URSOLISIN 150 mg Hard Capsule
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Інструкція із застосування URSOLISIN
Зміст інструкції
URSOLISIN 150 mg HARD CAPSULES, 300 mg HARD CAPSULES
URSODESOXYCHOLIC ACID
COMPOSITION
URSOLISIN 150 mg hard capsules
Each capsule contains:
Active ingredient: Ursodesoxycholic Acid 150 mg
Excipients:Corn starch, Sodium starch glycolate, Anhydrous colloidal silica, Magnesium stearate
Capsule shell composition:Highly purified gelatin, Titanium dioxide.
URSOLISIN 300 mg hard capsules
Each capsule contains:
Active ingredient: Ursodesoxycholic Acid 300 mg
Excipients:Corn starch, Sodium starch glycolate, Anhydrous colloidal silica, Magnesium stearate
Capsule shell composition:Highly purified gelatin, Titanium dioxide.
PHARMACEUTICAL FORM AND CONTENT
150 mg hard capsules - 20 Capsules
150 mg hard capsules - 30 Capsules
150 mg hard capsules - 40 Capsules
300 mg hard capsules - 10 Capsules
300 mg hard capsules - 20 Capsules
300 mg hard capsules - 100 Capsules
It is possible that not all pack sizes are available on the market.
PHARMACOTHERAPEUTIC CATEGORY
Hepatobiliary antilitogenic, litholytic.
MARKETING AUTHORISATION HOLDER
AESCULAPIUS FARMACEUTICI S.r.l. - Via Cefalonia, 70 - 25124 BRESCIA
MANUFACTURER AND FINAL CONTROLLER
ABC Farmaceutici S.p.A. – Via Canton Moretti, 29 (loc. LOCALITÀ SAN BERNARDO) 10015 Ivrea (TO)
THERAPEUTIC INDICATIONS
Qualitative or quantitative alterations of biliary function, including forms with bile supersaturated
with cholesterol, to oppose the formation of cholesterol stones or to create suitable conditions for
dissolution if they are already present, radio-transparent stones; in particular, cholecystic stones in a
functioning gallbladder and stones in the common bile duct remaining or recurring after biliary surgery.
Biliary dyskinesia.
CONTRAINDICATIONS
Ursolisin should not be used in patients suffering from:
- 1.acute inflammation of the gallbladder or bile ducts
- 2.obstruction of the bile ducts (obstruction of the common bile duct or cystic duct)
- 3.frequent episodes of biliary colic
- 4.calcified radio-opaque stones
- 5.impaired contractility of the gallbladder
- 6.hypersensitivity to bile acids or any of the excipients.
INTERACTIONS
Ursolisin should not be co-administered with cholestyramine, colestipol or antacids containing aluminum
hydroxide and/or smectite (aluminum oxide), as they bind ursodesoxycholic acid in the intestine and
therefore inhibit its absorption and efficacy. If the use of a preparation containing one of these
substances is necessary, it must be taken at least 2 hours before or after taking Ursolisin.
Ursolisin may affect the intestinal absorption of cyclosporine. In patients treated with cyclosporine, the
blood concentration of cyclosporine must therefore be monitored by the doctor and the dose of
cyclosporine must be adjusted if necessary.
In isolated cases, Ursolisin may reduce the absorption of ciprofloxacin.
In a clinical study on healthy volunteers, the concomitant use of ursodesoxycholic acid (500 mg/day) and
rosuvastatin (20 mg/day) led to slightly elevated plasma levels of rosuvastatin. The clinical relevance of
this interaction also with respect to other statins is not known.
Ursodesoxycholic acid has been shown to reduce the peak plasma concentrations (Cmax) and the area
under the curve (AUC) of the calcium antagonist nitrendipine in healthy volunteers.
Careful monitoring of the outcome due to the concomitant use of nitrendipine and ursodesoxycholic acid is
recommended. An increase in the dose of nitrendipine may be necessary. An interaction with a reduction in
the therapeutic effect of dapsone has also been reported. These observations, together with in vitro
evidence, indicate a potential induction of cytochrome P450 3A enzymes by ursodesoxycholic acid.
However, no induction was observed in a well-designed interaction study with budesonide, a known
substrate of cytochrome P450 3A.
Estrogen hormones and cholesterol-lowering agents such as clofibrate increase the secretion of hepatic
cholesterol and may therefore favor biliary lithiasis, which is an effect contrary to the use of ursodesoxycholic
acid used for dissolving stones.
SPECIAL WARNINGS
Ursolisin must be taken under medical supervision.
During the first 3 months of treatment, the liver function parameters AST (SGOT), ALT (SGPT) and -GT
must be monitored by the doctor every 4 weeks and subsequently every 3 months.
In addition to allowing the identification of responsive and non-responsive patients undergoing treatment for
primary biliary cirrhosis, this monitoring should also promote early diagnosis of potential liver
deterioration, particularly in patients with advanced primary biliary cirrhosis.
When used for the dissolution of cholesterol stones:
In order to prove therapeutic improvement and timely identification of any calcification of the stones, depending
on their size, the gallbladder must be visualized (oral cholecystography) with an overview and occluded
positions in the upright and supine position (control via ultrasound) 6-10 months after the start of
treatment.
If visualization of the gallbladder with X-ray images is not possible, or in the case of calcified stones,
impaired gallbladder contractility or frequent episodes of biliary colic, Ursolisin should not be used.
Patients taking Ursolisin for dissolving stones must use an effective non-hormonal contraceptive method
as hormonal contraceptives may increase biliary lithiasis (see paragraphs: “Interactions” and “Fertility,
pregnancy and breastfeeding”).
When used for the treatment of advanced primary biliary cirrhosis:
In very rare cases, decompensation of liver cirrhosis has been observed, which has partially regressed after
discontinuation of treatment.
In patients with PBC (primary biliary cirrhosis), in rare cases, clinical symptoms may worsen at the
beginning of treatment, for example, itching may increase. In such cases, the dose of ursodesoxycholic acid
should be reduced to one 250 mg capsule per day and then gradually increased as described in the
“Dosage, method and duration of administration” section.
In case of diarrhea, the dose should be reduced and in case of persistent diarrhea, the treatment should be
discontinued.
Fertility, pregnancy and breastfeeding
Studies on animals have not shown any influence of ursodesoxycholic acid on fertility. No data are available
in humans regarding the effects on fertility following treatment with ursodesoxycholic acid.
There are no or limited data on the use of ursodesoxycholic acid in pregnant women.
Studies conducted on animals have shown reproductive toxicity during the early stages of gestation.
Ursolisin should not be used during pregnancy unless absolutely necessary.
Women of childbearing potential must only be treated if they are using a safe non-hormonal contraceptive
method: oral contraceptives with low estrogen content are recommended. However, in patients taking
Ursolisin for dissolving stones, an effective non-hormonal contraceptive method must be used, as hormonal
oral contraceptives may increase biliary lithiasis. Pregnancy should be ruled out before starting
treatment.
Based on the few documented cases of breastfeeding women, the levels of ursodesoxycholic acid in breast
milk are very low and adverse reactions in breastfed infants are unlikely.
Driving and operating machinery
Ursodesoxycholic acid does not alter or negligibly alters the ability to drive vehicles or operate machinery.
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
The availability of 150 and 300 mg packs allows for the implementation of different dosage regimens useful in
the various clinical conditions in which the preparation is indicated.
In prolonged use to reduce the lithogenic characteristics of bile, the average daily dosage is 5-10 mg/kg:
in most cases, the daily dosage is between 300 and 600 mg, equivalent to 2-4 capsules of 150 mg per day,
with the possibility also of using 1 capsule of 300 mg twice a day (morning and evening); to maintain the
conditions suitable for dissolving already present stones, the duration of treatment must be at least 4-6
months, up to 12 and more.
In dyspeptic syndromes and maintenance therapy, doses of 150 mg once or twice a day are generally sufficient.
The doses can be modified at the doctor's discretion; in particular, the good tolerability of the preparation
allows the adoption of even significantly higher doses.
Assumptions should be made preferably during or after meals.
OVERDOSAGE
In case of overdose, diarrhea may occur. In general, other symptoms of overdose are unlikely as the
absorption of ursodesoxycholic acid decreases with increasing dose and is therefore excreted more in the
faeces.
No specific countermeasures are necessary and the consequences of diarrhea must be treated
symptomatically with fluid and electrolyte replacement.
Further information on special populations:
Long-term therapy with high doses of ursodesoxycholic acid (28-30 mg/kg/day) in patients with primary
sclerosing cholangitis (off-label use) has been associated with higher frequencies of serious adverse events.
UNDESIRABLE EFFECTS
Like all medicines, Ursolisin can cause side effects, although not everyone gets them.
The assessment of undesirable effects is based on the following frequency data:
Very common ( 1/10),
Common ( 1/100, < 1/10),
Uncommon ( 1/1000, < 1/100),
Rare ( 1/10000, < 1/1000),
Very rare/Not known (< 1/10000 / the frequency cannot be defined based on available data).
Gastrointestinal disorders:
In clinical studies, reports of loose stools or diarrhea during therapy with ursodesoxycholic acid have been
common.
Very rarely, severe upper right abdominal pain has occurred during treatment of primary biliary cirrhosis.
Hepatobiliary disorders:
In very rare cases, calcification of bile stones may occur during treatment with ursodesoxycholic acid. During
treatment of advanced primary biliary cirrhosis, decompensation of liver cirrhosis has been observed in very
rare cases, which has partially regressed after discontinuation of treatment.
Skin and subcutaneous tissue disorders:
Very rarely, urticaria may occur.
If any of these side effects worsen, or if you notice any side effects not listed in this leaflet, tell your
doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/en/content/segnalazioni-reazioni-avverse. Reporting side effects helps to provide
more information on the safety of this medicine.
EXPIRY DATE AND STORAGE
Expiry date: see the expiry date printed on the packaging.
The expiry date refers to the product in intact packaging stored correctly.
Do not use the medicine after the expiry date indicated on the packaging.
No special precautions for storage.
KEEP THE MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose
of medicines you no longer use. This will help protect the environment.
DRUG:
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- Країна реєстрації
- Лікарська формаHard capsule, 150 MG
- Код АТХA05AA02
- Діюча речовина
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до URSOLISINЛікарська форма: Hard capsule, 250 MGДіюча речовина: урсодезоксихолевая кислотаВиробник: ABC FARMACEUTICI S.P.A.Потрібен рецептЛікарська форма: Hard capsule, 300 MGДіюча речовина: урсодезоксихолевая кислотаВиробник: AUROBINDO PHARMA (ITALIA) S.R.L.Потрібен рецептЛікарська форма: Hard capsule, 300 MGДіюча речовина: урсодезоксихолевая кислотаВиробник: DOC GENERICI SRLПотрібен рецепт
Аналоги URSOLISIN в інших країнах
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Аналог URSOLISIN у Україна
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Часті запитання
URSOLISIN потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у URSOLISIN — урсодезоксихолевая кислота. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
URSOLISIN виробляється компанією AESCULAPIUS FARMACEUTICI SRL. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування URSOLISIN з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
Польща має добре розвинену систему охорони здоров'я у великих містах, таких як Варшава, Краків, Вроцлав і Гданськ. Аптеки широко доступні та працюють відповідно до чинного законодавства, забезпечуючи доступ до рецептурних препаратів.
Ви можете придбати URSOLISIN у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.
Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною (урсодезоксихолевая кислота) включають AKIDO URSODESOSSIKOLIKO ABK, AKIDO URSODESOSSIKOLIKO AUROBINDO, AKIDO URSODESOSSIKOLIKO DOK JENERIKI. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
