Alendronic Acid 10mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ALENDRONIC ACID

Available from:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

ATC code:

M05BA04

INN (International Name):

ALENDRONIC ACID 10 mg

Pharmaceutical form:

TABLET

Composition:

ALENDRONIC ACID 10 mg

Prescription type:

POM

Therapeutic area:

DRUGS FOR TREATMENT OF BONE DISEASES

Authorization status:

Withdrawn

Authorization date:

2014-04-21

Patient Information leaflet

Page 1 of 7

PACKAGE LEAFLET: INFORMATION FOR THE USER 

ALENDRONIC ACID 10 MG TABLETS 
Alendronic Acid 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE. 
- 
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 Alendronic Acid is and what it is used for 
2. 
Before you take Alendronic Acid  
3. 
How to take Alendronic Acid  
4. 
Possible side effects 
5. 
How to store Alendronic Acid  
6. 
Further information 

1. 
WHAT ALENDRONIC ACID IS AND WHAT IT IS USED FOR 

WHAT IS ALENDRONIC ACID? 
Alendronic acid belongs to a group of medicines called
'bisphosphonates'.  Alendronic acid 
prevents the loss of bone that occurs in men, post-menopausal women
and patients receiving 
glucocorticoids such as prednisolone and methylprednisolone.
Alendronic acid has also been shown 
to help rebuild

bone and makes bone less likely to fracture in post-menopausal women
and men 
with osteoporosis. 

WHAT IS ALENDRONIC ACID USED FOR? 
Your doctor has prescribed Alendronic Acid to treat your
osteoporosis. Alendronic Acid reduces 
the risk of spine and hip fractures.  

ALENDRONIC ACID IS USED:  
-  treat osteoporosis in post-menopausal women 
-  treat osteoporosis in men 
-  prevent osteoporosis in post-menopausal women who are taking
medicines called 
glucocorticoids   but are not taking oestrogen. 

WHAT IS OSTEOPOROSIS?  
Osteoporosis is thinning and weakening of your bones. It is common in
women after the 
menopause. Osteoporosis can also occur in men. Corticosteroids can
also cause bone loss and 
osteoporosis in both men and women. E

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Alendronic Acid 10 mg tablets 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each tablet contains 10 mg alendronic acid (equivalent to 13.052
mg of sodium alendronate 
trihydrate).  

For a full list of excipients, see section 6.1. 

3. PHARMACEUTICAL 
FORM 

Tablet 

White to off-white, round, biconvex, uncoated tablets debossed with
‘F’ on one side and ‘18’ on the 
other side. The tablets are 5 mm in diameter. 

4. CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

-  Treatment of postmenopausal osteoporosis. Alendronic acid reduces
the risk of vertebral and 
hip fractures.  
-  Treatment of osteoporosis in men at increased risk of fracture. A
reduction in the incidence of 
vertebral, but not of non-vertebral fractures has been demonstrated.

-  Prophylaxis of glucocorticoid-induced osteoporosis.  

4.2  POSOLOGY AND METHOD OF ADMINISTRATION 

For oral use.  
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 alendronic acid on an individual patient basis, particularly
after 5 or more years of use.  
_ _
_Treatment of osteoporosis in postmenopausal women _ 
The recommended dose is 10 mg per day.  
_ _
_Treatment of osteoporosis in men _ 
The recommended dose is 10 mg per day.  
_ _
_Prophylaxis of glucocorticoid-induced osteoporosis _ 
For post-menopausal women who are not receiving oestrogen treatment
the recommended dose is 
one 10 mg tablet daily.  

_To permit adequate absorption of alendronate: _
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Alendronic Acid 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