Țară: Armenia
Limbă: engleză
Sursă: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
ascorbic acid
Arpimed LLC
A11GA01
ascorbic acid
250mg
tablets
(10/1x10/) in blister
OTC
Registered
2020-05-01
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Vitamin C 250 mg tablets Vitamin C 500 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 250mg of ascorbic acid. Each tablet contains 500mg of ascorbic acid. For excipients, see 6.1. 3. PHARMACEUTICAL FORM Tablet 250mg tablets: round biconvex white tablets scored on one side; without odor 500mg tablets: slightly violet round biconvex tablets of white color; without odor 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention and treatment of scurvy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: Oral Dose Adults (including the elderly) and children over 6 years: _ _ _Prophylactic:_ 25 – 75 mg daily. Note: Thеsе unit dosages forms аre unsuitable for prophylactic use. _Therapeutic: _Not less than 250mg daily in divided doses. Maximum of 1000mg daily. Children under 6 years: These unit dosage forms are unsuitable for children under 6 years. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Ascorbic acid should not be given to patients with hyperoxaluria. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Increased intake of ascorbic acid over a prolonged period may result in an increase in renal clearance of ascorbic acid and deficiency may result if it is withdrawn rapidly (see section 4.8). Interference with serological testing Ascorbic acid may interfere with tests and assays for urinary glucose, giving false-negative results with methods utilising glucose oxidase with indicator (e.g. Labstix, Tes-Tape) and false- positive results with neocuproine methods. Estimation of uric acid by phosphotungstate or uricase with copper reduction and measurement of creatinine in non-deproteinised serum may also be affected. High doses of ascorbic acid may give false-negative readings in faecal occult blood tests. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not Citiți documentul complet