ACTONEL EC COMBI D risedronate sodium 35mg enteric-coated tablet / calcium carbonate 2500 mg and colecalciferol 22 microgram gra

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

active_ingredient:

calcium carbonate,colecalciferol,risedronate sodium

MAH:

Theramex Australia Pty Ltd

INN:

colecalciferol,Calcium carbonate,Risedronate sodium

authorization_status:

Registered

PIL

ACTONEL
®
EC Combi D - CMI Version 2.0
1
ACTONEL
® EC COMBI D
_risedronate sodium (enteric-coated), calcium carbonate,
cholecalciferol (Vitamin D3) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Actonel EC Combi
D.
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 Actonel EC
Combi D against the benefits this
medicine 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 ACTONEL EC
COMBI D IS USED FOR
Actonel EC Combi D is used to treat
bone disease. Actonel EC Combi D
works directly on your bones to make
them stronger and therefore less
likely to break or fracture.
Actonel EC Combi D is a
combination medicine consisting of
risedronate sodium, calcium
carbonate and cholecalciferol
(Vitamin D3). Each week of therapy
includes:
One Actonel EC 35mg Once-a-Week
enteric-coated tablet (the small
yellow tablet) and 6 sachets
containing calcium carbonate
2500mg and cholecalciferol 22mcg
(Vitamin D3 880 IU).
The active ingredient in Actonel EC
35mg Once-a-Week enteric-coated
tablets is called risedronate sodium
and belongs to a group of medicines
called bisphosphonates.
Actonel EC 35mg Once-a-Week
enteric-coated tablets are used to
treat:
•
osteoporosis (brittle or fragile
bones that may fracture easily)
•
osteoporosis caused by taking
steroids
The calcium carbonate contained in
the sachet helps to supply the
calcium your body needs to build
new bone.
The cholecalciferol (Vitamin D3)
contained in the sachet is an essential
nutrient required for calcium
absorption.
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 repla

SPC

ACTONEL EC, ACTONEL EC COMBI & ACTONEL EC COMBI D PI V2 160511
1
PRODUCT INFORMATION
ACTONEL EC, ACTONEL EC COMBI & ACTONEL EC COMBI D
NAME OF THE MEDICINE
AUSTRALIAN APPROVED NAME
Risedronate, Calcium carbonate, Cholecalciferol
NON-PROPRIETARY NAME
Risedronate
Each Actonel EC enteric-coated tablet contains the equivalent of 35 mg
of anhydrous risedronate
sodium in the form of the hemi-pentahydrate with small amounts of
monohydrate. The empirical
formula for risedronate sodium is C
7
H
10
NO
7
P
2
Na. The chemical name of risedronate sodium is [1-
hydroxy-2-(3- pyridinyl)ethylidene]bis(phosphonic acid) monosodium
salt.
Calcium Carbonate Tablet
Actonel EC Combi also contains 1250 mg calcium carbonate tablets. Each
calcium tablet contains
1250 mg calcium carbonate, which is equivalent to 500 mg elemental
calcium.
Calcium Carbonate/Cholecalciferol Sachet
Actonel EC Combi D also contains calcium carbonate/cholecalciferol
sachets. Each sachet
contains 2500 mg calcium carbonate and 22
µ
g (880 IU) cholecalciferol, which is equivalent to
1000 mg elemental calcium and 22
µ
g (880 IU) vitamin D3. The terms cholecalciferol and vitamin
D3 are equivalent. The chemical name of cholecalciferol is
(5Z,7E)-9,10-secocholesta-5,7,10(19)-
trien-3β-ol. Molecular formula: C
27
H
44
O.
CHEMICAL STRUCTURE
The chemical structure of risedronate sodium is the following:
Molecular Weight
Anhydrous: 305.10
Hemi-pentahydrate: 350.13
The CAS registry number is 115436-72-1
The chemical structure of cholecalciferol:
ACTONEL EC, ACTONEL EC COMBI & ACTONEL EC COMBI D PI V2 160511
2
Molecular Weight: 384.6
The CAS registry number is 67-97-0
DESCRIPTION
Risedronate sodium 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.
Calcium
carbonate is a white powder, practically insoluble in water, with a
relative molecular weight of
100.1. Cholecalciferol is a secosterol that is a natural precursor of
the calcium-regulating hormone
calcitriol