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 4.5 - Interaction with other medicinal products and other forms of interaction
• Change to section 4.6 - Fertility, pregnancy and lactation
• Change to section 4.8 - Undesirable effects - how to report a side effect
• Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 19-Sep-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

$0Followingchanges have been made to the mentioned sections of SPC:$0$0· Sec 4.2 Posology andmethod of administration$0$0Renal impairment: Repaglinideis not affected by renal disorders$0$0· Sec 4.4 Special warnings andprecautions for use$0$0General$0$0When a patientstabilised on any oral hypoglycaemic medicinal product is exposed to stresssuch as fever, trauma, infection or surgery, a loss of glycaemic control mayoccur. At such times, it may be necessary to discontinue repaglinide and treatwith insulin on a temporary basis.$0$0Combination with metformin$0$0Combination treatmentwith metformin is associated with an increased risk of hypoglycaemia.$0$0· Sec 4.5 Interaction with othermedicinal products and other forms of interaction$0$0Deferasirox & clopidogrel have been added.$0$0Following has been added :$0$0In an interaction study with healthy volunteers,co-administration of clopidogrel (300 mg loading dose), a CYP2C8 inhibitor,increased repaglinide exposure (AUC0–∞) 5.1-fold and continued administration(75 mg daily dose) increased repaglinide exposure (AUC0–∞) 3.9-fold. A small,significant decrease in blood glucose values was observed. Since the safetyprofile of the co‑treatment has not been established in these patients, theconcomitant use of clopidogrel and repaglinide should be avoided. Ifconcomitant use is necessary, careful monitoring of blood glucose and closeclinical monitoring should be performed (see section 4.4).$0$0· Sec4.6 Fertility, pregnancy and lactation$0$0Fertility$0$0Data from animal studies investigating effects on embryofetal andoffspring development as well as excretion in milk is described in section 5.3.$0$0· Sec4.8 Undesirable effects$0$0Reporting suspected adverse reactions after authorisationof the medicinal product is important. It allows continued monitoring of thebenefit/risk balance of the medicinal product. Healthcare professionals areasked to report any suspected adverse reactions via the Yellow Card Scheme at:www.mhra.gov.uk/yellowcard.$0

Reasons for adding or updating:

• Change to section 6.5 - Nature and contents of container
• Change to section 8 - Marketing authorisation number(s)
• Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 15-Sep-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Update in section 6.5 Nature and contents of container- Addition of 180 pack size

Update in section 8: Update in market authorisation  number

Update in section 10 date of revision of 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