Updated on 26/12/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 14-Dec-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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The main changes made to the SmPC are as follows:
To Section 4.2 the paediatric statement has been re-worded to be in line with that agreed during the work-sharing procedure.
To section 5.1 a new section has been added on use in paediatric patients.
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Updated on 11/11/2011 and displayed until 26/12/2011
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 28-Oct-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In accordance with the "COMMISSION IMPLEMENTING DECISION of the 13 July 2011 in the framework of Article 31 of Directive 2001/83/EC of the European Parliament and of the Council, the marketing authorisations of medicinal products for human use which contain the active substances alendronic acid, clodronic acid,etidronic acid, ibandronic acid, neridronic acid, pamidronic acid, risedronic acid and tiludronic acid", the following changes have been made to the Fosamax 10 mg SPC:
In Section 4.2 a statement regarding the optimal duration of treatment has not been established has been added and 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 section on "adverse experiences have been reported during clinical studies and/or post-marketing use", "atypical subtrochanteric and diaphyseal femoral fractures (bisphosphonate class adverse reaction)" has been added and in the post-marketing section where frequency unknown, "stress fractures of the proximal femoral shaft" has been deleted.
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Updated on 01/04/2011 and displayed until 11/11/2011
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 31-Mar-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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The changes made to the SmPC are as follows:
In section 4.4 and at the end of the first paragraph the following statement has been added:
"In patients with known Barrett's oesophagus prescribers should consider the benefits and potential risks of alendronate on an individual patient basis."
Also in section 4.4 the sixth paragraph has been amended. Instead of listing concomitant risk factors within a bracketed section, these have now been provided in a bulleted listed.
"The following risk factors should be considered when evaluating an individual's risk of developing osteonecrosis of the jaw:
- potency of the bisphosphonate (highest for zoledronic acid), route of administration (see above) and cumulative dose
- cancer, chemotherapy, radiotherapy, corticosteroids, smoking
- a history of dental disease, poor oral hygiene, periodontal disease, invasive dental procedures and poorly fitting dentures.
A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with poor dental status.concomitant risk factors (e.g. cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene, periodontal disease, smoking).
After the eighth paragraph in section 4.4, a new paragraph has been added regarding encouraging patients to maintain good oral hygiene, have regular updates and report any symptoms such as dental mobility, pain or swelling.
"During bisphosphonate treatment, 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."
Section 4.7 has been updated. The statement "There are no data to suggest that 'Fosamax' effects the ability to drive or use machines."
In section 4.8, under the sub-heading "Musculoskeletal, connective tissue and bone disorders" and under "rare", the statement on "Oesteonecrosis of the jaw" has been revised. A reference to section 4.4 has been added.
"Musculoskeletal, connective tissue and bone disorders
Rare: Osteonecrosis of the jaw (see section 4.4) has been reported in patients treated by bisphosphonates. The majority of the reports refer to cancer patients, but such cases have also been reported in patients treated for osteoporosis. Osteonecrosis of the jaw is generally associated with tooth extraction and / or local infection (including osteomyelitis). Diagnosis of cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene and smoking are also deemed as risk factors; severe musculoskeletal…."
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Updated on 30/03/2010 and displayed until 01/04/2011
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 17-Mar-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 4.2 "Posology and method of administration" the details on how to take the medicine have been updated to state "swallow whole" and to advise not to "Crush" or "chew" the tablets.
In section 4.4. "Specials warnings and precautions", the first paragraph has been updated as follows:
"...or 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 4.3 ‘Contraindications’)."
Also in the same section as above, "smoking" has been added as a possible risk factor where a dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates.
Also in section 4.4, a new paragraph has been added on stress fractures.
Also in section 4.4, the third paragraph from the end has been updated to state that "
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."
In section 4.5 " Interactions with other medicinal products and other forms of interaction", the first paragraph has been updated as follows:
"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 ‘Fosamax’. "
Also in the same section as above, a new paragraph has been added on NSAIDs.
Section 4.6 " Pregnancy and Lactation" has been updated as follows
: "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 5.3 ‘Preclinical safety data’).
Use during lactation
It is not known whether alendronate is excreted into human breast-milk. Alendronate should not be used by breast-feeding women."
In section 4.7 "Effects on ability to drive and use machines" has been updated as follows: "...
No studies on the effects on the ability to drive and use machines has 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)."
In section 4.8 "Undesirable Effects", and under the sub-section "Musculoskeletal, connective tissue and bone disorders", "smoking" has been added as a risk factor of osetonecrosis of the jaw.
Also in section 4.8 under post-marketing experience "
dysgeusia" and "stress fractures of the proximal shaft (see section 4.4)." have been added.
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Updated on 21/04/2009 and displayed until 30/03/2010
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic indications
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Correction of spelling/typing errors
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| Date of revision of text on the SPC: 16-Apr-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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An error occured in section 4.1. The indication for glucocorticoid-induced osteoporosis, stated for use in men, but this requires a 5 mg dose, which has been removed, and this is limited to post-menopausal women.
" Fosamax is indicated for the treatment of glucocorticoid-induced osteoporosis and prevention of bone loss in men and post-menopausal women considered at risk of developing the disease."
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Updated on 15/04/2009 and displayed until 21/04/2009
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic indications
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Change to section 4.2 - Posology and method of administration
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| Date of revision of text on the SPC: 30-Mar-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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The SPC had been revised to remove all references to the 5 mg dosage from section 4.1 and 4.2, as this strength is no longer available.
Section 4.1:
The following statement has been deleted:
‘Fosamax’ is indicated for the prevention of osteoporosis in those post-menopausal women considered at risk of developing the disease.
Section 4.2:
The following statements have been deleted:
For other patients (i.e. men, pre-menopausal women and post-menopausal women receiving HRT with an oestrogen), the recommended dosage is 5 mg once a day.
Prevention of osteoporosis in post-menopausal women: The recommended dosage is 5 mg once a day.
The recommended dosage is 5 mg once a day.
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Updated on 09/02/2009 and displayed until 15/04/2009
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 12-Jan-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 2 "Qualitative and Quantitative Composition" the quantity of lactose anhydrous in each tablet has been added.
In section 4.8 " Undesirable Effects" and under the post-marketing section, "alopecia" has been added under Skin and subcutaneous disorders..
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Updated on 07/08/2008 and displayed until 09/02/2009
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 29-Feb-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.2: The statement "use in children" has been updated to state that alendronate has been studied in a small number of patients with osteogenesis imperfecta under 18 years of age, but the results are insufficient to support its use in children.
Section 4.4: In the fourth paragraph which begins "Whilst no increased risk was observed in extensive clinical trials, there have been rare (post-marketing) reports of gastric and duodenal ulcers,….", the statement "However a casual relationship has not been established." has been deleted.
Section 4.4: The sixth paragraph beginning "A dental examination…", "peridontal disease" has been added as an example of types of risk factors.
Section 4.5: At the end of this section a reference to section 5.1 has been added.
Section 4.8: The side effects section has been revised in line with Fosamax Once weekly 70 mg Tablets to list side effects in order of MedDRA organ class system as well as frequency of occurrence. In addition, the following side effects have been added: dizziness, vertigo, joint swelling, asthenia and peripheral oedema.
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Updated on 05/03/2007 and displayed until 07/08/2008
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Reasons for adding or updating:
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New individual SPC (was previously included in combined SPC)
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 01/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Reference to the 5 mg tablet strength has been deleted as this strength is no longer available.
Section 4.4- Special warnings and precautions for use
ONJ wording has been added to this section in line with wording recommended by the Pharmacovigilance Working Party Class review of "Bisphosphonates and Osteonecrosis of the jaw".
The following excipients statement has been added to this section:
"This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product"
Section 4.8- Undesirable effects
The following sentence has been deleted from the Gastro-intestinal undesirable effects and listed under Musculoskeletal undesirable effects:
"Localised osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection, often with delayed healing."
The following statement regarding osteonecrosis of the jaw has been added to the list of Musculoskeletal undesirable effects:
"Osteonecrosis of the jaw has been reported in patients treated by bisphosphonates. The majority of the reports refer to cancer patients, but such cases have also been reported in patients treated for osteoporosis. Osteonecrosis of the jaw is generally associated with tooth extraction and/or local infection (including osteomyelitis). Diagnosis of cancer, chemotherapy, radiotherapy, corticosteroids and poor oral hygiene are also deemed as risk factors."
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Updated on 20/03/2006 and displayed until 05/03/2007
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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Updated on 23/01/2006 and displayed until 20/03/2006
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Reasons for adding or updating:
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.8 - Undesirable Effects
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Updated on 06/05/2004 and displayed until 23/01/2006
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Reasons for adding or updating:
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.8 - Undesirable Effects
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Updated on 21/12/2001 and displayed until 06/05/2004
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic Indications
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Change to section 4.2 - Posology and Method of Administration
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Change to section 5.1 - Pharmacodynamic Properties
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Updated on 24/08/2001 and displayed until 21/12/2001
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 17/07/2001 and displayed until 24/08/2001
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Reasons for adding or updating:
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Removal of Black Triangle
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Transferred from eMC version 1
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Updated on 15/01/2001 and displayed until 17/07/2001
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Reasons for adding or updating:
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Updated on 11/05/2000 and displayed until 15/01/2001
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Updated on 06/09/1999 and displayed until 11/05/2000
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