Repaglinide Accord

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

repaglinide

Διαθέσιμο από:

Accord Healthcare S.L.U.

Φαρμακολογική κατηγορία (ATC):

A10BX02

INN (Διεθνής Όνομα):

repaglinide

Θεραπευτική ομάδα:

Drugs used in diabetes

Θεραπευτική περιοχή:

Diabetes Mellitus, Type 2

Θεραπευτικές ενδείξεις:

Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise.Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.

Περίληψη προϊόντος:

Revision: 7

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2011-12-22

Φύλλο οδηγιών χρήσης

58
B. PACKAGE LEAFLET
59
PACKAGE LEAFLET: INFORMATION FOR THE USER
REPAGLINIDE ACCORD 0.5 MG TABLETS
REPAGLINIDE ACCORD 1 MG TABLETS
REPAGLINIDE ACCORD 2 MG TABLETS
Repaglinide
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 Repaglinide Accord is and what it is used for
2.
What you need to know before you take Repaglinide Accord
3.
How to take Repaglinide Accord
4.
Possible side effects
5.
How to store Repaglinide Accord
6.
Contents of the pack and other information
1. WHAT REPAGLINIDE ACCORD IS AND WHAT IT IS USED FOR
Repaglinide Accord is an
_oral antidiabetic medicine containing repaglinide _
which helps your
pancreas produce more insulin and thereby lower your blood sugar
(glucose).
TYPE 2 DIABETES
is a disease in which your pancreas does not make enough insulin to
control the
sugar in your blood or where your body does not respond normally to
the insulin it produces.
Repaglinide Accord is used to control type 2 diabetes in adults as an
add-on to diet and exercise:
treatment is usually started if diet, exercise and weight reduction
alone have not been able to control
(or lower) your blood sugar. Repaglinide Accord can also be given with
metformin, another medicine
for diabetes.
Repaglinide Accord has been shown to lower the blood sugar, which
helps to prevent complications
from your diabetes.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE REPAGLINIDE ACCORD
DO NOT TAKE REPAGLINIDE ACCORD
•
If you are allergic to repaglinide or any of the other ingredients in
this medicine (listed in sect

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Repaglinide Accord 0.5 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0.5 mg of repaglinide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White to off white, round, biconvex with beveled edge, uncoated
tablets, with inscription “R” on one
side and plain on other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Repaglinide is indicated in adults with type 2 diabetes mellitus whose
hyperglycaemia can no longer
be controlled satisfactorily by diet, weight reduction and exercise.
Repaglinide is also indicated in
combination with metformin in adults with type 2 diabetes mellitus who
are not satisfactorily
controlled on metformin alone.
Treatment should be initiated as an adjunct to diet and exercise to
lower the blood glucose in relation
to meals.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Repaglinide is given preprandially and is titrated individually to
optimise glycaemic control. In
addition to the usual self-monitoring by the patient of blood and/or
urinary glucose, the patient's blood
glucose must be monitored periodically by the physician to determine
the minimum effective dose for
the patient. Glycosylated haemoglobin levels are also of value in
monitoring the patient's response to
therapy. Periodic monitoring is necessary to detect inadequate
lowering of blood glucose at the
recommended maximum dose level (i.e. primary failure) and to detect
loss of adequate blood
glucose-lowering response after an initial period of effectiveness
(i.e. secondary failure).
Short-term administration of repaglinide may be sufficient during
periods of transient loss of control
in type 2 diabetic patients usually controlled well on diet.
Initial dose
The dosage should be determined by the physician, according to the
patient's requirements.
The recommended starting dose is 0.5 mg. One to two weeks should
elapse between titration steps (as
determined by blood glucose res