Lucomet SR 750 mg prolonged release tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Metformin Hydrochloride

Available from:

Consilient Health Limited

ATC code:

A10BA; A10BA02

INN (International Name):

Metformin Hydrochloride

Dosage:

750 milligram(s)

Pharmaceutical form:

Prolonged-release tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Biguanides; metformin

Authorization status:

Not marketed

Authorization date:

2014-10-24

Patient Information leaflet

PACKAGE LEAFLET
INFORMATION FOR THE
USER
LUCOMET
®
SR 750 MG PROLONGED-RELEASE
TABLETS
metformin
hydrochloride
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 symptoms 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.
WHAT IS IN THIS LEAFLET:
1. WHAT LUCOMET SR IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LUCOMET SR
3. HOW TO TAKE LUCOMET SR
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE LUCOMET SR
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT LUCOMET SR IS AND WHAT IT IS USED FOR
Lucomet SR prolonged release tablets contain the active ingredient
metformin hydrochloride
and belong to a group of medicines called biguanides, used in the
treatment of Type 2 (non-
insulin dependant diabetes mellitus.
Lucomet SR is used for the treatment of Type 2 diabetes 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.
Lucomet SR makes the body more sensitive to insulin and helps return
to normal the way
your body uses glucose.
Lucomet SR is associated with either a stable body weight or modest
weight loss.
Lucomet SR Prolonged Release Tablets are specially

Summary of Product characteristics

Health Products Regulatory Authority
14 July 2020
CRN009TPR
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lucomet SR 750 mg prolonged release tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 750 mg metformin hydrochloride
(equivalent to 585 mg metformin).
Excipients
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged release tablet
White tablet, shallow convex, dimension 20 x 9 mm, with marking "SR1"
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. Lucomet 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
_Adults with normal renal function (GFR≥ 90 mL/min)_
_Monotherapy and combination with other oralantidiabetic agents:_
Lucomet SR 750 mg is intended for patients who are already treated
with metformin tablets (prolonged or immediate release).
The dose of Lucomet SR 750 mg should be equivalent to the daily dose
of metformin tablets (prolonged or immediate release),
up to a maximum dose of 1500 mg given with the evening meal.
After 10 to 15 days, it is recommended to check that the dose of
Lucomet SR 750 mg is adequate on the basis of blood
glucose measurements.
_Combination withinsulin:_
For patients already treated with metformin and insulin in combination
therapy, the dose of Lucomet SR 750 mg should be
equivalent to the daily dose of metformin tablets, up to a maximum of
1500 mg given with the evening meal, while insulin
dosage is adjusted on the basis of blood glucose measurements.
_Elderly:_
Due to the potential for decreased renal function in elderly subjects,
the metformin dosage should be adjusted based on renal
function. Regular assessment of renal function is necessary (see
se