Calquence 100 mg film-coated tablets
*Company:
AstraZeneca Pharmaceuticals (Ireland) DACStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 22 August 2023
File name
20230816 Package Leaflet IE MT Calquence Tablets 100 mg PRAC Hypertension ADR ONC 23 0030.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
4. Possible side effects
[...]
Very common (may affect more than 1 in 10 people):
· muscle or joint pain
· headache
· rash
· feeling tired (fatigue), weakness or lack of energy
· feeling sick to your stomach (nausea),vomiting, stomach pain, constipation (infrequent or hard to pass stool), diarrhoea (frequent or loose stools)
· decreased number of red blood cells, decreased number of neutrophils (a type of white blood cells) or decreased number of cells that help blood clot (platelets).)
· high blood pressure
· dizziness
· headache, pressure in the eyes, nose or cheek area (sinusitis)
· sore throat and runny nose (nasopharyngitis)
· upper respiratory tract infection
· urinary tract infection (pain or burning feeling when passing urine).)
· new cancers, including cancers of the skin, may happen during treatment with Calquence (see section 2 ‘What you need to know before you take Calquence’)
[...]
6. Contents of the pack and other information
[...]
This leaflet was last revised in 0408/2023.
Updated on 22 August 2023
File name
20230816 SPC IE MT Calquence Tablets 100 mg PRAC Hypertension ADR ONC 23 0029.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Addition of Hypertension as an ADR to section 4.8, table 3 and table 4
10. DATE OF REVISION OF THE TEXT
14th June16 August 2023
Updated on 29 June 2023
File name
20230614 SPC IE MT Calquence Tablets 100 mg Shelf-life Update ONC 23 0023.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 29 June 2023
File name
20230614 SPC IE MT Calquence Tablets 100 mg Shelf-life Update ONC 23 0023.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
New product
Updated on 29 June 2023
File name
20230406 Package Leaflet IE MT Calquence Tablets Postcode update ONC 23 0011.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
New product