Repaglinide Aurobindo 2mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

REPAGLINIDE

Available from:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

ATC code:

A10BX02

INN (International Name):

REPAGLINIDE 2 mg

Pharmaceutical form:

TABLET

Composition:

REPAGLINIDE 2 mg

Prescription type:

POM

Therapeutic area:

DRUGS USED IN DIABETES

Authorization status:

Authorised

Authorization date:

2013-01-14

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
REPAGLINIDE AUROBINDO 0.5 MG TABLETS
REPAGLINIDE AUROBINDO 1 MG TABLETS
REPAGLINIDE AUROBINDO 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 Aurobindo is and what it is used for
2.
What you need to know before you take Repaglinide Aurobindo
3.
How to take Repaglinide Aurobindo
4.
Possible side effects
5.
How to store Repaglinide Aurobindo
6.
Contents of the pack and other information
1.
WHAT REPAGLINIDE AUROBINDO IS AND WHAT IT IS USED FOR
Repaglinide Aurobindo 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 Aurobindo 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 Aurobindo can also be given
with metformin, another
medicine for diabetes.
Repaglinide 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 AUROBINDO
DO NOT TAKE REPAGLINIDE AUROBINDO
•
If you are allergic to repaglinide or any of the other ingredients in
this medicine (listed in section

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Repaglinide Aurobindo 0.5 mg Tablets
Repaglinide Aurobindo 1 mg Tablets
Repaglinide Aurobindo 2 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains repaglinide 0.5 mg.
Each tablet contains repaglinide 1 mg.
Each tablet contains repaglinide 2 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Repaglinide Aurobindo 0.5 mg Tablets
White to off white, round, biconvex uncoated tablets, debossed with
‘H’ on one side and ‘10’ on other
side.
Repaglinide Aurobindo 1 mg Tablets
Yellow coloured, round, biconvex uncoated tablets, debossed with
‘H’ on one side and ‘11’ on other
side.
Repaglinide Aurobindo 2 mg Tablets
Peach coloured, mottled round, biconvex uncoated tablets, debossed
with ‘H’ on one side and ‘12’ 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 afte