DRONAL ONCE WEEKLY

Posology The recommended dosage is one 70 mg tablet once weekly. Patients should be instructed that if they miss a dose of DRONAL Once Weekly, 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.

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 ‘Dronal’ on an individual patient basis, particularly after 5 or more years of use.

Elderly In clinical studies there was no age-related difference in the efficacy or safety profiles of alendronate. Therefore no dosage adjustment is necessary for the elderly. Renal impairment No dosage adjustment is necessary for patients with creatinine clearance greater than 35 ml/min.

Alendronate is not recommended for patients with renal impairment where creatinine clearance is less than 35 ml/min, due to lack of experience. Paediatric population The safety and efficacy of DRONAL in children less than 18 years of age has not been established.

This medicinal product should not be used in children less than 18 years of age. 1. Method of administration Oral use.

To permit adequate absorption of alendronate:

DRONAL must be taken at least 30 minutes before the first food, beverage, or medicinal product of the day with plain water only. 5). 4): - DRONAL should only be swallowed upon arising for the day with a full glass of water (not less than 200 ml).

- Patients should only swallow DRONAL 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. - Patients should not lie down for at least 30 minutes after taking DRONAL and until after the first food of the day.

- DRONAL should not be taken at bedtime or before arising for the day. 4). DRONAL Once Weekly 70 mg has not been investigated in the treatment of glucocorticoid-induced osteoporosis.

Summary of the safety profile In a one-year study in postmenopausal women with osteoporosis the overall safety profiles of DRONAL Once Weekly 70 mg (n=519) and alendronate 10 mg/day (n=370) were similar. In two three-year studies of virtually identical design, in postmenopausal women (alendronate 10 mg: n=196, placebo: n=397) the overall safety profiles of alendronate 10 mg/day and placebo were similar.

4 †Frequency in Clinical Trials was similar in the medicinal product and placebo group. 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

Upper gastrointestinal adverse reactions Alendronate can cause local irritation of the upper gastro-intestinal 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 experiences 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. While on treatment, these patients should avoid invasive dental procedures if possible.

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.