Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Vantavo (previously Alendronate sodium and colecalciferol, MSD)

VANTAVO 70 mg/2800 IU tablets VANTAVO 70 mg/5,600 IU tablets · Abschnitt 4.8 · PDF-Seite 7–8

HOS-212415 · Präparat HOS-154886

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 disorders Uncommon rash, erythema Rare rash with photosensitivity, severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis‡ Musculoskeletal and Very common musculoskeletal (bone, muscle or joint) pain which connective tissue is sometimes severe†§ disorders Common joint swelling† Rare osteonecrosis of the jaw‡§, atypical subtrochanteric and diaphyseal femoral fractures (bisphosphonate class adverse reaction) Not known atypical fractures of other bones General disorders and Common asthenia†, peripheral oedema† administration site Uncommon transient symptoms as in an acute-phase response conditions (myalgia, malaise and rarely, fever), typically in association with initiation of treatment† §See section 4.4 †Frequency in Clinical Trials was similar in the medicinal product and placebo group.

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