RISEDRO ONCE A WEEK risedronate sodium 35 mg tablet blister pack

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

risedronate sodium

제공처:

Arrow Pharma Pty Ltd

INN (International Name):

Risedronate sodium

승인 상태:

Registered

환자 정보 전단

RISEDRO ONCE A WEEK- Consumer Medicine Information
Page 1 of 4
RISEDRO ONCE A WEEK
risedronate sodium
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about RISEDRO ONCE A
WEEK.
It does not contain all the available
information. It does not take the place
of talking to your doctor or pharmacist.
All medicines have benefits and risks.
Your doctor has weighed the risks of
you taking RISEDRO ONCE A WEEK
against the benefits they expect it will
have for you.
TALK TO YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY CONCERNS ABOUT TAKING
THIS MEDICINE.
KEEP THIS LEAFLET WITH YOUR MEDICINE.
You may need to read it again.
WHAT RISEDRO ONCE A WEEK
IS USED FOR
RISEDRO ONCE A WEEK is used to treat
bone disease and belongs to a group of
medicines called bisphosphonates.
It works directly on your bones to
make them stronger and therefore less
likely to break or fracture.
The tablets are used to treat:
•
osteoporosis (brittle or fragile bones
that may easily fracture)
•
osteoporosis caused by taking
steroids.
Osteoporosis is caused by changes in
the way bone is normally maintained.
UNDERSTANDING BONE
Bone is living, growing tissue consisting
of calcium and other minerals.
Throughout life, our bodies are
breaking down old bone and rebuilding
new bone in a continuous cycle. Until
our late 20s, while bones are still
developing, we gain bone by building
more than we lose. From then until
about age 35 the process is usually in
balance, so that the amount of bone
lost is about equal to the amount that
is replaced. After about age 35 this
balance is disturbed, with bone loss
occurring at a slightly faster rate than it
can be replaced. In women, after
menopause, hormonal changes cause
bone loss at an even faster rate. When
bone loss is excessive, bones can
become thinner and weaker, and
therefore are more likely to break.
OSTEOPOROSIS
"Osteo" means bone, and "porosis"
means something that has holes in it,
like a sponge. Therefore, osteoporosis
is a disease which causes bones to
become

제품 특성 요약

1
AUSTRALIAN PRODUCT INFORMATION – RISEDRO ONCE A WEEK
(RISEDRONATE SODIUM) UNCOATED TABLETS
1
NAME OF THE MEDICINE
Risedronate sodium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Risedro Once A Week tablets contain 35 mg of risedronate sodium.
For the full list of excipients, SEE SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
White to off-white capsule shaped Uncoated tablet, embossed with RE 35
on one side and plain on
the other
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Risedro Once A Week 35 mg tablets are indicated for the:
•
Treatment of osteoporosis.
•
Treatment of glucocorticoid-induced osteoporosis.
•
Preservation of bone mineral density in patients on long-term
corticosteroid therapy.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Risedro Once A Week must only be taken with plain water. Please note
that some mineral waters or
water from regional areas may have a higher concentration of calcium
and therefore should not be
used.
Risedro Once A Week must be taken 30 minutes before the first food or
drink other than water. To
facilitate delivery to the stomach, it should be taken in an upright
position and the patient should
avoid lying down for 30 minutes.
Patients should not chew or suck on the tablet because of the
potential for oropharyngeal irritation.
OSTEOPOROSIS
The recommended dose is 35 mg once a week, taken on the same day each
week.
USE IN THE ELDERLY
2
No dose adjustment is necessary.
RENAL IMPAIRMENT
No dose adjustment is necessary in patients with mild to moderate
renal insufficiency (creatinine
clearance 30 to 60 mL/minute). Risedronate is not recommended in
patients with severe renal
impairment (creatinine clearance < 30 mL/minute) due to limited
clinical data.
USE IN CHILDREN
Safety and efficacy of risedronate has not been established in
patients under 18 years of age.
COMPATIBILITY WITH OTHER DRUGS
Calcium, antacids, aluminium and some oral medications will interfere
with the absorption of
risedronate and therefore should be taken at a different time of the
day.
4.3
C
ONTRAI