ACIDO 150 mg Фильм-Coated Таблетки
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Инструкция по применению AKIDO URSODESOSSIKOLIKO MYLAN JENERIKS
Содержание инструкции
- Acido Ursodesossicolico Mylan Generics 150 mg tablets, 300 mg tablets
- What is Acido Ursodesossicolico Mylan Generics and what is it used for
- What you need to know before taking Acido Ursodesossicolico Mylan Generics
- How to take Acido Ursodesossicolico Mylan Generics
- Possible side effects
- How to store Acido Ursodesossicolico Mylan Generics
- Contents of the pack and other information
Acido Ursodesossicolico Mylan Generics 150 mg tablets, 300 mg tablets
ursodesoxycholic acid
Generic medicine
Read this leaflet carefully before taking this medicine because 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 Acido Ursodesossicolico Mylan Generics is and what it is used for
- 2. What you need to know before you take Acido Ursodesossicolico Mylan Generics
- 3. How to take Acido Ursodesossicolico Mylan Generics
- 4. Possible side effects
- 5. How to store Acido Ursodesossicolico Mylan Generics
- 6. Contents of the pack and other information
1. What is Acido Ursodesossicolico Mylan Generics and what is it used for
Acido Ursodesossicolico Mylan Generics is a preparation based on bile acids naturally present
in the body, which is able to solubilize cholesterol in bile.
This medicine is used, in adults, to treat alterations in the production of bile by
the liver and to improve the solubility of cholesterol-rich 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 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).
In children over 6 years of age it is used for liver and gallbladder disorders associated
with cystic fibrosis (a serious genetic disease).
2. What you need to know before taking Acido Ursodesossicolico Mylan Generics
Do not take Acido Ursodesossicolico Mylan Generics
- if you are allergic (hypersensitive) to ursodesoxycholic acid, bile acids or any of the other 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-ray;
- if you suffer from reduced motility of the gallbladder;
- 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 a yellowish discoloration of the skin (obstructive jaundice);
- if you have problems with the liver (severe hepatopathies) or kidneys;
- if you have severe alterations to the pancreas or intestine that may alter the blood circulation of bile salts;
- if this medicine is intended for a child with malformations of the biliary system (biliary atresia) whose portoenterostomy (surgical procedure to restore bile flow) has failed or there has been no recovery of good bile flow.
Warnings and precautions
Talk to your doctor or pharmacist before taking Acido Ursodesossicolico Mylan Generics.
Treatment with this medicine must occur under strict medical supervision.
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 every 4 weeks and, subsequently, every 3 months. This
allows evaluation of your response to therapy (for primary biliary cirrhosis) and diagnosis of
potential liver damage.
In the treatment of dissolving gallstones, you should undergo visualization
of the gallbladder (oral cholecystography) via ultrasound, 6-10 months after the start of treatment,
to assess the improvement of your condition.
Talk to 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
should be reduced to 250 mg once a day and then gradually increased
(see section 3). Other formulations are available on the market that are suitable for this dosage.
If you have problems with diarrhea, talk to your doctor, who may decide to reduce the dose or stop the
therapy.
This medicine is not suitable for the treatment of all types of gallstones; those that have a
higher probability of dissolving are those not visible on X-ray (radiotransparent) and of
small size in a functioning gallbladder.
Other medicines and Acido Ursodesossicolico Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Do not take Acido Ursodesossicolico Mylan Generics 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 Acido Ursodesossicolico Mylan Generics;
- 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 to treat infections;
- nitrendipine, a medicine used to lower blood pressure, in which case an increase in the dose of nitrendipine may be necessary;
- estrogens and agents that lower blood cholesterol, such as clofibrate, as they may promote the formation of gallstones;
- medicines that increase biliary cholesterol excretion (hormonal contraceptives, some hypolipidemic agents);
- medicines harmful to the liver (hepatotoxic).
Use this medicine with caution if you are taking rosuvastatin, a medicine used to
lower blood cholesterol, because they may increase the levels of rosuvastatin in the blood.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking 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 may 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 undergoing therapy to dissolve gallstones, use an effective non-hormonal contraceptive, as
hormonal oral contraceptives may increase the formation of gallstones.
Driving and using machines
This medicine does not or negligibly alters the ability to drive and operate
machinery.
Acido Ursodesossicolico Mylan Generics contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking
this medicine.
3. How to take Acido Ursodesossicolico Mylan Generics
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:to prevent the formation of stones, the recommended daily dose
is between 5-10 mg/kg (i.e. 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 up 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 should not, however, exceed 2 years.
Treatment of dyspepsia (digestive problems) and maintenance therapy:the recommended
dose is 300 mg per day, also divided into 2 administrations.
Use in children
In children with cystic fibrosis over 6 years of age, the recommended dose is 20 mg/kg/day
divided into 2-3 doses, with a further increase to 30 mg/kg/day if necessary.
If you take more Acido Ursodesossicolico Mylan Generics 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 more excreted with the feces.
In case of accidental ingestion of an excessive dose of this medicine, warn
your doctor immediately or go to the nearest hospital.
If you forget to take Acido Ursodesossicolico Mylan Generics
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, consult 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;
- serious liver problems (hepatic cirrhosis), which regress partially with discontinuation of therapy;
- urticaria.
Occasionally, intestinal irregularities have been reported, which generally disappear with continued
treatment.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the
national reporting system at https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse. By reporting side effects you can help to provide more information
on the safety of this medicine.
5. How to store Acido Ursodesossicolico Mylan Generics
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack 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 eliminate medicines that you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Acido Ursodesossicolico Mylan Generics contains
- The active ingredient is ursodeoxycholic acid. Each tablet contains 150 mg or 300 mg of ursodeoxycholic acid.
- The other ingredients are: lactose, microcrystalline cellulose, starch, magnesium stearate.
Description of the appearance of Acido Ursodesossicolico Mylan Generics and contents of the
pack
Pack of 20 tablets of 150 mg.
Pack of 20 tablets of 300 mg.
Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano
Manufacturers
ABC Farmaceutici S.p.A., Via Cantone Moretti 29, 10015 Ivrea (TO)
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- Страна регистрации
- Форма выпускаTablet, 150 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 AKIDO URSODESOSSIKOLIKO MYLAN JENERIKSФорма 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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