Fosamax Plus

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Alendronate sodium trihydrate 91.37mg equivalent to to 70 mg anhydrous free acid; Colecalciferol 70ug equivalent to 2800 IU;  

Available from:

Organon (New Zealand) Limited

INN (International Name):

Alendronate sodium trihydrate 91.37 mg (equiv. to 70 mg anhydrous free acid)

Dosage:

70/70

Pharmaceutical form:

Tablet

Composition:

Active: Alendronate sodium trihydrate 91.37mg equivalent to to 70 mg anhydrous free acid Colecalciferol 70ug equivalent to 2800 IU   Excipient: Colloidal silicon dioxide Croscarmellose sodium Lactose Magnesium stearate Microcrystalline cellulose

Units in package:

Blister pack, Sample pack, 1 tablet

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

MSD International GmbH (Ireland)

Therapeutic indications:

FOSAMAX PLUS is indicated for the treatment of osteoporosis in select patients where vitamin D supplementation is recommended.

Product summary:

Package - Contents - Shelf Life: Blister pack, Sample pack - 1 tablets - 18 months from date of manufacture stored at or below 30°C protect from light and moisture - Blister pack, - 4 tablets - 18 months from date of manufacture stored at or below 30°C protect from light and moisture

Authorization date:

2006-01-04

Patient Information leaflet

_NEW ZEALAND CONSUMER MEDICINE INFORMATION_
_ _
1
FOSAMAX PLUS™ 70/70
_alendronate sodium/colecalciferol _
70 mg/70 mcg tablet (No longer available in New Zealand)
FOSAMAX PLUS™ 70/140
_alendronate sodium/colecalciferol _
70 mg/140 mcg tablet
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about FOSAMAX PLUS. It is
particularly
important that you read the sections “When to take it” and “How
to take it” before you take
this medicine. The leaflet 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
FOSAMAX PLUS 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 FOSAMAX PLUS IS USED FOR
FOSAMAX PLUS is used for the treatment of osteoporosis in select
patients where vitamin
D supplementation is recommended.
UNDERSTANDING BONE
Bone is a 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. This balanced process keeps your skeleton healthy
and strong. 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.
OSTEOPOROSIS
“Osteo” means bone, and “porosis” means something that has
holes in it, like a sponge.
Therefore, osteoporosis is a disease which causes bones to become more
porous,
gradually making them weaker, more b

Summary of Product characteristics

S-WPC-OG0217A-T-012023
Page 1 of 13
NEW ZEALAND DATA SHEET
1 FOSAMAX PLUS™ 70/70 (70 MG/70 MCG TABLET)
FOSAMAX PLUS™ 70/140 (70 MG/140 MCG TABLET)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Alendronate sodium/colecalciferol 70 mg/70 mcg tablet (No longer
available in New
Zealand).
Each tablet contains 70 mg of alendronate sodium and 70 mcg (2800 IU)
of Vitamin D
3
.
Alendronate sodium/colecalciferol 70 mg/140 mcg tablet.
Each tablet contains 70 mg of alendronate sodium and 140 mcg (5600 IU)
of Vitamin D
3
.
COMPOSITION
Active Ingredients:
Each tablet of FOSAMAX PLUS contains 91.37 mg of alendronate
monosodium salt trihydrate
which is the molar equivalent to 70.0 mg of free acid, and 70 mcg or
140 mcg of colecalciferol
equivalent to 2800 IU or 5600 IU vitamin D, respectively.
Excipients with known effect
- Lactose
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
70 mg/70 mcg: White to off white modified capsule shaped tablet marked
with 710 on one side
and a bone shape on the other. Dimensions are 12.065 mm x 6.35 mm. (No
longer available
in New Zealand.)
70 mg/140 mcg: White to off white modified rectangle shaped tablet
marked with 270 on one
side and a bone shape on the other. Dimensions are 11.201 mm x 6.985
mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
FOSAMAX PLUS is indicated for the treatment of osteoporosis in select
patients where
vitamin D supplementation is recommended.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
The recommended dosage is one 70 mg/70 mcg or one 70 mg/140 mcg tablet
once weekly.
For most osteoporotic patients the appropriate dose is 70 mg/140 mcg
once weekly. The
optimal duration of use has not been determined. All patients on
bisphosphonate therapy
should have the need for continued therapy re-evaluated on a periodic
basis (see SECTION
4.8 UNDESIRABLE EFFECTS, CLINICAL STUDIES).
Patients should receive supplemental calcium and/or vitamin D, if
intake is inadequate (see
SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). Physician