Enyglid

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

repaglinide

Available from:

Krka, d.d., Novo mesto

ATC code:

A10BX02

INN (International Name):

repaglinide

Therapeutic group:

Drugs used in diabetes

Therapeutic area:

Diabetes Mellitus, Type 2

Therapeutic indications:

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. Repaglinide is also indicated in combination with metformin in type-2 diabetes patients 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.

Product summary:

Revision: 9

Authorization status:

Authorised

Authorization date:

2009-10-13

Patient Information leaflet

25
B. PACKAGE LEAFLET
26
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ENYGLID 0.5 MG TABLETS
ENYGLID 1 MG TABLETS
ENYGLID 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 Enyglid is and what it is used for
2.
What you need to know before you take Enyglid
3.
How to take Enyglid
4.
Possible side effects
5.
How to store Enyglid
6.
Contents of the pack and other information
1.
WHAT ENYGLID IS AND WHAT IT IS USED FOR
Enyglid 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.
Enyglid 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.
Enyglid can also be given with metformin, another medicine for
diabetes.
Enyglid 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 ENYGLID
DO NOT TAKE ENYGLID

if you are ALLERGIC to repaglinide or any of the other ingredients of
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 SEVERE LIVER DISEASE.
�

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Enyglid 0.5 mg tablets
Enyglid 1 mg tablets
Enyglid 2 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Enyglid 0.5 mg tablets
Each tablet contains 0.5 mg repaglinide.
Enyglid 1 mg tablets
Each tablet contains 1 mg repaglinide.
Enyglid 2 mg tablets
Each tablet contains 2 mg repaglinide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Enyglid 0.5 mg tablets
The tablets are white, round and biconvex with bevelled edges.
Enyglid 1 mg tablets
The tablets are pale brown-yellow, round, biconvex with bevelled edges
and possible darker spots.
Enyglid 2 mg tablets
The tablets are pink, marbled, round, biconvex with bevelled edges and
possible darker spots.
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-
3
lowering response after an initial period of effectiveness (i.e.
secondary failure).
Short-term administration of repaglinide