Medicinal Products

ART 50 mg

Generic drug of the therapeutic class: Rheumatology
Active ingredients: Diacerein
laboratory: Negma

capsule
Box of 30
All forms

Indication

Delayed symptomatic treatment of osteoarthritis of the hip and knee.

Dosage ART 50 mg Capsule Box of 30

RESERVED FOR ADULTS (over 15 years).
Oral way.
- The capsules are swallowed as is, without opening, with a glass of water, preferably in the middle of meals.
- The recommended dosage is 2 capsules per day, divided into 1 taken in the morning and 1 taken in the evening.
- In the elderly, in patients with moderate hepatic impairment or renal impairment, there is no need to change the dosage.
- In patients with severe renal impairment (creatinine clearance less than 30 ml / min), daily doses should be halved.

ANSM alert of the 08/12/2014

It is now recommended to prescribers:

- Initiate half-dose treatment at 50 mg once daily for dinner during the first 2 to 4 weeks of treatment and then at 50 mg twice daily during a meal.

Against indications

CONTRAINDICATED:
- This medicine is contraindicated in case of:
. hypersensitivity to rhein and substances of close activity,
. hypersensitivity to any of the excipients,
. inflammatory organic colopathy (ulcerative colitis, Crohn's disease ...),
. occlusive or subocclusive syndrome,
. abdominal pain syndromes of undetermined cause,
. severe hepatic insufficiency.
- Due to the presence of lactose, this drug should not be used in cases of congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency.
- ART 50 mg capsule should not be administered to children under 15 years of age.
NOT RECOMMENDED :
This drug is not recommended during pregnancy and lactation:
Pregnancy: in animals, an experimental study showed a delay in ossification in the fetus, due to a maternotoxic effect at high doses. In clinical practice, there are currently no data of sufficient relevance to evaluate the possible malformative or foetotoxic effect of diacerein when administered during pregnancy. As a result, the use of this drug is not recommended during pregnancy.
- breastfeeding: it is not recommended to administer this product to women during breastfeeding, the passage of anthraquinone derivatives in breast milk in minimal proportions has been highlighted in the literature.

ANSM alert of the 08/12/2014

It is now recommended to prescribers:

- not to prescribe drugs containing diacerein in persons over 65 years of age.

Prescribers must strictly respect contraindications and warnings when prescribing a drug containing diacerein:

- contraindicated in patients with a history of liver disease.

Adverse effects Art

- Gastrointestinal effects:
. The most commonly reported adverse reactions were diarrhea, loose stools, abdominal pain.
. Pigmentation of the rectocolic mucosa (colonic melanosis) was rarely observed.
. A dark coloration of the urine in relation to the structure of the molecule and without pathological value can be observed.
- Skin effects:
Cases of pruritus, rashes and eczema have been described. - Hepatobiliary disorders:
cases of liver damage, particularly cytolytic (see section on warnings and precautions for use) have been reported since marketing.

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