Actonel Combi 35mg + 500mg film-coated tablets

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Risedronate sodium; Calcium carbonate

Beschikbaar vanaf:

Theramex Ireland Limited

ATC-code:

M05BB; M05BB04

INN (Algemene Internationale Benaming):

Risedronate sodium; Calcium carbonate

Dosering:

35 mg/500 milligram(s)

farmaceutische vorm:

Film-coated tablet

Therapeutisch gebied:

Bisphosphonates, combinations; risedronic acid, calcium and colecalciferol, sequential

Autorisatie-status:

Marketed

Autorisatie datum:

2005-03-18

Productkenmerken

Health Products Regulatory Authority
17 October 2019
CRN008JLF
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Actonel Combi 35mg + 500mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Light-orange tablets:
Each film-coated tablet contains 35 mg risedronate sodium, which is
equivalent to 32.5 mg risedronic acid.
Blue tablets:
Each film-coated tablet contains 1250 mg calcium carbonate, which is
equivalent to 500 mg elemental calcium.
Excipient with known effect:
Each light-orange 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.
_Risedronate sodium tablet_:
Oval, light-orange, film-coated tablet with RSN on one side and 35 mg
on the other.
_Calcium carbonate tablet_:
Capsule-shaped, blue, film-coated tablet with NE 2 on both sides.
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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Actonel Combi is a two component therapy consisting of 7 tablets in a
blister, 1 Actonel 35 mg film‑coated tablet
(light‑orange tablet) and 6 calcium 500 mg film‑coated tablets
(blue tablets). Actonel Combi is intended for patients for whom
the amount of calcium included is considered to provide adequate
supplementation, based on individual assessment.
Supplemental vitamin D should be considered if the dietary intake is
inadequate.
Posology
The recommended dose in adults is 1 Actonel 35 mg tablet on the first
day followed beginning on the next day by 1 calcium
500 mg tablet daily for 6 days. This 7 day sequence is then repeated
each week.
Special populations
_Elderly_
Health Products Regulatory Authority
17 October 2019
CRN008JLF
Page 2 of 11
Since the target population is postmenopausal women, a specific dosage
instruction for the elderly