Страна: Армения
Език: английски
Източник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
solifencin, tamsulosin
Astellas Pharma Europe B.V.
solifencin, tamsulosin
6mg+0,4mg
tablets film-coated modified-release
Prescription
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Vesomni 6 mg/0.4 mg film-coated, bi-layered modified release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each bi-layered tablet contains a layer of 6 mg solifenacin succinate, corresponding to 4.5 mg solifenacin free base and a layer of 0.4 mg tamsulosin hydrochloride, corresponding to 0.37 mg of tamsulosin free base. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated, bi-layered modified release tablet Each tablet is round, approximately 9 mm in diameter, red film-coated and debossed with “6/0.4”. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of moderate to severe storage symptoms (urgency, increased micturition frequency) and voiding symptoms associated with benign prostatic hyperplasia (BPH) in men who are not adequately responding to treatment with monotherapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adult_ _males, including elderly _ One Vesomni tablet (6 mg/0.4 mg) once daily taken orally with or without food. The maximum daily dose is one Vesomni tablet (6 mg/0.4 mg). The tablet must be swallowed whole, intact without biting or chewing. Do not crush the tablet._ _ _Patients with renal impairment _ The effect of renal impairment on the pharmacokinetics of Vesomni has not been studied. However, the effect on the pharmacokinetics of the individual active substances is well known (see section 5.2). Vesomni can be used in patients with mild to moderate renal impairment (creatinine clearance > 30 mL/min). Patients with severe renal impairment (creatinine clearance ≤ 30 mL/min) should be treated with caution and the maximum daily dose in these patients is one Vesomni tablet (6 mg/0.4 mg) (see section 4.4). _Patients with hepatic impairment _ The effect of hepatic impairment on the pharmacokinetics of Vesomni has not been studied. However, the effect on the pharmacokinetics of the individual active substances is well known (see section 5.2). Vesomni can be used in patients with Прочетете целия документ