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  • Ursofalk
    / Rafa


    Active Ingredient
    Ursodeoxycholic Acid 250mg, 500mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Capsules

    100 X 250 mg

    full basket chart 65322 21092

    Film Coated Tablets

    50 x 500 mg

    full basket chart 55418 21120

    Dosage

    There are no age restrictions on the use of this drug.  For patients weighing less than 47 kg or patients who are unable to swallow 500mg tablets, 250 mg capsules are available.
    For the symptomatic treatment of primary biliary cirrhosis (PBC): The daily dose depends on body weight and ranges from 1½ to 3½ tablets (14 ± 2 mg of Ursodeoxycholic acid per kg of body weight). For the first 3 months of treatment, should be taken divided over the day. When the liver function parameters improve, the daily dose may be taken once daily in the evening. For dosage adjustments according to body weight – see prescribing information for full details. The tablets should be swallowed whole with some liquid. They must be taken regularly. The use of the drug in primary biliary cirrhosis may be continued indefinitely. In patients with primary biliary cirrhosis, in rare cases the clinical symptoms may worsen at the beginning of treatment, e.g. the itching may increase. In this event, therapy should first be continued with half of  500 mg tablet or one 250 mg capsule daily, and the dose then gradually increased (weekly increase of the daily dose by half a tablet or one 250 mg capsule) until the dose indicated in the respective dosage regimen is reached again.
    Elderly: There is no evidence to suggest that any alteration in the adult dose is needed but the relevant precautions should be taken into account.
    Children and adolescents:The indication is very rare in children and adolescents. Therefore there are no adequate data on the efficacy and safety in this population. The administration of the drug is based on body weight and the medical condition.


    Indications

    For the symptomatic treatment of primary biliary cirrhosis (PBC), in patients without decompensated hepatic cirrhosis.


    Contra-Indications

    Should not be used in patients with: Acute inflammation of the gall bladder or biliary tract. Occlusion of the biliary tract (occlusion of the common bile duct or cystic duct). Frequent episodes of biliary colic. Radio-opaque calcified gallstones. Impaired contractility of the gall bladder. Hypersensitivity to bile acids or any excipient of the medicinal product.


    Special Precautions

    During the first 3 months of treatment, liver function parameters AST (SGOT), ALT (SGPT) and g-GT should be monitored by the physician every 4 weeks, thereafter every 3 months. Apart from allowing for identification of responders or non-responders in patients being treated for primary biliary cirrhosis, this monitoring would also enable early detection of potential hepatic deterioration, particularly in patients with advanced stage primary biliary cirrhosis. When used for treatment of the advanced stages of primary biliary cirrhosis: In very rare cases decompensation of the hepatic cirrhosis has been observed; which partially regressed after the treatment discontinued. If diarrhoea occurs, the dose must be reduced and in cases of persistent diarrhoea, the therapy should be discontinued.


    Side Effects

    Pasty stools or diarrhea, abdominal pain.
    See prescribing information for full details.


    Drug interactions

    Should not be administered concomitantly with colestyramine, colestipol or antacids containing aluminium hydroxide and/or smectite (aluminium oxide), because these preparations bind ursodeoxycholic acid in the intestine and thereby inhibit its absorption and efficacy. Should the use of a preparation containing one of these substances be necessary, it must be taken at least 2 hours before or after use of Ursofalk 500 mg tablets.See prescribing information for full details. These observations, together with in-vitro findings could indicate a potential for ursodeoxycholic acid to induce cytochrome P450 3A enzymes. Controlled clinical studies have shown, however, that ursodeoxycholic acid does not have a relevant inductive effect on cytochrome P450 3A enzymes.
    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy: There are no adequate data on the use of Ursodeoxycholic acid, particularly in the first trimester of pregnancy.
    See prescribing information for full details.
    Lactation: It is not known whether Ursodeoxycholic acid passes into breast milk.                    


    Overdose

    Diarrhea may occur in cases of overdose. In general, other symptoms of overdose are unlikely because the absorption of Ursodeoxycholic acid decreases with increasing dose and therefore more is excreted with the faeces. No specific counter-measures are necessary and the consequences of diarrhea should be treated symptomatically with restoration of fluid and electrolyte balance.


    Manufacturer
    Dr. Falk Pharma
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