Ursocam

Package Leaflet: Information for the Patient

URSOCAM, 250 mg, tablets

Ursodeoxycholic acid

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is URSOCAM and what is it used for

URSOCAM is a medicine with strong choleretic and cholagogic effects. It reduces cholesterol secretion into bile, prevents the formation of cholesterol gallstones, and causes their dissolution. By reducing the content of other bile acids in bile, it reduces their toxic effects on liver cells.
URSOCAM is indicated for use in:

• dissolving cholesterol gallstones with a diameter not exceeding 15 mm, radiolucent, in patients with preserved gallbladder function despite the presence of gallstones,
• symptomatic treatment of primary biliary cirrhosis of the liver, provided that uncompensated cirrhosis does not occur,
• symptomatic treatment of intrahepatic cholestasis of pregnancy in the second and third trimester,
• treatment of symptomatic gastritis caused by bile reflux,
• treatment of symptomatic liver and bile duct diseases of various etiologies,
• treatment of functional disorders of the liver and bile ducts associated with cystic fibrosis in children and adolescents aged 6 to 18 years.

2. Important information before taking URSOCAM

Do not take URSOCAM if you have:

• hypersensitivity to the active substance or (and) excipients,
• acute cholecystitis and bile ducts,
• obstruction of the common bile duct or cystic duct. URSOCAM should not be used if the gallbladder is not visible on the X-ray, if there are calcifications in the gallstones, if the contractile function of the gallbladder is impaired, or if biliary colic occurs frequently.

Be particularly cautious when taking URSOCAM:

URSOCAM should be taken under medical supervision.
Liver function parameters - AspAT (GOT), AlAT (GPT), and γ-GT should be controlled by a doctor every 4 weeks for the first 3 months of treatment, and then every 3 months.
With a view to assessing the effectiveness of treatment and early detection of calcifications in gallstones, the doctor will order an X-ray examination of the gallbladder (oral cholecystography) after 6-10 months from the start of treatment, depending on the size of the gallstones. Images (overview and after contrast administration) should be taken in both standing and lying positions (ultrasound monitoring).
You should consult a doctor, even if the above warnings concern situations that have occurred in the past.

Pregnancy:

Before taking any medicine, consult a doctor.
Animal studies have shown a risk of damage during the use of URSOCAM in early pregnancy. Due to the lack of precise studies in humans, women of childbearing age should take this medicine only with the simultaneous use of contraceptive measures. Before starting treatment, inform your doctor about pregnancy. For safety reasons, the medicine should not be used in the first trimester of pregnancy.

Breast-feeding:

Before taking any medicine, consult a doctor.
There is insufficient data on the penetration of ursodeoxycholic acid into breast milk.
URSOCAM should not be used during breast-feeding.

Driving and using machines:

No effect of the medicine on the ability to drive vehicles and operate machinery has been observed.

Using other medicines:

URSOCAM should not be used with cholestyramine, colestipol, or aluminum hydroxide and (or) antacids containing aluminum hydroxide and magnesium trisilicate. These substances bind ursodeoxycholic acid in the gastrointestinal tract and prevent its absorption, making the treatment ineffective. If the use of a medicine containing one of these substances is necessary, URSOCAM should be taken 2 hours before or after the administration of that medicine.
URSOCAM may enhance the absorption of cyclosporine from the gastrointestinal tract. In patients treated with cyclosporine, the cyclosporine concentration in the blood should be monitored, and if necessary, the cyclosporine dose should be reduced.
In individual cases, URSOCAM may reduce the absorption of ciprofloxacin.
Ursodeoxycholic acid reduces the peak concentration of the calcium antagonist nitrendipine in blood serum (C) and the area under the curve (AUC) representing changes in the concentration of this medicine in blood serum over time. In one case, an interaction with dapsone (reduced therapeutic effect of this medicine) was described. Based on the effect on the pharmacokinetic properties of nitrendipine, the effect on dapsone, and the results of in vitro studies, it can be assumed that ursodeoxycholic acid induces the isoenzyme 3A4 of cytochrome P450, which metabolizes medicines.
Therefore, caution should be exercised when using medicines that are metabolized with the participation of this enzyme. It may be necessary to adjust the doses of medicines.
You should inform your doctor about all medicines taken recently, even those that are available without a prescription.

3. How to take URSOCAM

This medicine should always be taken exactly as advised by your doctor. If you are unsure, consult your doctor or pharmacist.
Adults
Dissolving gallstones orally, 8-10 mg/kg body weight per day, divided into 2 doses.
(according to the scheme given in the table)

The time required to dissolve gallstones usually ranges from 6 to 24 months. If, after 12 months, there is no reduction in the size of the gallstones, treatment should not be continued.
The effectiveness of treatment should be assessed using ultrasound or X-ray examination every 6 months. During follow-up examinations, it should be checked whether calcification of the gallstones has occurred in the meantime. In such a case, treatment should be discontinued.
Symptomatic treatment of primary biliary cirrhosis of the liver
The daily dose depends on body weight and ranges from 3 to 7 tablets (14 ± 2 mg of ursodeoxycholic acid per kg of body weight).
For the first 3 months of treatment, URSOCAM should be taken in divided doses throughout the day. When liver function parameters improve, the daily dose may be taken once in the evening.
Tablets should be swallowed whole, without chewing, with a small amount of liquid. It should be ensured that the tablets are taken regularly.
There are no time limits for taking URSOCAM in the case of primary biliary cirrhosis of the liver.
Treatment of intrahepatic cholestasis of pregnancy
10-16 mg/kg body weight per day, in 2-3 divided doses. This corresponds to 3 to 5 tablets.

Treatment of reflux gastritis caused by bile reflux
1 tablet of URSOCAM should be swallowed whole, with liquid, once a day, in the evening before bedtime.
In the treatment of gastritis with bile reflux, URSOCAM is usually taken for 10-14 days. The duration of use generally depends on the course of the disease. The attending physician will decide on the duration of use in individual cases.
Treatment of other liver and bile duct diseases of various etiologies
10-20 mg/kg body weight per day, in 2-3 divided doses. This corresponds to 3 to 7 tablets. If it is not possible to divide the daily dose evenly, the larger dose should be given in the evening.
Children and adolescents
Treatment of functional disorders of the liver and bile ducts associated with cystic fibrosis in children and adolescents aged 6 to 18 years
20 mg/kg body weight per day of ursodeoxycholic acid, in 2-3 divided doses, with the possibility of increasing to 30 mg/kg body weight per day if necessary.
Method of administration
Oral administration.

In case of taking a higher dose of URSOCAM than recommended:

In case of overdose, diarrhea may occur. Overdose of the medicine is unlikely, as increasing the dose worsens the absorption of ursodeoxycholic acid, and thus increases the proportion of the dose excreted in the feces.

In case of missing a dose of URSOCAM:

In case of missing a dose, do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, URSOCAM can cause side effects, although they may not occur in every patient.
Frequent(less frequent than in 1 in 10 patients)

• light stools or diarrhea.

Very rare(less frequent than in 1 in 10,000 patients, including individual cases)

• during treatment of primary biliary cirrhosis: occurrence of severe pain in the right upper quadrant of the abdomen, worsening of liver disease symptoms, which partially subsided after discontinuation of the medicine;
• calcification of gallstones;
• urticaria.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store URSOCAM

The medicine should be stored in a place inaccessible and invisible to children.
Do not use the medicine after the expiry date stated on the packaging.
There are no special precautions for storage.

6. Contents of the pack and other information

What URSOCAM contains

• The active substance of the medicine is ursodeoxycholic acid. One tablet contains 250 mg of ursodeoxycholic acid.
• Other ingredients are: microcrystalline cellulose (type 102), hydroxypropyl cellulose, magnesium stearate.

What URSOCAM looks like and what the pack contains

URSOCAM has the form of uncoated tablets, white to light cream in color, round, biconvex, with a uniform surface, without spots and damage.
Available packs: 25, 90, or 100 tablets.
Blisters with orange PVC film and aluminum foil, and containers made of plastic (PE/PP) or HDPE containers with PP caps, each containing 25 tablets (blister or container), 90 tablets (blister or container), and 100 tablets (blister or container) in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland (Poland)
Tel.: + 48 24 357 44 44
Fax: + 48 24 357 45 45
e-mail: polfarmex@polfarmex.pl

Date of last revision of the leaflet: