Actonel 30 mg film-coated tablets

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Risedronate sodium

Beschikbaar vanaf:

Accord Healthcare Limited

ATC-code:

M05BA; M05BA07

INN (Algemene Internationale Benaming):

Risedronate sodium

Dosering:

30 milligram(s)

farmaceutische vorm:

Film-coated tablet

Prescription-type:

Product subject to prescription which may be renewed (B)

Therapeutisch gebied:

Bisphosphonates; risedronic acid

Autorisatie-status:

Not marketed

Autorisatie datum:

2000-03-20

Productkenmerken

Health Products Regulatory Authority
31 January 2019
CRN008J10
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Actonel 30 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 30 mg risedronate sodium (equivalent
to 27.8 mg
risedronic acid).
Excipients: Each film-coated tablet contains lactose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
Oval white film-coated tablet with RSN on one side and 30 mg on the
other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of Paget’s disease of the bone.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended daily dose in adults is one 30 mg tablet orally for 2
months. If re
treatment is considered necessary (at least two months post
treatment), a new
treatment with the same dose and duration of therapy could be given.
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_
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_
Health Products Regulatory Authority
31 January 2019
CRN008J10
Page 2 of 10
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 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
stric