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URSODEOXYCHOLIC ACID 250MG/5ML SUSPENSION

Active substance(s): URSODEOXYCHOLIC ACID

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Ursofalk® 250mg/5ml Suspension

2915
25.04.16[1]

(ursodeoxycholic acid)
PATIENT INFORMATION LEAFLET
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.
This medicine is available using above name but will be referred to as
Ursofalk suspension throughout the following.
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

Pregnancy breastfeeding and fertility:
If you are pregnant or breast-feeding, 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 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.

1. WHAT URSOFALK 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.

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.

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.

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 values
improve, the total daily dose may be taken once a day in the evening.
Body
Daily
Cups * of Ursofalk suspension
weight
dose
first 3 months
subsequent
(kg)
(mg/kg
ly
BW)
morning
midday
evening
evening
(once 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

24-27
13-16
½
½
½

28-31
14-16
¼
½
1

32-39
12-16
½
½
1
2
40-47
13-16
½
1
1

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 (equivalent to 5ml suspension) contains 250mg ursodeoxycholic
acid.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE URSOFALK
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 (listed in section 6.)
- your gall bladder does not work properly.
- you have gallstones that are visible on an x-ray (calcified).
- 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).
- you are a child with biliary atresia and have poor bile flow, even after
surgery.
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.

How to take Ursofalk suspension
Take Ursofalk suspension regularly.

Warnings and precautions:
Talk to your doctor or pharmacist before taking Ursofalk suspension.

Duration of treatment
Ursofalk suspension may be continued indefinitely in cases of primary biliary
cirrhosis.

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 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.

To dissolve cholesterol gallstones
Dosage
Approximately 10 mg per kg body weight (BW) daily, as follows:
Body weight (kg)
Cups*
Equivalent in ml
5 to 7
¼
1.25
8 to 12
½
2.50
13 to 18
¾(= ¼ + ½ )
3.75
19 to 25
1
5.00
26 to 35

7.50
36 to 50
2
10.00
51 to 65

12.50
66 to 80
3
15.00
81 to 100
4
20.00
over 100
5
25.00
* One cup (equivalent to 5ml suspension) contains 250mg ursodeoxycholic
acid.
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.
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:
Use in children and adolescents:
The administration of Ursofalk is based on body weight and the condition
being treated.
Use in children (1 month to 18 years) for treatment of liver disease
associated with cystic fibrosis
Dosage
The recommended daily dose is 20mg 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.
Single doses for children with a body weight up to 10kg should be given with
a syringe as the cup provided does not cover volumes below 1.25ml. Use a
single-use 2ml syringe with a graduation of 0.1ml. Please note: Single-use
syringes are not included in the pack, but may be purchased from your
pharmacist.
To administer the required dose by syringe:
1. Shake the bottle well before opening.
2. Pour a small amount of suspension into the enclosed cup.
3. Draw the appropriate volume into the syringe.
4. Tap against the barrel of the syringe to remove any large air bubbles.
5. Check the appropriate volume of suspension in the syringe, adjust if
necessary
6. Carefully dispense the syringe contents directly into the child’s mouth.

Do not put the syringe into the bottle. Do not put unused suspension from
the syringe or the cup back into the bottle.
Up to 10kg body weight: Dosing 20mg Ursodeoxycholic acid/kg/day
Measuring device: single-use 2ml graduated syringe (not provided)
Body weight
Ursofalk suspension (ml)
(kg)
Morning
Evening
4
0.8
0.8
4.5
0.9
0.9
5
1.0
1.0
5.5
1.1
1.1
6
1.2
1.2
6.5
1.3
1.3
7
1.4
1.4
7.5
1.5
1.5
8
1.6
1.6
8.5
1.7
1.7
9
1.8
1.8
9.5
1.9
1.9
10
2.0
2.0
The cup provided can be used for children over 10kg body weight.
More than 10 kg body weight (BW): Dosing 20-25 Ursodeoxycholic
acid/kg/day
Measuring device: cup
Body weight
Daily dose
* Cups of Ursofalk suspension
(kg)
(mg/kg BW)
Morning
Evening
11-12
21-23
½
½
13-15
21-24
½
¾
16-18
21-23
¾
¾
19-21
21-23
¾
1
22-23
22-23
1
1
24-26
22-23
1

27-29
22-23


30-32
21-23


33-35
21-23


36-38
21-23


39-41
21-22


42-47
20-22

2
48-56
20-23


57-68
20-24


69-81
20-24


82-100
20-24
4
4
>100


* One cup (equivalent to 5ml suspension) contains 250mg ursodeoxycholic
acid.
Conversion table:
1 cup
¾ cup
½ cup
¼ cup

Ursofalk suspension
= 5ml
= 3.75ml
= 2.5ml
= 1.25ml

Ursodeoxycholic acid
= 250mg
=187.5mg
=125mg
= 62.5mg

How to take Ursofalk 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 suspension:
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. Please 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)
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
By reporting side effects, you can help provide more information on the
safety of this medicine.
5. HOW TO STORE URSOFALK SUSPENSION
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.
This medicinal product does not require any special storage conditions.
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 suspension (equivalent to 1spoon) contains 250mg ursodeoxycholic
acid.
The other ingredients are:
benzoic acid, citric acid anhydrous, glycerol, microcrystalline cellulose,
carmellose sodium, sodium chloride, sodium citrate, sodium cyclamate,
propylene glycol, purified water, xylitol and lemon flavour.
What Ursofalk suspension looks like and contents of the pack
Ursofalk suspension is a white liquid with small air bubbles and a lemon
odour.
Ursofalk suspension is available as 250ml of suspension in an amber glass
bottle, closed with a white ribbed plastic, child resistant screw cap.
A transparent plastic measuring spoon is enclosed for dispensing the
suspension.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by Dr. Falk Pharma GmbH, Leinenweberstrasse 5, D-79108
Freiburg, Germany. Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex, HA1
1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2915

Leaflet revision and issue date (Ref) 25.04.16[1]
Ursofalk is a trademark of Dr. Falk Pharma GmbH.

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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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