SETOFILM 4 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Setofilm 4 mg Oral Disintegrating Films EFG

Ondansetron

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Setofilm and what is it used for

Setofilm contains a medicine called ondansetron. This belongs to a group of medicines called antiemetics.

Setofilm is used to prevent and treat nausea and vomiting caused by chemotherapy or radiotherapy. It can also be used to prevent and treat nausea and vomiting after an operation.

2. What you need to know before you take Setofilm

Do not take 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 of the same group (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, pharmacist, or nurse before taking Setofilm if:

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

If you need to have a blood or urine test, tell the person taking the test that you are taking Setofilm.

If you are not sure if any of the above applies to you, tell your doctor, pharmacist, or nurse before taking Setofilm.

Other medicines and Setofilm

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Setofilm can affect the way some medicines work and some medicines can affect the way Setofilm works.

In particular, tell your doctor, pharmacist, or nurse if you are taking:

• Phenytoin, carbamazepine (medicines used to treat epilepsy)
• Rifampicin (to treat severe bacterial infections, such as tuberculosis)
• Antibiotics such as erythromycin
• Antifungal agents such as ketoconazole
• Tramadol (to treat pain)
• Anti-arrhythmics (used to treat fast or irregular heart rhythm)
• Betablockers (used to treat certain heart or eye disorders, anxiety, or to prevent migraines)
• Medicines that can affect the heart (such as haloperidol or methadone)
• Cancer medicines (especially anthracyclines and trastuzumab)
• Antidepressants such as SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety, including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, and escitalopram; or
• SNRIs (serotonin and noradrenaline reuptake inhibitors) used to treat 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 to cause a marked decrease in blood pressure and loss of consciousness.
• Buprenorphine/opioids (medicines used to treat pain or narcotic dependence).

If you are not sure if any of the above applies to you, talk to your doctor, pharmacist, or nurse before taking Setofilm.

Using Setofilm with food and drink

You can take Setofilm with or without food and drink.

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 a cleft lip and/or palate (openings or gaps in the upper lip or the roof of the mouth).

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. If you are a woman of childbearing age, you are advised to use an effective method of contraception.

Breastfeeding:

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

Fertility:

There is no information on the effects of ondansetron on human fertility.

Driving and using machines

Setofilm has little or no influence on the ability to drive and use machines.

3. How to take Setofilm

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Setofilm is taken by mouth only. It may be recommended for patients who may have difficulty swallowing tablets, such as children or elderly patients.

• Remove the oral disintegrating film from each sachet carefully, without damaging it, as follows: open the sachet only at the tear line and tear it slowly. Do not cut the sachet.
• Before using it, check that the film is not damaged, as you should only use intact films.
• Make sure your mouth is empty (and your fingers are dry) before placing the oral disintegrating film on your tongue.
• The film should dissolve on the tongue in a few seconds (in saliva that you can swallow afterwards).

Treatment and prevention of nausea and vomiting in patients receiving chemotherapy or radiotherapy

Elderly patients:

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

Adults:

8 mg, 1-2 hours before chemotherapy or radiotherapy, followed by 8 mg every 12 hours for up to 5 days. Your doctor may recommend that the first dose is given by injection.

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

Your doctor will recommend the dose of ondansetron to be given. The individual dose will depend on the child's weight or body surface area.

Prevention and treatment of post-operative nausea and vomiting

Elderly patients:

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

Adults:

• Take 16 mg of Setofilm 1 hour before the operation or
• give 8 mg 1 hour before the operation, followed by two further doses of 8 mg, separated by an interval of 8 hours, as directed by your doctor.

Children over 4 years and adolescents:

Children weighing 40 kg or more can take 4 mg of Setofilm 1 hour before the operation, followed by a further dose of 4 mg 12 hours later.

Liver impairment:

Do not take more than 8 mg of ondansetron per day if you have moderate or severe liver problems.

If you take more Setofilm than you should

If you or your child take more Setofilm than you should, talk to a doctor or go to the nearest hospital immediately. Take the medicine with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken. Take the medicine packaging with you.

If you forget to take Setofilm

If you forget to take Setofilm and you feel unwell or vomit

• Take a dose of Setofilm as soon as possible
• Take your next dose of Setofilm at the usual time
• Do not take a double dose to make up for a forgotten dose.

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

• Take the next dose
• Do not take a double dose to make up for a forgotten dose.

.

If you stop taking Setofilm

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

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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:

Signs of an allergic reaction can be:

• Sudden wheezing, chest pain, or tightness
• Intense itching of the skin
• Rash; red or purple spots on the skin (urticaria) anywhere on the body
• Swelling of the eyelids, throat, face, lips, tongue, or mouth
• Difficulty breathing or swallowing
• Fainting

Myocardial ischemia:

Signs include:

• Sudden chest pain or
• chest tightness

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)

• Feeling of warmth or flushing.
• Constipation: tell your doctor if you have abdominal pain or difficulty passing stools. They will need to monitor you closely to see how the treatment is affecting you.

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

• Hiccups
• Low blood pressure, which can make you feel weak or dizzy
• Palpitations (being aware of your heartbeat), or slow or irregular heartbeat
• Chest pain
• Seizures (convulsions)
• Unusual involuntary movements or tremors of the body or eyes
• Changes in liver function tests (more common if you are taking ondansetron with a medicine called cisplatin)

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

• Allergic reactions, sometimes severe, including anaphylaxis
• Feeling dizzy (when ondansetron is given by injection into a vein)
• Temporary disturbances in vision, e.g. blurred vision (mainly when ondansetron is given by injection into a vein)
• Abnormal heart rhythm and changes in ECG, including a special type of irregular heartbeat called Torsade de Pointes (which can sometimes cause loss of consciousness)

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

• Temporary loss of vision (mainly when ondansetron is given by injection into a vein), which usually recovers within 20 minutes
• Widespread rash with blisters and peeling of the skin, affecting a large area of the body (toxic epidermal necrolysis)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Vigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Setofilm

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

Keep the sachet tightly closed to protect it from moisture.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

Do not use Setofilm if you notice it is damaged.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Setofilm

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

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

Appearance and packaging of the product

Setofilm 4 mg are white, rectangular oral disintegrating films (3 cm2 in size).

Setofilm 4 mg oral disintegrating films are packaged in sachets. Each carton contains 6, 10, or 50 sachets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Norgine de España, S.L.U.

Paseo de la Castellana, 91, 2ª Planta

28046 Madrid

SPAIN

Manufacturer(s):

LTS Lohmann Therapie-Systeme AG

Lohmannstrasse 2

D-56626 Andernach

GERMANY

This medicine is authorised 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.

Date of last revision of this leaflet:April 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.