ZOFRAN 4 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Zofran 4mg Film-Coated Tablets

ondansetron hydrochloride dihydrate

Read all of this leaflet carefully before you start taking 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 or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack

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

1. What is Zofran and what is it 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.

Zofran is used to:

• prevent nausea and vomiting caused by:

• cancer chemotherapy in adults and children over 6 months of age.
• radiotherapy in adults.
• prevent post-operative nausea and vomiting in adults.

2. What you need to know before you take Zofran

Do not take Zofran

• If you are allergic (hypersensitive) to ondansetron hydrochloride dihydrate or any of the other ingredients of this medicine (listed in section 6).
• If you have had an allergic reaction (hypersensitivity) to other medicines for nausea or vomiting (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 take Zofran and consult your doctor.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Zofran.

• 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 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(a medicine 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 depressionand/or anxiety),
• venlafaxine, duloxetine(serotonin and noradrenaline reuptake inhibitors, used to treat depressionand/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

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 a cleft lip and/or cleft palate. 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 taking this medicine, as Zofran 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 will check if you are pregnant and perform a pregnancy test before starting treatment with Zofran.

Women of childbearing age must use an effective method of contraception during treatment with Zofran. Ask your doctor about 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 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.

Zofrantablets contain lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to Take Zofran

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

Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

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

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

Nausea and Vomiting Caused by Chemotherapy or Radiotherapy

Adults

Two tablets (8 mg) orally, 1-2 hours before the medical treatment that is likely to cause nausea and vomiting, and then 2 tablets (8 mg) 12 hours later.

To prevent nausea and vomiting on subsequent days, continue taking 2 tablets (8 mg) every 12 hours for 5 days.

Nausea and Vomiting Caused by Chemotherapy

Children over 6months and adolescents

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

Normally, 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.

Post-Operative Nausea and Vomiting

Adults

To prevent nausea and vomiting after surgery, 4 tablets (16 mg) orally, 1 hour before anesthesia.

Children

There is no data available on the oral administration of Zofran in the prevention of post-operative nausea and vomiting in children.

Dose Adjustments

Patients with Liver Impairment

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

Patients with Renal Impairment, Elderly Patients, or Slow Metabolizers of Sparsteine/Debrisoquine

No dose adjustment is necessary.

Duration of Treatment

Your doctor will decide 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 take more Zofran than you should

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

If you or your child take more Zofran than you should, talk to a doctor or go to the nearest hospital or call the Toxicology Information Service, phone: 91 5620420, indicating the medicine and the amount taken. Bring the medicine with you.

If you forget to take Zofran

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

If you forget to take a dose and have nausea or vomiting, take another dose as soon as possible. Then, continue taking the medicine as instructed.

If you forget to take a dose and do not have nausea or vomiting, wait for the next dose and continue taking the medicine as instructed.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

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

• headache.

Common Side Effects

May affect up to 1 in 10 people

• feeling of warmth or flushing,
• constipation.

Uncommon Side Effects

May affect up to 1 in 100 people

• rotating upward eye movements, abnormal muscle stiffness, body movements, tremors,

seizures,

• slow or irregular heartbeats,
• low blood pressure (hypotension),
• hypotension,
• increased levels in blood test results checking liver function.

Rare Side Effects

May affect up to 1 in 1,000 people

• sudden onset of ringing in the ears and pain or pressure in the chest,
• swelling of the eyelids, face, lips, mouth, or tongue,
• skin rash or hives anywhere on the body,
• abnormal heart rhythm (which can sometimes cause a sudden loss of consciousness),
• blurred vision.

• Stop taking the medicine immediately and tell your doctorif you experience any of these symptoms.

Very Rare Side Effects

May affect up to 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 experience any of these symptoms.

Side Effects of Unknown Frequency

Cannot be estimated from the available data,

• myocardial ischemia
• • sudden onset of chest pain or
  • pressure in the chest.
  • Stop taking the medicine immediately and tell your doctorif you experience any of these symptoms.

Reporting of Side Effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) at 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.

Do not store above 30°C.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

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

6. Contents of the Pack and Other Information

Composition of Zofran 4mg Film-Coated Tablets

The active substance is ondansetron hydrochloride dihydrate. Each film-coated tablet of Zofran contains 4 mg of ondansetron (as hydrochloride dihydrate).

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

Appearance and Packaging of the Product

Zofran 4 mg film-coated tablets are yellow, oval, and engraved with "GX ET3" on one side. Each pack contains 6, 15, or 500 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

BEXAL FARMACÉUTICA, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

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

Date of Last Revision of this Leaflet:May 2024

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