescents

The doctor will determine the dose. The maximum dose is 4 mg, administered as an intravenous injection. This dose will be given immediately before surgery.

To treat nausea and vomiting after surgery

Adults

The usual adult dose is 4 mg, administered as an intravenous or intramuscular injection.

Children over 1 month of age and adolescents.

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

Dose adjustments

Hepatic impairment

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

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

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

Duration of treatment

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

If you feel that the effect of Zofran is too strong or too weak, inform your doctor or pharmacist.

If you are given more Zofran than you should

This medicine will be administered in a hospital setting. 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 believe that you or your child has received too much or has missed a dose, inform your doctor or nurse. Symptoms of overdose may include vision problems, low blood pressure (which may cause dizziness or fainting), and palpitations (irregular heartbeat). In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service (Telephone: 91 5620420), indicating the drug and the amount administered.

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

4. Possible adverse effects

Like all medicines, Zofran may cause adverse effects, although not everyone experiences them.

Very common adverse effects

May affect more than 1 in 10 patients

• headache.

Common adverse effects

May affect up to 1 in 10 patients

• feeling of warmth or flushing,
• irritation at the injection site, as well as pain, burning sensation, swelling, redness, or itching,
• constipation.

Uncommon adverse effects

May affect up to 1 in 100 patients

• upward rolling eye movements, abnormal muscle rigidity, body movements, tremor,

• seizures,

• slow or irregular heartbeat,

• low blood pressure (hypotension),

• hiccups,

• increased liver function test results in blood tests.

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

Rare adverse effects

May affect less than 1 in 1,000 patients

• blurred vision,

• dizziness,

• changes in heart rhythm (sometimes may cause sudden loss of consciousness),

• allergic reactions (sometimes severe):

  • sudden onset of ringing in the ears and chest pain or tightness,
  • swelling of the eyelids, face, lips, mouth, or tongue,
  • skin rash or hives anywhere on the body.

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

Very rare adverse effects

May affect less than 1 in 10,000 patients

• transient blindness, which usually resolves within 20 minutes,

• changes in the electrocardiogram,

• widespread skin rash with blisters and peeling affecting a large part of the body surface (toxic epidermal necrolysis).

• Inform your doctor immediately if you experience any of these symptoms.

Adverse effects with unknown frequency

Frequency cannot be estimated from the available data

• myocardial ischemia

  • sudden onset of chest pain or
  • chest tightness.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Zofran Storage

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

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

Do not use this medicine after the expiry date stated on the label after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. If you have any questions, ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Zofran 4 mg injection solution

• The active substance is ondansetron dihydrochloride. Each ampoule contains 4 mg of ondansetron (as dihydrochloride).

• The other components (excipients) are: monohydrate citric acid (E330), disodium citrate dihydrate (E331), sodium chloride, and water for injections.

Appearance of the product and contents of the pack

Zofran 4 mg injection solution is presented as a clear, colourless injectable solution, packed in sterile 2 ml ampoules. Each pack contains 5, 10 or 50 ampoules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

BEXAL FARMACÉUTICA, S.A.

Centro Empresarial Parque Norte
Edificio Roble
C/Serrano Galvache 56,
28033 Madrid
Spain

Manufacturer

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

Date of most recent revision of this leaflet: May 2024

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

This information is intended for healthcare professionals only:

Instructions for use

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

The injection solution contains no preservatives and should be used immediately after opening. Any 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 injection solution is stable for seven days at temperatures below 25 °C under fluorescent light or when refrigerated, when mixed with the following recommended infusion solutions:

• Sodium chloride 0.9% w/v intravenous infusion solution BP.
• Glucose 5% w/v intravenous infusion solution BP.
• Mannitol 10% w/v intravenous infusion solution BP.
• Ringer's intravenous infusion solutions.
• 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 via a Y-connector in the intravenous administration set of ondansetron, in order to provide fluids with concentrations of 16–160 µg/ml (8 mg/500 ml, 8 mg/50 ml):