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    / CTS


    Active Ingredient

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Tablets

    20 X 10 mg

    full basket chart 1513 14159

    Related information


    Dosage

    Tablets
    Adolescents and Adults (above 12 years): 10-20mg three times daily before or after meals.
    Children (2-12 years): 10mg three times daily.


    Indications

    Adjunctive therapy in irritable bowel syndrome, neurogenic bowel disturbance.


    Contra-Indications

    Known idiosyncrasy to dicyclomine hydrochloride.


    Special Precautions

    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 syrup therapy but the cause and effect relationship has neither been disproved nor proved. The timing and nature of the reactions suggest that they were a consequence of local irritation and/or aspiration, rather than to a direct pharmacological effect.
    Although no causal relationship between these effects, observed in infants and dicyclomine administration has been established, dicyclomine hydrochloride is contra-indicated in infants under 6 months of age.


    Side Effects

    Side-effects seldom occur with dicyclomine. However, in susceptible individuals, dry mouth, thirst and dizziness may occur. On rare occasions, fatigue, sedation, blurred vision, rash, constipation, anorexia, nausea and vomiting, headache and dysuria have also been reported.


    Drug interactions

    Anticholinergics.


    Pregnancy and Lactation

    Pregnancy: Epidemiological studies in pregnant women with products containing dicyclomine hydrochloride (at doses up to 40mg/day) have not shown that dicyclomine hydrochloride increases the risk of foetal abnormalities if administered during the first trimester of pregnancy.
    Reproduction studies have been performed in rats and rabbits at doses of up to 100 times the maximum recommended dose (based on 60mg per day for an adult person) and have revealed no evidence of impaired fertility or harm to the foetus due to dicyclomine. Since the risk of teratogenicity cannot be excluded with absolute certainty for any product, the drug should be used during pregnancy only if clearly needed.
    Lactation: It is not known whether dicyclomine is secreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when dicyclomine is administered to a nursing mother.


    Overdose

    Symptoms of dicyclomine overdosage are headache, dizziness, nausea, dry mouth, difficulty in swallowing, dilated pupils and hot dry skin. Treatment may include emetics, gastric lavage and symptomatic therapy if indicated.


    Manufacturer
    CTS Chemical Industries Ltd
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