ACTONEL 5 Milligram Film Coated Tablet

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

RISEDRONATE SODIUM

可用日期:

Warner Chilcott UK Limited

ATC代码:

M05BA07

INN（国际名称）:

RISEDRONATE SODIUM

剂量:

5 Milligram

药物剂型:

Film Coated Tablet

处方类型:

Product subject to prescription which may be renewed (B)

治疗领域:

Bisphosphonates

授权状态:

Authorised

授权日期:

2010-04-30

资料单张

PACKAGE LEAFLET:
INFORMATION FOR THE PATIENT
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor
or pharmacist.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Actonel is and what it is used for
2. What you need to know before you take Actonel
3. How to take Actonel
4. Possible side effects
5. How to store Actonel
6. Contents of the pack and other information
1. WHAT ACTONEL IS AND WHAT IT IS USED
FOR
WHAT ACTONEL IS
Actonel belongs to a group of
non-hormonal medicines called
bisphosphonates which are used
to treat bone diseases. It works
directly on your bones to make
them stronger and therefore less
likely to break.
Bone is a living tissue. Old bone is constantly
removed from your skeleton and replaced with new
bone.
Postmenopausal osteoporosis is a condition
occurring in women after the menopause where the
bones become weaker, more fragile and more likely
to break after a fall or strain.
Osteoporosis is more likely to occur in women who
have reached the menopause early and also in
patients treated long-term with steroids.
The spine, hip and wrist are the most likely bones
to break, although this can happen to any bone in
your body. Osteoporosis – related fractures can also
cause back pain, height loss and a curved back.
Many patients with osteoporosis have no symptoms
and you may not even have known that you had it.
WHAT ACTONEL IS USED FOR
The treatment of osteoporosis
• in postmenopausal women
The prevention of osteoporosis
• in women with an increased risk of osteoporosis
(including low bone mass, early menopause or a
family history of osteo

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
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).
Excipient with known effect:
Each film-coated tablet contains lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
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
7.5 mg/day prednisone or equivalent.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended daily dose in adults is one 5 mg tablet orally.
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_
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 breakf