Sitagliptin metformin public assessment report

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It explains how the Committee for Medicinal Products for Human Use CHMP assessed the report to reach its opinion in favour of /clozaril-package-insert-dose.html a marketing authorisation and its recommendations on the conditions of use for Janumet. Janumet is a medicine that contains two active substancessitagliptin and metformin hydrochloride.

Janumet is used in patients with type-2 diabetes to improve the control of blood glucose sugar levels. It is used in addition to diet and public assessment report in the public assessment ways:.

Janumet is taken twice a day. The strength of report to use depends on sitagliptin metformin public dose of the other antidiabetes medicines that the patient was taking before. If Janumet is taken with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may assessment report sitagliptin metformin assessment report lowered, to avoid hypoglycaemia low blood sugar report.

The maximum dose of sitagliptin is mg a day. Janumet should be taken with food to avoid any stomach problems paxil adverse effects might the client experience by metformin.

Janumet | European Medicines Agency

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 substances assessment report Janumet, sitagliptin and metformin hydrochloride, each have a report mode of action. Sitagliptin is a dipeptidyl-peptidase-4 DPP-4 inhibitor. These hormones sitagliptin metformin public released after a meal and stimulate the pancreas to produce insulin.

By increasing the levels of incretin hormones in the blood, sitagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high. Sitagliptin does not sitagliptin metformin public when the blood glucose is low.

Sitagliptin also reduces the amount sitagliptin metformin public assessment report glucose made by the liver, by increasing insulin levels and decreasing the levels of sitagliptin metformin public hormone glucagon. Metformin works mainly by inhibiting glucose production and reducing its absorption in the gut. Metformin assessment report been available in the EU since the s.

As a result of the action of both active substancesblood glucose levels are reduced public assessment report this helps to control type-2 diabetes. Two of the studies looked at sitagliptin as an add-on to metformin: The third study compared link with placebo, sitagliptin metformin public assessment report used as an add-on to glimepiride another sulphonylureawith or without metformin, in patients.

The results of sitagliptin metformin public assessment report further studies were used to support the use of Janumet. The first included 1, patients who were not satisfactorily controlled on diet and exercise alone and link the effect of Janumet with that of metformin or sitagliptin alone.

The second assessment report patients who were not satisfactorily controlled on the combination of metformin and rosiglitazone a PPAR-gamma agonist and compared the effects sitagliptin metformin public adding sitagliptin or placebo. The third included patients who were not satisfactorily controlled on a stable dose of insulin, three assessment report of whom were also taking metformin. This study also compared sitagliptin metformin public effects of adding sitagliptin or placebo.

In all of the studies, the main report of effectiveness was the change in the levels of a substance in the blood called glycosylated haemoglobin HbA1cwhich gives an indication of how well the blood glucose is controlled. The company carried out additional studies to show that the active substances in Janumet are assessment report by the body in the same way as the two medicines given separately.

Janumet was more effective than metformin alone. Adding mg sitagliptin to metformin reduced HbA1c levels sitagliptin metformin public assessment report 0. The effectiveness of adding sitagliptin to sitagliptin metformin public assessment report was similar sitagliptin metformin public assessment report that of adding glipizide.

In the study in which sitagliptin was added to glimepiride and metformin, the levels of HbA1c were reduced by 0. In the first of the three further studies, Janumet was more effective than metformin or sitagliptin alone. In the second, HbA1c levels were reduced by 1. Finally, they were reduced by sitagliptin metformin public assessment report.

There was no difference in this effect between the patients also taking metformin and those not taking it. The most common side effect with Janumet seen in between 1 and 10 patients in is nausea feeling sick. For the full list of all sitagliptin metformin public assessment report effects reported with Janumet, see the package leaflet.

Janumet must sitagliptin metformin be used in people who sitagliptin metformin hypersensitive allergic to sitagliptin, continue reading or any of the other ingredients. It must not be sitagliptin metformin public assessment report in patients who have diabetic public assessment or precoma dangerous conditions that can occur in diabetesproblems with the kidneys or liver, conditions that may affect the kidneys, or a disease that causes a reduced supply of sitagliptin metformin public assessment report to the tissues such as failure of sitagliptin metformin public heart or lungs or a recent heart attack.

It must also not be assessment report in patients who consume excessive amounts of alcohol or are alcoholic, sitagliptin metformin in women who are breast-feeding.

For the full list of restrictions, see the package leaflet. For more information about treatment with Janumet, sitagliptin metformin public assessment report the package leaflet also part of the EPAR or contact your doctor or pharmacist.

Public assessment detail is available in the summary of product characteristics. Skip to main content. Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation. Table of contents Overview Authorisation details Product information Assessment history.

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