Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
bisoprolol (bisoprolol fumarate)
Zentiva a.s.
bisoprolol (bisoprolol fumarate)
5mg
tablets film-coated
Prescription
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Coronal 5 Coronal 10 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Coronal 5: bisoprololi fumarate 5 mg in 1 film-coated tablet. Coronal 10: bisoprololi fumarate 10 mg in 1 film-coated tablet. For the full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Coronal 5: light yellow, lenticular, round scored tablets Coronal 10: light pink, lenticular, round scored tablets 4. CLINICAL DATA 4.1_ _ THERAPEUTIC INDICATIONS • hypertension • ischemic heart disease (angina pectoris) 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults For both indications the dose is 5 mg bisoprolol fumarate once daily. If necessary, the dose can be increased to 10 mg bisoprolol fumarate once daily. The maximum recommended daily dose is 20 mg. The dose is always adjusted individually, based on heart rate and effectiveness of the therapy. Treatment duration The treatment with Coronal is generally long-term. The treatment with Coronal must not be stopped abruptly, as it can lead to a transient aggravation of the condition. Especially in patients with ischemic heart disease the treatment must not be interrupted abruptly. A gradual reduction of doses is recommended. Special populations _ _ _Renal or hepatic impairment _ 1 120307 In patients with mild to moderate hepatic or renal impairment, no dose adjustment is usually required. In patients with severe renal impairment (creatinine clearance < 20 ml/min) and severe hepatic impairment, doses higher than 10 mg bisoprolol fumarate daily should not be used. There is limited experience with the use of bisoprolol in patients on dialysis; however, no data on dosing scheme is available. _Elderly _ No dosage adjustment is required. _Children _ There is no experience with bisoprolol in children, therefore its use cannot be recommended for children. Method of administration Coronal tablets should be taken in the morning with or without food. The tablets should be swallowed whole with a drink and should not be che Прочитать полный документ