BINOSTO

Land: Israel

Språk: engelska

Källa: Ministry of Health

Aktiva substanser:

ALENDRONIC ACID AS TRIHYDRATE

Tillgänglig från:

TZAMAL BIO-PHARMA LTD

ATC-kod:

M05BA04

Läkemedelsform:

TABLETS EFFERVESCENT

Sammansättning:

ALENDRONIC ACID AS TRIHYDRATE 70 MG

Administreringssätt:

PER OS

Receptbelagda typ:

Required

Tillverkad av:

SWISS CO SERVICES LTD, SWITZERLAND

Terapiområde:

ALENDRONIC ACID

Terapeutiska indikationer:

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

Tillstånd datum:

2022-06-30

Bipacksedel

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
BINOSTO
EFFERVESCENT TABLETS
ACTIVE INGREDIENT AND ITS QUANTITY:
Each soluble tablet contains:
sodium alendronate trihydrate equivalent to 70 mg alendronic
acid
Inactive ingredients and allergens: See section 2 “Important
information about some of this medicine’s ingredients” and
section 6 “Additional information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING
THIS MEDICINE. This leaflet contains concise information about
this medicine. If you have any further questions, consult your
doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on
to others. It may harm them, even if it seems to you that their
medical condition is similar to yours.
This medicine is not intended for children and adolescents
below the age of 18.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
For treatment of osteoporosis in postmenopausal women to
prevent fractures.
For treatment to increase bone mass in men with osteoporosis.
BINOSTO IS A ONCE WEEKLY TREATMENT.
THERAPEUTIC GROUP:
bisphosphonates (non-hormonal drug class).
WHAT IS OSTEOPOROSIS
Osteoporosis is thinning and weakening of the bones. It is
common in postmenopausal women. At the menopause, the
ovaries stop producing the female hormone, oestrogen, which
helps to maintain the skeleton healthy. As a result, bone loss
occurs, and the bones become weaker. The earlier a woman
reaches the menopause, the greater the risk of osteoporosis.
At the early stages, osteoporosis is usually asymptomatic.
However, if left untreated, the condition can result in bone
fractures. Although bone fractures in the spine are usually
accompanied by pain, they may remain undiagnosed until
height loss occurs. Bone fractures can occur during normal
everyday activity such as lifting, or from minor injury that would
not usually lead to fracture of a healthy bone. Bone fractures
usually occur at the hip, spine or wrist, and c

Produktens egenskaper

1
BINOSTO
Prescribing Information
1.
NAME OF THE MEDICINAL PRODUCT
Binosto
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each effervescent tablet contains sodium alendronate trihydrate
equivalent to 70 mg Alendronic acid.
Excipient(s) with known effect: The total amount of sodium from both
the active substance and excipients
in each effervescent tablet is 603mg.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Effervescent Tablet
White to off-white round effervescent tablets of 25 mm diameter, flat
faced with bevelled edges. After
dissolution the solution has a pH of 4.8 – 5.4
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is one 70 mg effervescent tablet once weekly.
Patients should be instructed that if they miss a dose of Binosto 70
mg, they should take one effervescent
tablet on the morning after they remember.
They should not take two effervescent tablets on the same day but
should return to taking one
effervescent tablet once a week, as originally scheduled on their
chosen day.
The optimal duration of bisphosphonate treatment for osteoporosis has
not been established. The need for
continued treatment should be re-evaluated periodically based on the
benefits and potential risks of
Binosto on an individual patient basis, particularly after 5 or more
years of use.
_Elderly: _
In clinical studies there was no age-related difference in the
efficacy or safety profiles of alendronate.
Therefore, no dosage adjustment is necessary for the elderly.
2
_Renal impairment: _
No dosage adjustment is necessary for patients with creatinine
clearance greater than 35 ml/min.
Alendronate is not recommended for patients with renal impairment
where creatinine clearance is less
than 35 ml/min, due to lack of experience.
_Paediatric po