Proursan 250mg Capsules, Hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ursodeoxycholic acid

Available from:

PRO.MED.CS Praha a.s.

ATC code:

A05AA; A05AA02

INN (International Name):

Ursodeoxycholic acid

Dosage:

250 milligram(s)

Pharmaceutical form:

Capsule, hard

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Bile acid preparations; ursodeoxycholic acid

Authorization status:

Not marketed

Authorization date:

2017-05-12

Patient Information leaflet

- 1 -
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROURSAN 250 MG CAPSULES HARD
Ursodeoxycholic acid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Proursan is and what it is used for
2.
What you need to know before you take Proursan
3.
How to take Proursan
4.
Possible side effects
5.
How to store Proursan
6.
Contents of the pack and other information
1.
WHAT PROURSAN IS AND WHAT IT IS USED FOR
Ursodeoxycholic acid, the active substance in , is a
naturally-occurring bile acid.
Small amounts are found in human bile.
Proursan is used:
-
To dissolve gallstones caused by excess cholesterol in the gall
bladder (in patients for whom
surgery is not an option), where the gallstones are not visible on a
plain x-ray (gallstones that are
visible will not dissolve) and not more than 15 mm in diameter. The
gall bladder should still be
working despite the gallstone(s).
-
To treat inflammation of the stomach lining due to the backflow of
bile acids (bile reflux
gastritis).
-
For the treatment of primary biliary cholangitis (PBC) a condition
where the bile ducts in the liver
become damaged leading to a build-up of bile. This may cause scarring
of the liver (cirrhosis of
the liver). The liver should not be so damaged that it is not
functioning properly.
-
For liver disease associated with a condition called cystic fibrosis
in children aged 6 to 18 years.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PROURSAN
DO NOT TAKE PROURSAN IF
-
you are allergic to bile acids (like ursodeoxycholic acid) or t

Summary of Product characteristics

Health Products Regulatory Authority
26 August 2021
CRN00CFC9
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Proursan 250mg Capsules, Hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 250 mg ursodeoxycholic acid (UDCA) as the
active ingredient.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
White, hard gelatine capsules containing white or almost white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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.
Paediatric population
Hepatobiliar disorder associated with cystic fibrosis in children aged
6 years to less than 18 years.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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 ca