LITOFF 300 mg Coated Tablet
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Інструкція із застосування LITOFF
Зміст інструкції
Litoff 450 mg prolonged-release tablets, 300 mg tablets, 450 mg 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 their symptoms are the same as yours, as it could 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 Litoff is and what it is used for
- 2. What you need to know before you take Litoff
- 3. How to take Litoff
- 4. Possible side effects
- 5. How to store Litoff
- 6. Contents of the pack and other information
1. What is Litoff and what is it used for
Litoff 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 in the production of bile by the
liver and to improve the solubility of cholesterol in bile, 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 to
X-rays (radiotransparent); in particular, cholesterol stones in the gallbladder (functioning gallbladder)
and stones in the bile duct, possibly present even after surgical intervention on the biliary
tract.
Furthermore, Litoff is used to treat digestive problems due to dysfunction of the
gallbladder (biliary dyspepsia).
2. What you need to know before taking Litoff
Do not take Litoff
- if you are allergic to ursodeoxycholic acid, bile acids or any of the other ingredients of this medicine (listed in section 6);
- if you are pregnant (see “Pregnancy and breastfeeding”);
- if you suffer from diseases of the stomach or intestine (gastric or duodenal ulcer) in an active phase;
- 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 (radio-opaque calcified stones);
- if you suffer from reduced motility of the gallbladder (cholecystitis).
Warnings and precautions
Talk to your doctor or pharmacist before taking Litoff.
Treatment with this medicine must take place under strict medical supervision.
Pay particular attention with Litoff if you frequently suffer from pain in the upper abdomen (biliary colic), biliary infections or serious diseases of the pancreas or intestine that may alter the circulation of bile acids between the pancreas and the intestine, as in this case the use of the medicine is not recommended (see “Do not take Litoff”).
Before starting long-term therapy, your doctor will monitor your liver function (checking transaminases and alkaline phosphatase). During the first 3 months of treatment with this medicine, your doctor will check your liver function parameters (AST or SGOT and ALT or SGPT and -GT) every 4 weeks and, subsequently, every 3 months. This allows you to assess your response to therapy (if you are being treated for primary biliary cirrhosis) and to promote early diagnosis of potential liver damage, especially if the primary biliary cirrhosis is in an advanced stage.
If you are taking Litoff to dissolve cholesterol gallstones, you will be asked to undergo gallbladder checks
(oral cholecystography via ultrasound) 6-10 months after starting treatment, to assess the improvement in your condition.
Take special care with Litoffand tell 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 Litoff should be reduced to 250 mg per day and then
gradually increased.
if you experience diarrhea during treatment, as it may be necessary to reduce the dose of the
medicine and, in case of persistent diarrhea, to stop therapy.
if you are a woman of childbearing potential and are taking Litoff for the dissolution of gallstones; in this
case you must use a non-hormonal contraceptive method, as hormonal ones may
increase the likelihood of gallstone formation (see “Pregnancy, breastfeeding and fertility”).
This medicine is not suitable for the treatment of all types of gallstones; those that have
a higher probability of dissolution are those not visible on X-rays (radiotransparent) and of
small size in a functioning gallbladder.
Children and adolescents
Treatment in pediatric patients is not foreseen.
Other medicines and Litoff
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Do not take Litoff together with:
- cholestyramineand colestipol (medicinesused to lower cholesterol levels);
- antacids containing aluminum hydroxide and/or smectite (aluminum oxide) (medicines used for stomach acidity). These medicines reduce the effectiveness of Litoff. If the use of such medicines is necessary, they must be taken 2 hours before or after taking Litoff.
Also, pay particular attention if you are taking:
- cyclosporine(medicine used mainly after organ transplants). In this case, the doctor will have to check the concentration of cyclosporine in the blood and adjust the dose;
- ciprofloxacinand dapsone(antibiotics used against infections);
- nitrendipine(medicine used to lower blood pressure), as it may be necessary to increase the dose of nitrendipine;
- estrogensand medicines that reduce cholesterol levels in the blood (hypolipidemic agents) such as clofibrateas they may promote the formation of gallstones;
- medicines harmful to the liver (hepatotoxic);
- rosuvastatin, a medicine used to lower cholesterol in the blood.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Do not use Litoff during pregnancy unless your doctor considers it strictly
necessary for your health.
Make sure you are not pregnant before starting treatment.
If you are of childbearing potential, you can only start treatment with this medicine if you are using a
safe contraceptive method (non-hormonal oral contraceptives or low-dose estrogen).
If you are being treated for gallstone dissolution, use an effective non-hormonal contraceptive, as
hormonal oral contraceptives may increase the formation of gallbladder stones.
Levels of ursodeoxycholic acid in breast milk are very low and should not cause
adverse effects in breastfed infants.
Studies conducted on animals have not shown any influence of ursodeoxycholic acid on
fertility.
There is no adequate data regarding the effects on fertility in humans after
treatment with ursodeoxycholic acid.
Driving and operating machinery
This medicine does not alter or negligibly alters the ability to drive vehicles or operate
machinery.
Litoff containslactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking
this medicine.
Litoff 300 mg tablets: this medicine contains less than 1 mmol (23 mg) of sodium per
film-coated tablet, i.e. essentially ‘sodium-free’
3. How to take Litoff
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 dose of the medicine based on your clinical condition and your
tolerability to the medicine.
The recommended dosesare:
- Treatment of gallstones: in prolonged use, to prevent the formation of stones, the recommended daily dose is between 5-10 mg per kg of body weight (i.e. 300 to 600 mg), equivalent to 1-2 tablets of 300 mg twice a day (morning and evening), or 1 tablet of 450 mg once a day. Duration of treatment: 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 months or even more, continuously. The treatment must be continued for 3-4 months after the radiological or ultrasound disappearance of the stones themselves. The treatment must not, however, exceed 2 years.
- Treatment of dyspepsia (digestive problems) and maintenance therapy: the recommended dose is 300 mg per day, divided into 2-3 administrations.
Take the medicine preferably during or after meals.
If you take more Litoff than you should
No cases of overdose beyond 4 g per day have been reported (this dose has proven to be well
tolerated).
In case of accidental ingestion/intake of an excessive dose of Litoff, immediately inform
your doctor or go to the nearest hospital.
In case of overdose, diarrhea may occur. In general, other symptoms of overdose are
unlikely because the absorption of ursodeoxycholic acid decreases with increasing
dose and is therefore excreted more in the stool.
If you forget to take Litoff
If you miss a dose, take it as soon as possible. However, if it is almost time to take the next
dose, skip the missed dose. Do not take a double dose to make up for the
forgotten dose.
If you stop taking Litoff
Do not stop taking Litoff without first consulting your doctor.
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 diarrhoea.
Very rare(may affect up to 1 in 10,000 people)
- severe pain in the upper right abdomen;
- calcification of gallstones;
- in patients treated for advanced primary biliary cirrhosis, worsening of liver conditions (decompensation of hepatic cirrhosis) which regresses after discontinuation of treatment.
- urticaria.
Frequency not known(the frequency cannot be estimated on the basis of the available data)
- intestinal irregularities, which generally disappear 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 www.aifa.gov.it/content/segnalazioni-
reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Litoff
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is indicated on the pack. The expiry date refers to the last day of that month. The date refers to the product in
intact packaging, correctly stored.
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. Package Contents and Other Information
What Litoff contains
Litoff 300 mg tablets
- The active ingredient is ursodeoxycholic acid. Each divisible tablet contains 300 mg of ursodeoxycholic acid.
- The other ingredients are: lactose, sodium glycolate starch, gum arabic, talc, magnesium stearate, pregelatinized starch.
Litoff 450 mg tablets
- The active ingredient is ursodeoxycholic acid. Each tablet contains 450 mg of ursodeoxycholic acid.
- The other ingredients are: lactose, starch, gum arabic, talc, magnesium stearate.
Litoff 450 mg prolonged-release tablets
- The active ingredient is ursodeoxycholic acid. Each prolonged-release tablet contains 450 mg of ursodeoxycholic acid.
- The other ingredients are: hydroxypropylmethylcellulose methocel K15M, hydroxypropylmethylcellulose methocel K100M, microcrystalline cellulose, lactose, polyvinylpyrrolidone, talc, magnesium stearate.
Description of the appearance of Litoff and package contents
Litoff is available in tablet form.
20 tablets of 300 mg
20 tablets of 450 mg
20 prolonged-release tablets of 450 mg
Marketing Authorisation Holder
I.B.N. SAVIO S.r.l. - Via del Mare n. 36 – Pomezia (RM)
Manufacturer
For the 450 mg tablet pack:
Istituto Biochimico Nazionale SAVIO S.r.l. - Via E. Bazzano n. 14 - Ronco Scrivia (GE)
For the 300 mg tablet packs and the 450 mg prolonged-release tablet packs:
Special Product’s Line S.p.A., Via Fratta Rotonda Vado Largo 1 – Anagni (FR)
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- Країна реєстрації
- Лікарська формаCoated tablet, 300 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 LITOFFЛікарська 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 LITOFF в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог LITOFF у Іспанія
Аналог LITOFF у Польща
Аналог LITOFF у Україна
Лікарі онлайн щодо LITOFF
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на LITOFF онлайн
Заповніть форму за 2 хвилини
Розкажіть про симптоми, історію хвороби та потрібний препарат.
Оберіть лікаря або ми призначимо
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Отримайте в будь-якій аптеці
Електронний рецепт надсилається на вашу пошту — дійсний по всій Польщі.
Часті запитання
LITOFF потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у LITOFF — урсодезоксихолевая кислота. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
LITOFF виробляється компанією I.B.N. SAVIO S.R.L. 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 LITOFF 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 LITOFF 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.
