URSOFALK Capsule, hard Ref.[50874] Active ingredients: Ursodeoxycholic acid

There are no age restrictions on the use of Ursofalk 250mg hard capsules in the treatment of PBC and for the dissolution of radiolucent gallstones. For patients weighing less than 47 kg or patients who are unable to swallow Ursofalk capsules, Ursofalk suspension is available.

The following daily dose is recommended for the various indications:

For primary biliary cirrhosis (PBC)

The daily dose depends on body weight, and ranges from 3 to 7 capsules (14 ± 2 mg UDCA per kg of body weight).

For the first 3 months of treatment, Ursofalk capsules should be taken divided over the day. With improvement of the liver values the daily dose may be taken once daily in the evening.

The capsules should be swallowed whole with some liquid. Care should be taken to ensure that they are taken regularly.

The use of Ursofalk capsules in PBC may be continued indefinitely.

Dissolution of Gallstones

Adults: The usual dose is 8-12mg/kg/day to be taken in the evening, e.g. 750mg, daily in the evening.

The time required for dissolution of gallstones is likely to range from 6 to 24 months depending on stone size and composition.

Follow-up cholecystograms or ultrasound investigation may be useful at 6 month intervals until the gallstones have disappeared.

Treatment should be continued until 2 successive cholecystograms and/or ultrasound investigations 4-12 weeks apart have failed to demonstrate gallstones. This is because these techniques do not permit reliable visualisation of stones less than 2mm in diameter. The likelihood of recurrence of gallstones after dissolution by bile acid treatment has been estimated as up to 50% at 5 years. The efficiency of Ursofalk in treating radio-opaque or partially radio-opaque gallstones has not been tested but these are generally thought to be less soluble than radiolucent stones. Non-cholesterol stones account for 10-15% of radiolucent stones and may not be dissolved by bile acids.

Older people

There is no evidence to suggest that any alteration in the adult dose is needed but the relevant precautions should be taken into account.

Paediatric population

Cholesterol rich gallstones and PBC are very rare in children but when they occur, dosage should be related to bodyweight. There are no adequate data on the efficacy and safety in this population.

Hepatobiliary disorders associated with cystic fibrosis

Paediatric population

Children with cystic fibrosis aged 6 to 18 years: 20 mg/kg/day in 2-3 divided doses, with a further increase to 30 mg/kg/day if necessary.

Diarrhoea may occur in cases of overdose. In general, other symptoms of overdose are unlikely because the absorption of UDCA decreases with increasing dose and therefore more is excreted with the faeces.

No specific counter-measures are necessary and the consequences of diarrhoea should be treated symptomatically with restoration of fluid and electrolyte balance.

Additional information on special populations

Long-term, high-dose UDCA therapy (28-30 mg/kg/day) in patients with primary sclerosing cholangitis (off-label use) was associated with higher rates of serious adverse events.

5 years.

This medicinal product does not require any special storage conditions.

Clear PVC blister strips with aluminium foil backing packed in cardboard cartons. Available in cartons containing 60 capsules packaged in six blister strips of 10 capsules or 100 capsules packaged in 4 blister strips of 25 capsules.

No special requirements.