Ursofalk 250mg/5ml Suspension
Ref: 1460/010615/1/F
Ursofalk ® 250mg/5ml Suspension
(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.
Your medicine is called Ursofalk 250mg/5ml Suspension but will be referred to as Ursofalk suspension throughout the rest of this leaflet.
What is in this leaflet:
Q What Ursofalk suspension is and what it is used for ^ What you need to know before you take Ursofalk suspension Q How to take Ursofalk suspension Q Possible side effects Q How to store Ursofalk suspension Q Contents of the pack and further information
Q 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.
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.
Q 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.
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 breast-feeding 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 spoon (equivalent to 5ml) of Ursofalk Suspension contains 0.5mmol (11.39mg) sodium. To be taken into consideration by patients on a controlled sodium diet.
Q 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.
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 values improve, the total daily dose may be taken once a day in the evening.
|
Body weight (kg) |
Daily dose mg/kg BW |
Spoons* of Ursofalk Suspension | |||
|
first 3 months |
subsequently | ||||
|
morning |
midday |
evening |
evening (once daily) | ||
|
8 - 11 |
12 - 16 |
- |
% |
% |
/ |
|
12 - 15 |
12 - 16 |
% |
% |
% |
% |
|
16 - 19 |
13 - 16 |
/ |
- |
/ |
1 |
|
20 - 23 |
13 - 15 |
% |
/ |
/ |
1 % |
|
24 - 27 |
13 - 16 |
/ |
/ |
/ |
1 / |
|
28 - 31 |
14 - 16 |
% |
/ |
1 |
1 % |
|
32 - 39 |
12 - 16 |
/ |
/ |
1 |
2 |
|
40 - 47 |
13 - 16 |
/ |
1 |
1 |
2 / |
|
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 spoon (equivalent to 5ml suspension) contains 250mg ursodeoxycholic acid.
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 10mg per kg body weight (BW) daily, as follows:
|
Body weight (kg) |
Spoon* |
Equivalent in ml |
|
5 to 7 |
% |
1.25 |
|
8 to 12 |
/ |
2.50 |
|
13 to 18 |
% (= % + /) |
3.75 |
|
19 to 25 |
1 |
5.00 |
|
26 to 35 |
1/ |
7.50 |
|
36 to 50 |
2 |
10.00 |
|
51 to 65 |
2/ |
12.50 |
|
66 to 80 |
3 |
15.00 |
|
81 to 100 |
4 |
20.00 |
|
over 100 |
5 |
25.00 |
* One spoon (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.
Ursofalk ® 250mg/5ml Suspension
(ursodeoxycholic acid)
Patient Information Leaflet (continued)
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 spoon 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 onto the enclosed spoon.
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 spoon 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 (kg) |
Ursofalk Suspension (ml) | |
|
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 spoon provided can be used for children over 10kg body weight.
More than 10kg body weight (BW): Dosing 20-25mg Ursodeoxycholic acid/kg/day
Measuring device: spoon
|
Body weight (kg) |
Daily dose (mg/kg BW) |
Spoons of Ursofalk Suspension | |
|
Morning |
Evening | ||
|
11-12 |
21-23 |
/ |
/ |
|
13-15 |
21-24 |
/ |
% |
|
16-18 |
21-23 |
% |
% |
|
19-21 |
21-23 |
% |
1 |
|
22-23 |
22-23 |
1 |
1 |
|
24-26 |
22-23 |
1 |
1% |
|
27-29 |
22-23 |
1% |
1% |
|
30-32 |
21-23 |
1% |
1/ |
|
33-35 |
21-23 |
1/ |
1/ |
|
36-38 |
21-23 |
1/ |
1% |
|
39-41 |
21-22 |
1% |
1% |
|
42-47 |
20-22 |
1% |
2 |
|
48-56 |
20-23 |
2% |
2% |
|
57-68 |
20-24 |
2% |
2% |
|
69-81 |
20-24 |
3% |
3% |
|
82-100 |
20-24 |
4 |
4 |
|
>100 |
4/ |
4/ | |
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.
Q 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.
Q How to store Ursofalk suspension
* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
* After opening use within 4 months.
* Do not take Ursofalk after the expiry date shown on the bottle label or carton. If your doctor tells you to stop using this medicine, take any remaining medicine back to the pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.
* If your medicine becomes discoloured or shows any signs of deterioration, ask your pharmacist who will advise you what to do.
* 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.
0 Contents of the pack and further information
What Ursofalk suspension contains:
The active ingredient is ursodeoxycholic acid.
Each 5ml oral suspension contains 250mg of ursodeoxycholic acid.
The other ingredients are benzoic acid, microcrystalline cellulose, carboxymethylcellulose sodium, sodium chloride, sodium citrate, citric acid anhydrous, glycerol, propylene glycol, xylitol, sodium cyclamate, lemon flavour and purified water.
What Ursofalk suspension looks like and contents of the pack
Ursofalk suspension is a white suspension with a lemon odour.
Ursofalk suspension is in bottles of 250ml. Each pack contains a 5ml measuring spoon.
Manufacturer and Licence Holder
This medicine is manufactured by Dr Falk Pharma GmbH, Leinenweberstrasse 5, D-79108 Freiburg, Germany and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
POMI 15184/1460 Ursofalk 250mg/5ml Suspension Ursofalk is a registered trademark of Dr Falk Pharma GmbH.
Revision date: 01/06/15
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Phone Lexon (UK) Limited, Tel: 01527 505414 for help.
* One spoon (equivalent to 5ml oral suspension) contains 250mg ursodeoxycholic acid.
Conversion table:
|
Ursofalk suspension |
Ursodeoxycholic acid | |
|
1 Spoon |
= 5ml |
= 250mg |
|
% Spoon |
= 3.75ml |
= 187.5mg |
|
/ Spoon |
= 2.5ml |
= 125mg |
|
% Spoon |
= 1.25ml |
= 62.5mg |
How to take Ursofalk 250mg/5ml suspension
Take Ursofalk suspension two to three times per day, as advised. Take Ursofalk suspension regularly.