OSSMAX

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

Alendronate sodium

Dostępny od:

Ranbaxy Australia Pty Ltd

Klasa:

Medicine Registered

Ulotka dla pacjenta

Ossmax CMI V5 Mar 2010   

Page 1 of 9 
OSSMAX
®

ALENDRONATE (AS ALENDRONATE SODIUM) 70 MG ONCE-WEEKLY 
TABLETS

CONSUMER MEDICINE INFORMATION 

WHAT IS IN THIS LEAFLET  
This leaflet answers some common questions about OSSMAX   
(alendronate).  
It 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 
risks of you taking OSSMAX against the benefits it is expected to 
have for you. 
IF YOU HAVE ANY CONCERNS ABOUT USING/TAKING THIS MEDICINE, ASK YOUR 
DOCTOR OR PHARMACIST. 
Keep this leaflet with this medicine. You may need to read it again. 

WHAT OSSMAX IS USED FOR 
OSSMAX
 contains alendronate. 
OSSMAX 
is used to treat osteoporosis.  
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 femal

Charakterystyka produktu

OSSMAX PI V6 Mar 2010

 Page 1 of 22

OSSMAX 
 (ALENDRONATE TABLETS) 

OSSMAX 5 mg 
Tablets, 
OSSMAX 10 mg 
Tablets, 
OSSMAX 70 mg 
Tablets

Alendronate sodium 

_CAS Number_:_ _129318-43-0. 

DESCRIPTION 

OSSMAX tablets contain alendronate sodium anhydrous, which
is described chemically as: (4-
amino-1-hydroxybutylidene) bisphosphonic acid monosodium
salt. The molecular formula of 
Alendronate sodium anhydrous is C
4
H
12
NO
7
P
2
Na and molecular weight is 271.1. Alendronate 
sodium anhydrous is a
white or almost white, crystalline, nonhygroscopic powder. It
is soluble in 
water, very slightly soluble
in alcohol, and practically insoluble in
chloroform. Bisphosphonates are 
synthetic analogs of pyrophosphate that bind to the
hydroxyapatite found in bone. Alendronate is a 
bisphosphonate that acts as a potent,
specific inhibitor of osteoclast-mediated bone resorption.  

STRUCTURAL FORMULA OF ALENDRONATE  

Each tablet of OSSMAX contains either 5.442, 10.884 or
76.188 mg of alendronate sodium 
anhydrous, which is the molar equivalent to 5.0, 10.0 and 70
mg respectively of alendronic acid. 

OSSMAX tablets contain following inactive ingredients: Mannitol,
Croscarmellose Sodium, 
Magnesium stearate, Purified Talc, Colloidal Anhydrous Silica. 

PHARMACOLOGY 

  PHARMACODYNAMIC PROPERTIES 

Alendronate is a bisphosphonate that, in animal studies,
localizes preferentially to sites of bone 
resorption, specifically under osteoclasts, and inhibits
osteoclastic bone resorption with no direct 
OSSMAX PI V6 Mar 2010

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effect on bone formation. Since
bone formation and bone resorption
are coupled, bone formation is 
also reduced, but less so than resorption, leading
to progressive gains in bone mass. Following 
exposure to alendronate, normal bone
is formed that incorporates a