Metabet SR 1000mg tablets

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Metformin hydrochloride

Dostępny od:

Morningside Healthcare Ltd

Kod ATC:

A10BA02

INN (International Nazwa):

Metformin hydrochloride

Dawkowanie:

1gram

Forma farmaceutyczna:

Modified-release tablet

Droga podania:

Oral

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 06010202; GTIN: 5055132711985 5055132711992

Ulotka dla pacjenta

This medicine is intended for ADULT patients only.
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.
1. What Bolamyn SR is and what it is used for
2. What you need to know before you take Bolamyn SR
3. How to take Bolamyn SR
4. Possible side effects
5. How to store Bolamyn SR
6. Contents of the pack and other information
WHAT BOLAMYN SR IS AND WHAT IT IS USED FOR
Bolamyn SR 1000mg 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 dependent) diabetes mellitus.
Bolamyn SR is used together with diet and exercise to lower the
risk of developing Type 2 diabetes in overweight adults, when diet
and exercise alone for 3 to 6 months have not been enough to
control blood glucose (sugar). You are at high risk of developing
Type 2 diabetes if you have additional conditions like high blood
pressure, age above 40 years, an abnormal amount of lipids (fat)
in the blood or a history of diabetes during pregnancy.
The medicine is particularly effective if you are aged below 45
years, are very overweight, have high blood glucose levels after a
meal or developed diabetes during pregnancy.
Bolamyn 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 use it for energy or for
storage for future use. People with Type 2 diabetes do not make
enough insuli

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Metabet SR 1000 mg prolonged release tablets
Bolamyn SR 1000 mg prolonged release tablets
Metformin 1000 mg prolonged release tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged release tablet contains:
Metformin hydrochloride 1000 mg corresponding to 780 mg metformin base
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Prolonged release tablet .
Off-white coloured, oval, biconvex, film-coated tablets with score
line on one side and plain on
other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Reduction in the risk or delay of the onset of type 2 diabetes
mellitus in adult, overweight
patients with IGT* and/or IFG*, and/or increased HbA1C who are:
-
at high risk for developing overt type 2 diabetes mellitus (see
section 5.1) and
-
still progressing towards type 2 diabetes mellitus despite
implementation of intensive
lifestyle change for 3 to 6 months.
Treatment
with
Metabet
SR
/
Bolamyn
SR
/
Metformin
must
be
based
on
a
risk
score
incorporating
appropriate
measures
of
glycaemic
control
and
including
evidence
of
high
cardiovascular risk (see section 5.1).
Lifestyle modifications should be continued when metformin is
initiated, unless the patient is
unable to do so because of medical reasons.
*IGT: Impaired Glucose Tolerance; IFG: Impaired Fasting Glucose
•
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.
Metabet SR / Bolamyn SR / Metformin 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):
_Reduction in the risk or delay of the onset of type 2 diabetes _
•
Metformin should only be considered where intensive lifestyle
modifications for 3 to 6
months have not resulted in adequate glycaemic control.
•
The therapy shoul