URSOFALK 500 MG FILM-COATED TABLETS

Active substance: URSODEOXYCHOLIC ACID

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Ursofalk 500mg Filmtabletten Gebrauchsinformation (GI) für Großbritannien
Format: 420 x 150 mm
Druckfarben: 2/2 (Schwarz + Pant. 644)
Mat.-Nr.: Mock-up (Losan Pharma) Laetuscode: 1001
Grammatur: 40 g/m2
Falk-Datumscode: GB-IE/02.14

PL 1034/0010, Ursofalk 500mg film-coated tablets, Dr. Falk Pharma UK Ltd

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.  HAT URSOFALK 500mg FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR
W
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

2.  HAT YOU NEED TO KNOW BEFORE YOU TAKE URSOFALK 500mg FILM-COATED TABLETS
W
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 (these are listed in section 6).
– You have an acute inflammation of the gall bladder or biliary tract.

URT_eCTD seq. 0009, 02/2014, Response to RFI for CSP update
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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 aluminium hydroxide, smectite (aluminium oxide)
containing antacids (agents that bind gastric acid). 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.

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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.
Body weight
BW (kg)

Daily dose
(mg/kg BW)

47 – 62
63 – 78
79 – 93
94 – 109
over 110

12 – 16
13 – 16
13 – 16
14 – 16

Ursofalk 500mg Film-coated Tablets
First 3 months
Subsequently
Morning
Midday
Evening
Evening (once daily)
½
½
½

½
½
1
2
½
1
1

1
1
1
3
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 kg
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.

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PL 1034/0010, Ursofalk 500mg film-coated tablets, Dr. Falk Pharma UK Ltd

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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.

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)

What Ursofalk 500mg film-coated tablets look like and contents of the pack

Both indications:

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:

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

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
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.

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.

If you forget to take Ursofalk tablets

Do not take more tablets the next time, but just continue the treatment with the prescribed dose.

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

URT_eCTD seq. 0009, 02/2014, Response to RFI for CSP update
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UK:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland:
Reports may be made by following the links to the online reporting option accessible from the IMB homepage,
or by completing the downloadable report form also accessible from the IMB website, which may be
completed manually and submitted to the IMB via freepost, to the following address:
FREEPOST, Pharmacovigilance Section, Irish Medicines Board, Kevin O’Malley House, Earlsfort Centre,
Earlsfort Terrace, Dublin 2, Ireland.
Tel: + 353 1 6764971, Fax: + 353 16762517 Website: www.imb.ie, e-mail : imbpharmacovigilance@imb.ie
By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE URSOFALK 500mg FILM-COATED TABLETS
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.
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 FURTHER 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.

Marketing Authorisation Holder:

Manufactured by:
Leinenweberstr. 5
79108 Freiburg
Germany

E-mail: zentrale@drfalkpharma.de
www.drfalkpharma.de
This leaflet was last revised in February 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

Mock-up GB-IE/02.14

Ursofalk capsules or Ursofalk suspension are available if you weigh less than 47 kg or cannot swallow tablets.

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.

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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.

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