STEOVESS ONCE WEEKLY 70 Base Milligrams Tablets Effervescent

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

SODIUM ALENDRONATE TRIHYDRATE (MICRONISED)

Available from:

EffRx Pharma GmbH

INN (International Name):

SODIUM ALENDRONATE TRIHYDRATE (MICRONISED)

Dosage:

70 Base Milligrams

Pharmaceutical form:

Tablets Effervescent

Prescription type:

Product subject to prescription which may be renewed (B)

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

1

PACKAGE LEAFLET: INFORMATION FOR THE USER 

BINOSTO ONCE WEEKLY

70 MG EFFERVESCENT TABLETS 

Alendronic acid  

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
THIS MEDICINE, 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. 
  This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their 
symptoms are the same as yours. 
  If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet, please tell 
your doctor or pharmacist. 

IN THIS LEAFLET:  
1. 
What Binosto is and what it is used for 
2. 
Before you take Binosto 
3. 
How to take Binosto 
4. 
Possible side effects 
5. 
How to store Binosto 
6. 
Further information 

1. 
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

Summary of Product characteristics

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 91.37 mg of alendronate sodium trihydrate.
Excipients: each effervescent tablet contains 602.54 mg of sodium.
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.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of postmenopausal osteoporosis. 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.
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.
Method of administration
_To permit adequate absorption of alendronate:_
Binosto 70 mg must be taken at least 30 minutes before the first food, beverage, or medicinal product of the day with
plain water only. Other beverages (including mineral water), food and some medicinal products are likely to reduce the
absorption of alendronate (see section 4.5).
_To facilitate delivery to the stomach and thus