Repaglinide 1mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Repaglinide

Available from:

Alliance Healthcare (Distribution

ATC code:

A10BX02

INN (International Name):

Repaglinide

Dosage:

1mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06010203

Patient Information leaflet

Repaglinide, UK/H/6936/001-003, 03.09.18
14
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OUTER CARTON
1.
NAME OF THE MEDICINAL PRODUCT
/.../ 0.5 mg tablets
/.../ 1 mg tablets
/.../ 2 mg tablets
Repaglinide
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 0.5 mg, 1 mg or 2 mg of repaglinide
3.
LIST OF EXCIPIENTS
4.
PHARMACEUTICAL FORM AND CONTENTS
Tablet
30, 60, 90, 100, 120, 180 tablets
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
_ _
Read the package leaflet before use
Oral use
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE SIGHT AND REACH OF CHILDREN
Keep out of the sight and reach of children.
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
8.
EXPIRY DATE
EXP
9.
SPECIAL STORAGE CONDITIONS
10.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
Repaglinide, UK/H/6936/001-003, 03.09.18
15
11.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
<[To be completed nationally]>
{Name and Address}
<{tel}>
<{fax}>
<{e-mail}>
12.
MARKETING AUTHORISATION NUMBER(S)
<[To be completed nationally]>
13.
BATCH NUMBER
Lot:
14.
GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15.
INSTRUCTIONS ON USE
16.
INFORMATION IN BRAILLE
/…/ 0.5 mg
/.../ 1 mg
/.../ 2 mg
17.
UNIQUE IDENTIFIER – 2D BARCODE_ _
2D barcode carrying the unique identifier included.
18.
UNIQUE IDENTIFIER - HUMAN READABLE DATA_ _
PC:
SN:
NN:
Repaglinide, UK/H/6936/001-003, 03.09.18
16
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
BLISTER FOIL
1.
NAME OF THE MEDICINAL PRODUCT
/.../ 0.5 mg tablets
/.../ 1 mg tablets
/.../ 2 mg tablets
Repaglinide
2.
NAME OF THE MARKETING AUTHORISATION HOLDER
<[To be completed nationally]>
3.
EXPIRY DATE
EXP:
4.
BATCH NUMBER
Lot:
5.
OTHER
Repaglinide, UK/H/6936/001-003, 03.09.18
17
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
TABLET CONTAINER
1.
NAME OF THE MEDICINAL PRODUCT
/.../ 0.5 mg tablets
/.../ 1 mg tablets
/.../ 2 mg tablets
Repaglinide
2.
STATEMENT OF ACTIVE SUBSTANCE(S)

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Repaglinide 1mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg of repaglinide.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Repaglinide 1mg Tablets are mottled yellow, round, biconvex and
engraved with RE1
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 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 another oral hy