FOSAMAX Once Weekly 70 mg Tablets

  • Name:

    FOSAMAX Once Weekly 70 mg Tablets

  • Company:
    info
  • Active Ingredients:

    Alendronate Sodium Trihydrate

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 31/07/18

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Summary of Product Characteristics last updated on medicines.ie: 31/7/2018

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MSD Ireland (Human Health) Limited

MSD Ireland (Human Health) Limited

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1 - 0 of 84 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 31 July 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 31 July 2018 SmPC

Reasons for 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 4.4 - Special warnings and precautions for use
  • 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

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Align the PI with the outcome of the renewal procedure for a related CP product

Updated on 16 June 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 16 June 2016 PIL

Reasons for updating

  • Change to date of revision

Updated on 3 June 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 3 June 2016 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

  1. SPC Change Details: osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction)

Updated on 2 June 2016 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 3 March 2016 PIL

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability

Updated on 23 October 2015 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Reason for submission:  Change to section 4.4 warnings and precautions


Updated on 22 October 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 1 May 2015 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • 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 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Changes to sections: 1, 2, 4.1, 4.2, 4.3, 4.4, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3, 6.4, 6.5, 7, 8, 10
Reason for submission: Change to the marketing authorisation holder, section 4.6 Pregnancy & lactation – addition of Fertility sub-section, section 4.8 how to report a side effect, section 10 date of revision and change to improve clarity and readability.

Updated on 30 April 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder
  • Change to dosage and administration
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.

Updated on 28 July 2014 PIL

Reasons for updating

  • Change of manufacturer

Updated on 7 November 2012 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Sections 4.4 and 4.6

Updated on 27 February 2012 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Sections 4.2 & 5.1 - update to the paediatric information.

Updated on 23 November 2011 PIL

Reasons for updating

  • Change to side-effects
  • Change to drug interactions
  • Change to further information section

Updated on 21 October 2011 SmPC

Reasons for 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 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Updated Sections 4.2, 4.4, 4.8 & 6.5.

Updated on 15 July 2011 PIL

Reasons for updating

  • Change to side-effects

Updated on 23 May 2011 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Updates to Sections 4.8 & 5.1

Updated on 9 March 2011 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 23 November 2010 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4 Special warnings and precautions for use & 4.8 Undesirable effects - osteonecrosis of the jaw and smoking.

Updated on 16 April 2010 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 31 March 2010 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Additon of Barrets oesophagus to section 4.4

4.4 Special warnings and precautions for use

 

Alendronate can cause local irritation of the upper gastro-intestinal mucosa. Because there is a potential for worsening of the underlying disease, caution should be used when alendronate is given to patients with active upper gastro-intestinal problems, such as dysphagia, oesophageal disease, gastritis, duodenitis, ulcers, or with a recent history (within the previous year) of major gastro-intestinal disease such as peptic ulcer, or active gastro-intestinal bleeding, or 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 23 December 2009 SmPC

Reasons for 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

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.2 Posology and method of administration

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 potential for oropharyngeal

 

 4.4 Special warnings and precautions for use

Due to the positive effects of alendronate in increasing bone mineral, decreases in serum calcium and phosphate may occur especially in patients taking glucocorticoids in whom calcium absorption may be decreased. These are usually small and asymptomatic. However, there have been rare reports of symptomatic hypocalcemia, which have occasionally been severe and often occurred in patients with predisposing conditions (e.g. hypoparathyroidism, vitamin D deficiency and calcium malabsorption)

 

4.5 Interaction with other medicinal products and other forms of interaction
If taken at the same time, it is likely that food and beverages (including mineral water), calcium supplements, antacids, and some oral medicinal products will interfere with absorption of alendronate. Therefore, patients must wait at least 30 minutes after taking alendronate before taking any other oral medicinal product (see sections 4.2 and 5.2).

No other interactions with medicinal products of clinical significance are anticipated. A number of patients in the clinical trials received oestrogen (intravaginal, transdermal, or oral) while taking alendronate. No adverse experiences attributable to their concomitant use were identified.

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

Although specific interaction studies were not performed, in clinical studies alendronate was used concomitantly with a wide range of commonly prescribed medicinal products without evidence of clinical adverse interactions.

4.6 Pregnancy and lactation
Use during pregnancy

Alendronate should not be used during pregnancy. There are no adequate data from the use of alendronate in pregnant women. Animal studies do not indicate direct harmful effects with respect to pregnancy, embryonal/fetal development, or postnatal development. Alendronate given during pregnancy in rats caused dystocia related to hypocalcemia (see section 5.3). Given the indication, alendronate should not be used during pregnancy.

 

Use during lactation
It is not known whether alendronate is excreted into human breast milk. Given the indication, alendronate should not be used by breast-feeding women.

It is not known whether alendronate is excreted into human breast milk. Given the indication, alendronate should not be used by breast-feeding women.

4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.

No studies on the effects on the ability to drive and use machines have been performed.

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).

 

4.8 Undesirable effects
During post-marketing experience the following reactions have been reported (frequency unknown):

Nervous system disorders: dizziness

dizziness

, dysgeusia

 

 

Updated on 17 December 2009 PIL

Reasons for updating

  • Change to side-effects
  • Change to information about driving or using machinery
  • Change to dosage and administration

Updated on 3 September 2009 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company



Inclusion of reference to stress fractures.

Updated on 27 February 2009 PIL

Reasons for updating

  • Change to side-effects

Updated on 20 February 2009 PIL

Reasons for updating

  • Change to side-effects

Updated on 18 December 2008 PIL

Reasons for updating

  • PIL re-instated

Updated on 25 November 2008 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.8 (i.e. addition of alopecia ) of the SPC has been updated.

Updated on 24 November 2008 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 3 January 2008 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4 of the SPC has been updated (i.e. add periodontal disease).

Updated on 20 September 2007 PIL

Reasons for updating

  • Change due to harmonisation of patient information leaflet

Updated on 12 July 2007 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to section 4.4   Delete following:  "A casual relationship cannot be ruled out"
 
Change to section 4.8  Include post marketing adverse events
 
 

Updated on 12 April 2007 PIL

Reasons for updating

  • Change to side-effects
  • Change to further information section
  • Change to dosage and administration

Updated on 8 February 2007 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Variation to amend section 4.2

Updated on 1 September 2006 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Updates to Sections 4.4, 4.8, 6.5,9 and 10

Updated on 13 April 2005 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 16 November 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 18 June 2004 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 13 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)