Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Copalia HCT

Copalia HCT 5 mg/160 mg/12.5 mg film-coated tablets Copalia HCT 10 mg/160 mg/12.5 mg film-coated tablets Copalia HCT 5 mg/160 mg/25 mg film-coated tablets Copalia HCT 10 mg/160 mg/25 mg film-coated tablets Copalia HCT 10 mg/320 mg/25 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 15–16

HOS-122705 · Präparat HOS-095555

15 Gastrointestinal Abdominal discomfort, Uncommon Common Uncommon Rare disorders abdominal pain upper Breath odour Uncommon -- -- -- Change of bowel habit -- Uncommon -- -- Constipation -- -- -- Rare Decreased appetite -- -- -- Common Diarrhoea Uncommon Uncommon -- Rare Dry mouth Uncommon Uncommon -- -- Dyspepsia Common Uncommon -- -- Gastritis -- Very rare -- -- Gingival hyperplasia -- Very rare -- -- Nausea Uncommon Common -- Common Pancreatitis -- Very rare -- Very rare Vomiting Uncommon Uncommon -- Common Intestinal angioedema -- -- Very rare -- Hepatobiliary Liver function test abnormal, -- Very rare** Not known -- disorders including blood bilirubin increase Hepatitis -- Very rare -- -- Intrahepatic cholestasis, -- Very rare -- Rare jaundice Skin and Alopecia -- Uncommon -- subcutaneous Angioedema -- Very rare Not known -- tissue disorders Dermatitis bullous -- -- Not known -- Cutaneous lupus -- -- -- Very rare erythematosus-like reactions, reactivation of cutaneous lupus erythematosus Erythema multiforme -- Very rare -- Not known Exanthema -- Uncommon -- -- Hyperhidrosis Uncommon Uncommon -- -- Photosensitivity reaction* -- Very rare -- Rare Pruritus Uncommon Uncommon Not known -- Purpura -- Uncommon -- Rare Rash -- Uncommon Not known Common Skin discoloration -- Uncommon -- -- Urticaria and other forms of -- Very rare -- Common rash Vasculitis necrotising and -- Not known -- Very rare toxic epidermal necrolysis Exfoliative dermatitis -- Very rare -- -- Stevens-Johnson syndrome -- Very rare -- -- Quincke oedema -- Very rare -- -- Musculoskeletal Arthralgia -- Uncommon -- -- and connective Back pain Uncommon Uncommon -- -- tissue disorders Joint swelling Uncommon -- -- -- Muscle spasm Uncommon Uncommon -- Not known Muscular weakness Uncommon -- -- -- Myalgia Uncommon Uncommon Not known -- Pain in extremity Uncommon -- -- -- Ankle swelling -- Common -- --

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.