ADISOCOL 250 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Adisocol250 mg hard capsules EFG

ursodeoxycholic acid

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

1. What is Adisocol and what is it used for

Ursodeoxycholic acid is a naturally occurring bile acid. It is found in small amounts in human bile.

Adisocolis used:

• to treat a disease where the bile ducts in the liver are damaged, leading to a buildup of bile. This can cause scarring of the liver. The liver should not be so damaged that it does not function properly. This disease is called primary biliary cirrhosis (PBC);
• to dissolve gallstones caused by an excess of cholesterol in the gallbladder when the gallstones are not visible on a simple X-ray (visible gallstones do not dissolve) and are not more than 15 mm in diameter. The gallbladder should still be functioning despite the gallstones.
• for liver disease associated with a condition called cystic fibrosis in children aged 6 to 18 years.

2. What you need to know before you take Adisocol

Do not take Adisocol if:

• you are or have been told you are allergic (hypersensitive) to bile acids such as ursodeoxycholic acid or to any of the other ingredients of this medicine (listed in section 6);
• your gallbladder does not function properly;
• your doctor has told you that you have calcified gallstones (visible on an X-ray);
• you have acute inflammation of the gallbladder or biliary tract;
• you have a blockage of the common bile duct or cystic duct (obstruction of the bile ducts);
• you have frequent pains in the upper abdomen, similar to cramps (biliary colic);
• you are a child with a closure of the bile ducts (biliary atresia) and have a deficient bile flow, even after surgery.

Talk to your doctor about any of the above conditions. You should also ask if you have had any of these conditions in the past or if you are not sure if you have any of them.

Warnings and precautions

Talk to your doctor or pharmacist before you start taking this medicine.

Your doctor should check your liver function regularly every 4 weeks during the first 3 months of treatment. After this time, it should be checked at 3-month intervals.

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

When used to treat PBC, the symptoms may occasionally worsen at the start of treatment. If this happens, talk to your doctor so that they can reduce the initial dose.

When used to dissolve gallstones, your doctor should schedule a gallbladder examination after the first 6-10 months of treatment.

Tell your doctor immediately if you have diarrhea, as it may be necessary to reduce the dose or stop treatment.

Other medicines and Adisocol

The effects of these medicines may be altered:

It is possible that the effectsof the following medicines are reducedwhen taking ursodeoxycholic acid:

• cholestyramine, colestipol (to reduce blood lipids) or antacids that contain aluminum hydroxide or smectite (aluminum oxide). If you need to take any medicine that contains any of these ingredients, you should take it at least 2 hours before or after ursodeoxycholic acid.
• ciprofloxacin and dapsone (antibiotics), nitrendipine (used to treat high blood pressure). Your doctor may need to adjust the dose of these medicines.

It is possible that the effectsof the following medicines are alteredwhen taking this medicine:

• ciclosporin (to reduce the activity of the immune system). If you are being treated with ciclosporin, your doctor should check the amount of ciclosporin in your blood. Your doctor will adjust the dose if necessary.
• rosuvastatin (for high cholesterol and related conditions).

Please tell your doctor if you are taking any cholesterol-lowering agent such as clofibrate or estrogen-containing medicines; especially if you are taking ursodeoxycholic acid for the dissolution of gallstones, as they may stimulate the formation of gallstones.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.

Treatment with ursodeoxycholic acid may still be allowed. Your doctor will know what is best for you.

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:You should not take ursodeoxycholic acid during pregnancy unless your doctor considers it absolutely necessary.

Women of childbearing age:Women of childbearing age who take this medicine to dissolve gallstones should use effective non-hormonal or low-estrogen oral contraceptives. Women of childbearing age who take this medicine to dissolve gallstones should use an effective non-hormonal contraceptive, as hormonal contraceptives may promote the formation of gallstones.

Breastfeeding:According to the few documented cases of breastfeeding women, the levels of ursodeoxycholic acid in breast milk are very low and it is unlikely that adverse reactions will occur in breastfed infants. Tell your doctor if you are breastfeeding or about to start breastfeeding.

Driving and using machines

No special precautions are necessary.

3. How to take Adisocol

Follow the administration instructions for this medication exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Ursodeoxycholic acid is available in suspension if you need a lower dose or if you cannot swallow the capsules.

For primary biliary cirrhosis (chronic inflammation of the bile ducts)

Dosage

Stages I-III

The daily dose depends on body weight. During the first 3 months of treatment, you should take ursodeoxycholic acid in the morning, at noon, and at night. As liver function values improve, the total daily dose can be taken once a day at night.

Stage IV

If serum bilirubin levels increase, you will be given half the normal dose (see dosage for stages I-III). Your doctor will continuously monitor your liver function; if there is no deterioration in liver function over time, the dose may be increased and maintained at the normal dose.

Patient without an increase in serum bilirubin levels may receive the normal initial dose immediately (see dosage for stages I-III). However, close monitoring of liver function will also be applied in these cases.

How to take Adisocol

Swallow the capsules whole with a glass of water or other liquid. Take your medications regularly.

Duration of treatment

Ursodeoxycholic acid can be continued indefinitely in cases of PBC.

To dissolve cholesterol gallstones

Dosage

The recommended daily dose is 8-10 mg/kg body weight of ursodeoxycholic acid, equivalent to:

The dose should be divided into two doses after breakfast and dinner, with one dose always after dinner

Or

The capsule(s) should be taken at night before bedtime.

The capsules should be taken regularly.

How to take Adisocol

Swallow the capsules whole with a glass of water or other liquid. Take the capsules at night before bedtime. Take your medications regularly.

Duration of treatment

Dissolution of gallstones usually takes between 6 and 24 months. If the size of the gallstones does not decrease after 12 months, treatment should be discontinued.

Every 6 months, your doctor should check if the treatment is working. In 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 discontinue treatment.

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

Both indications

Use in elderly patients:

There is no evidence to suggest that the dose needs to be altered for adults, but your doctor will take your age and health status into account.

Use in children and adolescents

The administration of ursodeoxycholic acid is based on body weight and the disease being treated.

Use in children (6 to 18 years) for the treatment of liver disease associated with cystic fibrosis

Dosage

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

How to take Adisocol

Take the capsules two to three times a day, as recommended. Take the capsules regularly.

If you feel that the effect of this medication is too strong or too weak, consult your doctor or pharmacist.

If you take more Adisocol than you should

Diarrhea may occur as a result of an overdose. Inform your doctor immediately if you have persistent diarrhea. If you suffer from diarrhea, make sure to drink enough fluids to replenish the balance of fluids and salts (electrolytes).

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Adisocol

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

If you stop taking Adisocol

Always consult your doctor before deciding to stop treatment with this medication or before stopping treatment prematurely.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

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

• soft and loose stools or diarrhea. Inform your doctor immediately if you have persistent diarrhea, as it may be necessary to reduce the dose of your medication. If you suffer from diarrhea, make sure to drink enough fluids to replenish the balance of fluids and salts.

Very rare side effects(may affect up to 1 in 10,000 people):

• during the treatment of PBC: severe upper right abdominal pain, severe worsening of liver scarring, which partially subsides after treatment is discontinued.
• hardening of gallstones due to calcium accumulation. It does not present additional symptoms, but it will appear in the analyses.
• hives (urticaria).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Adisocol

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the box and on the packaging after "EXP". The expiration date is the last day of the month indicated.

Medications should not be thrown away through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE Collection Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Adisocol

The active ingredient is ursodeoxycholic acid. One capsule contains 250 mg of ursodeoxycholic acid.

The other ingredients are:

(capsule content): colloidal anhydrous silica, magnesium stearate, cornstarch.

(capsule shell): gelatin, titanium dioxide (E171), yellow iron oxide (E172).

Appearance of the product and package contents

Adisocol 250 mg hard capsules are size 0 with a yellow cap and a body filled with a homogeneous white powder.

Adisocol 250 mg hard capsules EFG are available in packages of 20, 30, 50, 60, or 100 capsules.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer

ABC Farmaceutici S.P.A.

Via Cantone Moretti 29

10015 – Ivrea

Italy

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7ª Planta

28045 Madrid

Spain

This medication is authorized in the Member States of the European Economic Area with the following names:

Date of the last revision of this leaflet:May 2024

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