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.
Sections 4.2 & 5.1 - update to the paediatric information.
Updated Sections 4.2, 4.4, 4.8 & 6.5.
Updates to Sections 4.8 & 5.1
Section 4.4 Special warnings and precautions for use & 4.8 Undesirable effects - osteonecrosis of the jaw and smoking.
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.
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.
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
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.
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.
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.
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
4.8 Undesirable effects During post-marketing experience the following reactions have been reported (frequency unknown): Nervous system disorders: dizziness
Nervous system disorders: dizziness
, dysgeusia
Inclusion of reference to stress fractures.
Section 4.8 (i.e. addition of alopecia ) of the SPC has been updated.
Section 4.4 of the SPC has been updated (i.e. add periodontal disease).
Updates to Sections 4.4, 4.8, 6.5,9 and 10