URSACOL 50 mg Таблетки
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Инструкция по применению URSAKOL
Содержание инструкции
URSACOL 50 mg tablets, 150 mg tablets, 300 mg tablets, 450 mg modified-release tablets
Ursodeoxycholic acid
Read this leaflet carefully before you start 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What URSACOL is and what it is used for
- 2. What you need to know before you take URSACOL
- 3. How to take URSACOL
- 4. Possible side effects
- 5. How to store URSACOL
- 6. Contents of the pack and other information
1. What is URSACOL and what is it used for
URSACOL is a preparation based on bile acids naturally present in the body, which is able to
solubilize cholesterol in bile.
This medicine is used to treat alterations (both in composition and quantity) in the
production of bile by the liver and to improve the solubility of cholesterol, both to prevent the
formation of cholesterol stones and to facilitate their dissolution. This medicine is not effective
against all types of stones, but only against those not visible on X-rays (radiotransparent), in particular,
cholesterol stones in the gallbladder (functioning gallbladder) and stones in the bile duct.
It is also used to treat digestive problems due to dysfunction of the gallbladder (biliary dyspepsia).
2. What you need to know before taking URSACOL
Do not take URSACOL
- 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 an 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 pain in the upper abdomen (biliary colic);
- if you have calcified gallstones visible on X-rays;
- if you suffer from reduced motility of the gallbladder (cholecystitis);
- if you are pregnant or breastfeeding;
- if you suffer from lesions of the stomach or intestine (gastric or duodenal ulcer) in an active phase;
- if you have problems with the liver (severe hepatopathy) or kidneys;
- if you have a yellowish discoloration of the skin (obstructive jaundice);
- if you have severe alterations to the pancreas or intestine that may alter the blood circulation of bile salts;
- If the person who is to take this medicine is a child.
Warnings and precautions
Consult your doctor or pharmacist before taking this medicine.
Treatment with this medicine must occur under strict medical supervision.
During the first 3 months of treatment with this medicine, your doctor will check your liver function parameters every 4 weeks (checking transaminases and alkaline phosphatase). And subsequently every 3 months. This allows you to assess your response to therapy (for primary biliary cirrhosis) and to diagnose potential liver damage.
In the treatment of dissolving gallstones, you will need to perform a visualization of the gallbladder (oral cholecystography) via ultrasound, 6-10 months after starting treatment, to assess the improvement of your condition.
Before starting long-term therapy, the doctor will monitor your liver function (checking transaminases and alkaline phosphatase).
Consult your doctor if, after starting treatment for advanced primary biliary cirrhosis, you experience an increase in symptoms such as itching. In this case, the dose of ursodeoxycholic acid must be reduced and then gradually increased (see section 3).
If you have problems with diarrhea, consult your doctor, who may decide to reduce the dose or stop therapy.
This medicine is not suitable for the treatment of all types of gallstones; those that have a higher probability of dissolving are those that are not visible on X-rays (radiotransparent) and of small size in a functioning gallbladder.
Other medicines and URSACOL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take URSACOL together with the following medicines:
- bile acid sequestrants, used to lower cholesterol levels such as cholestyramine and colestipol or antacids containing aluminum hydroxide and/or smectite (aluminum oxide), because they reduce the effectiveness of this medicine. If the use of such medicines is necessary, they must be taken 2 hours before or after taking URSACOL;
- cyclosporine, a medicine that reduces the activity of the immune system. In this case, the doctor will need to check the concentration of cyclosporine in the blood and adjust the dose;
- ciprofloxacin and dapsone, antibiotics used against infections, and nitrendipine, a medicine used to lower blood pressure, in which case an increase in the dose may be necessary;
- estrogens, and agents that lower cholesterol in the blood such as clofibrate, as they can promote the formation of gallstones;
- medicines that increase biliary cholesterol excretion (hormonal contraceptives, some hypolipemic agents);
- medicines harmful to the liver (hepatotoxic); Use this medicine with caution if you are taking rosuvastatin, a medicine used to lower cholesterol in the blood, because they may increase levels of rosuvastatin in the blood.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, do not use this medicine.
Do not use this medicine during pregnancy unless absolutely necessary.
Before starting treatment, make sure you are not pregnant.
If you are of childbearing potential, you can only start treatment if you are using a reliable non-hormonal contraceptive method (non-hormonal oral contraceptives or low-dose estrogen).
If you are undergoing therapy to dissolve gallstones, use an effective non-hormonal contraceptive, as hormonal oral contraceptives may increase the formation of gallbladder stones.
Driving and using machines
This medicine does not alter or mildly alters the ability to drive vehicles and use machinery.
URSACOL 50 mg, 150 mg and 300 mg tablets contain lactose.
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
3. How to take URSACOL
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Your doctor will adjust the dosage based on your clinical condition and your tolerability to the
medicine.
Treatment of gallstones:
- URSACOL 50 mg, 150 mg and 300 mg tablets: to prevent the formation of stones, the recommended daily dose is between 5-10 mg/kg (300 and 600 mg) per day, for a prolonged treatment.
Take the medicine during or after meals and in the evening.
To maintain the conditions suitable for dissolving existing stones, the duration of treatment
must be at least 4-6 months, which may increase to 12 or even more, continuously, and must
be continued for 3-4 months after the radiological or ultrasound disappearance of the stones themselves. The
treatment should not, however, exceed 2 years.
- URSACOL 450 mg modified-release tablets: to prevent the formation of stones, the recommended daily dose is 450 mg per day, for a prolonged treatment. In obese patients and those with stones larger than 2 cm in diameter, higher dosages are used, up to 675 mg.
Take the medicine in a single dose in the evening, preferably before bedtime.
To maintain the conditions suitable for dissolving existing stones, the duration of treatment
must be at least 4-6 months, which may increase to 9 or even more, continuously, and must
be continued for 3-4 months after the radiological or ultrasound disappearance of the stones themselves. The
treatment should not, however, exceed 2 years.
Treatment of dyspepsia and maintenance therapy:
- URSACOL 50 mg, 150 mg and 300 mg tablets: the recommended dose is 300 mg per day, divided into 2-3 administrations.
- URSACOL 450 mg modified-release tablets: lower doses, of 225 mg per day, are sufficient.
Use in children
The use of the medicine is not intended for children.
If you take more URSACOL than you should
In case of overdose, you may experience diarrhea. In general, other symptoms of overdose are unlikely
because the absorption of ursodeoxycholic acid decreases with increasing dose and is therefore
mostly excreted in the feces.
In case of accidental ingestion of an excessive dose of this medicine, immediately inform your
doctor or go to the nearest hospital.
If you forget to take URSACOL
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 the use of this medicine, ask 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:
Common(may affect up to 1 in 10 people)
- soft stools or diarrhea.
Very rare(may affect up to 1 in 10,000)
- severe abdominal pain in the upper right portion;
- calcification of gallstones;
- serious liver problems (decompensation of hepatic cirrhosis), which partially regresses with discontinuation of therapy;
- urticaria. Occasionally, intestinal irregularity has been reported, which usually disappears with continued treatment
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at the website 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 URSACOL
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date that is reported on the package after “Scad”.
The expiry date refers to the last day of that month and to the product in intact packaging,
correctly stored.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in 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 URSACOL contains
URSACOL 50 mg tablets
- The active ingredient is ursodeoxycholic acid. Each tablet contains 50 mg of ursodeoxycholic acid.
- The other ingredients are: lactose, starch, gum arabic, talc, magnesium stearate.
URSACOL 150 mg tablets
- The active ingredient is ursodeoxycholic acid. Each tablet contains 150 mg of ursodeoxycholic acid.
- The other ingredients are: lactose, crospovidone, povidone, magnesium stearate.
URSACOL 300 mg tablets
- The active ingredient is ursodeoxycholic acid. Each tablet contains 300 mg of ursodeoxycholic acid.
- The other ingredients are: lactose, crospovidone, povidone, magnesium stearate.
URSACOL 450 mg modified-release tablets
- The active ingredient is ursodeoxycholic acid. Each tablet contains 450 mg of ursodeoxycholic acid.
- The other ingredients are: microcrystalline cellulose, sodium starch glycolate, magnesium stearate, colloidal anhydrous silica, povidone, talc, titanium dioxide, acrylic acid copolymer, triethyl citrate.
Description of the appearance of URSACOL and contents of the pack
Pack of 20 or 40 tablets of 50 mg.
Pack of 20 or 40 tablets of 150 mg.
Pack of 10, 20 or 30 tablets of 300 mg.
Pack of 20 modified-release tablets of 450 mg.
Marketing Authorisation Holder
ZAMBON ITALIA S.r.l. - via Lillo del Duca 10 – 20091 Bresso (MI)
Manufacturers
Tablets:
ZAMBON S.p.A. - via della Chimica, 9 - Vicenza
Modified-release tablets:
SPECIAL PRODUCT’S LINE S.r.l. - Via Campobello, 15 - 00040 Pomezia (Roma)
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- Страна регистрации
- Форма выпускаTablet, 50 MG
- Код АТХA05AA02
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги URSAKOLФорма выпуска: Hard capsule, 250 MGДействующее вещество: урсодезоксихолевая кислотаПроизводитель: ABC FARMACEUTICI S.P.A.Отпускается по рецептуФорма выпуска: Hard capsule, 300 MGДействующее вещество: урсодезоксихолевая кислотаПроизводитель: AUROBINDO PHARMA (ITALIA) S.R.L.Отпускается по рецептуФорма выпуска: Hard capsule, 300 MGДействующее вещество: урсодезоксихолевая кислотаПроизводитель: DOC GENERICI SRLОтпускается по рецепту
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Действующее вещество URSAKOL — урсодезоксихолевая кислота. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
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Другие лекарства с тем же действующим веществом (урсодезоксихолевая кислота) включают AKIDO URSODESOSSIKOLIKO ABK, AKIDO URSODESOSSIKOLIKO AUROBINDO, AKIDO URSODESOSSIKOLIKO DOK JENERIKI. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
