Glucient SR 1000mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Metformin hydrochloride

Available from:

Consilient Health Ltd

ATC code:

A10BA02

INN (International Name):

Metformin hydrochloride

Dosage:

1gram

Pharmaceutical form:

Modified-release tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06010202; GTIN: 5391512452179 5391512452186

Patient Information leaflet

Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor, or pharmacist.
• This medicine has been prescribed for you
only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same
as yours.
• If you get any side effects, talk to your doctor,
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
In this leaflet:
1. What Glucient SR is and what is it used for
2. What you need to know before you take
Glucient SR
3. How to take Glucient SR
4. Possible side effects
5. How to store Glucient SR
6. Contents of the pack and other information
1. WHAT GLUCIENT SR IS AND WHAT IS IT
USED FOR
Glucient SR prolonged release tablets contain
the active ingredient metformin hydrochloride
and belong to a group of medicines called
biguanides, used in the treatment of diabetes
Glucient SR is used for the treatment of Type 2
(non-insulin dependant) diabetes mellitus when
diet and exercise changes alone have not been
enough to control blood glucose (sugar).
Insulin is a hormone that enables body tissues to
take glucose from the blood and to use it for
energy or for storage for future use. People with
Type 2 diabetes do not make enough insulin in
their pancreas or their body does not respond
properly to the insulin it does make. This causes
a build-up of glucose in the blood which can
cause a number of serious long-term problems
so it is important that you continue to take your
medicine, even though you may not have any
obvious symptoms. Glucient SR makes the body
more sensitive to insulin and helps return to
normal the way your body uses glucose.
Glucient SR is associated with either a stable
body weight or modest weight loss.
Glucient SR Prolonged Release Tablets are
specially made to release the drug slowly in your
body and therefore are different to many other
types of tablet cont

Summary of Product characteristics

OBJECT 1
GLUCIENT SR 1000 MG PROLONGED-RELEASE TABLET
Summary of Product Characteristics Updated 17-Dec-2015 | Consilient
Health Ltd
1. Name of the medicinal product
Glucient SR 1000 mg prolonged-release tablet
2. Qualitative and quantitative composition
Each prolonged release tablet contains 1000 mg metformin hydrochloride
(equivalent to 780 mg
metformin).
Each prolonged release tablet contains up to 20.7 mg sodium (1.0
mmol).
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Prolonged release tablet.
White tablet, shallow convex, dimension 22.25 x 9 mm, with marking
“SR2“ on one side and without
marking on the other 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
_Monotherapy and combination with other oral antidiabetic agents:_
“ Glucient SR 1000 mg should be taken once daily with the evening
meal at a maximum recommended
dose of 2 tablets per day.
“ Glucient SR 1000 mg is intended as a maintenance therapy for
patients currently treated with either
1000 mg or 2000 mg of metformin hydrochloride. On switch, the daily
dose of Glucient SR should be
equivalent to the current daily dose of metformin hydrochloride.
“ In patients treated with metformin hydrochloride at a dose above
2000 mg daily, switching to Glucient
SR is not recommended.
“ FOR PATIENTS NEW TO METFORMIN HYDROCHLORIDE, the usual starting
dose of Glucient SR is 500 mg once
daily given with the evening meal. After 10 to 15 days the dose should
be adjusted on the basis of blood
glucose measurements. A slow increment in dose may improve
gastrointestinal tolerability.
“ If glycaemic control is not achieved on once daily dosing of
Glucient SR at a maximum dose of 2000
mg a day, then a twice daily