Land: Armenië
Taal: Engels
Bron: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
eschscholtzia extract, hawthorn extract, magnesium oxide
Innothera Chouzy
N05CM
eschscholtzia extract, hawthorn extract, magnesium oxide
20mg+75mg+124,35mg
tablets film-coated
(40/2x20/) blisters
Prescription
Registered
2015-07-20
Validated 18/04/2011 PP DARP APPENDIX I SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT SYMPATHYL, film-coated tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Eschscholtzia (dry aqueous extract) .. .................................................................................... 20.00 mg Hawthorn (dry hydro-alcoholic extract of the flower) ............................................................ 75.00 mg Heavy magnesium oxide … .................................................................................................. 124.35 mg Equivalent to 75 mg elemental magnesium, i.e. ...................................................................... 6.2 mEq For one film-coated tablet For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Traditionally used in: the symptomatic treatment of neurotonic states in adults, minor sleep disorders, disorders due to cardiac erethism in adults with a healthy heart. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION For adults only. The usual dose is 4 tablets per day, 2 in the morning and 2 in the evening, before meals. 4.3. CONTRAINDICATIONS This medicinal product MUST NEVER be prescribed in the following cases: hypersensitivity to any of the constituents; severe renal impairment (creatinine clearance under 30ml/min/1.73 m 2 ) This medicinal product MUST NORMALLY NOT be prescribed in the following cases: in combination with quinidinics (see section 4.5). Validated 18/04/2011 PP DARP 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE This drug contains an azo colouring agent (E122) and may cause allergic reactions. 4.5. INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Combination not recommended: + QUINIDINICS Increased plasma concentrations of quinidine and risk of overdose (decreased renal excretion of quinidine because of urine alkalinisation). 4.6. PREGNANCY AND LACTATION PREGNANCY: There are no reliable data on tera Lees het volledige document