Zofran zydis

Package leaflet: Information for the patient

Zofran Zydis 8 mg oral lyophilisate
Ondansetron
Please read all of this leaflet before taking this medicine, because it contains important information for you.

• Keep this leaflet for future reference.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

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

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

Zofran Zydis contains the active substance ondansetron. This substance belongs to a group of medicines called antiemetics. Zofran Zydis is in the form of an oral lyophilisate that dissolves rapidly when placed on the tongue.
Ondansetron is a 5HT3 receptor antagonist. It acts by blocking 5HT3 receptors located on neurons in the peripheral and central nervous systems.
Zofran Zydis is used:

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

Please consult your doctor, nurse, or pharmacist if you need further information about the use of this medicine.

2. Important information before using Zofran Zydis

When not to use Zofran Zydis

• 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 to the patient, they should consult a doctor before using Zofran.

Warnings and precautions
Before starting treatment with Zofran Zydis, 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 Zydis causes dose-dependent QT interval prolongation (manifested as disturbances in heart rhythm). Cases of ventricular tachycardia of the Torsade de Pointes type (life-threatening heart rhythm disturbances) have been rarely observed in patients treated with this medicine. This mainly concerns patients with electrolyte imbalances (abnormal levels of potassium, sodium, and magnesium in the body), patients with congenital long QT syndrome (a heart condition characterized by irregular heartbeat), congestive heart failure, bradycardia (abnormally slow and irregular heartbeat), or patients taking medications that cause QT interval prolongation;
• the patient is taking medicines belonging to the group of selective serotonin reuptake inhibitors (SSRIs) or serotonin-noradrenaline reuptake inhibitors (SNRIs) used to treat depression and/or anxiety disorders, because concomitant use with Zofran Zydis may lead to serotonin syndrome. If simultaneous use of Zofran Zydis and these medicines is necessary, the patient will be under appropriate medical supervision. Symptoms of serotonin syndrome include headache, hallucinations, accelerated thought process, confusion, anxiety, insomnia, temporary difficulty concentrating, elevated body temperature, muscle stiffness, seizures, excessive sweating, high blood pressure, rapid heartbeat, nausea, vomiting, diarrhea, skin flushing, and dilated pupils. If any of these symptoms occur, inform the doctor immediately.

Hypokalaemia (low potassium levels in the blood) and hypomagnesaemia (low magnesium levels in the blood) should be corrected before administering Zofran Zydis.
Immediately inform the doctor or pharmacist if any of the following symptoms occur during or after treatment with Zofran Zydis:

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

Zofran Zydis and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take. This includes over-the-counter medicines and herbal remedies. This is important because Zofran Zydis may affect the action of certain medicines, and some other medicines may affect the action of Zofran Zydis.
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;
• selective serotonin reuptake inhibitors (SSRIs) (used in the treatment of depression and/or anxiety disorders), including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram;
• serotonin-noradrenaline 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, they should consult a doctor, nurse, or pharmacist before using Zofran Zydis.

Pregnancy and breastfeeding
Do not use Zofran Zydis during pregnancy. Zofran Zydis may have harmful effects on fetal development. This is because Zofran Zydis 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 already 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 Zydis, 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 while taking Zofran Zydis. Consult the doctor about effective contraceptive methods before taking this medicine.
Do not breastfeed while taking Zofran Zydis, as small amounts of the medicine pass into breast milk. Consult a doctor or midwife.

Driving and operating machinery
It has not been shown that Zofran Zydis impairs ability to perform tasks or causes sedation.

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

Aspartame
The medicine contains 1.25 mg of aspartame in the 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 improper excretion. If the patient has the inherited condition phenylketonuria, inform the doctor before using the medicine.

Sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate
The medicine may cause allergic reactions (including delayed-type reactions).

Ethanol
This medicine contains up to 0.06 mg of alcohol (ethanol) in the 8 mg dose. The amount of alcohol in this dose is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not cause noticeable effects.

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

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

3. How to take Zofran Zydis

This medicine should always be taken exactly as prescribed by your doctor. If you have any doubts, you should 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 induced by moderately emetogenic chemotherapy and tumour radiotherapy

On the day of chemotherapy or radiotherapy:

• the usual dose is 1 lyophilisate containing 8 mg (8 mg ondansetron) taken one or two hours before treatment, and 1 lyophilisate containing 8 mg (8 mg ondansetron) twelve hours later.

On subsequent days:

• the usual dose is 1 lyophilisate containing 8 mg (8 mg ondansetron) twice daily;
• this dose may be used for up to 5 days.

If the prescribed chemotherapy causes severe nausea and vomiting, during the first 24 hours the patient may receive ondansetron only in intravenous, intramuscular, or rectal forms. The dose will be determined by the doctor. In subsequent days, treatment continues as for moderately emetogenic chemotherapy.

Prevention and treatment of postoperative nausea and vomiting

To prevent postoperative nausea and vomiting, the usual dose is 2 lyophilisates containing 8 mg each (16 mg ondansetron) taken one hour before surgery.

For treatment of nausea and vomiting in the postoperative period, ondansetron should be administered intravenously or intramuscularly.

Children aged 6 months and older and adolescents

Prevention and control of nausea and vomiting induced by cancer chemotherapy

The doctor will decide which dose should be used.

On the day of chemotherapy:

• immediately 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 lyophilisates; they should be treated with syrup;
  • children with body weight above 10 kg: 4 mg ondansetron.

On subsequent days:

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

If a 4 mg dose of ondansetron is required, another medicinal product containing 4 mg ondansetron should be used. The maximum daily dose is 32 mg ondansetron given in divided doses.

Prevention and treatment of postoperative nausea and vomiting

In children over one month of age and in adolescents, ondansetron is recommended in the form of injection solution.

Patients with moderate or severe liver disease

The daily dose should not exceed 8 mg.

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

• Do not remove the lyophilisate from the blister until the patient is ready to take the medicine.

• Before taking Zofran Zydis, check whether the foil packaging (blister) has been punctured.

• Warning: Do not push the Zofran Zydis lyophilisate through the foil as is done with ordinary tablets. This is important because the Zofran Zydis lyophilisate is fragile and may break.

  1. Tear off the section of the foil (blister) containing one Zofran Zydis lyophilisate.
  2. Peel back the foil at the area indicated by arrows.
  3. Gently push the lyophilisate out.
  4. Place the Zofran Zydis lyophilisate on the surface of the tongue. The medicine will dissolve quickly. Then swallow it.

Zofran Zydis should start working within one to two hours after taking the dose.

If vomiting occurs within one hour after taking the dose:

• take the same dose of medicine again;
• in all 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 Zydis:

If an adult or child takes more than the recommended dose of Zofran Zydis, 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 Zydis:

If a dose of Zofran Zydis is missed and nausea or vomiting occurs, you should:

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

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

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

4. Possible adverse reactions

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

• sudden wheezing, chest pain or tightness;
• 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
• chest tightness

Other possible adverse reactions:
Other possible adverse reactions include those listed below. If these effects become severe, inform the 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 flushing;
• constipation.

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

• hiccups;
• low blood pressure, which may cause fainting or dizziness;
• abnormally slow or irregular heartbeat (rhythm disturbances);
• chest pain;
• seizures;
• unusual body movements or tremors;
• 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 type Torsade de Pointes.

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

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

Reporting of adverse reactions
If any adverse reactions occur, including any 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 Zydis

• Keep the medicine out of the sight and reach of children.
• Do not use Zofran Zydis after the expiry date stated on the carton and blister after: “Expiry date (EXP)”. The expiry date refers to the last day of the stated month.
• Store below 30 °C.
• The Zofran Zydis lyophilisate should be removed from the foil (blister) immediately before administration.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Zofran Zydis contains

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

*The 8 mg lyophilisate contains up to 0.06 mg ethanol, 0.00005 mg benzyl alcohol, 0.144 mg
propylene glycol)
What Zofran Zydis looks like and contents of the pack
Zofran Zydis is a white, round oral lyophilisate.
The 8 mg oral lyophilisate contains 8 mg of active substance (ondansetron).
The pack contains 10 units.
Marketing Authorisation 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 Warszawa
LEK Pharmaceuticals d.d.,
Verovškova ulica 57,
1526 Ljubljana,
Slovenia