מדינה: ישראל
שפה: אנגלית
מקור: Ministry of Health
DICYCLOMINE HYDROCHLORIDE
CTS CHEMICAL INDUSTRIES LTD
A03AA07
SYRUP
DICYCLOMINE HYDROCHLORIDE 10 MG / 5 ML
PER OS
Required
CTS CHEMICAL INDUSTRIES LTD
DICYCLOVERINE
DICYCLOVERINE
Adjunctive therapy in irritable bowel syndrome, neurogenic bowel disturbance.
2010-02-28
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Notensyl Tablets Notensyl Syrup 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet of Notensyl contains Dicyclomine hydrochloride 10mg Each 5ml of Notensyl Syrup contain Dicyclomine hydrochloride 10mg 3. PHARMACEUTICAL FORM Tablets , syrup 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adjunctive therapy in irritable bowel syndrome, neurogenic bowel disturbance 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: Oral _tablets _ _Adolescents and Adults (above 12 years): 10-20mg three times daily before or after meals. _ _Children (2-12 years):_ 10mg three times daily. syrup Adults 5-10 ml (10 - 20mg) three times daily before or after meals. Children (2-12 years): 5ml (10mg) three times daily. Children (6 months - 2 years) 2.5 ml (5mg) three or four times daily, 15 minutes before feeds. Do not exceed a daily dose of 40mg. 4.3 CONTRAINDICATIONS Tablets and syrup • Known idiosyncrasy to dicyclomine hydrochloride. syrup • Infant under 6 months of age • Patients with rare heredity problems of fructose intolerance, glucose galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Products containing dicyclomine hydrochloride should be used with caution in any patient with or suspected of having glaucoma or prostatic hypertrophy. Use with care in patients with hiatus hernia associated with reflux oesophagitis because anticholinergic drugs may aggravate the condition. There are reports of infants, 3 months of age and under, administered dicyclomine hydrochloride syrup who have evidenced respiratory symptoms (breathing difficulty, shortness of breath, breathlessness, respiratory collapse, apnoea) as well as seizures, syncope, asphyxia, pulse rate fluctuations, muscular hypotonia and coma. The above symptoms have occurred within minutes of ingestion and lasted 20-30 minutes. The symptoms were reported in association with dicyclomine hydrochloride syru קרא את המסמך השלם