Ursofalk 500mg tablets
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
20-04-2020
Summary of Product characteristics
(SPC)
20-06-2018
Active ingredient:
Ursodeoxycholic acid
Available from:
Dr. Falk Pharma UK Ltd
ATC code:
A05AA02
INN (International Name):
Ursodeoxycholic acid
Dosage:
500mg
Pharmaceutical form:
Oral tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 01090100; GTIN: 5060096430452
Patient Information leaflet
URSOFALK 500MG FILM-COATED TABLETS
(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 possible side effects not listed in this leaflet, see
section 4.
Your medicine is called Ursofalk 500mg film-coated tablets but will be
referred to as Ursofalk tablets throughout the rest of this leaflet.
WHAT IS IN THIS LEAFLET:
What Ursofalk tablets are and what they are used for
What you need to know before you take Ursofalk tablets
How to take Ursofalk tablets
Possible side effects
How to store Ursofalk tablets
Contents of the pack and other information
WHAT URSOFALK TABLETS ARE AND WHAT THEY ARE USED FOR
Ursofalk tablets contain the active substance ursodeoxycholic acid
(UDCA). Small amounts of UDCA are found in human bile.
URSOFALK TABLETS ARE USED:
– for the treatment of primary biliary cirrhosis (PBC) 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 (cirrhosis of the liver). The
liver should
not be so damaged that it is not functioning properly.
– to dissolve cholesterol gallstones. These stones must not be
visible on a plain X-ray (radiolucent) and be no larger than 15 mm in
diameter because they will not dissolve with UDCA. The gall bladder
must 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
TABLETS
DO NOT TAKE URSOFALK TABLETS IF:
– You are, or have been told you are, allergic (hypersensitive) to
bile acids
like UDCA or
Read the complete document
Summary of Product characteristics
OBJECT 1
URSOFALK 500MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 12-Jan-2015 | Dr. Falk
Pharma UK Ltd
1. Name of the medicinal product
Ursofalk 500mg film-coated tablets
2. Qualitative and quantitative composition
One Ursofalk 500mg film-coated tablet contains 500mg of
ursodeoxycholic acid (UDCA) as the active
substance.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablets
Appearance: white, oval, biconvex film-coated tablets with a breakline
on both sides.
The tablet can be divided into equal doses.
4. Clinical particulars
4.1 Therapeutic indications
For the treatment of primary biliary cirrhosis (PBC), provided there
is no decompensated hepatic
cirrhosis.
For the dissolution of cholesterol gallstones in the gall bladder. The
gallstones must not show as shadows
on X-ray images and should not exceed 15 mm in diameter. The gall
bladder must be functioning despite
the gallstone(s).
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 tablets 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 tablets, Ursofalk capsules and suspension are available.
The following daily dose is recommended for the various indications:
For the treatment of primary biliary cirrhosis (PBC)
The daily dose depends on body weight and ranges from 1½ to 3½
tablets (14 ± 2 mg of UDCA per kg of
body weight).
For the first 3 months of treatment, Ursofalk tablets 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
BW)
Film-coated tablets
first 3 months
subsequently
morning
midday
evening
evening
(1 x daily)
47 62
12 16
½
½
½
1½
63 78
13 16
½
½
1
2
79 93
13 16
½
1
1
2½
94 109
14 - 16
1
1
1
3
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