URSOFALK 250MG/5ML SUSPENSION

Active substance: URSODEOXYCHOLIC ACID

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Ursofalk Suspension Gebrauchsinformation (GI) für Großbritannien
Format: 342 x 215 mm
Druckfarben: 2/2 (Schwarz + Pant. 644)
Mat.-Nr.: Mock-up (Vifor AG)
Falk-Datumscode: GB/02.14

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 further information

1.  HAT URSOFALK 250mg/5ml SUSPENSION IS AND WHAT IT IS
W
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 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.
–  dissolve gallstones caused by excess cholesterol in the gall bladder where the
to
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).
–  liver disease associated with a condition called cystic fibrosis in children aged
for
1 month to 18 years.

2.  HAT YOU NEED TO KNOW BEFORE YOU TAKE URSOFALK
W
250mg/5ml SUSPENSION
Do NOT take Ursofalk suspension 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 this medicine (these
are listed in section 6.)
– 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 a blockage of the common bile duct or cystic duct
(obstruction of the biliary tract)
– you have frequent cramp-like upper abdominal pain (biliary colic).
– your doctor has said that you have calcified gallstones (they are visible on x-ray).
– you are a child with biliary atresia and have poor bile flow, even after surgery.

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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.
Warnings and precautions:
Talk to your doctor or pharmacist before taking Ursofalk suspension.
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 to dissolve gallstones, your doctor should arrange for a scan of your
gallbladder after the first 6 - 10 months of treatment.
When used in the treatment of PBC, in rare cases the symptoms may worsen when
you start treatment. Talk to your doctor if this happens as the dose may need to be
reduced.
Please inform your doctor immediately if you have diarrhoea as this may require a
reduction in the dose or discontinuation of treatment.

Other medicines and Ursofalk 250mg/5ml Suspension

The effects of these medicines may be altered:
A reduction in the effects of the following medicines is possible when taking
Ursofalk suspension:
– 
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.
– 
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.
A change in the effects of the following medicines is possible when taking Ursofalk
suspension:
– 
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)
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 for the dissolution of gallstones as they may stimulate the
formation of gallstones.
Please tell your doctor or pharmacist if you are taking or have recently taken or
might take any other medicines, even if they are medicines obtainable without a
prescription. Treatment with Ursofalk suspension 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.
Breast-feeding: Tell your doctor if you are breastfeeding or about to start breastfeeding.

Driving and using machines:

No particular precautions are necessary.
Important information about some of the ingredients of Ursofalk suspension:
One cup (equivalent to 5ml) of Ursofalk Suspension contains 0.5mmol (11.39mg)
sodium. To be taken into consideration by patients on a controlled sodium diet.

3. HOW TO TAKE URSOFALK 250mg/5ml SUSPENSION
Always take Ursofalk suspension exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.

Opening the child-resistant closure:

Always shake the closed bottle well before use. To open the bottle, depress the
closure firmly while turning it towards the left.

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

Dosage
During the first 3 months of treatment, Ursofalk suspension should be taken 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.
Body weight
(kg)

Daily dose
mg/kg BW

8 – 11
12 – 15
16 – 19
20 – 23
24 – 27
28 – 31
32 – 39
40 – 47
48 – 62
63 – 80
81 – 95
96 – 115
over 115

12 – 16
12 – 16
13 - 16
13 - 16
13 - 16
14 - 16
12 - 16
13 - 16
12 - 16
12 - 16
13 - 16
13 - 16

Cups* of Ursofalk Suspension
First 3 months
Subsequently
Morning
Midday
Evening Evening (once daily)

¼
¼
½
¼
¼
¼
¾
½

½
1
¼
½
½

½
½
½

¼
½
1

½
½
1
2
½
1
1

1
1
1
3
1
1
2
4
1
2
2
5
2
2
2
6
2
2
3
7

*  ne cup (equivalent to 5 ml oral suspension) contains 250 mg ursodeoxycholic acid
O
(UDCA).
How to take Ursofalk suspension
Take Ursofalk suspension regularly.
Duration of treatment
Ursofalk suspension may be continued indefinitely in cases of primary biliary cirrhosis.

To dissolve cholesterol gallstones

Dosage
Approximately 10 mg per kg body weight (BW) daily, as follows:
Body weight (kg)
51 to 65
66 to 80
81 to 100
over 100

Cups*

3
4
5

Equivalent in ml
12.50
15.00
20.00
25.00

*  ne cup (equivalent to 5 ml oral suspension) contains 250 mg ursodeoxycholic acid
O
(UDCA).
How to take Ursofalk suspension
Take the suspension in the evening at bedtime. Take the suspension 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.

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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.

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:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

Use in children and adolescents:
The administration of Ursofalk is based on body weight and the condition being
treated.

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

Use in children (1 month to 18 years) for treatment of hepatobiliar
disorder associated with cystic fibrosis

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

5. HOW TO STORE URSOFALK 250MG/5ML SUSPENSION

Dosage
20 mg per kg body weight two to three times a day, with an increase to 30mg if
advised by your doctor.
How to take Ursofalk 250mg/5ml Suspension
Take Ursofalk suspension two to three times per day, as advised.
Take Ursofalk suspension regularly.
Duration of treatment
Treatment can be continued long term (up to 18 years) in children with cystic fibrosis
associated hepatobiliary disorders.
If you feel that the effect of Ursofalk suspension is too strong or too weak, please
talk to your doctor or pharmacist.

If you take more Ursofalk suspension than you should:

If you or anyone else takes too much of the suspension, seek immediate medical
attention.

If you forget to take Ursofalk suspension:

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

If you stop taking Ursofalk uspension:

Always speak to your doctor before you decide to interrupt treatment with Ursofalk
suspension or to stop your treatment early.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Ursofalk suspension 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. 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)

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 and the
bottle after “Expiry date”. The expiry date refers to the last day of that month.
Opened bottles must be used within 4 months.
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 suspension contains

The active substance is ursodeoxycholic acid. 5ml oral suspension (equivalent to
1 cup) contains 250 mg ursodeoxycholic acid.
The other ingredients are benzoic acid, microcrystalline cellulose and
carboxymethylcellulose sodium, sodium chloride, sodium citrate, citric acid
anhydrous, glycerol, propylene glycol, xylitol, sodium cyclamate, purified water
and lemon flavouring

What Ursofalk suspension looks like and contents of the pack

Ursofalk 250mg/5ml Suspension is a white homogenous suspension with a lemon
odour.
Ursofalk 250mg/5ml Suspension is in bottles of 250ml.

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

Manufactured by:
Leinenweberstr. 5
79108 Freiburg
Germany

E-mail: zentrale@drfalkpharma.de
www.drfalkpharma.de
This leaflet was last revised in February 2014.
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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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