CHOLURSO Film-coated tablet Ref.[27920] Active ingredients: Ursodeoxycholic acid

Oral route.

For patients weighing less than 47 kg or patients who are unable to swallow Cholurso 250 mg film-coated tablets, other formulations with ursodeoxycholic acid (e g oral suspension) should be checked for availability.

The following daily dose is recommended for the various indications:

For treatment of primary biliary cholangitis (PBC)

Stage I-III

The daily dose is dependent on body weight and ranges from 3 to 7 film-coated tablets (12-16 mg ursodeoxycholic acid per kg of body weight).

During the first 3 months of treatment, Cholurso 250 mg film-coated tablets should be taken at mealtime in divided doses throughout the day. If liver function improves, the total daily dose can be taken once.

Stage IV

In combination with increased serum bilirubin levels (>40 micrograms/L; conjugated), only half the normal dosage should initially be given (see dosage for stages I-III), (6-8 mg ursodeoxycholic acid per kg body weight per day, equivalent to about 2 to 3 Cholurso 250 mg film-coated tablets).

Thereafter, liver function should be closely monitored for several weeks (once every 2 weeks for 6 weeks). If there is no deterioration in liver function (AP, ALAT, ASAT, gamma-GT, bilirubin) and if no increased pruritus occurs, the dosage can be increased further to the usual level. However, liver function should again be closely monitored for several weeks. Once again, if there is no deterioration in liver function, the patient can be maintained at the normal dosage over the long term.

In rare cases the clinical symptoms may worsen at the beginning of treatment, e.g. increased itching. Should this occur, therapy should be continued with one 250 mg tablet daily, and the therapy gradually increased (increase of the daily dose weekly by one 250 mg tablet) until the dose indicated in the respective dosage regimen is reached again.

Patients with primary biliary cholangitis (stage IV) without increased serum bilirubin levels are allowed to receive the normal starting dose immediately (see dosage stages I-III).

However, close monitoring of liver function, as described above, is likewise applicable in such cases; treatment of primary biliary cholangitis will need to be regularly assessed on the basis of liver (laboratory) values and clinical findings.

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

Dissolution of Gallstones

Adults: Approx. 10 mg ursodeoxycholic acid (UDCA) per kg body weight per day according to:

• up to 60 kg: 2 tablets
• 61-80 kg: 3 tablets
• 81-100 kg: 4 tablets
• above 100 kg: 5 tablets

The tablet should be swallowed whole with some liquid in the evening before bedtime. Care should be taken to ensure that they are taken regularly.

Based on experience to date, the duration of the dissolution process with Ursodeoxycholic acid is 6 months to 2 years, depending on the initial size of the stones. For a proper assessment of the therapeutic outcome, it is necessary, at the start of treatment, to accurately determine the size of the existing stones and subsequently to monitor them regularly, for example, every 3 to 4 months, via new X-rays and/or ultrasound scans.

It should also be observed 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.

In patients whose stones have not decreased in size after six months of treatment at the dosage stated, it is recommended that the biliary lithogenic index be determined via duodenal samples. If the bile has an index of >1.0, it is unlikely that a favourable result can be obtained and it is better to consider a different form of treatment for gallstones. Treatment must be continued for 3 to 4 months after ultrasound follow-up has confirmed complete dissolution of the gallstones. Discontinuation of treatment for 3-4 weeks leads to a return of bile supersaturation and prolongs the overall duration of therapy. Discontinuation of treatment upon dissolution of the gallstones may be followed by a relapse.

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.

Diarrhoea 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 diarrhoea should be treated symptomatically with restoration of fluid and electrolyte balance.

Additional information on special populations: Long-term, high-dose ursodeoxycholic acid therapy (28-30 mg/kg/day) in patients with primary sclerosing cholangitis (off-label use) was associated with higher rates of serious adverse events.

3 years.

This medicinal product does not require any special storage conditions.

20, 30, 50, 60 or 100 tablets in blister packs (PVC / PVDC / Aluminium).

Not all pack sizes may be marketed.

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.