Icandra (previously Vildagliptin / metformin hydrochloride Novartis)

vildagliptin / metformin

Overview
Authorisation details
Product information
Assessment history

Authorised

This medicine is authorised for use in the European Union.

Overview

Icandra is a diabetes medicine that is used together with diet and exercise to control the blood glucose (sugar) in adults with type 2 diabetes. It is used:

in patients whose blood glucose is insufficiently controlled with metformin taken alone;
in patients who are already taking the combination of vildagliptin and metformin as separate tablets;
together with other diabetes medicines, including insulin, when these medicines do not provide adequate control of the blood glucose.

Icandra contains the active substances vildagliptin and metformin hydrochloride. This medicine is the same as Eucreas, which is already authorised in the EU. The company that makes Eucreas has agreed that its scientific data can be used for Icandra (informed consent).

: Icandra is available as tablets (50 mg/850 mg and 50 mg/1,000 mg), and the recommended dose is one tablet twice a day (one in the morning and one in the evening). The starting tablet strength depends on the patient’s current treatment and the expected effects of Icandra. Taking Icandra with or just after food may reduce any stomach problems caused by metformin.
The doctor should carry out tests to check the patient’s kidney and liver function before treatment with Icandra and at regular intervals during treatment.
The medicine can only be obtained with a prescription. For more information about using Icandra, see the package leaflet or contact your doctor or pharmacist.

: Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the glucose level in the blood or the body is unable to use insulin effectively. Icandra contains two active substances, each with a different mode of action.
Vildagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor that works by blocking the breakdown of incretin hormones in the body. These hormones are released after a meal and stimulate the pancreas to produce insulin. By blocking the breakdown of incretin hormones in the blood, vildagliptin prolongs their action, stimulating the pancreas to produce more insulin when blood glucose levels are high. Vildagliptin does not work when the blood glucose is low. Vildagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Metformin works mainly by inhibiting glucose production and reducing its absorption in the gut. As a result of the action of both substances, the blood glucose is reduced, which helps to control type 2 diabetes.

: Vildagliptin on its own is approved for use in the EU under the name Galvus, and metformin has been available in the EU since 1959. Vildagliptin can be used with metformin in type 2 diabetes patients who are not satisfactorily controlled on metformin alone.
Studies with Galvus as an add-on to metformin, metformin and a sulphonylurea, or metformin and insulin have been used to support the use of Icandra in the same indications. The studies compared Galvus with placebo (a dummy treatment) and measured the levels of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Vildagliptin has been shown to be more effective than placebo at reducing HbA1c levels when it was added to metformin. Patients adding vildagliptin had falls in HbA1c levels of 0.88 percentage points after 24 weeks from a starting level of 8.38%. In contrast, patients adding placebo had smaller changes in HbA1c levels, with a rise of 0.23 percentage points from a starting level of 8.3%. In other studies, vildagliptin in combination with metformin has been shown to be more effective than placebo when used with a sulphonylurea or insulin.
The applicant also presented the results of two studies showing that the active substances in the two strengths of Icandra were absorbed in the body in the same way as when they were taken as separate tablets.

: The most common side effects with Icandra (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, diarrhoea, abdominal (belly) pain and loss of appetite. For the full list of all side effects reported with Icandra, see the package leaflet.
Icandra must not be used in people who are hypersensitive (allergic) to vildagliptin, metformin or any of the other ingredients. Icandra must also not be used in patients with certain kidney, liver or heart problems or those who could develop metabolic acidosis (build-up of acid in the blood). It must also not be used in patients who consume excessive amounts of alcohol or who have alcoholism, or in women who are breastfeeding. For the full list of restrictions, see the package leaflet.

: Studies have shown that vildagliptin taken with metformin is effective in reducing blood glucose levels and that the combination of vildagliptin and metformin was effective as an add-on to a sulphonylurea or insulin. The combination of the two active substances vildagliptin and metformin in one tablet may help patients to stick to their treatment. The European Medicines Agency therefore decided that Icandra’ benefits are greater than its risks and it can be authorised for use in the EU.

: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Icandra have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Icandra are continuously monitored. Suspected side effects reported with the medicine are carefully evaluated and any necessary action taken to protect patients.

: Vildagliptin/metformin hydrochloride Novartis received a marketing authorisation valid throughout the EU on 1 December 2008. The name of the medicine was changed to Icandra on 6 February 2009.

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Icandra : EPAR - Medicine overview (PDF/175.2 KB)

First published: 18/03/2009
Last updated: 08/09/2021
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- Spanish
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- Swedish
  (PDF/169.31 KB)

This EPAR was last updated on 09/11/2022

Authorisation details

Product details
Name	Icandra (previously Vildagliptin / metformin hydrochloride Novartis)
Agency product number	EMEA/H/C/001050
Active substance	vildagliptin metformin hydrochloride
International non-proprietary name (INN) or common name	vildagliptin metformin
Therapeutic area (MeSH)	Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code	A10BD08

Publication details
Marketing-authorisation holder	Novartis Europharm Limited
Revision	25
Date of issue of marketing authorisation valid throughout the European Union	30/11/2008
Contact address	Vista Building Elm Park Merrion Road Dublin 4 Ireland

Product information

14/10/2022 Icandra (previously Vildagliptin / metformin hydrochloride Novartis) - EMEA/H/C/001050 - WS2224

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Icandra : EPAR - Product Information (PDF/849.41 KB)

First published: 21/09/2009
Last updated: 09/11/2022
- Bulgarian
  (PDF/713 KB)
- Croatian
  (PDF/869.89 KB)
- Czech
  (PDF/893.11 KB)
- Danish
  (PDF/919.98 KB)
- Dutch
  (PDF/793.25 KB)
- Estonian
  (PDF/826.96 KB)
- Finnish
  (PDF/1.05 MB)
- French
  (PDF/873.58 KB)
- German
  (PDF/833.65 KB)
- Greek
  (PDF/999.69 KB)
- Hungarian
  (PDF/867.93 KB)
- Icelandic
  (PDF/531.02 KB)
- Italian
  (PDF/703.25 KB)
- Latvian
  (PDF/858.23 KB)
- Lithuanian
  (PDF/976.96 KB)
- Maltese
  (PDF/1.03 MB)
- Norwegian
  (PDF/827.17 KB)
- Polish
  (PDF/901.41 KB)
- Portuguese
  (PDF/781.65 KB)
- Romanian
  (PDF/910.78 KB)
- Slovak
  (PDF/813.18 KB)
- Slovenian
  (PDF/962.23 KB)
- Spanish
  (PDF/780.46 KB)
- Swedish
  (PDF/785.66 KB)

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

Product information documents contain:

summary of product characteristics (annex I);
manufacturing authorisation holder responsible for batch release (annex IIA);
conditions of the marketing authorisation (annex IIB);
labelling (annex IIIA);
package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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Icandra : EPAR - All Authorised presentations (PDF/99.94 KB)

First published: 03/03/2009
Last updated: 17/06/2020
- Bulgarian
  (PDF/112.68 KB)
- Croatian
  (PDF/104.72 KB)
- Czech
  (PDF/105.38 KB)
- Danish
  (PDF/102.6 KB)
- Dutch
  (PDF/100.3 KB)
- Estonian
  (PDF/101.36 KB)
- Finnish
  (PDF/99.82 KB)
- French
  (PDF/103.92 KB)
- German
  (PDF/103.12 KB)
- Greek
  (PDF/112.25 KB)
- Hungarian
  (PDF/108.08 KB)
- Icelandic
  (PDF/103.2 KB)
- Italian
  (PDF/101.78 KB)
- Latvian
  (PDF/106.33 KB)
- Lithuanian
  (PDF/107.18 KB)
- Maltese
  (PDF/106.9 KB)
- Norwegian
  (PDF/100.95 KB)
- Polish
  (PDF/104.13 KB)
- Portuguese
  (PDF/102.18 KB)
- Romanian
  (PDF/103.06 KB)
- Slovak
  (PDF/108.5 KB)
- Slovenian
  (PDF/105.21 KB)
- Spanish
  (PDF/102.36 KB)
- Swedish
  (PDF/101.77 KB)

Pharmacotherapeutic group

Drugs used in diabetes
Combinations of oral blood glucose lowering drugs

Therapeutic indication

Icandra is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:

in patients who are inadequately controlled with metformin hydrochloride alone.
in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets.
in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).

Assessment history

Changes since initial authorisation of medicine

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Icandra : EPAR - Procedural steps taken and scientific information after authorisation (PDF/409.37 KB)

First published: 21/09/2009
Last updated: 09/11/2022
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Icandra-H-C-1050-WS-1937-G : EPAR - Assessment Report - Variation (PDF/1.74 MB)

Adopted

First published: 08/09/2021
EMA/402373/2021
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CHMP post-authorisation summary of positive opinion for Icandra (WS-1937-G) (PDF/110.73 KB)

Adopted

First published: 21/05/2021
EMA/283696/2021
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Icandra-H-C-1050-A31-1432 : EPAR - Assessment Report - Variation (PDF/568.79 KB)

Adopted

First published: 03/01/2017
Last updated: 03/01/2017
EMA/867221/2016
List item

Icandra : EPAR - Scientific conclusion (PDF/32.54 KB)

First published: 03/01/2017
Last updated: 03/01/2017
- Bulgarian
  (PDF/69.5 KB)
- Croatian
  (PDF/62.6 KB)
- Czech
  (PDF/66.59 KB)
- Danish
  (PDF/29.27 KB)
- Dutch
  (PDF/30.09 KB)
- Estonian
  (PDF/28.67 KB)
- Finnish
  (PDF/29.33 KB)
- French
  (PDF/33.77 KB)
- German
  (PDF/31.79 KB)
- Greek
  (PDF/68.71 KB)
- Hungarian
  (PDF/48.06 KB)
- Icelandic
  (PDF/30.33 KB)
- Italian
  (PDF/29.01 KB)
- Latvian
  (PDF/65.13 KB)
- Lithuanian
  (PDF/65.13 KB)
- Maltese
  (PDF/67.26 KB)
- Norwegian
  (PDF/28.2 KB)
- Polish
  (PDF/49.5 KB)
- Portuguese
  (PDF/29.91 KB)
- Romanian
  (PDF/63.84 KB)
- Slovak
  (PDF/51.54 KB)
- Slovenian
  (PDF/60.9 KB)
- Spanish
  (PDF/29.91 KB)
- Swedish
  (PDF/29.93 KB)
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Icandra-H-C-PSUSA-00003113-201502 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/73.44 KB)

First published: 18/02/2016
Last updated: 18/02/2016
EMA/829798/2015
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Icandra-H-C-1050-WS-0272 : EPAR - Assessment Report - Variation (PDF/927.76 KB)

Adopted

First published: 20/02/2013
Last updated: 20/02/2013
EMA/CHMP/568007/2012
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CHMP post-authorisation summary of positive opinion for Icandra (PDF/52.33 KB)

Adopted

First published: 21/09/2012
Last updated: 21/09/2012
EMA/CHMP/600950/2012

Initial marketing-authorisation documents

List item

Icandra : EPAR - Public assessment report (PDF/35.98 KB)

First published: 23/12/2008
Last updated: 23/12/2008

Icandra (previously Vildagliptin / metformin hydrochloride Novartis)

Table of contents

Overview

Icandra : EPAR - Medicine overview (PDF/175.2 KB)

Authorisation details

Product information

Icandra : EPAR - Product Information (PDF/849.41 KB)

Icandra : EPAR - All Authorised presentations (PDF/99.94 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Icandra : EPAR - Procedural steps taken and scientific information after authorisation (PDF/409.37 KB)

Icandra-H-C-1050-WS-1937-G : EPAR - Assessment Report - Variation (PDF/1.74 MB)

CHMP post-authorisation summary of positive opinion for Icandra (WS-1937-G) (PDF/110.73 KB)

Icandra-H-C-1050-A31-1432 : EPAR - Assessment Report - Variation (PDF/568.79 KB)

Icandra : EPAR - Scientific conclusion (PDF/32.54 KB)

Icandra-H-C-PSUSA-00003113-201502 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/73.44 KB)

Icandra-H-C-1050-WS-0272 : EPAR - Assessment Report - Variation (PDF/927.76 KB)

CHMP post-authorisation summary of positive opinion for Icandra (PDF/52.33 KB)

Initial marketing-authorisation documents

Icandra : EPAR - Public assessment report (PDF/35.98 KB)

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