Actonel Once A Week 35 mg film-coated tablets

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Risedronate sodium

Dostupno od:

Accord Healthcare Limited

ATC koda:

M05BA; M05BA07

INN (International ime):

Risedronate sodium

Doziranje:

35 milligram(s)

Farmaceutski oblik:

Film-coated tablet

Tip recepta:

Product subject to prescription which may be renewed (B)

Područje terapije:

Bisphosphonates; risedronic acid

Status autorizacije:

Marketed

Datum autorizacije:

2003-01-24

Svojstava lijeka

Health Products Regulatory Authority
31 January 2019
CRN008J10
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Actonel Once A Week 35 mg film-coated tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 35 mg risedronate sodium (equivalent
to 32.5 mg
risedronic acid).
Excipient with known effect: Each film-coated tablet contains 126.0 mg
lactose
monohydrate (equivalent to 119.7 mg lactose).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Oval light-orange 11.7 x 5.8 mm film-coated tablet with RSN on one
side and 35 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 (see section 5.1).
Treatment of osteoporosis in men at high risk of fractures (see
section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose in adults is one 35 mg tablet orally once a week.
The tablet should
be taken on the same day each week.
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.
Health Products Regulatory Authority
31 January 2019
CRN008J10
Page 2 of 14
_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 (see section 5.1).
Method of administration
The absorption of risedronate sodium is affected by food, thus to
ensure adequate
a