DIABEX XR 750 metformin hydrochloride 750 mg extended release tablets blister pack

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

metformin hydrochloride, Quantity: 750 mg

Dostępny od:

Alphapharm Pty Ltd

INN (International Nazwa):

Metformin hydrochloride

Forma farmaceutyczna:

Tablet

Skład:

Excipient Ingredients: hypromellose; magnesium stearate; carmellose sodium

Droga podania:

Oral

Sztuk w opakowaniu:

100 tablets, 90 tablets, 120 tablets, 10 tablets, 60 tablets, 30 tablets

Typ recepty:

(S4) Prescription Only Medicine

Wskazania:

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. Diabex XR or Diabex XR 750 may be used as monotherapy or in combination with other oral antidiabetic agents, or with insulin.

Podsumowanie produktu:

Visual Identification: white to off-white, capsule-shaped, biconvex tablet, debossed "750" on one side and "Merck", on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 22 Months; Container Temperature: Store below 25 degrees Celsius

Status autoryzacji:

Registered

Data autoryzacji:

2009-10-28

Charakterystyka produktu

AUSTRALIAN PRODUCT INFORMATION
DIABEX
®
XR 500
DIABEX
®
XR 750
DIABEX
®
XR 1000
_Metformin hydrochloride extended release tablets _
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.
1
NAME OF THE MEDICINE
Metformin hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Diabex XR contains metformin hydrochloride as the active ingredient
and is available in three strengths:
Each Diabex XR 500, (500 mg) extended release tablet contains 500 mg
of metformin hydrochloride.
Each Diabex XR 750, (750 mg) extended release tablet contains 750 mg
of metformin hydrochloride.
Each Diabex XR 1000, (1000 mg) extended release tablet contains 1000
mg of metformin hydrochloride.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Oral. Extended release tablets.
DIABEX XR 500
:
Metformin hydrochloride 500 mg extended release tablets: white to
off-white,
capsule-shaped, biconvex tablet, debossed “500” on one side
DIABEX XR 750*
:
Metformin hydrochloride 750 mg extended release tablets: white to
off-white,
capsule-shaped, biconvex tablet, debossed “750” on one side and
“Merck:” on the
other side
DIABEX XR 1000
:
Metformin hydrochloride 1000 mg extended release tablets: white to
off-white,
capsule-shaped, biconvex tablet, debossed with ‘1000’ on one face
All three tablet strengths are gluten free.
The tablet shells may be present in the faeces. Patients should be
advised that this is normal.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
Metformin is indicated in the 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. Diabex XR 500,
DIABEX
®
XR 500, DIABEX
®
XR 750 AND DIABEX
®
XR 1000 – AUSTRALIAN PRODUCT INFORMATION
2
Diabex XR 750 or Diabex XR 1000 may be used as monotherapy or in
combination with oth