FOSAMAX ONCE WEEKLY 70 Milligram Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ALENDRONATE SODIUM

Available from:

Merck Sharp and Dohme Limited

INN (International Name):

ALENDRONATE SODIUM

Dosage:

70 Milligram

Pharmaceutical form:

Tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
FOSAMAX® ONCE WEEKLY 70 MG TABLETS
ALENDRONIC ACID AS ALENDRONATE SODIUM TRIHYDRATE
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.
-  It is particularly important to understand the information in
section 3. HOW TO TAKE FOSAMAX, before taking this medicine.
IN THIS LEAFLET:
1.  What FOSAMAX is and what it is used for
2.  Before you take FOSAMAX
3.  How to take FOSAMAX
4.  Possible side effects
5  How to store FOSAMAX
6.  Further information
1. WHAT FOSAMAX IS AND WHAT IT IS USED FOR
WHAT IS FOSAMAX?
FOSAMAX belongs to a group of non-hormonal medicines called
bisphosphonates. FOSAMAX 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 FOSAMAX USED FOR?
Your doctor has prescribed FOSAMAX to treat your osteoporosis. FOSAMAX
reduces the risk of spine and hip fractures.
FOSAMAX 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,
ho

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fosamax Once Weekly 70 mg tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains the equivalent of 70 mg alendronic acid as 91.37 mg of alendronate sodium trihydrate.
Excipients:
Each tablet contains 113.4 mg lactose anhydrous.
For a full list of excipients, see 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Oval white tablets, marked with an outline of a bone image on one side, and ‘31’ on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of postmenopausal osteoporosis. ‘Fosamax’ reduces the risk of vertebral and hip fractures.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The recommended dosage is one 70 mg tablet once weekly. 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 ‘Fosamax’ on an individual patient basis, particularly after 5 or more years of use.
_To permit adequate absorption of alendronate:_
‘Fosamax’ 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 reduce the potential for local and oesophageal irritation/adverse_
_experiences (see section 4.4):_
o
‘Fosamax’ should only be swallowed upon arising for the day with a full glass of water (not less than 200 ml or 7
fl.oz.).
o
Patients should only swallow ‘Fosamax’ whole. Patients should not crush or chew the tablet or allow the tablet to
dissolve in their mouths because of a pote