ALENDRONIC ACID/CHOLECALCIFEROL

Posology The recommended dose is one Alendronic acid/Cholecalciferol tablet once weekly. Patients should be instructed that if they miss a dose of Alendronic acid/Cholecalciferol they should take one tablet on the morning after they remember.

They should not take two tablets on the same day but should return to taking one tablet once a week, as originally scheduled on their chosen day. Due to the nature of the disease process in osteoporosis, Alendronic acid/Cholecalciferol is intended for long-term use.

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 alendronate/colecalciferol on an individual patient basis, particularly after 5 or more years of use.

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 2,800 IU of vitamin D3 weekly in alendronic acid/colecalciferol to daily dosing of vitamin D 400 IU has not been studied.

Elderly In clinical studies there was no age-related difference in the efficacy or safety profiles of alendronate. Therefore no dose adjustment is necessary for the elderly. Renal impairment Alendronate/colecalciferol is not recommended for patients with renal impairment where creatinine clearance is less than 35 ml/min, due to lack of experience.

No dose adjustment is necessary for patients with a creatinine clearance greater than 35 ml/min. Paediatric population The safety and efficacy of alendronate/colecalciferol in children less than 18 years of age have not been established.

This medicinal product should not be used in children less than 18 years of age because no data are available for the alendronic acid/colecalciferol combination. 1. Method of administration Oral use.

To permit adequate absorption of alendronate:

Alendronic acid/Cholecalciferol must be taken with water only (not mineral water) at least 30 minutes before the first food, beverage, or medicinal product (including antacids, calcium supplements and vitamins) of the day. 8). 4): • Alendronic acid/Cholecalciferol should only be swallowed after getting up for the day with a full glass of water (not less than 200 ml).

Summary of the safety profile The most commonly reported adverse reactions are upper gastrointestinal adverse reactions including abdominal pain, dyspepsia, oesophageal ulcer, dysphagia, abdominal distension and acid regurgitation (> 1 %).

Tabulated list of adverse reactions The following adverse reactions have been reported during clinical studies and/or post-marketing use with alendronate. No additional adverse reactions have been identified for the combination of alendronate and colecalciferol.

Frequencies are defined as: very common (≥1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000). 4 †Frequency in Clinical Trials was similar in the active and placebo groups.

4 ‡This adverse reaction was identified through post-marketing surveillance. The frequency of rare was estimated based on relevant clinical trials. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.

Alendronate Upper gastrointestinal adverse reactions Alendronate can cause local irritation of the upper gastrointestinal mucosa. 3). In patients with known Barrett's oesophagus, prescribers should consider the benefits and potential risks of alendronate on an individual patient basis.

Oesophageal reactions (sometimes severe and requiring hospitalisation), such as oesophagitis, oesophageal ulcers and oesophageal erosions, rarely followed by oesophageal stricture, have been reported in patients receiving alendronate.

8). The risk of severe oesophageal adverse reactions appears to be greater in patients who fail to take alendronate properly and/or who continue to take alendronate after developing symptoms suggestive of oesophageal irritation. 2). Patients should be informed that failure to follow these instructions may increase their risk of oesophageal problems.

8). Osteonecrosis of the jaw 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, angiogenesis inhibitors, 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.

1. • Abnormalities of the oesophagus and other factors which delay oesophageal emptying such as stricture or achalasia. • Inability to stand or sit upright for at least 30 minutes. • Hypocalcaemia.