Ursodeoxycholic acid 250mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ursodeoxycholic acid

Available from:

Kent Pharma (UK) 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

Patient Information leaflet

URSODEOXYCHOLIC ACID 250 MG CAPSULES
RIVOPHARM - UK
PACK INSERT
-----
1
3.0
BLACK
Record Number: 156201
Front & Back side printing. To be supplied in the folded size of 180 x
210mm
60 GSM Paper.
PRINTING CLARITY TO BE CLEAR AND SHARP.
180 X 420 MM
1036061
1034191
Front Side
Dimension - 180 x 420 mm
PACKAGE LEAFLET: INFORMATION FOR THE USER
URSODEOXYCHOLIC ACID 250 MG HARD CAPSULES
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
3. How to take Ursodeoxycholic acid
4. Possible side effects
5. How to store Ursodeoxycholic acid
6. Contents of the pack and other information
1. WHAT URSODEOXYCHOLIC ACID IS AND WHAT IT IS USED FOR
Ursodeoxycholic acid contains the active substance
ursodeoxycholic acid.
Ursodeoxycholic acid is a chemical present naturally in the
body and it helps to control the amount of cholesterol in the
blood.
URSODEOXYCHOLIC ACID 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).
–
for the treatment of 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. The liver should not be so
dam

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ursodeoxycholic acid 250mg Hard Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard gelatin capsule contains 250 mg of ursodeoxycholic acid.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard
White hard gelatin capsules (size ‘0’) containing a white to off
white powder.
4.1
THERAPEUTIC INDICATIONS
−
Treatment
of
primary
biliary
cholangitis
(PBC)
in
patients
without
decompensated cirrhosis.
−
Dissolution of radiolucent cholesterol gallstones not larger than 15
mm in
diameter in patients with a functioning gallbladder and for whom
surgical
treatment is not indicated.
−
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
Posology
There are no age restrictions on the use of Ursodeoxycholic acid
Strides
250 mg hard capsules. For patients weighing less than 47 kg or
patients
who are unable to swallow Ursodeoxycholic acid Strides 250 mg hard
capsules, other formulations are available (suspension).
The following daily dose is recommended for the various indications:
_Treatment of primary biliary cholangitis (PBC) _
Stage I-III
The daily dose is dependent on body weight and ranges from 3 to 7
capsules
(12-16 mg ursodeoxycholic acid per kg of body weight).
During the first 3 months of treatment, ursodeoxycholic acid should be
taken
in divided doses throughout the day. If liver function improves, the
total
daily dose can be taken once daily in the evening.
Ursodeoxycholic acid Strides 250 mg hard capsules
FIRST 3 MONTHS
SUBSEQUENTLY
Body
weight (kg)
Daily dose
(mg/kg body
weight)
Morning
Afternoon
Evening
Evening
(once daily)
47 – 62
12 – 16
1
1
1
3
63 – 78
13 – 16
1
1
2
4
79 – 93
13 – 16
1
2
2
5
94 – 109
14 – 16
2
2
2
6
More than
110
2
2
3
7
Stage IV:
In combination with increased serum bilirubin levels (> 40
μ
g/L; conjugated),
only
half the normal dosage should initially