OPTINATE ONCE A WEEK

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

RISEDRONATE SODIUM

Dostupné s:

Accord Healthcare Limited

ATC kód:

M05BA07

INN (Mezinárodní Name):

RISEDRONATE SODIUM

Dávkování:

35 Milligram

Léková forma:

Film Coated Tablet

Druh předpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

risedronic acid

Stav Autorizace:

Not Marketed

Datum autorizace:

2009-12-18

Charakteristika produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Optinate Once a Week 35mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film
-
coated tablet contains 35 mg risedronate sodium (equivalent to 32.5 mg
risedronic acid).
Excipients 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.
Method of administration
The absorption of risedronate sodium is affected by food, thus to
ensure adequate absorption patients should take
Optinate Once a Week 35 mg:
•
Before breakfast: At least 30 minutes before the first food, other
medicinal product or drink (other than
plain water) of the day.
Patients should be instructed that if a dose is missed, one Optinate
Once a Week 35 mg tablet should be taken on the
day that the tablet is remembered. Patients should then return to
taking one tablet once a week on the day the tablet is
normally taken. Two tablets should not be taken on the same day.
The tablet must be swallowed whole and not sucked or chewed. To aid
delivery of the tablet to the stomach Optinate
Once a Week 35 mg is to be taken while in an upright position with a
glass of plain water (>120 ml). Patients should
not lie down for 30 minutes after taking the tablet (see section 4.4).
Supplemental calcium and vitamin D should be considered if the