Apo-Risedronate risedronate sodium 75mg film coated tablets blister pack

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

risedronate sodium hemipentahydrate, Quantity: 86.7 mg

Disponible desde:

Arrotex Pharmaceuticals Pty Ltd

Designación común internacional (DCI):

Risedronate sodium hemipentahydrate

formulario farmacéutico:

Tablet, film coated

Composición:

Excipient Ingredients: hyprolose; iron oxide red; colloidal anhydrous silica; magnesium stearate; hypromellose; macrogol 8000; crospovidone; titanium dioxide; lactose

Vía de administración:

Oral

Unidades en paquete:

8, 2, 4, 6

clase:

Medicine Registered

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

The treatment of osteoporosis,The treatment of glucocorticoid-induced osteoporosis,The preservation of bone-mineral density in patients on long term corticosteroid therapy

Resumen del producto:

Visual Identification: Dark pink, round, biconvex coated tablet. Engraved "APO" on one side, "RIS" over "75" on the other side; Container Type: Blister Pack; Container Material: PVC/PVDC; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Estado de Autorización:

Licence status A

Fecha de autorización:

2012-03-08

Ficha técnica

1
AUSTRALIAN PRODUCT INFORMATION
APO-RISEDRONATE (RISEDRONATE SODIUM
HEMIPENTAHYDRATE) TABLETS
1
NAME OF THE MEDICINE
Risedronate sodium hemipentahydrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 35, 75 or 150 mg risedronate sodium as the active
ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Contains sugars as Lactose
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
FILM COATED TABLETS:
35 MG TABLETS
Orange, round, biconvex coated tablets, engraved “APO” on one
side, “RIS” over “35” on the
other side.
75 MG TABLETS
Dark pink, round, biconvex coated tablet, engraved “APO” on one
side, “RIS” over “75” on the
other side.
150 MG TABLETS
Blue, round, biconvex coated tablet, engraved “APO” on one side,
“RIS” over “150” on the
other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Treatment of osteoporosis
•
Treatment of glucocorticoid-induced osteoporosis.
•
Preservation of bone mineral density in patients on long-term
corticosteroid therapy.
2
4.2
DOSE AND METHOD OF ADMINISTRATION
Risedronate tablets are intended for oral administration.
DOSAGE
Risedronate must only be taken with PLAIN WATER.
Plain water is the only drink that should be taken with risedronate
tablets. Note that some
mineral waters or water from regional areas may have a higher
concentration of calcium and
therefore should not be used.
Risedronate must be taken 30 minutes before the first food or drink
other than water.
To facilitate delivery to the stomach, risedronate should be taken
while the patient is in an
upright position and the patients should avoid lying down for 30
minutes.
Patients should not chew or suck the tablet because of the potential
for oropharyngeal irritation.
OSTEOPOROSIS
The recommended dose is either:
•
5 mg daily;
•
35 mg once-a-week, taken on the same day each week;
•
75 mg taken for two consecutive days on the same dates each month; or
•
150 mg taken once-a-month. The tablet should be taken on the same date
ea