Ursodeoxycholic acid 150mg tablets

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Ursodeoxycholic acid

Beschikbaar vanaf:

DE Pharmaceuticals

ATC-code:

A05AA02

INN (Algemene Internationale Benaming):

Ursodeoxycholic acid

Dosering:

150mg

farmaceutische vorm:

Oral tablet

Toedieningsweg:

Oral

klasse:

No Controlled Drug Status

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 01090100

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
URSODEOXYCHOLIC ACID 150 MG TABLETS
URSODEOXYCHOLIC ACID 300 MG TABLETS
URSODEOXYCHOLIC ACID 450 MG TABLETS
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 Ursodeoxycholic Acid is and what it is used for
2.
What you need to know before you take Ursodeoxycholic Acid Tablets
4.
How to take Ursodeoxycholic Acid Tablets
5.
Possible side effects
6.
How to store
7.
Contents of the pack and other information
1.
WHAT URSODEOXYCHOLIC ACID IS AND WHAT IT IS USED FOR
Ursodeoxycholic Acid influences the composition of the bile, by which
cholesterol gallstones can be
solved. The effects of Ursodeoxycholic Acid in primary biliary
cholangitis and cystic fibrosis can be
explained by various mechanisms, such as a protective effect on the
liver cells and an effect on the
immune system.
1.
Ursodeoxycholic Acid Tablets is used in patients:
•
with small gallstones
•
who do not want to undergo surgery or are not eligible for gallstone
surgery
•
in whom too much cholesterol has been found in the bile
2.
Ursodeoxycholic Acid Tablets is used in patients with primary biliary
cholangitis. Primary biliary
cholangitis is a disease in which liver tissue is damaged by an
impaired drainage of the bile.
3.
Ursodeoxycholic Acid Tablets is used in children aged 6 years to 18
years old with liver and biliary
diseases caused by cystic fibrosis. Cystic fibrosis, also referred to
as mucoviscidosis, is an inherited
disorder in which the mucus is particularly tough i

Productkenmerken

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