Package Insert: Information for the Patient

Zofran 8Film-Coated Tablets

ondansetrón hydrochloride dihydrate

Read this entire package insert carefully before starting to take 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 or pharmacist.
• This medication has been prescribed for you only, 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 or pharmacist, 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 starting to take Zofran

3. How to take Zofran

4. Possible adverse effects

5. Storage of Zofran

6. Contents of the package and additional information

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

Zofran 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 postoperative nausea and vomiting in adults.

Do not take Zofran

• If you are allergic (hypersensitive) to ondansetron hydrochloride dihydrate or to any of the other components of this medication (listed in section 6),
• If you have or have had anyallergic reaction(hypersensitivity) with other anti-nausea or anti-vomiting medications (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 take Zofran and consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Zofran:

• If you have a blockage in the intestine or if you suffer from severe constipation. Zofran 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 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 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(a medication used to treatsevere 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 may affect theheart),
• anthracyclinesandtrastuzumab(medications used to treatcancer),
• fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram(selective serotonin reuptake inhibitors, used to treatdepressionand/oranxiety),
• venlafaxine, duloxetine(serotonin and noradrenaline reuptake inhibitors, used to treatdepressionand/oranxiety).

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 notice sudden or oppressive chest pain (myocardial ischemia).

Pregnancy and breastfeeding

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 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 Zofran may cause harm to the fetus. If you are a fertile woman, it is recommended that you use an effective contraceptive method.

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 Zofran.

Fertile women 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 may affect your baby.

Driving and operating machinery

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

Zofran tablets contain lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Your doctor will tell you exactly how much Zofran you should take.

Follow exactly the administration instructions for this medication indicated by your doctor or pharmacist.

Consult your doctor or pharmacist again in case of doubt.

Remember to take your medication. Swallow the whole tablets with a little water.

Your doctor will tell you the duration of your treatment with Zofran. Do not stop treatment before.

Nausea and vomiting caused by chemotherapy or radiation therapy

Adults

One tablet (8 mg) orally, 1-2 hours before the medical treatment potentially causing nausea and vomiting, and then 1tablet (8 mg)12hours later.

To prevent nausea and vomiting on subsequent days, continue taking 1 tablet (8 mg) every 12 hours for five days.

Nausea and vomiting caused by chemotherapy

Children over 6 months and adolescents

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

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

Postoperative nausea and vomiting

Adults

To prevent nausea and vomiting after surgery, 2 tablets (16 mg) orally, 1 hour before anesthesia.

Children

No data are available on the oral administration of Zofran for the prevention of postoperative nausea and vomiting in children.

Dose adjustments

Patients with liver insufficiency

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

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 Zofran. Do not stop treatment before.

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

If you take more Zofran than you should

In case of overdose, symptoms that may appear are: vision problems, low blood pressure (which may cause dizziness or fainting) and palpitations (irregular heartbeat).

If you or your child takesmore Zofran than you should, talk to a doctor or go immediately to the nearest hospital or call the Toxicology Information Service, phone: 91 5620420, indicating the medication and the amount ingested. Bring the medication with you.

If you forgot to take Zofran

Do not take a double doseto compensate for the missed doses. Do not increase or decrease the dose without your doctor's authorization.

If you forget to take a dose and experience discomfort or vomiting, take another dose as soon as possible. Then, continue taking the medication as instructed.

If you forget to take a dose and do not experience discomfort, wait for the next dose and continue taking the medication as instructed.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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

• sensation of heat or flushing,
• 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),
• hypo,
• increased levels in liver function test results.

Very rare side effects

May affect fewer than 1 in 1,000 patients

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

• 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 20minutes
• 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 from available data,

• myocardial ischemia
• • sudden onset of chest pain or,
  • chest discomfort.
  • 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 Medicinal Products 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.

Do not store at a temperature above 30 °C.

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.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Zofran 8 Composition mg tablets

The active ingredient is ondansetron hydrochloride dihydrate. Each film-coated Zofran tablet contains 8 mg of ondansetron (as hydrochloride dihydrate).

The other components are: lactose, microcrystalline cellulose (E460), pregelatinized cornstarch, magnesium stearate (E470b), hypromellose (E464), titanium dioxide (E171), and yellow iron oxide (E172).

Appearance of the product and contents of the packaging

Zofran 8 mg tablets are presented in the form of film-coated, yellow, oval-shaped tablets, engraved with “GX ET5” on one face. Each package contains 6, 15, or 500 film-coated tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

BEXAL FARMACÉUTICA, S.A.

Centro Empresarial Parque Norte

C/Serrano Galvache 56,

Edificio Roble

28033 Madrid

Spain

Responsible manufacturer

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona – Spain

or

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nuremberg

Germany

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