FOSAVANCE 70 MG5600 I.U. TABLETS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ALENDRONIC ACID AS ALENDRONATE SODIUM TRIHYDRATE; COLECALCIFEROL

Available from:

MERCK SHARP & DOHME ISRAEL LTD

ATC code:

A11CC05

Pharmaceutical form:

TABLETS

Composition:

COLECALCIFEROL 140 MCG; ALENDRONIC ACID AS ALENDRONATE SODIUM TRIHYDRATE 70 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

MERCK SHARP & DOHME CORP., USA

Therapeutic group:

COLECALCIFEROL

Therapeutic area:

COLECALCIFEROL

Therapeutic indications:

Fosavance is indicated for : - Treatment of Osteoporosis in postmenopausal women: Fosavance increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures). - Treatment to increase bone mass in men with osteoporosis.

Authorization date:

2014-06-30

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS
(PREPARATIONS) 1986
This medicine can be sold under doctor's prescription only
FOSAVANCE
® 70 MG/5600 IU TABLETS
Each tablet contains:
Alendronic Acid 70 mg (as alendronate sodium trihydrate)
Cholecalciferol (Vitamin D
3
) 140 microgram (5600 IU)
For a list of inactive ingredients see section 6 "WHAT FOSAVANCE
CONTAINS?”. See also section 2.7,
“IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS OF
FOSAVANCE”.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
•
This leaflet contains concise information about FOSAVANCE. If you have
any further questions, ask
your doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their
medical condition seems similar to yours.
•
This medicine is not intended for children. See also section 2.8.
•
FOSAVANCE is only intended for use in women after menopause. You
should not take FOSAVANCE if
you are pregnant or think you may be pregnant, or if you are
breast-feeding.
1. WHAT IS FOSAVANCE INTENDED FOR?
FOSAVANCE is indicated for:
•
the treatment of osteoporosis in women after menopause. FOSAVANCE
helps increase bone mass and
reduces the chance of having a hip or spinal fracture (break).
•
treatment to increase bone mass in men with osteoporosis.
THERAPEUTIC GROUP: FOSAVANCE is a tablet containing the two active
substances: alendronic acid, that
belongs to a non-hormonal medicines class called bisphosphonates, and
cholecalciferol known as vitamin
D
3
.
FOSAVANCE should not be used to treat vitamin D deficiency.
It is not known how long you need to take FOSAVANCE for the treatment
of osteoporosis. You should see
your doctor regularly to determine if FOSAVANCE is still right for
you.
2. BEFORE YOU TAKE FOSAVANCE
2.1 DO NOT TAKE FOSAVANCE IF YOU:

Are hypersensitive (allergic) to alendronate sodium or to
cholecalciferol or to any of the other
ingredients of FOSAVANCE (for a list of inactive ingredients, se

Summary of Product characteristics

FOSAVANCE
® 70 MG/ 5600 IU TABLETS
(ALENDRONATE SODIUM/CHOLECALCIFEROL)
1
THERAPEUTIC INDICATIONS AND USAGE
FOSAVANCE
®
70 mg/ 5600 IU TABLETS are indicated for:
1.1
TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
For the treatment of osteoporosis, FOSAVANCE 70 MG/ 5600 IU TABLETS
increases bone mass and
reduces the incidence of fractures, including those of the hip and
spine (vertebral compression fractures).
TREATMENT TO INCREASE BONE MASS IN MEN WITH OSTEOPOROSIS
FOSAVANCE 70 MG/ 5600 IU TABLETS is indicated for treatment to
increase bone mass in men with
osteoporosis _[see Clinical Studies (14.2)]_.
1.2
IMPORTANT LIMITATIONS OF USE
FOSAVANCE 70 MG/ 5600 IU TABLETS alone should not be used to treat
vitamin D deficiency.
The optimal duration of use has not been determined. The safety and
effectiveness of FOSAVANCE 70
MG/ 5600 IU TABLETS for the treatment of osteoporosis are based on
clinical data of four years duration.
All patients on bisphosphonate therapy should have the need for
continued therapy re-evaluated on a
periodic basis. Patients at low-risk for fracture should be considered
for drug discontinuation after 3 to 5
years of use. Patients who discontinue therapy should have their risk
for fracture re-evaluated periodically.
2
DOSAGE AND ADMINISTRATION
2.1
TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
The recommended dosage is one 70 mg alendronate/5600 IU vitamin D
3
tablet once weekly.
2.2
TREATMENT TO INCREASE BONE MASS IN MEN WITH OSTEOPOROSIS
The recommended dosage is one 70 mg alendronate/5600 IU vitamin D
3
tablet once weekly.
2.3
IMPORTANT ADMINISTRATION INSTRUCTIONS
Instruct patients to do the following:
•
Take FOSAVANCE 70 MG/ 5600 IU TABLETS _at least _one-half hour before
the first food, beverage,
or medication of the day with plain water only _ [see Patient
Counseling Information (17.2) ]_. Other
beverages (including mineral water), food, and some medications are
likely to reduce the absorption
of alendronate _[see Drug Interactions (7.1)]_. Waiting less than 30
minutes, or taking