ALENDRO ONCE-WEEKLY alendronic acid 70 mg (as sodium alendronate monohydrate) tablet blister pack

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

alendronate sodium monohydrate, Quantity: 81.24 mg (Equivalent: alendronic acid, Qty 70 mg)

제공처:

Arrotex Pharmaceuticals Pty Ltd

INN (국제 이름):

alendronate sodium monohydrate

약제 형태:

Tablet, uncoated

구성:

Excipient Ingredients: croscarmellose sodium; microcrystalline cellulose; lactose monohydrate; magnesium stearate

관리 경로:

Oral

패키지 단위:

4 tablets

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

Treatment of osteoporosis, including glucocorticoid induced osteoporosis. Osteoporosis must be confirmed by the finding of low bone mass of at least two standard deviations below the gender specific mean for young adults or by the presence of history of osteoporotic fracture. Paget's disease of bone.

제품 요약:

Visual Identification: white to off-white oval shaped tablet engraved with 'AN70' on one side and plain on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

승인 상태:

Registered

승인 날짜:

2005-05-27

환자 정보 전단

ALENDRO ONCE WEEKLY- Consumer Medicine Information
Page 1of 4
ALENDRO ONCE WEEKLY
alendronate sodium monohydrate
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ALENDRO ONCE
WEEKLY.
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 ALENDRO ONCE
WEEKLY 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 ALENDRO ONCE
WEEKLY ARE USED FOR
ALENDRO ONCE WEEKLY is used to
treat osteoporosis in men and
postmenopausal women.
This condition is caused by changes
in the way bone is normally
maintained.
UNDERSTANDING BONE
Bone is living, growing tissue.
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 more
porous, gradually making them
weaker, more brittle and likely to
break.
Osteoporosis is common in
postmenopausal women. The
menopause occurs when the
ovaries virtually stop producing the
female hormone, oestrogen, or are
removed (which may occur, for
example, at the time of a
hysterectomy). At

제품 특성 요약

1
AUSTRALIAN PRODUCT INFORMATION – ALENDRO (ALENDRONIC
ACID) TABLETS
1
NAME OF THE MEDICINE
Alendronic acid (as alendronate sodium monohydrate).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Alendro tablets come in three strengths and contain 10 mg, 40 mg or 70
mg of alendronic acid as
alendronate sodium monohydrate.
Alendro tablets contains lactose monohydrate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Alendro 10
White to off-white capsule-shaped tablet embossed with “AN 10” on
one
side and the Arrow logo on the other.
Alendro 40
White to off-white triangle shaped tablet embossed with “AN” over
“40” on
one side and the Arrow logo on the other.
Alendro Once Weekly
White to off-white oval-shaped tablet embossed with “AN 70” on one
side
and plain on the other.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
(See SECTION 4.2 DOSE AND METHOD OF ADMINISTRATION)
Treatment of osteoporosis, including glucocorticoid induced
osteoporosis.
Osteoporosis must be confirmed by the finding of low bone mass of at
least two standard deviations
below the gender specific mean for young adults, or by the presence of
osteoporotic fracture.
Paget's disease of bone.
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
Alendronate must be taken at least 30 minutes before the first food,
beverage or medication of the
day with plain water only. Other beverages (including mineral water),
food and some medications
are likely to reduce the absorption of alendronate (see SECTION 4.5
INTERACTIONS WITH OTHER
MEDICINES AND OTHER FORMS OF INTERACTIONS).
To facilitate delivery to the stomach and thus reduce the potential
for oesophageal irritation,
alendronate should only be swallowed upon arising for the day with a
full glass of water and patients
should not lie down for at least 30 minutes and until after their
first food of the day. Alendronate
should not be taken at bedtime or before arising for the day. Failure
to follow these instructions
may increase the risk of oesophageal adverse expe