Active ingredient
- ondansetron
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 20011/0041.
Setofilm 4mg
Package leaflet: Information for the user
SETOFILM® 4 mg, Orodispersible Films
SETOFILM® 8 mg, Orodispersible Films
Ondansetron
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet:
1. What Setofilm is and what it is used for
2. What you need to know before you use 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. This belongs to a group of drugs called antiemetics.
Setofilm is used to treat and prevent nausea (feeling sick) and vomiting (being sick) caused by chemotherapy or radiotherapy. It can also be used after an operation to prevent and treat nausea and vomiting.
2. What you need to know before you use Setofilm
Do not use Setofilm
Warnings and precautions
Talk to your doctor, nurse or pharmacist before taking Setofilm if:
If you need to have a blood or urine test, you should tell the person performing the test that you are taking Setofilm.
If you are not sure if any of the above apply to you, talk to your doctor, nurse or pharmacist before taking Setofilm.
Other medicines and Setofilm
Please tell your doctor, nurse or pharmacist if you are taking or have recently taken or might take 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. Also some other medicines can affect the way Setofilm works.
In particular, tell your doctor, nurse or pharmacist if you are taking any of the following medicines:
If you are not sure if any of the above applies to you, talk to your doctor, nurse or pharmacist before having Setofilm.
Setofilm with food and drink
You may take Setofilm with food and drink.
Pregnancy and breast-feeding
Pregnancy:
Only use Setofilm during the first trimester of pregnancy after discussion with your doctor of the potential benefits and risks to you and your unborn baby of the different treatment options. This is because Setofilm can slightly increase the risk of a baby being born with cleft lip and/or cleft palate (openings or splits in the upper lip and/or the roof of the mouth). If you are already pregnant, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking Setofilm. If you are a woman of childbearing potential you may be advised to use effective contraception.
Breast-feeding:
You should not breast-feed whilst using Setofilm as it can pass into your breast milk.
Driving and using machines
Setofilm has little or no effect on your ability to drive or use machines.
3. How to use Setofilm
Always use Setofilm exactly as your doctor or pharmacist has told you. Check with your doctor, or pharmacist if you are not sure.
Setofilm is for oral use only. It may be recommended for patients who may have problems with taking or swallowing tablets; for example children or elderly.
Treatment and prevention of sickness (nausea and vomiting) in patients receiving chemotherapy or radiotherapy
Elderly:
Setofilm is well tolerated by elderly patients. They may take the same dosage as 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 your first dose is given by injection.
Children (aged 6 months and over) and adolescents (<18 years):
Your doctor will recommend what dose of ondansetron should be given. The individualised dose will depend on the weight or body surface area of the child.
Prevention and Treatment of post-operative sickness (nausea and vomiting).
Elderly:
Ondansetron is well tolerated by elderly patients. They may take the same dosage as adults; see below.
Adults:
Take 16 mg of Setofilm 1 hour before your operation or 8 mg administered one hour before your operation, followed by two further doses of 8 mg 8 hours apart as directed by your doctor.
Children aged over 4 years and adolescents:
In children weighing 40 kg and above, take 4mg of Setofilm 1 hour before your operation, followed by one further dose of 4 mg after 12 hours.
Liver dysfunction:
Do not take more than 8 mg of ondansetron daily if your liver does not work properly (moderate to severe liver problems).
If you take more Setofilm than you should
Contact your doctor, or go to the hospital immediately if you or your child have taken more Setofilm than recommended in this package leaflet or than prescribed by your doctor. Take the medicine pack with you.
If you forget to take Setofilm
If you forget to take Setofilm and feel sick or vomit
If you miss a dose but do not feel sick or vomit
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, Setofilm can cause side effects, although not everybody gets them.
Allergic reactions:
If you have an allergic reaction, stop taking Setofilm and immediately contact your doctor or go to the nearest hospital. The signs of an allergic reaction may include:
Other side effects include:
Very common side effects (affects more than 1 in 10 people)
Common side effects (affects less than 1 in 10 people)
Uncommon side effects (affects less than 1 in 100 people)
Rare (affects less than 1 in 1,000 people)
Very rare (affects less than 1 in 10,000 people):
Reporting of side effects
If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 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 the sight and reach of children.
Keep the sachet tightly closed in order to protect from moisture.
Do not use Setofilm after the expiry date (EXP) which is stated on the carton. The expiry date refers to the last day of that month.
Do not use Setofilm if you notice that it is damaged.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Setofilm contains
The active substance is ondansetron. Each film contains 4 mg or 8 mg of ondansetron.
The other ingredients are: poly (vinyl alcohol), Macrogol 1000, acesulfame potassium E950, glycerol E422, titanium dioxide E171, rice starch, levomenthol and polysorbate 80 E433.
What Setofilm looks like and contents of the pack
Setofilm 4 mg are white and rectangular (size 3 cm2) orodispersible films.
Setofilm 8 mg are white and rectangular (size 6 cm2) orodispersible films.
Setofilm 4 mg Orodispersible Film is placed into sachets. Each carton contains 2, 4, 6, 10, 30 or 50 sachets.
Setofilm 8 mg Orodispersible Film is placed into sachets. Each carton contains 2, 4, 6, 10, 30 or 50 sachets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Manufacturer:
This medicinal product is authorised in the Member States of the EEA under the following names:
Setofilm: France, UK, Belgium, Spain, Italy
This leaflet was last revised in November 2020.
Other sources of information
If you need the information on this leaflet in an alternative format, such as large print, or Braille please ring 0800 198 5000.
Norgine House, Widewater Place, Moorhall Road, Harefield, Middlesex, UB9 6NS
+44 (0)1895 825 865