Ursodeoxycholic acid Strides 250mg Hard Capsules

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Ursodeoxycholic acid

Verfügbar ab:

Strides Arcolab International Limited

ATC-Code:

A05AA; A05AA02

INN (Internationale Bezeichnung):

Ursodeoxycholic acid

Dosierung:

250 milligram(s)

Darreichungsform:

Capsule, hard

Verschreibungstyp:

Product subject to prescription which may be renewed (B)

Therapiebereich:

Bile acid preparations; ursodeoxycholic acid

Berechtigungsstatus:

Not marketed

Berechtigungsdatum:

2014-01-31

Gebrauchsinformation

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 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 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 cholangitis.
–
to treat children and adolescents, aged 6 years to less than
18 years, who have liver problems associated with cystic
fibrosis.
2.
WHAT YOU

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ursodeoxycholic acid Strides 250mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard gelatin capsule contains Ursodeoxycholic Acid 250 mg.
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 cirrhosis (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
There are no age restrictions on the use of Ursodeoxycholic acid
Strides 250mg hard capsules. For patients weighing
less than 47 kg or patients who are unable to swallow Ursodeoxycholic
acid Strides 250mg hard capsules, other
formulations are available (suspension).
The following daily dose is recommended for the various indications:
_For treatment of primary biliary cirrhosis (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 Strides
250mg hard capsules 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 250mg 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
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