INTEB 3 mg Modified-Release Hard Capsules
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Інструкція із застосування INTEB
Зміст інструкції
Inteb 3 mg modified-release hard capsules
Generic medicine
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 Inteb is and what it is used for
- 2. What you need to know before you take Inteb
- 3. How to take Inteb
- 4. Possible side effects
- 5. How to store Inteb
- 6. Contents of the pack and other information
1. What is Inteb and what is it used for
Inteb reduces inflammation in the small intestine and the first part of the large intestine.
Inteb 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.
Inteb is used to treat microscopic colitis, a disease that causes chronic inflammation of the colon
and often leads to watery diarrhea. Inteb 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 Inteb
Do not take Inteb
- if you are allergic to budesonide or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Inteb 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 may be more problematic when you take Inteb. Therefore, if you have been infected
contact your doctor.
Contact your doctor if you experience blurred vision or other visual disturbances.
When switching from a cortisone tablet therapy to Inteb or when stopping taking Inteb, you may
temporarily experience symptoms such as skin rash, 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 to undergo surgery, you must inform your doctor that you are taking Inteb as for
a while you may need additional treatment with cortisone tablets.
Children and adolescents
Regular monitoring of height growth in children and adolescents undergoing
treatment with Inteb is recommended.
Other medicines and Inteb
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
Some medicines can influence or be influenced by treatment with Inteb, 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-based tablets)
- medicines for menopausal symptoms (oestrogens) and pregnancy (contraceptive pills)
- carbamazepine (for epilepsy)
- some medicines may increase the effects of Inteb 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).
Inteb can affect a test performed to check the function of the pituitary gland, the so-called ACTH
stimulation test, giving falsely low results.
Inteb with food and drink
Taking grapefruit juice should be avoided during therapy with Inteb because grapefruit can
increase the absorption of budesonide from the intestine (juices from other fruits such as orange or apple do not have
an effect on 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
Inteb if you are pregnant.
Budesonide is excreted in breast milk. Talk to your doctor before taking Inteb regularly during
breastfeeding.
Driving and using machines
It is unlikely that Inteb will affect your ability to drive and use machines.
Inteb contains sugar spheres (corn starch, sucrose)
Inteb contains sucrose, a type of sugar. If your doctor has diagnosed you with intolerance to some
sugars, contact him/her before taking this medicine.
3. How to take Inteb
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any 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 the disease in the active phase: 3 modified-release capsules (i.e. 9 mg of budesonide) in the
morning for 8 weeks. It may take 2 to 4 weeks before Inteb 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 the disease in the active phase: 3 modified-release capsules (i.e. 9 mg of budesonide) in the
morning for 8 weeks. When you reach the end of the treatment, the dose will need to be reduced in a
regular manner 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 Inteb in children is not recommended.
If you take more Inteb than you should
If you take more Inteb than you should, inform your doctor or pharmacist immediately.
If you forget to take Inteb
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 the doctor.
If you stop taking Inteb
Do not stop taking Inteb without first consulting your doctor. If you suddenly stop
taking the capsules you may feel unwell.
If you have any further 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 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)
- hives and skin rashes
- muscle cramps
- menstrual disorders
- fat deposits on the torso and face, skin changes, 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)
- aggressiveness
- 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)
- severe allergic reactions
- growth delay
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 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 Inteb
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 other signs of deterioration consult your doctor or pharmacist
before taking the medicine.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.
Keep 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 Inteb contains
- The active ingredient is budesonide
- The other ingredients are:
Capsule contents
Ethylcellulose
Methacrylic acid-ethyl acrylate copolymer
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 Inteb and contents of the pack
Inteb capsules are gelatin capsules approximately 19 mm in size with an opaque light grey body and an
orange cap.
The capsules are filled with pellets ranging in colour from white to off-white.
Inteb is available in HDPE bottles with a PP screw cap containing a desiccant in packs of 20,
45, 50, 90 or 100 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
S.F. Group Srl
Via Tiburtina, 1143
- 00156 – Rome Italy
Manufacturers
Laboratorios Liconsa S.A.
Avenida Miralcampo 7,
Poligono Industrial Miralcampo,
19200Azuqueca De Henares, Guadalajara
Spain
This medicinal product is authorised in the Member States of the European Economic Area under the
following designations:
| Sweden | Budesonid Liconsa 3 mg capsule with modified release, hard |
| Belgium | Budesonide Liconsa 3 mg capsules with prolonged release, hard |
| France | o Budésonide Teva Santé 3 mg, modified release capsule |
| Ireland | Pinacort 3 mg modified release hard capsules |
| Italy | c Inteb 3 mg modified release hard capsules |
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- 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 INTEBЛікарська форма: Modified-release hard capsule, 3 mgДіюча речовина: БудесонидВиробник: DOC GENERICI SRLПотрібен рецептЛікарська форма: Extended-release tablet, 9 MGДіюча речовина: БудесонидВиробник: FERRING S.P.A.Рецепт не потрібенЛікарська форма: Enteric-coated hard capsule, 3 MGДіюча речовина: БудесонидВиробник: DR. FALK PHARMA GMBHПотрібен рецепт
Аналоги INTEB в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог INTEB у Іспанія
Аналог INTEB у Польща
Аналог INTEB у Україна
Лікарі онлайн щодо INTEB
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на INTEB онлайн
Заповніть форму за 2 хвилини
Розкажіть про симптоми, історію хвороби та потрібний препарат.
Оберіть лікаря або ми призначимо
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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
INTEB потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у INTEB — Будесонид. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
INTEB виробляється компанією S.F. GROUP 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 INTEB 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 INTEB 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 BUDESONIDE DOK, KORTIMENT, 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.
