Leaflet: information for the user

Setofilm 4 mg buccal films EFG

Ondansetron

Read this leaflet carefully before you start using the medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, nurse or pharmacist.
• This medicine has been prescribed for you only and should not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, nurse or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Setofilm and what it is used for

2. What you need to know before starting to use Setofilm

3. How to use Setofilm

4. Possible side effects

5. Storage of Setofilm

6. Contents of the pack and additional information

Setofilmcontains a medication called ondansetron. Thisbelongs to a group of drugs called antiemetics.

Setofilm is used to treat and prevent nausea and vomiting caused by chemotherapy or radiation therapy. It may also be used after surgery to prevent and treat nausea and vomiting.

Do not use Setofilm

-if you are allergic to ondansetron or any of the other ingredients of this medicine (listed in section 6).

-if you are allergic to other medicines that belong to the group of serotonin 5-HT3receptor antagonists (e.g. granisetron, dolasetron).

-if you are taking apomorphine (used to treat Parkinson's disease).

For more information, see the section “Other medicines and Setofilm”.

Warnings and precautions

Consult your doctor, nurse or pharmacist before starting to take Setofilm if:

• you have ever had heart problems
• your heart rate is irregular (arrhythmia)
• you have liver problems
• you have intestinal obstruction or severe constipation
• you have electrolyte imbalances in the blood, such as potassium, sodium and magnesium
• you are going to have or have recently had a tonsillectomy or adenoidectomy because the treatment with Setofilm may mask the symptoms of internal bleeding
• the medicine is prescribed to a child under 2 years old or with a body surface area less than 0.6m2, and/or a weight equal to or less than 10 kg
• you have depression or other conditions treated with antidepressants. The use of these medicines together with Setofilm may cause the serotonin syndrome, a potentially fatal condition (see “Other medicines and Setofilm”).

Inform the person who will perform the blood or urine test that you are taking Setofilm.

If you are unsure whether the above applies to you, inform your doctor, nurse or pharmacist before taking Setofilm.

Other medicines and SetofilmInform your doctor, nurse or pharmacist if you are taking, have taken recently or may need to take any other medicine. This includes medicines that are available over the counter and herbal medicines. This is because Setofilm may affect the way some medicines work. Additionally, some medicines may affect the functioning of Setofilm.

In particular, inform your doctor, nurse or pharmacist if you are taking the following medicines:

•Phenytoin, carbamazepine (medicines used to treat epilepsy)

•Rifampicin (to treat serious bacterial infections, such as tuberculosis)

•Antibiotics such as erythromycin

•Antimycotics such as ketoconazole

•Tramadol (to treat pain)

•Anti-arrhythmics (used to treat irregular heart rate or rapid heart rate)

•Beta-blockers (used to treat certain heart or eye disorders, anxiety or prevent migraines)

•Medicines that may affect the heart (such as haloperidol or methadone)

•Cancer medicines (especially anthracyclines and trastuzumab)

•Antidepressants such as SSRIs (selective serotonin reuptake inhibitors) used in the treatment of depression and/or anxiety, including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, and escitalopram; or

•SNRIs (selective norepinephrine reuptake inhibitors) used in the treatment of depression and/or anxiety, including venlafaxine and duloxetine

•Apomorphine (a medicine for the treatment of Parkinson's disease), which during concomitant treatment with Setofilm (Ondansetron), has been reported an excessive drop in blood pressure and loss of consciousness.

•Buprenorphine/opioids (medicines used to treat pain or opioid dependence).

If you are unsure whether any of the above applies to you, speak with your doctor, nurse or pharmacist before taking Setofilm.

Use of Setofilm with food and drinks

You can take Setofilm with food and drinks.

Pregnancy, breastfeeding and fertility

Pregnancy:

Setofilm should not be used during the first trimester of pregnancy. This is because Setofilm 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 pregnant, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine. If you are a fertile woman, it is recommended to use an effective contraceptive method.

Breastfeeding:

You should not breastfeed while taking Setofilm as Setofilm may pass into breast milk.

Fertility:

No information is available on the effects of ondansetron on human fertility.

Driving and operating machinery

The influence of Setofilm on the ability to drive and operate machinery is low or negligible.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Setofilm is administered orally only. It may be recommended for patients who may have problems swallowing tablets, for example, children or elderly patients.

• Remove the buccal dispersible film from each blister pack carefully without damaging it, as follows: open the blister pack only by the tear-off strip and tear it slowly. Do not cut the blister pack.
• Before using it, check that the film is not deteriorated, as you should only use intact films.
• Make sure your mouth is empty (and your fingers are dry) before depositing the buccal dispersible film on the tongue.
• The film must disintegrate on the tongue without water in a few seconds (in saliva that can be swallowed afterwards).

Treatment and prevention of nausea and vomiting in patients receiving chemotherapy or radiation therapy

Elderly patients:

Setofilm is well tolerated by these patients. These patients can take the same doses as the rest of adults (see below).

Adults:

8 mg, 1-2 hours before chemotherapy or radiation therapy, followed by 8 mg every 12 hours for 5 days maximum. Your doctor may recommend that the first dose be administered intravenously.

Children (from 6 months) and adolescents (<18 years):

Your doctor will recommend the dose of ondansetron that should be administered. The personal dose will depend on the weight or body surface area of the child.

Prevention and treatment of postoperative nausea and vomiting

Elderly patients:

Ondansetron is well tolerated by these patients. These patients can take the same doses as the rest of adults (see below).

Adults:

- Take 16 mg of Setofilm 1 hour before surgery or

- Administer 8 mg 1 hour before surgery, followed by two other doses of 8 mg separated by an interval of 8 hours, as indicated by your doctor.

Children over 4 years and adolescents:

Children with a weight of 40 kg or more can take 4 mg of Setofilm 1 hour before surgery followed by another dose of 4 mg 12 hours later.

Liver insufficiency:

Do not take more than 8 mg of ondansetron per day, if your liver function is not adequate (moderate or severe liver disorders).

If you take more Setofilm than you should

If you or your child takes more Setofilm than you should, talk to a doctor or go immediately to the nearest hospital. Bring the medication with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. Bring the packaging of the medication with you.

If you forgot to take Setofilm

If you forget to take Setofilm,and you feel bad or vomit

• Take a dose of Setofilm as soon as possible
• Take your next dose of Setofilmat the usual time
• Do not take a double dose to compensate for the missed dose.

If you forget to take a dose but do not feel bad or vomit

• Take the next dose
• Do not take a double dose to compensate for the missed dose.

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If you interrupt the treatment with Setofilm

If you feel unwell and stop taking Setofilm, inform your doctor or nurse as soon as possible.

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

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

Some side effects can be serious:

Stop taking Setofilm and contact your doctor or go to the nearest hospital immediately if you or your child experience any of the following symptoms:

Allergic reactions:

The signs of an allergic reaction may be:

• Wheezing, and chest pain or a feeling of tightness in the chest, sudden
• Intense skin itching
• Skin rash; red spots or bumps under the skin (urticaria) anywhere on the body
• Swelling of the eyelids, throat, face, lips, tongue, or mouth
• Difficulty breathing or swallowing
• Low blood pressure

Myocardial ischemia:

The signs include:

• Sudden chest pain or
• Chest pressure

Other side effects include:

Very common side effects (affect more than 1 in 10 people)

-Headache.

Common side effects (affect less than 1 in 10 people)

-Sensation of heat or dizziness.

-Constipation: inform your doctor if you experience abdominal cramps or difficulty defecating. They will closely monitor you to see how the treatment is affecting you.

Uncommon side effects (affect less than 1 in 100 people)

• Hiccup
• Low blood pressure, which may make you feel weak or dizzy
• Palpitations (awareness of heartbeats), or slow or irregular heartbeats
• Chest pain
• Seizures (convulsions)
• Unusual involuntary body or eye movements
• Changes in liver function test results (more common if you take ondansetron with a medication called cisplatin)

Rare side effects (affect less than 1 in 1,000 people)

• Allergic reactions, sometimes severe, including anaphylaxis
• Sensation of dizziness (when ondansetron is administered intravenously, i.e., through a vein)
• Temporary visual disturbances, e.g., blurred vision (predominantly when ondansetron is administered intravenously)
• Changes in heart rhythm and ECG changes, including a specific type of heart rhythm disorder called Torsade de Pointes (which sometimes causes loss of consciousness)

Very rare side effects (affect less than 1 in 10,000 people)

• Temporary loss of vision (predominantly when ondansetron is administered intravenously), which usually recovers within 20 minutes
• Widespread skin rash with blisters and peeling thataffects a large part of the body surface (toxic epidermal necrolysis)

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for 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.

Keep the package perfectly closed to protect it from moisture.

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.

Do not use Setofilm if you observe that it is deteriorated.

Medications should not be disposed of through drains or trash.Deposit the packaging and medications that you do not need at the SIGRE collection pointof the pharmacy.In case of doubtask your pharmacist how to dispose of the packaging and medications that you do not need.This way you will help protect the environment.

Composition of Setofilm

The active ingredient is ondansetron. Each film contains 4 mg or 8 mg of ondansetron.

The other components are: polyvinyl alcohol, Macrogol 1000, potassium acesulfame (E950), glycerol (E422), titanium dioxide (E171), rice starch, levomenthol, and polisorbate 80 (E433).

Appearance of the product and contents of the packaging

Setofilm 4 mg are white, rectangular buccal dispersible films (3 cm x 2 in size).

Setofilm 4 mg buccal dispersible films are supplied in blister packs. Each box contains 6, 10, or 50 blister packs.

Only some packaging sizes may be commercially available.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Norgine de España, S.L.U.

Paseo de la Castellana, 91, 2nd Floor

28046 Madrid

SPAIN

Manufacturer(s):

LTS Lohmann Therapie-Systeme AG

Lohmannstrasse 2

D-56626 Andernach

GERMANY

This medicinal product is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:Setofilm: France, United Kingdom (Northern Ireland), Belgium, Spain, Italy.

Last review date of this leaflet:April 2023

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