ZOFRAN 8 mg Lyophilizate

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Zofran Zydis 8 mg oral lyophilisate
   1. You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Zofran Zydis and what is it used for
4. Important information before taking Zofran Zydis
   1. When not to take Zofran Zydis
   2. Warnings and precautions
   3. The patient should immediately inform their doctor or pharmacist if they experience any of the following symptoms during and after treatment with Zofran Zydis:
   4. Zofran Zydis and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and operating machinery
   7. Zofran Zydis contains aspartame, methyl parahydroxybenzoate sodium, propyl parahydroxybenzoate sodium, ethanol, benzyl alcohol, and sodium
   8. Aspartame
   9. Methyl parahydroxybenzoate and propyl parahydroxybenzoate
   10. Etanol
   11. Benzyl alcohol
   12. Sodium
5. How to take Zofran Zydis
   1. Adults Prevention and treatment of nausea and vomiting caused by chemotherapy with moderate emetogenic potential and radiotherapy for cancer
   2. Children aged 6 months and older and adolescents Prevention and treatment of nausea and vomiting caused by cancer chemotherapy
   3. Patient with moderate or severe liver disease
   4. How to remove Zofran Zydis lyophilisate from the blister and how to take the medicine
   5. In case of vomiting within 1 hour after taking the dose:
   6. Taking a higher dose of Zofran Zydis than recommended:
   7. Missing a dose of Zofran Zydis:
6. Possible side effects
   1. Some side effects may be serious
   2. Myocardial ischemia
   3. Other possible side effects:
   4. Very common (occurring in more than 1 in 10 patients)
   5. Common (occurring in up to 1 in 10 patients)
   6. Uncommon (occurring in up to 1 in 100 patients)
   7. Rare (occurring in up to 1 in 1,000 patients)
   8. Very rare (occurring in up to 1 in 10,000 patients)
   9. Reporting side effects
7. How to store Zofran Zydis
8. Contents of the packaging and other information
   1. What Zofran Zydis contains
   2. What Zofran Zydis looks like and what the packaging contains
   3. Marketing authorization holder:
   4. Manufacturer/Importer:
   5. Date of last revision of the leaflet: 05/2024

Leaflet accompanying the packaging: patient information

Zofran Zydis 8 mg oral lyophilisate

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 their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

1. What is Zofran Zydis and what is it used for

Zofran Zydis contains the active substance ondansetron. This substance belongs to a group of antiemetic medicines. Zofran Zydis is in the form of a lyophilisate, which dissolves very quickly when placed on the surface of the tongue.
Ondansetron is a 5HT3 receptor antagonist. It works by blocking the action of 5HT3 receptors in the peripheral and central nervous system.
Zofran Zydis is used for:

• preventing and treating nausea and vomiting caused by cancer chemotherapy and radiotherapy (in adults),
• preventing nausea and vomiting after surgical operations (in adults),
• preventing and treating nausea and vomiting caused by cancer 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 Zydis

When not to take Zofran Zydis

• 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 Zydis.

Warnings and precautions

Before starting to take Zofran Zydis, 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). Zofran Zydis can cause a prolonged QT interval (leading to heart rhythm disturbances) in a dose-dependent manner. In patients taking this medicine, rare cases of life-threatening ventricular tachycardia of the Torsade de Pointes type have been observed. This mainly affects patients with electrolyte disturbances (abnormal levels of potassium, sodium, and magnesium in the body), patients with congenital long QT syndrome (a heart condition characterized by irregular heartbeat), heart failure, bradycardia (abnormally slow and irregular heartbeat), or patients taking medicines that prolong the 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 Zydis may cause serotonin syndrome. If concomitant use of Zofran Zydis and these medicines is necessary, the patient will be under medical supervision. The syndrome includes headache, hallucinations, accelerated thinking, confusion, agitation, insomnia, temporary concentration problems, elevated body temperature, muscle stiffness, seizures, excessive sweating, hypertension, accelerated heart rate, nausea, vomiting, diarrhea, skin redness, and pupil dilation. If these symptoms occur, the patient should inform their doctor.

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

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

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

Zofran Zydis and other medicines

The patient should tell their doctor or pharmacist about all medicines they are 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 Zydis may affect the action of some medicines. Also, some other medicines may affect the action of Zofran Zydis.
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;
• medicines from the group of selective serotonin reuptake inhibitors (SSRIs) (used to treat depression and/or anxiety disorders), including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, and escitalopram;
• medicines from the group of serotonin-norepinephrine reuptake inhibitors (SNRIs) (used to treat depression and/or anxiety disorders), including venlafaxine and duloxetine. If the patient is unsure whether the above situations apply to them, they should consult a doctor, nurse, or pharmacist before taking Zofran Zydis.

Pregnancy and breastfeeding

Zofran Zydis should not be taken during pregnancy. Zofran Zydis may have a harmful effect on fetal development. This is because Zofran Zydis may slightly increase the risk of cleft lip and/or palate (a hole or slit 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 a doctor or pharmacist before taking this medicine.
Before starting to take Zofran Zydis, 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 Zydis. The patient should ask their doctor about effective methods of contraception.
Zofran Zydis should not be taken during breastfeeding, as small amounts of the medicine pass into breast milk. The patient should consult a doctor or midwife.

Driving and operating machinery

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

Zofran Zydis contains aspartame, methyl parahydroxybenzoate sodium, propyl parahydroxybenzoate sodium, ethanol, benzyl alcohol, and sodium

Aspartame

The medicine contains 1.25 mg of aspartame per 8 mg dose. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its abnormal excretion. If the patient has the genetic disorder phenylketonuria, they should inform their doctor before taking the medicine.

Methyl parahydroxybenzoate and propyl parahydroxybenzoate

The medicine may cause allergic reactions (possible late reactions).

Etanol

This medicine contains up to 0.06 mg of ethanol per 8 mg dose. The amount of ethanol in this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of ethanol in this medicine will not have noticeable effects.

Benzyl alcohol

The medicine contains 0.00005 mg of benzyl alcohol per 8 mg dose. Benzyl alcohol may cause allergic reactions.

Sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

3. How to take Zofran Zydis

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 the patient is undergoing.

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

On the day of chemotherapy or radiotherapy

• the usual dose is 1 lyophilisate of 8 mg (8 mg of ondansetron) taken 1-2 hours before treatment and 1 lyophilisate of 8 mg (8 mg of ondansetron) 12 hours later.

In subsequent days

• the usual dose is 1 lyophilisate of 8 mg (8 mg of ondansetron) twice a day;
• such a dose may be taken for up to 5 days.

If the prescribed chemotherapy causes severe nausea and vomiting, on the first day of treatment, the patient may receive ondansetron only in intravenous, 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 surgery
To prevent nausea and vomiting after surgery, the usual dose is 2 lyophilisates of 8 mg (16 mg of ondansetron) taken 1 hour before surgery.
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 Prevention and treatment of nausea and vomiting caused by cancer chemotherapy

The doctor will decide on the dose to be taken.
On the day of chemotherapy:

• the first dose of ondansetron is usually administered intravenously by a doctor or nurse before the start of chemotherapy;
• 12 hours after chemotherapy, the medicine is usually taken orally in the following doses:
  • for children with a body weight of up to 10 kg, lyophilisates are not administered, but a syrup is used instead;
  • for children with a body weight over 10 kg, 4 mg of ondansetron.

In subsequent days:

• oral doses as above, twice a day, for up to 5 days.

If it is necessary to take a dose of 4 mg of ondansetron, the patient should take a different medicinal product containing 4 mg of ondansetron. The maximum daily dose is 32 mg of ondansetron in divided doses.
Prevention and treatment of nausea and vomiting after surgery
In children over one month and adolescents, it is recommended to use ondansetron in the form of an injection solution.

Patient with moderate or severe liver disease

The dose should not exceed 8 mg per day.

How to remove Zofran Zydis lyophilisate from the blister and how to take the medicine

• The lyophilisate should not be removed from the blister until the patient is ready to take the medicine.
• Before taking Zofran Zydis, the patient should check if the foil packaging (blister) has been punctured.
• Warning:The patient should not push the Zofran Zydis lyophilisate through the foil, as they would with ordinary tablets. This is important because the Zofran Zydis lyophilisate is fragile and may break.
• 1. Tear off the fragment of the foil (blister) containing one Zofran Zydis lyophilisate.
• 2. Remove the foil layer at the point indicated by the arrows.
• 3. Gently push the Zofran Zydis lyophilisate.
• 4. Place the Zofran Zydis lyophilisate on the surface of the tongue. The medicine will dissolve quickly. Then, the patient should swallow it.

Zofran Zydis should start working within 1-2 hours after taking the dose.

In case of vomiting within 1 hour after 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 Zydis than recommended:

If an adult or childtakes a higher dose of Zofran Zydis than recommended, they should immediately contact a 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 Zydis:

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

• take the dose of Zofran Zydis as soon as possible, and then
• take the next dose at the usual time (according to the doctor's instructions).
• The patient should not take a double dose to make up for the missed dose. If the patient misses a dose of Zofran Zydis, if nausea or vomiting does not occur, they should:
• take the next dose at the usual time (according to the doctor's instructions).
• The patient should not take a double dose to make up for the missed dose.

4. Possible side effects

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

Some side effects may be serious

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

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

Myocardial ischemia

Symptoms include:

• sudden chest pain or
• pressure in the chest

Other possible side effects:

Other possible side effects include the following effects listed below. If these effects worsen to a severe degree, the patient should inform their doctor, pharmacist, or healthcare provider.

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

• headache.

Common (occurring in up to 1 in 10 patients)

• feeling of warmth or redness;

• constipation.

Uncommon (occurring in up to 1 in 100 patients)

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

Rare (occurring in up to 1 in 1,000 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 up to 1 in 10,000 patients)

• widespread rash with blisters and peeling of the skin, 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 those not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Zofran Zydis

• The medicine should be stored out of sight and reach of children.
• Zofran Zydis should not be taken after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month stated.
• Store at a temperature below 30°C.
• Zofran Zydis lyophilisate should be removed from the foil (blister) immediately before taking.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the packaging and other information

What Zofran Zydis contains

• The active substance of the medicine is ondansetron. Each Zofran Zydis lyophilisate contains 8 mg of ondansetron.
• The other ingredients are: gelatin, mannitol, aspartame, methyl parahydroxybenzoate sodium, propyl parahydroxybenzoate sodium, and strawberry flavor (*contains ethanol, benzyl alcohol, and propylene glycol (E 1520)).

* The 8 mg lyophilisate contains up to 0.06 mg of ethanol, 0.00005 mg of benzyl alcohol, and 0.144 mg of propylene glycol.

What Zofran Zydis looks like and what the packaging contains

Zofran Zydis is a white, round oral lyophilisate.
The 8 mg oral lyophilisate contains 8 mg of the active substance (ondansetron).
The packaging contains 10 units.

Marketing authorization holder:

Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria
tel. 22 209 70 00

Manufacturer/Importer:

Novartis Poland Sp. z o.o.
ul. Marynarska 15
02-674 Warsaw
Aspen Bad Oldesloe GmbH
Industriestrasse 32 – 36
23843 Bad Oldesloe
Germany
Novartis Pharma GmbH
Roonstraße 25
Nürenberg, 90429
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

Date of last revision of the leaflet: 05/2024