Ursodeoxycholic acid 150mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ursodeoxycholic acid

Available from:

Mawdsley-Brooks & Company Ltd

ATC code:

A05AA02

INN (International Name):

Ursodeoxycholic acid

Dosage:

150mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01090100

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
URSODEOXYCHOLIC
ACID TABLETS
150MG
(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 Tablets
3. How to take Ursodeoxycholic Acid Tablets
4. Possible side effects
5. How to store Ursodeoxycholic Acid Tablets
6. Contents of the pack and other information
1. WHAT URSODEOXYCHOLIC ACID IS AND WHAT IT IS USED FOR
Ursodeoxycholic Acid Tablets contain
ursodeoxycholic acid (UDCA) as the active
substance. UDCA is a bile acid normally only
found in small amounts in human bile.
Ursodeoxycholic Acid Tablets are used to dissolve
gallstones that are rich in cholesterol. They can
also be used 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 TABLETS
DO NOT TAKE URSODEOXYCHOLIC ACID TABLETS
- 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 stomach or duodenal ulcer
- if you have a stoma because part of your bowel
has been removed
- if you

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Ursogal Tablets 150mg/
Ursodeoxycholic Acid Tablets 150mg.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ursodeoxycholic acid (UDCA) Ph. Eur. 150mg per tablet.
Excipient(s) with known effect: 98mg of lactose per tablet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
4.1.
THERAPEUTIC INDICATIONS
Ursogal Tablets 150mg/Ursodeoxycholic Acid Tablets 150mg are indicated
for the
dissolution of radiolucent cholesterol-rich gallstones in adults,
including the elderly, and
children with a functioning gallbladder.
Ursogal Tablets 150mg/Ursodeoxycholic Acid Tablets 150mg 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 (3 or 4 tablets of UDCA 150mg 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).
_Children with cystic fibrosis aged 6 years to less than 18 years: _
20mg/kg/day in 2-3 divided doses, with a further increase to
30mg/kg/day if necessary.
Method of administration
For oral use.
4.3.
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
UDCA should not