URSOFALK 250MG HARD CAPSULES

Active substance: URSODEOXYCHOLIC ACID

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Ursofalk® 250mg hard capsules
Ursodeoxycholic acid
Read all of this leaflet carefully before you start taking this medicine.
– 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. Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
− If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
n this leaflet:
I
1. 
What Ursofalk 250mg hard capsules are and what they are used for
. Before you take Ursofalk 250mg hard capsules
2
. How to take Ursofalk 250mg hard capsules
3
. Possible side effects
4
5. How to store Ursofalk 250mg hard capsules
6. Further information
1. WHAT URSOFALK 250mg HARD CAPSULES ARE AND WHAT THEY ARE USED FOR
Ursodeoxycholic acid, the active substance in Ursofalk 250mg hard capsules, is a naturally-occurring bile
acid. Small amounts are found in human bile.

Ursofalk 250mg hard capsules are used:

– 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 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.

2. BEFORE YOU TAKE URSOFALK 250mg HARD CAPSULES

Do NOT take Ursofalk 250mg hard capsules if:

– you are, or have been told you are allergic (hypersensitive) to bile acids like ursodeoxycholic acid or to
any of the other ingredients of Ursofalk 250mg hard capsules (these are listed in section “6. Further
information”)
– your gall bladder does not work properly
– you have gallstones that are visible on an x-ray
– you have acute inflammation of the gall bladder or biliary tract
– you have an obstruction of the biliary tract (blockage of the common bile duct or a cystic duct)
– you suffer from frequent cramp-like pains in the upper abdomen (biliary colic).
– you have hardening of the gallstones caused by a build-up of calcium.
Please ask your doctor about any of 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.
Further precautions:
Ursofalk 250mg hard capsules must be used under medical supervision.
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.
Please inform your doctor immediately if you have diarrhoea as this may require a reduction in the dose
or discontinuation of treatment.

Taking other medicines with Ursofalk 250mg hard capsules

Please tell your doctor if you are taking or have recently taken any other medicines which contain the
following ingredients. The effects of these medicines may be altered (interactions):
A reduction in the effects of the following medicines is possible when taking Ursofalk 250mg hard capsules:
– 
colestyramine, charcoal, 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.
– 
ciprofloxacin and dapsone (antibiotics), nitrendipine (used to treat high blood pressure). It may be
necessary for your doctor to alter the dose of these medicines.
An increase in the effects of the following medicines is possible when taking Ursofalk 250mg hard capsules:
– 
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.
Please inform your doctor if you are taking any blood cholesterol lowering agents such as clofibrate or
medicines that contain oestrogen (estrogen) especially if you are taking Ursofalk 250mg hard capsules for
the dissolution of gallstones as they may stimulate the formation of gallstones.

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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 250mg hard capsules
may still be allowed. Your doctor will know what is right for you.

Pregnancy and breastfeeding:

Ask your doctor or pharmacist for advice before taking/using any medicine.
– 
You should not take Ursofalk 250mg hard capsules during pregnancy unless your doctor thinks it is
absolutely necessary. Use of Ursofalk during the first three months of pregnancy may affect the foetus.
– Check that you are not pregnant before taking this medicine.
– 
Use a reliable method of contraception – non-hormonal contraceptives (barrier methods) or low-oestrogen oral contraceptives are recommended. If you are taking Ursofalk 250mg hard capsules for dissolution of gallstones, only use non-hormonal contraceptives, as hormonal oral contraceptives may
stimulate the formation of gallstones.
–  not take this medicine if you are breastfeeding as the active ingredient in Ursofalk 250mg hard
Do
capsules may pass into breast milk. If treatment with Ursofalk 250mg hard capsules is necessary,
then stop breastfeeding.

Use in children:

There are no age limits to the use of Ursofalk 250mg hard capsules. The administration of Ursofalk
250mg hard capsules is based on body weight and the medical condition.

Driving and using machines:

No particular precautions are necessary.
3. HOW TO TAKE URSOFALK 250mg HARD CAPSULES
Always take Ursofalk 250mg hard capsules exactly as your doctor has told you. You should check with
your doctor or pharmacist if you are not sure.

To dissolve cholesterol gallstones
Dosage
Approximately 10 mg per kg body weight (BW) daily, as follows:
50 - 62 kg
63 – 85 kg
86 – 120 kg

2 capsules daily
3 capsules daily
4 capsules daily

28.09.2011 9:09:52 Uhr

Dosage
During the first 3 months of treatment, you should take Ursofalk 250mg hard capsules in the morning, at
midday and in the evening. As liver function tests improve, the total daily dose may be taken once a day
in the evening.
Ursofalk 250mg hard capsules
First 3 months

Subsequently

Morning

Midday

Evening

Evening

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

2

2

3

7

over 110

Ursofalk suspension is available if you weigh less than 47kg or cannot swallow capsules.
How to take Ursofalk 250mg hard capsules
Swallow the capsules whole with a drink of water or other liquid. Take your medicine regularly.
Duration of treatment
Ursofalk 250mg hard capsules may be continued indefinitely in cases of primary biliary cirrhosis.
Note:
In patients with primary biliary cirrhosis, the symptoms may worsen at the start of treatment, e.g. the
itching may increase. This only occurs in rare cases. If this happens, therapy can be continued with a

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If you or anyone else take too many of the capsules, seek immediate medical attention.

Keep all medicines out of the reach and sight of children.
Do not use this medicine after the expiry date. This date is stated on the carton and the container after
“Expiry date”. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.

If you forget to take Ursofalk 250mg hard capsules:

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

6. FURTHER INFORMATION

If you stop taking Ursofalk 250mg hard capsules:

For primary biliary cirrhosis (chronic inflammation of the bile ducts)

Body weight BW (kg) Daily dose (mg/kg BW)

If you take more Ursofalk 250mg hard capsules than you should:

5. HOW TO STORE URSOFALK 250mg HARD CAPSULES

What Ursofalk 250mg hard capsules contain:

Always speak to your doctor before you decide to interrupt treatment with Ursofalk 250mg hard capsules or to stop your treatment early.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Ursofalk 250mg hard capsules can cause side effects, although not everybody gets
them.
You should contact your doctor immediately if you experience any of the following symptoms after
taking Ursofalk 250mg hard capsules:
Common side effects (occurring in less than 1 in 10 but more than 1 in 100 patients):
– 
soft, loose stools or diarrhoea. Inform your doctor immediately if you have persistent diarrhoea,
as this may require a reduction in the dose. If you do suffer from diarrhoea, make sure you drink
enough liquids to replace your fluid and salt balance.
Diarrhoea may also occur as a result of overdose.
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 scarring - this partially improves after treatment is stopped.
– 
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)
If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

The active substance is ursodeoxycholic acid. One capsule contains 250 mg ursodeoxycholic acid.
The other ingredients are gelatin, colloidal silica anhydrous, magnesium stearate, maize starch, titanium
dioxide, sodium lauryl sulphate.

What Ursofalk 250mg hard capsules look like and contents of the pack

Ursofalk 250mg hard capsules are white, opaque hard gelatine capsules containing a white powder or
granules.
Ursofalk 250mg hard capsules are available in packs of 60 or 100 capsules.

Marketing Authorisation Holder:
Dr Falk Pharma UK Ltd
Unit K, Bourne End Business Park
Cores End Road
Bourne End, Buckinghamshire
SL8 5AS, UK

GB/10.11

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 a build-up of calcium causing hardening of the stones has
occurred since the last time. If this happens, your doctor will stop the treatment.

lower daily dose of Ursofalk 250mg hard capsules. Each week, your doctor will then gradually increase
the daily dose, until you reach the required dose.
If you feel that the effect of Ursofalk 250mg hard capsules is too strong or too weak, please talk to your
doctor or pharmacist.

Manufactured by:
Leinenweberstr. 5
79108 Freiburg
Germany

E-mail: zentrale@drfalkpharma.de

www.drfalkpharma.de
This leaflet was last approved in September 2011.

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How to take Ursofalk 250mg hard capsules
Swallow the capsules whole with a drink of water or other liquid. Take the capsules in the evening at
bedtime. Take your medicine regularly.

28.09.2011 9:09:55 Uhr

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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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