ACRIS COMBI risedronate sodium 35 mg film-coated tablets and calcium carbonate 1250 mg tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

calcium carbonate,risedronate sodium

Available from:

Alphapharm Pty Ltd

INN (International Name):

Calcium carbonate,Risedronate sodium

Authorization status:

Registered

Patient Information leaflet

ACRIS COMBI
_contains the active ingredient risedronate sodium and calcium
carbonate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Acris Combi.
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 Acris Combi
against the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT ACRIS COMBI IS
USED FOR
Acris Combi is a combination
medicine consisting of 7 tablets for
each week of therapy. Each week of
therapy includes:
One Acris 35mg Once-a-Week tablet
(the small light-orange tablet) and 6
Calcium Carbonate 1250mg tablets
(the light lavender tablets).
Acris Combi belongs to a group of
medicines called bisphosphonates. It
is used to treat:
•
osteoporosis (brittle or fragile
bones that may fracture easily)
•
osteoporosis caused by taking
steroids.
Bone is a living tissue consisting of
calcium and other minerals.
Throughout life, old bone is
constantly broken down and replaced
by new bone.
Acris 35mg Once-a-Week tablets
works by helping to:
•
slow down the process of
removing old bone. This allows
the cells time to rebuild
•
maintaining and increasing bone
density.
•
reverse the progression of
osteoporosis.
The Calcium Carbonate tablets help
to supply the calcium your body
needs to build new bone.
_OSTEOPOROSIS_
Osteoporosis is a disease which
causes bones to become less dense,
gradually making them weaker, more
brittle and consequently, more likely
to break.
Broken bones may result from injury
or falls. Breaks may occur in normal,
everyday activity, such as lifting, or
from minor injury that would not
ordinarily fracture normal bone.
Fractures usually occur at the hip,
spine or wrist, although can occur in
any bone of the body.
Osteoporosis can also cause back
pain, heig

Summary of Product characteristics

PRODUCT INFORMATION
ACRIS COMBI
_Risedronate sodium tablets and calcium carbonate tablets _
NAME OF THE MEDICINE
RISEDRONATE SODIUM
Active ingredient
:
Risedronate sodium hemipentahydrate
Chemical name
:
[1-hydroxy-2-(3-
pyridinyl)ethylidene]bis(phosphonic
acid)
monosodium
salt
hemipentahydrate
Structural formula
:
Molecular formula
:
C
7
H
10
NO
7
P
2
Na.2.5H
2
O
Molecular weight
:
350.13
CAS Registry no.
:
329003-65-8
CALCIUM CARBONATE
Active ingredient
:
Calcium carbonate
Molecular formula
:
CaCO
3
Molecular weight
:
100.1
CAS Registry no.
:
471-34-1
DESCRIPTION
RISEDRONATE
Risedronate sodium (as hemipentahydrate) is a fine, white to
off-white, odourless, crystalline powder. It is
soluble in water and in aqueous solutions and essentially insoluble in
common organic solvents.
Each risedronate tablet contains 35 mg risedronate sodium (as
hemipentahydrate) and the following inactive
ingredients: Mannitol, microcrystalline cellulose, crospovidone,
silicon dioxide, magnesium stearate, Opadry II
beige 40L97490 (ARTG No. 107225) and Opadry clear YS-1-7006 (ARTG No.
12789).
CALCIUM CARBONATE
Calcium carbonate is a white powder, practically insoluble in water.
Each calcium tablet contains 1250 mg calcium carbonate as a mixture of
calcium carbonate and pregelatinised
maize starch and the following inactive ingredients:
Hydroxypropylcellulose, polysorbate 80, purified water,
microcrystalline cellulose, croscarmellose sodium, Indigo carmine,
Allura red AC, purified talc, magnesium
stearate, Opadry Aqueous film coating Y-19-7483 (ARTG No. 3751).
ACRIS Combi – PRODUCT INFORMATION
2
PHARMACOLOGY
PHARMACODYNAMICS
RISEDRONATE
Risedronate is a potent pyridinyl bisphosphonate that binds to bone
hydroxyapatite and inhibits osteoclast-
mediated bone resorption. Risedronate is a third generation
bisphosphonate. In preclinical studies risedronate
demonstrated potent anti-osteoclast and anti-resorptive activity,
increasing bone mass and biomechanical
strength dose-dependently. The activity of risedronate was confirmed
by bone marke