Updated on 09/05/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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| Date of revision of text on the SPC: 19-Apr-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Editorial changes have been made throughout the SPC but no new information has been added.
Section 4.7. "Effects on ability to drive and use machines" has been updated as follows:
"FOSAVANCE has no or negligible direct influence on the ability to drive and use machines. Certain adverse reactions (for example blurred vision, dizziness and severe bone muscle or joint pain (see section 4.8)) that have been reported with FOSAVANCE may affect some patients' ability to drive or operate machines.
Certain adverse reactions that have been reported with FOSAVANCE may affect some patients' ability to drive or operate machinery. Individual responses to FOSAVANCE may vary (see section 4.8)."
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Updated on 19/07/2011 and displayed until 09/05/2012
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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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Change to section 6. 5 - Nature and Contents of Container
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| Date of revision of text on the SPC: 29-Jun-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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New text as follows has been added
Section 4.2 Posology and method of administration
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 <drug name> on an individual patient basis, particularly after 5 or more years of use.
Section 4.4 Special warnings and precautions for use
Atypical fractures of the femur
Atypical subtrochanteric and diaphyseal femoral fractures have been reported with bisphosphonate therapy, primarily in patients receiving long-term treatment for osteoporosis. These transverse or short oblique fractures can occur anywhere along the femur from just below the lesser trochanter to just above the supracondylar flare. These fractures occur after minimal or no trauma and some patients experience thigh or groin pain, often associated with imaging features of stress fractures, weeks to months before presenting with a completed femoral fracture. Fractures are often bilateral; therefore the contralateral femur should be examined in bisphosphonate-treated patients who have sustained a femoral shaft fracture. Poor healing of these fractures has also been reported. Discontinuation of bisphosphonate therapy in patients suspected to have an atypical femur fracture should be considered pending evaluation of the patient, based on an individual benefit risk assessment.
During bisphosphonate treatment patients should be advised to report any thigh, hip or groin pain and any patient presenting with such symptoms should be evaluated for an incomplete femur fracture.
Section 4.8 Undesirable effects
During post-marketing experience the following reactions have been reported (frequency rare):
Atypical subtrochanteric and diaphyseal femoral fractures (bisphosphonate class adverse reaction)
In addition, to the above recommendations, MSD will shortly be introducing a new style pack for Fosavance. Currently the product is supplied in blisters which are placed inside a wallet and this is enclosed in a carton. The new pack will no longer have a wallet, but all the information currently on it will now appear on the carton. As a result of this change, section 6.5 of the SmPC has been amended as follows:
Section 6.5 "Nature and contents of container"
Wallets with sealed Aluminium/aluminium blisters in cartons containing 2 (1 wallet x 2 tablets), 4 (1 wallet x 4 tablets), 6 (3 wallets x 2 tablets), 12 (3 wallets x 4 tablets) or 40 (10 wallets x 4 tablets) tablets.
Aluminium/aluminium blisters in cartons containing 2 (1 x 2 tablets), 4 (1 x 4 tablets), 6 (3 x 2 tablets), 12 (3 x 4 tablets) tablets.
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Updated on 05/04/2011 and displayed until 19/07/2011
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 22-Mar-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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All changes have been made to section 4.8. There are no new adverse events added, but the section has been re-structured and some adverse effects have moved to new frequency categories.
The frequency category "Unknown" has been removed.
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 the 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.
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Updated on 12/01/2011 and displayed until 05/04/2011
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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 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 01-Dec-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 Special warnings and precautions for use
The sub-section "Osteonecrosis of the jaw" has been amended. Potential risk factors, which should be considered when evaluating an individual's risk of developing osteonecrosis of the jaw, have been detailed in a list of bullets.
In addition a statement has been added that a dental examination should be considered prior to treatment in patients with poor dental status.
Also, a statement has been added that patients should be encouraged to maintain good oral hygiene, receive routine dental check-ups, and report oral symptoms such as dental mobility, pain or swelling.
Section 4.8 Undesirable effects
Under the post-marketing experience the statement on "osteonecrosis of the jaw" has been revised to refer directly to section 4.4 for information.
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Updated on 20/07/2010 and displayed until 12/01/2011
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Reasons for adding or updating:
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Removal of Black Triangle
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| Date of revision of text on the SPC: 29-Jun-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Removal of Black Triangle
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Updated on 26/11/2009 and displayed until 20/07/2010
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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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| Date of revision of text on the SPC: 09-Nov-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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In section 4.4, first paragraph, under the sub-heading "alendronate" 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."
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Updated on 23/07/2009 and displayed until 26/11/2009
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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 4.5 - Interaction with other medicinal products and other forms of interaction
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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: 08-Jul-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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In section 4.2, patients are now advised to only swallow their tablet whole. In addition, the advice has been extended to state that the tablets should not be crushed.
In section 4.4 the 15th paragraph beginning "Due to positive effects of alendronate in increasing bone mineral…" has been revised as follows:
"..decreases in serum calcium and phosphate may occur especially in patients taking glucocrticoids in whom calcium absorption may be decreased. These are usually small and asymptomatic….."
In section 4.5 the following statement has been added:
"Since NSAID use is associated with gastrointestinal irritation, caution should be used during concomitant use with alendronate."
Section 4.7 has been revised to state that some adverse reactions have been reported with Fosavance which may affect some patients' ability to drive or operate machinery.
In section 4.8 and under post-marketing experience the following has been added:
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Nervous system disorders:
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Dizziness, dysgeusia
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Updated on 29/04/2009 and displayed until 23/07/2009
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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 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 07-Apr-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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The SPC has been updated with information on stress fractures. The changes are:
The changes are as follows:
section 4.4 Special warnings and precautions for use, the following paragraph has been added.
"Stress fractures (also known as insufficiency fractures) of the proximal femoral shaft have been reported in patients treated long-term with alendronic acid (time to onset in the majority of cases ranged from 18 months to 10 years). The fractures occurred after minimal or no trauma and some patients experienced thigh pain, often associated with imaging features of stress fractures, weeks to months before presenting with a completed femoral fracture. Fractures were often bilateral; therefore the contralateral femur should be examined in bisphosphonate-treated patients who have sustained a femoral shaft fracture. Poor healing of these fractures was also reported. Discontinuation of bisphosphonate therapy in patients with stress fracture is advisable pending evaluation of the patient, based on an individual benefit risk assessment."
section 4.8 Undesirable effects, and postmarketing experience, "stress fractures of the proximal femoral shaft (see section 4.4)." has been added to "Musculoskeletal, connective tissue and bone disorders
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Updated on 16/09/2008 and displayed until 29/04/2009
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 22-Aug-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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In section 4.8 Undesirable effects and in the second table regarding "post-marketing experience", the following has been added:
"Skin and Subcutaneous tissue disorders: alopecia"
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Updated on 24/01/2008 and displayed until 16/09/2008
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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Change to section 2 - Qualitative and quantitative composition
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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 4.5 - 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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Change to section 4.9 - Overdose
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 5.3 - Preclinical Safety Data
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Change to section 6.1 - List of Excipients
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Change to section 6. 5 - Nature and Contents of Container
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| Date of revision of text on the SPC: 10/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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1) Section 1: The strength of the tablet has been added.
2) Section 2: The amount of lactose and sucrose in each tablet has been added.
3) Section 4.2: The strength of the tablet (70 /70 microgram) has been replaced with the product name Fosavance.
4) Also in section 4.2 and in the instructions for taking the medication, the phrase "upon arising" has been replaced with "after getting up".
5) Also in section 4.2 and the following paragraph has been revised: " Patients should receive supplemental calcium if intake from diet is inadequate (see section 4.4). Additional supplementation with vitamin D should be considered on an individual basis taking into account any vitamin D intake from vitamins and dietary supplements. The equivalence of intake of 2800 IU of vitamin D3 weekly in FOSAVANCE to daily dosing of vitamin D 400 IU has not been studied."
6) In section 4.4 the following periodontal disease has been added to 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)."
7) In section 4.5 the following paragraph has been reworded: "No other clinically significant 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 reactions attributable to their concomitant use were identified."
8) In section 4.8 the side effects have been reorganised into a tabular format. No new side effects have been added.
9) In section 4.9 the term "overdosage" has been changed to "overdose".
10) In section 5.1 the pharmacotherapeutic group has been updated.
11) Also in section 5.1 and in the paragraph beginning " Vitamin D3 is required for normal bone formation…" The following sentence has been added: " Supplemental vitamin D reduces these risks and their consequences."
12) Also in section 5.1 and under the sub-heading "Fosavance studies" clarification has been added as to the strength of Fosavance used.
13) In section 5.2 the following sentence has been clarified: " The alendronate component in the FOSAVANCE (70 mg/2800 IU) combination tablet is bioequivalent to the alendronate 70 mg tablet."
14) Also in section 5.2 and under "Colecaliferol" and the sub-heading "Elimination" the same clarification has been added.
15) In section 5.3 the following paragraph has been re-worded: " Non-clinical studies with the combination of alendronate and colecalciferol have not been conducted."
16) In section 6.1 the excipient has been changed to:" Butylated hydroxytoluene (E321)".
17) In section 6.5 the following clarification has been made: " Wallet with sealed aluminium/aluminium blisters, in cartons containing 2 (1 wallet x 2 tablets), 4 (1 wallet x 4 tablets), 6 (3 wallets x 2 tablets), 12 (3 wallets x 4 tablets) or 40 (10 wallets x 4 tablets) tablets."
The following changes have been made to the PIL:
1) The strength has been added to the product name at the beginning of the leaflet.
2) The section "What is Fosavance" has been reworded as follows: " FOSAVANCE is a tablet containing the two active substances, alendronate sodium trihydrate and colecalciferol known as vitamin D3."
3) Section 4 "Possible side effects " has been editorially changed and all side effects classified as common, uncommon, rare etc are listed together. No new side effects have been added.
4) In the section "What Fosavance looks like" the strength of the tablet has been added.
5) Editorial changes have also been made to the section "What Fosavance contains", "Marketing Authorisation Holder and Manufacturer", and list of "Local Representatives".
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Updated on 16/04/2007 and displayed until 24/01/2008
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 18/01/2007 and displayed until 16/04/2007
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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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| 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
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Deletion of causality statement regarding gastric and duodenal ulcers in section 4.4 of the SPC
Addition of asthenia, peripheral oedema, joint swelling, dizziness and vertigo to section 4.8 of the SPC
Addition of cautionary wording for osteonecrosis of the jaw to sections 4.4 and 4.8 of the SPC in line with class labelling for bisphosphonates.
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Updated on 28/09/2005 and displayed until 18/01/2007
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 01/09/2005 and displayed until 28/09/2005
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Reasons for adding or updating:
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