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Novo Nordisk Limited
Broadfield Park, Brighton Road, Crawley, West Sussex, RH11 9RT
Telephone: +44 (0)1293 613555
Fax: +44 (0)1293 613535
Medical Information Direct Line: +44 (0)845 600 5055
Medical Information e-mail: ukmedicalinfo@novonordisk.com
Customer Care direct line: +44 (0)845 600 5055
Medical Information Fax: +44 (0)1293 613211

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 14/05/2012
SPC Prandin 0.5mg, 1mg, 2mg Tablets

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 14/05/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   20-Apr-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


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

 

Sentence added:

 

In an interaction study with healthy volunteers, co-administration of deferasirox (30 mg/kg/day, 4 days), a moderate inhibitor of CYP2C8 and CYP3A4, and repaglinide (single dose, 0.5 mg) resulted in an increase in repaglinide systemic exposure (AUC) to 2.3-fold (90% CI [2.03-2.63]) of control, a 1.6-fold (90% CI [1.42-1.84]) increase in Cmax, and a small, significant decrease in blood glucose values. Since the interaction has not been established with dosages higher than 0.5 mg for repaglinide, the concomitant use of deferasirox with repaglinide should be avoided. If the combination appears necessary, careful clinical and blood glucose monitoring should be performed (see section 4.4).

 

Section 10.DATE OF REVISION OF THE TEXT

 

04/2012
Updated on 06/07/2011 and displayed until 14/05/2012
Reasons for adding or updating:
  • Change of Marketing Authorisation Holder
Date of revision of text on the SPC:   31-Mar-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to marketing Authorisation Holder
Updated on 02/02/2009 and displayed until 06/07/2011
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
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   18-Dec-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.5
- Repaglinide appears to be substrate for active hepatic uptake (organic anion transporting protein OATP1B1).

- Addition of ‘ciclosporin’ in list of substances that may enhance and/or prolong the hypoglycaemic effect of repaglinide.
- Ciclosporin (100 mg), an inhibitor of CYP3A4 and a strong OATP1B1 inhibitor, increased the repaglinide (0.25 mg) Cmax 1.8-fold and the AUC 2.5-fold in an interaction study with healthy volunteers.

Section 4.8
- Addition under ‘Immune system disorders’ of ‘Very rare: Allergy. Generalised hypersensitivity reactions (e.g. anaphylactic reaction), or immunological reactions such as vasculitis.’

- Addition of the statement, ‘Interactions with other medicinal products may increase the risk of hypoglycaemia (see section 4.5).'

Section 10
Date of revision of text:  12/2008

    
Updated on 26/09/2008 and displayed until 02/02/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 4.8 - Undesirable Effects
  • 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 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
Date of revision of text on the SPC:   23-Jul-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.2 Posology and method of administration
Comment added regarding the time of dose with regards to mealtimes. Also, a statement that children under age 18 should not use repaglinide.

4.3 Contraindications
Pregnancy and lactation, and children <12 years of age have been removed from the list of contraindications.

4.4 Special warnings and precautions for use
General
Comment about no trials of combination therapy have been performed, has been removed, and a statement has been added regarding the latest from combination therapy trials.

Concomitant use
Comment regarding the safety profile has been removed, in addition to the paragraph containing the concomitant administration of particular drugs. A comment had been added advising the use of caution when receiving drugs which influence repaglinide metabolism.

Specific patient groups
A comment has been added regarding careful dose titration in debilitated or malnourished patients.

4.8 Undesirable effects
Frequency definition has been amended and side effects updated.

6.5 Nature and contents of container
360 blister pack quantity has been removed.

8. MA numbers
Numbers have been updated. 

9. Date of first authorisation/renewal of the authorisation
Renewal date amended to 23 July 2008

Updated on 07/12/2007 and displayed until 26/09/2008
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   06/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 Special warnings and precautions for use Addition of statement:  'The use of repaglinide might be associated with an increased incidence of acute coronary syndrome (e.g. myocardial infarction) (see section 4.8 and 5.1).'
 
Section 4.8 Undesirable effects Addition of statement: 'Cardiac disorders - Rare: Cardiovascular disease. Type 2 diabetes is associated with an increased risk for cardiovascular disease. In one epidemiological study, a higher incidence of acute coronary syndrome was reported in the repaglinide group. However, the causality of the relationship remains uncertain (see sections 4.4 and 5.1).'
 
Section 5.1 Pharmacodynamic properties Addition of statement: 'One epidemiological study suggested an increased risk of acute coronary syndrome in repaglinide treated patients as compared to sulfonylurea treated patients (see sections 4.4 and 4.8).'
Updated on 16/11/2006 and displayed until 07/12/2007
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  repaglinide