Інструкція із застосування MYKOBUTIN
Зміст інструкції
Mycobutin 150 mg hard capsules
Rifabutina
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 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 Mycobutin is and what it is used for
- 2. What you need to know before you take Mycobutin
- 3. How to take Mycobutin
- 4. Possible side effects
- 5. How to store Mycobutin
- 6. Contents of the pack and other information
1. What is Mycobutin and what is it used for
Mycobutin contains the active ingredient rifabutin, an antibiotic. Rifabutin blocks the growth of
mycobacteria, a type of bacteria that cannot be eliminated with common antibiotics.
Mycobutin is indicated in adultsand the elderlyfor:
- preventinginfections caused by Mycobacterium avium complex(MAC) and other mycobacteria;
- treatinginfections caused by Mycobacterium tuberculosis, Mycobacterium avium complex(MAC), Mycobacterium xenopiand other mycobacteria. Mycobutin must be used in association with other “antimycobacterial” antibiotics, not belonging to the rifamycin group.
2. What you need to know before taking Mycobutin
Do not take Mycobutin:
- if you are allergicto rifabutin, to other similar antibiotics called rifamycins (e.g. rifampicin) or to any of the other ingredients of this medicine (listed in section 6);
- if you are pregnantor breastfeeding.
Mycobutin should not be administered to children.
Warnings and precautions
Stop taking Mycobutin and contact your doctor immediately if you experience any of the following
symptoms (drug reaction with eosinophilia and systemic symptoms (DRESS)):
- rash, fever
- enlargement of the lymph nodes and changes in blood counts
Consult your doctor or pharmacist beforetaking Mycobutin if:
- you have tuberculosisor another infection caused by mycobacteria;
- you have serious problems with yourliveror kidneys.
Inform your doctor or pharmacist if any of the following conditions occur or worsen
duringtreatment with Mycobutin:
- rednessof the white part of the eye, especially if you are taking Mycobutin together with clarithromycin (an antibiotic) or fluconazole (a medicine against fungal infections). In this case, have an eye examination; diarrhoea, which may develop into inflammation of the intestine (colitis), which can be fatal. Inform your doctor immediatelyif you experience severe and persistent diarrhoea even if several months have passed since stopping treatment with Mycobutin. Mycobutin can cause a red/orangediscoloration of urine, skin and other body fluids. These effects do not need to cause concern because they have no consequences for you. Avoid using soft contact lenses, as Mycobutin may alter the color of contact lenses.
Other medicines and Mycobutin
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
The following medicines can affect the action of Mycobutin or Mycobutin can reduce the effectiveness of the
following medicines. Therefore, caution is necessary:
- amprenavir, bictegravir,delavirdine, didanosine, doravirine,fosamprenavir/ritonavir, indinavir, lopinavir/ritonavir, saquinavir, rilpivirine,ritonavirand tipranavir/ritonavir(medicines used against HIV infection);
- fluconazole, itraconazole, posaconazole, voriconazole(medicines used against fungal infections);
- dapsone, sulfamethoxazole/trimethoprim, clarithromycin, ethambutol, isoniazid, pyrazinamide(antibiotics against various types of infections);
- methadone(medicine against pain and to counteract drug dependence);
- oral contraceptives(medicines used to prevent pregnancy). It is recommended to use alternative methods of contraception (e.g. condom) to avoid pregnancy;
- tacrolimus(medicine against rejection in case of organ transplantation);
- theophylline(medicine used for the treatment of asthma).
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Do nottake Mycobutin if you are or think you may be pregnant or if you are breastfeeding.
Driving and using machines
It is not known whether this medicine affects the ability to drive or operate machines.
Mycobutin contains sodium
Mycobutin contains less than 1 mmol (23 mg) of sodium per hard capsule, i.e. it is
essentially “sodium-free”.
3. How to take Mycobutin
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Swallow the capsules with half a glass of water. Take the capsules once a day, at any
time of the day, independently of meals.
Mycobutin is usually taken together with other antibiotics for the treatment of infections from
mycobacteria.
- Preventionof infections fromMycobacterium avium complex (MAC)The recommended dose is 2 capsules once a day.
- Treatmentof mycobacterial infections(but not caused by Mycobacterium tuberculosis) The recommended dose is 3 - 4 capsules once a day. The doctor will establish the duration of the treatment.
- Treatmentof pulmonary tuberculosis infections(caused by Mycobacterium tuberculosis) The recommended dose for chronic tuberculosis infections is 2 - 3 capsules once a day. The doctor will establish the duration of the treatment. The recommended dose for recent tuberculosis infections is 1 capsule a day for 6 months.
If you take more Mycobutin than you should
If you take an excessive dose of this medicine, contact your doctor immediatelyor go to the nearest
hospital emergency room. Always bring with you the package of the medicine with the label,
even if there are no Mycobutin capsules left.
If you forget to take Mycobutin
If you forget to take a dose, take it as soon as you remember unless it is time to
take the next dose. Do not take a double dose to compensate for a missed dose.
If you stop taking Mycobutin
Do not stop taking Mycobutin unless your doctor prescribes it, as the infection may
reappear.
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.
manifest.
STOPtreatment with Mycobutin immediately and contact your doctor urgently if
you experience the following side effects:
- severe allergic reaction ( anaphylactic shock). Symptoms may include confusion, drowsiness, cold and clammy skin, shallow or difficult breathing, rapid heartbeat;
- diarrhea, stomach pain and blood in the stools, as these may be symptoms of a severe inflammation of the colon(the last part of the intestine) (see section 2 “Warnings and precautions”);
- sudden wheezing, difficulty breathing or swallowing, swelling of eyelids, face or lips, rash or itching (especially itching all over the body). This may be a sign of a severe hypersensitivity reaction (can occur in an unknown number of subjects) (Acute Generalized Exanthematous Pustulosis, AGEP).
- a drug reaction with symptoms such as fever, rash, altered blood count, swollen lymph nodes and effects on internal organs (DRESS syndrome, occurs in an unknown number of subjects).
- an extremely severe allergic reaction with rash usually in the form of blisters or ulcers in the mouth and eyes, as well as other mucous membranes, for example the genitals (occurs in an unknown number of subjects) (Stevens-Johnson syndrome, SJS).
- inflamed and peeling skin, severe widespread skin damage (detachment of the epidermis and superficial mucous membranes) (occurs in an unknown number of subjects) (toxic epidermal necrolysis, TEN).
See your doctor if you experience any of the following side effects:
Very common(may affect more than 1 in 10 people):
- decreased number of leukocytes (a type of white blood cells) in the blood
Common(may affect up to 1 in 10 people):
- anemia (decreased hemoglobin in the blood)
- rash
- nausea
- muscle pain
- fever
Uncommon(may affect up to 1 in 100 people):
- decrease or increase in the number of eosinophils (a type of white blood cells) in the blood
- decreased number of white blood cells, red blood cells and platelets in the blood
- allergies
- difficulty breathing
- eye pain and redness, changes in the cornea (the transparent front part of the eye) that can cause vision loss
- vomiting
- yellowing of the skin and the white of the eye
- increased levels of enzymes produced by the liver
- skin discoloration
- joint pain
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: 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 Mycobutin
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package, blister or
vial after Exp. The expiry date refers to the last day of that month.
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 Mycobutin contains
The active ingredient is rifabutin.
Each Mycobutin hard capsule contains 150 mg of rifabutin.
The other ingredients are: microcrystalline cellulose, sodium lauryl sulfate (see section “Mycobutin
contains sodium”), magnesium stearate, gelatin, silica gel, titanium dioxide, red iron oxide.
Description of the appearance of Mycobutin and contents of the pack
Mycobutin capsules are hard capsules available in PVC/aluminium blisters or in glass
bottles containing 30 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pfizer Italia S.r.l.
Via Isonzo 71,
04100 Latina (LT)
Manufacturer
Pfizer Italia S.r.l.
Località Marino del Tronto
63100 Ascoli Piceno (AP)

- Країна реєстрації
- Лікарська формаHard capsule, 150 MG
- Код АТХJ04AB04
- Діюча речовина
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до MYKOBUTINЛікарська форма: Hard capsule, 300 MGДіюча речовина: РифампицинВиробник: SANOFI S.R.L.Потрібен рецептЛікарська форма: Film-coated tablet, 50 MGДіюча речовина: ДеламанидВиробник: OTSUKA NOVEL PRODUCTS GMBHПотрібен рецептЛікарська форма: Tablet, 200 MGДіюча речовина: претоманидаВиробник: MYLAN IRE HEALTHCARE LIMITEDПотрібен рецепт
Аналоги MYKOBUTIN в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог MYKOBUTIN у Іспанія
Лікарі онлайн щодо MYKOBUTIN
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на MYKOBUTIN онлайн
Заповніть форму за 2 хвилини
Розкажіть про симптоми, історію хвороби та потрібний препарат.
Оберіть лікаря або ми призначимо
Оберіть спеціаліста або ми підберемо найближчого доступного лікаря.
Лікар розглядає ваш випадок
Зазвичай протягом 30 хвилин. Може ставити уточнювальні запитання в чаті.
Отримайте в будь-якій аптеці
Електронний рецепт надсилається на вашу пошту — дійсний по всій Польщі.
Часті запитання
MYKOBUTIN потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у MYKOBUTIN — rifabutin. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
MYKOBUTIN виробляється компанією PFIZER ITALIA 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 MYKOBUTIN 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 MYKOBUTIN 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 (rifabutin) включають RIFADIN, DELTYBA, DOVPRELA. 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.
















