NovoNorm

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

repaglinide

Available from:

Novo Nordisk A/S

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: 16

Authorization status:

Authorised

Authorization date:

1998-08-16

Patient Information leaflet

45
B. PACKAGE LEAFLET
46
PACKAGE LEAFLET: INFORMATION FOR THE USER
NOVONORM 0.5 MG TABLETS
NOVONORM 1 MG TABLETS
NOVONORM 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 NovoNorm is and what it is used for
2.
What you need to know before you take NovoNorm
3.
How to take NovoNorm
4.
Possible side effects
5.
How to store NovoNorm
6.
Contents of the pack and other information
1.
WHAT NOVONORM IS AND WHAT IT IS USED FOR
NovoNorm 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.
NovoNorm 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. NovoNorm can also be given with metformin, another
medicine for diabetes.
NovoNorm 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 NOVONORM
DO NOT TAKE NOVONORM
•
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
SEVERE LIV

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
NovoNorm 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
Repaglinide tablets are white, round and convex and engraved with Novo
Nordisk logo (Apis bull).
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 response).
If patients are transferred from an