Zofran

Package leaflet: Information for the patient

Zofran, 4 mg, film-coated tablets
Zofran, 8 mg, film-coated tablets
Ondansetron
Please read the entire leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse.

Leaflet contents:

1. What Zofran is and what it is used for
2. Important information before using Zofran
3. How to use 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 contains the active substance – ondansetron. This substance belongs to a group of medicines called antiemetics.
Ondansetron is a 5HT receptor antagonist. It acts by blocking 5HT receptors located in the peripheral and central nervous system.
Zofran is used:

• to prevent and control nausea and vomiting caused by chemotherapy and radiotherapy for cancer (in adults),
• to prevent nausea and vomiting after surgical operations (in adults),
• to prevent and control nausea and vomiting caused by chemotherapy (in children).

Consult your doctor, nurse, or pharmacist if you need further information regarding the use of this medicine.

2. Important information before using Zofran

When not to use Zofran

• If the patient is taking apomorphine (used in the treatment of Parkinson's disease);
• If the patient is allergic to ondansetron or any of the other ingredients of this medicine (listed in section 6). If any of the above situations apply, the patient should consult a doctor before using Zofran.

Warnings and precautions
Before starting treatment with Zofran, discuss with a doctor or pharmacist if:

• the patient is allergic to medicines similar to ondansetron, such as granisetron or palonosetron;
• the patient has liver disease;
• the patient has intestinal obstruction;
• the patient has or may develop QT interval prolongation (a measurement on the ECG). Zofran causes dose-dependent QT interval prolongation (which may manifest as heart rhythm disturbances). Cases of ventricular tachycardia of the Torsade de Pointes type (a life-threatening heart rhythm disorder) have been rarely observed in patients receiving this medicine. This mainly concerns patients with electrolyte imbalances (abnormal levels of potassium, sodium, and magnesium in the body), congenital long QT syndrome (a heart condition causing irregular heartbeat), congestive heart failure, bradycardia (abnormally slow and irregular heartbeat), or those taking medicines that cause QT interval prolongation;
• the patient is taking medicines belonging to the group of selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs), used to treat depression and (or) anxiety disorders, because concomitant use of Zofran with these medicines may lead to serotonin syndrome. If simultaneous use of Zofran and these medicines is necessary, the patient will be under appropriate medical supervision. Serotonin syndrome includes headache, hallucinations, accelerated thought process, confusion, anxiety, insomnia, temporary concentration problems, elevated body temperature, muscle stiffness, seizures, excessive sweating, high blood pressure, rapid heartbeat, nausea, vomiting, diarrhea, skin redness, and dilated pupils. If any of these symptoms occur, inform the doctor immediately.

Before using Zofran, hypokalemia (low potassium levels in the blood) and hypomagnesemia (low magnesium levels in the blood) should be corrected.
Immediately inform the doctor or pharmacist if the patient experiences any of the following symptoms during or after treatment with Zofran:

• sudden chest pain or chest tightness (myocardial ischemia).

Zofran and other medicines
Inform the doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines the patient plans to take. This includes over-the-counter medicines and herbal remedies. This is important because Zofran may affect the action of certain medicines, and some other medicines may affect the action of Zofran. In particular, inform the doctor, nurse, or pharmacist if the patient is taking any of the following medicines:

• carbamazepine or phenytoin (used in the treatment of epilepsy);
• rifampicin (used to treat infections such as tuberculosis);
• tramadol (a painkiller);
• medicines affecting the heart, including those affecting the QT interval;
• medicines causing electrolyte imbalances;
• medicines used in cancer treatment (especially anthracyclines);
• antibiotics such as erythromycin or ketoconazole;
• medicines belonging to the group of selective serotonin reuptake inhibitors (SSRIs) (used in the treatment of depression and (or) anxiety disorders), including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram;
• medicines belonging to the group of serotonin-norepinephrine reuptake inhibitors (SNRIs) (used in the treatment of depression and (or) anxiety disorders), including venlafaxine and duloxetine. If the patient is unsure whether any of the above situations apply, consult a doctor, nurse, or pharmacist before using Zofran.

Pregnancy and breastfeeding
Zofran should not be used during pregnancy. Zofran may have harmful effects on fetal development. This is because Zofran may slightly increase the risk of cleft lip and (or) cleft palate [an opening or fissure in the upper lip and (or) palate]. If the patient is pregnant, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Before starting treatment with Zofran, the doctor will check whether a woman of childbearing potential is pregnant and, if necessary, perform a pregnancy test. Sexually active women should use an effective method of contraception during treatment with Zofran.
Ask the doctor about effective methods of contraception before taking this medicine.
Breastfeeding should be avoided during treatment with Zofran, as small amounts of the medicine pass into breast milk. Consult a doctor or midwife.

Driving and operating machinery
Zofran has not been shown to impair the ability to perform tasks or cause sedation.

Zofran contains anhydrous lactose
The medicine contains 81.875 mg of anhydrous lactose per 4 mg dose. The medicine contains 163.75 mg of anhydrous lactose per 8 mg dose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Zofran

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure,
contact your doctor, nurse, or pharmacist again. The prescribed dose of the medicine depends on
the treatment being administered to the patient.
Adults
Prevention and control of nausea and vomiting caused by moderately emetogenic chemotherapy and radiotherapy for cancer
On the day chemotherapy or radiotherapy is administered:

• the usual dose is 2 tablets of 4 mg or 1 tablet of 8 mg (8 mg of ondansetron) taken one or two hours before treatment, and then 2 tablets of 4 mg or 1 tablet of 8 mg (8 mg of ondansetron) twelve hours later.
  On subsequent days:
• the usual dose is 2 tablets of 4 mg or 1 tablet of 8 mg (8 mg of ondansetron) twice daily;
• this dose may be continued for up to 5 days.

If the prescribed chemotherapy causes severe nausea and vomiting, during the first 24 hours the
patient may receive Zofran only in intravenous, intramuscular, or rectal forms. The dose will be
determined by the doctor. In subsequent days, the medicine is administered as in the case of
moderately emetogenic chemotherapy.
Prevention and treatment of nausea and vomiting after surgery
To prevent nausea and vomiting after surgery, the usual dose in adults is 4 tablets of 4 mg or 2 tablets of 8 mg (16 mg of ondansetron) taken one hour before surgery.
For treatment of nausea and vomiting in the postoperative period, ondansetron is recommended to be administered intravenously or intramuscularly.
Children aged 6 months and older and adolescents
Prevention and control of nausea and vomiting caused by cancer chemotherapy
The doctor will decide which dose to use.
On the day chemotherapy is administered:

• just before starting chemotherapy, the doctor or nurse will administer the first dose of ondansetron intravenously as an injection solution;
• 12 hours after chemotherapy, the medicine is usually given orally in the following doses:
  • children with body weight up to 10 kg should not be given tablets; they should be treated with syrup,
  • children with body weight above 10 kg - 1 tablet of 4 mg (4 mg of ondansetron).
    On subsequent days:
• oral doses as above, twice daily for up to 5 days.

The maximum daily dose is 32 mg of ondansetron, given in divided doses.
Prevention and treatment of nausea and vomiting after surgery
In children aged one month and older and in adolescents, Zofran is recommended in the form of injection solution.
Patients with moderate or severe liver disease
The daily dose should not exceed 8 mg.
Zofran should start working within one to two hours after taking a dose.
If vomiting occurs within one hour after taking a dose of medicine:

• take the same dose again;
• in other cases, do not take a higher dose than prescribed by your doctor. If nausea persists, inform your doctor or nurse.

Taking more than the recommended dose of Zofran:
If an adult or child takes more than the recommended dose of Zofran, contact your doctor immediately or go to hospital. Take the medicine packaging with you.
In most cases of overdose, symptoms similar to adverse reactions are observed (see section 4).
Missing a dose of Zofran
If a dose of Zofran is missed and nausea or vomiting occurs, you should:

• take the missed dose of Zofran as soon as possible, then
• take the next dose at the usual time (as prescribed by your doctor);
• do not take a double dose to make up for the missed dose.

If a dose of Zofran is missed and no nausea or vomiting occurs, you should:

• take the next dose at the usual time (as prescribed by your doctor);
• do not take a double dose to make up for the missed dose.

4. Possible adverse reactions

Like all medicines, Zofran may cause adverse reactions, although not everyone will experience them.
Some adverse reactions may be serious
You should STOP taking Zofran and seek immediate medical help if any of the following symptoms occur in the patient:
Severe allergic reactions: These occur rarely in people taking Zofran.
Symptoms include:

• sudden wheezing, chest pain or tightness in the chest;
• swelling of the eyelids, face, lips, mouth or tongue;
• rash – red spots or patches under the skin anywhere on the body (urticaria);
• fainting.

Myocardial ischaemia
Symptoms include:

• sudden chest pain or
• tightness in the chest

Other possible adverse reactions:
Other possible adverse reactions include the following, listed below. If any of these effects become severe, inform your doctor, pharmacist or healthcare provider.
Very common (occur in more than 1 in 10 patients)

• headache.

Common (occur in no more than 1 in 10 patients)

• feeling of warmth or skin flushing;
• constipation.

Uncommon (occur in no more than 1 in 100 patients)

• hiccups;
• low blood pressure, which may cause fainting or dizziness;
• too slow or irregular heartbeat (arrhythmias);
• chest pain;
• seizures;
• unusual body movements or tremor;
• changes in liver function test results.

Rare (occur in no more than 1 in 1,000 patients)

• dizziness;
• blurred vision;
• heart rhythm disorders (sometimes leading to sudden loss of consciousness), including life-threatening ventricular tachycardia of the Torsade de Pointes type.

Very rare (occur in no more than 1 in 10,000 patients)

• widespread blistering rash with peeling of the skin, affecting a large part of the body (toxic epidermal necrolysis);
• impaired vision or transient vision loss, which usually resolves within 20 minutes.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder. Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Zofran

• Keep the medicine out of the sight and reach of children.
• Do not use Zofran after the expiry date stated on the carton and blister. The expiry date refers to the last day of the stated month.
• Store below 30 °C.
• If your doctor advises you to stop taking Zofran, return any unused tablets to the pharmacist.

6. Contents of the packaging and other information

What Zofran contains

• The active substance is ondansetron. Each tablet contains 4 mg or 8 mg of ondansetron.
• The other ingredients are: anhydrous lactose, microcrystalline cellulose, pregelatinized corn starch, magnesium stearate, hypromellose, titanium dioxide (E171), and yellow iron oxide (E172).

What Zofran looks like and contents of the pack

• Zofran coated tablets are yellow, oval-shaped, and available in two strengths.
• The 4 mg tablets contain 4 mg of the active substance (ondansetron) and are marked with the code "GXET3", with the other side being smooth.
• The 8 mg tablets contain 8 mg of the active substance (ondansetron) and are marked with the code "GXET5", with the other side being smooth.

Zofran tablets are available in packs containing 10 tablets.
Marketing Authorisation Holder:
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria
Manufacturer/Importer:
LEK Pharmaceuticals d.d.,
Verovškova ulica 57,
1526 Ljubljana,
Slovenia