Active ingredient
- osimertinib mesylate
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.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
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: PLGB 17901/0340 .
TAGRISSO 40 mg and 80 mg film-coated tablets
Package leaflet: Information for the patient
TAGRISSO 40 mg film-coated tablets
TAGRISSO 80 mg film-coated tablets
osimertinib
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
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 TAGRISSO is and what it is used for
2. What you need to know before you take TAGRISSO
3. How to take TAGRISSO
4. Possible side effects
5. How to store TAGRISSO
6. Contents of the pack and other information
1. What TAGRISSO is and what it is used for
TAGRISSO contains the active substance osimertinib, which belongs to a group of medicines called protein kinase inhibitors which are used to treat cancer. TAGRISSO is used to treat adults with a type of lung cancer called ‘non-small cell lung cancer.’ If a test has shown that your cancer has certain changes (mutations) in a gene called ‘EGFR’ (epidermal growth factor receptor) and has spread to your other lung or other organs, your cancer is likely to respond to treatment with TAGRISSO.
TAGRISSO can be prescribed for you:
How TAGRISSO works
TAGRISSO works by blocking EGFR and may help to slow or stop your lung cancer from growing. It may also help to reduce the size of the tumour.
If you have any questions about how this medicine works or why this medicine has been prescribed for you, ask your doctor.
2. What you need to know before you take TAGRISSO
Do not take TAGRISSO if:
If you are not sure, talk to your doctor, pharmacist or nurse before taking TAGRISSO.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking TAGRISSO if:
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking this medicine.
Tell your doctor straight away while taking this medicine if:
See ‘Serious side effects’ in section 4 for more information.
Children and adolescents
TAGRISSO has not been studied in children or adolescents. Do not give this medicine to children or adolescents under the age of 18 years.
Other medicines and TAGRISSO
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes herbal medicines and medicines obtained without a prescription. This is because TAGRISSO can affect the way some other medicines work. Also some other medicines can affect the way TAGRISSO works.
Tell your doctor before taking TAGRISSO if you are taking any of the following medicines:
The following medicines may reduce how well TAGRISSO works:
TAGRISSO may affect how well the following medicines work and/or increase side effects of these medicines:
If you are taking any of the medicines listed above, tell your doctor before taking TAGRISSO.
Your doctor will discuss appropriate treatment options with you.
Pregnancy – information for women
Pregnancy – information for men
Contraception – information for women and men
You must use effective contraception during treatment.
You must also do this after completing treatment with TAGRISSO:
Breast-feeding
Do not breast-feed while taking this medicine. This is because it is not known if there is a risk to your baby.
Driving and using machines
TAGRISSO has no or no marked influence on the ability to drive and use machines.
Information on other ingredients in this medicine
This medicine contains less than 1 mmol sodium (23 mg) per 40 mg or 80 mg tablet, that is to say essentially “sodium-free”.
3. How to take TAGRISSO
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
How to take
If you have trouble swallowing the tablet, you can mix it in water:
If you take more TAGRISSO than you should
If you take more than your normal dose, contact your doctor or nearest hospital straight away.
If you forget to take TAGRISSO
If you forget a dose, take it as soon as you remember it. However, if it is less than 12 hours until your next dose is due, skip the missed dose. Take your next normal dose at its scheduled time.
If you stop taking TAGRISSO
Do not stop taking this medicine - talk to your doctor first. It is important to take this medicine every day, for as long as your doctor prescribes it for you.
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.
Serious side effects
Tell your doctor straight away if you notice the following serious side effects:
Tell your doctor straight away if you notice the serious side effects listed above.
Other side effects
Very common (may affect more than 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at 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 TAGRISSO
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 TAGRISSO contains
What TAGRISSO looks like and contents of the pack
TAGRISSO 40 mg is supplied as beige, film-coated, round and biconvex tablets, marked with “AZ” and “40” on one side, and plain on the other.
TAGRISSO 80 mg is supplied as beige, film-coated, oval and biconvex tablets, marked with “AZ” and “80” on one side, and plain on the other.
TAGRISSO is supplied in blisters containing 30 x 1 film-coated tablets, packed in cartons containing 3 blisters of 10 tablets each.
TAGRISSO is supplied in blisters containing 28 x 1 film-coated tablets, packed in cartons containing 4 blisters of 7 tablets each.
Marketing Authorisation Holder
Manufacturer
This leaflet was last revised in November 2020.
© AstraZeneca 2020
TAGRISSO is a registered trademark of the AstraZeneca group of companies.
ONC 20 0051
Other sources of information
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
Product name Reference number
Tagrisso 40 mg Tablets 17901/0340
Tagrisso 80 mg Tablets 17901/0341
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