FOSALAN ONCE-WEEKLY 70 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ALENDRONATE AS SODIUM

Available from:

ORGANON PHARMA ISRAEL LTD., ISRAEL

ATC code:

M05BA04

Pharmaceutical form:

TABLETS

Composition:

ALENDRONATE AS SODIUM 70 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

ORGANON LLC, USA

Therapeutic group:

ALENDRONIC ACID

Therapeutic area:

ALENDRONIC ACID

Therapeutic indications:

Fosalan is indicated for the treatment of osteoporosis in postmenopausal women to prevent fractures, including those of the hip and spine (vertebral compression fractures). Treatment to increase bone mass in men with osteoporosis.

Authorization date:

2021-03-31

Patient Information leaflet

[Organon] Proprietary
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS
(PREPARATIONS) 1986
This medicine is marketed upon physician’s prescription only
FOSALAN
® ONCE-WEEKLY 70 MG
TABLETS
Each tablet contains:
Alendronate Sodium 91.37 mg (equivalent to 70 mg free acid)
For a list of inactive ingredients see section 6 "FURTHER
INFORMATION”. See also section 2.7, “IMPORTANT
INFORMATION ABOUT SOME OF THE INGREDIENTS OF FOSALAN”.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
•
This leaflet contains concise information about FOSALAN. 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.
•
FOSALAN is only intended for use in women after menopause. You should
not take FOSALAN if you
are pregnant or think you may be pregnant, or if you are
breast-feeding.
1. WHAT FOSALAN ONCE-WEEKLY 70 MG IS INTENDED FOR?
FOSALAN ONCE-WEEKLY 70 MG is indicated for:
•
the treatment of osteoporosis in postmenopausal women, to prevent
fractures.
•
Treatment to increase bone mass in men with osteoporosis.
THERAPEUTIC GROUP:_ _bisphosphonates.
It is not known how long you need to take FOSALAN for the treatment of
osteoporosis. You should see
your doctor regularly to determine if FOSALAN is still right for you.
2. BEFORE YOU TAKE FOSALAN
2.1 DO NOT TAKE FOSALAN IF YOU:
−
Are hypersensitive (allergic) to alendronate sodium or to any of the
other ingredients of FOSALAN (for
a list of inactive ingredients, see section 6 "FURTHER INFORMATION")
−
Have certain problems with your esophagus (the tube that connects your
mouth with your stomach)
−
Cannot stand or sit upright for at least 30 minutes
−
Have low levels of calcium in your blood
2.2 SPECIAL WARNINGS CONCERNING USE OF FOSALAN
BEFORE STARTING TREATMENT WITH FOSALAN, TELL YOUR DOCTOR IF YOU:
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Summary of Product characteristics

[Organon] Proprietary
FOSALAN
®
ONCE-WEEKLY 70MG TABLETS
(ALENDRONATE SODIUM)
1
THRERAPEUTIC INDICATIONS AND USAGE
1.1
TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
FOSALAN
®
is indicated for the treatment of osteoporosis in postmenopausal women
to prevent fractures,
including those of the hip and spine (vertebral compression
fractures). _[See Clinical Studies (14.1).] _
TREATMENT TO INCREASE BONE MASS IN MEN WITH OSTEOPOROSIS
1.2
IMPORTANT LIMITATIONS OF USE
The optimal duration of use has not been determined. The safety and
effectiveness of FOSALAN 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 tablet once weekly
2.2
TREATMENT TO INCREASE BONE MASS IN MEN WITH OSTEOPOROSIS
The recommended dosage is: one 70 mg tablet once weekly
2.3
IMPORTANT ADMINISTRATION INSTRUCTIONS
Instruct patients to do the following:
•
Take FOSALAN _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
FOSALAN _[see Drug Interactions _
_(7.1)]. _Waiting less than 30 minutes, or taking FOSALAN with food,
beverages (other than plain water)
or other medications will lessen the effect of FOSALAN by decreasing
its absorption into the body.
•
Take FOSALAN upon arising for the day. To facilitate delivery to the
stomach and thus reduce the
potential for esophageal irritation, a FOSALAN tablet should be
swallowed with a full glass of water (not
less than 200 ml). Pati