Zofran

Leaflet attached to the packaging: patient information

Zofran, 4 mg, coated tablets

Zofran, 8 mg, coated tablets

Ondansetron

You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not mentioned in this leaflet, they should tell their doctor, pharmacist, or nurse.

Table of contents of the leaflet:

• 1. What is Zofran and what is it used for
• 2. Important information before taking Zofran
• 3. How to take Zofran
• 4. Possible side effects
• 5. How to store Zofran
• 6. Package contents and other information

1. What is Zofran and what is it used for

Zofran contains the active substance – ondansetron. This substance belongs to the group of antiemetic medicines.
Ondansetron is a 5HT receptor antagonist. It works by blocking the 5HT receptors of neurons located in the peripheral and central nervous system.
Zofran is used for:

• preventing and treating nausea and vomiting caused by chemotherapy and radiotherapy of tumors (in adults),
• preventing nausea and vomiting after surgical operations (in adults),
• preventing and treating nausea and vomiting caused by chemotherapy (in children).

You should consult a doctor, nurse, or pharmacist if the patient needs additional information about taking the medicine.

2. Important information before taking Zofran

When not to take Zofran

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

Warnings and precautions

Before starting to take Zofran, the patient should discuss it with their 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 have a prolonged QT interval (a section measured in an ECG recording). Zofran can cause a prolonged QT interval (manifested as heart rhythm disturbances) in a dose-dependent manner. In patients taking this medicine, rare cases of life-threatening heart rhythm disturbances (Torsade de Pointes) have been observed. This mainly applies to patients with electrolyte disturbances (disturbances in the concentration of potassium, sodium, and magnesium in the body), patients with congenital long QT syndrome (a heart condition characterized by irregular heartbeat), heart failure, bradycardia (too slow and irregular heart rate), or patients taking medicines that cause a prolonged QT interval;
• the patient is taking selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) used to treat depression and/or anxiety disorders, as concomitant use with Zofran may cause serotonin syndrome. If concomitant use of Zofran and these medicines is necessary, the patient will be under medical supervision. The syndrome includes headache, hallucinations, accelerated thinking, confusion, anxiety, insomnia, temporary concentration problems, elevated body temperature, muscle stiffness, seizures, excessive sweating, hypertension, rapid heartbeat, nausea, vomiting, diarrhea, skin redness, and dilated pupils. If these symptoms occur, the patient should tell their doctor.

Before taking Zofran, the patient should correct hypokalemia (low potassium levels in the blood) and hypomagnesemia (low magnesium levels in the blood).

The patient should immediately tell their doctor or pharmacist if they experience any of the following symptoms during and after treatment with Zofran:

• if the patient experiences sudden chest pain or chest tightness (myocardial ischemia).

Zofran and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This includes medicines that are available without a prescription and herbal medicines. This is important because Zofran may affect the action of some medicines. Also, some other medicines may affect the action of Zofran.
In particular, the patient should tell their doctor, nurse, or pharmacist if they are taking any of the following medicines:

• carbamazepine or phenytoin (used to treat epilepsy);
• rifampicin (used to treat infections such as tuberculosis);
• tramadol (a pain reliever);
• medicines that affect the heart, including those that affect the QT interval;
• medicines that cause electrolyte disturbances;
• medicines used to treat cancer (especially anthracyclines);
• antibiotics such as erythromycin or ketoconazole;
• selective serotonin reuptake inhibitors (SSRIs) (used to treat depression and/or anxiety disorders), including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, and escitalopram;
• serotonin-norepinephrine reuptake inhibitors (SNRIs) (used to treat depression and/or anxiety disorders), including venlafaxine and duloxetine. If the patient is not sure if the above situations apply to them, they should consult their doctor, nurse, or pharmacist before taking Zofran.

Pregnancy and breastfeeding

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Zofran should not be taken during pregnancy. Zofran may have a harmful effect on fetal development. This is because Zofran may slightly increase the risk of cleft lip and/or palate [an opening or fissure in the upper lip and/or palate].
If the patient is already pregnant, suspects they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Before starting to take Zofran, the doctor will check if the patient of childbearing age is pregnant and, if necessary, perform a pregnancy test. Sexually active women should use effective contraception while taking Zofran.
Before taking this medicine, the patient should ask their doctor about effective contraception methods.
Zofran should not be taken during breastfeeding, as small amounts of the medicine pass into breast milk. The patient should consult their doctor or midwife.

Driving and operating machinery

It has not been shown that Zofran impairs the performance of tasks or causes sedation.

Zofran contains lactose

The medicine contains 81.875 mg of lactose per 4 mg dose. The medicine contains 163.75 mg of lactose per 8 mg dose. If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Zofran

This medicine should always be taken according to the doctor's instructions. In case of doubts, the patient should contact their doctor, nurse, or pharmacist again. The prescribed dose of the medicine depends on the treatment used in the patient.

Adults Prevention and treatment of nausea and vomiting caused by chemotherapy with moderate emetogenic potential and radiotherapy of tumors

On the day of chemotherapy or radiotherapy:

• the usual dose is 2 tablets of 4 mg or 1 tablet of 8 mg (8 mg of ondansetron) taken 1-2 hours before treatment and 2 tablets of 4 mg or 1 tablet of 8 mg (8 mg of ondansetron) 12 hours later; In subsequent days:
• the usual dose is 2 tablets of 4 mg or 1 tablet of 8 mg (8 mg of ondansetron) twice a day;
• such a dose may be taken for a period of up to 5 days.

If the prescribed chemotherapy causes severe nausea and vomiting, on the first day of treatment, the patient may receive Zofran only in injectable, intramuscular, or rectal forms. The doctor will decide on the dose. In subsequent days, the medicine is taken as in the case of chemotherapy with moderate emetogenic potential.
Prevention and treatment of nausea and vomiting after surgical operations
To prevent nausea and vomiting after surgical operations, the usual dose in adults is 4 tablets of 4 mg or 2 tablets of 8 mg (16 mg of ondansetron) taken 1 hour before the operation.
To treat nausea and vomiting in the postoperative period, it is recommended to administer ondansetron intravenously or intramuscularly.

Children aged 6 months and older and adolescents

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Prevention and treatment of nausea and vomiting caused by chemotherapy
The doctor will decide what dose to use.
On the day of chemotherapy:

• immediately before starting chemotherapy, the doctor or nurse will administer the first dose of ondansetron in the form of an injection solution;
• 12 hours after chemotherapy, the medicine is usually administered orally in the following doses:
  • for children with a body weight of up to 10 kg, tablets are not given, but syrup is used instead;
  • for children with a body weight over 10 kg, 1 tablet of 4 mg (4 mg of ondansetron) is given.
  In subsequent days:
• oral doses as above, twice a day, for a period of up to 5 days.

The maximum daily dose is 32 mg of ondansetron in divided doses.
Prevention and treatment of nausea and vomiting after surgical operations
In children aged 1 month and older and in adolescents, it is recommended to use Zofran in the form of an injection solution.

Patients with moderate or severe liver disease

The dose should not exceed 8 mg per day.
Zofran should start working within 1-2 hours of taking the dose.

If vomiting occurs within 1 hour of taking the dose:

• the patient should take the same dose again;
• in other cases, the patient should not take a higher dose than prescribed by the doctor. If the patient still has nausea, they should inform their doctor or nurse.

Taking a higher dose of Zofran than recommended:

If an adult or childtakes a higher dose of Zofran than recommended, they should immediately contact their doctor or go to the hospital. They should take the packaging of the medicine with them.
In most cases of overdose, symptoms similar to side effects (see section 4) are observed.

Missing a dose of Zofran

If the patient misses a dose of Zofran, if they have nausea or vomiting, they should:

• take the dose of Zofran as soon as possible, and then
• take the next dose at the usual time (according to the doctor's instructions);
• not take a double dose to make up for the missed dose.

If the patient misses a dose of Zofran, if they do not have nausea or vomiting, they should:

• take the next dose at the usual time (according to the doctor's instructions);
• not take a double dose to make up for the missed dose.

4. Possible side effects

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

Some side effects may be serious

The patient should STOPtaking Zofran and seek medical help immediately if they experience any of the following symptoms:
Severe allergic reactions:These occur rarely in people taking Zofran.
Symptoms include:

• sudden wheezing, chest pain or tightness; 4 addition BRS
• swelling of the eyelids, face, lips, mouth, or tongue;
• hives - red spots or patches under the skin anywhere on the body;
• fainting.

Myocardial ischemia

Symptoms include:

• sudden chest pain or
• chest tightness

Other possible side effects:

Other possible side effects include the following effects listed below. If these effects become severe, the patient should tell their doctor, pharmacist, or healthcare provider.

Very common (occurring in more than 1 in 10 patients)

• headache.

Common (occurring in less than 1 in 10 patients)

• feeling of warmth or skin redness;
• constipation.

Uncommon (occurring in less than 1 in 100 patients)

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

Rare (occurring in less than 1 in 1000 patients)

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

Very rare (occurring in less than 1 in 10,000 patients)

• widespread rash with blisters and skin peeling, covering a large area of the body (toxic epidermal necrolysis)
• visual impairment or transient blindness, which usually resolves within 20 minutes.

Reporting side effects

If side effects occur, including any side effects not mentioned in this leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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.
Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Zofran

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• The medicine should be stored out of sight and reach of children.
• Zofran should not be taken after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month.
• Store in a temperature below 30°C.
• If the doctor advises stopping treatment with Zofran, unused tablets should be returned to the pharmacist.

6. Package contents and other information

What Zofran contains

• The active substance of Zofran is ondansetron. Each tablet contains 4 mg or 8 mg of ondansetron.
• The other ingredients are: lactose, microcrystalline cellulose, maize 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, and come in two strengths.
• 4 mg tablets contain 4 mg of the active substance (ondansetron) and are marked with "GXET3" and are smooth on the other side
• 8 mg tablets contain 8 mg of the active substance (ondansetron) and are marked with "GXET5" and are smooth on the other side.

Zofran tablets are available in packs containing 10 tablets.

Marketing authorization holder:

Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria

Manufacturer/Importer:

Novartis Poland Sp. z o.o.
ul. Marynarska 15
02-674 Warsaw
GlaxoSmithKline Pharmaceuticals S.A.
ul. Grunwaldzka 189
60-322 Poznań
Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg
Germany
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
LEK Pharmaceuticals d.d.,
Verovškova ulica 57,
1526 Ljubljana,
Slovenia
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Date of last revision of the leaflet:04/2024
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