ALENDRONATE PLUS D3 70 mg/70 ug APOTEX alendronate (as sodium) 70 mg and colecalciferol 70 microgram (2800 IU) tablet blister pa

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

alendronate sodium, Quantity: 91.37 mg (Equivalent: alendronic acid, Qty 70 mg); colecalciferol, Quantity: 0.07 mg

Available from:

Dr Reddys Laboratories Australia Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

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

Administration route:

Oral

Units in package:

4 Tablets, 1 Tablet

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ALENDRONATE PLUS D3 70 mg/70 microgram APOTEX 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 28 on the other side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2018-11-16

Patient Information leaflet

ALENDRONATE PLUS
D3 APOTEX
_Alendronate sodium and colecalciferol _
CONSUMER MEDICINE INFORMATION
FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 095 055
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Alendronate Plus D3
APOTEX. It does not contain all the
available information. 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
Alendronate Plus D3 APOTEX
contains both alendronate and
colecalciferol (vitamin D). It is used
to treat osteoporosis and to provide
additional vitamin D.
Alendronate belongs to a group of
medicines called bisphosphonates.
Vitamin D is an essential nutrient
required for calcium absorption and
healthy bones.
_UNDERSTANDING BONE _
Throughout life, old bone is being
broken down and rebuilt as 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 age 35 this balance is
disturbed, with bone loss occurring at
a slightly faster rate than it can be
replaced. After menopause, hormonal
changes in women cause bone loss at
an even faster rate. Excessive bone
loss causes bones to become thinner
and weaker, and therefore more
likely to break.
_OSTEOPOROSIS _
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 earlier
a woman reaches the menopause, the
greater the risk of osteoporosis.
Osteoporosis also occurs in men but
is less common than in women. Early
osteoporosis usua

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION–
ALENDRONATE PLUS D3 70 MG/70
µ
G APOTEX
(ALENDRONATE SODIUM AND COLECALCIFEROL)
ALENDRONATE PLUS D3 70 MG/140
µ
G APOTEX
(ALENDRONATE SODIUM AND COLECALCIFEROL)
1
NAME OF THE MEDICINE
Alendronate sodium and colecalciferol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of Alendronate Plus D3 70 mg/70
µ
g APOTEX 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 70 mg/140
µ
g APOTEX 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 70 mg/ 70
µ
g APOTEX 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 70 mg/ 140
µ
g APOTEX 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 70 mg/70
µ
g APOTEX and Alendronate Plus D3 70 mg/140
µ
g APOTEX
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
1
4.2
DOSE AND METHOD OF ADMINISTRATION
Alendronate Plus D3 (70 mg/70 microgram or 70 mg/140 microgram)
Treatment of osteoporosis in patients where vitamin D3 supplementation
is recommended
The recommended dose is one tablet of Alendronate Plus D3 (70 mg/70
microgram or 70
mg/140 microgram) once weekly.
The optimal du