País: Israel
Idioma: anglès
Font: Ministry of Health
TROSPIUM CHLORIDE
MEGAPHARM LTD
G04BD09
COATED TABLETS
TROSPIUM CHLORIDE 20 MG
PER OS
Required
MADAUS GMBH, GERMANY
TROSPIUM
TROSPIUM
Symptomatic treatment of urge incontinence and /or increased urinary frequency and urgency as may occur in patients with overactive bladder (e.g. idiopathic or neurologic detrusor overactivity) .
2022-03-31
.سفنتلا يف ةبوعص ىلإ · حفط ،سفنت قيضب بوحصملا ّ يئاجف ي ّ سسحت لعف در .مدلا طغض يف ضافخناو ريفص ، ّ يدلج · ،ةريطخ روثبب بوحصملا ،ريطخ ةيساسح طرف لعف در ،مفلا ،نويعلا ،ناتفشلا) ةيطاخم ةيشغأ وأ/و دلجلا ر ّ شقت ا ً ضيأ رعشت نأ لمتحملا نم .(ة ّ يلسانتلا ءاضعلأاو فنلأا تلاضع ملأ ،ةريرعشق ،ةنوخس :ةيلاتلا ضارعلأاب .ديج ريغ ماع روعشو نم رثكأ ىدل رهظت ضارعأ) ا ً دج ةعئاش ة ّ يبناج ضارعأ :(١٠ نم دحاو لمعتسم · مفلا يف فافج نيلمعتسم ١٠-١ ىدل رهظت ضارعأ) ةعئاش ة ّ يبناج ضارعأ :(١٠٠ نيب نم · كاسمإ · نايثغ · نطب ملاآ · مضهلا يف تابوعص ١٠-١ ىدل رهظت ضارعأ) ةعئاش ريغ ة ّ يبناج ضارعأ :( ١,٠٠٠ نيب نم نيلمعتسم · (Tachycardia) بلقلا عرست · عاد ُ ص · خافتنا · لاهسإ · ردصلا يف ملاآ نيلمعتسم ١٠-١ ىدل رهظت ضارعأ) ةردان ةيبناج ضارعأ :(١٠,٠٠٠ نيب نم · راود · ةناثملا غيرفت يف لكاشم · لوبلا سابتحا · بيرق نع ماسجلأا ةيؤر يف لكاشم · ّ يدلج حفط · لصافمو تلاضع ملاآ :ة ّ يفاضإ ة ّ يبناج ضارعأ · (tachyarrhythmia) مظتنم ريغو عيرس ضبن · سفنتلا يف تابوعص · ة ّ كح · ىرش · فعضلاب ماع موعش · دبكلا تاميزنإ ميق ضعب يف طسوتم ىتح فيفخ عافترا (ة ّ يلصم نيمأ تلاقان) · تظحول ةيبصعلاو كابترلاا ،ةسولهلا نم ةقرفتم تلااح امك ،نيجلاعتملا نم ةغلابلا ةيناكسلا ةئفلا ىدل بلغلأا ىلع لمع ةيلأ تاذ ىرخأ ةيودأو ة ّ ي Llegiu el document complet
Spasmolyt – Summary of Product Characteristics SPASPC 032011 MegaPharm Ltd. 1 1. NAME OF THE MEDICINAL PRODUCT SPASMO-LYT 20 MG, coated tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredient is trospium chloride. Each coated tablet contains 20 mg trospium chloride. Excipients: includes 7mg lactose monohydrate, 39mg sucrose and 19mg wheat starch per coated tablet. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Coated tablet. Brownish-yellow, glossy coated, biconvex tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder (e.g. idiopathic or neurologic detrusor overactivity). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION One coated tablet twice daily (equivalent to 40 mg of trospium chloride per day). In patients with severe renal impairment (creatinine clearance between 10 and 30 mL/min/1.73 m 2 ) the recommended dosage is: One coated tablet per day or every second day (equivalent to 20 mg of trospium chloride per day or every second day). The coated tablet should be swallowed whole with a glass of water before the meals on empty stomach. The need for continued treatment should be reassessed at regular intervals of 3-6 months. Since no data are available the use in children under 12 years of age is contraindicated. 4.3 CONTRAINDICATIONS Trospium chloride is contraindicated in patients with urinary retention, severe gastro-intestinal condition (including toxic megacolon), myasthenia gravis, narrow-angle glaucoma, and tachyarrhythmia. Trospium chloride is also contraindicated in patients who have demonstrated hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Trospium chloride should be used with caution by patients: - With obstructive conditions of the gastrointestinal tract such as pyloric stenosis - With obstruction of the urinary flow with the risk of formation of urina Llegiu el document complet