Sitagliptin / Metformin hydrochloride Mylan
Authorised
This medicine is authorised for use in the European Union
sitagliptin hydrochloride monohydrate / metformin hydrochloride
MedicineHumanAuthorised
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.
Product information
Latest procedure affecting product information: IB/0011
17/04/2024
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).
Product details
- Name of medicine
- Sitagliptin / Metformin hydrochloride Mylan
- 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
Pharmacotherapeutic group
Drugs used in diabetesTherapeutic 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. |
News on Sitagliptin / Metformin hydrochloride Mylan
This page was last updated on