Reasons for adding or updating:

• Change to section 4.2 - Posology and method of administration
• Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
• 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 10 - Date of revision of the text

Date of revision of text on the SPC: 24-Jul-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



• In section 4.2, method of administration revised in line latest QRD template

Method of administration

 

Tablets should be swallowed without chewing with some liquid.

• In section 4.5,

Colesevelam binds to glimepiride and reduces glimepiride absorption from the gastro-intestinal tract. No interaction was observed when glimepiride was taken at least 4 hours before colesevelam. Therefore, glimepiride should be administered at least 4 hours prior to colesevelam.

• In section 4.8,

Blood and lymphatic system disorders

Rare: thrombocytopenia, leukopenia, granulocytopenia, agranulocytosis, erythropenia, haemolytic anaemia and pancytopenia, which are in general reversible upon discontinuation of medication.

Not known: severe thrombocytopenia with platelet count less than 10,000/µl and thrombocytopenic purpura.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

• In section 5.1,

Pharmacotherapeutic group     : Blood glucose lowering drugs, excl. insulins: Sulfonamides, urea derivatives

Reasons for adding or updating:

• Change to section 3 - Pharmaceutical form

Date of revision of text on the SPC: 20-Feb-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 3 - Pharmaceutical form of SPC the colouring system was replaced from blue to white coloured tablets.

Reasons for adding or updating:

• Change to section 4.3 - Contraindications
• Change to section 4.4 - Special warnings and precautions for use
• Change to section 6.1 - List of excipients
• Change to section 6.4 - Special precautions for storage
• 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: 24-Feb-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Following the renewal application the following sections were updated:

4.3.      Contraindications

4.5.      Interaction with other medicinal products and other forms of interaction

6.1       List of excipients

6.4       Special precautions for storage

6.6       Special precautions for disposal

9        Date of first authorisation/renewal of the authorisation

10      Date of revision of the text

Reasons for adding or updating:

• New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Legal Category:POM

Black Triangle (CHM): NO