Adisocol 500 mg hard capsules EFG
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Adisocol 500 mg hard capsules EFG
ursodeoxycholic acid
Read this entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again. If you have any questions, consult your doctor.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if these are adverse reactions not listed in this leaflet. See section 4.
Contents of the leaflet
- What Adisocol is and what it is used for
- What you need to know before taking Adisocol
- How to take Adisocol
- Possible side effects
- How to store Adisocol
- Contents of the pack and other information
1. What Adisocol is and what it is used for
Ursodeoxycholic acid is a natural bile acid. Small amounts are found in human bile.
Adisocol is used:
- for the treatment of a disease in which the bile ducts of the liver are damaged, causing bile to accumulate. This may lead to scarring of the liver. The liver must not be so damaged that it no longer functions properly. This disease is called primary biliary cholangitis (PBC);
- to dissolve cholesterol-rich gallstones in the gallbladder when the gallstones are not visible on plain X-ray (gallstones that are visible on X-ray do not dissolve) and are no larger than 2 cm in diameter. This medicine may be used in patients whose gallbladder functions properly despite the presence of gallstones, in patients who refuse surgery, for whom surgical procedures are not indicated, or in patients who have very high levels of cholesterol in the bile;
- as an adjunct before and after fragmentation of gallstones (lithotripsy);
- for liver disease associated with a condition called cystic fibrosis in children aged 6 to 18 years.
2. What you need to know before taking Adisocol
Do not take Adisocol if:
- you are or have been told you are allergic (hypersensitive) to bile acids such as ursodiol (ursodeoxycholic acid) or to any of the other ingredients of this medicine (listed in section 6);
- your gallbladder is not functioning properly;
- your doctor has told you that you have calcified gallstones (visible on X-ray);
- you have acute inflammation of the gallbladder or biliary tract;
- you have an obstruction of the common bile duct or cystic duct (biliary tract obstruction);
- you have frequent cramp-like pain in the upper abdomen (biliary colic);
- you are a child with biliary atresia (closure of the bile ducts) and have insufficient bile flow, even after surgery;
- you have active gastric or duodenal ulcers.
Consult your doctor about any of the conditions listed above. You should also ask if you have previously suffered from any of these diseases or if you are unsure whether you have any of them.
Warnings and precautions
Talk to your doctor or pharmacist before starting to take this medicine.
Your doctor should check your liver function regularly every 4 weeks during the first 3 months of treatment. After this period, monitoring should continue at 3-month intervals.
If you are a woman taking this medicine to dissolve gallstones, you should use effective non-hormonal contraception, as hormonal contraceptives (the “pill”) may promote gallstone formation.
When used in the treatment of PBC, symptoms may rarely worsen at the beginning of treatment. If this occurs, speak with your doctor, who may reduce your initial dose.
When used to dissolve gallstones, your doctor should schedule an examination of the gallbladder after the first 6–10 months of treatment.
Inform your doctor immediately if you develop diarrhea, as it may be necessary to reduce the dose or discontinue treatment.
Other medicines and Adisocol
The effects of the following medicines may be altered:
Reduced effects of the following medicines may occur when taking ursodeoxycholic acid hard capsules:
- cholestyramine, colestipol (used to lower blood lipids), or antacids containing aluminum hydroxide or smectite (aluminum oxide). If you need to take any medicine containing these ingredients, you should take it at least two hours before or after ursodeoxycholic acid.
- ciprofloxacin and dapsone (antibiotics), nitrendipine (used to treat high blood pressure). Your doctor may need to adjust the dose of these medicines.
Changes in effects may occur with the following medicines when taking ursodeoxycholic acid hard capsules:
- cyclosporine (used to reduce immune system activity). If you are being treated with cyclosporine, your doctor should monitor the level of cyclosporine in your blood and adjust the dose if necessary.
- rosuvastatin (for high cholesterol and related conditions).
If you are taking this medicine to dissolve gallstones, inform your doctor if you are taking medications containing estrogens (found in the “pill” and also used during menopause) or clofibrate (used to reduce blood cholesterol levels). These medicines may promote gallstone formation and thereby reduce the effectiveness of this medicine.
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those not requiring a prescription.
Nevertheless, treatment with ursodeoxycholic acid may still be allowed. Your doctor will know what is most appropriate for you.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
Pregnancy: You should not take ursodeoxycholic acid during pregnancy unless your doctor considers it absolutely necessary.
Women of childbearing potential: Women of childbearing age who take this medicine to dissolve gallstones should use effective non-hormonal contraception or oral contraceptives with low estrogen content, as hormonal contraceptives may promote gallstone formation.
Breastfeeding: Based on the limited number of documented cases in breastfeeding women, levels of ursodeoxycholic acid in breast milk are very low and adverse effects in breastfed infants are unlikely. Inform your doctor if you are breastfeeding or intend to breastfeed.
Driving and using machines
No special precautions are required.
3. How to take Adisocol
Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.
Ursodeoxycholic acid suspension is available if you require a lower dose or if you cannot swallow capsules.
For primary biliary cirrhosis (chronic inflammation of the bile ducts)
Dosage
Stages I-III
The daily dose depends on body weight. During the first 3 months of treatment, you should take ursodeoxycholic acid in the morning, at midday, and in the evening. As liver function values improve, the total daily dose may be taken once daily at night.
Body weight BW (kg) | Adisocol 250 mg hard capsules EFG | |||
First 3 months | Thereafter | |||
Morning | Afternoon | Night | Night (once daily) | |
47 – 62 | 1 | 1 | 1 | 3 |
63 – 78 | 1 | 1 | 2 | 4 |
79 – 93 | 1 | 2 | 2 | 5 |
94 – 109 | 2 | 2 | 2 | 6 |
more than 110 | 2 | 2 | 3 | 7 |
Body weight BW (kg) |
Daily dose (mg/kg BW) |
Adisocol 500 mg hard capsules EFG |
|||
First 3 months |
Subsequently |
||||
Morning |
Afternoon |
Night |
Night (once daily) |
||
47 – 62 |
12-16 |
Use a lower dose (250 mg capsule) |
1 + Co-prescription of one 250 mg Adisocol capsule |
||
63 – 78 |
13-16 |
Use a lower dose (250 mg capsule) |
Use a lower dose (250 mg capsule) |
1 |
2 |
79 – 93 |
13-16 |
Use a lower dose (250 mg capsule) |
1 |
1 |
2 + Co-prescription of one 250 mg Adisocol capsule |
94 – 109 |
14-16 |
1 |
1 |
1 |
3 |
over 110 |
1 |
1 |
1 + Co-prescription of one 250 mg Adisocol capsule |
3 + Co-prescription of one 250 mg Adisocol capsule |
Stage IV
Primary biliary cirrhosis Stage IV | ||
Daily dose (Adisocol 250 mg hard capsules EFG) | Adisocol 250 mg hard capsules EFG | |
Morning | Night | |
2 capsules | 1 | 1 |
3 capsules | 1 | 2 |
If serum bilirubin levels increase, you will be given half the normal dose (see dosing for stages I-III). Your doctor will continuously monitor your liver function; if there is no deterioration in liver function over time, the dose may be increased and maintained at the normal dose.
Patients without increased serum bilirubin levels may receive the normal initial dose immediately (see dosing for stages I-III). However, close monitoring of liver function will also be applied in these cases.
How to take Adisocol
Swallow the capsules whole with a glass of water or another liquid. Take your medication regularly.
Duration of treatment
The duration of treatment depends on your doctor's recommendations and your response to treatment, which may require regular blood tests.
This medication will be continued in the treatment of liver damage caused by reduced bile flow (primary biliary cholangitis) and liver and biliary tract disorders associated with cystic fibrosis, in order to maintain the protective effect of ursodeoxycholic acid.
If you feel that the effect of this medicine is too strong or too weak, consult your doctor or pharmacist.
For dissolving cholesterol gallstones (with or without gallstone fragmentation)**
Dosage
The recommended daily dose is 8–10 mg/kg of body weight of ursodeoxycholic acid, equivalent to:
Body weight (kg) | Adisocol 250 mg hard capsules EFG | Adisocol 500 mg hard capsules EFG |
< 60 kg | 2 | 1 |
61-80 kg | 3 | 1 + 250 mg capsule |
81-100 kg | 4 | 2 |
> 100 kg | 5 | 2 + 250 mg capsule |
The dose should be divided into two administrations, after breakfast and after dinner, with one dose always taken after dinner
OR
The capsule(s) should be taken at night before going to bed.
How to take Adisocol
Swallow the capsules whole with a glass of water or other liquid. Take your medication regularly.
Duration of treatment
Dissolution of gallstones usually takes between 6 and 24 months. If there is no reduction in the size of the gallstones after 12 months, the treatment should be discontinued.
Every 6 months, your doctor should check whether the treatment is working. At each of these follow-up examinations, it should be verified whether calcium accumulation has occurred since the last examination, which could lead to hardening of the stones. If this occurs, your doctor will discontinue the treatment.
Even if your symptoms have disappeared, you must continue the treatment: stopping the treatment will prolong the total duration of therapy. After dissolution of the gallstones, the treatment should be continued for 3–4 months.
Both indications
Use in elderly patients:
There is no evidence suggesting the need to alter the adult dose; however, your doctor will take into account your age and general health status.
Use in children and adolescents:
The administration of ursodeoxycholic acid is based on body weight and the disease being treated.
Use in children (6 to 18 years) for the treatment of liver disease associated with cystic fibrosis
Dosage
The recommended daily dose is 20 mg per kg of body weight, divided into 2–3 doses. If necessary, your doctor may increase the dose to 30 mg per kg of body weight per day.
Body weight BW [kg] | Daily dose [mg/kg BW] | Adisocol 250 mg hard capsules EFG | ||
Morning | Midday | Night | ||
20 – 29 | 17-25 | 1 | -- | 1 |
30 – 39 | 19-25 | 1 | 1 | 1 |
40 – 49 | 20-25 | 1 | 1 | 2 |
50 – 59 | 21-25 | 1 | 2 | 2 |
60 – 69 | 22-25 | 2 | 2 | 2 |
70 – 79 | 22-25 | 2 | 2 | 3 |
80 – 89 | 22-25 | 2 | 3 | 3 |
90 – 99 | 23-25 | 3 | 3 | 3 |
100 – 109 | 23-25 | 3 | 3 | 4 |
>110 | 3 | 4 | 4 |
Body weight BW [kg] | Daily dose [mg/kg BW] | Adisocol 500 mg hard capsules EFG | ||
Morning | Midday | Night | ||
20 – 29 | 17-25 | Use a lower dose (250 mg capsule) | -- | Use a lower dose (250 mg capsule) |
30 – 39 | 19-25 | Use a lower dose (250 mg capsule) | Use a lower dose (250 mg capsule) | Use a lower dose (250 mg capsule) |
40 – 49 | 20-25 | Use a lower dose (250 mg capsule) | Use a lower dose (250 mg capsule) | 1 |
50 – 59 | 21-25 | Use a lower dose (250 mg capsule) | 1 | 1 |
60 – 69 | 22-25 | 1 | 1 | 1 |
70 – 79 | 22-25 | 1 | 1 | 1 + Co-prescription of one 250 mg Adisocol capsule |
80 – 89 | 22-25 | 1 | 1 + Co-prescription of one 250 mg Adisocol capsule | 1 + Co-prescription of one 250 mg Adisocol capsule |
90 – 99 | 23-25 | 1 + Co-prescription of one 250 mg Adisocol capsule | 1 + Co-prescription of one 250 mg Adisocol capsule | 1 + Co-prescription of one 250 mg Adisocol capsule |
100 – 109 | 23-25 | 1 + Co-prescription of one 250 mg Adisocol capsule | 1 + Co-prescription of one 250 mg Adisocol capsule | 2 |
>110 | 1 + Co-prescription of one 250 mg Adisocol capsule | 2 | 2 |
How to take Adisocol
Take the capsules two to three times a day, as recommended. Take the capsules regularly.
If you have difficulty swallowing the capsule due to its size, the capsule may be opened and its contents mixed with yoghurt, for example.
If you feel that the effect of this medicine is too strong or too weak, consult your doctor or pharmacist.
If you take more Adisocol than you should
Diarrhoea may occur as a result of an overdose. Inform your doctor immediately if you experience persistent diarrhoea. If you develop diarrhoea, make sure you drink enough fluids to restore the balance of fluids and salts (electrolytes).
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take Adisocol
Do not take extra capsules next time; simply continue treatment with the prescribed dose.
If you stop taking Adisocol
Always consult your doctor before deciding to discontinue treatment with this medicine or deciding to stop treatment prematurely.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Frequent adverse effects (may affect up to 1 in 10 people):
- soft stools or diarrhoea. Inform your doctor immediately if you have persistent diarrhoea, as it may be necessary to reduce your medicine dose. If you experience diarrhoea, make sure you drink enough fluids to restore the balance of liquids and salts.
Very rare adverse effects (may affect up to 1 in 10,000 people):
- during treatment of CBP: severe upper right abdominal pain, serious worsening of liver scarring, which partially resolves after stopping treatment.
- hardening of gallstones due to calcium accumulation. This causes no additional symptoms but will show up in laboratory tests.
- rash (urticaria).
Frequency not known (cannot be estimated from available data):
- pruritus.
- nausea, vomiting.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Adisocol
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 carton and container following “EXP”. The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Adisocol
The active substance is ursodeoxycholic acid. One capsule contains 500 mg of ursodeoxycholic acid.
The other components are:
(contents of the capsule): colloidal anhydrous silica, magnesium stearate and maize starch.
(capsule shell): gelatin and titanium dioxide (E171).
Appearance of the product and pack contents
Adisocol 500 mg hard capsules are size 00 with a white cap and body filled with a homogeneous white powder.
Adisocol 500 mg hard capsules EFG are available in packs of 20, 30, 50, 60 or 100 capsules.
Only some pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer:
Marketing Authorization Holder:
Glenmark Arzneimittel GmbH
Industriestr. 31
82194 Gröbenzell
Germany
Manufacturer:
ICE S.p.A.
Cantone Moretti, 29
10015 Ivrea
Italy
Glenmark Pharmaceuticals s.r.o.
Fibichova 143
566 17 Vysoké Mýto
Czech Republic
Further information on this medicinal product can be obtained by contacting the local representative of the Marketing Authorization Holder:
Glenmark Farmacéutica, S.L.U.
C/ Retama 7, 7th Floor
28045 Madrid
Spain
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Country | Medicinal product name |
Austria | Ursodeoxycholsäure Pharmaceutical Innovation 500 mg Hard Capsules |
Bulgaria | Urzodeoxycholeva kiselina PI 500 mg tvardi kapsuli |
Spain | Adisocol 500 mg hard capsules EFG |
Greece | Ursodeoxycholic acid/Pharmaceutical Innovation |
Netherlands | Ursodeoxycholzuur PI 500 mg harde capsules |
Poland | Kwas ursodeoksycholowy Pharmaceutical Innovation |
Portugal | Ursodeoxycholic acid 500 mg hard capsules |
Romania | Acid ursodeoxicolic Pharmaceutical Innovation 500 mg capsule |
Date of last review of this leaflet: October 2025
Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).