GLUCOVANCE 500/5 metformin hydrochloride 500 mg and glibenclamide 5 mg tablet blister pack

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

metformin hydrochloride, Quantity: 500 mg; glibenclamide, Quantity: 5 mg

Dostupné s:

Alphapharm Pty Ltd

Léková forma:

Tablet, film coated

Složení:

Excipient Ingredients: croscarmellose sodium; povidone; magnesium stearate; microcrystalline cellulose; titanium dioxide; lactose monohydrate; hypromellose; quinoline yellow; iron oxide yellow; iron oxide red; macrogol 4000

Podání:

Oral

Jednotky v balení:

120 Tablets, 60 Tablets, 90 Tablets, 10 Tablets, 30 Tablets

Druh předpisu:

(S4) Prescription Only Medicine

Terapeutické indikace:

Second line treatment of diabetes mellitus type II in adult patients whose glycaemic control is inadequate after diet and exercise alone and where combined therapy with metformin and glibenclamide is appropriate.

Přehled produktů:

Visual Identification: Yellow capsule shaped, biconvex. film-coated tablet with '5' engraved on one side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Stav Autorizace:

Licence status A

Datum autorizace:

2004-08-05

Informace pro uživatele

GLUCOVANCE
®
_metformin hydrochloride and glibenclamide_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Glucovance.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Glucovance
against the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT GLUCOVANCE IS
USED FOR
Glucovance is used to control blood
glucose levels (the amount of sugar
in the blood) in adults with type II
diabetes mellitus. This type of
diabetes is also known as non-insulin
dependent diabetes mellitus
(NIDDM) or maturity onset diabetes.
Glucovance is used:
•
when diet, exercise and treatment
with either metformin or a
sulfonylurea medicine are not
enough to control your blood
glucose
•
in people whose blood sugar
levels are already well controlled
by the combination of metformin
and a sulfonylurea medicine.
Glucovance is to replace these
two medicines.
Glucovance contains two active
ingredients, metformin hydrochloride
and glibenclamide.
Metformin belongs to a group of
medicines called biguanides.
Metformin lowers blood glucose by
helping your body make better use of
insulin.
Glibenclamide belongs to a group of
medicines called sulfonylureas.
Glibenclamide lowers blood glucose
by increasing the amount of insulin
produced by your pancreas.
If your blood glucose is not properly
controlled, you may experience
hypoglycaemia (low blood glucose)
or hyperglycaemia (high blood
glucose).
HYPOGLYCAEMIA
Hypoglycaemia (low blood glucose)
can occur suddenly. Signs may
include:
•
weakness, trembling or shaking
•
sweating
•
light headedness, dizziness,
headache or lack of concentration
•
irritability, tearfulness or crying
•
hunger
•
numbness around the lips and
tongue.
If not treated quickly, these may

Charakteristika produktu

AUSTRALIAN PRODUCT INFORMATION
GLUCOVANCE
®
_Metformin hydrochloride and Glibenclamide Tablet _
LIFE THREATENING LACTIC ACIDOSIS CAN OCCUR DUE TO ACCUMULATION OF
METFORMIN. THE MAIN RISK FACTOR IS
RENAL IMPAIRMENT, OTHER RISK FACTORS INCLUDE OLD AGE ASSOCIATED WITH
REDUCED RENAL FUNCTION_ _AND HIGH
DOSES OF METFORMIN ABOVE 2 G PER DAY.
1
NAME OF THE MEDICINE
Metformin hydrochloride and Glibenclamide.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Glucovance contains metformin hydrochloride and glibenclamide
combination and is available in three
strength combinations:
Each Glucovance 250/1.25 tablet contains 250 mg metformin
hydrochloride and 1.25 mg glibenclamide.
Each Glucovance 500/2.5 tablet contains 500 mg metformin hydrochloride
and 2.5 mg glibenclamide.
Each Glucovance 500/5 tablet contains 500 mg metformin hydrochloride
and 5 mg glibenclamide.
Glucovance also contains trace amounts of lactose.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Oral. Film-coated tablets.
Glucovance 250/1.25
:
Yellow film-coated, capsule-shaped, biconvex tablets, engraved with
“250” on one side and “1.25” on the other side
Glucovance 500/2.5
:
Pale orange film-coated, capsule-shaped, biconvex tablets, engraved
with “2.5” on one side
Glucovance 50/5
:
Yellow film-coated, capsule-shaped, biconvex tablets, engraved with
“5” on one side
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
Second line treatment of diabetes mellitus type II in adult patients
whose glycaemic control is
inadequate
after
diet
and
exercise
alone
and
where
combined
therapy
with
metformin
and
glibenclamide is appropriate.
GLUCOVANCE – AUSTRALIAN PRODUCT INFORMATION
2
4.2
DOSE
AND
METHOD
OF
ADMINISTRATION
Life threatening lactic acidosis can occur due to accumulation of
metformin. The main risk factor
is renal impairment, other risk factors include old age associated
with reduced renal function
_ _
and
high doses of metformin above 2 g per day.
As with all hypoglycaemic drugs, the dosage should be indi