Ursoxin

Leaflet accompanying the packaging: information for the user

URSOXYN, 250 mg, hard capsules

Ursodeoxycholic acid

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine 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, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Ursoxyn is and what it is used for

This medicine contains ursodeoxycholic acid, a naturally occurring bile acid, which is found in small amounts in the human body in bile.

Indications for use

• Dissolving cholesterol gallstones in patients:
• who have one or more gallstones that are permeable to X-rays, with a diameter not exceeding 2 cm, with normal gallbladder function;
• who are not suitable for surgical treatment;
• who have an increased cholesterol concentration in bile (saturation) confirmed by laboratory tests.
• Before and after the shock wave lithotripsy procedure.
• Treating a condition where bile duct destruction leads to bile accumulation in the liver, which can cause scarring. The liver should not be damaged to the extent that it cannot function properly. This condition is called primary biliary cholangitis/cirrhosis (PBC).
• Treating liver disease in children and adolescents with cystic fibrosis, aged 6 to 18 years.

2. Important information before taking Ursoxyn

When not to take Ursoxyn

In case of doubt about the above symptoms, you should consult a doctor. If you have had any of these symptoms in the past or are unsure if they have occurred, you should tell your doctor.

Warnings and precautions

Before starting treatment with Ursoxyn, you should discuss it with your doctor or pharmacist. This medicine should be taken under medical supervision. During the first 3 months of treatment, your doctor should check your liver function regularly every 4 weeks. Further checks should be performed every 3 months. If this medicine is used to dissolve gallstones, your doctor should perform a gallbladder examination after the first 6-10 months of treatment. In patients taking this medicine to dissolve gallstones, it is recommended to use effective non-hormonal methods of contraception, as hormonal contraceptives may increase the formation of gallstones. If this medicine is used to treat primary biliary cholangitis/cirrhosis (PBC), at the beginning of treatment, symptoms (such as itching) may worsen in rare cases. In such a situation, you should contact your doctor to reduce the initial dose. If diarrhea occurs, you should immediately consult your doctor, as it may be necessary to reduce the dose or discontinue treatment with Ursoxyn.

Children

There are no age restrictions for the use of Ursoxyn, 250 mg, hard capsules, except for use in children aged 6 to 18 years with cystic fibrosis.

Ursoxyn and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. The effects of the following medicines may be altered (interactions):

• Cholestyramine, cholestypol (lipid-lowering medicines), aluminum hydroxide, smectite (bile acid binders). If you are taking a medicine containing one of these active substances, you should take it 2 hours before or 2 hours after taking Ursoxyn; Taking Ursoxyn may reduce the effectiveness of the following medicines:
• Ciprofloxacin, dapsone (antibiotics), nitrendipine (a medicine used to treat high blood pressure) and other medicines eliminated from the body in a similar way; if necessary, your doctor may change the dose of these medicines.

Taking Ursoxyn may alter the effects of the following medicines:

• Cyclosporine (a medicine that reduces the activity of the immune system). If you are taking cyclosporine, your doctor should monitor its blood levels. If necessary, your doctor will adjust the dose;
• Rosuvastatin (a medicine used to treat high lipid levels in the blood).

If you are taking Ursoxyn to dissolve gallstones, you should inform your doctor about any other medicines you are taking that contain estrogen hormones (e.g., "birth control pills") and about certain cholesterol-lowering medicines, such as clofibrate. These medicines may stimulate the formation of gallstones, which is a counter-therapeutic effect to Ursoxyn treatment.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine. Pregnancy There are no data or limited data on the use of ursodeoxycholic acid in pregnant women. You should not take Ursoxyn during pregnancy unless your doctor considers it absolutely necessary. Based on animal studies, taking ursodeoxycholic acid during pregnancy may affect the development of the unborn child. Women of childbearing age Even if you are not pregnant, you should discuss this with your doctor. Women of childbearing age should be treated with concurrent use of reliable non-hormonal contraceptives. Non-hormonal contraceptives or hormonal contraceptives with a low dose of estrogen ("birth control pills") are recommended. If you are taking Ursoxyn to dissolve gallstones, you should use non-hormonal contraceptives, as hormonal contraceptives may increase the formation of gallstones. Before starting treatment, your doctor should rule out pregnancy. Breastfeeding There are only a few documented cases of ursodeoxycholic acid use during breastfeeding. The level of ursodeoxycholic acid in breast milk is very low. Therefore, the occurrence of side effects in breastfed infants is unlikely. Fertility/Reproductive capacity Animal studies have not shown any effect of this medicine on fertility/reproductive capacity. So far, there is no experience showing an effect of this medicine on fertility/reproductive capacity in humans.

Driving and using machines

No special precautions are necessary.

3. How to take Ursoxyn

This medicine should always be taken exactly as your doctor has told you. If you are unsure, you should ask your doctor or pharmacist.

Taking Ursoxyn to dissolve cholesterol gallstones (alone or in combination with lithotripsy)

Dosage

The recommended dose is 2-4 Ursoxyn capsules (8-10 mg/kg body weight of ursodeoxycholic acid), taken during meals according to the following schedule:

• in case of a dose of 2 capsules per day: both capsules during the evening meal;
• in case of a dose of 3 capsules per day: 1 capsule in the morning and 2 capsules in the evening;
• in case of a dose of 4 capsules per day: 2 capsules in the morning and 2 in the evening; OR

the daily dose of 2-4 capsules can be taken in the evening, before bedtime.

Method of administration

The capsule should be swallowed whole with water or another liquid. The capsules should be taken regularly.

Duration of treatment

Gallstone dissolution usually occurs after 6-24 months. The duration of treatment depends on the size of the gallstones at the start of treatment. If the diameter of the gallstones has not decreased after 12 months, treatment should be discontinued. Your doctor should assess the effectiveness of treatment every 6 months. During follow-up visits, your doctor should check if the gallstones have calcified since the last visit, leading to hardening of the gallstones. If this happens, your doctor will discontinue treatment. Even if symptoms have disappeared, treatment should be continued: discontinuing treatment before completion will prolong the total duration of treatment. After the gallstones have dissolved, treatment should be continued for a further 3-4 months.

Treating primary biliary cholangitis/cirrhosis (chronic bile duct inflammation)

Dosage

Stages I-III

The daily dose depends on body weight. During the first 3 months of treatment, Ursoxyn should be taken in the morning, afternoon, and evening. Once liver function parameters have improved, the daily dose can be taken once a day in the evening.

Stage IV

At the start of treatment with Ursoxyn, 2 to 3 capsules should be taken per day, during meals:

• in case of a dose of 2 capsules per day: 1 capsule in the morning and 1 in the evening;
• in case of a dose of 3 capsules per day: 1 capsule in the morning and 2 in the evening. In case of a good response to treatment at the prescribed doses (after blood tests and/or the doctor's assessment), your doctor may prescribe a higher dose (a dose corresponding to stages I-III).

Method of administration

The capsules should be swallowed whole with a small amount of water or another liquid. The medicine should be taken regularly.

Duration of treatment

There are no time limits for the use of Ursoxyn in primary biliary cholangitis/cirrhosis.

Note

In patients with primary biliary cholangitis/cirrhosis, at the start of treatment, symptoms (such as itching) may worsen in rare cases. This happens only in rare cases. If this occurs, you can continue treatment with a reduced daily dose. Subsequently, your doctor will increase the daily dose every week until the recommended dose is reached.

you can continue treatment with a reduced daily dose. Subsequently, your doctor will increase the daily dose every week until the recommended dose is reached.

Taking Ursoxyn in children and adolescents (aged 6 to 18 years) to treat liver disorders in cystic fibrosis

Dosage

The recommended daily dose is 20 mg/kg body weight per day, divided into 2-3 doses. If necessary, your doctor may recommend a further increase in the dose to 30 mg/kg body weight per day. Body weight (kg) Daily dose (mg/kg body weight) Morning Afternoon Evening 20-29 17-25 1 - 1 30-39 19-25 1 1 1 40-49 20-25 1 1 2 50-59 21-25 1 2 2 60-69 22-25 2 2 2 70-79 22-25 2 2 3 80-89 22-25 2 3 3 90-99 23-25 3 3 3 100-109 23-25 3 3 4 over 110 3 4 4

Method of administration

The capsules should be swallowed whole with a small amount of water or another liquid. The capsules should be taken regularly. If the size of the capsule causes swallowing difficulties or the patient's body weight is less than 47 kg, other medicines containing ursodeoxycholic acid are available. If you feel that the effect of Ursoxyn is too strong or too weak, you should consult your doctor or pharmacist.

Taking a higher dose of Ursoxyn than recommended

As a result of taking too high a dose of Ursoxyn, diarrhea may occur. If chronic diarrhea occurs, you should immediately consult your doctor. During diarrhea, you should replenish fluids to maintain water and electrolyte balance.

Missing a dose of Ursoxyn

You should not take a double dose to make up for a missed dose. You should continue treatment with the prescribed dose.

Stopping treatment with Ursoxyn

Before stopping treatment with Ursoxyn or ending it prematurely, you should consult your doctor. If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ursoxyn can cause side effects, although not everybody gets them. Common side effects(may occur in less than 1 in 10 patients):

• soft, loose stools or diarrhea.

Very rare side effects(may occur in less than 1 in 10,000 patients):

• during treatment of primary biliary cholangitis/cirrhosis: severe pain in the right upper quadrant of the abdomen, significant worsening of liver scarring, which partially resolves after discontinuation of treatment;
• calcification of gallstones (hardening of gallstones due to calcium accumulation);
• hives.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 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 this medicine.

5. How to store Ursoxyn

Do not store above 30°C. Store in the original packaging to protect from moisture. Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the blisters and carton after "EXP". The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Ursoxyn contains

• The active substance of Ursoxyn is ursodeoxycholic acid. One hard capsule contains 250 mg of ursodeoxycholic acid.
• The other ingredients are: cornstarch, silicon dioxide, magnesium stearate; capsule shell: titanium dioxide (E 171), gelatin (E 441).

What Ursoxyn looks like and contents of the pack

White, hard, gelatin capsules, size 0, approximately 21.7 mm x 7.64 mm, containing a white or almost white powder. The capsules are packaged in PVC/Aluminum blisters in a cardboard box. 10 capsules in a blister. The cardboard box contains 5, 6, or 10 blisters (50, 60, or 100 capsules). Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

AS GRINDEKS. Krustpils iela 53, LV-1057 Rīga, Latvia. Tel.: +371 67083205. Fax: +371 67083505. E-mail: [email protected]. For more information, you should contact the representative of the marketing authorization holder: Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland.

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria Ursogrix 250 mg Hartkapseln Belgium URSOGRIX 250 mg harde capsules Bulgaria Ursogrix 250 mg hard capsules Урсогрикс 250 mg твърди капсули Czech Republic URSOGRIX Croatia URSOGRIX 250 mg tvrde kapsule Denmark Ursogrix Estonia URSOGRIX France ACIDE URSODESOXYCHOLIQUE GRINDEKS 250 mg, gélule Greece Ursogrix 250 mg Σκληρά καψάκια Latvia URSOGRIX 250 mg cietās kapsulas Lithuania URSOGRIX 250 mg kietosios kapsulės Spain Ácido Ursodesoxicólico Grindeks 250 mg cápsulas duras Netherlands GRINTEROL 250 mg harde capsules Ireland Ursogrix 250 mg hard capsules Poland Ursoxyn Germany Ursogrix 250 mg Hartkapseln Norway URSOGRIX 250 mg harde kapsler Portugal GRINTEROL 250 mg cápsulas duras Romania Ursogrix 250 mg capsule Slovakia Ursogrix 250 mg tvrdé kapsuly Sweden Ursogrix 250 mg hårda kapslar Hungary Urzodezoxikólsav Grindeks 250 mg kemény kapszula United Kingdom Ursodeoxycholic Acid 250 mg Capsules, hard

Date of last revision of the leaflet: 06/2021