Active ingredient
- trifluridine
- tipiracil hydrochloride
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 are: EU/1/16/1096/001, EU/1/16/1096/002, EU/1/16/1096/003, EU/1/16/1096/004, EU/1/16/1096/005, EU/1/16/1096/006.
Lonsurf
Package leaflet: Information for the patient
Lonsurf® 15 mg/6.14 mg film-coated tablets
Lonsurf® 20 mg/8.19 mg film-coated tablets
trifluridine/tipiracil
Read all of this leaflet carefully before you start taking this medicine - because it contains important information for you.
What is in this leaflet
1. What Lonsurf is and what it is used for
2. What you need to know before you take Lonsurf
3. How to take Lonsurf
4. Possible side effects
5. How to store Lonsurf
6. Contents of the pack and other information
1. What Lonsurf is and what it is used for
Lonsurf is a type of cancer chemotherapy which belongs to the group of medicines called "cytostatic antimetabolite medicines".
Lonsurf contains two different active substances: trifluridine and tipiracil.
Lonsurf is used to treat adults with colon or rectal cancer - sometimes called 'colorectal' cancer and stomach cancer (including cancer of the junction between the oesophagus and the stomach).
2. What you need to know before you take Lonsurf
Do not take Lonsurf
Do not take Lonsurf if the above applies to you. If you are not sure, talk to your doctor before taking Lonsurf.
Warnings and precautions
Talk to your doctor or pharmacist before taking Lonsurf if:
If you are not sure, talk to your doctor or pharmacist before taking Lonsurf.
Treatment may lead to the following side effects (see section 4):
Tests and checks
Your doctor will do blood tests before each cycle of Lonsurf. You start a new cycle every 4 weeks.
The tests are needed because Lonsurf can sometimes affect your blood cells.
Children and adolescents
This medicine is not indicated for use in children and adolescents below the age of 18 years. This is because it may not work or be safe.
Other medicines and Lonsurf
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because Lonsurf can affect the way some other medicines work. Also some other medicines can affect the way Lonsurf works.
In particular tell your doctor or pharmacist if you are taking medicines used for treatment of HIV, such as zidovudine. This is because zidovudine may not work as well if you are taking Lonsurf. Talk to your doctor about whether to switch to a different HIV medicine. If the above applies to you (or you are not sure), talk to your doctor or pharmacist before taking Lonsurf.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, or if you think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Lonsurf may harm your unborn baby. If you become pregnant, you and your doctor will have to decide if the benefits of Lonsurf are greater than the risk of harm to the baby.
Do not breast-feed if you are taking Lonsurf as it is not known whether Lonsurf passes into the mother's milk.
Contraception
You must not become pregnant while taking this medicine. This is because it may harm your unborn baby. You and your partner should use effective methods of contraception while taking this medicine. You should also do this for 6 months after you stop taking the medicine. If you or your partner become pregnant during this time, you must talk to your doctor or pharmacist straight away.
Driving and using machines
It is not known whether Lonsurf changes your ability to drive or use machines. Do not drive or use any tools or machines if you experience symptoms that affect your ability to concentrate and react.
Lonsurf contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Lonsurf
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
How much to take
When to take Lonsurf
You will take Lonsurf for 10 days during the first 2 weeks, and then have 2 weeks off. This 4-week period is called a 'cycle.' The specific dosing schedule is as follows:
You will then start again with another cycle of 4 weeks following the above pattern.
How to take
If you take more Lonsurf than you should
If you take more Lonsurf than you should, talk to a doctor or go to a hospital straight away.
Take your pack(s) of medicine with you.
If you forget to take Lonsurf
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may happen with this medicine:
Serious side effects
Tell your doctor immediately if you notice any of the following serious side effects (many of the side effects are shown in laboratory tests - for example those affecting your blood cells):
Some of these serious side effects may lead to death.
Other side effects
Tell your doctor if you notice any of the following side effects. Many of the side effects are shown in laboratory tests - for example those affecting your blood cells. Your doctor will be looking out for these side effects in your test results.
Very common: may affect more than 1 in 10 people:
Common: may affect up to 1 in 10 people:
Uncommon: may affect up to 1 in 100 people
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App Store
5. How to store Lonsurf
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the outer carton or blister after "EXP." The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 to protect the environment.
6. Contents of the pack and other information
What Lonsurf contains
Lonsurf 15 mg/6.14 mg film-coated tablet
Lonsurf 20 mg/8.19 mg film-coated tablet
What Lonsurf looks like and contents of the pack
Each pack contains 20 film-coated tablets (2 blisters of 10 tablets each) or 40 film-coated tablets (4 blisters of 10 tablets each), or 60 film-coated tablets (6 blisters of 10 tablets each). A desiccant is incorporated into each blister foil.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in 12/2020
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
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