Ursofalk
Poland
Table of Contents
- Patient Information Leaflet
- 1. What Ursofalk oral suspension is and what it is used for
- 2. Important information before using Ursofalk oral suspension
- 3. How to use Ursofalk oral suspension
- 4. Possible adverse effects
- 5. How to store Ursofalk oral suspension
- 6. Contents of the package and other information
Patient Information Leaflet
Ursofalk 250 mg/5 ml, oral suspension
Acidum ursodeoxycholicum
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.
- Keep this leaflet as you may need to read it again.
- If you have any further questions, please ask your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
- If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Table of contents
- What Ursofalk oral suspension is and what it is used for
- Important information before taking Ursofalk oral suspension
- How to take Ursofalk oral suspension
- Possible side effects
- How to store Ursofalk oral suspension
- Contents of the pack and other information
1. What Ursofalk oral suspension is and what it is used for
Active substance: ursodeoxycholic acid is a naturally occurring bile acid, present in small amounts in human bile.
Indications
- Dissolution of cholesterol gallstones in the gallbladder in patients for whom surgery is contraindicated. The stones must not exceed 15 mm in diameter, must be radiolucent (visible on cholecystography as non-shaded areas on X-ray), and gallbladder function must be preserved despite the presence of stones.
- Treatment of primary biliary cholangitis (a chronic inflammatory disease of the bile ducts associated with liver cirrhosis), provided that decompensated cirrhosis is not present (acute liver disease stage in which remaining liver tissue is no longer able to compensate for impaired function).
- Liver disorders associated with cystic fibrosis (mucoviscidosis) in children aged 1 month to 18 years.
2. Important information before using Ursofalk oral suspension
When not to use Ursofalk oral suspension
- if the patient has a known allergy (hypersensitivity) to bile acids (i.e. ursodeoxycholic acid) or to any of the other ingredients of this medicine (listed in section 6);
- if the patient has acute inflammation of the gallbladder or bile ducts;
- if the patient has obstruction of the common bile duct or cystic duct;
- if the patient experiences frequent upper abdominal pain resembling cramps (episodes of biliary colic);
- if the patient has calcified gallstones visible on X-ray;
- if the patient has impaired gallbladder contractility;
- if the patient is a child and has biliary atresia and insufficient bile flow despite surgical intervention.
If in doubt about any of the above symptoms, consult a doctor. If any of the above conditions occurred in the past, inform the doctor.
Warnings and precautions
Ursofalk oral suspension should be used under medical supervision.
During treatment, the doctor may recommend liver function tests every 4 weeks for the first 3 months, and then every 3 months thereafter.
If Ursofalk oral suspension is used to dissolve gallstones, the doctor should perform an ultrasound examination of the gallbladder after the first 6–10 months of treatment.
Female patients taking Ursofalk oral suspension for gallstone dissolution should use effective non-hormonal methods of contraception, as hormonal contraceptives may promote gallstone formation.
When Ursofalk oral suspension is used in the treatment of primary biliary cholangitis (PBC), symptoms such as itching may rarely worsen at the beginning of treatment. In such cases, contact the doctor to consider reducing the initial dose.
In case of chronic diarrhoea, consult a doctor immediately, as it may be necessary to reduce the dose or discontinue treatment with Ursofalk.
Ursofalk oral suspension and other medicines
Inform the doctor about all medicines currently or recently taken, as well as any medicines planned for use.
The effects of the following medicines may be altered (interactions).
Ursofalk oral suspension may reduce the effectiveness of the following medicines:
- cholestyramine, colestipol (cholesterol-lowering agents) or aluminium hydroxide, aluminium oxide (acid-binding agents). If treatment with any of these agents is necessary, they should be taken at least two hours before or after Ursofalk oral suspension.
- ciprofloxacin, dapsone (antibiotics), nitrendipine (a medicine used to lower blood pressure), and other drugs metabolized in a similar way. If necessary, the doctor may adjust the doses of these medicines.
Ursofalk oral suspension may alter the effect of the following medicines:
- cyclosporine (an immunosuppressive medicine). In patients receiving cyclosporine, the doctor may recommend monitoring its blood concentration and, if necessary, reducing the cyclosporine dose;
- rosuvastatin (a medicine used to lower high blood cholesterol levels).
If the patient is taking Ursofalk oral suspension to dissolve gallstones, they should inform the doctor about any concomitant use of oestrogen-containing medicines or cholesterol-lowering agents such as clofibrate. These medicines may promote gallstone formation and thus act against the therapeutic effect of Ursofalk oral suspension.
Inform the doctor about all recently used medicines, including those available without a prescription.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Fertility
Animal studies have not shown any effect of this medicine on fertility. There are no available data on the effect of this medicine on human fertility.
Pregnancy
There is insufficient data on the use of ursodeoxycholic acid in pregnant women. Animal studies have indicated a risk of fetal harm.
Ursofalk oral suspension should not be used during pregnancy unless the doctor considers it absolutely necessary.
Women of childbearing potential should only use this medicine in combination with effective contraceptive methods. Non-hormonal methods or low-oestrogen oral contraceptives are recommended. However, in female patients taking Ursofalk oral suspension for gallstone dissolution, effective non-hormonal contraceptive methods should be used, as hormonal oral contraceptives may exacerbate gallstone disease.
Before starting treatment with Ursofalk oral suspension, pregnancy should be ruled out.
Breastfeeding
There are only a few documented cases of ursodeoxycholic acid use during breastfeeding. The concentration of ursodeoxycholic acid in breast milk is very low, so adverse effects in breastfed infants are unlikely.
Driving and operating machinery
Ursofalk oral suspension does not affect the ability to drive or operate machinery.
Ursofalk oral suspension contains benzoic acid, propylene glycol, sodium, ethanol (alcohol), sulphites, citral, citronellol, d-limonene, geraniol and linalool.
The medicine contains 7.5 mg of benzoic acid in each 5 ml of suspension. Benzoic acid may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in neonates (up to 4 weeks of age).
The medicine contains 50 mg of propylene glycol in each 5 ml of suspension. Before administering the medicine to a child under 4 weeks of age, consult a doctor or pharmacist, especially if the child is taking other medicines containing propylene glycol or alcohol.
The medicine contains 11 mg of sodium in each 5 ml of suspension. This corresponds to 0.6% of the maximum recommended daily sodium intake in adults.
This medicine may contain trace amounts of ethanol (alcohol). The small amount of alcohol in this medicine will not cause noticeable effects.
This medicine may contain trace amounts of sulphites, which may cause severe hypersensitivity reactions and bronchospasm.
3. How to use Ursofalk oral suspension
This medicine should always be used as directed by the physician. If in doubt, consult your
doctor or pharmacist.
Instructions for opening
Always shake the closed bottle before use.
To open the bottle, press down firmly and simultaneously turn the cap to the left.
Dosage depends on the indication and is as follows:
Dissolution of cholesterol gallstones
Dosage
Approximately 10 mg/kg body weight/day, corresponding to:
Body weight Full scoop* Equivalent in ml
51 to 65 kg 2½ 12.50
66 to 80 kg 3 15.00
81 to 100 kg 4 20.00
over 100 kg 5 25.00
*1 scoop (to 5 ml of oral suspension) contains 250 mg of ursodeoxycholic acid.
Administration of Ursofalk oral suspension
Ursofalk oral suspension should be taken in the evening, before bedtime. The medicine should be taken
regularly.
Duration of therapy
Dissolution of gallstones usually takes 6–24 months. If the diameter of the stones has not
decreased within 12 months, treatment should be discontinued.
The doctor should assess treatment efficacy every 6 months. During follow-up visits, monitor whether the stones have become calcified. The presence of calcification is an indication to discontinue
therapy.
Treatment of primary biliary cholangitis (chronic cholangitis)
Dosage
During the first 3 months of treatment, Ursofalk oral suspension should be taken in the morning,
at noon, and in the evening. When liver function parameters have improved, the daily dose may be
taken once daily, in the evening.
| Body weight (kg) | Daily dose (mg/kg body weight) | Scoop* of Ursofalk oral suspension | |||
| First 3 months | Later therapy | ||||
| morning | noon | evening | evening (1 x daily) | ||
| 40 – 47 | 13 – 16 | ½ | 1 | 1 | 2 ½ |
| 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 | |
*1 measuring spoon (5 ml of oral suspension) contains 250 mg of ursodeoxycholic acid.
Conversion table:
Oral suspension Ursodeoxycholic acid
(equivalent in ml) (equivalent in mg)
1 spoon 5 ml 250 mg
¾ spoon 3.75 ml 187.5 mg
½ spoon 2.5 ml 125 mg
¼ spoon 1.25 ml 62.5 mg
Instructions for use of Ursofalk oral suspension
The medicine should be taken regularly.
Duration of therapy
There are no time limitations for the use of Ursofalk oral suspension in primary biliary cholangitis.
Other recommendations
In rare cases, in patients with primary biliary cholangitis, symptoms (e.g. pruritus) may worsen at the beginning of treatment. If this occurs, the physician may reduce the daily dose of Ursofalk oral suspension and then gradually increase the dose (weekly) until the recommended dose is reached.
Use in children (aged 1 month to 18 years) for the treatment of liver disorders in cystic fibrosis (mucoviscidosis)
Dosage:
The recommended daily dose is 20 mg per kg of body weight, divided into 2–3 doses. If necessary, the physician may recommend further increasing the dose up to 30 mg per kg of body weight per day.
In children with body weight below 10 kg, individual doses should be measured using a syringe, as the provided measuring spoon does not indicate volumes below 1.25 ml. Use single-use 2 ml syringes with 0.1 ml graduations. Note: Single-use syringes are not included in the package and must be obtained separately from a pharmacy.
To administer the required dose using a syringe:
- Shake the bottle before opening.
- Pour a small amount of suspension into the provided measuring spoon.
- Draw slightly more than the required volume of suspension into the syringe.
- Tap the syringe gently with your fingers to remove air bubbles from the suspension.
- Check whether the syringe contains the correct volume; adjust if necessary.
- Carefully administer the contents of the syringe directly into the child's mouth.
Do not insert the syringe into the bottle. Do not pour unused suspension from the syringe or measuring spoon back into the bottle.
Dosing in children with body weight up to 10 kg using a single-use syringe as a measuring device:
20 mg ursodeoxycholic acid/kg body weight/day
| Body weight (kg) | Ursofalk oral 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 |
For children with body weight above 10 kg, the measuring spoon provided in the package may be used:
Dosage for children with body weight above 10 kg using the provided measuring spoon:
20–25 mg ursodeoxycholic acid/kg body weight/day
| Body weight (kg) | Daily dose (mg/kg body weight) | Spoonfuls* of Ursofalk 250 mg/5 ml oral suspension | |
| 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 | 1¼ |
| 27 – 29 | 22–23 | 1¼ | 1¼ |
| 30 – 32 | 21–23 | 1¼ | 1½ |
| 33 – 35 | 21–23 | 1½ | 1½ |
| 36 – 38 | 21–23 | 1½ | 1¾ |
| 39 – 41 | 21–22 | 1¾ | 1¾ |
| 42 – 47 | 20–22 | 1¾ | 2 |
| 48 – 56 | 20–23 | 2¼ | 2¼ |
| 57 – 68 | 20–24 | 2¾ | 2¾ |
| 69 – 81 | 20–24 | 3¼ | 3¼ |
| 82 – 100 | 20–24 | 4 | 4 |
| >100 | 4½ | 4½ | |
- 1 measuring spoon (5 ml of oral suspension) contains 250 mg of ursodeoxycholic acid.
Conversion table:
| Oral suspension (equivalent in ml) | Ursodeoxycholic acid (equivalent in mg) | |
| 1 measuring spoon | 5 ml | 250 mg |
| ¾ measuring spoon | 3.75 ml | 187.5 mg |
| ½ measuring spoon | 2.5 ml | 125 mg |
| ¼ measuring spoon | 1.25 ml | 62.5 mg |
If you feel that the effect of the medicine is too strong or too weak, consult your doctor or pharmacist.
Use of a higher than recommended dose of Ursofalk oral suspension
Diarrhea may occur as a result of taking an excessive dose of the medicine. If chronic diarrhea develops, consult your doctor immediately. During diarrhea, fluids and electrolytes should be replenished.
Missed dose of Ursofalk oral suspension
Do not take a double dose to make up for a missed dose; continue treatment with the prescribed dose.
Stopping treatment with Ursofalk oral suspension
Before interrupting or prematurely discontinuing therapy with Ursofalk oral suspension, consult your doctor.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Common: not more frequent than in 1 out of 10 treated patients
- loose, pale stools or diarrhea.
Very rare: not more frequent than in 1 out of 10,000 treated patients
- during therapy for primary biliary cholangitis: severe pain in the upper right quadrant of the abdomen, worsening of liver disease symptoms, which partially resolve after discontinuation of therapy;
- calcification of gallstones;
- urticaria.
Frequency not known: frequency cannot be determined from available data
- itching;
- nausea, vomiting.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309;
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.
5. How to store Ursofalk oral suspension
Store in an upright position.
Do not store above 25°C.
Keep the medicine out of the sight and reach of children.
Do not use Ursofalk oral suspension after the expiry date stated on the bottle and carton: EXP. The expiry date refers to the last day of the stated month.
Usable period after first opening the bottle: 4 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
6. Contents of the package and other information
What Ursofalk oral suspension contains
- The active substance is ursodeoxycholic acid. One measuring spoon (5 ml of oral suspension) contains 250 mg of ursodeoxycholic acid.
- Other ingredients are: benzoic acid, xylitol, glycerol, Avicel RC-591 (microcrystalline cellulose + sodium carmellose), propylene glycol, sodium citrate, sodium cyclamate, citric acid, sodium chloride, lemon flavor (Givaudan PHL-134488, containing citral, citronellol, d-limonene, geraniol, linalool, ethanol and sulphites), purified water.
What Ursofalk oral suspension looks like and contents of the pack
Ursofalk oral suspension is a white, homogeneous suspension with small air bubbles and has a lemon odor.
An amber glass bottle containing 250 ml of suspension, with a child-resistant plastic screw cap and a 5 ml measuring spoon with 4 marked graduations: 1.25 ml, 2.5 ml, 3.75 ml and 5 ml.
Marketing Authorisation Holder, Manufacturer and Importer
Dr. Falk Pharma GmbH
Leinenweberstrasse 5
79108 Freiburg
Germany
For further information, please contact the representative of the Marketing Authorisation Holder in Poland:
Ewopharma AG Sp. z o.o., ul. Leszno 14, 01-192 Warsaw, tel. 22 620 11 71.