Package Insert: Information for the Patient

Adisocol 150 mg Tablets EFG

Ursodeoxycholic Acid

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you only, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Ursodeoxycholic acid affects the composition of bile, which dissolves cholesterol gallstones. The effect of ursodeoxycholic acid on primary biliary cholangitis and cystic fibrosis can be explained by several mechanisms, including a protective effect on liver cells and an effect on the immune system.

1. Ursodeoxycholic acid is used in patients:

• with small gallstones,
• who do not wish to undergo surgery or are not eligible for gallstone surgery
• in whom too much cholesterol has been found in the bile.

1. Ursodeoxycholic acid is used in patients with primary biliary cholangitis. Primary biliary cholangitis is a disease in which the liver tissue is damaged by a defective bile drainage.

1. Ursodeoxycholic acid is used in children between 6 and 18 years old with liver and bile problems caused by cystic fibrosis. Cystic fibrosis, also known as mucoviscidosis, is a hereditary disease in which the mucous membranes are particularly rigid throughout the body. This can cause, among other conditions, obstructions and inflammation of the liver and bile ducts.

Do not take Adisocol:

• If you have an acute inflammation of the gallbladder or bile ducts.
• If you have an obstruction or blockage of the bile duct.
• If you frequently experience painful cramps in the upper abdomen (biliary colic).
• If you have calcified gallstones that do not show up on X-rays.
• If you have a gallbladder that cannot contract properly.
• If you are allergic to bile acids or any of the other components of this medication (listed in section 6).
• If you have an active gastric or duodenal ulcer.

Children

In children with interrupted bile drainage due to the production of connective tissue in the bile duct (biliary atresia) in whom the bile flow has not been restored by healing or through an artificial bile duct (portoenterostomy).

Warnings and precautions

This medication should be taken under medical supervision.

Your doctor should examine your liver every 4 weeks during the first three months of treatment. After that, they should do it every 3 months. Apart from allowing the identification of patients being treated for primary biliary cholangitis between those who respond and those who do not respond, this monitoring should also allow for early detection of potential liver deterioration, particularly in patients with advanced primary biliary cholangitis.

When used to dissolve gallstones:

To be able to evaluate the therapeutic progression of gallstone dissolution and to identify in time the possible calcification of gallstones, the gallbladder, depending on the size of the stones, should be visualized from 6 to 10 months after the start of treatment (oral cholecystography) with total image and occlusions and in standing and lying positions (ultrasound control).

If the gallbladder cannot be visualized with X-rays, or in cases where the gallstones are calcified, in damaged gallbladder contractility, or frequent episodes of biliary colic, treatment with ursodeoxycholic acid should be interrupted.

When used for the treatment of advanced primary biliary cholangitis

In very rare cases, decompensation of liver cirrhosis is observed, which decreases partially after treatment interruption.

Women taking Adisocol to dissolve gallstones should stop taking the contraceptive pill and other methods to prevent pregnancy, because the hormones in the contraceptive pill can trigger the formation of gallstones.

In the final phase of primary biliary cholangitis, liver function may be severely reduced in very rare cases. Liver function will partially recover after treatment interruption.

If you experience diarrhea problems, your doctor will reduce the dose. If diarrhea persists, your doctor may decide to interrupt treatment.

Consult your doctor or pharmacist before starting to take this medication.

Other medications and Adisocol

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This also applies to non-prescription medications.

The effects of the following medications may be influenced (interactions):

It is possible that the following medications will have areduced effect:

• Medications that bind to stomach acid containing aluminum hydroxide and substances that bind to bile acids (cholestyramine, colestipol) that may bind to ursodeoxycholic acid and thus prevent its absorption.

Therefore, these medications cannot be taken simultaneously with ursodeoxycholic acid, but if always two hours before or after.

• Ursodeoxycholic acid may reduce the absorption of ciprofloxacin, dapsone (antibiotics) and nitrendipine (anti-hypertensive agent) from the intestine. When one of these medications is used simultaneously with Adisocol, your doctor should monitor you closely.

It is possible that the following medications will have anintensified effectwhen using ursodeoxycholic acid:

• Ursodeoxycholic acid may increase the absorption of ciclosporin from the intestine: if necessary, the dose should be adjusted based on ciclosporin blood levels.

The estrogens, oral contraceptives ("the pill") and cholesterol-lowering agents (such as clofibrate) may trigger the formation of gallstones and may counteract the effect of gallstone treatment with ursodeoxycholic acid.

Inform your doctor or pharmacist if you are taking or have taken other medications. This also applies to non-prescription medications.

Pregnancy and lactation

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Pregnancy

You should not take this medication while pregnant unless your doctor considers it absolutely necessary.

Women of childbearing age

Even if you are not pregnant, you should discuss this possibility with your doctor, because women of childbearing age can only be treated if they are using a reliable contraceptive method. Non-hormonal contraceptives or low-dose estrogen contraceptives are recommended. However, if you are taking this medication for gallstone treatment, you can only use non-hormonal contraceptives because hormonal contraceptives trigger the formation of gallstones.

Lactation

Inform your doctor if you are breastfeeding or about to start. According to a few documented cases in lactating women, the levels of ursodeoxycholic acid in milk are very low and probably no adverse reactions are expected in infants.

Driving and operating machines

The influence of ursodeoxycholic acid on driving and operating machines is negligible or insignificant.

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

Your doctor will determine the dose based on your weight.

Take the tablets after a meal with a glass of milk or a snack. Take the number of tablets prescribed distributed throughout the day.

1. Disolution of gallstones:

Four to six 150 mg tablets, two to three 300 mg tablets, or two 450 mg tablets per day (600-900 mg of ursodeoxycholic acid per day).

Two tablets must always be taken after dinner.

When taking a dose two or three times a day: for example, one tablet after a meal and two tablets after dinner.

When taking a dose of two tablets per day: take both tablets preferably two hours after dinner and one hour before going to sleep.

1. Primary biliary cholangitis (liver tissue damage due to a damaged bile flow):

• Phase I-III:

Four to eight 150 mg tablets, two to four 300 mg tablets, or two 450 mg tablets per day (600-1200 mg of ursodeoxycholic acid per day).

Take the prescribed dose in two or three doses per day after meals.

• Phase IV:

Your doctor will determine based on liver function examination whether you are prescribed a normal dose, as in Phase I-III, or half of this dose.

Children between 6 and 18 years old with cystic fibrosis

1. Liver and bile duct diseases caused by cystic fibrosis (mucoviscidosis):

Four to ten 150 mg tablets, two to five 300 mg tablets, or two to three 450 mg tablets per day (600-1500 mg of ursodeoxycholic acid per day).

Take the tablets with a glass of milk or a snack. Take the prescribed dose in two or three doses per day after meals.

Crushed tablets can be divided if you have trouble swallowing due to the size of the tablet, so that you take it sequentially half a tablet twice.

If you notice that this medication is too strong or too weak, consult your doctor or pharmacist.

If you take more Adisocol than you should

You must inform your doctor if you have taken more ursodeoxycholic acid than you should. It is unlikely that you will notice any problems, but you may experience diarrhea.

If you forgot to take Adisocol

Take the prescribed dose at the next dose.

Do not take a double dose to compensate for the missed doses.

How long should you take Adisocol?

The duration of treatment depends on the size of the gallstone, but it is usually not less than 3 to 4 months. Treatment should not be interrupted prematurely, even if symptoms have disappeared. Only an X-ray or ultrasound scan can show that the gallstones have completely dissolved. After seeing with the help of an ultrasound that the gallstones have completely disappeared, treatment should continue for another three or four months.

Treatment with Adisocol for primary biliary cholangitis and liver and bile duct disorders resulting from cystic fibrosis will continue to maintain the protective effect of Adisocol.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Frequent Adverse Effects(occur in fewer than 1 in 10 patients but in more than 1 in 100 patients)

• Soft stools or diarrhea

Rare Adverse Effects(may affect up to 1 in 10,000 patients)

• In the treatment of primary biliary cholangitis: acute pain in the upper right abdomen, severe deterioration (decompensation) of liver cirrhosis that partially decreases after treatment cessation;
• Bile stone calcification;
• Urticaria (hives).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctororpharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging after (CAD). The expiration date is the last day of the month indicated.

Do not store above 25°C.

Do not dispose of medications through drains or trash. Dispose of packaging and medications you no longer need at the pharmacy's Punto Sigre. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Adisocol

• The active ingredient is ursodeoxycholic acid
• The other excipients are microcrystalline cellulose (Microcel 101) (E460), polyvinylpyrrolidone (Plasdona K-90) (E1201), magnesium stearate (E572), and sodium carboxymethylcellulose Type A (Primojel).

Appearance of the product and contents of the packaging

Adisocol 150 mg are white to almost white, round, film-coated tablets of approximately 9.5 mm in size with a notch and "G" "442" engraved on one face and smooth on the other.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Glenmark Arzneimittel GmbH

Industriestr. 31,

82194 Gröbenzell,

Germany

Responsible for manufacturing

Glenmark Pharmaceuticals s.r.o.,

Fibichova 143, 566 01 VysokeMyto,

Czech Republic

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

Viso Farmacéutica, S.L.U.

c/ Retama 7, 7th Floor

28045 Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: April 2018

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).