Proursan

Package leaflet: Information for the patient

Proursan, 400 mg, coated tablets
Ursodeoxycholic acid
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms appear identical.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Proursan is and what it is used for
2. Important information 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 in Proursan, is a naturally occurring bile acid. Small amounts are normally present in human bile.
Proursan is used:

• for dissolving cholesterol gallstones caused by excessive cholesterol accumulation in the gallbladder (in patients for whom surgical treatment is not possible), which are not visible on standard X-ray imaging (radiopaque stones will not dissolve), and which are no larger than 15 mm in diameter. Gallbladder function should be preserved despite the presence of stones.
• for the treatment of primary biliary cirrhosis, a disease characterized by damage to the bile ducts in the liver, leading to bile accumulation. This may result in liver scarring (liver cirrhosis). The liver must not be so severely damaged that its normal function is impaired.

Children and adolescents

• for the treatment of liver disease associated with cystic fibrosis (mucoviscidosis) in children aged 6 to 18 years.

2. Important information before taking Proursan

When not to take Proursan

• if the patient is allergic to bile acids (such as ursodeoxycholic acid) or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has acute inflammation of the gallbladder or bile ducts;
• if the patient has obstruction of the common bile duct or cystic duct (biliary obstruction);
• if the patient experiences frequent upper abdominal pain resembling spasms (episodes

of biliary colic);

• if the patient has calcified gallstones;
• if the patient has impaired gallbladder function;
• if the patient is a child with biliary atresia (complete blockage of the bile ducts) and insufficient bile flow, even after surgical intervention.

Warnings and precautions
Before starting Proursan, discuss it with your doctor or pharmacist.
Proursan should only be taken under medical supervision.
During treatment, your doctor should recommend regular monitoring of liver function tests every
4 weeks for the first 3 months, and then every 3 months.
If the medicine is used to dissolve gallstones, your doctor should perform an imaging examination of the gallbladder after the first 6–10 months of treatment.
If you are taking Proursan to dissolve gallstones, inform your doctor about any medications you are taking that contain estrogen hormones, such as hormonal contraceptives, because these medicines may promote gallstone formation.
In the treatment of primary biliary cirrhosis, symptoms may rarely worsen at the beginning of treatment. In such a case, consult your doctor, as a reduction in the initial dose may be necessary.
If diarrhoea occurs, contact your doctor immediately, as it may be necessary to reduce the dose or discontinue treatment.

Children and adolescents
Proursan can be used regardless of age. The use of Proursan depends on body weight and the type of disease.

Proursan with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
The effect of these medicines may be altered:
Concomitant use of the following medicines may reduce the effect of Proursan:

• colestyramine, colestipol (a medicine that lowers blood lipid levels), or antacids containing aluminium hydroxide or aluminium compounds (aluminium oxide) (medicines that bind gastric acid): If it is necessary to take a medicine containing any of these substances, it should be taken at least two hours before or after taking Proursan.

Proursan may reduce the effect of the following medicines:

• ciprofloxacin and dapsone (antibiotics), nitrendipine (used to treat hypertension), and other medicines metabolized in a similar way. If necessary, your doctor may adjust the doses of these medicines.

Proursan may alter the effect of the following medicines:

• cyclosporine (an immunosuppressant). In patients treated with cyclosporine, your doctor should monitor blood cyclosporine levels. If necessary, your doctor will adjust the dose accordingly.
• rosuvastatin (used in the treatment of high cholesterol levels and related conditions).

If you are taking Proursan to dissolve gallstones, inform your doctor about any medications containing estrogen hormones or cholesterol-lowering medicines such as clofibrate. These medicines promote gallstone formation and therefore act in opposition to Proursan.

Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Pregnancy
There are insufficient data on the use of ursodeoxycholic acid in pregnant women. Animal studies have shown harmful effects on reproduction. Proursan should not be used during pregnancy unless clearly necessary.

Women of childbearing potential
The patient should consult a doctor, even if she is not pregnant.
Women of childbearing potential should take this medicine only in combination with effective contraception: non-hormonal methods or low-estrogen oral contraceptives are recommended. However, if you are taking Proursan to dissolve gallstones, you should use effective non-hormonal contraceptive methods, as hormonal oral contraceptives may promote gallstone formation.
Before starting treatment, your doctor must exclude pregnancy.

Breastfeeding
In several documented cases, the concentration of ursodeoxycholic acid in the milk of breastfeeding women has been shown to be very low; therefore, no adverse effects in breastfed infants are expected.

Fertility
Animal studies have not shown any effect of ursodeoxycholic acid on fertility. There are no available data from human studies on the effect of ursodeoxycholic acid treatment on fertility.

Driving and operating machinery
No effects on the ability to drive or operate machinery have been observed.

Proursan contains sodium (sodium carboxymethyl starch type A)
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to take Proursan

This medicine should always be taken according to the recommendations of your doctor or pharmacist. In case of
doubt, consult your doctor or pharmacist.
Recommended dose:
For dissolving cholesterol gallstones
Dosage
The recommended dose of ursodeoxycholic acid is approximately 10 mg per kg of body weight per day, as
follows:

For patients with body weight below 47 kg or unable to swallow Proursan tablets, other formulations (suspension) containing ursodeoxycholic acid are available.
Administration method
Tablets should be swallowed whole, with water or another liquid. Tablets should be taken in the evening, before bedtime. The medicine should be taken regularly.
Duration of treatment
Dissolution of gallstones usually takes from 6 to 24 months. If the diameter of gallstones has not decreased after 12 months, treatment should be discontinued.
The physician should evaluate treatment efficacy every six months. During follow-up visits, it should be checked whether the gallstones have become calcified since the last visit. If calcification occurs, the physician will discontinue treatment.

Treatment of primary biliary cirrhosis (chronic cholangitis)
Dosage
The daily dose depends on body weight and ranges from 2 to 4 coated tablets.
Proursan 400 mg, coated tablets

Subsequent
Body weight first 3 months
therapy
(kg)
in the morning at noon in the evening (once daily)
47 – 50 ½ ½ ½ 1 ½
51 – 62 ½ ½ 1 2
63 – 78 ½ ½ 1 ½ 2 ½
79 – 93 ½ 1 1 ½ 3
94 – 109 1 1 1 ½ 3 ½
Above 109 1 1 2 4

For patients with body weight below 47 kg or unable to swallow Proursan tablets, other formulations (suspension) containing ursodeoxycholic acid are available.
Administration method
Tablets should be swallowed whole (without chewing), with water or another liquid.
During the first 3 months of treatment, Proursan should be taken in the morning, at noon, and in the evening.
When liver function parameters improve, the daily dose may be taken once daily in the evening. The medicine should be taken regularly.
Duration of treatment
There are no time limitations for the use of Proursan in primary biliary cirrhosis.
Note:
In patients with primary biliary cirrhosis, symptoms may worsen at the beginning of treatment. One such symptom may be increased itching. However, this occurs only rarely. If this happens, treatment may be continued using a lower daily dose of Proursan. The physician will then gradually increase the daily dose by weekly increments until the recommended dose is reached again.

Use in children and adolescents (6 to 18 years of age) for the treatment of liver disease in cystic fibrosis (mucoviscidosis)
A daily dose of approximately 20 mg/kg body weight, divided into 2–3 doses, is recommended. If necessary, the physician may increase the dose up to 30 mg per kg body weight per day.

Body weight Daily dose Proursan 400 mg, coated tablets
(kg) (mg/kg body weight) morning noon evening
20 – 23 17 – 20 ½ - ½
24 – 32 19 – 25 ½ ½ ½
33 – 39 21 – 24 ½ ½ 1
40 – 49 20 – 25 ½ ½ 1 ½
50 – 59 20 – 24 ½ 1 1 ½
60 – 69 20 – 23 1 1 1 ½
70 – 79 20 – 23 1 1 ½ 1 ½
80 – 89 20 – 23 1 ½ 1 ½ 1 ½
90 – 99 20 – 22 1 ½ 1 ½ 2
100 – 109 20 – 22 1 ½ 2 2

110 ≤22 2 2 2

For patients unable to swallow Proursan tablets, alternative formulations (suspension) containing ursodeoxycholic acid are available.
If you feel that the effect of Proursan is too strong or too weak, consult your doctor or pharmacist.

Overdose of Proursan
In case of overdose, diarrhea may occur. If chronic diarrhea develops, you should immediately inform your doctor. During diarrhea, drink sufficient fluids to replace water and electrolytes lost from the body.

Missed dose of Proursan
Do not take a double dose to make up for a missed dose. Continue treatment according to the prescribed dosing schedule.

Discontinuation of Proursan treatment
Before stopping treatment with Proursan or ending therapy early, always consult your doctor.

If you have any further questions about the use of this medicine, please consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Common adverse reactions (may occur in up to 1 in 10 people)

• pale, loose stools or diarrhoea.

Very rare adverse reactions (occur in 1 in 10,000 patients)

• during treatment of primary biliary cirrhosis: severe pain in the upper right quadrant of the abdomen, serious worsening of symptoms of liver fibrosis, which partially
  improves after discontinuation of the medicine.

• calcification of gallstones due to calcium accumulation.

• urticaria (hives).

Frequency unknown (frequency cannot be estimated from the available data)

• itching.
• nausea, vomiting.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse effects not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can
be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: + 48 22 49-21-301,
fax: + 48 22 49-21-309, Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder or the representative of the marketing authorisation holder.
Reporting adverse reactions allows further information on the safety of the medicine to be collected.

5. How to store Proursan

Keep this medicine out of sight and reach of children.
No special storage conditions apply to this medicinal product.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Proursan contains

• The active substance is ursodeoxycholic acid. Each tablet contains 400 mg of ursodeoxycholic acid.
• Other ingredients are:
  • tablet core: maize starch, pregelatinized maize starch, sodium carboxymethyl starch (type A), colloidal anhydrous silica, magnesium stearate,
  • tablet coating: hypromellose 2910/6cP, titanium dioxide (E 171), macrogol 400.

What Proursan looks like and contents of the pack
Almost white, round, biconvex coated tablets with a division line on both sides.
The tablet can be divided into equal doses.
Proursan is available in packs containing 10, 20, 30, 50, 60, 90 or 100 coated tablets.
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.
For further information about this medicinal product, contact the local representative of the Marketing Authorisation Holder:
PRO.MED.PL Sp. z o.o.
e-mail: [email protected]
This medicinal product is authorised for marketing in the European Economic Area under the following names:
Germany Ursonorm 400 mg Film Tablets
Poland Proursan
Czech Republic URSOSAN
Slovakia URSOSAN 400 mg film-coated tablets