Glucient SR 500mg tablets

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Metformin hydrochloride

Disponível em:

Consilient Health Ltd

Código ATC:

A10BA02

DCI (Denominação Comum Internacional):

Metformin hydrochloride

Dosagem:

500mg

Forma farmacêutica:

Modified-release tablet

Via de administração:

Oral

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 06010202; GTIN: 5391512451042 5391512451035

Folheto informativo - Bula

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

Características técnicas

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