Ursodeoxycholic acid Strides 250 mg Hard Capsules

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Ursodeoxycholic acid

Boleh didapati daripada:

Strides Pharma (Cyprus) Limited

Kod ATC:

A05AA; A05AA02

INN (Nama Antarabangsa):

Ursodeoxycholic acid

Dos:

250 milligram(s)

Borang farmaseutikal:

Capsule, hard

Kawasan terapeutik:

Bile acid preparations; ursodeoxycholic acid

Status kebenaran:

Not marketed

Tarikh kebenaran:

2014-01-31

Risalah maklumat

PACKAGE LEAFLET: INFORMATION FOR THE USER
URSODEOXYCHOLIC ACID STRIDES 250MG 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, 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 Strides is and what it is used for
2.
What you need to know before you take Ursodeoxycholic acid Strides
3.
How to take Ursodeoxycholic acid Strides
4.
Possible side effects
5.
How to store Ursodeoxycholic acid Strides
6.
Contents of the pack and other information
1. WHAT URSODEOXYCHOLIC ACID STRIDES IS AND WHAT IT IS USED FOR
Ursodeoxycholic acid Strides 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 STRIDES 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 damaged that it is not
functioning properly. This condition is called primary biliary
cirrhosis.
–
for paediatric population: to treat children, aged 6 years to less
than 18 years, who have liver
problems associated with cyst

Ciri produk

Health Products Regulatory Authority
21 June 2023
CRN00DFJD
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ursodeoxycholic acid Strides 250 mg 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 CLINICAL PARTICULARS
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: Hepatobiliary 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:
_For 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.
Body
weight
(kg) ​
​
Daily
dose
(mg/kg
body
weight)
​
​
Ursodeoxycholic acid Strides 250 mg Hard
Capsules ​
​
​
FIRST 3 MONTHS ​
​
SUBSEQUENTLY
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