Інструкція із застосування BUDESONIDE DOK
Зміст інструкції
BUDESONIDE DOC
3 mg modified-release hard capsules
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 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 BUDESONIDE DOC is and what it is used for
- 2. What you need to know before you take BUDESONIDE DOC
- 3. How to take BUDESONIDE DOC
- 4. Possible side effects
- 5. How to store BUDESONIDE DOC
- 6. Contents of the pack and other information
1. What is BUDESONIDE DOC and what is it used for
BUDESONIDE DOC reduces inflammation in the small intestine and the first part of the large intestine.
BUDESONIDE DOC is used for the treatment of Crohn's disease of the small intestine and the first part
of the large intestine. Crohn's disease is an inflammatory bowel disease that causes symptoms such as
diarrhea, fever and stomach pain.
BUDESONIDE DOC is used to treat microscopic colitis, a disease that causes inflammation
of the colon and often leads to watery diarrhea. BUDESONIDE DOC can be used to treat the
disease in the active phase as well as in severe cases to prevent relapses (maintenance treatment).
2. What you need to know before taking BUDESONIDE DOC
Do not take BUDESONIDE DOC
- if you are allergic to budesonide or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking BUDESONIDE DOC if you have:
- an infection caused by bacteria, fungi or viruses
- liver problems
- osteoporosis
- gastric ulcer
- hypertension
- diabetes (even if there is a family history of diabetes)
- any eye disease (even if there is a family history of eye diseases)
Chickenpox and measles can be more problematic when you take BUDESONIDE DOC. If you are or have been
infected, therefore contact your doctor.
Contact your doctor if you experience blurred vision or other visual disturbances.
When switching from a therapy with cortisone tablets to BUDESONIDE DOC or when stopping
taking BUDESONIDE DOC, you may temporarily experience symptoms such as skin rashes, runny nose and muscle pain.
Contact your doctor if you experience any of the above effects or if you are worried about headache, fatigue
or nausea.
If you are going to have surgery, you must tell your doctor that you are taking BUDESONIDE DOC
as you may need additional treatment with cortisone tablets for a while.
For athletes
The use of the drug without therapeutic necessity constitutes doping and may still result in a positive
doping test.
Children and adolescents
Regular monitoring of height growth is recommended in children and adolescents
treated with BUDESONIDE DOC.
Other medicines and BUDESONIDE DOC
Tell your doctor if you are taking, have recently taken or may take any other
medicines.
Some medicines can influence or be influenced by treatment with BUDESONIDE DOC, for
example:
- some medicines prescribed for fungal infections (e.g. itraconazole)
- medicines used to treat Cushing's syndrome - when the body produces an excess of cortisol (ketoconazole tablets)
- medicines for menopause symptoms (estrogens) and pregnancy (contraceptive pills)
- carbamazepine (for epilepsy)
- some medicines may increase the effects of BUDESONIDE DOC and your doctor may need to carefully monitor your therapy if you are taking these medicines (e.g. some medicines for the treatment of HIV: ritonavir (or other protease inhibitors), cobicistat).
BUDESONIDE DOC can affect a test performed to check the function of the pituitary gland, the so-called
ACTH stimulation test, giving falsely low results.
BUDESONIDE DOC with food and drink
Taking grapefruit juice should be avoided during therapy with BUDESONIDE DOC because
grapefruit can increase the absorption of budesonide from the intestine (juices from other fruits such as orange or
apple do not affect the absorption of budesonide).
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, suspect you are pregnant or are planning a pregnancy,
ask your doctor or pharmacist for advice before taking this medicine.
There is a risk that the medicine may have an effect on the fetus. Therefore, always consult your doctor before taking
BUDESONIDE DOC if you are pregnant.
Budesonide is excreted in breast milk. Talk to your doctor before taking BUDESONIDE DOC regularly
during breastfeeding.
Driving and operating machinery
It is unlikely that BUDESONIDE DOC will affect your ability to drive vehicles and operate machinery.
BUDESONIDE DOC contains sugar spheres (corn starch, sucrose)
BUDESONIDE DOC contains sucrose, a type of sugar. If your doctor has diagnosed you with
intolerance to certain sugars, contact him before taking this medicine.
3. How to take BUDESONIDE DOC
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
The capsules must be swallowed whole with water.
If you have difficulty swallowing, you can open the capsule and ingest the contents mixed with a spoonful of
applesauce. The capsules must not be broken or chewed.
Crohn's Disease
Recommended daily dose for adults and children over 8 years of age weighing more than 25 kg:
For the treatment of active disease: 3 modified-release capsules (i.e. 9 mg of budesonide) in the
morning for 8 weeks. It may take 2 to 4 weeks before BUDESONIDE
DOC has full effect.
Do not forget to take the capsules even if you feel better.
Treatment should be discontinued by gradually reducing the dose.
Microscopic Colitis
Recommended dose in adults:
For the treatment of active disease: 3 modified-release capsules (i.e. 9 mg of budesonide) in the
morning for 8 weeks. When you reach the end of treatment, the dose will need to be reduced regularly
over the last two weeks.
Maintenance therapy: 2 capsules (i.e. 6 mg of budesonide) (or the minimum effective dose).
Use in children
The use of BUDESONIDE DOC in children is not recommended.
If you take more BUDESONIDE DOC than you should
If you take more BUDESONIDE DOC than you should, inform your doctor or pharmacist immediately.
If you forget to take BUDESONIDE DOC
Do not take a double dose to make up for the dose you have forgotten. Continue with the next dose
according to the schedule initially prescribed by your doctor.
If you stop taking BUDESONIDE DOC
Do not stop taking BUDESONIDE DOC without first consulting your doctor. If you suddenly stop
taking the capsules you may feel unwell.
If you have any further 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 with this medicine:
Common (may affect up to 1 in 10 people)
- low levels of potassium in the blood
- changes in behaviour such as nervousness, insomnia, mood swings and depression
- unusually fast or irregular heartbeat
- difficulty digesting (dyspepsia)
- urticaria and skin rashes
- muscle cramps
- menstrual disorders
- fat deposits on the torso and face, changes in the skin, fluid retention in the body (so-called Cushingoid symptoms)
Uncommon (may affect up to 1 in 100 people)
- tremors
- restlessness, excessive motor activity with concomitant mental anxiety (psychomotor hyperactivity)
- anxiety
Rare (may affect up to 1 in 1,000 people)
- aggression
- opacification of the natural lens of the eye including the back of the lens, glaucoma, blurred vision
- blue-purple discoloration of the skin due to bleeding under the skin
Very rare (may affect up to 1 in 10,000 people)
- serious allergic reactions
- growth delay
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 provide more information on the safety of this medicine.
5. How to store BUDESONIDE DOC
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 bottle. The expiry date refers to
the last day of that month.
If the capsules change colour or show any other signs of deterioration, consult your doctor or pharmacist
before taking the medicine.
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.
Store the medicine in the original bottle to protect from light and humidity.
This medicine does not require any particular storage temperature.
6. Contents of the pack and other information
What BUDESONIDE DOC contains
- The active ingredient is budesonide
- The other ingredients are: Capsule ContentEthylcellulose Copolymer of methacrylic acid-ethyl acrylate Oleic acid Polysorbate 80 Sugar spheres (corn starch, sucrose) Talc Triethyl citrate Medium chain triglycerides
Capsule
Black iron oxide E172
Red iron oxide E172
Titanium dioxide E 171
Gelatin
Description of the appearance of BUDESONIDE DOC and contents of the pack
BUDESONIDE DOC capsules are gelatin capsules of approximately 19 mm with an opaque light grey body
and an opaque orange cap. The capsules are filled with pellets ranging in color from white to off-white.
BUDESONIDE DOC is available in HDPE bottles with a PP screw cap containing a desiccant silica gel in
packs of 20, 45, 50 or 100 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
DOC Generici Srl
Via Turati 40
20121 Milan
Italy
Manufacturers
Laboratorios Liconsa S.A.
Avenida Miralcampo 7, Poligono Industrial Miralcampo, Azuqueca De Henares, Guadalajara
19200 Spain
This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
SE: Budesonid DOC
IT: BUDESONIDE DOC
- Країна реєстрації
- Лікарська формаModified-release hard capsule, 3 mg
- Код АТХA07EA06
- Діюча речовина
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до BUDESONIDE DOKЛікарська форма: Extended-release tablet, 9 MGДіюча речовина: БудесонидВиробник: FERRING S.P.A.Рецепт не потрібенЛікарська форма: Modified-release hard capsule, 3 MGДіюча речовина: БудесонидВиробник: S.F. GROUP S.R.L.Потрібен рецептЛікарська форма: Enteric-coated hard capsule, 3 MGДіюча речовина: БудесонидВиробник: DR. FALK PHARMA GMBHПотрібен рецепт
Аналоги BUDESONIDE DOK в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог BUDESONIDE DOK у Іспанія
Аналог BUDESONIDE DOK у Польща
Аналог BUDESONIDE DOK у Україна
Лікарі онлайн щодо BUDESONIDE DOK
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на BUDESONIDE DOK 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
BUDESONIDE DOK потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у BUDESONIDE DOK — Будесонид. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
BUDESONIDE DOK виробляється компанією DOC GENERICI 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 BUDESONIDE DOK 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 BUDESONIDE DOK 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 (Будесонид) включають KORTIMENT, INTEB, INTESTIKORT. 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.
















