Ursofalk 250mg capsules

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Ursodeoxycholic acid

Dostępny od:

Waymade Healthcare Plc

Kod ATC:

A05AA02

INN (International Nazwa):

Ursodeoxycholic acid

Dawkowanie:

250mg

Forma farmaceutyczna:

Oral capsule

Droga podania:

Oral

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 01090100

Ulotka dla pacjenta

URSOFALK 250MG CAPSULES
(ursodeoxycholic acid)
PATIENT INFORMATION LEAFLET
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 side effects not listed in this leaflet, see section 4.
Your medicine is called Ursofalk 250mg Capsules, throughout this
leaflet it
will be referred to as Ursofalk Capsules.
WHAT IS IN THIS LEAFLET:
What Ursofalk Capsules are and what they are used for
What you need to know before you take Ursofalk Capsules
How to take Ursofalk Capsules
Possible side effects
How to store Ursofalk Capsules
Contents of the pack and further information
WHAT URSOFALK CAPSULES ARE AND WHAT THEY ARE USED
FOR
Ursodeoxycholic acid (UDCA), the active substance in Ursofalk
Capsules, is a naturally occurring bile acid. Small amounts are found
in
human bile.
URSOFALK 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.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE URSOFALK
CAPSULES
DO NOT TAKE URSOFALK CAPSULES IF
– you are, or have been told you are, allergic (hypersen

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ursofalk 250mg hard capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 250mg ursodeoxycholic acid as (UDCA) the active
ingredient.
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Capsule, hard
White, opaque, hard gelatin capsules (size 0) containing a white
compressed powder
or granules.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ursofalk 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
There are no age restrictions on the use of Ursofalk 250mg 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
Ursofalk capsules, Ursofalk suspension is available.
The following daily dose is recommended for the various indications:
_For primary biliary cirrhosis (PBC) _
The daily dose depends on body weight, and ranges from 3 to 7 capsules
(14 ±
2 mg UDCA per kg of body weight).
For the first 3 months of treatment, Ursofalk capsules should be taken
divided
over the day. With improvement of the liver values the daily dose may
be
taken once daily in the evening.
Ursofalk 250mg hard
capsules
FIRST 3 MONTHS
subsequently
Body
weight (kg)
Daily dose
(mg/kg
BW)
morning
midday
evening
evening
(1 x 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
Over 110
2
2
3
7
The capsules should be swallowed whole with some liquid. Care should
be
taken to ensure that they are taken regularly.
The use of Ursofalk capsules in PBC may be continued indefinitely.
_Dissolution of Gallstones: _
Adults: The usual dose is 8–12mg/kg/day to be taken in the evening,
e.g.
750mg, daily in the evening.
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