TaurO

Package leaflet: Information for the patient

Tauro 150 mg hard capsules

tauro-ursodeoxycholic acid dihydrate
Please read this leaflet carefully before taking this medicine because 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 their symptoms are the same as yours, as it may be dangerous.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Tauro is and what it is used for

Tauro contains the active substance tauroursodeoxycholic acid dihydrate.
Tauroursodeoxycholic acid is naturally present in the human body. It works by inhibiting cholesterol synthesis and increasing the solubility of cholesterol itself.
Tauro is used to:

• prevent the formation of cholesterol stones,
• promote the dissolution of existing cholesterol stones.

Tauro is used both for gallstones (in the gallbladder, the sac where bile accumulates) and for stones in the bile ducts that have remained or re-formed after surgical procedures.

2. What you need to know before taking Tauro

Do NOT take Tauro

• if you are allergic to tauroursodeoxycholic acid dihydrate or to any of the other ingredients of this medicine (listed in section 6);
• if you have an active gastric or duodenal ulcer;
• if you are pregnant (see section “Pregnancy and breastfeeding”);
• if you have gallstones that appear opaque on X-rays (radiopaque);
• if you have diseases requiring surgical removal of the gallbladder (cholecystectomy), including:
  o inflammation of the gallbladder (cholecystitis) unresponsive to medication,
  o inflammation of the bile ducts (cholangitis),
  o obstruction of the bile ducts,
  o inflammation of the pancreas (pancreatitis) due to gallstones.

Tauro must not be used under the following conditions unless your doctor has specifically decided to prescribe it:

• if you have frequent biliary colic;
• if you have infections of the biliary tract;
• if you have severe pancreatic disorders;
• if you have intestinal diseases or conditions that may alter bile flow between liver and intestine (enterohepatic circulation).

Warnings and precautions
Talk to your doctor or pharmacist before taking Tauro.
Before starting treatment, your doctor may prescribe appropriate tests to confirm proper functioning of the gallbladder and to rule out diseases that might interfere with bile circulation between liver and intestine.
If you are being treated with Tauro for dissolution of gallstones, your doctor may prescribe periodic examinations every 3–6 months to assess treatment effectiveness.

Children and adolescents
Tauro must not be used in pediatric patients.

Other medicines and Tauro
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Avoid taking Tauro at the same time as:

• agents that block intestinal absorption of bile acids, such as colestyramine;
• drugs that increase cholesterol excretion in bile, such as:
  o estrogens,
  o hormonal contraceptives,
  o certain lipid-lowering agents (hypolipidemics).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
You must not take Tauro during pregnancy.
If you are a woman of childbearing potential, you may use Tauro, but you must discontinue it if you become pregnant.

Driving and using machines
To date, no effects of Tauro on the ability to drive or operate machinery are known.

Tauro contains lactose
Tauro contains lactose: if your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Tauro

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
You should take the medicine in several divided daily doses, after meals.
The recommended dose is 5–10 mg per kilogram of body weight per day; in most cases, the daily dose ranges between 250 and 750 mg.
Your doctor will prescribe Tauro based on your body weight and the severity of your condition.
If you take more Tauro than you should
If you accidentally take an excessive dose of Tauro, inform your doctor immediately or go to the nearest hospital.
In case of overdose, your doctor will treat your condition according to the symptoms.
If you forget to take Tauro
Do not take a double dose to make up for the missed dose.
If you stop taking Tauro
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

• Occasionally, intestinal function disturbances have been reported, which usually disappear while continuing treatment.
• Nausea, vomiting or diarrhoea may rarely occur.
• In some patients, deposition of calcium salts (calcification) in gallstones has occurred.

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.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tauro

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tauro contains

• The active substance is ursodeoxycholic acid monohydrate. Each hard capsule contains 150 mg of ursodeoxycholic acid monohydrate.
• The other ingredients are maize starch, microcrystalline cellulose, lactose, magnesium stearate. Capsule shell composition: gelatin, yellow iron oxide (E 172), titanium dioxide (E 171).

Description of the appearance of Tauro and package contents
Each pack contains 20 hard capsules of 150 mg.
Marketing Authorization Holder
TEOFARMA S.r.l.
Via F.lli Cervi, 8
27010 Valle Salimbene (PV)
Manufacturer
TEOFARMA S.r.l.
Viale Certosa, 8/A
27100 Pavia
Patient Information Leaflet

Tauro 250 mg hard capsules

tauro-ursodeoxycholic acid dihydrate
Please read this leaflet carefully before taking this medicine because 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 their symptoms are the same as yours, as it may be harmful.
• If any adverse reaction occurs, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Tauro is and what it is used for

Tauro contains the active substance tauro-ursodeoxycholic acid dihydrate.
Tauro-ursodeoxycholic acid is naturally present in the human body. It works by inhibiting cholesterol synthesis and increasing the solubility of cholesterol.
Tauro is used to:

• prevent the formation of cholesterol stones,
• promote the dissolution of cholesterol stones.

Tauro is used both for gallbladder stones (the sac where bile accumulates) and for bile duct stones that have remained or re-formed after surgical procedures.

2. What you need to know before taking Tauro

DO NOT take Tauro

• if you are allergic to tauroursodeoxycholic acid dihydrate or to any of the other ingredients of this medicine (listed in section 6);
• if you have an active gastric or duodenal ulcer;
• if you are pregnant (see section “Pregnancy and breastfeeding”);
• if you have gallstones that appear opaque on X-rays (radiopaque);
• if you suffer from diseases requiring surgical removal of the gallbladder (cholecystectomy), including:
  o inflammation of the gallbladder (cholecystitis) unresponsive to medication,
  o inflammation of the bile ducts (cholangitis),
  o obstruction of the bile ducts,
  o inflammation of the pancreas (pancreatitis) caused by gallstones.

Tauro must not be used under the following conditions unless your doctor has decided to prescribe it:

• if you have frequent biliary colic;
• if you have infections of the biliary tract;
• if you have severe pancreatic disorders;
• if you have intestinal diseases or conditions that may alter bile flow between liver and intestine (enterohepatic circulation).

Warnings and precautions
Talk to your doctor or pharmacist before taking Tauro.
Before starting treatment, your doctor may prescribe appropriate tests to confirm proper gallbladder function and rule out diseases that might interfere with bile circulation between liver and intestine.
If you are being treated with Tauro for dissolution of gallstones, your doctor may order periodic examinations every 3–6 months to assess treatment effectiveness.

Children and adolescents
Tauro must not be used in pediatric patients.

Other medicines and Tauro
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Avoid taking Tauro at the same time as:

• substances that block intestinal absorption of bile acids, such as colestyramine;
• medications that increase cholesterol excretion in bile, such as:
  o estrogens,
  o hormonal contraceptives,
  o certain lipid-lowering agents (hypolipidemics).

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
You must not take Tauro during pregnancy.
If you are a woman of childbearing age, you may use Tauro, keeping in mind that you must discontinue it if you become pregnant.

Driving and using machines
To date, no effects of Tauro on the ability to drive or operate machinery have been reported.

Tauro contains lactose
Tauro contains lactose: if your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take Tauro

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
You must take the medicine in divided doses throughout the day, after meals.
The recommended dose is 5–10 mg per kilogram of body weight per day; in most cases, the daily dose ranges between 250 and 750 mg.
Your doctor will prescribe Tauro based on your body weight and the severity of your condition.
If you take more Tauro than you should
If you accidentally take too much Tauro, contact your doctor immediately or go to the nearest hospital.
In case of overdose, your doctor will treat your condition according to the symptoms presented.
If you forget to take Tauro
Do not take a double dose to make up for the missed dose.
If you stop taking Tauro
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

• Occasionally, disturbances in intestinal function have been reported, which usually disappear with continued treatment.
• Nausea, vomiting or diarrhoea may rarely occur.
• In some patients, deposition of calcium salts (calcification) in gallstones has occurred.

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.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tauro

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tauro contains

• The active substance is tauro-ursodeoxycholic acid dihydrate. Each hard capsule contains 250 mg of tauro-ursodeoxycholic acid dihydrate.
• The other components are maize starch, microcrystalline cellulose, lactose, magnesium stearate. Composition of the hard capsule: gelatin, yellow iron oxide (E 172), titanium dioxide (E 171), indigo carmine (E132), erythrosine (E127).

Description of the appearance of Tauro and contents of the pack
Each pack contains 20 hard capsules of 250 mg.
Marketing Authorization Holder
TEOFARMA S.r.l.
Via F.lli Cervi, 8
27010 Valle Salimbene (PV)
Manufacturer
TEOFARMA S.r.l.
Viale Certosa, 8/A
27100 Pavia