Jentadueto
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
10-02-2020
Karatteristiċi tal-prodott
(SPC)
10-02-2020
Rapport ta 'Valutazzjoni Pubblika
(PAR)
21-07-2016
Ingredjent attiv:
linagliptin, metformin
Disponibbli minn:
Boehringer Ingelheim International GmbH
Kodiċi ATC:
A10BD11
INN (Isem Internazzjonali):
linagliptin / metformin hydrochloride
Grupp terapewtiku:
Drugs used in diabetes,
Żona terapewtika:
Diabetes Mellitus, Type 2
Indikazzjonijiet terapewtiċi:
Treatment of adult patients with type-2 diabetes mellitus:Jentadueto is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of linagliptin and metformin.Jentadueto is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.
Sommarju tal-prodott:
Revision: 17
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2012-07-19
Fuljett ta 'informazzjoni
48
B. PACKAGE LEAFLET
49
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
JENTADUETO 2.5 MG / 850 MG FILM-COATED TABLETS
JENTADUETO 2.5 MG / 1,000 MG FILM-COATED TABLETS
linagliptin/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 Jentadueto is and what it is used for
2.
What you need to know before you take Jentadueto
3.
How to take Jentadueto
4.
Possible side effects
5.
How to store Jentadueto
6.
Contents of the pack and other information
1.
WHAT JENTADUETO IS AND WHAT IT IS USED FOR
The name of your tablet is Jentadueto. It contains two different
active substances linagliptin and
metformin.
-
Linagliptin belongs to a class of medicines called DPP-4 inhibitors
(dipeptidyl peptidase-4
inhibitors).
-
Metformin belongs to a class of medicines called biguanides.
HOW JENTADUETO WORKS
The two active substances work together to control blood sugar levels
in adult patients with a form of
diabetes called ‘type 2 diabetes mellitus’. Along with diet and
exercise, this medicine helps to improve
the levels and effects of insulin after a meal and lowers the amount
of sugar made by your body.
This medicine can be used alone or with certain other medicines for
diabetes like sulphonylureas,
empagliflozin, or insulin.
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 happens, sugar (glucose) buil
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Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Jentadueto 2.5 mg/850 mg film-coated tablets
Jentadueto 2.5 mg/1,000 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Jentadueto 2.5 mg/850 mg film-coated tablets
Each tablet contains 2.5 mg of linagliptin and 850 mg of metformin
hydrochloride.
Jentadueto 2.5 mg/1,000 mg film-coated tablets
Each tablet contains 2.5 mg of linagliptin and 1,000 mg of metformin
hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Jentadueto 2.5 mg/850 mg film-coated tablets
Oval, biconvex, light orange, film-coated tablet of 19.2 mm x 9.4 mm
debossed with "D2/850" on one
side and the company logo on the other.
Jentadueto 2.5 mg/1,000 mg film-coated tablets
Oval, biconvex, light pink, film-coated tablet of 21.1 mm x 9.7 mm
debossed with ”D2/1000" on one
side and the company logo on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Jentadueto is indicated in adults with type 2 diabetes mellitus as an
adjunct to diet and exercise to
improve glycaemic control:
•
in patients inadequately controlled on their maximally tolerated dose
of metformin alone
•
in combination with other medicinal products for the treatment of
diabetes, including insulin, in
patients inadequately controlled with metformin and these medicinal
products
•
in patients already being treated with the combination of linagliptin
and metformin as separate
tablets.
(see sections 4.4, 4.5 and 5.1 for available data on different
combinations).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults with normal renal function (GFR ≥90 ml/min)_
The dose of antihyperglycaemic therapy with Jentadueto should be
individualised on the basis of the
patient’s current regimen, effectiveness, and tolerability, while
not exceeding the maximum
recommended daily dose of 5 mg linagliptin plus 2,000 mg of metformin
hydrochloride.
_Patients inadequately controlled on maximal tolerated dose of
metformin mon
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