Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: PRO.MED.CS Praha a.s., Telcska 377/1, Praha 4, Michle, 14000, Czech Republic
For the dissolution of cholesterol gallstones in the gall bladder. The gallstones must not show as shadows on X-ray images and should not exceed 15 mm in diameter. The gall bladder must be functioning despite the gallstone(s).
For treatment of gall reflux gastritis.
For symptomatic treatment of primary biliary cholangitis (PBC), provided there is no decompensated hepatic cirrhosis.
Hepatobiliar disorder associated with cystic fibrosis in children aged 6 years to less than 18 years.
There are no age restrictions on the use of Proursan. Proursan is suitable for patients with body weight of 47 kg and over.
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:
| up to 60 kg | 2 hard capsules |
| 61 to 80 kg | 3 hard capsules |
| 81 to 100 kg | 4 hard capsules |
| over 100 kg | 5 hard capsules |
The hard capsules should be taken unchewed in the evening before bedtime with some liquid.
The capsules 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 treatment of gall reflux gastritis:
Take 1 hard capsule of Proursan once per day in the evening, before bedtime, unchewed with some liquid.
For treatment of gall reflux gastritis Proursan should generally be taken for 10 to 14 days. Generally, the duration of administration conforms to the course of disease. The attending doctor decides in detail throughout the duration of administration.
For symptomatic treatment of primary biliary cholangitis (PBC):
The daily dose depends on the body weight, and ranges from 3 to 7 hard capsules (14 ± 2 mg of ursodeoxycholic acid per kg of body weight).
For the first 3 months of treatment Proursan should be taken divided over the day. With improvement of the liver values, the daily dose may be taken once daily in the evening.
| Body weight (kg) | Proursan 250 mg capsules hard | |||
|---|---|---|---|---|
| first 3 months | subsequently | |||
| morning | midday | evening | evening (1 × daily) | |
| 47–62 | 1 | 1 | 1 | 3 |
| 63–78 | 1 | 1 | 2 | 4 |
| 79–93 | 1 | 2 | 2 | 5 |
| 94–109 | 2 | 2 | 2 | 6 |
| over 110 | 2 | 2 | 3 | 7 |
The hard capsules should be swallowed unchewed with some liquid. Care should be taken to ensure that they are taken regularly.
The use of Proursan 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 1 hard capsule of Proursan per day and the therapy gradually (increase in the daily dose by 1 hard capsule per week) carried on, until the dose planned in the respective dosage plan is reached again.
20 mg/kg/day in 2–3 divided doses, with a further increase to 30 mg/kg/day if necessary.
| Body weight (kg) | Proursan 250 mg capsules hard | ||
|---|---|---|---|
| morning | midday | evening | |
| 20–29 | 1 | - | 1 |
| 30–39 | 1 | 1 | 1 |
| 40–49 | 1 | 1 | 2 |
| 50–59 | 1 | 2 | 2 |
| 60–69 | 2 | 2 | 2 |
| 70–79 | 2 | 2 | 3 |
| 80–89 | 2 | 3 | 3 |
| 90–99 | 3 | 3 | 3 |
| 100–109 | 3 | 3 | 4 |
| over 110 | 3 | 4 | 4 |
For patients who are unable to swallow Proursan, other pharmaceutical forms (suspension) containing ursodeoxycholic acid are available.
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.
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.
4 years.
This medicinal product does not require any special storage conditions.
PVC/PVdC and Al blister, carton.
Pack size: 10, 30, 50, 60, 90 or 100 capsules.
Not all pack sizes may be marketed.
No special requirements.
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