ADISOCOL 500 MG HARD CAPSULES
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How to use ADISOCOL 500 MG HARD CAPSULES
Introduction
Package Leaflet: Information for the Patient
Adisocol 500 mg Hard Capsules EFG
Ursodeoxycholic Acid
Read this package leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this package leaflet, you may need to read it again. If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.
Contents of the Package Leaflet
- What is Adisocol and what is it used for
- What you need to know before you take Adisocol
- How to take Adisocol
- Possible side effects
- Storage of Adisocol
- Package Contents and Further Information
1. What is Adisocol and what is it used for
Ursodeoxycholic acid is a naturally occurring bile acid. It is found in small amounts in human bile.
Adisocolis used:
- for the treatment of a disease in which the bile ducts of the liver are damaged, leading to a buildup of bile. This can cause scarring of the liver. The liver should not be so damaged that it does not function properly. This disease is called primary biliary cirrhosis (PBC);
- to dissolve cholesterol gallstones in the gallbladder when the stones are not visible on a simple X-ray (visible stones do not dissolve) and are not larger than 15 mm in diameter. The gallbladder should still be functioning despite the gallstones.
- for liver disease associated with a condition called cystic fibrosis in children aged 6 to 18 years.
2. What you need to know before you take Adisocol
Do not take Adisocol if:
- you are or have been told you are allergic (hypersensitive) to bile acids such as ursodeoxycholic acid or any of the other ingredients of this medicine (listed in section 6);
- your gallbladder does not function properly;
- your doctor has told you that you have calcified gallstones (visible on an X-ray);
- you have acute inflammation of the gallbladder or bile duct;
- you have a blockage of the common bile duct or cystic duct (obstruction of the bile ducts);
- you have frequent pains in the upper abdomen, similar to cramps (biliary colic);
- you are a child with a closure of the bile ducts (biliary atresia) and have a deficient bile flow, even after surgery.
Talk to your doctor about any of the above conditions. You should also ask if you have previously had any of these conditions or if you are unsure if you have any of them.
Warnings and Precautions
Talk to your doctor or pharmacist before you start taking this medicine.
Your doctor should check your liver function regularly every 4 weeks during the first 3 months of treatment. After this time, it should be checked at 3-month intervals.
If you are a woman and are taking this medicine to dissolve gallstones, you should use effective non-hormonal contraceptives, as hormonal contraceptives (the "pill") may promote the formation of gallstones.
When used to treat PBC, the symptoms may rarely worsen at the start of treatment. If this happens, talk to your doctor so that they can reduce the initial dose.
When used to dissolve gallstones, your doctor should schedule a gallbladder examination after the first 6-10 months of treatment.
Tell your doctor immediately if you have diarrhea, as it may be necessary to reduce the dose or stop treatment.
Other Medicines and Adisocol
The effects of these medicines may be altered:
It is possible that the effectsof the following medicines are reducedwhen taking ursodeoxycholic acid:
- cholestyramine, colestipol (to reduce blood lipids) or antacids containing aluminum hydroxide or smectite (aluminum oxide). If you need to take any medicine that contains any of these ingredients, you should take it at least 2 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.
It is possible that the effectsof the following medicines are alteredwhen taking this medicine:
- cyclosporin (to reduce the activity of the immune system). If you are being treated with cyclosporin, your doctor should check the amount of cyclosporin in your blood. Your doctor will adjust the dose if necessary.
- rosuvastatin (for high cholesterol and related conditions).
Please tell your doctor if you are taking any cholesterol-lowering agents such as clofibrate or estrogen-containing medicines; especially if you are taking ursodeoxycholic acid for the dissolution of gallstones, as they may stimulate the formation of gallstones.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
Treatment with ursodeoxycholic acid may still be allowed. Your doctor will know what is best for you.
Pregnancy, Breast-feeding, and Fertility
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy:You should not take ursodeoxycholic acid during pregnancy unless your doctor considers it absolutely necessary.
Women of Childbearing Age:Women of childbearing age who take this medicine to dissolve gallstones should use effective non-hormonal or low-estrogen contraceptives. Women of childbearing age who take this medicine to dissolve gallstones should use an effective non-hormonal contraceptive, as hormonal contraceptives may promote the formation of gallstones.
Breast-feeding:According to the few documented cases of breast-feeding women, the levels of ursodeoxycholic acid in milk are very low and it is unlikely that you will expect adverse reactions in breast-fed infants. Tell your doctor if you are breast-feeding or about to start breast-feeding.
Driving and Using Machines
No special precautions are needed.
3. How to take Adisocol
Follow the administration instructions for this medication exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.
Ursodeoxycholic acid is available in suspension if you need a lower dose or if you cannot swallow the 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 noon, and at night. As liver function values improve, the total daily dose may be taken once a day at night.
Body weight (kg) | Adisocol 250 mg hard capsules | |||
First 3 months | Subsequently | |||
Morning | Afternoon | Night | Night (once a day) | |
47 – 62 | 1 | 1 | 1 | 3 |
63 – 78 | 1 | 1 | 2 | 4 |
79 – 93 | 1 | 2 | 2 | 5 |
94 – 109 | 2 | 2 | 2 | 6 |
over 110 | 2 | 2 | 3 | 7 |
Body weight (kg) | Daily dose (mg/kg body weight) | Adisocol 500 mg hard capsules | |||
First 3 months | Subsequently | ||||
Morning | Afternoon | Night | Night (once a day) | ||
47 – 62 | 12-16 | Use a lower dose (250 mg capsule) | 1 + Co-prescription of a 250 mg ursodeoxycholic acid 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 a 250 mg ursodeoxycholic acid capsule |
94 – 109 | 14-16 | 1 | 1 | 1 | 3 |
over 110 | 1 | 1 | 1 + Co-prescription of a 250 mg ursodeoxycholic acid capsule | 3 + Co-prescription of a 250 mg ursodeoxycholic acid capsule |
Stage IV
Primary biliary cirrhosis Stage IV | ||
Daily dose (ursodeoxycholic acid 250 mg hard capsules) | Ursodeoxycholic acid 250 mg hard capsules | |
Morning | Night | |
2 capsules | 1 | 1 |
3 capsules | 1 | 2 |
If serum bilirubin levels increase, you will be given half the normal dose (see dosage 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 an increase in serum bilirubin levels may receive the normal initial dose immediately (see dosage 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 other liquid. Take your medications regularly.
Duration of treatment
Ursodeoxycholic acid may be continued indefinitely in cases of PBC.
To dissolve cholesterol gallstones
Dosage
The recommended daily dose is 8-10 mg/kg body weight of ursodeoxycholic acid, equivalent to:
Body weight (kg) | Adisocol 250 mg hard capsules | Adisocol 500 mg hard capsules |
< 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 doses after breakfast and dinner, with one dose always after dinner
Or
The capsule(s) should be taken at night before bedtime.
The capsules should be taken regularly.
How to take Adisocol
Swallow the capsules whole with a glass of water or other liquid. Take the capsules at night before bedtime. Take your medications regularly.
Duration of treatment
Dissolution of gallstones usually takes between 6 and 24 months. If the size of the gallstones does not decrease after 12 months, treatment should be discontinued.
Every 6 months, your doctor should check if the treatment is working. In each of these follow-up exams, it should be checked if there has been an accumulation of calcium that causes the gallstones to harden since the last time. If this occurs, your doctor will discontinue treatment.
Even if your symptoms have disappeared, you should continue treatment: discontinuing treatment leads to prolongation of the total duration of treatment. After dissolution of the gallstones, treatment should be continued for 3-4 months.
Both indications
Use in elderly patients:
There is no evidence to suggest that the dose needs to be altered for adults, but your doctor will take your age and health status into account.
Use in children and adolescents
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 body weight, divided into 2-3 doses. If necessary, your doctor may increase the dose to 30 mg per kg body weight per day.
Body weight (kg) | Daily dose (mg/kg body weight) | Adisocol 250 mg hard capsules | ||
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 (kg) | Daily dose (mg/kg body weight) | Adisocol 500 mg hard capsules | ||
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 a 250 mg ursodeoxycholic acid capsule |
80 – 89 | 22-25 | 1 | 1 + Co-prescription of a 250 mg ursodeoxycholic acid capsule | 1 + Co-prescription of a 250 mg ursodeoxycholic acid capsule |
90 – 99 | 23-25 | 1 + Co-prescription of a 250 mg ursodeoxycholic acid capsule | 1 + Co-prescription of a 250 mg ursodeoxycholic acid capsule | 1 + Co-prescription of a 250 mg ursodeoxycholic acid capsule |
100 – 109 | 23-25 | 1 + Co-prescription of a 250 mg ursodeoxycholic acid capsule | 1 + Co-prescription of a 250 mg ursodeoxycholic acid capsule | 2 |
>110 | 1 + Co-prescription of a 250 mg ursodeoxycholic acid capsule | 2 | 2 |
How to take Adisocol
Take the capsules two to three times a day, as recommended. Take the capsules regularly.
If you feel that the effect of this medication is too strong or too weak, consult your doctor or pharmacist.
If you take more Adisocol than you should
Diarrhea may occur as a result of an overdose. Inform your doctor immediately if you have persistent diarrhea. If you suffer from diarrhea, make sure to drink enough fluids to restore fluid and electrolyte balance.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.
If you forget to take Adisocol
Do not take more capsules the next time, just continue treatment with the prescribed dose.
If you stop taking Adisocol
Always consult your doctor before deciding to stop treatment with this medication or deciding to stop treatment prematurely.
If you have any other questions about the use of this medication, ask your doctor or pharmacist.
4. Possible side effects
Like all medications, this medication can cause side effects, although not everyone will experience them.
Common side effects(may affect up to 1 in 10 people):
- soft and loose stools or diarrhea. Inform your doctor immediately if you have persistent diarrhea, as it may be necessary to reduce the dose of your medication. If you suffer from diarrhea, make sure to drink enough fluids to restore fluid and electrolyte balance.
Very rare side effects(may affect up to 1 in 10,000 people):
- during treatment of PBC: severe upper right abdominal pain, severe worsening of liver scarring, which partially subsides after treatment is discontinued.
- hardening of gallstones due to calcium accumulation. It does not present additional symptoms, but it will appear in the analyses.
- hives (urticaria).
Reporting side effects
If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.
5. Storage of Adisocol
Keep this medication out of the sight and reach of children.
This medication does not require special storage conditions.
Do not use this medication after the expiration date shown on the box and on the packaging after "EXP". The expiration date is the last day of the month indicated.
Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.
6. Package contents and additional information
Composition of Adisocol
The active ingredient is ursodeoxycholic acid. One capsule contains 500 mg of ursodeoxycholic acid.
The other ingredients are:
(capsule contents): colloidal anhydrous silica, magnesium stearate, cornstarch.
(capsule shell): gelatin, titanium dioxide (E171).
Appearance of the product and package contents
Adisocol 500 mg hard capsules are size 00 with a white cap and a body filled with a homogeneous white powder.
Adisocol 500 mg hard capsules EFG are available in packages of 20, 30, 50, 60, or 100 capsules.
Only some package sizes may be marketed.
Marketing authorization holder and manufacturer:
Marketing authorization holder
Glenmark Arzneimittel GmbH
Industriestr. 31
82194 Gröbenzell
Germany
Manufacturer
ABC Farmaceutici S.P.A.
Via Cantone Moretti 29
10015 – Ivrea
Italy
You can request more information about this medication from the local representative of the marketing authorization holder:
Glenmark Farmacéutica, S.L.U.
C/ Retama 7, 7ª Planta
28045 Madrid
Spain
This medication is authorized in the Member States of the European Economic Area under the following names:
Country | Medication name |
Austria | Ursodeoxycholsäure Pharmaceutical Innovation 500 mg Hartkapseln |
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 | Ursodeoxicocólico 500 mg hard capsules |
Romania | Acid ursodeoxicolic Pharmaceutical Innovation 500 mg capsule |
Date of the last revision of this leaflet:May 2024
Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es).
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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