Medicinal Products

DIACEREIN ZENTIVA 50 mg

Generic Medicine of Art
Therapeutic class: Rheumatology
active ingredients: Diacerein
laboratory: Sanofi-Aventis France

capsule
Box of 30
All forms

Indication

Delayed symptomatic treatment of osteoarthritis of the hip and knee.

Dosage DIACEREINE ZENTIVA 50 mg Capsule Box of 30

RESERVED FOR ADULTS (over 15 years).

Oral way.

The capsules are swallowed as is, without opening them, 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 dosages should be reduced by half.

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

This medicine is contraindicated in case of:

inflammatory organic colopathy (ulcerative colitis, Crohn's disease),

occlusive or sub-occlusive syndrome,

abdominal pain syndromes of undetermined cause,

hypersensitivity to rhein and substances of close activity,

hypersensitivity to any of the excipients,

severe hepatic insufficiency.

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.

Undesirable effects Diacereine Zentiva

Gastrointestinal effects:

The most commonly reported adverse reactions were diarrhea, loose stools, abdominal pain.

Pigmentation of the recto-colic 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 Warnings and Precautions section ) have been reported since the product was placed on the market.

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