When a pharmaceutical company changes an SPC or PIL, 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.
SPC sections changed: 6.5 Nature and contents of container - to remove wallet from pack
Section 4.4 & 4.8 - WS0038 variation relating to Osteonecrosis of the jaw. Section 4.4. Special warnings and precautions for use Osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection (including osteomyelitis), has been reported in patients with cancer who are receiving treatment regimens including primarily intravenously administered bisphosphonates. Many of these patients were also receiving chemotherapy and corticosteroids. Osteonecrosis of the jaw has also been reported in patients with osteoporosis receiving oral bisphosphonates. 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 oral bisphosphonates in patients with poor dental status. While on treatment, these patients should avoid invasive dental procedures if possible. For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw. Clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment. 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 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, smoking). Section 4.8. Undesirable effects During post-marketing experience the following reactions have been reported (frequency not known): Musculoskeletal, connective tissue and bone disorders: 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 and smoking are also deemed as risk factors (see section 4.4); joint swelling; stress fractures of the proximal femoral shaft (see section 4.4)
Osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection (including osteomyelitis), has been reported in patients with cancer who are receiving treatment regimens including primarily intravenously administered bisphosphonates. Many of these patients were also receiving chemotherapy and corticosteroids. Osteonecrosis of the jaw has also been reported in patients with osteoporosis receiving oral bisphosphonates.
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.
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 oral bisphosphonates in patients with poor dental status.
While on treatment, these patients should avoid invasive dental procedures if possible. For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw. Clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.
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
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, smoking).
Section 4.8. Undesirable effects
During post-marketing experience the following reactions have been reported (frequency not known):
Musculoskeletal,
connective tissue and
bone disorders:
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 and smoking are also deemed as risk factors (see section 4.4); joint swelling; stress fractures of the proximal femoral shaft (see section 4.4)
Addition of following text to section 4.4 4.4 Special warnings and precautions for use In patients with known Barrett's oesophagus, prescribers should consider the benefits and potential risks of alendronate on an individual patient basis.
The main changes relate to the following: Section 4.2 Patients should only swallow FOSAVANCE 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.
Section 4.4
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.
Section 4.5
Since NSAID use is associated with gastrointestinal irritation, caution should be used during concomitant use with alendronate.
Section 4.7
However, 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). However, there is no information to indicate that FOSAVANCE affects a patient’s ability to drive or operate machines.
Section 4.8:
Nervous system disorders: dizziness, dysgeusia
Section 4.4: Addition of new paragraph in relation to stress fractures. Section 4.8: Inclusion of stress fractures to side effects as follows: Musculoskeletal, connective tissue and bone disorders: stress fractures of the proximal femoral shaft
The changes relate to addition of alopecia in section 4.8