ZOFRAN 4 mg INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the Patient

Zofran 4mg Solution for Injection

ondansetron hydrochloride dihydrate

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

• Keep this leaflet, you may need to read it again. If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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 given
4. Possible side effects
5. Storage of 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 in the central and peripheral nervous system.

Ondansetron is used to:

• prevent nausea and vomiting caused by:
• cancer chemotherapy in adults and children over 6 months of age.
• radiotherapy in adults.
• prevent and treat post-operative 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 useZofran
• If you are allergic(hypersensitive) to ondansetron 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 any of these apply to you, do not use Zofran and talk to your doctor.

Warnings and precautions

• Talk to your doctor, pharmacist, or nurse before starting Zofran if you have a blockage in your intestine or if you have severe constipation. Zofran may make the blockage or constipation worse.
• If you have ever had heart problems, including an irregular heartbeat (arrhythmia).
• If you are having a tonsillectomy.
• If you have liver problems.

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

Other medicines and Zofran

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

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

• rifampicin(an antibiotic used to treat infections such as tuberculosis),
• tramadolor buprenorphine(medicines used to treat severe pain),
• phenytoinor carbamazepine(medicines used to treat epilepsy),
• medicines used to treat heart problemssuch as irregular heartbeats (antiarrhythmics) and/or to treat high blood pressure(beta blockers),
• haloperidolor methadone(medicines that can affect the heart),
• anthracyclinesand 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).

Tell your doctor or pharmacistif you are taking any of these medicines.

Tell your doctor or pharmacist immediatelyif you notice any of these symptoms during or after treatment

• if you notice a sudden pain or pressure in your chest (myocardial ischemia).

Zofran solution for injection should not be given in the same syringe or infusion as other medicines.

Ondansetron should only be mixed with those infusion solutions recommended.

Pregnancy, breast-feeding, and fertility

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

Zofran should not be used during the first trimester of pregnancy. This is because Zofran may slightly increase the risk of your baby being born with a cleft lip and/or cleft palate (an opening or split in the upper lip or roof of the mouth). If you are already pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking Zofran, as Zofran may harm the fetus.

If you are a woman of childbearing age, your doctor or nurse will need to check if you are pregnant before you start treatment with Zofran and will do a pregnancy test before starting treatment.

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

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

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

Driving and using machines

Zofran is unlikely to affect your ability to drive or use machines.

Zofran contains sodium

This medicine contains less than 1 mmol 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 you receive will be greater.

3. How Zofran is given

Zofran should always be given 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).

Dose

Your doctor will decide on the correct dose of Zofran for you.

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

Nausea and vomiting caused by chemotherapy or radiotherapy

Adults

On the day you have chemotherapy or radiotherapy, you will be given the usual adult dose of 8 mg by injection into a vein immediately before your treatment, and another 8 mg 12 hours later.

In the following days:

• the usual intravenous or intramuscular 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.

If it is likely that your chemotherapy or radiotherapy will cause severe nausea and vomiting, you may be given a higher dose of Zofran than usual. Your doctor will decide what to do. A single dose of more than 16 mg should not be given due to the increased risk of QT interval prolongation.

Nausea and vomiting caused by chemotherapy

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 given by injection into a vein immediately before your child's treatment.

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

Post-operative nausea and vomiting

To prevent nausea and vomiting after surgery

Adults

The usual dose is 4 mg, given by injection into a vein or intramuscular injection. This dose will be given immediately before surgery.

Children over 1 month of age and adolescents

Your doctor will decide on the dose. The maximum dose is 4 mg, given by injection into a vein. This dose will be given immediately before surgery.

To treat nausea and vomiting after surgery

Adults

The usual dose in adults is 4 mg, given by injection into a vein or intramuscular injection.

Children over 1 month of age and adolescents.

Your doctor will decide on the dose. A single dose of ondansetron may be given by slow intravenous injection (no 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

Liver failure

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

Older people, kidney failure, or slow metabolizers of sparteine/debrisoquine

No dose adjustment is necessary.

Duration of treatment

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

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

If you are given more Zofran than you should

This medicine will be given to you in hospital. Your doctor or nurse will give you Zofran, so it is unlikely that you will be given too much. If you think you have been given too much or have not been given a dose, tell 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 (Telephone: 91 5620420) stating the medicine and the amount taken.

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

4. Possible side effects

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

Very common side effects

May affect more than 1 in 10 people

• headache.

Common side effects

May affect up to 1 in 10 people

• 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

• rotating upward movements of the eyes, abnormal muscle stiffness, body movements, tremor,
• seizures,
• slow or irregular heartbeats,
• low blood pressure,
• hypoglycemia,
• increased levels in blood tests checking liver function.

• Tell your doctor or pharmacist immediatelyif you get any of these symptoms.

Rare side effects

May affect less than 1 in 1,000 people

• 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,
  • skin rash or hives anywhere on the body.

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

Very rare side effects

May affect less than 1 in 10,000 people

• temporary 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 (toxic epidermal necrolysis).

• Tell your doctor immediatelyif you get any of these symptoms.

Side effects of unknown frequency

Cannot be estimated from the available data

• myocardial ischemia
• • sudden onset of chest pain or
  • tightness in the chest.

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

Reporting of side effects

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

5. Storage of Zofran

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 which is stated on the label after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container contents and additional information

Composition of Zofran 4 mg injectable solution

• The active ingredient is ondansetron hydrochloride dihydrate. Each ampoule contains 4 mg of ondansetron (as hydrochloride dihydrate).

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

Appearance of the product and container contents

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

Only some package 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 the last revision of this prospectus:May 2024

Detailed information about this medicinal product 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 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. The 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 refrigerated, with the following recommended infusion solutions:

• Intravenous infusion solution BP of sodium chloride 0.9% p/v.
• Intravenous infusion solution BP of glucose 5% p/v.
• Intravenous infusion solution BP of mannitol 10% p/v.
• Ringer's solutions for intravenous infusion.
• Intravenous infusion solution BP of potassium chloride 0.3% p/v and sodium chloride 0.9% p/v.
• Intravenous infusion solution BP of potassium chloride 0.3% p/v and glucose 5% p/v.

Compatibility with other medicinal products

The following medicinal products can be administered through the Y-connector of the ondansetron intravenous administration equipment, in order to provide fluids with concentrations of 16-160 μg/ml (8 mg/500 ml, 8 mg/50 ml):