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Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU
Telephone: +44 (0)1992 467 272
Fax: +44 (0)1992 479 292
Medical Information e-mail: medicalinformationuk@merck.com

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 20/09/2011
SPC Fosamax Once Weekly 70mg Tablets

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 20/09/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   07-Sep-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The main changes made to the SmPC are as follows:

In Section 4.4 the paragraph on "stress fractures" has been revised to the wording agreed for all bisphosphonates during the article 31 referral. Section 4.8 has also been updated. In the table on adverse reactions reported in clinical trials and post-marketing use, "stress fractures of the proximal femoral shaft" has been revised to "atypical subtrochanteric and diaphyseal femoral fractures (bisphosphonate class adverse reaction).

Updated on 02/06/2011 and displayed until 20/09/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   17-May-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The frequency category "very common" has been added.

All side effects are listed in a table.

To "Nervous system disorders", "dizziness" has been added under "common" and "dysgeusia" added under "uncommon".

Under "eye Disorders" all have been re-classified as "Uncommon" and "eye inflammation" added.

"Ear and Labyrinth disorders" has more from post-marketing and "vertigo" has been classified as "Common".

To "Skin and soft tissue disorders", "alopecia" has been added as "common" and "pruritus" moved to "common". The category, "very rare" has been removed.

To "Musculoskeletal and connective tissue disorders", those adverse events classed as "Common" have been changed to "very common" and 

 

to the category "Common", has been added "joint swelling". Also "oestonecrosis of the jaw" and "stress fractures of the proximal femoral shaft" have been moved to this section and given the frequency category "rare".

 

 

 To  "general disorders and administration site conditions", "asthenia" and "peripheral oedema" have been added as "common" and those adverse events that were listed as "Rare" have been re-classified as "Uncommon".

The post-marketing sub-section has now been removed.

 

 The section "laboratory Findings" has been moved to section 5.1.

 
Updated on 03/02/2011 and displayed until 02/06/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   25-Jan-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.4: - After the fifth paragraph a list of factors has been added which should be considered when evaluating an individuals' risk of developing osteonecrosis of the jaw.

Also to section 4.4 - a statement has been added that all patients should be encouraged to maintain good oral hygiene, receive routine dental check-ups, and report any oral symptoms such as dental mobility, pain or swelling.

In section 4.8 and under post-marketing experience and in the sub-section "Musculoskeletal, connective tissue and bone disorders:" a reference to section 4.4 has been added regarding "osteonecrosis of the jaw" and all other information removed as this is now contained in section 4.4.
Updated on 23/02/2010 and displayed until 03/02/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   05-Feb-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The only change made to the SmPC is to include Barrett's oesophagus as one of the oesophageal diseases requiring caution when alendronate therapy is administered.

 

 

 

 

In section 4.4 " Special warnings and precautions for use", at the end of the first paragraph the following text has been added:

….."surgery of the upper gastro-intestinal tract other than pyloroplasty (see section 4.3). In patients with known Barrett's oesophagus, prescribers should consider the benefits and potential risks of alendronate on an individual patient basis."

 

 

 

 

 

 
Updated on 26/11/2009 and displayed until 23/02/2010
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   06-Nov-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The changes made to the SmPC are as follows:

In section 4.2 the second bullet has been revised as follows:

"Patients should not only swallow Fosamax whole. Patients should not crush or chew the tablet or allow the tablet to dissolve in their mouths because of a potential for oropharyngeal ulceration.

In section 4.4 the paragraph beginning "due to positive effects of alendronate…" has been updated as follows:

"Due to positive effects of alendronate in increasing bone mineral, decreases in serum calcium and phosphate may occur especailly in patients taking glucocorticoids in whom calcium absorption may be decreased. These are …."

In section 4.5 the following paragraph has been added:

"Since NSAID use is associated with gastrointestinal irritation, caution should be used during concomitant use with alendronate."

In section 4.6 the statement "Given the indication, alendronate should not be used during pregnancy." has been moved to the beginning of this section.

In section 4.7 the following statement has been added:

"However, certain adverse reactions that have been reported with Fosamax may affect some patients' ability to drive or operate machinery. Individual responses to Fosamax may vary (see section 4.8)"

In section 4.8 the side effect "dysgeusia" has been added.
Updated on 20/07/2009 and displayed until 26/11/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   01-Jul-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.4: Special Warnings and Special Precautions for Use

A new paragraph on reports of stress fractures in patients on long-term treatment with alendronic acid has been added.

Section 4.8: Undesirable Effects

In the post-marketing experience sub-section and under the sub-heading "

Musculoskeletal, connective tissue and bone disorders"", stress fractures has been added.

 

 
Updated on 09/02/2009 and displayed until 20/07/2009
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   01-Dec-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


1) Section 2 of the SPC has been updated to state the quantity of lactose anhydrous in each tablet.

2) In section 4.8 "Undesirable Effects" and in the post-marketing section, a new statement has been added as follows:

"Skin and subcutaneous tissue disorders: alopecia"

Updated on 15/11/2007 and displayed until 09/02/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   10/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

The only change is to section 4.4 Special Warnings and Precautions for Use, and the following paragraph:

A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g. cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene, periodontal disease).

Updated on 31/08/2007 and displayed until 15/11/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   06/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.4 - Deletion of the causality statement relating to gastric and duodenal ulcers

Section 4.8 - Addition of the following undesirable effects: dizziness, vertigo, joint swelling, asthenia and peripheral oedema

Updated on 05/03/2007 and displayed until 31/08/2007
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   11/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Amendment of paediatric statement in section 4.2 of the SPC to state that "Alendronate has been studied in a small number if patients with osteogenesis imperfecta under 18 years of age. Results are insufficient to support its use in children."
Updated on 02/01/2007 and displayed until 05/03/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   11/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

 
Addition of Osteonecrosis of the Jaw warning to sections 4.4 and 4.8
Addition of an excipients statement to section 4.4 of the SPC detailing that the medicinal product contains lactose.
Rearrangement of the list of adverse experiences in Section 4.8
Updated on 07/09/2006 and displayed until 02/01/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   07/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
                section 4.4: a new statement added

Excipients

This medicinal product contains lactose. Patients with rare hereditary problems of galactose interolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
 
Section 4.8:  updated in line with format required for body systems and frequencies in the EU SPC guideline.
Updated on 13/04/2005 and displayed until 07/09/2006
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Updated on 15/06/2004 and displayed until 13/04/2005
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
Updated on 20/12/2002 and displayed until 15/06/2004
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Updated on 25/07/2002 and displayed until 20/12/2002
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 5.1 - Pharmacodynamic Properties
Updated on 11/07/2001 and displayed until 25/07/2002
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instruction for Use/Handling
  • Change to section 10 (date of (partial) revision of the text
Updated on 02/01/2001 and displayed until 11/07/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  alendronate sodium trihydrate