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
• 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 6.6 - Special precautions for disposal and other handling
• 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:

• Change to section 7 - Marketing authorisation holder
• Change to section 8 - Marketing authorisation number(s)

Date of revision of text on the SPC: 01-Aug-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Update to section 7 and Section 8  – Marketing Authorisation Holder and Marketing Authorisation Number

Reasons for adding or updating:

• Change to section 6. 5 - Nature and Contents of Container

Date of revision of text on the SPC: 01-Mar-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Changes to section 6.5.Nature and Contents of Container

Reasons for adding or updating:

• Change to section 4.4 - Special warnings and precautions for Use

Date of revision of text on the SPC: 01-May-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.4

to include precautionary information concerning that Clostridium difficile associated diarrhoea (CDAD) with use of nearly all antibacterial agents, and may range in severity from mild diarrhoea to fatal colitis

Reasons for adding or updating:

• Individual SPC superseded by joint SPC covering several presentations
• 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-Sep-2009

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

SPC now combined to cover both 75mg and 150mg capsules

Renewal Approval received August 2009 so dates of renewal and date of last update have been updated.

Reasons for adding or updating:

• Change to section 10 date of revision of the text
• Change to section 6.1 - List of Excipients
• Change to section 3 - Pharmaceutical form

Date of revision of text on the SPC: 01-Apr-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 3 - Pharmaceutical form updated

Section 6.1 - List of excipients updated

Section 10 - Date of revision of text updated

Reasons for adding or updating:

• Change to section 7 - Marketing Authorisation Holder

Date of revision of text on the SPC: 01-Jul-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

7.  Marketing Authorisation Holder

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 4.7 - Effects on Ability to Drive and Use Machines
• Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC: 01-Dec-2005

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

 

4.2 – No dosage modification necessary in patients with renal or hepatic insufficiency

4.4 – deletion of the dosage reduction in patients with renal or hepatic impairment

4.7 – revised statement

4.8 – as stated above  

Reasons for adding or updating:

• Change to section 4.8 - Undesirable Effects

Reasons for adding or updating:

• Change to separate SPCs covering individual presentations
• Change to section 1 - trade name
• Change to section 2 - qualitative and quantitative composition
• Change to section 3 - pharmaceutical form
• Change to section 4.3 - Contra-indications
• Change to section 5 - Pharmacological Properties
• Change to section 6.1 - List of Excipients
• Change to section 10 (date of (partial) revision of the text