Sitagliptin / Metformin hydrochloride Sun

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

sitagliptin fumarate, metformin hydrochloride

Saadav alates:

Sun Pharmaceutical Industries Europe B.V.

ATC kood:

A10BD07

INN (Rahvusvaheline Nimetus):

sitagliptin, metformin hydrochloride

Terapeutiline rühm:

Drugs used in diabetes

Terapeutiline ala:

Diabetes Mellitus, Type 2

Näidustused:

For adult patients with type 2 diabetes mellitus:Sitagliptin/Metformin hydrochloride SUN 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 SUN 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 SUN is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPARγ) 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 PPARγ agonist.Sitagliptin/Metformin hydrochloride SUN 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.

Volitamisolek:

Authorised

Loa andmise kuupäev:

2023-03-31

Infovoldik

34
B.
PACKAGE LEAFLET
35
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SITAGLIPTIN/METFORMIN HYDROCHLORIDE SUN 50 MG/850 MG FILM-COATED
TABLETS
SITAGLIPTIN/METFORMIN HYDROCHLORIDE SUN 50 MG/1 000 MG FILM-COATED
TABLETS
sitagliptin/metformin hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist, or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Sitagliptin/Metformin hydrochloride SUN is and what it is used
for
2.
What you need to know before you take Sitagliptin/Metformin
hydrochloride SUN
3.
How to take Sitagliptin/Metformin hydrochloride SUN
4.
Possible side effects
5.
How to store Sitagliptin/Metformin hydrochloride SUN
6.
Contents of the pack and other information
1.
WHAT SITAGLIPTIN/METFORMIN HYDROCHLORIDE SUN IS AND WHAT IT IS USED
FOR
Sitagliptin/Metformin hydrochloride SUN contains two different
medicines called sitagliptin and
metformin.
•
sitagliptin belongs to a class of medicines called DPP-4 inhibitors
(dipeptidyl peptidase-4
inhibitors)
•
metformin belongs to a class of medicines called biguanides.
They work together to control blood sugar levels in adult patients
with a form of diabetes called ‘type
2 diabetes mellitus’. This medicine helps to increase the levels of
insulin produced after a meal and
lowers the amount of sugar made by your body.
Along with diet and exercise, this medicine helps lower your blood
sugar. This medicine can be used
alone or with certain other medicines for diabetes (insulin,
sulphonylureas, or glitazones).
What is type 2 diabetes?
Type 2 diabetes is a condition in which your

Toote omadused

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Sitagliptin/Metformin hydrochloride SUN 50 mg/850 mg film-coated
tablets
Sitagliptin/Metformin hydrochloride SUN 50 mg/1 000 mg film-coated
tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sitagliptin/Metformin hydrochloride SUN 50 mg/850 mg film-coated
tablets
Each tablet contains sitagliptin fumarate equivalent to 50 mg of
sitagliptin and 850 mg of metformin
hydrochloride.
_Excipient with known effect _
Each film-coated tablet contains 6.9 mg of hydrogenated castor oil.
Sitagliptin/Metformin hydrochloride SUN 50 mg/1 000 mg film-coated
tablets
Each tablet contains sitagliptin fumarate equivalent to 50 mg of
sitagliptin and 1 000 mg of metformin
hydrochloride.
_Excipient with known effect _
Each film-coated tablet contains 8.0 mg of hydrogenated castor oil.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Sitagliptin/Metformin hydrochloride SUN 50 mg/850 mg film-coated
tablets
Pink, capsule-shaped film-coated tablets, dimensions approximately 20
mm x 10 mm x 6 mm,
debossed with “SC1”on one side.
Sitagliptin/Metformin hydrochloride SUN 50 mg/1 000 mg film-coated
tablets
Brown to reddish brown, capsule-shaped film-coated tablets, dimensions
approximately 22 mm x 11
mm x 7 mm, debossed with “SC7” on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For adult patients with type 2 diabetes mellitus:
Sitagliptin/Metformin hydrochloride SUN 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 SUN 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.
3
Sitagliptin/Metformin hydr