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

Ülke: Malta

Dil: İngilizce

Kaynak: Medicines Authority

Mevcut itibaren:

Hennig Arzneimittel GmbH & Co KG Liebigstrasse 1-2, D-65439 Flörsheim am Main, Germany

ATC kodu:

A10BD07

INN (International Adı):

SITAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 850 mg

Farmasötik formu:

FILM-COATED TABLET

Kompozisyon:

SITAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 850 mg

Reçete türü:

POM

Terapötik alanı:

DRUGS USED IN DIABETES

Ürün özeti:

Licence number in the source country: NOT APPLICAPABLE

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2022-06-17

Bilgilendirme broşürü

Page
1
of
7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SITAGLIPTIN/METFORMIN HYDROCHLORIDE HENNIG 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 hydrochloride Hennig is and what it is used
for
2.
What you need to know before you take Sitagliptin/Metformin
hydrochloride Hennig
3.
How to take Sitagliptin/Metformin hydrochloride Hennig
4.
Possible side effects
5.
How to store Sitagliptin/Metformin hydrochloride Hennig
6.
Contents of the pack and other information
1.
WHAT SITAGLIPTIN/METFORMIN HYDROCHLORIDE HENNIG IS AND WHAT IT IS USED
FOR
Sitagliptin/Metformin hydrochloride Hennig 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

Ürün özellikleri

Page
1
of
21
1.
NAME OF THE MEDICINAL PRODUCT
Sitagliptin/Metformin hydrochloride Hennig 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.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Pink, oblong oval-shaped film-coated tablets with a scoreline on one
side and ‘SA’ on the other side.
Tablet diameter: 19.5 ± 0.5mm
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For adult patients with type 2 diabetes mellitus:
Sitagliptin/Metformin hydrochloride Hennig 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 Hennig 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 Hennig 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 hydrochloride Hennig 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
hydrochloride Henni