Buffered Binosto 70 mg Effervescent Tablets

Țară: Malaezia

Limbă: engleză

Sursă: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredient activ:

ALENDRONATE MONOSODIUM SALT TRIHYDRATE

Disponibil de la:

ZUELLIG PHARMA SDN BHD

INN (nume internaţional):

ALENDRONATE MONOSODIUM SALT TRIHYDRATE

Unități în pachet:

12tablet Tablets; 4tablet Tablets

Produs de:

SWISSCO SERVICES AG

Prospect

BUFFERED BINOSTO
®
Alendronic Acid (70mg) Effervescent Tablets
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_Buffered Binosto_
_®_
is used for
2.
How
_Buffered Binosto_
_®_
works
3.
Before you use
_Buffered Binosto_
_®_
4.
How to use
_Buffered Binosto_
_®_
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
_Buffered _
_Binosto_
_®_
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
1.
WHAT _BUFFERED BINOSTO_
_®_ IS USED
FOR
Your
doctor
has
prescribed
_Buffered _
_Binosto_
_®_
to
treat
your
osteoporosis.
_Buffered _
_Binosto_
_®_
reduces
the
risk
of
spine and hip fractures.
_BUFFERED _
_BINOSTO_
_®_
IS
A
ONCE
WEEKLY
TREATMENT.
WHAT IS OSTEOPOROSIS?
Osteoporosis
is
a
thinning
and
weakening of the bones.
It
is
common
in
women
after
the
menopause.
At
the
menopause,
the
ovaries
stop
producing
the
female
hormone, oestrogen, which helps to keep
a woman’s skeleton healthy. As a result,
bone
loss
occurs
and
bones
become
weaker. The earlier a woman reaches the
menopause,
the
greater
the
risk
of
osteoporosis.
Early
on,
osteoporosis
usually
has
no
symptoms.
If left untreated, however, it can result in
broken
bones.
Although
these
usually
hurt, breaks in the bones of the spine
may go unnoticed until they cause height
loss.
Broken bones can happen during normal,
everyday activity, such as lifting, or from
minor injury that would not generally
break
normal
bone.
Broken
bones
usually occur at the hip, spine, or wrist
and can lead not only to pain but also to
considerable
problems
like
stooped
posture (‘dowager’s hump’) and loss of
mobility.
HOW CAN OSTEOPOROSIS BE TREATED?
Osteoporosis
can
be
treated
and
it
is
never
too
late
to
begin
treatment.
_Buffered Binosto_
_®_
not only prevents the
loss of bone but actually helps to rebuild
bone you may have lost and reduces the
risk of bones breaking in the spine and
hip.
As well as your treatment with
_Buffered _
_Binosto_
_®_
, your doctor may suggest you
make changes t

Caracteristicilor produsului

Read package insert carefully before use.
Consult your doctor for more information.
Prescription medicine only. Keep out of reach of children.
1. NAME OF THE MEDICINAL PRODUCT
Buffered Binosto 70 mg effervescent tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each effervescent tablet contains 70 mg alendronic acid as 91.37 mg of alendronate sodium trihydrate.
Excipients: Sodium dihydrogen citrate, Citric acid anhydrous , Sodium hydrogen carbonate, Sodium
carbonate anhydrous, Strawberry flavour [Maltodextrin (Maize), Arabic gum, Propylene glycol (E 1520),
nature-identical flavouring substances], Acesulfame potassium, Sucralose.
Each effervescent tablet contains 602.54 mg of sodium.
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 postmenopausal osteoporosis. Alendronate sodium (Buffered Binosto) 70 mg reduces the
risk of vertebral and hip fractures.
4.2 Posology and method of administration
Posology
The recommended dose is one 70 mg effervescent tablet once weekly.
Al en drona te Sodi um
Buffere d Binosto ®