Package leaflet: Information for the patient

URSONON FORTE 450 mg prolonged-release hard capsules

Ursodeoxycholic acid
Generic medicine
Please read all of 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ACIDO URSODESOSSICOLICO EG STADA is and what it is used for

ACIDO URSODESOSSICOLICO EG STADA is a preparation based on naturally occurring bile acids present in the body, capable of solubilizing cholesterol in bile.
This medicinal product 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-ray (radiolucent stones); in particular, cholesterol gallstones in the gallbladder (with functioning gallbladder) and gallstones in the bile duct.
It is also used to treat digestive problems caused by gallbladder dysfunction (biliary dyspepsia).

2. What you should know before taking ACIDO URSODESOSSICOLICO EG STADA

Do not take ACIDO URSODESOSSICOLICO EG STADA

if you are allergic 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 or cystic bile duct);
if you frequently suffer from upper abdominal pain (biliary colic);
if you have calcified gallstones visible on X-ray;
if you have reduced gallbladder motility;
if you are pregnant or breastfeeding;
if you have active gastric or intestinal lesions (gastric or duodenal ulcer);
if you have severe pancreatic or intestinal disorders that may affect the circulation of bile salts.

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, your doctor will prescribe blood tests to monitor your liver function.
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. This allows assessment of your response to therapy (in primary biliary cirrhosis) and early detection of potential liver damage.
When treating gallstones, an ultrasound imaging of the gallbladder (oral cholecystography) should be performed 6–10 months after starting treatment to evaluate improvement.
Contact your doctor if, after starting treatment for primary biliary cirrhosis, you experience worsening symptoms such as itching. In this case, your doctor may reduce the dose of ursodeoxycholic acid and then gradually increase it again.
If you experience diarrhea, consult your doctor, who may decide to reduce the dose or discontinue treatment.
This medicine is not suitable for treating all types of gallstones; those most likely to dissolve are radiolucent (not visible on X-ray), small stones in a functioning gallbladder.

Other medicines and ACIDO URSODESOSSICOLICO EG STADA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Avoid taking ACIDO URSODESOSSICOLICO EG STADA together with the following medicines, as their efficacy may be reduced:

bile acid sequestrants used to lower cholesterol levels, such as cholestyramine and colestipol, or antacids containing aluminum hydroxide and/or smectite (aluminum oxide), as they reduce its effectiveness. If these medicines are required, they should be taken at least 2 hours before or after ACIDO URSODESOSSICOLICO EG STADA;
cyclosporine, a medicine that suppresses the immune system. In this case, your doctor must monitor its blood levels and adjust the dose accordingly;
ciprofloxacin and dapsone, antibiotics used to treat infections;
nitrendipine, a medicine used to lower blood pressure, in which case a higher dose may be needed;
estrogens and cholesterol-lowering agents such as clofibrate, which may promote gallstone formation;
medicines that are harmful to the liver (hepatotoxic).

Additionally, inform your doctor if you are taking rosuvastatin, a medicine used to lower blood cholesterol.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are of childbearing age, you may only start treatment if you are using a reliable contraceptive method (non-hormonal 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.
Do not take this medicine during pregnancy unless absolutely necessary. Before starting treatment, ensure you are not pregnant.
Do not take this medicine while breastfeeding. If treatment with this medicine is necessary, discontinue breastfeeding.

Driving and using machines
This medicine has no effect or has a negligible effect on the ability to drive vehicles or operate machinery.

3. How to take ACIDO URSODESOSSICOLICO EG STADA

Take this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Your doctor will adjust the dosage according to your clinical condition and your tolerance to the medicine.

Treatment of gallstones: to prevent the formation of gallstones, the recommended daily dose is 450 mg per day, for long-term treatment. Higher doses are used in obese patients and in patients with gallstones larger than 2 cm in diameter.
To maintain conditions suitable for dissolving existing gallstones, treatment should last at least 4–6 months, and may extend up to 9 months or longer, continuously, and should be continued for 3–4 months after radiological or ultrasonographic disappearance of the gallstones. However, treatment must not exceed 2 years.

Treatment of dyspepsia and maintenance therapy: in biliary dyspepsia or maintenance therapies, doses should be spaced apart.
Take the medicine as a single dose in the evening, before going to bed.

Use in children
This medicine is not intended for use in children.

If you take more ACIDO URSODESOSSICOLICO EG STADA than you should
In case of overdose, diarrhea may occur. Generally, other symptoms of overdose are unlikely, as the absorption of ursodeoxycholic acid decreases with increasing dose, and therefore more is excreted in the feces.
If an excessive dose is accidentally ingested, inform your doctor immediately or go to the nearest hospital.

If you forget to take ACIDO URSODESOSSICOLICO EG STADA
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 everyone experiences them.
The following side effects may occur:
Common (may affect up to 1 in 10 people)

soft stools or diarrhoea.

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

severe pain in the upper right abdominal quadrant;
calcification of gallstones;
serious liver problems (hepatic cirrhosis), which partially improves upon discontinuation of therapy;
urticaria.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist.
You may also report side effects directly through the national reporting system at the following 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 EG STADA

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 and to the product in its original, unopened 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. Package contents and other information

What ACIDO URSODESOSSICOLICO EG STADA 450 mg prolonged-release hard capsules contain

The active substance is ursodeoxycholic acid. Each capsule contains 450 mg of ursodeoxycholic acid.
The other components are: polyvinylpyrrolidone, polysorbate 80, eudragit "L", talc. Capsule components: titanium dioxide, gelatin.

Description of the appearance of ACIDO URSODESOSSICOLICO EG STADA and package contents
Box containing 20 prolonged-release hard capsules.
Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 20136 Milan - Italy
Manufacturer
Fine Foods & Pharmaceuticals NTM S.p.A., via Follereau, 25 24027 Nembro (BG) - Italy