Actonel 5 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:

5 milligram(s)

Darreichungsform:

Film-coated tablet

Verschreibungstyp:

Product subject to prescription which may be renewed (B)

Therapiebereich:

Bisphosphonates; risedronic acid

Berechtigungsstatus:

Marketed

Berechtigungsdatum:

2000-03-20

Fachinformation

Health Products Regulatory Authority
31 January 2019
CRN008J10
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Actonel 5 mg film coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg risedronate sodium (equivalent
to 4.64 mg
risedronic acid).
Excipient with known effect:
Each film-coated tablet contains lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Oval yellow film-coated tablet with RSN on one side and 5 mg on the
other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of postmenopausal osteoporosis, to reduce the risk of
vertebral fractures.
Treatment of established postmenopausal osteoporosis, to reduce the
risk of hip
fractures. Prevention of osteoporosis in postmenopausal women with
increased risk
of osteoporosis (see section 5.1)
To maintain or increase bone mass in postmenopausal women undergoing
long‑term (more than 3 months), systemic corticosteroid treatment at
doses
³7.5 mg/day prednisone or equivalent.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended daily dose in adults is one 5 mg tablet orally.
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.
_Renal Impairment_
Health Products Regulatory Authority
31 January 2019
CRN008J10
Page 2 of 14
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 (see section 5.1).
Method of administration
The absorption of Actonel is affected by food, thus to ensure adequate
absorption patients
should take Actonel:
- Before breakfast: At l