Ilgaper 0.5mg Tablets

País: Malta

Idioma: inglés

Fuente: Medicines Authority

Ingredientes activos:

REPAGLINIDE

Disponible desde:

Actavis Group PTC ehf

Código ATC:

A10BX02

Designación común internacional (DCI):

REPAGLINIDE

formulario farmacéutico:

TABLET

Composición:

REPAGLINIDE 0.5 mg

tipo de receta:

POM

Área terapéutica:

DRUGS USED IN DIABETES

Estado de Autorización:

Authorised

Fecha de autorización:

2010-07-14

Información para el usuario

Page 1 of 7
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
ILGAPER
0.5 MG TABLETS
1 MG TABLETS
2 MG TABLETS
4 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 ILGAPER IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ILGAPER
3.
HOW TO TAKE ILGAPER
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE ILGAPER
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT ILGAPER IS AND WHAT IT IS USED FOR
Ilgaper 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.
Ilgaper 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. Ilgaper can also be given with metformin, another
medicine for diabetes.
Ilgaper 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 ILGAPER
DO NOT TAKE ILGAPER:
-
if you are ALLERGIC to repaglinide or any of the other ingredients in
this medicine (listed in
section 6).
-
if you have TYPE 1 DIABETES.
-
if the acid level in your body is raised (DIABETIC KETOACIDOSIS).
-
if you have a SEVERE LIVER DISEASE.
3
-
if you take

Ficha técnica

Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 11
1.
NAME OF THE MEDICINAL PRODUCT
Ilgaper 0.5 mg tablets
Ilgaper 1 mg tablets
Ilgaper 2 mg tablets
Ilgaper 4 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0.5 mg, 1 mg, 2 mg or 4 mg of repaglinide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Ilgaper 0.5 mg tablets are white, round, biconvex and engraved with RE
on one side.
Ilgaper 1 mg tablets are mottled yellow, round, biconvex and engraved
with RE1 on one side.
Ilgaper 2 mg tablets are mottled pink, round, biconvex and engraved
with RE2 on one side.
Ilgaper 4 mg tablets are mottled pink, round, biconvex and engraved
with RE4 on one 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 lo