Sitagliptin/Metformin Pharmacare 50 mg/1000 mg film-coated tablets

Nchi: Malta

Lugha: Kiingereza

Chanzo: Medicines Authority

Inapatikana kutoka:

Pharmacare Srl Via Marghera, 29 20149, Milan, Italy

ATC kanuni:

A10BD07

INN (Jina la Kimataifa):

SITAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 1000 mg

Dawa fomu:

FILM-COATED TABLET

Tungo:

SITAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 1000 mg

Dawa ya aina:

POM

Eneo la matibabu:

DRUGS USED IN DIABETES

Bidhaa muhtasari:

Licence number in the source country: NOT APPLICAPABLE

Idhini hali ya:

Authorised

Idhini ya tarehe:

2023-05-19

Taarifa za kipeperushi

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SITAGLIPTIN/METFORMIN PHARMACARE 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 Pharmacare is and what it is used for
2.
What you need to know before you take Sitagliptin/Metformin Pharmacare
3.
How to take Sitagliptin/Metformin Pharmacare
4.
Possible side effects
5.
How to store Sitagliptin/Metformin Pharmacare
6.
Contents of the pack and other information
1.
WHAT SITAGLIPTIN/METFORMIN PHARMACARE IS AND WHAT IT IS USED FOR
Sitagliptin/Metformin
Pharmacare
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

Tabia za bidhaa

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1.
NAME OF THE MEDICINAL PRODUCT
Sitagliptin/Metformin Pharmacare 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 Pharmacare 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 Pharmacare 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 Pharmacare 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 Pharmacare 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
Pharmacare
should
be
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individualised on the basis of the