Sitagliptin / Metformin hydrochloride Mylan

sitagliptin hydrochloride monohydrate / metformin hydrochloride

Overview
Authorisation details
Product information
Assessment history

Authorised

This medicine is authorised for use in the European Union.

Overview

Sitagliptin/Metformin hydrochloride Mylan 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:
• in patients whose blood glucose levels are not satisfactorily controlled with metformin (a diabetes medicine) used on its own;
• in patients who are already taking a combination of sitagliptin and metformin as separate tablets;
• in combination with a sulphonylurea, a PPAR-gamma agonist such as a thiazolidinedione, or insulin (other types of diabetes medicines) in patients whose blood glucose levels are not satisfactorily controlled with either of these medicines and metformin.
Sitagliptin/Metformin hydrochloride Mylan contains the active substances sitagliptin and metformin hydrochloride and is a ‘generic medicine’. This means that Sitagliptin/Metformin hydrochloride Mylan contains the same active substances and works in the same way as a ‘reference medicine’ already authorised in the EU called Janumet. For more information on generic medicines, see the question-and-answer document here.

: Sitagliptin/Metformin hydrochloride Mylan is available as tablets and can only be obtained with a prescription. The medicine is taken twice a day and the strength of the tablet depends on the dose of the other diabetes medicines that the patient was taking before. If Sitagliptin/Metformin hydrochloride Mylan is taken with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be lowered to avoid hypoglycaemia (low blood sugar levels). The maximum dose of sitagliptin is 100 mg a day. Sitagliptin/Metformin hydrochloride Mylan should be taken with food to avoid any stomach problems caused by metformin.
For more information about using Sitagliptin/Metformin hydrochloride Mylan, 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 where the body is unable to use insulin effectively. The active substances in Sitagliptin/Metformin hydrochloride Mylan each have a different mode of action.
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.
Metformin works mainly by inhibiting glucose production and reducing its absorption in the gut.
Together, these processes reduce blood glucose levels and help to control type 2 diabetes.

: Studies on the benefits and risks of the active substances in the authorised use have already been carried out with the reference medicine, Janumet, and do not need to be repeated for Sitagliptin/Metformin hydrochloride Mylan.
As for every medicine, the company provided data on the quality of Sitagliptin/Metformin hydrochloride Mylan. The company also carried out studies 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/Metformin hydrochloride Mylan 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/Metformin hydrochloride Mylan has been shown to have comparable quality and to be bioequivalent to Janumet. Therefore, the Agency’s view was that, as for Janumet, the benefits of Sitagliptin/Metformin hydrochloride Mylan 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/Metformin hydrochloride Mylan have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Sitagliptin/Metformin hydrochloride Mylan are continuously monitored. Suspected side effects reported with Sitagliptin/Metformin hydrochloride Mylan are carefully evaluated and any necessary action taken to protect patients.

: Sitagliptin/Metformin hydrochloride Mylan received a marketing authorisation valid throughout the EU on 16 February 2022.

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Sitagliptin / Metformin hydrochloride Mylan : EPAR - Medicine Overview (PDF/161.21 KB)

First published: 08/03/2022
EMA/2302/2022
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Sitagliptin / Metformin hydrochloride Mylan : EPAR - Risk management plan summary (PDF/77.65 KB)

First published: 08/03/2022

This EPAR was last updated on 30/05/2023

Authorisation details

Product details
Name	Sitagliptin / Metformin hydrochloride Mylan
Agency product number	EMEA/H/C/005678
Active substance	sitagliptin hydrochloride monohydrate metformin hydrochloride
International non-proprietary name (INN) or common name	sitagliptin hydrochloride monohydrate metformin hydrochloride
Therapeutic area (MeSH)	Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code	A10BD07
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	Mylan Ireland Limited
Revision	2
Date of issue of marketing authorisation valid throughout the European Union	16/02/2022
Contact address	Unit 35/36 Grange Parade Baldoyle Industrial Estate Dublin 13 Ireland

Product information

29/05/2023 Sitagliptin / Metformin hydrochloride Mylan - EMEA/H/C/005678 - N/0008

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Sitagliptin / Metformin hydrochloride Mylan : EPAR - Product Information (PDF/484.19 KB)

First published: 08/03/2022
Last updated: 30/05/2023
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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.

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Sitagliptin / Metformin hydrochloride Mylan : EPAR - All authorised presentations (PDF/17.82 KB)

First published: 08/03/2022
Last updated: 21/06/2022
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Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

For adult patients with type 2 diabetes mellitus:

Sitagliptin/Metformin hydrochloride Mylan is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.

Sitagliptin/Metformin hydrochloride Mylan is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.

Sitagliptin/Metformin hydrochloride Mylan is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPARg) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPARg agonist.

Sitagliptin/Metformin hydrochloride Mylan is also indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.

Assessment history

Changes since initial authorisation of medicine