REPAGLINIDE MEVON TABLETS 2 MG

Země: Singapur

Jazyk: angličtina

Zdroj: HSA (Health Sciences Authority)

Aktivní složka:

Repaglinide

Dostupné s:

NOVEM PHARMA PRIVATE LIMITED

ATC kód:

A10BX02

Léková forma:

TABLET

Složení:

Repaglinide 2.0 mg

Podání:

ORAL

Druh předpisu:

Prescription Only

Výrobce:

Pharmathen S.A.

Stav Autorizace:

ACTIVE

Datum autorizace:

2021-11-12

Charakteristika produktu

1.4.3 PACKAGE INSERT
1.
NAME OF THE MEDICINAL PRODUCT
Repaglinide MEVON 0.5 mg tablets
Repaglinide MEVON 1 mg tablets
Repaglinide MEVON 2 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Repaglinide MEVON 0.5 mg tablets: Each tablet contains 0.5 mg of
repaglinide.
Repaglinide MEVON 1.0 mg tablets: Each tablet contains 1.0 mg of
repaglinide.
Repaglinide MEVON 2.0 mg tablets: Each tablet contains 2.0 mg of
repaglinide.
For the full list of excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Repaglinide MEVON 0.5 mg tablets are white, round and biconvex.
Repaglinide MEVON 1 mg tablets are yellow, round and biconvex.
Repaglinide MEVON 2 mg tablets are pink, round and biconvex.
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 pati