Ursofalk 250mg/5ml oral suspension

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ursodeoxycholic acid

Available from:

Dr. Falk Pharma UK Ltd

ATC code:

A05AA02

INN (International Name):

Ursodeoxycholic acid

Dosage:

50mg/1ml

Pharmaceutical form:

Oral suspension

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01090100; GTIN: 5060096430070

Patient Information leaflet

PACKAGE LEAFLET: Information for the user
URSOFALK® 250MG/5ML SUSPENSION
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 Ursofalk suspension is and what it is used for
2. What you need to know before you take Ursofalk suspension
3. How to take Ursofalk suspension
4. Possible side effects
5. How to store Ursofalk suspension
6. Contents of the pack and other information
1. WHAT URSOFALK 250MG/5ML SUSPENSION IS AND WHAT IT IS USED FOR
Ursodeoxycholic acid, the active substance in Ursofalk suspension, is
a naturally
occurring bile acid. Small amounts of ursodeoxycholic acid are found
in human bile.
URSOFALK SUSPENSION IS 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. The liver should not be so damaged that it is not
functioning properly.
– 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 1
month to 18 years.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE URSOFALK 250MG/5ML
SUSPENSION
DO NOT TAKE URSOFALK SUSPENSION IF:
– you are, or have been told you are, allergic (hypersensitive) to
bile acids (like
ursodeoxych

Summary of Product characteristics

OBJECT 1
URSOFALK 250MG/5ML SUSPENSION
Summary of Product Characteristics Updated 12-Jan-2015 | Dr. Falk
Pharma UK Ltd
1. Name of the medicinal product
Ursofalk 250mg/5ml Suspension
2. Qualitative and quantitative composition
5ml (= 1 cup) of Ursofalk Suspension contains 250mg of ursodeoxycholic
acid (UDCA) as the active
ingredient.
The suspension also contains 11.39 mg sodium per 5ml.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral suspension.
Appearance: white, homogenous oral suspension with small air bubbles
and an odour of lemon.
4. Clinical particulars
4.1 Therapeutic indications
Ursofalk 250mg/5ml Suspension 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 1 month to 18 years.
4.2 Posology and method of administration
There are no age restrictions on the use of Ursofalk 250mg/5ml
suspension in the treatment of PBC and
for the dissolution of radiolucent gallstones. 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 is approximately 14 ± 2 mg
UDCA per kg of body weight.
For the first 3 months of treatment, Ursofalk suspension should be
taken divided over the day. When the
liver function parameters improve, the daily dose can be administered
once a day in the evening.
Body weight (kg)
Daily dose (mg/kg
BW)
Cups* of Ursofalk suspension
FIRST 3 MONTHS
SUBSEQUENTLY
morning
midday
evening
evening
(1 x daily)
8 – 11
12 – 16
-
¼
¼
½
12 – 15
12 – 16
¼
¼
¼
¾
16 – 19
13 – 16
½
-
½
1
20 – 23
13 – 15
¼
½
½
1 ¼
24 – 27
13 – 16
½
½
½
1 ½
28 – 31
14 – 16
¼
½
1
1 ¾
32 – 39
12 – 16
½
½
1
2
40 – 47
13 – 16
½
1
1
2 ½
48 – 62
12 – 16
1
1
1
3
63 – 80
12 – 16
1
1
2
4
81 – 95
13 – 16
1
2
2
5
96 – 115
13 – 16
2
2
2
6
Over 115
2
2
3
7
*One cup