Sitagliptin/Metformin hydrochloride Rowex 50/850 mg Film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sitagliptin Hydrochloride; Metformin Hydrochloride

Available from:

Rowex Ltd

ATC code:

A10BD07

INN (International Name):

Sitagliptin Hydrochloride; Metformin Hydrochloride

Dosage:

50/850 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

metformin and sitagliptin

Authorization status:

Not marketed

Authorization date:

2021-03-05

Patient Information leaflet

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

Summary of Product characteristics

Health Products Regulatory Authority
05 March 2021
CRN009CX5
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sitagliptin/Metformin hydrochloride Rowex 50/850 mg Film-coated
tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains sitagliptin hydrochloride monohydrate
equivalent to 50 mg of sitagliptin, and 850 mg of
metformin hydrochloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Light orange film-coated tablet of oval, biconvex shape (approximately
10x20 mm), debossed with "SM 2" on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For adult patients with type 2 diabetes mellitus:
Sitagliptin/Metformin hydrochloride Rowex 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 Rowex 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 Rowex 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 Rowex 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 anti-hyperglycaemic therapy with Sitagliptin/Metformin
hydrochloride Rowex should be individualised on the basis
of