Medicinal Products

DELURSAN 500 mg

Generic drug of the therapeutic class: Gastro-Entero-Hepatology
active ingredients: Ursodeoxycholic acid
laboratory: Aptalis

Coated tablet
Box of 20
All forms

Indication

Primary biliary cirrhosis

Primary sclerosing cholangitis

Chronic cholestasis of cystic fibrosis

Progressive familial intrahepatic cholestasis type III

Symptomatic cholestasis

Biliary lithiasis of LPAC syndrome (Low phospholipid Associated Cholethiasis)

Cholesterol cholestatic cholelithiasis : in a non-sclero-atrophic, normal-walled, symptomatic vesicle in patients with a contraindication to surgery.

Dosage DELURSAN 500 mg Film-coated tablet Box of 20

Oral way.

cholestasis

Primary biliary cirrhosis: 13 to 15 mg / kg / day

Primary sclerosing cholangitis: 15 to 20 mg / kg / day. Do not exceed the dosage of 20 mg / kg / day

Chronic cystic fibrosis: 20 to 30 mg / kg / day

Genetic cholestasis: 20 to 30 mg / kg / day

The initial dosage is of the order of 13 to 15 mg / kg / day. It is recommended to gradually increase the dose in stages to obtain the optimal dosage after 4 and 8 weeks of treatment without exceeding the dose of 20 mg / kg / day in primary sclerosing cholangitis (see section Warnings and precautions for use). special warnings)

Symptomatic cholestasis: 10 to 20 mg / kg / day in continuous treatment until delivery. The maximum daily dose in pregnancy cholestasis should not exceed 1000mg / day, divided into 2 doses, morning and evening, at mealtimes.

Cholesterol biliary lithiasis:

The recommended dosage is in the range of 5 to 10 mg / kg / day, depending on the weight of the patient.

It is recommended to take the treatment either one in the evening or two in the morning and evening.

Against indications

This medicine should not be used in the following cases:

· Acute cholecystitis,

· Cholangitis,

· Obstruction of the bile ducts,

· Sclero-atrophic vesicle,

Hypersensitivity to the active substance or to any of the excipients.

Delursan side effects

The side effects are listed below, listed by organ class and frequency. Frequencies are defined as very common (> 1/10), frequent (> 1/100 to <1/10), uncommon (> 1/1, 000 to <1/100), rare (1/10, 000 <1/1, 000) and very rare (<1/10, 000) including isolated cases. Very frequent and frequent effects have generally been described in clinical trials. Rare and very rare side effects are usually from spontaneous post-marketing reports.

Gastrointestinal disorders

· Common: pasty stools, diarrhea

· Very rare: pain of the right hypochondrium during treatment of primary biliary cirrhosis

Hepatobiliary disorders

· Very rare: calcified gallstones, decompensation of hepatic cirrhosis, partially regressive at the end of treatment, in case of initiation of treatment of advanced biliary cirrhosis

Skin and subcutaneous tissue disorders

· Very rare: urticaria.

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