APO-Alendronate Plus D3 and calcium alendronic acid (as sodium) 70 mg/ colecalciferol 140 ug tablets and 1250 mg calcium carbonate tablets composite pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

calcium carbonate, Quantity: 1.2492 g (Equivalent: calcium, Qty 500 mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

alendronate sodium,colecalciferol,Calcium carbonate

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: sodium lauryl sulfate; dibasic sodium phosphate; hypromellose; polydextrose; magnesium stearate; indigo carmine aluminium lake; monobasic sodium phosphate; titanium dioxide; macrogol 8000; croscarmellose sodium; pregelatinised maize starch

Administration route:

Oral

Units in package:

4 weekly supply (4 x Alendronate Plus D3 70 mg/140 ug tablets and 48 x Calcium carbonate 1250 mg tablets)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Alendronate/vitamin D3 and calcium composite pack is indicated for the treatment of:,? Osteoporosis* in select patients where vitamin D and calcium supplementation is recommended,* Prior to treatment, osteoporosis must be confirmed by: ? the finding of low bone mass of at least 2 standard deviations below the gender specific mean for young adults or by ? the presence of osteoporotic fracture

Product summary:

Visual Identification: Blue, modified oval, biconvex, film coated tablets engraved APO-CAL on one side, other side plain; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2016-05-05