Ülke: Ermenistan
Dil: İngilizce
Kaynak: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
diosmectite
Beaufour Ipsen Industrie
A07BC05
diosmectite
3g
powder for oral suspension with orange flavour
(10) sachets 3,76g, (30) sachets 3,76g
OTC
Registered
2015-02-20
_CIS 6 956 407 3 _ 1 _MOOO/1000/003 _ APPENDIX I SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT SMECTA 3 G ORANGE-VANILLA, POWDER FOR ORAL SUSPENSION IN SACHET 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Diosmectite ………………………………………………………………………..3.000 g For one sachet of 3.760 g. Excipients with a known effect: glucose, sucrose. A full list of excipients is given in section 6.1. 3. PHARMACEUTICAL FORM Powder for oral suspension . 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Treatment of acute diarrhoea in children and infants, in addition to oral rehydration and in adults. Symptomatic treatment of chronic functional diarrhoea in adults. Symptomatic treatment of pain associated with functional bowel diseases in adults. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Treatment of acute diarrhoea: In infants and children: • Up to 1 year: 2 sachets per day for 3 days, then 1 sachet per day. • 1 year and older: 4 sachets per day for 3 days, then 2 sachets per day. In adults: on average, 3 sachets per day. In practice the daily dose can be doubled at the start of treatment. Other indications: In adults: on average of 9 grams (3 sachets) per day. METHOD OF ADMINISTRATION Oral route The contents of the sachet must be mixed in suspension, just before use. In infants and children, the contents of the sachet can be mixed in a feeding bottle of 50 ml of water to be given at intervals during the day, or mixed with semi-liquid food, such as broth, compote, puree, baby food... In adults, the contents of the sachet can be mixed into half a glass of water. 4.3. CONTRAINDICATIONS Hypersensitivity to diosmectite or to any of the excipients listed in section 6.1. 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE _CIS 6 956 407 3 _ 2 _MOOO/1000/003 _ Diosmectite must be used with caution in patients with a history of severe chronic constipation. In children, acute diarrhoea must be treated in conjunction with early administration of an oral rehydrat Belgenin tamamını okuyun