METSWIFT XR 750 (Metformin Hydrochloride Prolonged Release Tablets 750mg)

País: Malásia

Língua: inglês

Origem: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredientes ativos:

METFORMIN HYDROCHLORIDE

Disponível em:

SYNERRV SDN BHD

DCI (Denominação Comum Internacional):

METFORMIN HYDROCHLORIDE

Unidades em pacote:

2 x 14 Tablets

Fabricado por:

IND-SWIFT LIMITED

Folheto informativo - Bula

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
METSWIFT XR 500
METSWIFT XR 750
METSWIFT XR 1000
Metformin Hydrochloride (500mg, 750mg & 1000mg)
1
WHAT IS IN THIS LEAFLET
1.
What METSWIFT XR is used
for
2.
How METSWIFT XR works
3.
Before you use METSWIFT XR
4.
How to use METSWIFT XR
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
METSWIFT XR
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT IS METSWIFT XR USED FOR
METSWIFT XR prolonged release
tablets contain the active ingredient
metformin hydrochloride and belong
to a group of medicines called
biguanides, used in the treatment of
diabetes. METSWIFT XR is used to
delay the onset and treat Type 2
(non-insulin dependent) diabetes
mellitus when diet and exercise
changes alone have not been enough
to control blood glucose (sugar).
HOW METSWIFT XR WORKS
Insulin is a hormone produced by the
pancreas that makes your body take
in glucose (sugar) from the blood.
Your body uses glucose to produce
energy or stores it for future use.
If you have diabetes, your pancreas
does not make enough insulin, or
your body is not able to use properly
the insulin it produces. This leads to
a high level of glucose in your blood.
METSWIFT XR makes the body
more sensitive to insulin and helps
return to normal the way your body
uses glucose.
METSWIFT XR is associated with
either a stable body weight or modest
weight loss.
METSWIFT XR prolonged release
tablets are specially made to release
the drug slowly in your body and
therefore are different to many other
types of tablet containing metformin.
BEFORE YOU USE METSWIFT XR
_-When you must not use it _
Do not take METSWIFT XR if:
•
You are allergic to
metformin or to any of the
other ingredients which are
listed later on in the leaflet.
•
You have lactic acidosis
[too much lactic acid in the
blood (see “Risk of lactic
acidosis” below)] or
ketoacidosis. Ketoacidosis
is a condition in which
substances called ‘ketone
bodies’ accumulate in the
blo

Características técnicas

Aw. No.: 20000XXXX Metswift 750 Leaflet
Front
Back
COMPOSITION:
Each Prolonged Release Tablet Contains
Metformin hydrochloride Ph. Eur. 750mg equivalent to 585mg of
metformin base
PRESENTATION:
Box of 28 tablets (2 blisters of 14 tablets each)
PRESENTATION:
White to off white, capsule shaped, biconvex, tablets, debossed on one
side with '750' and other side plain. The tablets are approximately
20.0mm in length and 9.6mm in breadth
PHARMACODYNAMICS:
ORAL ANTI-DIABETICS
(A10BA02 – Gastrointestinal tract and metabolism)
Metformin is a biguanide with anti-hyperglycaemic effects, lowering
both basal and postprandial plasma glucose. It does not stimulate
insulin secretion and therefore does not produce
hypoglycaemia.
Mechanism of action
Metformin may act via 3 mechanisms:
- reduction of hepatic glucose production by inhibiting
gluconeogenesis and glycogenolysis.
- in muscle, by increasing insulin sensitivity, improving peripheral
glucose uptake and utilisation
- and delay of intestinal glucose absorption.
Metformin stimulates intracellular glycogen synthesis by acting on
glycogen synthase. Metformin increases the transport capacity of all
types of membrane glucose transporters (GLUT).
Pharmacodynamic effects
The major non glycaemic effect of metformin is either weight stability
or modest weight loss.
In humans, independently of its action on glycaemia, immediate release
metformin has favourable effects on lipid metabolism. This has been
shown at therapeutic doses: immediate release
metformin reduces total cholesterol, LDL cholesterol and triglyceride
levels. A similar action has not been demonstrated with the prolonged
release formulation, possibly due to the evening
administration, and an increase in triglycerides may occur.
Pharmacokinetics:
Absorption
After an oral dose of the prolonged release tablet, metformin
absorption is significantly delayed compared to the immediate release
tablet with a T
at 7 hours (T
for the immediate release
max
max
tablet is 2.5 hours).
At steady state, similar to the immediate release