Země: Arménie
Jazyk: angličtina
Zdroj: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
bismuth tripotassium dicitrate (bismuth oxide)
KRKA d.d.
A02BX05
bismuth tripotassium dicitrate (bismuth oxide)
120mg
tablets film-coated
(28/2x14/), (56/4x14/) in blister
Prescription
Registered
2017-05-11
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Přečtěte si celý dokument
1.3.1 Bismuth subcitrate SPC, Labeling and Package Leaflet AM SmPCPIL150888_1 29.05.2020 – Updated: 29.05.2020 Page 1 of 4 1. NAME OF THE MEDICINAL PRODUCT Ulcavis ® 120 mg fim-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains tripotassium dicitratobismuthate- 303.03 mg (equivalent to 120.00 mg bismuth oxide). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM White to almost white, round, slightly biconvex, film coated tablets with bevel edge. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Acute stomach and duodenal ulcer, including that associated with _Helicobacter pylori_ infection. Active chronic gastritis and gastroduodenitis, including that associated with _Helicobacter pylori_ infection. Irritable bowel syndrome with primarily diarrhea symptoms. Functional dyspepsia not associated with organic gastrointestinal diseases. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and the elderly_ The recommended dose is 1 tablet 4 times daily, 30 minutes prior to meals and before bedtime OR 2 tablets twice daily, 30 minutes prior to meals. _For children_ Not recommended. Method of administration The tablets should be taken 30 minutes prior to meals with a small amount of water. The treatment course is 4 to 8 weeks. Bismuth-containing products should not be used in the following 8 weeks. For the eradication of _Helicobacter plyori_ Ulcavis should preferably be used in combination with other antibacterial agents against this microorganism. 4.3 CONTRAINDICATIONS Severe renal insufficiency (creatinine clearance below 30 ml/min). Period of pregnancy and breast-feeding. CONFIDENTIAL VOL: 1; P: 16 / 42 1.3.1 Bismuth subcitrate SPC, Labeling and Package Leaflet AM SmPCPIL150888_1 29.05.2020 – Updated: 29.05.2020 Page 2 of 4 Hypersensitivity to the drug. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Treatment with Ulcavis should not exceed 8 weeks. The recommended daily dose for the appropriate age group should not be exceeded. Other bismuth co Přečtěte si celý dokument