Ursodeoxycholic acid Doc Generici
Italy
Table of Contents
Package leaflet: Information for the patient
URSEDOXICOLIC ACID DOC Generics 300 mg hard capsules
Ursodeoxycholic acid
Generic medicine
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 could be harmful.
- If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What URSEDOXICOLIC ACID DOC Generics is and what it is used for
- What you need to know before taking URSEDOXICOLIC ACID DOC Generics
- How to take URSEDOXICOLIC ACID DOC Generics
- Possible side effects
- How to store URSEDOXICOLIC ACID DOC Generics
- Contents of the pack and other information
1. What ACIDO URSODESOSSICOLICO DOC Generici is and what it is used for
ACIDO URSODESOSSICOLICO DOC Generici is a preparation based on naturally occurring bile acids present in the body, capable of solubilizing cholesterol in bile.
This medicine is used to treat alterations in bile production by the liver and to improve cholesterol solubility, both to prevent gallstone formation and to facilitate the dissolution of existing stones. This medicine is not effective against all types of gallstones, but only against those not visible on X-rays (radiolucent stones); in particular, cholesterol gallstones in the gallbladder (with a functioning gallbladder) and stones in the bile duct.
It is also used to treat digestive problems caused by impaired gallbladder function (biliary dyspepsia).
2. What you need to know before taking ACIDO URSODESOSSICOLICO DOC Generici
Do not take ACIDO URSODESOSSICOLICO DOC Generici
- if you are allergic (hypersensitive) to ursodeoxycholic acid, bile acids, or any of the 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 reduced gallbladder motility.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine.
Treatment with this medicine must be carried out under close medical supervision.
Before starting long-term therapy, liver function (transaminases and alkaline phosphatase levels) should be checked. During the first 3 months of treatment with this medicine, your doctor will monitor your liver function parameters every 4 weeks. After this period, monitoring will be performed every 3 months.
When treating gallstones, an overall visualization of the gallbladder (oral cholecystography) and imaging of the obstructed ducts in both supine and upright positions (ultrasound examination) should be performed 6–10 months after starting treatment, to assess improvement and detect any gallbladder calcification at an early stage.
If you experience diarrhea, consult your doctor, who may decide to reduce the dose or discontinue treatment.
Other medicines and ACIDO URSODESOSSICOLICO DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Avoid taking ACIDO URSODESOSSICOLICO DOC Generici together with the following medicines, as they may interfere with or be affected by treatment with ursodeoxycholic acid:
- bile acid sequestrants used to lower cholesterol levels, such as cholestyramine and colestipol, or antacids containing aluminum hydroxide and/or smectite (aluminum oxide). If use of these medicines is necessary, they should be taken at least 2 hours before or after ACIDO URSODESOSSICOLICO DOC Generici.
- cyclosporine, a medicine that reduces immune system activity. In this case, your doctor must monitor blood levels of cyclosporine and adjust the dose if necessary;
- ciprofloxacin and dapsone, antibiotics used to treat infections;
- nitrendipine, a medicine used to lower blood pressure; in this case, an increased dose may be required;
- estrogens and cholesterol-lowering agents such as clofibrate, as they may promote gallstone formation;
- medicines that are harmful to the liver (hepatotoxic);
- rosuvastatin, a medicine used to lower blood cholesterol, because blood levels of rosuvastatin may increase.
Pregnancy and breastfeeding
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 use this medicine during pregnancy unless absolutely necessary. Before starting treatment, ensure that you are not pregnant.
If you are of childbearing age, you may begin treatment only if you are using a reliable contraceptive method (non-hormonal contraceptives or low-estrogen oral contraceptives).
If you are undergoing therapy for gallstone dissolution, use an effective non-hormonal contraceptive method, since hormonal oral contraceptives may increase the risk of gallstone formation.
Driving and operating machinery
This medicine does not impair the ability to drive vehicles or operate machinery.
3. How to take ACIDO URSODESOSSICOLICO DOC Generici
Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Treatment of gallstones: to prevent the formation of stones, the recommended daily dose is
5–10 mg/kg (in most cases between 300 and 600 mg, corresponding to 1–2 capsules
per day), taken long-term.
Take the medicine during or after meals, in the evening.
To maintain conditions suitable for dissolving existing stones, treatment should last at least 4–6 months, possibly extending up to 12 months or longer, continuously, and should continue for 3–4 months after radiological or ultrasonographic disappearance of the stones. However, treatment must not exceed 2 years.
Treatment of dyspepsia and maintenance therapy: the recommended dose is 300 mg per day,
divided into 2–3 doses.
Use in children
This medicine is not intended for use in children.
If you take more ACIDO URSODESOSSICOLICO DOC Generici than you should
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital.
Diarrhea may occur in case of overdose. Generally, other overdose symptoms are unlikely, since the absorption of ursodeoxycholic acid decreases as the dose increases, resulting in greater excretion via feces.
Treatment of overdose includes fluid and electrolyte replacement.
In case of accidental ingestion of very high doses of ursodeoxycholic acid, administration of cholestyramine is recommended, as it is capable of binding bile acids.
If you forget to take ACIDO URSODESOSSICOLICO DOC Generici
Do not take a double dose to make up for the missed dose. Take the next dose at the scheduled time.
If you have any doubts about how to use 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:
Very common (may affect more than 1 in 10 people)
- soft stools or diarrhoea.
Very rare (may affect up to 1 in 10,000 people)
- calcification of gallstones;
- 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 the website: http://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 ACIDO URSODESOSSICOLICO DOC Generici
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Expiry".
The expiry date refers to the last day of that month.
The expiry date applies to the product in its original, undamaged packaging, stored correctly.
This medicine does not require any special storage conditions.
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. Contents of the pack and other information
What ACIDO URSODESOSSICOLICO DOC Generici contains
ACIDO URSODESOSSICOLICO DOC Generici 300 mg hard capsules
- The active substance is ursodeoxycholic acid. Each hard capsule contains 300 mg of ursodeoxycholic acid (UDCA).
- The other components are: starch; magnesium stearate; colloidal silicon dioxide.
- Capsule shell components: gelatin; titanium dioxide.
Description of the appearance of ACIDO URSODESOSSICOLICO DOC Generici and contents of the pack
Carton pack containing 20 hard capsules.
Marketing Authorization Holder
DOC Generici Srl – Via Turati 40 - 20121 MILAN, Italy
Manufacturer
ABC Farmaceutici S.p.A. – Via Cantone Moretti 29 (località San Bernardo) - 10090 Ivrea (TO) - Italy
Patient Information Leaflet
ACIDO URSODESOSSICOLICO DOC Generici 450 mg modified-release hard capsules
Ursodeoxycholic acid
Generic medicine
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 could be harmful.
- If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What ACIDO URSODESOSSICOLICO DOC Generici is and what it is used for
- What you need to know before taking ACIDO URSODESOSSICOLICO DOC Generici
- How to take ACIDO URSODESOSSICOLICO DOC Generici
- Possible side effects
- How to store ACIDO URSODESOSSICOLICO DOC Generici
- Contents of the pack and other information
1. What ACIDO URSODESOSSICOLICO DOC Generici is and what it is used for
ACIDO URSODESOSSICOLICO DOC Generici is a preparation based on naturally occurring bile acids present in the body, which are capable of solubilizing cholesterol in bile.
This medicine is used to treat alterations in bile production by the liver and to improve cholesterol solubility, both to prevent the formation of gallstones and to facilitate their dissolution. This medicine is not effective against all types of gallstones, but only against those not visible on X-rays (radiolucent stones); in particular, cholesterol gallstones in the gallbladder (in a functioning gallbladder) and gallstones in the bile duct.
It is also used to treat digestive problems due to gallbladder dysfunction (biliary dyspepsia).
2. What you should know before taking ACIDO URSODESOSSICOLICO DOC Generici
Do not take ACIDO URSODESOSSICOLICO DOC Generici
- if you are allergic (hypersensitive) to ursodeoxycholic acid, bile acids, or any of the ingredients of this medicine (listed in section 6);
- if you have acute inflammation of the gallbladder (cholecystitis) or of the 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 reduced gallbladder motility;
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine.
Treatment with this medicine must be carried out under strict medical supervision.
Before starting long-term therapy, liver function should be checked (monitoring of transaminases and alkaline phosphatase). During the first 3 months of treatment with this medicine, your doctor will check your liver function parameters every 4 weeks. After this period, checks will be performed every 3 months.
When treating gallstones, an overall visualization of the gallbladder (oral cholecystography) and imaging of the bile ducts in both supine and upright positions (ultrasound examination) should be performed 6–10 months after starting treatment, in order to assess improvement and detect any gallbladder calcification at an early stage.
If you experience diarrhea, consult your doctor, who may decide to reduce the dose or discontinue treatment.
Other medicines and ACIDO URSODESOSSICOLICO DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Avoid taking ACIDO URSODESOSSICOLICO DOC Generici together with the following medicines, as they may interfere with or be affected by ursodeoxycholic acid treatment:
- bile acid sequestrants used to lower cholesterol levels, such as cholestyramine and colestipol, or antacids containing aluminium hydroxide and/or smectite (aluminium oxide). If concomitant use is necessary, these medicines should be taken at least 2 hours before or after ACIDO URSODESOSSICOLICO DOC Generici.
- cyclosporine, a medicine that suppresses the immune system. In this case, your doctor must monitor cyclosporine blood levels and adjust the dose if necessary;
- ciprofloxacin and dapsone, antibiotics used to treat infections;
- nitrendipine, a medicine used to lower blood pressure, for which an increased dose may be required;
- estrogens and agents that lower blood cholesterol, such as clofibrate, as they may promote gallstone formation;
- medicines that are harmful to the liver (hepatotoxic);
- rosuvastatin, a medicine used to lower blood cholesterol, because rosuvastatin blood levels may increase.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not use this medicine during pregnancy unless strictly necessary. Before starting treatment, ensure that you are not pregnant.
If you are of childbearing age, you may begin treatment only if you are using a reliable contraceptive method (non-hormonal contraceptives or low-estrogen oral contraceptives).
If you are undergoing treatment for gallstone dissolution, use an effective non-hormonal contraceptive, as hormonal oral contraceptives may increase the risk of gallstone formation.
Driving and using machines
This medicine does not impair your ability to drive vehicles or operate machinery.
3. How to take ACIDO URSODESOSSICOLICO DOC Generici
Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Treatment of gallstones: to prevent the formation of gallstones, the recommended daily dose is
450 mg per day, for long-term treatment. In obese patients and in those with stones larger than 2 cm
in diameter, higher doses may be used, up to 675 mg.
Take the medicine as a single dose in the evening, before going to bed.
To maintain conditions suitable for dissolving existing stones, treatment should last
at least 4–6 months, which may be extended up to 9 months or longer, continuously, and should be
continued for 3–4 months after radiological or ultrasonographic disappearance of the stones. However, treatment
should not exceed 2 years.
Treatment of dyspepsia and maintenance therapy: lower doses of 225 mg per day are sufficient.
Use in children
This medicine is not intended for use in children.
If you take more ACIDO URSODESOSSICOLICO DOC Generici than you should
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital.
Diarrhea may occur in case of overdose. Generally, other symptoms of overdose are unlikely, since the absorption of ursodeoxycholic acid decreases as the dose increases, and therefore more is excreted in the feces.
Treatment of overdose includes fluid and electrolyte replacement. In case of accidental ingestion of very high doses of ursodeoxycholic acid, administration of cholestyramine is recommended, as it is capable of binding bile acids.
If you forget to take ACIDO URSODESOSSICOLICO DOC Generici
Do not take a double dose to make up for a missed dose. Take the next dose at the scheduled time.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur:
Very common (may affect more than 1 in 10 people)
- soft stools or diarrhoea.
Very rare (may affect up to 1 in 10,000 people)
- calcification of gallstones;
- 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 the website: http://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 URSODESOXYCHOLIC ACID DOC GENERICS
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 carton and on the blister after
“Expiry”.
The expiry date refers to the last day of that month.
The expiry date applies to the product in its original, unopened packaging, correctly stored.
This medicine does not require any special storage conditions.
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 DOC Generici 450 mg modified-release hard capsules contains
- The active substance is ursodeoxycholic acid. Each capsule contains 450 mg of ursodeoxycholic acid (UDCA).
- The other components are: hydroxypropylcellulose; microcrystalline cellulose.
- Capsule components: gelatin; titanium dioxide.
Description of the appearance of ACIDO URSODESOSSICOLICO DOC Generici and contents of the
packaging
Box containing 20 modified-release hard capsules of 450 mg.
Marketing Authorization Holder
DOC Generici Srl - Via Turati 40 - 20121 Milano - Italy
Manufacturer
ABC Farmaceutici S.p.A. – Via Cantone Moretti 29 (località San Bernardo) - 10090 Ivrea (TO) - Italy