Patient Information Leaflet

TUDCABIL 250 mg Hard Capsules

Tauro-ursodeoxycholic acid dihydrate
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What TUDCABIL is and what it is used for
What you need to know before taking TUDCABIL
How to take TUDCABIL
Possible side effects
How to store TUDCABIL
Contents of the pack and other information

1. What TUDCABIL is and what it is used for

TUDCABIL is a preparation based on naturally occurring bile acids in the body that are capable of solubilizing cholesterol present in bile.
This medicinal product is used to treat alterations in bile production by the liver (qualitative and quantitative changes in biligenic function, including cases induced by cholesterol-supersaturated bile), to prevent the formation of gallstones or to facilitate the dissolution of existing radiolucent stones (not visible on X-ray). Specifically, it is indicated in cases of gallbladder stones (gallstones in a functioning gallbladder) and stones present in the bile duct (choledochal stones) that persist even after surgical intervention on the bile ducts carrying bile to the intestine (biliary tract).

2. What you should know before taking TUDCABIL

Do not take TUDCABIL

if you are allergic to tauroursodeoxycholic acid dihydrate, to similar substances (bile acids), or to any of the other ingredients of this medicine (listed in section 6);
if you are pregnant (see "Pregnancy, breastfeeding and fertility");
if you have stomach or intestinal lesions (active gastric or duodenal ulcer);
if you have acute inflammation of the gallbladder or bile ducts;
if you have a blockage of the bile ducts (obstruction of the common or cystic bile duct);
if you suffer from frequent pain due to gallstones (biliary colic);
if you have gallstones that appear opaque on X-rays (radiopaque calcified stones);
if you have gallbladder problems (reduced gallbladder motility).

Warnings and precautions
Talk to your doctor or pharmacist before taking TUDCABIL.
Always take this medicine under direct medical supervision.
Do not take TUDCABIL if any of the following apply to you:

your doctor is unable to visualize the gallbladder on X-ray imaging;
you have calcified gallstones. This medicine is effective only if cholesterol stones are non-calcified, appear transparent on X-rays (radiolucent), and are small in size;
you have gallbladder problems (impaired or altered gallbladder motility);
you suffer from frequent pain due to gallstones in the bile ducts (biliary colic);
you have developed infections of the biliary tract;
you have pancreatic (severe pancreatic disorders) or intestinal conditions (intestinal diseases such as ileal resection or ileostomy, regional ileitis) that may impair the passage of bile acids from the liver to the intestine (enterohepatic circulation).

Before starting treatment, your doctor will perform appropriate tests to determine whether your gallbladder is functioning properly and whether you have diseases that may interfere with the passage of bile acids from the liver to the intestine (enterohepatic circulation).
During the first 3 months of treatment, your doctor will monitor liver function (AST-SGOT, ALT-SGPT, and gamma-GT) every 4 weeks, and thereafter every 3 months. These checks help assess your response to treatment with this medicine, especially if you have a chronic liver disease (primary biliary cirrhosis), and allow early detection of potential liver damage (possible hepatic deterioration).
Additionally, your doctor will perform ultrasound examinations every 3–6 months and, if necessary, radiographic imaging of the gallbladder (cholecystographic exams) to evaluate the effectiveness of this medicine.
If you develop diarrhoea during treatment with TUDCABIL, inform your doctor, who may reduce your dose.
If diarrhoea is prolonged (persistent), your doctor may advise you to discontinue treatment.

Children
This medicine is not intended for use in children.

Other medicines and TUDCABIL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Avoid taking TUDCABIL together with the following medicines:

cholestyramine, colestipol (medicines used to lower blood cholesterol levels), and aluminium-containing antacids (aluminium hydroxide, aluminium oxide), used to reduce stomach acidity, as they reduce the effects of bile acids. If you must take these medicines, take them 2 hours before or after taking TUDCABIL;
sex hormones (estrogens), medicines used to prevent pregnancy (hormonal contraceptives), and certain medicines used to lower blood cholesterol levels (lipid-lowering agents) such as clofibrate, as they increase the amount of cholesterol in bile (biliary excretion);
medicines that may cause liver damage (hepatotoxic medicines).

Take TUDCABIL with caution and inform your doctor if you are taking any of the following medicines:

cyclosporine, used to prevent organ transplant rejection, as TUDCABIL increases its absorption. In this case, your doctor must monitor the blood levels of cyclosporine (blood concentration) and possibly adjust the dose;
nitrendipine (a calcium channel blocker) used to treat high blood pressure, dapsone used to treat leprosy, and ciprofloxacin used to treat certain infections, as TUDCABIL may reduce their effectiveness;
sex hormones (estrogens), clofibrate, and other medicines used to lower blood cholesterol levels (serum cholesterol reducers), as they may reduce the effectiveness of TUDCABIL.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take TUDCABIL if you are pregnant, except in cases of absolute necessity and under direct medical supervision (see "Do not take TUDCABIL").
Do not take TUDCABIL if you are breastfeeding.
If you are a woman of childbearing potential, take this medicine only if you are protected by an effective contraceptive method (non-hormonal or low-estrogen oral contraceptives).
Ensure you are not pregnant before starting treatment with this medicine.

Driving and using machines
This medicine does not affect the ability to drive or use machinery.

TUDCABIL contains lactose
If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take TUDCABIL

Take this medicine exactly as instructed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Your doctor may decide to prescribe you dosing cycles (posological cycles) based on your body weight and
the severity of your condition.
The recommended dose is 5–10 mg per kg of body weight per day.
Generally, the recommended dose ranges from 250 to 750 mg per day, taken in divided doses
after meals.
If you take more TUDCABIL than you should
Overdose is rare because the toxic dose is much higher than the recommended
treatment dose.
After taking an excessive dose of this medicine, diarrhoea may occur. Other
symptoms are unlikely, as higher doses of tauroursodeoxycholic acid are mainly
eliminated in the faeces. If diarrhoea occurs, specific countermeasures are not necessary.
Your doctor will advise you on how to replace fluids and electrolytes lost through diarrhoea.
In case of accidental ingestion of an excessive dose of TUDCABIL, contact your
doctor immediately or go to the nearest hospital.
If you forget to take TUDCABIL
Do not take a double dose to make up for the missed capsule.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:
Common (may affect up to 1 in 10 people)

soft stools;
diarrhoea;
intestinal disturbances (irregular bowel movements) which disappear with continued treatment.

Rare (may affect up to 1 in 1,000 people)

nausea, vomiting;
liquid stools.

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

calcification of gallstones;
skin irritation (urticaria).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TUDCABIL

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 refers to the last day of that month. The expiry date applies to the product in its original, unopened packaging, properly stored.
Store below 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What TUDCABIL contains

The active substance: tauroursodeoxycholic acid dihydrate. Each capsule contains 250 mg of tauroursodeoxycholic acid dihydrate.
The other components are:
- Inner core: microcrystalline cellulose, lactose, maize starch, magnesium stearate;
- Outer capsule shell: gelatin F.P., titanium dioxide (E 171), erythrosine (E 127), indigo carmine (E 132), quinoline yellow.

Description of the appearance of TUDCABIL and contents of the pack
Box containing 20 hard capsules.
Marketing Authorization Holder
Bruschettini s.r.l. – Via Isonzo, 6 – 16147 Genoa – Italy
Manufacturer
Bruschettini s.r.l. – Via Isonzo, 6 – 16147 Genoa – Italy