Actonel 75 mg Film Coated Tablets

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Risedronate sodium

Verfügbar ab:

Accord Healthcare Limited

ATC-Code:

M05BA; M05BA07

INN (Internationale Bezeichnung):

Risedronate sodium

Dosierung:

75 milligram(s)

Darreichungsform:

Film-coated tablet

Verschreibungstyp:

Product subject to prescription which may be renewed (B)

Therapiebereich:

Bisphosphonates; risedronic acid

Berechtigungsstatus:

Not marketed

Berechtigungsdatum:

2008-10-24

Fachinformation

Health Products Regulatory Authority
31 January 2019
CRN008J10
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Actonel 75 mg Film Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Film-coated tablet contains 75 mg risedronate sodium, (equivalent
to 69.6 mg
risedronic acid).
For the list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Oval pink 11.7 x 5.8 mm film-coated tablet engraved with RSN on one
side and 75 mg on the
other.
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 75 mg tablet orally on two
consecutive days a
month. The first tablet should be taken on the same day each month,
followed by the second
tablet the next day.
Special populations
_Elderly_
No dosage adjustment is necessary since bioavailability, distribution
and elimination were
similar in elderly (>60 years of age) compared to younger subjects.
This has also been shown in the very elderly, 75 years old and above,
postmenopausal
population.
_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).
Health Products Regulatory Authority
31 January 2019
CRN008J10
Page 2 of 13
_Paediatric population_
Risedronate sodium is not recommended for use in children below age 18
due to
insufficient data on safety and efficacy (see section 5.1).
Method of administration
- The absorption of risedronate sodium is affected by food and
polyvalent cations (see
section 4.5), thus to ensure adequate absorption patients should take
Optinate 75 mg before
breakfast: at least 30 minutes before the first food, other medicinal
product or drink (other
than plain water) of the day. Plain water is the on