Fosamax

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Alendronate sodium trihydrate 91.37mg equivalent to 70 mg alendronic acid

Available from:

Organon (New Zealand) Limited

INN (International Name):

Alendronate sodium trihydrate 91.37 mg (equivalent to 70 mg alendronic acid)

Dosage:

70 mg

Pharmaceutical form:

Tablet

Composition:

Active: Alendronate sodium trihydrate 91.37mg equivalent to 70 mg alendronic acid Excipient: Croscarmellose sodium Lactose Magnesium stearate Microcrystalline cellulose

Units in package:

Blister pack, Al/Al 1x (sample), 2 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

MSD International GmbH (Ireland)

Therapeutic indications:

FOSAMAX is indicated: · In postmenopausal women for the treatment of osteoporosis to prevent fractures, including those of the hip and spine (vertebral compression fractures). · In postmenopausal women who are at risk of developing osteoporosis FOSAMAX is indicated for the prevention of osteoporosis to reduce the risk of future fracture. · For the treatment of osteoporosis in men to prevent fractures. · For the treatment and prevention of glucocorticoid-induced osteoporosis in men, premenopausal women and postmenopausal women receiving oestrogen. · For treatment of Paget's disease of bone in men and women.

Product summary:

Package - Contents - Shelf Life: Blister pack, Al/Al 1x (sample) - 2 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/Al 1x (sample) - 2 tablets - 24 months from date of manufacture stored at or below 30°C - Blister pack, Al/Al - 4 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/Al - 4 tablets - 36 months from date of manufacture stored at or below 30°C

Authorization date:

2000-02-16

Patient Information leaflet

_NEW ZEALAND CONSUMER MEDICINE INFORMATION_
_ _
1
FOSAMAX
® ONCE WEEKLY
_alendronate sodium _
70 mg tablet
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about FOSAMAX. 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 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 ONCE WEEKLY IS USED FOR
FOSAMAX is used to treat osteoporosis in men and in postmenopausal
women.
These conditions are caused by changes in the way bone is normally
maintained.
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 brittle and likely to break.
Osteoporosis is common in postmenopausal women and also may occur in
men.
Osteoporo

Summary of Product characteristics

Page 1 of 10
NEW ZEALAND DATA SHEET
1 PRODUCT NAME
FOSAMAX
®
70 mg once weekly tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Alendronate sodium 70 mg tablets.
List of excipients with known effect:
-
lactose
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
A white oval tablet with the outline of a bone image on one side and
31 on the other.
Dimensions are 12.7 mm x 5.542 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
FOSAMAX is indicated:
•
In postmenopausal women for the treatment of osteoporosis to prevent
fractures,
including those of the hip and spine (vertebral compression
fractures).
•
For the treatment of osteoporosis in men to prevent fractures.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN AND IN MEN
The recommended dosage is one 70 mg tablet once weekly.
SPECIAL POPULATIONS
No dosage adjustment is necessary for the elderly or for patients with
mild-to-moderate renal
insufficiency (creatinine clearance 35 to 60 mL/min). FOSAMAX is not
recommended for
patients with more severe renal insufficiency (creatinine clearance <
35 mL/min) due to lack
of experience.
PAEDIATRIC POPULATION
See SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE, PAEDIATRIC
POPULATION.
Patients should be instructed that if they miss a dose of FOSAMAX once
weekly, they should
take one tablet on the morning after they remember. They should not
take two tablets on the
same day but should return to taking one tablet once a week, as
originally scheduled on their
chosen day.
METHOD OF ADMINISTRATION
FOSAMAX must be taken at least one-half hour before the first food,
beverage, or medication
of the day with plain water only. Other beverages (including mineral
water), food, and some
medications are likely to reduce the absorption of FOSAMAX (see
SECTION 4.5 INTERACTIONS
WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS).
To facilitate delivery to the stomach and thus reduce the potential
for oesophageal irritation,
Page 2 of 10
FOSAMA