Sitagliptin/Metformin P-Care 50 mg/1000 mg film-coated tablets

Land: Malta

Taal: Engels

Bron: Medicines Authority

Beschikbaar vanaf:

Pharmacare Srl Via Marghera, 29 20149, Milan, Italy

ATC-code:

A10BD07

INN (Algemene Internationale Benaming):

METFORMIN HYDROCHLORIDE 1000 mg SITAGLIPTIN 50 mg

farmaceutische vorm:

FILM-COATED TABLET

Samenstelling:

METFORMIN HYDROCHLORIDE 1000 mg SITAGLIPTIN 50 mg

Prescription-type:

POM

Therapeutisch gebied:

DRUGS USED IN DIABETES

Product samenvatting:

Licence number in the source country: NOT APPLICAPABLE

Autorisatie-status:

Authorised

Autorisatie datum:

2023-05-19

Bijsluiter

Page
1
of
7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SITAGLIPTIN/METFORMIN P-CARE 50 MG/850 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 P-Care is and what it is used for
2.
What you need to know before you take Sitagliptin/Metformin P-Care
3.
How to take Sitagliptin/Metformin P-Care
4.
Possible side effects
5.
How to store Sitagliptin/Metformin P-Care
6.
Contents of the pack and other information
1.
WHAT SITAGLIPTIN/METFORMIN P-CARE IS AND WHAT IT IS USED FOR
Sitagliptin/Metformin P-Care 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 not make enough
insulin, and the insulin
that your body produces does not work as well as it should. Your body
can also make too much
sugar.
When this hap

Productkenmerken

Page
1
of
20
1.
NAME OF THE MEDICINAL PRODUCT
Sitagliptin/Metformin P-Care 50mg/1000 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains sitagliptin hydrochloride monohydrate equivalent
to 50 mg of sitagliptin and
1,000 mg of metformin hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Red to brown, oblong oval-shaped film-coated tablets with a scoreline
in between ‘S’ and ‘B’ on
one side and with a scoreline on the other side.
Tablet diameter: 21.3 ± 0.5mm
The score line is not intended for breaking the tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For adult patients with type 2 diabetes mellitus:
Sitagliptin/Metformin P-Care 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
P-Care
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
P-Care
is
indicated
as
triple
combination
therapy
with
a
peroxisome
proliferator-activated receptor gamma (PPAR

) 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

agonist.
Sitagliptin/Metformin P-Care 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 antihyperglycaemic therapy with Sitagliptin/Metformin
P-Care should be individualised
Page
2
of
20
on the basis of the patient’s current regi