Ursofalk 250mg capsules

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Ursodeoxycholic acid

Saadav alates:

Dowelhurst Ltd

ATC kood:

A05AA02

INN (Rahvusvaheline Nimetus):

Ursodeoxycholic acid

Annus:

250mg

Ravimvorm:

Oral capsule

Manustamisviis:

Oral

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 01090100

Infovoldik

Ursofalk Kapseln Gebrauchsinformation (GI) für Großbritannien-Irland
Format: 540 x 200 mm
Druckfarben: (2/2) Schwarz + Pantone 644
Mat.-Nr.: Mock-up (Losan Pharma)
Laetuscode: 522
Grammatur: 40 g/m
2
Falk-Datumscode: GB-IE/04.15
Machart: vorgefalzt
PACKAGE LEAFLET: INFORMATION FOR THE USER
URSOFALK
® 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 side effects not listed in this leaflet, see section 4.
WHAT IS IN THIS LEAFLET:
1. What Ursofalk capsules are and what they are used for
2. What you need to know before you take Ursofalk capsules
3. How to take Ursofalk capsules
4. Possible side effects
5. How to store Ursofalk capsules
6. Contents of the pack and further information
1. WHAT URSOFALK 250MG HARD 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
fib

Toote omadused

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.
Th