Ursodeoxycholic acid ratiopharm
Italy
Table of Contents
Package leaflet: Information for the patient
Ursodeoxycholic Acid ratiopharm 300 mg tablets
Equivalent medicine
Please read this entire 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 their symptoms are the same as yours, as it could be harmful.
- If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Contents of this leaflet
- What Ursodeoxycholic Acid ratiopharm is and what it is used for
- What you need to know before taking Ursodeoxycholic Acid ratiopharm
- How to take Ursodeoxycholic Acid ratiopharm
- Possible side effects
- How to store Ursodeoxycholic Acid ratiopharm
- Contents of the pack and other information
1. What Acido Ursodesossicolico ratiopharm is and what it is used for
Acido Ursodesossicolico ratiopharm contains bile acids.
Acido Ursodesossicolico ratiopharm is indicated for the treatment of:
- cholesterol gallstones (cholesterol stones present in the bile);
- biliary dyspepsia (digestive problems due to impaired gallbladder function);
- chronic cholestatic liver disease affecting bile production by the liver:
- primary biliary cirrhosis;
- sclerosing cholangitis;
- liver damage caused by cystic fibrosis (a genetic disease) in adults and children aged 6 years and older.
2. What you need to know before taking Acido Ursodesossicolico ratiopharm
Do not take Acido Ursodesossicolico ratiopharm
- if you are allergic to the active substance, bile acids, or any of the other ingredients of this medicine (listed in section 6);
- if you have acute inflammation of the gallbladder (cholecystitis) or bile ducts;
- if you have a blockage of the bile ducts (obstruction of the common bile duct or cystic duct);
- if you frequently suffer from episodes of upper abdominal pain (biliary colic);
- if you have calcified gallstones visible on X-ray;
- if you have impaired gallbladder function (reduced gallbladder motility);
- if you have active stomach or intestinal diseases (gastric or duodenal ulcer);
- if the person to be treated is a child with congenital malformations of the biliary system (biliary atresia), in whom surgical intervention to restore bile flow (portoenterostomy) has failed to restore adequate bile flow.
Warnings and precautions
Talk to your doctor or pharmacist before taking Acido Ursodesossicolico ratiopharm.
Treatment with this medicine must be carried out under strict medical supervision.
If you develop diarrhoea during treatment, consult your doctor, who may decide to reduce the dose or discontinue treatment in case of persistent diarrhoea.
Avoid using Acido Ursodesossicolico ratiopharm if you have biliary infections, severe pancreatic disorders, or intestinal diseases.
Before starting treatment and during treatment, your doctor will monitor liver function tests, including transaminases (AST or SGOT and ALT or SGPT), alkaline phosphatase, and gamma-GT.
Inform your doctor if you have medical conditions predisposing to intestinal narrowing or delayed intestinal transit (e.g. surgical enteroanastomoses, Crohn's disease), see also above "Do not take Acido Ursodesossicolico ratiopharm". In such cases, treatment with ursodeoxycholic acid may pose a risk of developing gastrointestinal stones (enteroliths). Inform your doctor if obstructive gastrointestinal symptoms such as abdominal pain and vomiting occur.
When Acido Ursodesossicolico ratiopharm is prescribed to dissolve cholesterol gallstones, your doctor will also schedule monitoring of the gallbladder and bile ducts (oral cholecystography and ultrasound).
If you suffer from advanced primary biliary cirrhosis, a liver disease, your symptoms may rarely worsen at the beginning of treatment; for example, pruritus may increase. Your doctor will determine the dosage of the medicine based on your clinical condition and tolerance to the drug. Very rarely, Acido Ursodesossicolico ratiopharm may cause worsening of this disease (decompensation of liver cirrhosis), and conditions may partially improve after discontinuation of treatment.
If you are a woman of childbearing age, your doctor will advise you to use an effective non-hormonal contraceptive method before prescribing Acido Ursodesossicolico ratiopharm.
Other medicines and Acido Ursodesossicolico ratiopharm
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Acido Ursodesossicolico ratiopharm and consult your doctor if you are taking the following medicines:
- cholestyramine and colestipol, used to lower cholesterol levels, and antacids containing aluminium hydroxide and/or smectite (aluminium oxide);
- cyclosporine, a medicine that reduces the activity of the immune system;
- ciprofloxacin and dapsone, medicines used to treat bacterial infections;
- nitrendipine, a medicine used to lower blood pressure;
- estrogens and hormonal contraceptives;
- certain cholesterol-lowering drugs such as clofibrate;
- medicines that may be harmful to the liver (potentially hepatotoxic);
- rosuvastatin, a medicine used to lower cholesterol in the blood.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not use this medicine during pregnancy unless your doctor considers it absolutely necessary, particularly during the first trimester. Before starting treatment, ensure you are not pregnant.
If you are a woman of childbearing age, treatment may only be started if you are using a reliable contraceptive method (non-hormonal contraceptives or low-estrogen hormonal contraceptives).
If you are undergoing treatment for gallstone dissolution, use an effective non-hormonal contraceptive, since hormonal oral contraceptives may increase the risk of gallstone formation.
Breastfeeding
Levels of ursodeoxycholic acid in breast milk are very low and are unlikely to cause adverse effects in the breastfed infant. If you are being treated with ursodeoxycholic acid, consult your doctor before breastfeeding.
Fertility
Animal studies have not shown any effect of ursodeoxycholic acid on fertility. Adequate data on effects on fertility in humans following treatment with ursodeoxycholic acid are not available.
Driving and using machines
Acido Ursodesossicolico ratiopharm does not affect or has a negligible effect on the ability to drive or use machines.
Acido Ursodesossicolico ratiopharm contains
- lactose: if your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine;
- sodium: this medicine contains less than 1 mmol (23 mg) of sodium per 300 mg tablet, i.e., essentially “sodium-free”.
3. How to take Ursodeoxycholic Acid ratiopharm
Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the dosage of this medicine based on your
clinical condition and your tolerance to the medicine.
Cholesterol gallstones
The recommended daily dose is 10 mg/kg, divided into 2–3 doses per day.
The duration of treatment should be at least 4–6 months, possibly extended up to 24 months,
without interruption, and should continue for 3–4 months after the complete disappearance of the stones,
as confirmed by radiographic or ultrasound examinations. However, treatment should not exceed 2 years.
For maintenance therapy, the dose is 300 mg divided into 2–3 doses per day.
Chronic cholestatic liver disease
- Primary biliary cirrhosis and sclerosing cholangitis: the recommended dose is 13–15 mg/kg/day, divided into two separate doses taken in the morning and evening, with meals. The dose should be gradually increased in increments until the optimal dose is reached after 4–8 weeks of treatment;
- Cholestatic liver disease due to liver damage caused by cystic fibrosis: the recommended dose is 20 mg/kg/day divided into 2–3 doses, with a possible further increase to 30 mg/kg/day, if necessary.
Biliary dyspepsia
The recommended dose is 300 mg per day, divided into 2–3 doses.
If the 300 mg tablets do not allow the prescribed daily doses to be taken as required for treatment, other formulations and dosage strengths are available on the market to facilitate dose adjustment.
If you take more Ursodeoxycholic Acid ratiopharm than you should
If you accidentally ingest or take an excessive amount of this medicine, contact your doctor immediately or go to the nearest hospital.
In case of overdose, diarrhea may occur.
No cases of overdose exceeding 4 g per day are known.
If you forget to take Ursodeoxycholic Acid ratiopharm
Do not take a double dose to make up for the missed dose. Take the next dose at the scheduled time.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects may occur:
Common (may affect up to 1 in 10 people)
- soft stools;
- diarrhoea.
Very rare (may affect up to 1 in 10,000 people)
- severe pain in the upper right part of the abdomen;
- bowel irregularity (frequency and quality of evacuation);
- calcification of gallstones;
- worsening of liver condition in case of hepatic cirrhosis, a serious liver disease;
- skin rash (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 may also report side effects directly through the national reporting system at https://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 Acido Ursodesossicolico ratiopharm
Keep this medicine out of the sight and reach of children.
This medicine requires no special storage conditions.
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 Acido Ursodesossicolico ratiopharm contains
- The active substance is ursodeoxycholic acid. Each tablet contains 300 mg of ursodeoxycholic acid.
- The other ingredients are lactose, pregelatinized starch, arabic gum, talc, magnesium stearate, sodium starch glycolate.
Description of the appearance of Acido Ursodesossicolico ratiopharm and contents of the pack
Box containing 20 tablets in blisters.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
ratiopharm GmbH - Graf-Arco-Strasse 3 - Ulm (Germany).
Manufacturer
ICE S.p.A. - Via Cantone Moretti, 29 10015 – Ivrea (TO) - Italy
Patient information leaflet: information for the patient
Ursodeoxycholic Acid ratiopharm 450 mg prolonged-release tablets
Equivalent medicine
Please read this entire 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, consult 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 could be harmful.
- If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet
- What Ursodeoxycholic Acid ratiopharm is and what it is used for
- What you need to know before taking Ursodeoxycholic Acid ratiopharm
- How to take Ursodeoxycholic Acid ratiopharm
- Possible side effects
- How to store Ursodeoxycholic Acid ratiopharm
- Package contents and other information
1. What Acido Ursodesossicolico ratiopharm is and what it is used for
Acido Ursodesossicolico ratiopharm contains bile acids.
Acido Ursodesossicolico ratiopharm is indicated for the treatment of:
- cholesterol gallstones (cholesterol stones present in the bile);
- biliary dyspepsia (digestive problems due to impaired gallbladder function).
2. What you should know before taking Acido Ursodesossicolico ratiopharm
Do not take Acido Ursodesossicolico ratiopharm
- if you are allergic to the active substance, bile acids, or any of the other ingredients of this medicine (listed in section 6);
- if you have acute inflammation of the gallbladder (cholecystitis) or bile ducts;
- if you have a blockage of the bile ducts (obstruction of the common bile duct or cystic duct);
- if you frequently suffer from upper abdominal pain (biliary colic);
- if you have radiopaque (visible on X-ray) calcified gallstones;
- if you have impaired gallbladder function (reduced gallbladder motility);
- if you have active gastrointestinal diseases (active gastric or duodenal ulcer).
Warnings and precautions
Talk to your doctor or pharmacist before taking Acido Ursodesossicolico ratiopharm.
Treatment with this medicine must be under strict medical supervision.
If you develop diarrhoea during treatment, consult your doctor, who may decide to reduce the dose or discontinue treatment in case of persistent diarrhoea.
Avoid using Acido Ursodesossicolico ratiopharm if you have biliary infections, severe pancreatic disorders, or intestinal diseases.
Before starting treatment and during therapy, your doctor will monitor liver function tests, including transaminases (AST or SGOT and ALT or SGPT), alkaline phosphatase, and gamma-GT.
Inform your doctor if you have medical conditions predisposing to intestinal narrowing or delayed intestinal transit (e.g. surgical enteric anastomoses, Crohn's disease); see also above "Do not take Acido Ursodesossicolico ratiopharm". In such cases, treatment with ursodeoxycholic acid may pose a risk of developing gallstones in the gastrointestinal tract (enteroliths). Inform your doctor if obstructive gastrointestinal symptoms such as abdominal pain and vomiting occur.
When Acido Ursodesossicolico ratiopharm is prescribed to dissolve cholesterol gallstones, your doctor will also schedule monitoring of the gallbladder and bile ducts (oral cholecystography and ultrasound).
If you have an advanced liver disease called primary biliary cirrhosis, your symptoms may rarely worsen at the beginning of treatment.
If you are a woman of childbearing age, your doctor will advise you to use an effective non-hormonal contraceptive method before prescribing Acido Ursodesossicolico ratiopharm.
Other medicines and Acido Ursodesossicolico ratiopharm
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Acido Ursodesossicolico ratiopharm and consult your doctor if you are taking the following medicines:
- cholestyramine and colestipol, used to lower cholesterol levels, and antacids containing aluminum hydroxide and/or smectite (aluminum oxide);
- cyclosporine, a medicine that reduces the activity of the immune system;
- ciprofloxacin and dapsone, medicines used to treat bacterial infections;
- nitrendipine, a medicine used to lower blood pressure;
- estrogens and hormonal contraceptives;
- certain cholesterol-lowering drugs such as clofibrate;
- medicines that may be harmful to the liver (potentially hepatotoxic);
- rosuvastatin, a medicine used to lower blood cholesterol.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not use this medicine during pregnancy unless your doctor considers it absolutely necessary, particularly during the first trimester. Before starting treatment, ensure that you are not pregnant.
If you are a woman of childbearing age, treatment should only begin if you are using a reliable contraceptive method (non-hormonal contraceptives or low-estrogen hormonal contraceptives).
If you are being treated to dissolve gallstones, use an effective non-hormonal contraceptive, as hormonal oral contraceptives may increase the risk of gallstone formation.
Breastfeeding
Levels of ursodeoxycholic acid in breast milk are very low and are not expected to cause adverse effects in the breastfed infant. If you are undergoing treatment with ursodeoxycholic acid, consult your doctor before breastfeeding.
Fertility
Animal studies have not shown any influence of ursodeoxycholic acid on fertility. Adequate data on effects on fertility in humans after treatment with ursodeoxycholic acid are not available.
Driving and using machines
Acido Ursodesossicolico ratiopharm does not affect or has negligible influence on the ability to drive vehicles or operate machinery.
Acido Ursodesossicolico ratiopharm contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
3. How to take Acido Ursodesossicolico ratiopharm
Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the dosage of the medicine according to your
clinical condition and your tolerance to the medicine.
Cholesterol gallstones
The recommended dose is 1 prolonged-release tablet of 450 mg daily.
If you are obese or have other significant factors favouring gallstone formation, the recommended
dose is 675 mg.
The duration of treatment should be at least 4–6 months, which may extend up to 24 months,
continuously, and should be continued for 3–4 months after disappearance of gallstones,
confirmed by radiographic or ultrasonographic examinations. However, treatment should not
exceed 2 years.
For maintenance therapy, the dose is 225 mg daily.
Biliary dyspepsia
The recommended dose is 225 mg daily.
Method of administration: take the prolonged-release tablet in the evening before going to bed.
If the 450 mg tablets do not allow the prescribed daily dose to be taken, other formulations and
dosage strengths are available on the market for dose adjustment.
If you take more Acido Ursodesossicolico ratiopharm than you should
In case of accidental ingestion/overdose of this medicine, contact your doctor immediately or go to
the nearest hospital.
Diarrhoea may occur in case of overdose.
There are no known cases of overdose exceeding 4 g daily.
If you forget to take Acido Ursodesossicolico ratiopharm
Do not take a double dose to make up for the missed dose. Take the next dose at the scheduled time.
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.
Very rare (may affect up to 1 in 10,000 people)
- severe pain in the upper right part of the abdomen;
- bowel irregularity (frequency and quality of evacuation);
- calcification of gallstones;
- worsening of liver condition in case of hepatic cirrhosis, a serious liver disease;
- skin rash (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 https://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 Ursodeoxycholic Acid ratiopharm
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
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 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 Acido Ursodesossicolico ratiopharm contains
- The active substance is ursodeoxycholic acid. Each prolonged-release tablet contains 450 mg of ursodeoxycholic acid.
- The other ingredients are hypromellose (Methocel K15M), hypromellose (Methocel K100M), microcrystalline cellulose, lactose, povidone, talc, magnesium stearate.
Description of the appearance of Acido Ursodesossicolico ratiopharm and package contents
Box containing 20 prolonged-release tablets in blisters.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
ratiopharm GmbH - Graf - Arco Strasse 3 - Ulm (Germany).
Manufacturer
ICE S.p.A. - Via Cantone Moretti, 29 10015 – Ivrea (TO) - Italy