Proursan

Package leaflet: Information for the patient

Proursan 500 mg film-coated tablets

Ursodeoxycholic acid
equivalent medicine
Please read this leaflet carefully before taking this medicine because 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 give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Proursan is and what it is used for

Ursodeoxycholic acid, the active substance of Proursan, is a natural bile acid. It is present in
small amounts in human bile.
Proursan is used:

• to dissolve gallstones caused by excess cholesterol in the gallbladder, if the gallstones are not visible on simple X-ray imaging (gallstones visible on X-ray do not dissolve) and measure no more than 15 mm in diameter. The gallbladder must still be functioning despite the presence of gallstone(s).
• for the treatment of symptoms of primary biliary cholangitis (PBC, a chronic disease of the bile ducts that may progress to liver cirrhosis) in patients without decompensated liver cirrhosis (a widespread and chronic liver disease in which impaired liver function due to the disease can no longer be compensated),
• for the treatment of liver disease (hepatopathy) associated with a condition called cystic fibrosis in children aged between 6 and 18 years.

2. What you need to know before taking Proursan

Do not take Proursan 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 acute inflammation of the gallbladder (cholecystitis) or bile ducts,
• you have a blockage of the common bile duct or cystic duct (biliary obstruction),
• 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 with biliary atresia and have poor bile flow, even after surgical intervention.

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Proursan.

During the first 3 months of treatment, your doctor must regularly monitor your liver function, every 4 weeks. Afterward, monitoring should be repeated every 3 months.

If this medicine is used to dissolve gallstones, your doctor should prescribe an ultrasound scan of your gallbladder after the first 6–10 months of treatment.

If you are taking Proursan to dissolve gallstones, inform your doctor if you are taking medicines containing estrogen hormones, as these medicines may promote gallstone formation.

When used in the treatment of PBC (primary biliary cholangitis), symptoms may rarely worsen at the beginning of treatment. If this occurs, consult your doctor to consider reducing the initial dose.

Inform your doctor immediately if you develop diarrhea, as this may require a dose reduction or discontinuation of treatment.

Children and adolescents

Proursan is not suitable for children under 6 years of age due to the tablet dosage.

Other medicines and Proursan

Inform 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 (interactions):

Reduced effect of Proursan may occur when taken simultaneously with the following medicines:

• colestyramine, colestipol (used to lower blood lipid levels), or antacids containing aluminium hydroxide or smectite (aluminium oxide) (used to bind gastric acid): If you must take a medicine containing any of these substances, take it at least two hours before or after Proursan.

Reduced effect of the following medicines may occur when taken simultaneously with Proursan:

• ciprofloxacin and dapsone (antibiotics), nitrendipine (used to treat high blood pressure), and other medicines metabolized similarly. Your doctor may need to adjust the dose of these medicines.

Altered effect of the following medicines may occur when taken simultaneously with Proursan:

• cyclosporine (to reduce immune system activity). If you are being treated with cyclosporine, your doctor must monitor its blood levels. If necessary, your doctor will adjust the dose.
• rosuvastatin (for high cholesterol and related conditions).

If you are taking Proursan to dissolve gallstones, inform your doctor if you are taking medicines containing estrogen hormones or agents that reduce blood cholesterol, such as clofibrate. These medicines promote gallstone formation, which counteracts the effect of Proursan treatment.

Pregnancy, breastfeeding and fertility

If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy

There are no or limited data on the use of ursodeoxycholic acid in pregnant women. Animal studies have shown reproductive toxicity. Proursan 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 should only be treated if using reliable contraceptive methods: non-hormonal contraception or low-estrogen oral contraceptives are recommended.

However, if you are taking Proursan to dissolve gallstones, you must use effective non-hormonal contraception, as oral hormonal contraceptives may promote gallstone formation.

Your doctor should exclude the possibility of pregnancy before starting treatment.

Breastfeeding

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

Fertility

Animal studies have not shown any influence of ursodeoxycholic acid on fertility. There are no data on effects on fertility in humans after treatment with ursodeoxycholic acid.

Driving and using machines

No effects on the ability to drive vehicles or operate machinery have been observed.

Proursan contains sodium (sodium starch glycolate A)

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e. it is essentially "sodium-free".

3. How to take Proursan

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
For dissolving 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 Proursan tablets, other formulations containing ursodeoxycholic acid may be available for you.
Method of administration
Swallow the tablets whole with a glass of water or another liquid. Take the tablets in the evening before going to bed. Take the medicine regularly.
Duration of treatment
It usually takes 6–24 months to dissolve gallstones. If no reduction in gallstone size has occurred after 12 months, treatment should be discontinued.
Your doctor should check every 6 months whether the treatment is working. During each of these follow-up examinations, it should be verified whether gallstones have become hardened compared to the previous examination, due to calcium accumulation. In such a case, your doctor will discontinue the treatment.
For the treatment of primary biliary cholangitis (chronic inflammatory disease of the bile ducts)
Dosing
The daily dose of these film-coated tablets depends on body weight and ranges from one and a half to three and a half tablets.

If you weigh less than 47 kg or are unable to swallow Proursan tablets, another formulation containing ursodeoxycholic acid may be available for you.
Method of administration
Take the tablets whole (do not chew) with a glass of water or another liquid.
During the first 3 months of treatment, you must take Proursan in the morning, at midday, and in the evening.
When liver function values improve, you may take the total daily dose once daily in the evening.
Take the medicine regularly.
Treatment duration
Treatment with Proursan may be continued indefinitely in the case of primary biliary cholangitis.
Note
If you have primary biliary cholangitis, your symptoms may worsen at the beginning of treatment. For example, you may experience an increase in pruritus, although this occurs only rarely. If this happens, treatment may be continued with a reduced daily dose of Proursan. Your doctor will then increase the daily dose by weekly increments until the required dose is reached again.
Use in children and adolescents (6–18 years) for the treatment of liver disease (hepatopathy) associated with cystic fibrosis
Dose
The recommended dose is approximately 20 mg per kg of body weight per day, divided into 2–3 doses.
If necessary, your doctor may further increase the dose to 30 mg per kg of body weight per day.

If you feel that the effect of Proursan is too strong or too weak, consult your doctor or
pharmacist.
If you take more Proursan than you should
Diarrhoea may occur in case of overdose. Inform your doctor immediately if you have persistent diarrhoea. If you suffer from diarrhoea, make sure you drink sufficient amounts of liquid to restore your fluid and electrolyte balance.
If you forget to take Proursan
Do not take a double dose to make up for the forgotten dose, but continue treatment with the prescribed dose.
If you stop treatment with Proursan
Always consult your doctor before deciding to stop or discontinue treatment with Proursan prematurely.
If you have any doubts about the use of this medicinal product, 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 liquid 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, marked worsening of liver cirrhosis, which partially improves after stopping treatment,
• hardening of gallstones,
• urticaria.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Proursan

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of medicines via 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 Proursan contains
The active substance is ursodeoxycholic acid. Each film-coated tablet contains 500 mg of ursodeoxycholic acid.
The other components are:

• tablet core: maize starch, pregelatinized maize starch, sodium starch glycolate A, colloidal anhydrous silica, magnesium stearate,
• tablet coating: Opadry White 03B28796: hypromellose 6, titanium dioxide (E171), macrogol 400.

Description of the appearance of Proursan and the contents of the pack
Proursan consists of nearly white, film-coated oval tablets, with a score line on both sides, 17 mm in length and 9 mm in width. The tablet can be divided into equal doses.
Proursan is available in packs containing 20, 40, 50, 60, 80 or 100 film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
PRO.MED.CS Praha a.s., Telčská 377/1, Michle, 140 00 Prague 4, Czech Republic

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Italy Proursan
Hungary Proursan 500mg filmtabletta
Bulgaria Proursan 500mg филмирани таблетки
Croatia Ursosan 500mg filmom obložene tablete
Denmark Proursan
France Proursan 500mg comprimé pelliculé