Ursodeoxycholic acid 250mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ursodeoxycholic acid

Available from:

Galen Ltd

ATC code:

A05AA02

INN (International Name):

Ursodeoxycholic acid

Dosage:

250mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01090100; GTIN: 5016298944570

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
URSODEOXYCHOLIC
ACID CAPSULES
250MG
(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, pharmacist or nurse.
- 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,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ursodeoxycholic Acid is and what it is
used for
2.
What you need to know before you take
Ursodeoxycholic Acid Capsules
3.
How to take Ursodeoxycholic Acid Capsules
4.
Possible side effects
5.
How to store Ursodeoxycholic Acid Capsules
6.
Contents of the pack and other information
1. WHAT URSODEOXYCHOLIC ACID IS AND WHAT IT IS USED FOR
Ursodeoxycholic Acid Capsules contain
ursodeoxycholic acid (UDCA) as the active
substance. UDCA is a bile acid normally only found
in small amounts in human bile. Ursodeoxycholic
Acid Capsules are used to dissolve gallstones that
are rich in cholesterol. Ursodeoxycholic Acid
Capsules are also used in the treatment of a
condition called primary biliary cirrhosis and to treat
children, aged 6 years to less than 18 years, who
have liver problems associated with cystic fibrosis.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE URSODEOXYCHOLIC ACID CAPSULES
DO NOT TAKE URSODEOXYCHOLIC ACID CAPSULES
- if you have acute inflammation of the gall
bladder or biliary tract
- if you have a blockage of the biliary tract
- if you have frequent episodes of biliary colic
(recurrent pain in the upper abdomen)
- if your gall bladder does not work correctly
- if you have gallstones that are visible on an x-ray
- if you are pregnant or you think you might be
pregnant
- if there is a chance you might become pregnant
- if you have a s

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Ursogal Capsules 250mg/
Ursodeoxycholic Acid Capsules 250mg.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ursodeoxycholic acid (UDCA) Ph. Eur. 250mg per capsule.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule.
4.1.
THERAPEUTIC INDICATIONS
Ursogal Capsules 250mg/Ursodeoxycholic Acid Capsules 250mg are
indicated for the
dissolution of radiolucent cholesterol-rich gallstones in adults,
including the elderly, and
children with a functioning gallbladder.
Ursogal Capsules 250mg/Ursodeoxycholic Acid Capsules 250mg are
indicated for the
treatment of primary biliary cirrhosis.
Ursogal Capsules 250mg/Ursodeoxycholic Acid Capsules 250mg are
indicated for
hepatobiliary disorder associated with cystic fibrosis in children
aged 6 years to less than
18 years.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Dissolution of radiolucent cholesterol-rich gallstones: _
A daily dose of 8-10mg/kg (2 or 3 capsules of UDCA 250mg per day for
most patients) is
recommended. Obese patients may require a higher dose of UDCA (up to
15mg/kg/day).
This should be taken in two divided doses after meals, with at least
half the dose being
taken after the evening meal.
The time required for dissolution of gallstones is generally in the
range of 6-24 months,
and is dependent on the size and composition of the stones. Treatment
should be
regularly monitored (by cholecystograms) and continued for 3-4 months
following the
disappearance of the gallstones. Stones may recur after successful
treatment. The time
required to effect stone dissolution may be increased if UDCA is
temporarily
discontinued (for 3-4 weeks) during treatment.
The dose of UDCA for elderly patients and for children should be
related to body weight
(8-10mg/kg/day).
_Treatment of primary biliary cirrhosis: _
A daily dose of 10-15mg/kg (2-5 capsules of UDCA 250mg per day for
most patients) is
recommended for the treatment of primary biliary cirrhosis in adults
and the elderly. This
should be taken in two to four divided