Intended for UK patients and members of the public
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.
Report a side effect or a product complaintDiscontinued Other versions of this medicine may still be available. Information for reference purposes.
Product Documentation
Last updated on this site: 22 Sep 2025
Description of update: To submit type IB (C.I.2.a) variation to sections 4.3, 4.4, 4.5 of the SmPC and sections 2, 4 of the leaflet in-line with information of reference product (Kaletra 200 mg/50 mg film-coated tablets, EU procedure number: EU/1/01/172/001-006; MAH: AbbVie Deutschland GmbH & Co. KG, Germany) along with minor editorial changes.
In addition:
The carton Braille has been updated in line with the UEB Code, in order to correct the forward slash from ‘⠌’ to ‘⠸⠌’ and to include a number indicator before ‘50’.
The tablet description in PIL section 6 has been updated to align with SmPC section 3.
QRD updates have been made to the PIL.
Editorial and formatting updates have been made to SmPC sections 4.2, 4.3, 4.4, 4.5 and PIL.
Date of approval: 30/07/2025
SmPC sections updated: 4.2, 4.3, 4.4, 4.5 and 10
Last updated on this site: 22 Sep 2025
Description of update:
To submit type IB (C.I.2.a) variation to sections 4.3, 4.4, 4.5 of the SmPC and sections 2, 4 of the leaflet in-line with information of reference product (Kaletra 200 mg/50 mg film-coated tablets, EU procedure number: EU/1/01/172/001-006; MAH: AbbVie Deutschland GmbH & Co. KG, Germany) along with minor editorial changes.
In addition:
The carton Braille has been updated in line with the UEB Code, in order to correct the forward slash from ‘⠌’ to ‘⠸⠌’ and to include a number indicator before ‘50’.
The tablet description in PIL section 6 has been updated to align with SmPC section 3.
QRD updates have been made to the PIL.
Editorial and formatting updates have been made to SmPC sections 4.2, 4.3, 4.4, 4.5 and PIL.
Date of approval: 30/07/2025
PIL sections updated: Heading, Index, 1, 2, 4, 5 and 6
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.
Report a side effect or a product complaintFor any further assistance, please get in touch.