TUDCABIL 250 mg Twarde Kapsułki
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Treść ulotki
TUDCABIL 250 mg hard capsules
Tauroursodeoxycholic acid dihydrate
Read this leaflet carefully before 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 TUDCABIL is and what it is used for
- 2. What you need to know before you take TUDCABIL
- 3. How to take TUDCABIL
- 4. Possible side effects
- 5. How to store TUDCABIL
- 6. Contents of the pack and other information
1. What is TUDCABIL and what is it used for
TUDCABIL is a preparation based on bile acids naturally present in the body that is able to
solubilize the cholesterol present in bile.
This medicine is used to treat alterations in bile production by the liver
(qualitative and quantitative alterations of biligenetic function, including cases induced by bile supersaturated with
cholesterol), to prevent the formation of gallstones or to facilitate the dissolution of stones already present
not visible on X-rays (radiotransparent). In particular, it is indicated in cases of gallstones (cholecystic calculi in a functioning gallbladder) and stones present in the bile duct (choledochal calculi) that
persist even after surgical intervention on the ducts that carry bile to the intestine (biliary tract).
2. What you need to know before taking TUDCABIL
Do not take TUDCABIL
- if you are allergic to tauroursodeoxycholic acid hydrate, to similar substances (bile acids) or to any of the other components of this medicine (listed in section 6);
- if you are pregnant (see “Pregnancy, breastfeeding and fertility”);
- if you suffer from lesions to the stomach or intestine (active gastric or duodenal ulcer);
- if you have acute inflammation of the gallbladder or bile ducts;
- if you have a blockage of the bile ducts (obstruction of the common bile duct or cystic duct);
- if you suffer from frequent pain due to the presence of gallstones (biliary colic);
- if you have gallstones that appear opaque in X-rays (radio-opaque calcified stones);
- if you have problems with the gallbladder (reduced motility of the gallbladder).
Warnings and precautions
Consult your doctor or pharmacist before taking TUDCABIL.
Take this medicine only under the direct supervision of your doctor.
Do not take TUDCABIL if any of the following conditions apply to you:
- the doctor is unable to visualize the gallbladder with an X-ray (radiography);
- you have calcified gallstones. This medicine is effective only if cholesterol stones are not calcified, are transparent in X-rays (radiotransparent) and are of small size;
- you have problems with the gallbladder (damaged or altered gallbladder motility);
- you suffer from frequent pain due to the presence of gallstones in the bile ducts (biliary colic);
- you have developed infections of the bile ducts;
- you suffer from problems with the pancreas (severe pancreatic alterations) or the intestine (intestinal conditions, such as resections and ileostomy, regional ileitis) that may make it difficult for bile acids to pass from the liver to the intestine (enterohepatic circulation).
Before starting treatment, your doctor will perform appropriate tests to determine if your
gallbladder is functioning correctly and if you have any diseases that may alter the passage of bile
acids from the liver to the intestine (enterohepatic circulation).
During the first 3 months of treatment, your doctor will check liver function (AST-SGOT),
ALT-SGPT, and gamma-GT) every 4 weeks and then every 3 months. These checks allow
to assess if you are responding to treatment with this medicine, especially if you suffer from a
chronic liver disease (primary biliary cirrhosis), and to diagnose any liver damage early (potential hepatic deterioration).
In addition, your doctor will perform ultrasounds every 3-6 months and possibly gallbladder X-rays (cholecystographic examinations) to assess whether this medicine is effective.
If you experience diarrhea during treatment with TUDCABIL, inform your doctor who will reduce the dose
of medicine to be taken.
If the diarrhea is persistent, your doctor will advise you to stop treatment.
Children
This medicine is not indicated in children.
Other medicines and TUDCABIL
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Avoid taking TUDCABIL together with the following medicines:
- cholestyramine, colestipol (medicines used to lower cholesterol levels in the blood), antacids containing aluminum (aluminum hydroxide, aluminum oxide), used to reduce stomach acidity, as they reduce the effects of bile acids. If you must necessarily take these medicines, do so 2 hours before or after taking TUDCABIL;
- hormones that regulate sexual functions (estrogens), medicines used to prevent pregnancy (hormonal contraceptives), some medicines used to lower cholesterol levels in the blood (hypolipidemic agents), such as clofibrate, because they increase cholesterol in the bile (biliary excretion);
- medicines that can cause liver damage (hepatotoxic).
Take TUDCABIL with caution and inform your doctor if you are taking any of the following medicines:
- cyclosporine, used against rejection reactions after an organ transplant, because TUDCABIL increases its absorption. In this case, the doctor will need to check the amount of cyclosporine in the blood (blood concentration) and possibly adjust the dose;
- nitrendipine (calcium antagonist) used for the treatment of high blood pressure, dapsone used for the treatment of leprosy and ciprofloxacin used for the treatment of some infections, because TUDCABIL may reduce their effects;
- hormones that regulate sexual functions (estrogens), clofibrate and other medicines used to lower cholesterol levels in the blood (serum cholesterol reducers) because they reduce the effect of TUDCABIL.
Pregnancy, breastfeeding and fertility
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 take TUDCABIL if you are pregnant, unless absolutely necessary and under the direct
supervision of your doctor (see “Do not take TUDCABIL”).
Do not take TUDCABIL if you are breastfeeding.
If you are a woman of childbearing potential, take this medicine only if you are protected by effective
contraception (non-hormonal or low-estrogen oral contraceptives).
Make sure you are not pregnant before starting treatment with this medicine.
Driving and operating machinery
This medicine does not impair the ability to drive vehicles and operate machinery.
TUDCABIL contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking
this medicine.
3. How to take TUDCABIL
Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The doctor may decide to have you undergo dosage cycles (dosage regimens) based on your weight and
the severity of your condition.
The recommended dose is 5-10 mg per kg of body weight per day.
Generally, the recommended dose ranges from 250 to 750 mg per day, to be taken in divided doses,
after meals.
If you take more TUDCABIL than you should
An overdose is rare because the toxic dose is much higher than the dose
recommended for treatment.
Following the intake of an excessive dose of this medicine, diarrhea may occur. Other
symptoms are unlikely because, if you take high doses of tauroursodeoxycholic acid, the medicine
is more readily eliminated with the feces. In case of diarrhea, no specific countermeasures are
necessary. The doctor will advise you on how to replenish fluids and electrolytes lost with diarrhea.
In case of accidental intake/ingestion of an excessive dose of TUDCABIL, immediately inform
your doctor or go to the nearest hospital.
If you forget to take TUDCABIL
Do not take a double dose to make up for the missed capsule.
If you have any questions 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;
- diarrhoea;
- intestinal disorders (irregular bowel movements) that disappear with continued therapy.
Rare(may affect up to 1 in 1,000 people)
- nausea, vomiting;
- loose stools.
Very rare(may affect up to 1 in 10,000 people)
- calcification of gallstones;
- skin irritation (urticaria).
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.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 TUDCABIL
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 packaging after “Scad.”. The
expiry date refers to the last day of that month. The expiry date refers to the product
in intact packaging, correctly stored.
Store at a temperature not exceeding 25°C.
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 TUDCABIL contains
- The active ingredient: is tauroursodeoxycholic acid dihydrate. Each capsule contains 250 mg of tauroursodeoxycholic acid dihydrate.
- The other ingredients are: o inner: microcrystalline cellulose, lactose, corn starch, magnesium stearate; o outer shell: gelatin F.U., titanium dioxide (E 171), erythrosine (E 127), indigotine (E 132), quinoline yellow.
Description of the appearance of TUDCABIL and contents of the pack
Pack of 20 hard capsules.
Marketing Authorisation Holder
Bruschettini s.r.l. – Via Isonzo, 6 – 16147 Genova – Italy
Manufacturer
Bruschettini s.r.l. – Via Isonzo, 6 – 16147 Genova – Italy
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- Kraj rejestracji
- Postać farmaceutycznaHard capsule, 250 MG
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki TUDKABILPostać farmaceutyczna: Hard capsule, 250 MGSubstancja czynna: chenodeoxycholic acidProducent: LEADIANT GMBHWymaga receptyPostać farmaceutyczna: Hard capsule, 250 MGSubstancja czynna: ursodeoxycholic acidProducent: ABC FARMACEUTICI S.P.A.Wymaga receptyPostać farmaceutyczna: Hard capsule, 300 MGSubstancja czynna: ursodeoxycholic acidProducent: AUROBINDO PHARMA (ITALIA) S.R.L.Wymaga recepty
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TUDKABIL jest produkowany przez BRUSCHETTINI S.R.L.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie TUDKABIL jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
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Inne leki zawierające tę samą substancję czynną () to m.in. AKIDO KENODESOSSIKOLIKO LEADIANT, AKIDO URSODESOSSIKOLIKO ABK, AKIDO URSODESOSSIKOLIKO AUROBINDO. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
