Ursofalk 250 mg Ursodeoxycholic acid Capsules × 50

Please note that the doctor may have prescribed the medicine for a different use and/or with a different dosage than stated in the package insert.

• • Always follow your doctor prescribing indicated on the pharmacy label.

• • Ursodeoxycholic acid, the active ingredient in Ursofalk capsules, is a natural bile acid that is found in small amounts in the bile of humans.

Ursofalk is used:

• • To dissolve small gallstones.

• • For a liver disease (primary biliary cirrhosis) among other things to stimulate bile flow.

• • For a liver disease associated with a condition called cystic fibrosis (also called mucoviscidosis) in children aged 6 to under 18.

How To Use:

• • Always use Ursofalk exactly as your doctor has told you. Contact a doctor or pharmacist if you are unsure.

Dissolution of gallstones:

• • The usual dose is 10-12 mg per kg of body weight daily, divided into 2 doses.

• • It usually takes 6-24 months for gallstones to dissolve. If the size of the gallstones does not decrease after 12 months, treatment should be discontinued.

• • For treatment to dissolve gallstones, a test will be carried out after 6 to 10 months of treatment to check whether the treatment is successful.

Primary biliary cirrhosis:

• • The usual dose is 12-16 mg per kg of body weight daily.

• • In the first 3 months after treatment has begun, intake of Ursofalk should be spread throughout the day. When the liver values ​​have improved, the dose can be taken once a day, preferably in the evening.

• • There are no restrictions on the duration of treatment with this medicine in primary biliary cirrhosis.

• • In patients with primary biliary cirrhosis, a worsening of symptoms may occur in rare cases at the beginning of treatment, e.g. Itch. If this happens, treatment can continue with a lower dosage of Ursofalk. Later, every week your doctor will increase the daily dose to the recommended daily dose.

• • The capsules are swallowed whole with plenty of liquid. They must be taken regularly to achieve successful results.

Warnings And Precautions:

Do not use Ursofalk:

• • if you are allergic to bile acids or any of the other ingredients of this medicine.

• • if you have acute inflammation of the gallbladder or bile duct.

• • if you have frequent episodes of biliary colic.

• • if you have a blockage in the bile ducts.

• • if your gallbladder cannot contract sufficiently.

• • if you have radiopaque calcified gallstones.

• • if your child has narrow ducts and poor bile flow, even after surgery.

Consult a doctor or pharmacist before using Ursofalk:

• • During the first three months of treatment, your liver function will be checked to see if the treatment is working and to check for side effects in the liver.

• • Women taking Ursofalk to dissolve gallstones should only use non-hormonal contraception because oral hormonal contraception can stimulate the formation of gallstones.

• • In patients with primary biliary cirrhosis, a worsening of symptoms may occur in rare cases at the beginning of treatment, e.g. itch. If this happens, treatment can continue with a lower dosage of Ursofalk. Later, every week your doctor will increase the daily dose to the recommended daily dose.

• • You must inform your doctor if you get diarrhea, as the dose of Ursofalk may need to be adjusted.

Ingredients:

• The active ingredient is ursodexycholic acid 250 mg.