500 mg film-coated tablets
ursodeoxycholic acid
What Ursofalk is and what it is used for
Ursofalk contains the active substance ursodeoxycholic acid, which is a naturally occurring bile acid found in small amounts in human bile.
Ursofalk is used to dissolve small gallstones and in liver disease (primary biliary cirrhosis ) to stimulate bile flow, among other things.
Ursofalk is also used for a liver disease associated with a condition called cystic fibrosis (also called cystic fibrosis) in children aged 6 to 18 years.
What you need to know before using Ursofalk
Do not use Ursofalk
- if you are allergic to ursodeoxycholic acid or any of the other ingredients of this medicine (listed in section 6).
- if you have acute inflammation of the gallbladder or bile ducts
- if you have a blockage in the common bile duct or bile ducts.
- if you often have biliary colic (cramp-like pain in the upper abdomen)
- if your doctor has told you that you have calcified gallstones
- if you have impaired gallbladder function
- if your child has bile duct atresia (a rare disease in which the bile ducts outside the liver do not work) and has poor bile flow, even after surgery.
Ask your doctor about the conditions mentioned above. Also, ask your doctor if you have previously had any of these conditions.
Warnings and precautions
During the first three months of treatment, the function of your liver will be tested to see how the treatment is working and to detect side effects in the liver.
When treating to dissolve gallstones, tests will be carried out after 6 to 10 months of treatment to check if the treatment is successful.
Women taking Ursofalk for the dissolution of gallstones should only use non-hormonal contraceptives as hormonal contraceptives can increase the formation of gallstones (see also section pregnancy, breastfeeding, and fertility below).
When treating the liver disease primary biliary cirrhosis, in rare cases certain symptoms (e.g. itching ) may worsen at the beginning of treatment. If this occurs, talk to your doctor. The treatment can be continued with a lower daily dose. Each week your doctor will then gradually increase the daily dose by one to the recommended daily dose.
If you get diarrhea, you must tell your doctor, your dose of Ursofalk may need to be changed.
Other medicines and Ursofalk
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. It is especially important if you are taking the following medicines:
- colestipol and cholestyramine (for high blood lipids)
- antacids (against a sour stomach) containing aluminum hydroxide or aluminum oxide.
- ciclosporin (to reduce the effect on the immune system during transplants)
- ciprofloxacin (for infection )
- nitrendipine (for high blood pressure )
- dapsone (for HIV )
- estrogenic hormones (found in some birth control pills and medicines for menopause)
- clofibrate (for high blood lipids)
- rosuvastatin (for high blood lipids)
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 using this medicine.
It is unknown whether Ursofalk affects the fetus or passes into breast milk. Ursofalk should not be used during pregnancy or breastfeeding unless necessary.
Before you start treatment with Ursofalk, a check must be made to rule out that you are pregnant.
Women of childbearing age
Women of childbearing age should only be treated with Ursofalk if contraception is used at the same time. Non-hormonal contraceptives or birth control pills with low-dose estrogen are recommended.
If you take Ursofalk to dissolve gallstones, only non-hormonal contraceptives should be used, as hormonal contraceptives can increase the formation of gallstones.
Driving ability and use of machinery
Ursofalk has no or negligible effect on the ability to drive and use machines.
How to use Ursofalk
Always use Ursofalk according to your doctor’s instructions. Ask your doctor or pharmacist if you are unsure.
Dissolving gallstones:
The recommended dose for adults is 10-12 mg/kg body weight daily, divided into 2 dosing occasions.
It generally takes 6-24 months for gallstones to dissolve. If the size of the gallstones does not decrease after 12 months, treatment should be discontinued.
Primary biliary cirrhosis: Usual dose for adults is 12-16 mg/kg body weight daily.
During the first 3 months after starting treatment, Ursofalk tablets should be taken spread out over the day. When the liver values have improved, dose one can be taken once a day, preferably in the evening.
The use of Ursofalk in the treatment of primary biliary cirrhosis can be continued indefinitely.
Use in children (6 years up to 18 years) for the treatment of a liver disease associated with cystic fibrosis
Dosage
The recommended daily dose is 20 mg per kg of body weight, divided into 2-3 doses. Your doctor may wish to increase the dose further to 30 mg per kg of body weight per day if necessary.
| Body weight(kg) | Daily dose(mg/kg body weight) | Ursofalk 500 mg film-coated tablet | ||
| Morning | Dinner | Evening | ||
| 20 – 29 | 17-25 | ½ | – | ½ |
| 30 – 39 | 19-25 | ½ | ½ | ½ |
| 40 – 49 | 20-25 | ½ | ½ | 1 |
| 50 – 59 | 21-25 | ½ | 1 | 1 |
| 60 – 69 | 22-25 | 1 | 1 | 1 |
| 70 – 79 | 22-25 | 1 | 1 | 1½ |
| 80 – 89 | 22-25 | 1 | 1½ | 1½ |
| 90 – 99 | 23-25 | 1½ | 1½ | 1½ |
| 100 – 109 | 23-25 | 1½ | 1½ | 2 |
| >110 | – | 1½ | 2 | 2 |
How to take Ursofalk
The tablets can be divided into two equal parts. When dosing with ½ tablet, the remaining part can be saved for the next dose.
Swallow the tablets without chewing or crushing them together with a glass of water or other liquid. You must take the tablets regularly.
If you weigh less than 47 kg or cannot swallow Ursofalk tablets, Ursofalk oral solution may be an alternative.
If you have used too much Ursofalk
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
In case of overdose, diarrhea may occur. Contact your doctor immediately if you have persistent diarrhea.
If you forget to take Ursofalk
Do not take double doses to make up for missed doses.
If you stop taking Ursofalk
Always talk to your doctor before you stop taking Ursofalk.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 people): Diarrhoea, pale stools.
Very rare (may affect up to 1 in 10,000 users): Severe pain in the upper right part of the stomach in the treatment of liver disease (primary biliary cirrhosis ), deterioration of liver function in the treatment of liver disease (primary biliary cirrhosis ) which may return to the normal at the end of treatment, calcium deposits in gallstones (shown by the test, you don’t get any further symptoms), hives.
How Ursofalk should be stored
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the packaging after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
The medicine must not be thrown into the drain or among the household waste. Ask the pharmacist how to deal with drugs that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is ursodeoxycholic acid (UDCA). One film-coated tablet contains 500 mg of ursodeoxycholic acid.
- Other ingredients are magnesium stearate, polysorbate 80, povidone K 25, microcrystalline cellulose, colloidal anhydrous silica, crospovidone (type A), talc, hypromellose and macrogol 6000.
Appearance and package sizes of the medicine
White, oval, biconvex tablet with a score on both sides.
Packs of 50 and 100 film-coated tablets.
Dr. Falk Pharma GmbH
Leinenweberstrasse. 5
79108 Freiburg
Germany