Sitagliptin/Metformin hydrochloride Tiefenbacher 50/1000 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

SITAGLIPTIN, METFORMIN HYDROCHLORIDE

Available from:

ALFRED E. TIEFEMBACHER (GmbH &Co. KG) Van-der-Smissen-Straße 1, 22767 Hamburg, Germany

ATC code:

A10BD07

INN (International Name):

SITAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 1000 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

SITAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 1000 mg

Prescription type:

POM

Therapeutic area:

DRUGS USED IN DIABETES

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Withdrawn

Authorization date:

2020-12-21

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SITAGLIPTIN/METFORMIN HYDROCHLORIDE TIEFENBACHER 50/850 MG FILM-COATED
TABLETS
SITAGLIPTIN/METFORMIN HYDROCHLORIDE TIEFENBACHER 50/1000 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 or pharmacist.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Sitagliptin/Metformin hydrochloride Tiefenbacher is and what it
is used for
2.
What you need to know before you take Sitagliptin/Metformin
hydrochloride Tiefenbacher
3.
How to take Sitagliptin/Metformin hydrochloride Tiefenbacher
4.
Possible side effects
5.
How to store Sitagliptin/Metformin hydrochloride Tiefenbacher
6.
Contents of the pack and other information
1.
WHAT SITAGLIPTIN/METFORMIN HYDROCHLORIDE TIEFENBACHER IS AND WHAT IT
IS USED FOR
Sitagliptin/Metformin
hydrochloride
Tiefenbacher
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

Summary of Product characteristics

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1.
NAME OF THE MEDICINAL PRODUCT
Sitagliptin/Metformin hydrochloride Tiefenbacher 50/850 mg film-coated
tablets
Sitagliptin/Metformin hydrochloride Tiefenbacher 50/1000 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.
Each tablet contains sitagliptin hydrochloride monohydrate equivalent
to 50 mg of sitagliptin
and 1000 mg of metformin hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Capsule-shaped, biconvex, pink film-coated tablet plain on both sides,
with dimensions of
approximately 20.2 x 9.9 mm.
Capsule-shaped, biconvex, red film-coated tablet plain on both sides,
with dimensions of
approximately 21.4 x 10.5 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For adult patients with type 2 diabetes mellitus:
Sitagliptin/metformin 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 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 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 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 METH