URSOFALK caps. 250 mg. 100 caps

What is and what it is used Ursofalk ® capsules ?

Ursodeoxycholic acid, the active substance in the capsules is Ursofalk ® bile acid , which is found in small amounts in human bile .

Ursofalk  capsules are used:

- For the dissolution of cholesterol gallstones , permeable to X-rays , with a diameter not larger than 15 mm in patients with normal function of the gall bladder, irrespective of gallstones .

- For the treatment of gastritis caused by reflux of bile .

- For the symptomatic treatment of primary biliary cirrhosis ( chronic inflammation of the gall perfusion associated with liver cirrhosis ) , provided that no decompensation of liver cirrhosis (severe liver disease , in the stages when the intact liver tissue can still compensate for the reduced liver function ) .

2 . Before taking Ursofalk  capsules

Do not take Ursofalk  capsules:

If you have an allergy to bile acids or any of the other ingredients of Ursofalk ® capsules ( p.6 other information)

- If you suffer from acute inflammation of the gallbladder or bile ducts
- If you suffer from obstruction of the common bile duct or channel emanating from the gallbladder ( biliary obstruction ) .
- If you suffer from frequent cramp -like pain in the upper abdomen ( biliary colic )
- If your doctor has told you that you have calcified gallstones .
- If you suffer from impaired contractility of the gallbladder.

Ask your doctor. This goes for when you had some of these complaints.

additional warnings

Ursofalk  capsules should be taken under medical supervision.

Liver function tests should be monitored every 4 weeks during the first 3 months of treatment , then once every 3 months.
Please tell your doctor if you have diarrhea , as this may require dose reduction or discontinuation Ursofalk capsules.

Interactions with other drugs

Please tell your doctor if you are taking or have recently taken these medications. Effect of these drugs may be altered ( interactions ):

When taken Ursofalk ® capsules it is possible to reduce the effect of these drugs :

- Colestyramine, colestipol or antacids containing aluminum hydroxide and / or smectite / alumina / . If it is necessary the use of a product containing one of these substances, it must be taken at least 2 hours before or after Ursofalk ® kapcyli .

- Ciprofloxacin, dapsone ( antibiotics ), nitrendipine ( used to treat high blood pressure ), and other drugs which are metabolized in a similar manner . You may need your doctor to adjust the dose of these drugs.

When taken Ursofalk  Capsules is possible to increase the effect of the following medicines:

ciplosporin ( inhibits the activity of the immune system). Patients who are receiving cyclosporine subject to control serum and the same need for dose adjustment of cyclosporine by your doctor.

If you take Ursofalk "' capsules to dissolve gallstones , please tell your doctor if you are taking any medications that contain estrogen hormones or cholesterol-lowering blood products such as clofibrate . Such drugs can stimulate the formation of gallstones , which an adverse effect on the treatment of Ursofalk " capsules.

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and lactation

Contact your doctor or pharmacist for advice before taking medication. Ursofalk ® capsules should not be used during pregnancy unless your doctor considers it necessary. Women of childbearing age should be treated with Ursofalk  capsules only apply if reliable contraception

Recommended non-hormonal contraception or oral contraceptives with a low content of estrogen. If you take Ursofalk * capsules to dissolve gallstones , however , you must use only non-hormonal contraceptive measures as hormonal oral contraceptives can stimulate the formation of gallstones .
Before initiation of therapy should be excluded existing pregnancy.
There is not enough experience with people in the first trimester of pregnancy.
Experiments on animals have shown teratogenic effects in early gestation phase.
Since data on the passage of urzodezoksiholeva acid in the milk and insufficient use during lactation is contraindicated.

Use in children

There are no age restrictions on the use of Ursofalk  capsules. It depends on the body weight and condition . Available Ursofalk ® suspension for children who can not swallow capsules or who weigh less than 47 kg.

Effects on ability to drive and use machines

No effects on ability to drive and use machines.

3 . How to take Ursofalk  capsules ?

Always take Ursofalk  capsules exactly as your doctor has instructed . If you are not sure, talk to your doctor or pharmacist. Suggested daily dose for various indications

For the dissolution of cholesterol gall stones

About 10 mg per kg body weight per day, equivalent to :

60 kg - 2 capsules

61-80 kg - 3 capsules

81-100 kg - 4 capsules

Over 100 kg - 5 capsules

dosage

The capsules should be swallowed whole with some liquid before bedtime . Take Ursofalk ® capsules regularly.

Duration of treatment

For the dissolution of gallstones usually takes 6-24 months. If you do not decrease the size of gallstones after 12 months, treatment should be discontinued.

Effectiveness of treatment should be checked by your doctor every 6 months. In each of these tracking tests should be carried out if the calcification has occurred gallstones , compared to the previous visit. If this is the case , your doctor will stop treatment

For the treatment of gastritis caused by reflux of bile :

dosage

One capsule daily should be swallowed whole with liquid before bedtime. Duration of treatment

Ursofalk  capsules should generally be administered for 10-14 days. The duration of treatment depends on the progress of the disease and is evaluated for each individual case by the prescribing physician.

For the treatment of primary biliary cirrhosis / inflammation of the bile duct /

dosage

During the first 3 months of treatment should take Ursofalk ® capsules in the morning , noon and evening. By improving liver function daily dose can be taken once daily in the evening .




body

weight (kg)


living

dose


capsules










first

three months

then







morning

lunch

night

Night / one day /



47-62

12-16

1

1

1

3



63-78

13-16

1

1

2

4



79-93

13-16

1

2

2

5



94-109

14-16



2

2

2

6



More than 110



2

2

3

7


Patients with body weight below 47 kg and patients who can not swallow capsules available Ursofalk ® suspension.

How to take Ursofalk  capsules ?

The capsules should be swallowed whole with a little water or other liquid. Ursofalk capsules should be taken regularly .

Duration of treatment

Use Ursofalk  capsules in primary biliary cirrhosis may continue indefinitely.

note

In rare cases, patients with primary biliary cirrhosis , clinical symptoms may be affected (e.g., may increase itching ) at the beginning of treatment. In this case, treatment should be continued at a lower dose Ursofalk capsules every week, your doctor may need to increase the daily dose gradually until it reaches the specified dosage.

If you have the impression that the effect of Urzofalk capsules is too strong or too weak, talk to your doctor .

If you take more capsules Urzofalk than it should

In case of overdose can occur diarrhea. Tell your doctor if diarrhea persists .
If you suffer from diarrhea, you should drink plenty of fluids to restore electrolyte balance .

If you forget to take Ursofalk  capsules

Do not take more capsules next time and continue treatment with the prescribed dose .

If you stop taking Ursofalk  capsules

Always consult your doctor before you decide to interrupt or stop earlier treatment Ursofalk ® capsules.

4 . Possible side effects

Like all medicines Urzofalk capsules can cause side effects Common side effects (in more than 1 in 10 but more than 1 in 100 patients):

soft stools or diarrhea Very rare side effects ( in 1 case in 10,000 patients):

- During the treatment of primary biliary cirrhosis may occur severe abdominal pain, right abdominal half decompensation of liver cirrhosis which partially regressed after treatment discontinuation .

- Calcified gallstones

- Urticaria (hives )

If any side effects are serious or not mentioned in this leaflet, please contact your doctor or pharmacist.

5 . Storage Urzofalk capsules

Medicines should be kept out of reach of children.

Do not use this medicine after the expiry date . This date is shown on the blister and carton after the words " EXP" The expiry date refers to the last day of that month.

6 . other Information

What does Ursofalk  capsules ?

Active ingredient - ursodeoxycholic acid 1 capsule contains 250 mg ursodeoxycholic acid

Auxiliary components: gelatin, colloidal silicon dioxide / E 171 / , magnesium stearate , corn starch , sodium dodecyl sulfate , titanium dioxide / E171 / water.

Packaging Data

Ursofalk  capsules white and opaque . Ursofalk ® capsules contain white powder or granules.

Ursofalk  capsules come in packs 50 and 100 capsules.