ProUrsan Forte Dosage/Direction for Use

There are no age restrictions on the use of Ursodeoxycholic Acid (ProUrsan Forte). Ursodeoxycholic Acid (ProUrsan Forte) is suitable for patients with body weight of 47 kg and over. For patients weighing less than 47 kg or patients who are unable to swallow Ursodeoxycholic Acid (ProUrsan Forte) other formulations are available.
The following daily dosage is recommended for the various indications: For the dissolution of cholesterol gallstones Approx. 10 mg of ursodeoxycholic acid per kg of body weight corresponding to: See Table 1.

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The film-coated tablets should be taken unchewed in the evening before bedtime with some liquid.
The tablets have to be taken regularly.
The time required for dissolution of gallstones is generally 6 to 24 months, depending on stone size and composition. If there is no reduction in the size of the gallstones after 12 months, the therapy should not be continued.
The success of treatment should be checked sonographically or radiographically every 6 months. It should also be checked during follow-up examinations whether in the meantime there has been any calcification of the stones. If this is the case, the treatment should be ended.
For symptomatic treatment of primary biliary cholangitis (PBC): The daily dose depends on the body weight and ranges from 1 ½ to 3 ½ film-coated tablets (14±2 mg of ursodeoxycholic acid per kg of body weight).
For the first 3 months of treatment Ursodeoxycholic Acid (ProUrsan Forte) should be taken divided over the day. With improvement of the liver values, the daily dose may be taken once daily in the evening. (See Table 2.)

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The film-coated tablets should be swallowed unchewed with some liquid. Care should be taken to ensure that they are taken regularly.
The use of Ursodeoxycholic Acid (ProUrsan Forte) in PBC may be continued indefinitely.
It is possible that at the beginning of treatment in patients with primary biliary cholangitis the clinical symptoms worsen, e.g. an aggravation of itching occurs. If this is the case, the therapy is to be continued with ½ filmcoated tablets of Ursodeoxycholic Acid (ProUrsan Forte) per day and the therapy gradually (increase in the daily dose by ½ film-coated tablets per week) carried on, until the dose planned in the respective dosage plan is reached again.
Paediatric population: Children with cystic fibrosis aged 6 to less than 18 years: 20 mg/kg/day in 2-3 divided doses, with a further increase to 30 mg/kg/day if necessary. (See Table 3.)

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