Fosavance · 4.1 Therapeutic indications · 1

HOS-094112 · has-adverse-reaction-information · PDF-Seite 7

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), not known (cannot be estimated from the available data). 7  System organ class Frequency Adverse reactions Immune system disorders Rare hypersensitivity reactions including urticaria and angioedema Metabolism and nutrition Rare symptomatic hypocalcaemia, often in association disorders with predisposing conditions§ Nervous system disorders Common headache, dizziness† Uncommon dysgeusia† Eye disorders Uncommon eye inflammation (uveitis, scleritis, or episcleritis) Ear and labyrinth Common vertigo† disorders Very rare osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction) Gastrointestinal disorders Common abdominal pain, dyspepsia, constipation, diarrhoea, flatulence, oesophageal ulcer*, dysphagia*, abdominal distension, acid regurgitation Uncommon nausea, vomiting, gastritis, oesophagitis*, oesophageal erosions*, melena† Rare oesophageal stricture*, oropharyngeal ulceration*, upper gastrointestinal PUBs (perforation, ulcers, bleeding)§ Skin and subcutaneous Common alopecia†, pruritus† tissue di

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HOS-094108 · has-contraindication-information · PDF-Seite 4

- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. - 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.

HOS-094107 · has-indication-information · PDF-Seite 2

FOSAVANCE is indicated for the treatment of postmenopausal osteoporosis in women at risk of vitamin D insufficiency. It reduces the risk of vertebral and hip fractures.

HOS-094110 · has-interaction-information · PDF-Seite 6

Alendronate 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). Since Non Steroidal Anti-Inflammatory Drug (NSAID) use is associated with gastrointestinal irritation, caution should be used during concomitant use with alendronate. Colecalciferol Olestra, mineral oils, orlistat, and bile acid sequestrants (e.g. cholestyramine, colestipol) may impair the absorption of vitamin D. Anticonvulsants, cimetidine and thiazides may increase the catabolism of vitamin D. Additional vitamin D supplements may be considered on an individual basis.

HOS-094111 · has-pregnancy-information · PDF-Seite 6

FOSAVANCE is only intended for use in postmenopausal women and therefore it should not be used during pregnancy or in breast-feeding women. Pregnancy There are no or limited amount of data from the use of alendronate in pregnant women. Studies in animals have shown reproductive toxicity. Alendronate given during pregnancy in rats caused dystocia related to hypocalcaemia (see section 5.3). Studies in animals have shown hypercalcaemia and reproductive toxicity with high doses of vitamin D (see section 5.3). FOSAVANCE should not be used during pregnancy. 6 Breast-feeding It is unknown whether alendronate/metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. Colecalciferol and some of its active metabolites pass into breast milk. FOSAVANCE should not be used during breast-feeding. Fertility Bisphosphonates are incorporated into the bone matrix, from which they are gradually released over a period of years. The amount of bisphosphonate incorporated into adult bone, and hence, the amount available for release back into the systemic circulation, is directly related to the dose and duration of bisphosphonate use (see section 5.2). There are no data on foetal risk in humans. However, there is a theoretical risk of foetal harm, predominantly skeletal, if a woman becomes pregnant after completing a course of bisphosphonate therapy. The impact of variables such as time between cessation of bisphosphonate therapy to conception, the particular bisphosphonate used, and the route of administration (intravenous versus oral) on the risk has not been studied.

HOS-094109 · has-warning-information · PDF-Seite 4

Alendronate Upper gastrointestinal adverse reactions Alendronate can cause local irritation of the upper gastrointestinal 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 gastrointestinal problems, such as dysphagia, oesophageal disease, gastritis, duodenitis, ulcers, or with a recent history (within the previous year) of major gastrointestinal disease such as peptic ulcer, or active gastrointestinal bleeding, or surgery of the upper gastrointestinal 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. 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. Physicians should therefore be alert to any signs or symptoms signalling a possible oesophageal reaction and patients should be instructed to discontinue alendronate and seek medical attention if they develop symptoms of oesophageal irritation such as dysphagia, pain on swallowing or retrosternal pain or new or worsening heartburn (see section 4.8). 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. It is very important that the full dosing instructions are provided to, and are understood by the patient (see section 4.2). Patients should be informed that failure to follow these instructions may increase their risk of oesophageal problems. While no increased risk was observed in extensive clinical trials with alendronate, there have been rare (post-marketing) reports of gastric and duodenal ulcers, some of which were severe and with complications (see section 4.8). 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 re

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