METFORMIN XR 1000 APOTEX metformin hydrochloride 1000 mg modified release tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

metformin hydrochloride, Quantity: 1000 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Metformin hydrochloride

Pharmaceutical form:

Tablet, modified release

Composition:

Excipient Ingredients: magnesium stearate; hypromellose; methylcellulose; colloidal anhydrous silica

Administration route:

Oral

Units in package:

500 Tablets (Bulk pack for Dose Administration Aid Packers), 60 Tablets

Prescription type:

(S4) Prescription Only Medicine

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. Metformin may be used as monotherapy or in combination with other oral hypoglycaemic agents, or with insulin.

Product summary:

Visual Identification: White to off-white capsule-shaped biconvex tablet engraved MXR 1000 on one side and plain on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2014-09-09

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
METFORMIN XR APOTEX (METFORMIN HYDROCHLORIDE)
MODIFIED 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 AND HIGH DOSES OF METFORMIN HYDROCHLORIDE
(≥ 2 G PER
DAY).
1
NAME OF THE MEDICINE
Metformin hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified release tablet contains either 500 mg or 1000 mg
metformin hydrochloride
(HCl).
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
METFORMIN XR 500 APOTEX
METFORMIN XR 1000 APOTEX
3
PHARMACEUTICAL FORM
METFORMIN XR 500 APOTEX
Modified release tablet.
White to off-white capsule-shaped, unscored tablet; engraved “APO”
on one side and “XR500”
on the other side.
METFORMIN XR 1000 APOTEX
Modified release tablet.
White to off-white capsule-shaped biconvex tablet; engraved “MXR
1000” on one side and
plain 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. Metformin
may be used as monotherapy or in combination with other oral
hypoglycaemic agents, or with
insulin.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
Intended for oral administration.
2
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 HCL (≥ 2 G PER
DAY).
MONOTHERAPY AND COMBINATION WITH OTHER ORAL HYPOGLYCAEMIC AGENTS
Initiating Therapy with Metformin XR
For patients new to metformin, the usual starting dose is one
Metformin XR 500 tablet, once
daily, with the evening meal. If the starting dose requires 750 mg
modified release metformin
HCl, then alternative brands will be required, as Metformin XR 500
cannot be divide