Apo-Risedronate risedronate sodium 75mg tablets bottle

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

risedronate sodium hemipentahydrate, Quantity: 86.7 mg

Disponível em:

Arrotex Pharmaceuticals Pty Ltd

DCI (Denominação Comum Internacional):

Risedronate sodium hemipentahydrate

Forma farmacêutica:

Tablet, film coated

Composição:

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

Via de administração:

Oral

Unidades em pacote:

30

Classe:

Medicine Registered

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

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

Resumo do produto:

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

Status de autorização:

Registered

Data de autorização:

2012-03-08

Características técnicas

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
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