Binosto Once Weekly 70 mg effervescent tablets

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Alendronic acid

Tilgængelig fra:

Clonmel Healthcare Ltd

ATC-kode:

M05BA; M05BA04

INN (International Name):

Alendronic acid

Dosering:

70 milligram(s)

Lægemiddelform:

Effervescent tablet

Indgivelsesvej:

Oral use

Enheder i pakken:

Packs with 4, 12 or 24 effervescent tablets

Recept type:

Product subject to prescription which may be renewed (B)

Terapeutisk gruppe:

Drugs affecting bone structure and mineralisation, bisphosphonates

Terapeutisk område:

Bisphosphonates; alendronic acid

Terapeutiske indikationer:

Treatment of postmenopausal osteoporosis. Binosto 70 mg reduces the risk of vertebral and hip fractures

Autorisation status:

Marketed

Autorisation dato:

2012-03-02

Indlægsseddel

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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.
•
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 side effects, talk to your doctor, or pharmacist or
nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
•
It is particularly important to understand the information in section
3 before taking this medicine.
WHAT IS IN THIS LEAFLET
1.
What Binosto is and what it is used for
2.
What you need to know before you take Binosto
3.
How to take Binosto
4.
Possible side effects
5.
How to store Binosto
6.
Contents of the pack and other information
1.
WHAT BINOSTO IS AND WHAT IT IS USED FOR
Binosto is an effervescent tablet containing the active substance
alendronic acid (commonly called
alendronate) and 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.
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

Produktets egenskaber

Health Products Regulatory Authority
25 June 2021
CRN00C45Q
Page 1 of 10
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 alendronate sodium trihydrate
equivalent to 70 mg alendronic acid.
_Excipient(s) with known effect_: The total amount of sodium from both
the active ingredient and excipients in each effervescent
tablet is 603 mg.
For the 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
Binosto is indicated in adults for the treatment of postmenopausal
osteoporosis. It 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.
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.
_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, d