ACTONEL ONCE A WEEK

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

RISEDRONATE SODIUM

Prieinama:

Accord Healthcare Limited

ATC kodas:

M05BA07

INN (Tarptautinis Pavadinimas):

RISEDRONATE SODIUM

Dozė:

35 Milligram

Vaisto forma:

Tablets Gastro-Resistant

Recepto tipas:

Product subject to prescription which may be renewed (B)

Gydymo sritis:

risedronic acid

Leidimo data:

2016-12-16

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Actonel Once a Week 35 mg gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 35 mg risedronate sodium
(equivalent to 32.5 mg risedronic acid).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet.
Oval, yellow, gastro-resistant tablet with “EC 35” engraved on one
side.
The dimensions of the tablet are as follows: width 13.05 mm, length
5.94 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of osteoporosis in postmenopausal women at increased risk of
fractures (see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose in adults is one Optinate Septimum 35 mg
gastro-resistant tablet orally once a week. The tablet
should be taken on the same day each week.
The optimal duration of bisphosphonate treatment for osteoporosis has
not been established. The need for continued
treatment should be re
-
evaluated periodically based on the benefits and potential risks of
risedronate on an individual
patient basis, particularly after 5 or more years of use.
Special populations
_Elderly_
Of the patients receiving risedronate 35 mg gastro-resistant tablets
in postmenopausal osteoporosis studies, 59% were
65 and over, while 13 % were 75 and over.
No overall differences in safety and effectiveness were observed
between
these patients and younger patients.
_Patients with renal impairment_
No dosage adjustment is required for those patients with mild to
moderate renal impairment. The use of risedronate
sodium is contraindicated in patients with severe renal impairment
(creatinine clearance lower than 30 ml/min) (see
sections 4.3 and 5.2).
_Paediatric population_
Risedronate sodium is not recommended for use in children below age 18
due to insufficient data on safety and efficacy
(also see section 5.1).
Method of administration
Optinate Septimum 35 mg gastro-resistant tablets should be taken
orally in the morning immediate