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    / Trima


    Active Ingredient
    Diacerein 50 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Capsules

    30 X 50 mg

    partial basket chart 12510 4467

    Related information


    Dosage

    Adults (aged over 15 years): As some patients may experience loose stools or diarrhea, the recommended starting dose is 50 mg once daily with evening meal for the first 2 to 4 weeks of treatment, after which the recommended daily dose is 50mg twice daily .
    The treatment should be taken with food, one capsule with breakfast and the other capsule with evening meal. The capsules must be swallowed intact, without opening them, together with a glass of water.
    Patients older than 65 years: caution should be exercised during use of this medicine; close supervision and monitoring of adverse reactions should be performed.
    Elderly and in moderate renal impairment: there is no need to change the dosage. In severe renal insufficiency (creatinine clearance below 30 ml/min), the daily dosage are to be halved.


    Indications

    Symptomatic treatment of functional symptoms of osteoarthritis.


    Contra-Indications

    – Inflammatory organic bowel disease (ulcerative colitis, Crohn’s disease).
    – Intestinal obstruction or partial obstruction.
    – Abdominal pain syndromes of indeterminate etiology.
    – Known allergy to rhein (substance in the anthraquinone group) and substances with similar activity.
    – Known hypersensitivity to any excipient.
    – Current and/or history of liver disease.


    Special Precautions

    Diacerin capsules should not be given to children under 15 years.
    This medicine is not recommended during pregnancy and lactation.
    This product contains lactose. This medicine must not be administered in the event of congenital galactosemia, glucose or galactose malabsorption syndrome or lactase deficiency.
    See prescribing information for full details.


    Side Effects

    Very common (> 1/10): diarrhea, abdominal pain.
    Common (> 1/100 and < 1/10): frequent bowel movements, flatulence. pruritus, rash, eczema.
    See prescribing information for full details.


    Drug interactions

    Combinations requiring precautions for use
    – Antacids (aluminum, calcium, and magnesium salts, oxides or hydroxides):
    Decreased of digestive absorption of diacerein.
    Antacids should be taken separately from diacerein, allowing for an interval of greater than 2 hours if possible.
    – Diuretic and/or cardiac glycosides:
    Intake of diacerein can lead to diarrhea and hypokalemia. Caution must be exercised in the concomitant administration of diuretics (high-ceiling loop and thiazides) and/or cardiac glycosides (digitoxin, digoxin), as the risk of arrhythmia is increased.


    Pregnancy and Lactation

    Pregnancy: Clinically, there is currently no adequate data to assess a potential teratogenic or foetotoxic effect of diacerin when administered during pregnancy.
    Accordingly, the use of this medicine is not recommended during pregnancy.
    Lactation: It is not recommended to administer the product to women during lactation, the passage of the anthraquinone derivatives in breast milk in minimal proportions were highlighted in the literature.


    Overdose

    Profuse diarrhea may occur in the event of overdose. Symptomatic treatment should then be instituted and electrolyte disorders and dehydration corrected if necessary.


    Manufacturer
    Trima Israel Pharmaceutical Products Maabarot Ltd. Israel
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