Artrodar Special Precautions

ARTRODAR has a slow onset of action but its effects persist for at least 2 months after treatment is stopped. In fact, due to this delay in the onset of action (30 to 45 days to attain an analgesic effect) it may be necessary not only to begin treatment with the usual analgesics/anti-inflammatory drugs whose onset of action is immediate, but also to take ARTRODAR without interruption for a minimum of one month to be able to observe its beneficial effects (see Dosage & Administration).
Patients with moderate renal insufficiency should be followed as a precaution. In addition, the doses of diacerein should be decreased in accordance with that stated in the Dosage & Administration section and tests of renal function carried out periodically.
To assure the tolerability of the preparation (for example, loose stools), clinical experience suggests that treatment should be started with half the recommended daily dose (50 mg/day diacerein) for the first 2 to 4 weeks and then, the dose can be increased to the recommended dose of 100 mg/day (see Dosage & Administration).
Diarrhoea: Intake of diacerein frequently leads to diarrhoea that can consequently lead to dehydration and hypokalaemia. Patients should be advised to stop diacerein treatment in case of diarrhoea and contact their physician to discuss treatment alternatives. As elderly patients are more vulnerable to complications associated with severe diarrhoea, diacerein is not recommended in patients older than 65 years.
Caution should be exercised in patients receiving diuretics, because dehydration and hypokalaemia may occur. Particular caution should also be exercised in case of hypokalaemia in patients treated with cardiac glycosides (digitoxin, digoxin).
Laxatives should not be taken concomitantly with ARTRODAR.
Hepatotoxicity: Elevated serum hepatic enzyme levels and symptomatic acute hepatic injury have been reported with diacerein in the post-marketing phase.
Before treatment with diacerein is initiated, the patient should be questioned about possible comorbid conditions and past or concurrent liver disease and screened for major causes of active hepatic disease. A diagnosis of liver disease is a contraindication to diacerein use.
Signs of hepatic injury should be monitored and caution should be exercised when diacerein is used concomitantly with other medicinal products associated with hepatic injury. Patients should be advised to limit their alcohol intake while on treatment with diacerein.
Treatment with diacerein should be stopped if elevation of hepatic enzymes or suspected signs or symptoms of liver damage are detected. Patients should be advised about the signs and symptoms of hepatotoxicity and must be advised to immediately contact their physician in case of appearance of symptoms suggestive of liver damage (see Side Effects).
Due to the presence of lactose, this medicine is contraindicated in patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
Effects on ability to drive and use machines: No sedative effect, which may affect the ability to handle machines, is known for diacerein.