Ursodeoxycholic acid Aurobindo 250 mg capsules, hard

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

ATC code:

A05AA02

INN (International Name):

URSODEOXYCHOLIC ACID 250 mg

Pharmaceutical form:

HARD CAPSULE

Composition:

URSODEOXYCHOLIC ACID 250 mg

Prescription type:

POM

Therapeutic area:

BILE AND LIVER THERAPY

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2023-05-03

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
URSODEOXYCHOLIC ACID AUROBINDO 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 Ursodeoxycholic acid Aurobindo is and what it is used for
2.
What you need to know before you take Ursodeoxycholic acid Aurobindo
3.
How to take Ursodeoxycholic acid Aurobindo
4.
Possible side effects
5.
How to store Ursodeoxycholic acid Aurobindo
6.
Contents of the pack and other information
1.
WHAT URSODEOXYCHOLIC ACID AUROBINDO IS AND WHAT IT IS USED FOR
This medicine contains ursodeoxycholic acid – a natural bile acid.
However, small amount only is
found in human bile.
URSODEOXYCHOLIC ACID AUROBINDO IS USED:
-
to dissolve cholesterol gallstones. These stones must be radiolucent
(not visible on a plain X-ray)
and no larger than 15 mm in diameter. The gall bladder must still be
working despite the
gallstone(s).
-
to treat inflammation of the stomach lining caused by the reflux of
bile acids (bile reflux
gastritis)
-
for the symptomatic treatment of primary biliary cirrhosis (PBC which
is a disease of the bile
ducts up to cirrhosis of the liver), in patients without decompensated
liver cirrhosis (diffuse
chronic disease of the liver, at a stage when the disease-related
reduction in liver function can no
longer be compensated for).
-
for the treatment of liver disease associated with cystic fibrosis
(mucoviscidosis) in children and
adolescents aged 6-18 years.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE URSODEOXYCHOLIC ACID AUROBINDO

Summary of Product characteristics

1.3.1. SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ursodeoxycholic acid Aurobindo 250 mg capsules, hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 250 mg of ursodeoxycholic acid.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, Hard
Ursodeoxycholic acid Aurobindo 250 mg capsules, hard: [Size about 22
mm]
White Opaque Cap and White opaque body, size ‘0’hard gelatin
capsule shells imprinted with
‘UROH’ on cap and ‘250’ on body with black ink, filled with
white to off- white granular 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. Gall
bladder function must
not be significantly impaired, despite the gallstones.
-
For the treatment of bile reflux gastritis.
-
For the symptomatic treatment of primary biliary cirrhosis (PBC), in
patients without
decompensated hepatic cirrhosis.
Paediatric population
Hepatobiliary disorders as a result of cystic fibrosis in children and
adolescents aged 6 to 18 years.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
There are no age restrictions on the use of Ursodeoxycholic acid
Aurobindo.
The following daily dose is recommended for the various indications:
For dissolution of cholesterol gallstones
The recommended dose is 10 mg of ursodeoxycholic acid per kg of body
weight, equivalent to:
Up to 60 kg
2 hard capsules
61 – 80 kg
3 hard capsules
81 – 100 kg
4 hard capsules
Over 100 kg
5 hard capsules
The capsules should be swallowed whole with some liquid in the evening
before bedtime.
The capsules should be taken on a regular basis.
The time required for the dissolution of gallstones is generally 6-24
months. If there is no reduction in
the size of the gallstones after 12 months, the therapy should not be
continued.
The success of the treatment should be checked by means of ultrasound
or X-ray examination every 6
mon