Skip to Content

URSOFALK 500 MG FILM-COATED TABLETS

Active substance: URSODEOXYCHOLIC ACID

View full screen / Print PDF » Download PDF ⇩
Transcript
Ursofalk 500mg Filmtabletten Gebrauchsinformation (GI) für Großbritannien-Irland
Format: 540 x 200 mm
Druckfarben: 2/2 (Schwarz + Pant. 644)
Mat.-Nr.: Mock-up (Losan Pharma) Laetuscode: 1001
Grammatur: 40 g/m2
Falk-Datumscode: GB-IE/11.14

Package leaflet: Information for the user

Ursofalk ® 500mg film-coated tablets
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 tablets are and what they are used for
2. What you need to know before you take Ursofalk tablets
3. How to take Ursofalk tablets
4. Possible side effects
5. How to store Ursofalk tablets
6. Contents of the pack and other information
1. What Ursofalk 500mg film-coated 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

Mockup_URT_GI_GB-IE.indd 1

2.  hat you need to know before you take
W
Ursofalk 500mg film-coated tablets
Do NOT take Ursofalk tablets if:
– You are, or have been told you are, allergic (hypersensitive) to bile
acids like UDCA or to any of the other ingredients of this medicine
(listed in section 6).
– You have an acute inflammation of the gall bladder or biliary tract.
– You have a blockage of the common bile duct or cystic duct
(obstruction of the biliary tract).
– You have frequent cramp-like upper abdomen pain (biliary colic).
– Your doctor has said you have calcified gallstones (they are visible on
an x-ray).
– Your gall bladder does not work properly.
– You are a child with biliary atresia and have poor bile flow, even after
surgery.
Please ask your doctor about the conditions mentioned above. You
should also ask if you have previously had any of these conditions or if
you are unsure whether you have any of them.
Warnings and precautions:
Talk to your doctor or pharmacist before taking Ursofalk tablets.
Your doctor should test your liver function regularly every 4 weeks for
the first 3 months of treatment. After this time, it should be monitored
at 3 month intervals.
When used in the treatment of PBC, in rare cases the symptoms may
worsen at the beginning of treatment. If this happens, please speak to
your doctor about reducing your initial dose.
When used to dissolve gallstones, your doctor should arrange for a
scan of your gall bladder after the first 6-10 months of treatment.
Please talk to your doctor immediately if you have diarrhoea, as this
may require a reduction in the dose or discontinuation of the treatment
with Ursofalk tablets.
Other medicines and Ursofalk tablets
Please tell your doctor if you are taking or have recently taken or might
take any other medicines.
The effects of these medicines may be altered:
A reduction in the effects of the following medicines is possible
when taking Ursofalk tablets:
– 
colestyramine, colestipol (to lower blood lipids) or antacids
containing aluminium hydroxide or smectite (aluminium oxide).

If you must take medication that contains any of these ingredients, it
must be taken at least two hours before or after Ursofalk tablets.
– 
ciprofloxacin, dapsone (antibiotics), nitrendipine (used to treat high
blood pressure) and other medicines which are metabolised in a
similar way. It may be necessary for your doctor to alter the dose of
these medicines.
A change in the effects of the following medicines is possible when
taking Ursofalk tablets:
– 
ciclosporin (to reduce the activity of the immune system). If you
are being treated with ciclosporin, your doctor should check the
amount of ciclosporin in your blood. Your doctor will adjust its dose,
if necessary.
– 
rosuvastatin (for high cholesterol and related conditions).
If you are taking Ursofalk tablets for the dissolution of gallstones,
please inform your doctor in case you are taking any medicines that
contain oestrogenic hormones or blood cholesterol lowering agents
such as clofibrate. These medicines stimulate the formation of
gallstones, which is a counter-effect to the treatment with Ursofalk.
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, even if they are medicines obtainable
without a prescription. Treatment with Ursofalk tablets may still be
allowed. Your doctor will know what is right for you.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or
are planning to have a baby, ask your doctor or pharmacist for advice
before taking this medicine.
Pregnancy: You should not take Ursofalk during pregnancy unless your
doctor thinks it is absolutely necessary.
Women of child-bearing potential: Even if you are not pregnant, you
should still discuss this possibility with your doctor. Before starting
treatment with Ursofalk, your doctor will check that you are not
pregnant and review your contraceptive method to make sure it is
appropriate.
Breastfeeding: Tell your doctor if you are breast-feeding or about to
start breastfeeding.
Driving and using machines:
No particular precautions are necessary.

3. How to take Ursofalk 500mg film-coated tablets
Always take Ursofalk tablets exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
For the treatment of primary biliary cirrhosis
(inflammation of the bile ducts)
Dosage
During the first 3 months of treatment, you should take Ursofalk
tablets in divided doses during the day. As liver function tests improve,
the total daily dose may be taken once a day in the evening.
Ursofalk 500mg Film-coated Tablets
Body weight Daily dose
First 3 months
Subsequently
BW (kg) (mg/kg BW)
Evening
Morning Midday Evening
(once daily)
47 – 62
12 – 16
½
½
½

63 – 78
13 – 16
½
½
1
2
79 – 93
13 – 16
½
1
1

94 – 109
14 – 16
1
1
1
3
over 110
1
1


How to take Ursofalk tablets
The tablet can be divided into equal doses. Swallow the tablets with a
drink of water or other liquid. Do not crush or chew the tablets. Take
the tablets regularly.
Duration of treatment
Ursofalk tablets can be continued indefinitely in cases of PBC.
To dissolve cholesterol gallstones
Dosage
Approximately 10 mg per kg body weight (BW) daily, as follows:
up to 60 g
k
1 tablet
61 – 80 kg
1½ tablets
81 – 100
kg
2 tablets
over 100
kg
2½ tablets
How to take Ursofalk tablets
The tablet can be divided into equal doses. Swallow the tablets with a
drink of water or other liquid.
Do not crush or chew the tablets. Take the tablets in the evening at
bedtime. Take the tablets regularly.
Duration of treatment
It generally takes 6 - 24 months to dissolve gallstones. If there is no
reduction in the size of the gallstones after 12 months, therapy should
be stopped.

Every 6 months, your doctor should check whether the treatment
is working. At each of these follow-up examinations, it should be
checked whether calcification of the stones has occurred since the
last time. If this is the case, your doctor will stop the treatment.
Both indications:
Ursofalk capsules or Ursofalk suspension are available if you weigh
less than 47 kg or cannot swallow tablets.
Use in elderly:
There is no evidence to suggest that any alteration in the adult dose is
needed but the relevant precautions should be taken into account.
Use in children and adolescents:
There are no age limits to the use of Ursofalk tablets. The administration
of Ursofalk tablets is based on body weight and the medical condition.
Use in children (6 to 18 years) for treatment of liver disease
associated with cystic fibrosis
Dosage
The recommended daily dose is 20 mg per kg body weight, divided in
2-3 doses. Your doctor may want to increase the dose further to 30mg
per kg body weight daily if necessary
Body weight Daily dose Ursofalk 500mg Film-coated Tablets
BW (kg)
(mg/kg BW) Morning
Midday
Evening
20 – 29
17-25
½

½
30 – 39
19-25
½
½
½
40 – 49
20-25
½
½
1
50 – 59
21-25
½
1
1
60 – 69
22-25
1
1
1
70 – 79
22-25
1
1

80 – 89
22-25
1


90 – 99
23-25



100 – 109
23-25


2
>110

2
2
How to take Ursofalk tablets
The tablet can be divided into equal doses. Swallow the tablets with a
drink of water or other liquid. Do not crush or chew the tablets. Take
the tablets regularly.
Duration of treatment
Treatment can be continued long term (up to 12 years) in children with
cystic fibrosis associated hepatobiliary disorders.
If you feel that the effect of Ursofalk 500mg film-coated tablets is too
strong or too weak, please talk to your doctor or pharmacist.

25.11.14 09:37

If you take more Ursofalk tablets than you should:
Diarrhoea may occur as a result of overdose. Please inform your doctor
immediately if you have persistent diarrhoea. If you do suffer from
diarrhoea, make sure you drink enough liquids to replace your fluid and
salt balance.

By reporting side effects, you can help provide more information on
the safety of this medicine.

If you forget to take Ursofalk tablets
Do not take more tablets the next time, but just continue the treatment
with the prescribed dose.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.

If you stop taking Ursofalk tablets:
Always speak to your doctor before you decide to interrupt treatment
with Ursofalk tablets or decide to stop your treatment early.
4. Possible side effects
Like all medicines, Ursofalk tablets can cause side effects, although
not everybody gets them.
Common side effects (occurring in less than 1 in 10 but more than
1 in 100 patients):
– 
soft, loose stools or diarrhoea
Very rare side effects (occurring in less than 1 in 10,000 patients):
– 
during the treatment of primary biliary cirrhosis: severe right-sided
upper abdominal pain, severe worsening of liver cirrhosis which
partially eases after treatment is discontinued
– 
hardening of gallstones due to build-up of calcium. There are no
additional symptoms of this but it will show up in tests
– nettle rash (urticaria)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet.
You can also report side effects directly via:
UK:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Republic of Ireland:
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
E-mail: medsafety@hpra.ie

5. How to store Ursofalk 500mg film-coated tablets

Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help to protect the environment.
6. Contents of the pack and other information
What Ursofalk tablets contain:
The active substance is ursodeoxycholic acid (UDCA). Each film-coated
tablet contains 500 mg UDCA.
The other ingredients are:
Tablet core: magnesium stearate, polysorbate 80, povidone K 25,
microcrystalline cellulose, colloidal anhydrous silica, crospovidone
(Type A), talc. Coating: talc, hypromellose and macrogol 6000.

Manufactured by:

Leinenweberstr. 5
79108 Freiburg
Germany

E-mail: zentrale@drfalkpharma.de
www.drfalkpharma.de
This leaflet was last revised in November 2014.
Other sources of information:
Further information, help, advice and details of local support groups
can be found at:
The PBC Foundation
The British Liver Trust
2 York Place
2 Southampton Road
Edinburgh Ringwood
Scotland England
EH1 3EP BH24 1HY
Telephone: +44 (0) 131 556 6811 Telephone: +44 (0) 1425 481320
www.pbcfoundation.org.uk www.britishlivertrust.org.uk

What Ursofalk 500mg film-coated tablets look like and
contents of the pack
Ursofalk 500mg film-coated tablets are white, oval, biconvex and scored
on both sides. The tablet may be divided into half.
Ursofalk 500mg film-coated tablets are available in packs of 50 and 100.
Not all packs may be marketed.
Marketing Authorisation Holder:
Ireland: PA 573/5/3
UK: PL 10341/0010
Dr. Falk Pharma GmbH
Dr Falk Pharma UK Ltd
Leinenweberstrasse 5
Unit K, Bourne End Business Park
79108 Freiburg
Cores End Road
Germany
Bourne End
Tel.: + 49 (0) 761 1514-0
Buckinghamshire
Fax: + 49 (0) 761 1514-321
SL8 5AS
UK

Tel.: + 44 (0) 1628 536600

Fax: + 44 (0) 1628 536601
Email: office@drfalkpharma.co.uk
Mock-up GB-IE/11.14

Mockup_URT_GI_GB-IE.indd 2

25.11.14 09:37

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide