LIVUROX 250 mg Капсулы

Содержание инструкции

1. Livurox 250 mg hard capsules
   1. What is Livurox and what is it used for
   2. What you need to know before taking Livurox
   3. How to take Livurox
   4. Possible side effects
   5. How to store Livurox
   6. Package contents and

Livurox 250 mg hard capsules

Ursodesoxycholic acid
equivalent medicine

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Livurox is and what it is used for
• 2. What you need to know before you take Livurox
• 3. How to take Livurox
• 4. Possible side effects
• 5. How to store Livurox
• 6. Contents of the pack and other information

1. What is Livurox and what is it used for

Ursodeoxycholic acid, the active ingredient of Livurox, is a natural bile acid. It is present in
small quantities in human bile.
Livurox is used:

• to dissolve gallstones caused by an excess of cholesterol in the gallbladder, if the gallstones are not visible with a simple X-ray (X-ray visible gallstones do not dissolve) and do not measure more than 15 mm in diameter. The gallbladder must still be functioning despite the gallstone(s).
• to treat inflammation of the stomach lining due to reflux of bile acids (bile reflux gastritis),
• for the treatment of symptoms of primary biliary cholangitis (PBC, a chronic disease of the bile ducts that can progress to cirrhosis of the liver) in patients without decompensated cirrhosis of the liver (a widespread and chronic liver disease, in which poor liver function due to the disease can no longer be corrected),
• for the treatment of liver disease (hepatopathy) related to a disease called cystic fibrosis in children between 6 and 18 years of age.

2. What you need to know before taking Livurox

Do not take Livurox if

• you are allergic to bile acids (such as ursodeoxycholic acid) or to any of the other ingredients of this medicine (listed in section 6),
• you have an acute inflammation of the gallbladder (cholecystitis) and bile ducts,
• you have a blockage of the common bile duct or cystic duct (obstruction of the bile ducts),
• you have frequent cramp-like pains in the upper abdomen (biliary colic),
• your doctor has told you that you have calcified gallstones,
• you have a problem with gallbladder contraction,
• you are a child suffering from biliary atresia and have a poor bile flow, even after surgery.

Consult your doctor if you have any of the diseases or conditions listed above, or if you have had them in the
past.

Warnings and precautions
Consult your doctor or pharmacist before taking Livurox.
For the first 3 months of treatment, your doctor must regularly check liver function,
every 4 weeks. Subsequently, the checks must be repeated every 3 months.
If the medicine is used to dissolve gallstones, your doctor must prescribe you an examination
to subject you to a gallbladder scan after the first 6-10 months of treatment.
If you are taking Livurox to dissolve gallstones, tell your doctor if you are taking
medicines that contain estrogenic hormones, as these medicines stimulate the formation of
gallstones.
When used in the treatment of PBC, in rare cases symptoms may worsen at the beginning of
treatment. If this occurs, consult your doctor to evaluate a reduction of the initial dose.
Immediately inform your doctor if you have diarrhea, as this may require a reduction
of the dose or discontinuation of treatment.

Children and adolescents
Livurox is not suitable for children under 6 years of age due to the capsule dosage.

Other medicines and Livurox
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, as the effects of these medicines may be altered.
A reduction in effectsof Livurox is possible when taken simultaneously with the following
medicines:

• cholestyramine, colestipol (used to lower blood fat levels) or antacids containing aluminum hydroxide or smectite (aluminum oxide) (used to bind stomach acid): If you absolutely need to use a medicine containing any of these substances, you must take it at least two hours before or after Livurox. A reduction in effectsof the following medicines is possible when taken simultaneously with Livurox:
• ciprofloxacin and dapsone (antibiotics), nitrendipine (used to treat high blood pressure) and other medicines metabolized in a similar way. Your doctor may need to adjust the dose of these medicines. A change in effectsof the following medicines is possible when taken simultaneously with Livurox:
• cyclosporine (to reduce the activity of the immune system). If you are being treated with cyclosporine, your doctor must check its amount in the blood. If necessary, your doctor will adjust the dose.
• rosuvastatin (for high cholesterol and related diseases).

If you are taking Livurox to dissolve gallstones, tell your doctor if you are taking
medicines that contain estrogenic hormones or agents that reduce blood cholesterol, such as
clofibrate. These medicines stimulate the formation of gallstones, which is an effect contrary to
that of treatment with Livurox.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
There are no data available regarding the use of ursodeoxycholic acid in pregnant women,
or they are limited. Studies conducted in animals have shown reproductive toxicity. Livurox
should not be used during pregnancy unless strictly necessary.

Women of childbearing potential
If you are a woman, you should consult your doctor even if you are not pregnant.
Women of childbearing potential must be treated only if they use reliable contraceptive methods: the
use of non-hormonal or low-dose oral contraceptives is recommended.
However, if you are taking Livurox to dissolve gallstones, you should use effective non-hormonal contraceptives,
as hormonal oral contraceptives may promote the formation of
gallstones.
The doctor must exclude the possibility of pregnancy before starting treatment.

Breastfeeding
According to some documented cases of breastfeeding women, levels of ursodeoxycholic acid in
breast milk are very low and adverse reactions in breastfed infants are unlikely.
to be expected.

Fertility
Studies in animals have not shown an influence of ursodeoxycholic acid on fertility.
There are no data on the effects on fertility in humans after treatment with ursodeoxycholic acid.

Driving and using machines
No effects on the ability to drive and use machines have been observed.

3. How to take Livurox

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.

To dissolve cholesterol gallstones

Dosage
The recommended dose is approximately 10 mg of ursodeoxycholic acid per kg of body weight (b.w.) per
day, as follows:
If you weigh less than 47 kg or are unable to swallow Livurox, other formulations containing ursodeoxycholic acid may be available to you.

Method of administration
Swallow the capsules whole with a glass of water or other liquid. Take the capsules in the evening before
going to bed. Take the medicine regularly.

Duration of treatment
It usually takes 6-24 months to dissolve gallstones. If after 12 months there has been no
reduction in the size of the gallstones, therapy should be discontinued.
Every 6 months the doctor must check whether the treatment is working. On each of
these check-ups, it must be checked whether the gallstones have hardened compared to

the previous examination, due to a build-up of calcium. In such a case, the doctor will stop the
treatment.

To treat bile reflux gastritis

Dosage and method of administration
Take 1 capsule a day in the evening before going to bed. Swallow the capsule whole (without chewing)
with some liquid.
If you weigh less than 47 kg or are unable to swallow Livurox, other formulations containing ursodeoxycholic acid may be available to you.

Duration of treatment
For the treatment of bile reflux gastritis, Livurox should normally be taken for 10-
14 days. The doctor will determine the duration of treatment based on the course of the disease.

For the treatment of primary biliary cholangitis (chronic inflammatory disease of the
bile ducts)

Dosage
The daily dose depends on body weight and varies from 3 to 7 hard capsules.
If you weigh less than 47 kg or are unable to swallow Livurox, other formulations containing ursodeoxycholic acid may be available to you.

Method of administration
Swallow the capsules whole with a glass of water or other liquid.
During the first 3 months of treatment, you must take Livurox in the morning, at noon and in the evening.
When liver function values improve, you can take the total daily dose once a
day, in the evening.
Take the medicine regularly.

Duration of treatment
Treatment with Livurox can be continued indefinitely in case of primary biliary
cholangitis

Note
If you suffer from primary biliary cholangitis, symptoms may worsen at the beginning of treatment. For
example, an increase in itching may occur, although this happens only in rare cases. If this occurs, treatment may be continued with a reduced daily dose of Livurox. The doctor
will then increase the daily dose every week, until the required dose is reached again.

Use in children and adolescents (6-18 years) for the treatment of liver
disease (hepatopathy) related to cystic fibrosis

Dosage
The recommended dose is approximately 20 mg per kg per day divided into 2-3 doses.
If necessary, the doctor may further increase the dose to 30 mg per kg of body weight per
day.
If you feel that the effect of Livurox is too strong or too weak, consult your doctor or
pharmacist.

If you take more Livurox than you should
In case of overdose, diarrhea may occur. Inform your doctor immediately if you have persistent diarrhea. If you suffer from diarrhea, make sure to drink enough fluids to restore
electrolyte balance.

If you forget to take Livurox
Do not take a double dose to make up for a missed dose, but continue treatment
with the prescribed dose.

If you stop taking Livurox
Always consult your doctor before deciding to stop taking Livurox or to
discontinue it prematurely.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects(may affect up to 1 in 10 people):

• soft or loose stools or diarrhoea.

Very rare side effects (may affect up to 1 in 10,000 people):

• during treatment of primary biliary cholangitis: severe pain in the upper right side of the abdomen, severe worsening of liver cirrhosis, which improves partially after stopping treatment,
• hardening of bile stones,
• urticaria.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni- avverse
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Livurox

Keep this medicine out of the sight and reach of children.
This medicine does not require any particular storage conditions.
Do not use this medicine after the expiry date which is stated on the package and on the blister after
“Exp.”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and

other information What Livurox contains
The active ingredient is ursodeoxycholic acid. Each capsule contains
250 mg of ursodeoxycholic acid.
The other ingredients are:
Capsule content: corn starch, pregelatinized corn starch, colloidal anhydrous silica, magnesium stearate.
Capsule shell: gelatin, titanium dioxide (E171).

Description of the appearance of Livurox and package contents
Livurox consists of white size 0 capsules, which contain a powder from
white to almost white.
Livurox is available in packs of 20, 40, 50, 60, 80 or 100 capsules. Not all pack sizes
may be marketed.

Marketing authorisation holder and manufacturer
PRO.MED.CS Praha a.s., Telčská 377/1, Michle, 140 00 Prague 4, Czech Republic

This medicinal product is authorised in the Member States of the European Economic
Area under the following denominations:
Italy Livurox
Hungary Proursan 250 mg hard capsule
France Proursan 250 mg capsule