SETOFILM

Package leaflet: Information for the user

Setofilm 4 mg, orodispersible films, 8 mg, orodispersible films

Ondansetron
Equivalent medicine
Please read this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, nurse or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, nurse or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Setofilm is and what it is used for

Setofilm contains a medicine called ondansetron, which belongs to a group of medicines known as antiemetics.
Setofilm is used to treat and prevent nausea and vomiting caused by chemotherapy or radiotherapy. It can also be used after surgery to prevent and treat nausea and vomiting.

2. What you need to know before using Setofilm

Do not use Setofilm

• if you are allergic to ondansetron or to any of the other ingredients of this medicine listed in section 6.
• if you are allergic to other medicines belonging to the group of selective serotonin (5-HT ) receptor antagonists (e.g. granisetron or dolasetron).
• if you are taking apomorphine (used in the treatment of Parkinson's disease). For further information, see section “Other medicines and Setofilm”.

Warnings and precautions:
Talk to your doctor, nurse or pharmacist before using Setofilm if:

• you have ever suffered from heart problems
• you suffer from irregular or abnormal heartbeats (arrhythmia)
• you have liver problems
• you suffer from intestinal obstruction or severe constipation
• you have problems with blood levels of salts such as potassium, sodium and magnesium
• you are due to have, or have recently had, your tonsils or adenoids removed, as treatment with Setofilm may mask symptoms of internal bleeding
• this medicine is prescribed for a child under 2 years of age or with a body surface area less than 0.6 m and/or weighing up to 10 kg
• you suffer from depression or other conditions treated with antidepressants. Using these medicines together with Setofilm may lead to serotonin syndrome, a condition which can be fatal (see “Other medicines and Setofilm”).

If you need to undergo blood or urine tests, inform the person performing the test that you are taking Setofilm.
If you are unsure whether any of the above apply to you, discuss them with your doctor, nurse or pharmacist before taking Setofilm.
Other medicines and Setofilm
Inform your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines, including those without a prescription and herbal medicines. This is because Setofilm may affect the action of some medicines, and other medicines may affect the action of Setofilm.
In particular, inform your doctor, nurse or pharmacist if you are taking any of the following medicines:
Apomorphine (a medicine used in the treatment of Parkinson's disease), as a marked drop in blood pressure and loss of consciousness have been reported when Setofilm (ondansetron) is administered together with apomorphine.
phenytoin, carbamazepine (medicines used to treat epilepsy)
rifampicin (for the treatment of serious bacterial infections such as tuberculosis (TB))
antibiotics such as erythromycin
antifungal agents such as ketoconazole
tramadol (for pain relief)
antiarrhythmics (used to treat rapid or irregular heartbeat)
beta-blockers (used to treat heart or eye problems, anxiety or to prevent migraine)
medicines that may affect the heart (such as haloperidol or methadone)
anticancer 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, escitalopram; or
SNRIs (serotonin/noradrenaline reuptake inhibitors) used to treat depression and/or anxiety, including venlafaxine, duloxetine
Buprenorphine/opioids (medicines used to treat pain or narcotic dependence).
If you are unsure whether any of these conditions apply to you, talk to your doctor, nurse or pharmacist before taking Setofilm.
Setofilm with food and drink
You may take Setofilm with food and drink.
Pregnancy, breastfeeding and fertility
Pregnancy:
Setofilm must not be used during the first trimester of pregnancy, as Setofilm may slightly increase the risk of the baby being born with cleft lip and/or cleft palate (fissures or splits in the upper lip and/or the roof of the mouth).
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine. If you are a woman of childbearing age, you may be advised to use effective contraception.
Breastfeeding:
You must not breastfeed while taking Setofilm, as it may be excreted in breast milk.
Fertility
There is no information available on the effects of ondansetron on human fertility.
Driving and using machines
Setofilm has no or negligible effects on the ability to drive vehicles or operate machinery.

3. How to use Setofilm

Use this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Setofilm is for oral use only. It may be recommended for patients who may have difficulty swallowing tablets; for example, children or elderly patients.
Remove the orodispersible film of Setofilm from the individual sachet, taking care not to damage the film, as follows: open the sachet only at the indicated point and tear slowly. Do not cut the sachet.
Before use, check that the film is not damaged, as only undamaged films should be used.
Ensure that the mouth is empty (and fingers are dry) before placing the Setofilm orodispersible film on the tongue.
Within a few seconds, the film will dissolve on the tongue without water (in saliva, which should then be swallowed).

Treatment and prevention of nausea and vomiting in patients undergoing chemotherapy or radiotherapy.
Elderly:
Setofilm is well tolerated in elderly patients, who may take the same dosage as adults (see below).

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

Children (from 6 months of age) and adolescents (<18 years):
Your doctor will determine the appropriate ondansetron dosage. The individual dose will depend on the child's weight or body surface area.

Prevention and treatment of postoperative nausea and vomiting.
Elderly:
Ondansetron is well tolerated in elderly patients, who may take the same dosage as adults; see below.

Adults:
Take 16 mg of Setofilm 1 hour before surgery, or 8 mg administered 1 hour before surgery, followed by two additional 8 mg doses every 8 hours as directed by the doctor.

Children over 4 years of age and adolescents:
In children weighing more than or equal to 40 kg, take 4 mg of Setofilm 1 hour before surgery, followed by an additional 4 mg dose after 12 hours.

Hepatic impairment:
Do not exceed 8 mg of ondansetron daily in case of hepatic impairment (moderate to severe liver problems).

If you take more Setofilm than you should
Contact your doctor or go to hospital immediately if you or your child have taken more Setofilm than recommended in this leaflet or prescribed by your doctor. Take the medicine packaging with you.

If you forget to take Setofilm
If you forget to take Setofilm and experience nausea or vomiting:

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

If you forget to take a dose but do not experience nausea or vomiting:

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

If you stop treatment with Setofilm
If you feel unwell and stop treatment with Setofilm, consult your doctor or nurse as soon as possible.

If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Some side effects may be serious:
Stop taking Setofilm and contact your doctor immediately or go to the nearest hospital if you or your child experience any of the following conditions:

Allergic reactions:
Symptoms of an allergic reaction may include:
sudden shortness of breath and chest pain or chest tightness
severe itching of the skin
skin rash – red spots or swelling of the skin (urticaria) anywhere on the body
swelling of the eyelids, throat, face, lips, tongue or mouth
difficulty breathing or swallowing
collapse

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 hot flushes
constipation: if you experience abdominal pain or difficulty passing stools, contact your doctor, who may consider it necessary to monitor you closely to assess the consequences of treatment

Uncommon side effects (affect less than 1 in 100 people):
hiccups
low blood pressure, which may cause feelings of weakness or dizziness
palpitations (awareness of your heartbeat), irregular or slow heartbeat
chest pain
seizures (fits)
unusual and involuntary movements of the eye or body, or tremor
changes in liver function test results (changes are more common if you are taking ondansetron in combination with a medicine called Cisplatin)

Rare side effects (affect less than 1 in 1,000 people):
allergic reactions, sometimes severe, including anaphylactic reactions
dizziness or lightheadedness [when ondansetron is administered intravenously (e.g. through a tube into a vein)]
temporary visual disturbances, for example blurred vision (mainly when ondansetron is administered intravenously)
disturbances in heart rhythm and changes in ECG, including a particular type of heart rhythm disorder called Torsade de Pointes (which may sometimes cause sudden loss of consciousness)

Very rare side effects (affect less than 1 in 10,000 people):
blurred vision or temporary loss of vision (mainly during intravenous administration of ondansetron), which usually resolves within 20 minutes
toxic skin rash including widespread rash with blisters and peeling of the skin over large areas of the body (toxic epidermal necrolysis)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Setofilm

Keep this medicine out of sight and reach of children.
Keep the sachets tightly closed to protect the medicine from moisture.
Do not use this medicine after the expiry date (Exp.) stated on the packaging. The expiry date refers to the last day of that month.
Do not use Setofilm if you notice any signs of damage.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Setofilm contains
The active substance is ondansetron. Each film contains 4 mg or 8 mg of ondansetron.
The other components are: polyvinyl alcohol, Macrogol 1000, acesulfame potassium E950, glycerol E422, titanium dioxide E171, rice starch, levomenthol and polysorbate 80 E433.
Description of the appearance of Setofilm and contents of the pack
Setofilm 4 mg is in the form of white, rectangular orodispersible films (size 3 cm).
Setofilm 8 mg is in the form of white, rectangular orodispersible films (size 6 cm).
Each orodispersible film of Setofilm 4 mg is contained within a sachet. Each pack contains 6, 10 or 50 sachets.
Each orodispersible film of Setofilm 8 mg is contained within a sachet. Each pack contains 6, 10 or 50 sachets.
Some pack sizes may not be marketed.
Marketing Authorization Holder:
Norgine Italia S.r.l.
Via Fabio Filzi 25
20124 Milano
Italy
Manufacturer:
LTS Lohmann Therapie-Systeme AG
Lohmannstrasse 2
D-56626 Andernach
GERMANY
This medicinal product is authorized in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Setofilm: France, United Kingdom (Northern Ireland), Belgium, Spain, Italy
Sole distributor:
GENTILI (logo)
ISTITUTO GENTILI S.r.l.
[email protected]