Sitagliptin/Metformin hydrochloride Teva 50 mg/850 mg film-coated tablets

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Sitagliptin Hydrochloride Monohydrate; Metformin Hydrochloride

Tilgængelig fra:

Norton Waterford

ATC-kode:

A10BD07

INN (International Name):

Sitagliptin Hydrochloride Monohydrate; Metformin Hydrochloride

Lægemiddelform:

Film-coated tablet

Terapeutisk område:

metformin and sitagliptin

Autorisation status:

Marketed

Autorisation dato:

2022-04-14

Indlægsseddel

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SITAGLIPTIN/METFORMIN HYDROCHLORIDE TEVA 50 MG/850 MG FILM-COATED
TABLETS
SITAGLIPTIN/METFORMIN HYDROCHLORIDE TEVA 50 MG/1000 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 Teva is and what it is used
for
2.
What you need to know before you take Sitagliptin/Metformin
hydrochloride Teva
3.
How to take Sitagliptin/Metformin hydrochloride Teva
4.
Possible side effects
5.
How to store Sitagliptin/Metformin hydrochloride Teva
6.
Contents of the pack and other information
1.
WHAT SITAGLIPTIN/METFORMIN HYDROCHLORIDE TEVA IS AND WHAT IT IS USED
FOR
Sitagliptin/Metformin hydrochloride Teva 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 you

Produktets egenskaber

Health Products Regulatory Authority
14 April 2022
CRN009PYH
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sitagliptin/Metformin hydrochloride Teva 50 mg/850 mg film-coated
tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains sitagliptin hydrochloride monohydrate equivalent
to 50 mg of sitagliptin and 850 mg of metformin
hydrochloride.
Excipients with known effect
Each tablet contains 13.02 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
50 mg/850 mg film-coated tablets are oval-shaped, biconvex,
film-coated tablets approximately 20.5 mm x 9.5 mm, pink,
debossed with "S476" on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For adult patients with type 2 diabetes mellitus:
Sitagliptin/Metformin hydrochloride Teva 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 Teva 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 Teva is indicated as triple
combination therapy with a peroxisome proliferator-activated
receptor gamma (PPAR
g
) 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 PPAR
g
agonist.
Sitagliptin/Metformin hydrochloride Teva 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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose of antihyperg