Ilgaper 1mg Tablets

Țară: Malta

Limbă: engleză

Sursă: Medicines Authority

Ingredient activ:

REPAGLINIDE

Disponibil de la:

Sigillata Limited (Ireland) Inniscarra, Main Street, Rathcoole, Co. Dublin D24 E029 , Ireland

Codul ATC:

A10BX02

INN (nume internaţional):

REPAGLINIDE 1 mg

Forma farmaceutică:

TABLET

Compoziție:

REPAGLINIDE 1 mg

Tip de prescriptie medicala:

POM

Zonă Terapeutică:

DRUGS USED IN DIABETES

Statutul autorizaţiei:

Authorised

Data de autorizare:

2010-07-14

Prospect

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE USER
ILGAPER 0.5 MG TABLETS
ILGAPER 1 MG TABLETS
ILGAPER 2 MG TABLETS
ILGAPER 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 blood is raised (
DIABETIC KETOACIDOSIS
).
-
if you have a

Caracteristicilor produsului

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SUMMARY OF PRODUCT CHARACTERISTICS
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 loss of
control