Glucient SR 500mg tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Metformin hydrochloride

Tilgjengelig fra:

Consilient Health Ltd

ATC-kode:

A10BA02

INN (International Name):

Metformin hydrochloride

Dosering :

500mg

Legemiddelform:

Modified-release tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 06010202; GTIN: 5391512451042 5391512451035

Informasjon til brukeren

PACKAGE LEAFLET
INFORMATION FOR THE USER
GLUCIENT
® SR 500 MG
PROLONGED-RELEASE TABLETS
METFORMIN HYDROCHLORIDE
P0078 (15-2-11) vector.indd 1
15/02/11 16:11
P0078 (15-2-11) vector.indd 2
15/02/11 16:11

Preparatomtale

OBJECT 1
GLUCIENT SR 500 MG PROLONGED-RELEASE TABLETS
Summary of Product Characteristics Updated 13-Sep-2011 | Consilient
Health Ltd
1. Name of the medicinal product
Glucient
®
SR 500mg prolonged release tablets
2. Qualitative and quantitative composition
Each prolonged-release tablet contains 500 mg metformin hydrochloride
(equivalent to 390 mg
metformin).
Excipients
Each prolonged release tablet contains up to 10.8mg sodium (0.5mmol)
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Prolonged-release tablet
White, convex, capsule-shaped tablet marked “XR“ on one side.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of type 2 diabetes mellitus in adults, particularly in
overweight patients, when dietary
management and exercise alone does not result in adequate glycaemic
control. Glucient SR may be used
as monotherapy or in combination with other oral antidiabetic agents,
or with insulin.
4.2 Posology and method of administration
Posology
_Monotherapy and combination with other oral antidiabetic agents:_
“ The usual starting dose is one tablet of 500 mg once daily.
“ After 10 to 15 days the dose should be adjusted on the basis of
blood glucose measurements. A slow
increase of dose may improve gastro-intestinal tolerability. The
maximum recommended dose is 4 tablets
of 500 mg daily.
“ Dosage increases should be made in increments of 500 mg every 10-15
days, up to a maximum of 2000
mg once daily with the evening meal. If glycaemic control is not
achieved on 2000 mg of Glucient SR
once daily, 1000 mg of Glucient SR twice daily should be considered,
with both doses being given with
food. If glycaemic control is still not achieved, patients may be
switched to standard metformin tablets to
a maximum dose of 3000 mg daily.
“ In patients already treated with metformin tablets, the starting
dose of Glucient SR should be
equivalent to the daily dose of metformin immediate-release tablets.
In patients treated with metformin at
a dose above 2000 mg daily, switching to Glucient SR is n