ACTONEL TABLET 5 mg
Land: Singapúr
Tungumál: enska
Heimild: HSA (Health Sciences Authority)
Upplýsingar fylgiseðill
(PIL)
21-04-2011
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Senda beiðni.
Virkt innihaldsefni:
RISEDRONATE SODIUM
Fáanlegur frá:
SANOFI-AVENTIS SINGAPORE PTE. LTD.
ATC númer:
M05BA07
Skammtar:
5 mg
Lyfjaform:
TABLET, FILM COATED
Stjórnsýsluleið:
ORAL
Gerð lyfseðils:
Prescription Only
Framleitt af:
NORWICH PHARMACEUTICALS INC
Leyfisdagur:
2001-06-21
Upplýsingar fylgiseðill
_Actonel_
®
5mg
_ _
_Risedronate sodium _
film-coated tablet
[sanofi aventis logo]
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).
For excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
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
≥ 7.5mg/day prednisone or
equivalent.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The recommended daily dose in adults is one 5 mg
tablet orally.
The absorption of Actonel is affected by food, thus to ensure
adequate absorption patients should
take Actonel:
• Before breakfast: At least 30 minutes before the first
food, other medicinal product or drink
(other than plain water) of the day.
In the particular instance that before breakfast dosing is not
practical, Actonel can be taken
between meals or in the evening at the same time
everyday, with strict adherence to the following
instructions,
to ensure Actonel is taken on an empty stomach:
• Between meals: Actonel should be taken at least
2 hours before and at least
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