Sitagliptin SUN

sitagliptin fumarate

Overview
Authorisation details
Product information
Assessment history

Authorised

This medicine is authorised for use in the European Union.

Overview

Sitagliptin SUN is a medicine used to control blood glucose (sugar) levels in adults with type 2 diabetes. It is used together with diet and exercise in the following ways:

on its own, in patients whose blood glucose levels are not satisfactorily controlled with diet and exercise and who cannot take metformin (a diabetes medicine);
in combination with metformin or a PPAR-gamma agonist (a type of diabetes medicine) such as a thiazolidinedione, in patients whose blood glucose levels are not satisfactorily controlled with metformin or the PPAR-gamma agonist used on its own;
in combination with a sulphonylurea (another diabetes medicine) in patients whose blood glucose levels are not satisfactorily controlled with a sulphonylurea used on its own and who cannot take metformin;
in combination with both metformin and a sulphonylurea or a PPAR-gamma agonist, in patients whose blood glucose levels are not satisfactorily controlled with the two medicines;
in combination with insulin, with or without metformin, in patients whose blood glucose levels are not satisfactorily controlled with a stable dose of insulin.

Sitagliptin SUN contains the active substance sitagliptin and is a ‘generic medicine’. This means that Sitagliptin SUN contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Januvia. For more information on generic medicines, see the question-and-answer document here.

: Sitagliptin SUN is available as tablets and can only be obtained with a prescription. The recommended dose is 100 mg once a day. The dose may be lowered in some patients with reduced kidney function. If Sitagliptin SUN is taken with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be lowered to reduce the risk of hypoglycaemia (low blood glucose levels).
For more information about using Sitagliptin SUN, 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 level of glucose in the blood or when the body is unable to use insulin effectively. The active substance in Sitagliptin SUN, sitagliptin, is a dipeptidyl-peptidase-4 (DPP-4) inhibitor. It 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 increasing levels of incretin hormones in the blood, sitagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high. Sitagliptin does not work when blood glucose levels are low. Sitagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon. Together, these processes reduce blood glucose levels and help to control type 2 diabetes.

: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Januvia, and do not need to be repeated for Sitagliptin SUN.
As for every medicine, the company provided data on the quality of Sitagliptin SUN. The company also carried out a study that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

: Because Sitagliptin SUN is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

: The European Medicines Agency concluded that, in accordance with EU requirements, Sitagliptin SUN has been shown to have comparable quality and to be bioequivalent to Januvia. Therefore, the Agency’s view was that, as for Januvia, the benefits of Sitagliptin SUN outweigh the identified 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 Sitagliptin SUN have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Sitagliptin SUN are continuously monitored. Suspected side effects reported with Sitagliptin SUN are carefully evaluated and any necessary action taken to protect patients.

: Sitagliptin SUN received a marketing authorisation valid throughout the EU on 09 December 2021.

List item

Sitagliptin SUN : EPAR - Medicine overview (PDF/168.09 KB)

First published: 17/01/2022
EMA/604084/2021
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List item

Sitagliptin SUN : EPAR - Risk management plan summary (PDF/122.17 KB)

First published: 17/01/2022

This EPAR was last updated on 27/10/2022

Authorisation details

Product details
Name	Sitagliptin SUN
Agency product number	EMEA/H/C/005741
Active substance	sitagliptin fumarate
International non-proprietary name (INN) or common name	sitagliptin fumarate
Therapeutic area (MeSH)	Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code	A10BH01
Generic	This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder	Sun Pharmaceutical Industries Europe B.V.
Revision	1
Date of issue of marketing authorisation valid throughout the European Union	09/12/2021
Contact address	Polarisavenue 87 2132JH Hoofddorp The Netherlands

Product information

08/07/2022 Sitagliptin SUN - EMEA/H/C/005741 - IB/0002

List item

Sitagliptin SUN : EPAR - Product Information (PDF/485.47 KB)

First published: 17/01/2022
Last updated: 27/10/2022
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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.

List item

Sitagliptin SUN : EPAR - All authorised presentations (PDF/51.57 KB)

First published: 17/01/2022
- Bulgarian
  (PDF/77.95 KB)
- Croatian
  (PDF/80.25 KB)
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  (PDF/68.28 KB)
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- Icelandic
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- Latvian
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- Slovak
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- Slovenian
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- Spanish
  (PDF/54.51 KB)
- Swedish
  (PDF/59.55 KB)

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

For adult patients with type 2 diabetes mellitus, Sitagliptin SUN is indicated to improve glycaemic control:

as monotherapy:
- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance.

as dual oral therapy in combination with:
- metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.
- a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance.
- a peroxisome proliferator-activated receptor gamma (PPARγ) agonist (i.e. a thiazolidinedione) when use of a PPARγ agonist is appropriate and when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control.

as triple oral therapy in combination with:
- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
- a PPARγ agonist and metformin when use of a PPARγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.

Sitagliptin SUN is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

Assessment history

Changes since initial authorisation of medicine

List item

Sitagliptin SUN : EPAR - Procedural steps taken and scientific information after authorisation (PDF/86.38 KB)

First published: 27/10/2022

Initial marketing-authorisation documents

News

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 October 2021

15/10/2021

Sitagliptin SUN

Table of contents

Overview

Sitagliptin SUN : EPAR - Medicine overview (PDF/168.09 KB)

Sitagliptin SUN : EPAR - Risk management plan summary (PDF/122.17 KB)

Authorisation details

Product information

Sitagliptin SUN : EPAR - Product Information (PDF/485.47 KB)

Sitagliptin SUN : EPAR - All authorised presentations (PDF/51.57 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Sitagliptin SUN : EPAR - Procedural steps taken and scientific information after authorisation (PDF/86.38 KB)

Initial marketing-authorisation documents

Sitagliptin SUN : EPAR - Public assessment report (PDF/518.26 KB)

CHMP summary of opinion for Sitagliptin SUN (PDF/157.03 KB)

News

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