Binosto Once Weekly 70 mg Effervescent Tablets

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Sodium alendronate trihydrate (micronised)

Boleh didapati daripada:

Lexon (UK) Ltd

Kod ATC:

M05BA; M05BA04

INN (Nama Antarabangsa):

Sodium alendronate trihydrate (micronised)

Dos:

70 milligram(s)

Borang farmaseutikal:

Effervescent tablet

Jenis preskripsi:

Product subject to prescription which may be renewed (B)

Kawasan terapeutik:

Bisphosphonates; alendronic acid

Status kebenaran:

Authorised

Tarikh kebenaran:

2018-04-27

Risalah maklumat

BINOSTO ONCE WEEKLY 70 MG EFFERVESCENT TABLETS
(alendronic acid)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE,
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU, EVEN IF THIS IS A
REPEAT PRESCRIPTION.
*
Keep this leaflet. You may need to read it again.
*
If you have any further questions, ask your doctor or pharmacist or
nurse.
*
This medicine has been prescribed for you. Do not pass it on to
others. It
may harm them, even if their signs of illness are the same as yours.
*
If you get any of the side effects, talk to your doctor, or pharmacist
or
nurse. This includes any possible side effects not listed in this
leaflet. See
section 4.
WHAT IS IN THIS LEAFLET:
What Binosto is and what it is used for
What you need to know before you take Binosto
How to take Binosto
Possible side effects
How to store Binosto
Contents of the pack and other information
WHAT BINOSTO IS AND WHAT IT IS USED FOR
WHAT IS BINOSTO?
Alendronate, the active substance of Binosto belongs to a group of
non-hormonal medicines called bisphosphonates. Binosto prevents the
loss
of bone that occurs in women after they have been through the
menopause,
and helps to rebuild bone. It reduces the risk of spine and hip
fractures.
WHAT IS BINOSTO USED FOR?
Your doctor has prescribed Binosto to treat your osteoporosis. Binosto
reduces the risk of spine and hip fractures.
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, e

Ciri produk

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Binosto Once Weekly 70 mg Effervescent Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each effervescent tablet contains 70 mg alendronic acid as 91.37mg of
alendronate sodium trihydrate.
Excipients: each effervescent tablet contains 602.54 of sodium.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Effervescent Tablet
_Product imported from Spain_
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. The appearance of the product after
dissolution is a clear colourless solution.
4 CLINICAL PARTICULARS
As per PA0126/280/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0126/280/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF 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
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the blister and outer package of the product on the
market in the country of origin.
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6.4 SPECIAL PRECAUTIONS FOR STORA