URSODESOXYCHOLIC ACID GRINDEKS 250 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Ursodeoxycholic Acid Grindeks 250 mg hard capsules EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Ursodeoxycholic Acid Grindeks 250 mg and what is it used for
2. What you need to know before you take Ursodeoxycholic Acid Grindeks 250 mg
3. How to take Ursodeoxycholic Acid Grindeks 250 mg
4. Possible side effects
5. Storage of Ursodeoxycholic Acid Grindeks 250 mg
6. Contents of the pack and other information

1. What is Ursodeoxycholic Acid Grindeks 250 mg and what is it used for

This medicine contains ursodeoxycholic acid, a natural bile acid. However, it is only found in small amounts in human bile.

Ursodeoxycholic Acid Grindeks 250 mg is used:

• For the dissolution of cholesterol gallstones in patients:

• who have one or more radiotransparent (radionegative) gallstones, preferably with a diameter not exceeding 2 cm, in a functioning gallbladder;
• for whom surgery is not an option;
• in whom cholesterol supersaturation has been demonstrated by chemical tests in the bile.
• Before and after dissolution of gallstones by shock waves (lithotripsy).

• For the treatment of a disease in which the bile ducts of the liver are damaged and bile accumulates. This can cause scarring in the liver. The liver should not be damaged to the point of not functioning properly. This disease is called primary biliary cholangitis (PBC, also known as primary biliary cirrhosis).

For the treatment of liver disease associated with cystic fibrosis (mucoviscidosis) in children and adolescents aged 6-18 years.

2. What you need to know before you take Ursodeoxycholic Acid Grindeks 250 mg

Do not take Ursodeoxycholic Acid Grindeks 250 mg

• if you are allergic to ursodeoxycholic acid or bile acids or any of the other ingredients of this medicine (listed in section 6);
• if you have acute inflammation of the gallbladder or biliary tract;
• if your bile ducts are closed (closure of the cystic duct or common bile duct);
• if you suffer from frequent pains similar to cramps in the upper abdomen (biliary colic);
• if your doctor has told you that you have a calcification of a gallstone;
• if the ability of your gallbladder to contract is affected;
• if you are a child with closed bile ducts (biliary atresia) and have a deficient bile flow, even after surgery.

Talk to your doctor about any of the above-mentioned diseases. You should also talk to your doctor if you have had any of these diseases before or if you are not sure if you have them.

Warnings and precautions

Talk to your doctor or pharmacist before you start taking this medicine. This medicine must be used under medical supervision.

In the first 3 months of treatment, your doctor should regularly check your liver function every 4 weeks. After that, checks should be carried out every 3 months.

If you are taking this medicine to dissolve gallstones, your doctor should perform ultrasound examinations of the gallbladder after 6-10 months of treatment.

If you are a woman and are taking this medicine to dissolve gallstones, you should use effective non-hormonal contraceptive methods, as hormonal contraceptives (e.g. the contraceptive pill) may contribute to the formation of gallstones.

If you are taking this medicine for the treatment of PBC, in rare cases the symptoms (e.g. itching) may worsen at the start of treatment. In this case, talk to your doctor about the possibility of reducing your initial dose.

Tell your doctor if you have diarrhea, as it may be necessary to reduce the dose or interrupt treatment with this medicine.

Children

There is no age restriction for the use of this medicine except for cystic fibrosis (6 to 18 years).

Other medicines and Ursodeoxycholic Acid Grindeks 250 mg

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

The effect of this medicine may be altered (interactions):

A reduction of the effectsof ursodeoxycholic acid may occur when taken with the following medicines:

• cholestyramine, colestipol (medicines used to reduce lipid levels in the blood) or antacids containing aluminum hydroxide or smectite (aluminum oxide) (preparations that bind to gastric acids). If you are taking a medicine that contains one of these active substances, intake should be done with a delay of at least 2 hours before or after taking this medicine;

A reduction of the effectsof ursodeoxycholic acid may occur when taken with the following medicines:

• ciprofloxacin, dapsone (antibiotic), nitrendipine (medicine used to treat high blood pressure) and other medicines that are eliminated in a similar way: it may be necessary for your doctor to modify the dose of these medicines.

A change in the effectsof the following medicines may occur when taking this medicine:

• cyclosporin (a medicine that reduces the activity of the immune system). If you are receiving treatment with cyclosporin, your doctor should monitor the cyclosporin concentration in the blood. Your doctor will adjust the dose if necessary;
• rosuvastatin (a medicine used to treat high lipid levels in the blood).

If you are taking this medicine to dissolve gallstones, tell your doctor if you are also taking medicines that contain estrogens (e.g. the contraceptive pill) or certain medicines to reduce cholesterol levels, such as clofibrates. These medicines may contribute to the formation of gallstones in addition to counteracting their dissolution with this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

There are limited or no data on the use of ursodeoxycholic acid in pregnant women.

You should not take this medicine during pregnancy unless your doctor considers it absolutely necessary.

According to studies conducted in animals, the use of ursodeoxycholic acid during pregnancy may affect fetal development.

Women of childbearing age

Although you are not pregnant, you should discuss this with your doctor. Women of childbearing age should only be treated with the concomitant use of reliable contraceptive methods. Non-hormonal contraceptive methods or oral contraceptives with low doses of estrogen (such as the contraceptive pill) are recommended. If you are taking this medicine to dissolve gallstones, you should use effective non-hormonal contraceptive methods, as hormonal contraceptives can contribute to the formation of gallstones.

Before starting treatment, your doctor will check that you are not pregnant.

Breastfeeding

There are only a few documented cases of ursodeoxycholic acid intake during breastfeeding. The levels of ursodeoxycholic acid in breast milk are very low. Therefore, adverse reactions in breastfed infants are unlikely.

Fertility/pregnancy ability

Animal studies have not shown any effect of this medicine on fertility/pregnancy ability.

So far, there is no experience that demonstrates an influence of this medicine on human fertility.

Driving and using machines

No special precautions are necessary.

3. How to take Ursodeoxycholic Acid Grindeks 250 mg

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

For the dissolution of gallstones(alone or in combination with lithotripsy)

Dosage

The recommended dose is 2-4 capsules of this medicine (8-10 mg/kg body weight of ursodeoxycholic acid), which should be taken with a meal as follows:

• at a daily dose of 2 capsules: both capsules with dinner;
• at a daily dose of 3 capsules: 1 capsule in the morning and 2 in the evening;
• at a daily dose of 4 capsules: 2 capsules in the morning and 2 in the evening.

Or

take a daily dose of 2-4 capsules at night before bedtime.

Method of administration

Swallow the capsules whole with a little water or other liquid. Take the capsules regularly.

Duration of treatment

It usually takes between 6 and 24 months to dissolve gallstones. The duration of treatment depends on the size of the gallstones at the start of treatment. If there is no reduction in the size of the gallstones after 12 months, therapy should be discontinued.

Every 6 months, your doctor should check if the treatment is working. At each of these follow-up examinations, it should be checked if there has been an accumulation of calcium that causes the gallstones to harden since the last time. If this occurs, your doctor will interrupt the treatment.

Even if your symptoms have disappeared, you should continue treatment: interrupting treatment prolongs the total duration of treatment. After the dissolution of gallstones, treatment should be continued for 3-4 months.

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

Dosage

Stage I-III

The daily dose depends on body weight. During the first 3 months of treatment, you should take this medicine in the morning, at noon, and in the evening. With the improvement of liver function values, the daily dose may be taken once a day in the evening.

Stage IV

At the start of treatment, 2-3 capsules of this medicine should be taken daily with a meal:

• at a daily dose of 2 capsules: 1 capsule in the morning and 1 in the evening;
• at a daily dose of 3 capsules: 1 capsule in the morning and 2 in the evening.

If you respond well to this dose (after blood analysis and/or at the discretion of your doctor), your doctor will prescribe a higher dose (dose for stage I-III treatment).

Method of administration

Swallow the capsules whole with a little water or other liquid. Take the capsules regularly.

Duration of administration

There is no time limit for the administration of this medicine in primary biliary cholangitis.

Note

If you have primary biliary cholangitis, the symptoms of your disease, e.g. itching, may worsen at the start of treatment. This occurs only rarely. In this case, therapy may be continued with a reduced daily dose of this medicine. After that, your doctor will increase the daily dose every week until the necessary dose is reached again.

Use in children and adolescents (6-18 years) for the treatment of liver diseases associated with cystic fibrosis

Dosage

The recommended daily dose is 20 mg/kg body weight, divided into 2-3 doses. If necessary, your doctor may increase the dose to 30 mg/kg body weight per day.

Method of administration

Swallow the capsules whole with a little water or other liquid. Take the capsules regularly.

If you have difficulty swallowing the capsules or a body weight below 47 kg, other formulations with ursodeoxycholic acid are available.

Ask your doctor or pharmacist if you think the effect of this medicine is too strong or too weak.

If you take more Ursodeoxycholic Acid Grindeks 250 mg than you should

In case of overdose or accidental ingestion, talk to your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

In case of overdose, diarrhea may occur. Tell your doctor immediately if you have persistent diarrhea. If you have diarrhea, make sure to drink enough fluids to replace the fluid and electrolyte balance.

If you forget to take Ursodeoxycholic Acid Grindeks 250 mg

Do not take more capsules the next time; just continue treatment with the prescribed dose.

If you stop taking Ursodeoxycholic Acid Grindeks 250 mg

Always talk to your doctor before you decide to stop taking this medicine or to stop treatment prematurely.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

• soft and loose stools or diarrhea.

Very rare(may affect less than 1 in 10,000 people):

• in the treatment of primary biliary cholangitis: severe pain in the upper right abdomen, severe worsening of liver scarring, which improves partially after discontinuing treatment;
• calcification (hardening of gallstones due to calcium accumulation) of gallstones;
• hives (urticaria).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ursodeoxycholic Acid Grindeks 250 mg

Do not store above 30°C.

Keep in the original package to protect from moisture.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging after "EXP". The expiry date is the last day of the month shown.

Medicines should 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. Container Content and Additional Information

Composition ofUrsodeoxycholic Acid Grindeks 250 mg

• The active ingredient is ursodeoxycholic acid.

Each capsule contains 250 mg of ursodeoxycholic acid.

• The other excipients are: corn starch, silicon dioxide (E 551), magnesium stearate (E 470B), hard gelatin capsule (body and cap composition): titanium dioxide (E 171), gelatin (E 441).

Appearance ofUrsodeoxycholic Acid Grindeks 250 mgand Container Content

White hard gelatin capsules, size 0, approximately 21.7 mm x 7.64 mm. The content: white or off-white powder.

The capsules are packaged in PVC/aluminum blisters.

10 capsules per blister.

5, 6 or 10 blisters (50, 60 or 100 capsules) per cardboard box.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

AS GRINDEKS.

Krustpils iela 53, Riga, LV-1057, Latvia

Tel.: +371 67083205

Fax: +371 67083505

Email: grindeks@grindeks.lv

Further information about this medicinal product can be obtained from the local representative of the Marketing Authorization Holder

Grindeks Kalceks España, S.L.

C/ José Abascal, 58 – 2º Dcha.

Madrid, 28003, Spain

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

Germany Ursogrix 250 mg Hartkapseln

Austria Ursogrix 250 mg Hartkapseln

Belgium URSOGRIX 250 mg hard capsules

Bulgaria Ursogrix 250 mg hard capsules

?????????? 250 mg ?????? ???????

Croatia URSOGRIX 250 mg tvrde kapsule

Denmark Ursogrix

Slovakia Ursogrix 250 mg tvrdé kapsuly

Spain Ursodeoxycholic Acid Grindeks 250 mg hard capsules

Estonia URSOGRIX

France ACIDE URSODESOXYCHOLIQUE GRINDEKS 250 mg, gélule

Greece Ursogrix 250 mg Σκληρ? καψ?κια

Hungary Urzodezoxikólsav Grindeks 250 mg kemény kapszula

Ireland Ursogrix 250 mg hard capsules

Latvia URSOGRIX 250 mg cietas kapsulas

Lithuania URSOGRIX 250 mg kietosios kapsules

Norway URSOGRIX 250 mg harde kapsler

Netherlands GRINTEROL 250 mg harde capsules

Poland URSOXYN

Portugal GRINTEROL 250 mg cápsulas duras

United Kingdom Ursodeoxycholic Acid 250 mg Capsules, hard

Czech Republic URSOGRIX

Romania Ursogrix 250 mg capsule

Sweden Ursogrix 250 mg hårda kapslar

Date of the last revision of this leaflet:June 2021.

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es)