Ursodeoxycholic Acid 250 mg capsules, hard

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Ursodeoxycholic acid

Dostopno od:

Amdipharm Limited

Koda artikla:

A05AA; A05AA02

INN (mednarodno ime):

Ursodeoxycholic acid

Odmerek:

250 milligram(s)

Farmacevtska oblika:

Capsule, hard

Tip zastaranja:

Product subject to prescription which may be renewed (B)

Terapevtsko območje:

Bile acid preparations; ursodeoxycholic acid

Status dovoljenje:

Not marketed

Datum dovoljenje:

2016-02-05

Navodilo za uporabo

PACKAGE LEAFLET: INFORMATION FOR THE USER
URSODEOXYCHOLIC ACID 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, 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 capsules are and what they are used for
2. What you need to know before you take Ursodeoxycholic acid capsules
3. How to take Ursodeoxycholic acid capsules
4. Possible side effects
5. How to store Ursodeoxycholic acid capsules
6. Contents of the pack and other information
1.
WHAT URSODEOXYCHOLIC ACID CAPSULES ARE AND WHAT THEY ARE USED FOR
Ursodeoxycholic acid capsules contains the active substance
ursodeoxycholic acid which is a
naturally occurring bile acid which is found in small amounts in human
bile.
Ursodeoxycholic acid capsules are used:

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 (PBC).

to dissolve gallstones caused by excess cholesterol in the gall
bladder 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 liver disease associated with a condition called cystic fibrosis
in children aged 6 to 18
years.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE URSODEOXYCHOLIC ACID CAPSULES
DO NOT TAKE URSODEOXYCHOLIC ACID CAPS

Lastnosti izdelka

Health Products Regulatory Authority
17 November 2021
CRN00CJ95
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ursodeoxycholic Acid 250 mg capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 250 mg ursodeoxycholic acid (UDCA).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsules, hard.
Hard gelatine capsuleswith white body and cap filled with powder
The length of the capsules are 21.7 ± 0.3 mm
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ursodeoxycholic acid is indicated in the treatment of primary biliary
cirrhosis (PBC) and for the dissolution of radiolucent
gallstones in patients with a functioning gall bladder.
_Paediatric population_
Hepatobiliary disorders associated with cystic fibrosis in children
aged 6 to 18 years.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
There are no age restrictions on the use of Ursodeoxycholic acid 250
mg hard capsules in the treatment of PBC and for the
dissolution of radiolucent gallstones. For patients weighing less than
47 kg or patients who are unable to swallow
Ursodeoxycholic acid capsules, Ursodeoxycholic acid suspension is
available.
The following daily dose is recommended for the various indications:
_Treatment of Primary biliary cirrhosis (PBC): _
The daily dose depends on body weight, and ranges from 3 to 7 capsules
(14 ±2 mg ursodeoxycholic acid per kg of body
weight).
For the first 3 months of treatment, Ursodeoxycholic acid should be
taken divided over the day.
With improvement of the liver values the daily dose may be taken once
daily in the evening
Body weight (kg)
Daily dose (mg/kg body weight)
Ursodeoxycholic acid 250 mg
hard capsules
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Dosage for the first 3 months
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Subsequently
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Morning
Mid-day
Evening
Evening (1 x daily)
47 – 62
12 – 16
250 mg
250 mg
250 mg
750 mg
63 – 78
13 – 16
250 mg
250 mg
500 mg
1000 mg
79 – 93
13 – 16
250 mg
500 mg
500 mg
1250 mg
94 – 109
14 – 16
500 mg
500 mg
500 mg
1500 mg
Over 110
500