ACRIS Once-a-Month risedronate sodium (as hemipentahydrate) 150 mg film-coated tablet blister pack

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

risedronate sodium hemipentahydrate, Quantity: 172.1 mg (Equivalent: risedronate sodium, Qty 150 mg)

Tillgänglig från:

Bafna Pharmaceuticals Pty Ltd

INN (International namn):

Risedronate sodium hemipentahydrate

Läkemedelsform:

Tablet, film coated

Sammansättning:

Excipient Ingredients: crospovidone; colloidal anhydrous silica; microcrystalline cellulose; mannitol; magnesium stearate; titanium dioxide; hypromellose; macrogol 8000; sunset yellow FCF aluminium lake; polydextrose; macrogol 400; indigo carmine aluminium lake

Administreringssätt:

Oral

Enheter i paketet:

4, 3, 2, 1

Receptbelagda typ:

(S4) Prescription Only Medicine

Terapeutiska indikationer:

? Treatment of osteoporosis.,? Treatment of glucocorticoid-induced osteoporosis.,? Preservation of bone mineral density in patients on long term corticosteroid therapy.

Produktsammanfattning:

Visual Identification: Blue, round, biconvex, beveled edge film-coated tablets and debossed with "RR over 2" on one side and "M" on the other side; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Bemyndigande status:

Licence status A

Tillstånd datum:

2013-02-04

Bipacksedel

ACRIS
®
; ACRIS
® ONCE-
A-MONTH
_contains the active ingredient risedronate sodium_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ACRIS.
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 against
the benefits this medicine is expected
to have 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 IS USED
FOR
ACRIS is used for bone disease and
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.
_UNDERSTANDING BONE_
Bone is a living tissue consisting of
calcium and other minerals.
Throughout life, old bone is
constantly broken down and replaced
with new bone. After the age of 35,
bone loss may occur faster than your
body can replace it. If you lose too
much bone then they become weaker
and are more likely to break.
ACRIS works by helping to:
•
slow down the process of
removing old bone. This allows
the bone-forming cells time to
rebuild normal bone.
•
maintaining and increasing bone
density by rebuilding bone mass.
•
reverse the progression of
osteoporosis.
_OSTEOPOROSIS_
Osteoporosis (brittle bone disease) is
a disease that 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
usually 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, height loss and a curvature of
the spine.
Many patients with osteoporosis have
no symptoms and

Produktens egenskaper

PRODUCT INFORMATION
ACRIS
ACRIS ONCE-A-MONTH
_Risedronate sodium _
NAME OF THE MEDICINE
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
DESCRIPTION
Risedronate sodium (as hemipentahydrate) is a fine, white to
off-white, odourless, crystalline powder. It is
soluble in water and essentially insoluble in common organic solvents.
ACRIS tablets contain 35 mg risedronate sodium (as hemipentahydrate)
and the following inactive ingredients:
Mannitol, microcrystalline cellulose, crospovidone, silicon dioxide,
magnesium stearate, Opadry II complete
film coating system 40L97490 beige (ARTG No. 107225) and Opadry
complete film coating system YS-1-
7006 clear (ARTG No. 12789).
ACRIS Once-a-Month contains 150 mg risedronate sodium and the
following inactive ingredients: Mannitol,
microcrystalline cellulose, crospovidone, colloidal anhydrous silica,
magnesium stearate, Opadry II complete
film coating system 40C10881 Blue (ARTG No. 108066).
PHARMACOLOGY
ACRIS risedronate sodium tablets are currently available as a 35 mg or
150 mg tablet.
PHARMACODYNAMICS
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 marker measurements during
pharmacodynamic and clinical studies. With risedronate 5 mg daily,
decreases in biochemical markers of bone
ACRIS and ACRIS Once-a-Month – PRODUCT INFORMATION
2
turnover were observed within 1 month of treatment and reached a
maximum decrease in 3-6 months,
remaining stable during the course of therapy. This data demon