Package Insert: Information for the Patient

Zofran Zydis 4 mg Lyophilized Oral

ondansetron

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
  If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Zofran Zydis and how is it used

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

3. How to take Zofran Zydis

4. Possible adverse effects

5. Storage of Zofran Zydis

6. Contents of the package and additional information

Zofran Zydis belongs to a group of medications called antiemetics. Ondansetron is a 5HT3 receptor antagonist. It acts by inhibiting 5HT3 receptors on neurons located in the central and peripheral nervous systems.

Ondansetron is used for:

- preventing nausea and vomiting caused by:

- chemotherapy in the treatment of cancer in adults and older children aged 6 months and above.

- radiation therapy in the treatment of cancer in adults.

- preventing postoperative nausea and vomiting in adults.

Do not take Zofran Zydis

• If you are allergic (hypersensitive) to ondansetron or any of the components of Zofran Zydis (including those listed in section6).
• If you have or have had anyallergic reaction(hypersensitivity) with other anti-nausea or anti-vomiting medications (for example, granisetron or dolasetron).
• If you are taking apomorphine (a medication used to treat Parkinson's disease).

→ If you consider this applies to you, do not take Zofran Zydis and consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Zofran Zydis.

• If you have a blockage in the intestine or if you suffer from severe constipation.Zofran Zydis may increase the blockage or constipation.
• If you have ever had heart problems, including irregular heart rhythm (arrhythmia).
• If you are undergoing a tonsillectomy.
• If you have liver problems.

If you are to undergo any diagnostic tests (including blood, urine, skin tests that use allergens, etc.) inform your doctor that you are taking this medication, as it may alter the results.

Other medications and Zofran Zydis

Inform your doctor or pharmacist if you are taking or have taken recently or may need to take any other medication.

In particular, it is essential to inform your doctor if you are taking any of the following medications, as it may be necessary to interrupt treatment or adjust the dose of one of them:

• rifampicin(an antibiotic used to treat infections such astuberculosis).
• tramadolandbuprenorphine(medications used to treat severe pain).
• phenytoinorcarbamazepine(medications used to treatepilepsy).
• medications used to treatheart problemssuch as arrhythmias (antiarrhythmics) and/or to treathigh blood pressure(beta-blockers).
• haloperidolormethadone(medications that can affect theheart).
• anthracyclinesandtrastuzumab(medications used to treatcancer).
• fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram(Selective serotonin reuptake inhibitors, used to treat depression and/or anxiety)
• venlafaxine, duloxetine(Selective serotonin and noradrenaline reuptake inhibitors, used to treat depression and/or anxiety).

Inform your doctor or pharmacistif you are taking any of these medications.

Inform your doctor or pharmacist immediately if you notice any of these symptoms during or after treatment

• if you experience sudden chest pain or pressure (myocardial ischemia)

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Zofran Zydis should not be used during the first trimester of pregnancy. This is because Zofran Zydis may slightly increase the risk of a baby being born with cleft lip and/or palate (openings or clefts in the upper lip or palate). If you are already pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using Zofran Zydis, as Zofran Zydis may cause harm to the fetus. If you are a woman of childbearing age, it is recommended that you use an effective contraceptive method.

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

Women of childbearing age should use an effective contraceptive method during treatment with Zofran Zydis. Consult your doctor about the options for contraceptive methods.

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

It is not recommended to breastfeed during treatment with Zofran Zydis, as the ingredients in Zofran Zydis (ondansetron) may pass into breast milk and affect your baby.

Driving and operating machinery

It is unlikely that Zofran Zydis will affect your ability to drive and operate machinery.

Zofran Zydis contains aspartame (E951), sodium para-hydroxybenzoate (E219), sodium para-hydroxybenzoate, and benzyl alcohol (E1519)

This medication contains 0.625mg of aspartame per oral lyophilisate. Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

This medication may cause allergic reactions (possibly delayed) because it contains sodium para-hydroxybenzoate and sodium para-hydroxybenzoate.

This medication contains less than 1 mmol of sodium (23 mg) per oral lyophilisate, which is essentially "sodium-free".

This medication contains 0.000025mg of benzyl alcohol in each oral lyophilisate.

Benzyl alcohol may cause allergic reactions. Benzyl alcohol has been linked to the risk of severe adverse effects that include respiratory problems ("breathing difficulty") in children. Do not administer this medication to your newborn (up to 4weeks old) unless your doctor recommends it. This product should not be used for more than a week in children under 3years old unless your doctor or pharmacist advises it. Consult your doctoror pharmacist if you are pregnant or breastfeeding or if you have liver or kidney diseases. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Your doctor will tell you exactly how much Zofran Zydis you should take.If you are unsure, consult your doctor or pharmacist again.

Remember to take your medicine. Your doctor will tell you how long you should take Zofran Zydis. Do not stop treatment before.

Nausea and vomiting caused by chemotherapy or radiation therapy

Adults

Two oral lyophilisates (8 mg) 1-2 hours before the potentially nausea-causing medical treatment, and then 2 oral lyophilisates (8 mg) 12 hours later.

To prevent nausea and vomiting on subsequent days, continue taking 2 oral lyophilisates (8 mg) every 12 hours for five days.

Nausea and vomiting caused by chemotherapy

Children over 6 months of age and adolescents

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

Normally, 12 hours after chemotherapy, your child will receive ondansetron orally. The usual dose is 4 mg twice a day and may continue for up to 5 days.

Postoperative nausea and vomiting

Adults

To prevent nausea and vomiting after surgery, 4 oral lyophilisates (16 mg) 1 hour before anesthesia.

Children

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

Dose adjustments

Patients with liver insufficiency

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

Older patients, patients with renal insufficiency or slow metabolizers of sparteine/debrisoquine

No adjustment of the daily dose or frequency of the dose or route of administration is necessary.

Treatment duration

Your doctor will decide the duration of your treatment with Zofran Zydis. Do not stop treatment before.

If you think the action of Zofran Zydis is too strong or too weak, tell your doctor or pharmacist.

Zofran Zydis is a type of oral lyophilisate that, when deposited on the top of the tongue, disappears very quickly.

Separate the upper aluminum sheet from a blister and carefully remove the oral lyophilisate unit of Zofran Zydis.

Do not attempt to remove the oral lyophilisate of Zofran Zydis by breaking the upper aluminum sheet, as the oral lyophilisate unit is fragile and would break inside.

Place the oral lyophilisate on the top of the tongue; it will disappear very quickly; then swallow it normally.

If you take more Zofran Zydis than you should

In case of overdose, symptoms that may appear are: vision problems, low blood pressure (which may cause dizziness or fainting) and palpitations (irregular heartbeat).

If you or your child take more Zofran Zydis than you should, talk to a doctor or go immediately to the nearest hospital or call the Toxicology Information Service, phone: 91 5620420, indicating the medication and the amount ingested. Bring the medication with you.

If you forgot to take Zofran Zydis

Do not take a double dose to compensate for the missed doses. Do not increase or decrease the dose without a doctor's authorization.

If you forget to take a dose of Zofran Zydis 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 of Zofran Zydis and do not experience discomfort, wait for the next dose and continue taking the medicine as directed.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Very common side effects

May affect more than 1 in 10 patients

-headache.

Common side effects

May affect up to 1 in 10 patients

-sensation of heat or flushing,

-constipation.

Uncommon side effects

May affect up to 1 in 100 patients

-eye movements, abnormal muscle stiffness, body movements, tremor,

-convulsions,

-slow or irregular heartbeats,

-low blood pressure (hypotension),

-hypothermia,

-increase in liver function test results.

Rare side effects

May affect fewer than 1 in 1,000 patients

-sudden onset of ringing and pain or pressure in the chest,

-swelling of eyelids, face, lips, mouth, or tongue,

-skin rash or urticaria anywhere on the body,

-alteration of heart rhythm (in some cases 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 side effects

May affect fewer than 1 in 10,000 patients

-transient blindness, which usually resolves in 20 minutes,

-electrocardiogram alterations,

-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.

Side effects of unknown frequency

Cannot be estimated from available data

.myocardial ischemia

-sudden onset of sudden chest pain or,

oppression in the chest (myocardial ischemia).

→ If you experience any of these symptoms,stop taking the medicine immediately and inform your doctor.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://

www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not store at a temperature above 30 °C.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE E point of the pharmacy. Ask your pharmacist how to dispose of packaging and unused medications. This will help protect the environment.

Composition of Zofran Zydis 4 mg lyophilized oral

The active ingredient is ondansetron.Each lyophilized oral contains 4mg of ondansetron.

The other components (excipients) are: gelatin, mannitol (E421), aspartame (E951), methyl parahydroxybenzoatesodium, propyl parahydroxybenzoatesodium, and strawberry flavor (contains strawberry aroma, propylene glycol (E1520),benzyl alcohol(E1519) and sodium).

Appearance of the product and contents of the packaging

Zofran Zydis 4 mg is presented in the form of round, white, flat-convex lyophilized orals that disperse quickly. Eachpackaging contains 10 or 500lyophilized orals.

Only some packaging sizes may be commercially marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

BEXAL FARMACÉUTICA, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer

Aspen Bad Oldesloe GmbH

Industriestrasse 32-36

23843 Bad Oldesloe

Germany

or

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona – Spain

or

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Germany

or

LEK Pharmaceuticals d.d.,

Verovškova ulica 57,

1526 Ljubljana,

Slovenia

Last review date of this leaflet:July 2024.

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