Prandin

repaglinide

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This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is Prandin?

Prandin is a medicine that contains the active substance repaglinide. It is available as round tablets (white: 0.5 mg; yellow: 1 mg; peach: 2 mg).

What is Prandin used for?

Prandin is used in patients who have type-2 diabetes (non-insulin-dependent diabetes). It is used together with diet and exercise to lower blood glucose (sugar) levels in patients whose hyperglycaemia (high blood glucose levels) cannot be controlled by diet, weight reduction and exercise. Prandin may also be used with metformin (another antidiabetes medicine) in type-2 diabetes patients whose blood glucose levels are not satisfactorily controlled on metformin alone.

How is Prandin used?

Prandin is taken before meals, normally up to 15 minutes before each main meal. The dose is adjusted to give the best control. A doctor should regularly test the patient’s blood glucose to find the lowest effective dose. Prandin can also be used for type-2 diabetes patients whose blood glucose levels are usually controlled well on diet, but are experiencing temporary loss of blood glucose control.

The recommended starting dose is 0.5 mg. This dose may need to be increased after one or two weeks.

If patients are transferred from another antidiabetes medicine, the recommended starting dose is 1 mg.

Prandin is not recommended for patients below 18 years of age because of a lack of information on safety and effectiveness in this age group.

How does Prandin work?

Type-2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively. Prandin helps the pancreas to produce more insulin at mealtimes and is used to control type-2 diabetes.

How has Prandin been studied?

Prandin has been studied in 45 ‘clinical pharmacology’ studies (looking at how the medicine works in the body) and 16 clinical trials (looking at its effects in treating type-2 diabetes patients). A total of 2,156 patients received Prandin in all trials combined.

The main studies compared Prandin with other medicines used in type-2 diabetes (glibenclamide, glipizide or gliclazide). Another study looked at the effect of adding Prandin to metformin. The studies measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c) which gives an indication of how well the blood glucose is controlled.

What benefit has Prandin shown during the studies?

In all studies, Prandin led to a decrease in the level of HbA1c, which showed that blood glucose levels had been controlled to a similar level to that seen with the comparator medicines. In the study where Prandin was added to metformin, the effects of the two medicines were at least additive (equivalent to the effects of the two medicines added together).

Prandin produced a good insulin response to a meal within 30 minutes of being dosed in type 2 diabetes patients, leading to a blood glucose-lowering effect throughout the meal. The raised insulin levels returned to normal after the meal.

What is the risk associated with Prandin?

The most common side effects with Prandin (seen in between 1 and 10 patients in 100) are hypoglycaemia (low blood glucose levels), abdominal (tummy) pain and diarrhoea. For the full list of all side effects seen with Prandin, see the package leaflet.

Prandin should not be used in people who may be hypersensitive (allergic) to repaglinide or any of the other ingredients. It should also not be used in patients with type 1 (insulin-dependent) diabetes who do not have any ‘C-peptide’ in their blood (a marker of type 1 diabetes). It should also not be used in patients with diabetic ketoacidosis (high levels of ketones [acids] in the blood), in patients with severe liver problems or in patients also taking gemfibrozil (a medicine used to reduce blood fat levels). Prandin doses may also need to be adjusted when given with some medicines used in heart conditions, and to treat pain, asthma and other conditions. The full list is available in the package leaflet.

Why has Prandin been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Prandin’s benefits are greater than its risks for the treatment of type-2 diabetes. The Committee recommended that Prandin be given marketing authorisation.

Other information about Prandin

The European Commission granted a marketing authorisation valid throughout the European Union for Prandin to Novo Nordisk A/S on 29 January 2001. The marketing authorisation was renewed on 18 August 2003 and on 18 August 2008.

Name Language First published Last updated
Prandin : EPAR - Summary for the public BG = bălgarski 2008-10-20  
Prandin : EPAR - Summary for the public ES = español 2008-10-20  
Prandin : EPAR - Summary for the public CS = čeština 2008-10-20  
Prandin : EPAR - Summary for the public DA = dansk 2008-10-20  
Prandin : EPAR - Summary for the public DE = Deutsch 2008-10-20  
Prandin : EPAR - Summary for the public ET = eesti keel 2008-10-20  
Prandin : EPAR - Summary for the public EL = elliniká 2008-10-20  
Prandin : EPAR - Summary for the public EN = English 2008-10-20  
Prandin : EPAR - Summary for the public FR = français 2008-10-20  
Prandin : EPAR - Summary for the public IT = italiano 2008-10-20  
Prandin : EPAR - Summary for the public LV = latviešu valoda 2008-10-20  
Prandin : EPAR - Summary for the public LT = lietuvių kalba 2008-10-20  
Prandin : EPAR - Summary for the public HU = magyar 2008-10-20  
Prandin : EPAR - Summary for the public MT = Malti 2008-10-20  
Prandin : EPAR - Summary for the public NL = Nederlands 2008-10-20  
Prandin : EPAR - Summary for the public PL = polski 2008-10-20  
Prandin : EPAR - Summary for the public PT = português 2008-10-20  
Prandin : EPAR - Summary for the public RO = română 2008-10-20  
Prandin : EPAR - Summary for the public SK = slovenčina 2008-10-20  
Prandin : EPAR - Summary for the public SL = slovenščina 2008-10-20  
Prandin : EPAR - Summary for the public FI = suomi 2008-10-20  
Prandin : EPAR - Summary for the public SV = svenska 2008-10-20  

This EPAR was last updated on 23/06/2016 .

Authorisation details

Product details

Product details for Prandin
NamePrandin
Agency product numberEMEA/H/C/000362
Active substance

repaglinide

International non-proprietary name (INN) or common name

repaglinide

Therapeutic area Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code A10BX02

Publication details

Publication details for Prandin
Marketing-authorisation holder

Novo Nordisk A/S

Revision15
Date of issue of marketing authorisation valid throughout the European Union29/01/2001

Contact address:

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark

Product information

Product information

26/05/2016  Prandin -EMEA/H/C/000362 -WS/0951

Name Language First published Last updated
Prandin : EPAR - Product Information SV = svenska 2009-02-18 2016-06-23
Prandin : EPAR - Product Information SV = svenska 2009-02-18 2016-06-23
Prandin : EPAR - Product Information SV = svenska 2009-02-18 2016-06-23
Prandin : EPAR - Product Information SV = svenska 2009-02-18 2016-06-23
Prandin : EPAR - Product Information SV = svenska 2009-02-18 2016-06-23
Prandin : EPAR - Product Information SV = svenska 2009-02-18 2016-06-23
Prandin : EPAR - Product Information SV = svenska 2009-02-18 2016-06-23
Prandin : EPAR - Product Information SV = svenska 2009-02-18 2016-06-23
Prandin : EPAR - Product Information SV = svenska 2009-02-18 2016-06-23
Prandin : EPAR - Product Information SV = svenska 2009-02-18 2016-06-23
Prandin : EPAR - Product Information SV = svenska 2009-02-18 2016-06-23
Prandin : EPAR - Product Information SV = svenska 2009-02-18 2016-06-23
Prandin : EPAR - Product Information SV = svenska 2009-02-18 2016-06-23
Prandin : EPAR - Product Information SV = svenska 2009-02-18 2016-06-23
Prandin : EPAR - Product Information SV = svenska 2009-02-18 2016-06-23
Prandin : EPAR - Product Information SV = svenska 2009-02-18 2016-06-23
Prandin : EPAR - Product Information SV = svenska 2009-02-18 2016-06-23
Prandin : EPAR - Product Information SV = svenska 2009-02-18 2016-06-23
Prandin : EPAR - Product Information SV = svenska 2009-02-18 2016-06-23
Prandin : EPAR - Product Information SV = svenska 2009-02-18 2016-06-23
Prandin : EPAR - Product Information SV = svenska 2009-02-18 2016-06-23
Prandin : EPAR - Product Information SV = svenska 2009-02-18 2016-06-23
Prandin : EPAR - Product Information SV = svenska 2009-02-18 2016-06-23
Prandin : EPAR - Product Information SV = svenska 2009-02-18 2016-06-23
Prandin : EPAR - Product Information SV = svenska 2009-02-18 2016-06-23

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Prandin : EPAR - All Authorised presentations SV = svenska 2006-08-31  
Prandin : EPAR - All Authorised presentations SV = svenska 2006-08-31  
Prandin : EPAR - All Authorised presentations SV = svenska 2006-08-31  
Prandin : EPAR - All Authorised presentations SV = svenska 2006-08-31  
Prandin : EPAR - All Authorised presentations SV = svenska 2006-08-31  
Prandin : EPAR - All Authorised presentations SV = svenska 2006-08-31  
Prandin : EPAR - All Authorised presentations SV = svenska 2006-08-31  
Prandin : EPAR - All Authorised presentations SV = svenska 2006-08-31  
Prandin : EPAR - All Authorised presentations SV = svenska 2006-08-31  
Prandin : EPAR - All Authorised presentations SV = svenska 2006-08-31  
Prandin : EPAR - All Authorised presentations SV = svenska 2006-08-31  
Prandin : EPAR - All Authorised presentations SV = svenska 2006-08-31  
Prandin : EPAR - All Authorised presentations SV = svenska 2006-08-31  
Prandin : EPAR - All Authorised presentations SV = svenska 2006-08-31  
Prandin : EPAR - All Authorised presentations SV = svenska 2006-08-31  
Prandin : EPAR - All Authorised presentations SV = svenska 2006-08-31  
Prandin : EPAR - All Authorised presentations SV = svenska 2006-08-31  
Prandin : EPAR - All Authorised presentations SV = svenska 2006-08-31  
Prandin : EPAR - All Authorised presentations SV = svenska 2006-08-31  

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Repaglinide is also indicated in combination with metformin in type-2 diabetes patients who are not satisfactorily controlled on metformin alone.

Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Prandin : EPAR - Procedural steps taken before authorisation SV = svenska 2006-08-31  
Prandin : EPAR - Scientific Discussion SV = svenska 2006-08-31  

Authorised

This medicine is approved for use in the European Union

Related information

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