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  • Laxative Compound
    / Teva

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    1-3 tablets at bedtime.




    Hypersensitivity to any ingredient of the preparation.
    Pregnancy and breastfeeding.
    Children under 12 years old.
    Acute surgical abdomen.
    Not to be taken in the presence of nausea, vomiting, abdominal pain or other symptoms of appendicitis; fecal impaction, intestinal obstruction, undiagnosed rectal bleeding, inflammatory colon diseases (e.g. Crohn’s disease, ulcerative colitis), and severe dehydration state with water and electrolyte depletion.
    Obstructive uropathy (e.g. bladder neck obstruction due to prostatic hypertrophy).

    Special Precautions

    If laxatives are needed every day the cause of the constipation should be investigated. Long-term use of laxatives should be avoided.
    If stimulant laxatives are taken for longer than a brief period of treatment, this may lead to impaired function of the intestine and dependence on laxatives, and also to electrolyte imbalance.
    Patients with kidney disorders should be aware of possible electrolyte imbalance.
    If symptoms worsen or do not improve after 7 days, contact a doctor.
    Abuse of Laxatives: Typical symptoms of Laxative abuse include abdominal pain, weakness, fatigue, thirst, vomiting, edema, bone pain (due to osteomalacia), fluid and electrolyte imbalance, hypoalbuminemia (due to protein-losing gastroenteropathy), and syndromes that mimic colitis. If the bowel has not been permanently damaged, it may require several months to retain the bowel without the assistance of laxatives.
    Belladonna alkaloids may produce a delay in gastric emptying (antral stasis) which would complicate the management of gastric ulcer. Theoretically, with overdosage, a curare-like action may occur.
    In the presence of a high environmental temperature, heat prostration can occur with belladonna alkaloids (fever and heatstroke due to decreased sweating).
    Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance treatment with this drug would be inappropriate and possibly harmful.
    Use in Pediatrics: Not to be used in children under 12 years of age.
    See prescribing information for full details.

    Side Effects

    Abdominal colic and flatulence may occur.
    Skin rashes or eruptions may appear in individuals sensitive to phenolphthalein.
    Cardiac distress has occurred with phenolphthalein use.
    Respiratory distress has occurred with the use of phenolphthalein.

    Drug interactions

    Laxative-induced diarrhea may interfere with the full absorption of many drugs. It would therefore be prudent to ensure an adequate interval of time (at least 2 hours), between the ingestion of laxatives and other drugs (including antacids). In the case of oral contraceptives, it is recommended to use additional precautionary measures.
    Hypokalaemia (resulting from long-term laxative abuse) potentiates the action of cardiac glycosides and interacts with antiarrhythmic medicinal products, with
    medicinal products, which induce reversion to sinus rhythm (e.g. quinidine) and with medicinal products inducing QT-prolongation. Concomitant use with other medicinal products inducing hypokalaemia (e.g. diuretics, corticosteroids and liquorice root) may enhance electrolyte imbalance.

    Pregnancy and Lactation

    Pregnancy: Safety of use in pregnancy has not been established. Therefore this drug should not be used during pegnancy.
    Breastfeeding: Phenolphthalein appears in breast milk. Use during breastfeeding is not recommended.

    Teva Pharmaceutical Industries Ltd, Israel