Alendronic acid ALENDRONATE SANDOZ 70mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

alendronate sodium, Quantity: 91.35 mg (Equivalent: alendronic acid, Qty 70 mg)

Available from:

Sandoz Pty Ltd

INN (International Name):

alendronate sodium

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: microcrystalline cellulose; croscarmellose sodium; colloidal anhydrous silica; macrogol 8000; carrageenan; magnesium stearate

Administration route:

Oral

Units in package:

4 tablets

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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.

Product summary:

Visual Identification: White, round, biconvex filem coated tablet debossed with "ALN 70" on one side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2008-05-06

Patient Information leaflet

ALENDRONATE SANDOZ
®
1
ALENDRONATE SANDOZ
®
_Alendronate sodium 70 mg tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Alendronate Sandoz.
It is particularly important that you
read the section "When and how to
take it" before you take this
medicine. This leaflet does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risk of you taking this medicine
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT
ALENDRONATE
SANDOZ IS USED
FOR
Alendronate Sandoz is used to treat
osteoporosis including osteoporosis
caused by a group of medicines
known as corticosteroids.
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

Summary of Product characteristics

210219-Alendronate Sandoz-pi
Page 1 of 20
AUSTRALIAN PRODUCT INFORMATION
ALENDRONATE SANDOZ
® 70 MG (ALENDRONATE SODIUM) TABLETS
1.
NAME OF THE MEDICINE
Alendronate sodium
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Alendronate Sandoz tablet contains 91.4 mg of alendronate sodium,
which is the molar
equivalent to 70 mg of alendronic acid.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Alendronate Sandoz 70 mg tablets: White, round, bi-convex film-coated
tablet, debossed with
“ALN 70” on one side.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Alendronate Sandoz is indicated for the treatment of osteoporosis,
including glucocorticoid-
induced osteoporosis. Prior to treatment, osteoporosis must be
confirmed by the finding of low
bone mass of at least 2 standard deviations below the gender specific
mean for young adults,
or by the presence of osteoporotic fracture.
4.2.
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
Although no specific studies have been conducted on the effects of
switching patients on
another therapy for osteoporosis to alendronate, there are no known or
theoretical safety
concerns related to alendronate in patients who previously received
any other antiosteoporotic
therapy.
_ADULTS _
_Treatment of osteoporosis: _
The recommended dosage is one 70 mg tablet once weekly.
_Severe oesophageal ulceration has been reported in patients taking
alendronate (See Section _
_4.4 Special warnings and precautions for use). Patients should be
instructed that if they _
_develop symptoms of oesophageal disease (such as difficulty or pain
upon swallowing, _
_retrosternal pain or new or worsening heartburn) they should stop
taking Alendronate Sandoz _
_and consult their doctor. _
In clinical trials, alendronate was administered with appropriate
calcium and vitamin D
supplementation. The use of vitamin D as the sole treatment of
osteoporosis has not been
established.
Patients should receive supplemental calcium and/or vitamin D if
intake is inadequate (see
Sect