Reasons for adding or updating:

• Change to section 2 - Qualitative and quantitative composition
• Change to section 4.2 - Posology and method of administration
• Change to section 4.3 - Contraindications
• Change to section 4.4 - Special warnings and precautions for use
• Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
• Change to section 4.7 - Effects on ability to drive and use machines
• Change to section 4.8 - Undesirable effects - how to report a side effect
• Change to section 5.1 - Pharmacodynamic properties
• Change to section 5.3 - Preclinical safety data
• Change to section 6.5 - Nature and contents of container
• Change to section 9 - Date of first authorisation/renewal of the authorisation
• Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 01-May-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The SPC has been updated as follows

Sections  2,  4.2,  4.3, 4.5, 4.7, 5.1, 5.3,  6.6, 9 and 10 editorial and/or QRD updates.

Sections 4.2 – addition of advisory statement for renal / hepatic impairment.

Section 4.4-  amended warnings (hypersensitivity and severe skin reactions) in line with December 2015 CDS for systemic clindamycin.

Section 4.8 – amended undesirable effects (addition of the adverse drug reactions, clostridium difficile colitis, anaphylactic shock, anaphylactic reaction, hypersensitivity and angioedema) to s4.8 of the systemic clindamycin December 2015 CDS.

Reasons for adding or updating:

• Change to section 4.2 - Posology and method of administration
• Change to section 4.4 - Special warnings and precautions for use
• Change to section 4.6 - Fertility, pregnancy and lactation
• Change to section 4.7 - Effects on ability to drive and use machines
• Change to section 4.8 - Undesirable effects
• Change to section 5.2 - Pharmacokinetic properties

Date of revision of text on the SPC: 01-Mar-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The SPC has been updated as follows

Sections 1, 2, 3, 4.1, 4.2,  4.8, 5.1, 6.1, 6.2, 6.3, 6.4, 6.6, 9 and 10 editorial and/or QRD updates.

Sections 4.2 – addition of advisory statement for elderly patients.

Section 4.4-  amended warnings in line with June 2013 CDS and November 2013 EU CSP for Clindamycin Hydrochloride.

Section 4.6 – amended advisory text  in line with June 2013 CDS and November 2013 EU CSP for Clindamycin Hydrochloride.

Section 4.7 -  amended advisory statement in line with June 2013 CDS and November 2013 EU CSP for Clindamycin Hydrochloride.

Section 4.8 – amended in line with June 2013 CDS and November 2013 EU CSP for Clindamycin Hydrochloride.

Section 5.2 – updated in line with June 2013 CDS and November 2013 EU CSP for Clindamycin Hydrochloride..

Reasons for adding or updating:

• Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
• Change to section 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC: 01-Jun-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Updates to:

Section 4.5: Additions of PRAC recommendation text provided

Vitamin K antagonists

Increased coagulation tests (PT/INR) and/or bleeding, have been reported in patients treated with clindamycin in combination with a vitamin K antagonist (e.g. warfarin, acenocoumarol and fluindione). Coagulation tests, therefore, should be frequently monitored in patients treated with vitamin K antagonists.

Section 4.8

Addition of the Reporting of suspected adverse reactions text

Reasons for adding or updating:

• New individual SPC (was previously included in joint SPC)

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Previous version was under Pharmacia Ltd