ALENDRONATE PLUS D3 SANDOZ 70 mg/140 microgram alendronate (as sodium) 70 mg and colecalciferol 140 microgram (5600 IU) tablet b

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

colecalciferol, Quantity: 0.14 mg; alendronate sodium, Quantity: 91.37 mg (Equivalent: alendronic acid, Qty 70 mg)

Available from:

Dr Reddys Laboratories Australia Pty Ltd

INN (International Name):

alendronate sodium,colecalciferol

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: Gelatin; croscarmellose sodium; butylated hydroxytoluene; colloidal anhydrous silica; sucrose; magnesium stearate; microcrystalline cellulose; povidone; medium chain triglycerides

Administration route:

Oral

Units in package:

4 Tablets, 1 Tablet

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

TRADENAMES are indicated for the treatment of: ? Osteoporosis* in select patients where vitamin D supplementation is recommended,* 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

Product summary:

Visual Identification: White to off-white, modified capsule-shaped uncoated tablet, debossed with ADC on one side and 56 on the other side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2013-12-16

Patient Information leaflet

ALENDRONATE PLUS D3 SANDOZ
1
ALENDRONATE PLUS
D3 SANDOZ
_Contains the active ingredient alendronate sodium and colecalciferol
_
CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some of the
common questions about
Alendronate Plus D3 Sandoz. It is
particularly important that you read
the sections “When to take it” and
“How to take it” before you take this
medicine.
It does not contain all the
information that is known about
alendronate and colecalciferol.
It does not take the place of talking to
your doctor and pharmacist.
All medicines have risks and
benefits. Your doctor will have
weighed the risks of you taking this
medicine against the benefits they
expect it will 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 THIS MEDICINE IS
USED FOR
The name of your medicine is
Alendronate Plus D3 Sandoz. It
contains the active ingredients
alendronate sodium and
colecalciferol.
It is used to treat osteoporosis and to
provide additional vitamin D.
Osteoporosis is caused by changes in
the way bone is normally maintained.
Vitamin D (colecalciferol) is an
essential nutrient required for
calcium absorption and healthy
bones.
_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

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
ALENDRONATE PLUS D3 SANDOZ 70 MG/70 MCG
(ALENDRONATE SODIUM AND COLECALCIFEROL)
ALENDRONATE PLUS D3 SANDOZ 70 MG/140 MCG
(ALENDRONATE SODIUM AND COLECALCIFEROL)
1
NAME OF THE MEDICINE
Alendronate sodium and colecalciferol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of Alendronate Plus D3 Sandoz 70 mg/70 mcg contains 91.37
mg of alendronate
sodium, which is the molar equivalent to 70 mg of alendronic acid, and
70 microgram of
colecalciferol equivalent to 2800 IU vitamin D.
Each tablet of Alendronate Plus D3 Sandoz 70 mg/140 mcg contains 91.37
mg of alendronate
sodium, which is the molar equivalent to 70 mg of alendronic acid, and
140 microgram of
colecalciferol equivalent to 5600 IU vitamin D.
EXCIPIENTS WITH KNOWN EFFECT
Sucrose
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
Alendronate Plus D3 Sandoz 70 mg/ 70 mcg once weekly tablet is a white
to off-white, modified
capsule- shaped uncoated tablet, debossed with 'ADC' on one side and
'28' on the other side.
Alendronate Plus D3 Sandoz 70 mg/ 140 mcg once weekly tablet is a
white to off-white,
modified capsule- shaped uncoated tablet, debossed with 'ADC' on one
side and '56' on the
other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Alendronate Plus D3 Sandoz 70 mg/70 mcg and Alendronate Plus D3 Sandoz
70 mg/140 mcg
are indicated for the treatment of:
•
Osteoporosis in select patients where vitamin D supplementation is
recommended
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
DOSE AND METHOD OF ADMINISTRATION
Alendronate Plus D3 Sandoz (70 mg/70 mcg or 70 mg/140 mcg)
1
Treatment of osteoporosis in patients where vitamin D
3
supplementation is recommended
The recommended dose is one tablet of Alendronate Plus D3 (70 mg/70
mcg or 70 mg/140
mcg) once weekly.
The optimal duration of use has not been