Publisher: Rafa Laboratories Ltd, POB 405, Jerusalem 91003
This medicinal product is contraindicated in case of:
ART 50 mg, capsule must not be administered to children under the age of 15 years.
This medicinal product should not be taken during pregnancy or lactation.
Taking into account frequency of diarrhoea, beware of dehydration risk, especially for elderly and/or for subjects receiving ACE inhibitors or diuretics, due to an increase of salt and water depletion risk. Treatment with Art 50 mg, hard capsule should be stopped in case of symptoms suggesting a hepatic disorder.
Due to the presence of lactose, this medicinal product must not be administered in the event of congenital galactosemia, glucose or galactose malabsorption syndrome or lactase deficiency.
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.
Animal studies have shown retarded foetal ossification due to a maternotoxic effect at high doses.
In clinical practice, no sufficiently pertinent data are currently available for evaluation of a potential malformative or fetotoxic effect of diacerein administered during pregnancy.
Therefore, the use of this medicinal product during pregnancy is not advised.
This product should not be administered to lactating women, minimal excretion of anthraquinone derivatives in breast milk has been reported in the literature.
Not applicable.
Gastrointestinal effects: The most frequently reported adverse effects were diarrhoea, soft stools, abdominal pain. Pigmentation of the colorectal mucosa (colonic melanosis) has been rarely observed. Urine dark coloration related to the molecule structure and without pathological account may be noticed.
Cutaneous effects: Cases of pruritus, rash, and eczema have been reported.
Hepatobiliary affections: Cases of hepatic disorder, especially cytolytic (see chapter 4.4) have been reported since marketing of the medicinal product.
Not applicable.
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