NOVONORM 1 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

REPAGLINIDE

Available from:

NOVO NORDISK LTD., ISRAEL

ATC code:

A10BX02

Pharmaceutical form:

TABLETS

Composition:

REPAGLINIDE 1 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

NOVO NORDISK A/S, DENMARK

Therapeutic group:

REPAGLINIDE

Therapeutic area:

REPAGLINIDE

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.

Authorization date:

2019-06-30

Patient Information leaflet

לע העדוה לע העדוה לע העדוה
( הרמחה
( הרמחה
( הרמחה עדימ עדימ עדימ
ל ןולעב )תוחיטב
ל ןולעב )תוחיטב
ל ןולעב )תוחיטב
אפור
אפור
אפור
ןכדועמ(
ןכדועמ(
ןכדועמ(
.102.50
.102.50
.102.50
)
)
) רשוא
–
61
.
8
ךיראת
:
13/07/2016
םושירה רפסמו תילגנאב רישכת םש :
NOVONORM 0.5 MG – 114 47 29661
NOVONORM 1 MG -- 114 48 29662
NOVONORM 2 MG -- 114 49 29663
םושירה לעב םש :
מ"עב קסידרונ ובונ
ימ הז ספוט
! דבלב תורמחהה טורפל דעו
תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
INDICATION
CONTRAINDICATIONS
POSOLOGY, DOSAGE &
ADMINISTRATION
SPECIAL WARNINGS AND
SPECIAL PRECAUTIONS FOR USE
INTERACTION WITH OTHER
MEDICAMENTS AND OTHER
FORMS OF INTERACTION
In an interaction study with healthy
volunteers, co-administration of _clopidogrel_
(300 mg loading dose), a CYP2C8 inhibitor,
increased repaglinide exposure (AUC0–∞)
5.1-fold and continued administration (75 mg
daily dose) increased repaglinide exposure
(AUC0–∞) 3.9-fold. A small, significant
decrease in blood glucose values was
observed.
In an interaction study with healthy volunteers, co-
administration of _clopidogrel_ (300 mg loading
dose), a CYP2C8 inhibitor, increased repaglinide
exposure (AUC0–∞) 5.1-fold and continued
administration (75 mg daily dose) increased
repaglinide exposure (AUC0–∞) 3.9-fold. A small,
significant decrease in blood glucose values was
observed.
Since the safety profile of the co-
treatment has not been established in these patients,
the concomitant use of clopidogrel and repaglinide
should be avoided. If concomitant use is necessary,
careful monitoring of blood glucose and close
clinical monitoring should be performed (see
section 4.4).
FERTILITY, PREGNANCY AND
LACTATION
ADVERSE EVENTS ב"צמ
נמוסמ ובש ,ןולעה
תו תורמחהה
שקובמה תו
בוהצ עקר לע
.
ונמוס תורמחה

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
NovoNorm
®
0.5 mg tablets
NovoNorm
®
1 mg tablets
NovoNorm
®
2 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
0.5 mg of repaglinide
1 mg of repaglinide
2 mg of repaglinide
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Repaglinide tablets are white (0.5 mg), yellow (1 mg) or
peach-coloured (2 mg), 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 betw