Zofran 4 mg film-coated tablets

Package leaflet: Information for the patient

Introduction

Package leaflet: information for the patient

Zofran 4mg film-coated tablets

ondansetron hydrochloride dihydrate

Read the entire leaflet carefully before you start taking this medicine, as 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 or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Zofran is and what it is used for
2. What you need to know before taking Zofran
3. How to take Zofran
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 system.

Zofran 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 postoperative nausea and vomiting in adults.

2. What you need to know before starting to take Zofran

Do not take Zofran

• If you are allergic (hypersensitive) to ondansetron hydrochloride dihydrate 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 medicines for nausea or vomiting (for example, granisetron or dolasetron).
• If you are taking apomorphine (a medicine used to treat Parkinson's disease).

If you think any of the above applies to you, do not take Zofran and consult your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Zofran.

• if you have a blockage in the intestine or suffer from severe constipation. Zofran may worsen the blockage or constipation.
• if you have ever had heart problems, including irregular heartbeat (arrhythmia).
• if you are undergoing tonsil surgery.
• if you have liver problems.
• If you are due to have any diagnostic tests (including blood or urine tests, skin tests using allergens, etc.), tell 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 of one or more of them:

• 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).

Tell 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).

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 cleft palate (openings or splits in the upper lip or in the palate). If you are already pregnant or breastfeeding, think you might be pregnant, or intend 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, you are advised to use an effective method of contraception.

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

Women of childbearing age must use an effective contraceptive method during treatment with Zofran. Consult your doctor regarding contraceptive options.

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

Breastfeeding is not recommended during treatment with Zofran. The ingredients of 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 or operate machinery.

Zofran tablets contain lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Zofran

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

Always follow exactly the instructions given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Your doctor will tell you how long to take Zofran. Do not stop treatment early.

Nausea and vomiting caused by chemotherapy or radiotherapy

Adults

Two tablets (8 mg) orally, 1 to 2 hours before the medical treatment that may cause nausea and vomiting, followed by 2 more tablets (8 mg) 12 hours later.

To prevent nausea and vomiting in the following days, continue taking 2 tablets (8 mg) every 12 hours for five days.

Nausea and vomiting caused by chemotherapy

Children over 6 months of age and adolescents

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

Usually, twelve hours after chemotherapy, your child will receive ondansetron orally. The usual dose is 4 mg twice daily and may continue for up to 5 days.

Postoperative nausea and vomiting

Adults

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

Children

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

Dose adjustments

Patients with hepatic impairment

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

Elderly patients, patients with renal impairment, or slow metabolizers of sparteine/debrisoquine

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

Duration of treatment

Your doctor will decide how long you should take Zofran. Do not stop treatment early.

If you think that 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 occur include: vision problems, low blood pressure (which may cause dizziness or fainting), and palpitations (irregular heartbeat).

If you or your child takes more Zofran than you should, speak to a doctor immediately, go to the nearest hospital, or call the Toxicology Information Service at telephone number: 91 5620420, indicating the medicine and the amount ingested. Take the medicine with you.

If you forget to take Zofran

Do not take a double dose to make up for 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 medicine as directed.

If you forget to take a dose and do not experience discomfort, wait until the next scheduled dose and continue taking the medicine as directed.

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

4. Possible adverse effects

Like all medicines, this medicine 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

• sensation of warmth or flushing,
• constipation.

Uncommon adverse effects

May affect up to 1 in 100 patients

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

seizures,

• slow or irregular heartbeat,
• lower than normal blood pressure (hypotension),
• hiccups,
• increased levels in blood tests assessing liver function.

Rare adverse effects

May affect less than 1 in 1,000 patients

• 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,

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

• blurred vision.

• If you experience any of these symptoms, stop taking the medicine immediately and inform 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,

• extensive 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 of 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 inform 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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Zofran

Keep this medicine out of sight and reach of children.

Do not store above 30 °C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point in your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Zofran 4 mg tablets

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

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

Appearance of the product and contents of the pack

Zofran 4 mg tablets are yellow, oval-shaped, film-coated tablets, embossed with "GX ET3" on one side. Packs contain 6, 15 or 500 film-coated tablets.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

BEXAL FARMACÉUTICA, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

LEK Pharmaceuticals d.d.,

Verovškova ulica 57,

1526 Ljubljana,

Slovenia

Date of the most recent revision of this leaflet: May 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es