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ENTOCORD 3 mg MODIFIED-RELEASE CAPSULES

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About the medicine

How to use ENTOCORD 3 mg MODIFIED-RELEASE CAPSULES

Translated with AI

This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Patient Information: Summary of Product Characteristics

Entocord 3 mg Modified Release Capsules

budesonide

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

  1. What Entocord 3 mg Capsules are and what they are used for
  2. Before you take Entocord 3 mg Capsules
  3. How to take Entocord 3 mg Capsules
  4. Possible side effects
  5. Storing Entocord 3 mg Capsules
  6. Contents of the pack and other information

1. What Entocord 3 mg Capsules are and what they are used for

Entocord (budesonide) belongs to a group of medicines called glucocorticosteroids (a type of cortisone) that are used to reduce inflammation.

Entocord is indicated for the treatment of Crohn's disease (inflammation of the small intestine and the first part of the large intestine).

Entocord is also indicated for the treatment of acute episodes of microscopic colitis in its collagenous and lymphocytic variant (a disease with chronic inflammation of the large intestine, causing chronic watery diarrhea).

Doctor consultation

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Discuss your symptoms and treatment with a doctor online.

2. Before you take Entocord 3 mg Capsules

Do not take Entocord 3 mg Capsules

If you are allergic to budesonide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting treatment with Entocord.

You should always inform your doctor about the following situations:

? If you have other health problems, such as liver disease.

? If you are suffering from, have suffered from, or contract any infection, particularly chickenpox or measles.

? If you have diabetes (including family history), brittle bones (osteoporosis), stomach ulcers, or high blood pressure.

? If you have any eye disease such as glaucoma (including family history) or cataracts.

? If your symptoms worsen while taking Entocord.

Do not stop treatment with Entocord until your doctor tells you to

Contact your doctor if you experience blurred vision or other visual disturbances.

Entocord has been prescribed specifically for your current condition. Do not use it for other problems unless your doctor tells you to.

If you were previously treated with "cortisone" tablets (such as prednisone, prednisolone, or methylprednisolone) and your medication has been changed to Entocord, symptoms that may have bothered you before may temporarily reappear, such as skin rashes, muscle and joint pain. If any of these symptoms bother you, or if symptoms such as headache, fatigue, nausea, or vomiting appear, please contact your doctor.

Children and adolescents

There is no long-term treatment data in children and adolescents; regular monitoring of their height is recommended.

Other medicines and Entocord 3 mg Capsules

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.

Certain medicines may interact with Entocord; in these cases, it may be necessary to change the dose or stop treatment with one of the medicines.

It is essential that you inform your doctor if you are taking any of the following medications: ketoconazole, itraconazole (medicines used against fungal infections), carbamazepine (antiepileptic), or in women, estrogens, and some contraceptives.

Some medicines may increase the effects of Entocord, and your doctor may want to monitor you closely if you are taking these medicines (including some medicines for the treatment of HIV: ritonavir (and other HIV protease inhibitors, cobicistat).

Diagnostic tests for pituitary gland activity may show falsely low results due to adrenal function suppression.

Taking Entocord 3 mg Capsules with food and drinks

During treatment with Entocord, you should avoid regular consumption of large amounts of grapefruit or grapefruit juice, as grapefruit consumption may increase the amount of budesonide absorbed from the intestine (other fruits such as oranges or apples do not affect budesonide absorption).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor, pharmacist, or nurse before using this medicine.

There is very limited experience with Entocord in pregnant or breastfeeding women. If you become pregnant during treatment with Entocord, you should contact your doctor as soon as possible.

Driving and using machines

Entocord does not affect the ability to drive vehicles or operate machinery.

Entocord 3 mg Capsules contain sucrose and sodium

Entocord contains sucrose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

This medicine contains less than 23 mg of sodium (1mmol) per capsule; this is essentially "sodium-free".

If you are an athlete, you should be aware that this medicine contains a component that may result in a positive doping test.

3. How to take Entocord 3 mg Capsules

Follow exactly the administration instructions of this medicine indicated by your doctor, pharmacist, or nurse. In case of doubt, consult your doctor, pharmacist, or nurse again.

Your doctor will indicate the duration of your treatment with Entocord. Do not stop treatment until your doctor tells you to, as they may want to gradually reduce the dose.

The dosage is adapted to each individual. Carefully follow your doctor's instructions. These instructions may be different from the information contained in this leaflet.

The route of administration of Entocord is oral. The capsules should be swallowed whole with water. For children and adults with difficulty swallowing, the capsules can be opened and the contents taken after mixing with a spoonful of apple sauce. It is essential that the capsule contents are not crushed or chewed.

Recommended dose for adults

Crohn's disease: The recommended dose is 3 capsules (9 mg of budesonide) per day. The dose is administered once a day, in the morning. In most cases, treatment lasts up to 8 weeks.

Microscopic colitis: The recommended dose is 3 capsules (9 mg of budesonide) once a day, in the morning. In most cases, treatment lasts up to 8 weeks.

Use in children

Crohn's disease: The usual dose is 3 capsules (9 mg of budesonide) per day in children aged 8 years and older, with a body weight of more than 25 kg. The dose is administered once a day, in the morning. Treatment usually lasts up to 8 weeks. Once symptom control is achieved, treatment should be adjusted to the lowest effective dose. Experience in children is limited.

Microscopic colitis: Safety and efficacy in microscopic colitis have not been established in children and adolescents.

Treatment with Entocord capsules should be gradually reduced before discontinuation.

Recommended dose for elderly patients

The same dosage as for adults should be used. However, experience with Entocord in elderly patients is limited.

Note:The full effect is usually achieved within 2-4 weeks. Do not forget to take your Entocord doses even if you start to feel better.

If you take more Entocord 3 mg Capsules than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Entocord 3 mg Capsules

If you occasionally forget to take a dose of Entocord, it is not necessary to make up for the missed dose; simply continue with the next dose as prescribed.

Do not take a double dose to make up for missed doses.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you have an allergic reaction, consult your doctor immediately. The signs may include skin lumps (hives) or swelling of the face, lips, mouth, tongue, or throat. This can make it difficult to breathe.

Other possible side effects:

Common: may affect up to 1 in 10 people

? Stomach or intestine pain, such as stomach pain, flatulence, diarrhea, heartburn, and feeling unwell.

? Cramps.

? Skin reactions, such as rash and skin eruption.

? Changes in behavior, such as nervousness, insomnia, mood changes, and depression.

? Palpitations.

? Menstrual disorders.

? Low potassium levels in the blood.

? Cushingoid features such as rounded face, acne, weight gain, and easy bruising.

Uncommon: may affect up to 1 in 100 people

? Involuntary movements or extreme restlessness, possibly accompanied by muscle spasms or twitching.

? Anxiety.

? Tremor.

Rare: may affect up to 1 in 1,000 people

? Adrenal gland disorder (a small gland near the kidney).

  • Aggression.
  • Cataracts, including posterior subcapsular cataracts.
  • Glaucoma (increased eye pressure).
  • Blurred vision.
  • Changes in skin pigmentation due to internal bleeding.

Very rare: may affect up to 1 in 10,000 people

? Severe allergic reaction (anaphylaxis) that can cause difficulty breathing or shock. ? Delayed growth rate in children and adolescents.

Frequency not known: cannot be estimated from the available data

  • Allergic reactions that can cause swelling of the face, especially the eyelids, lips, tongue, or throat (angioedema).

Medicines like Entocord (corticosteroids) can affect the normal production of steroid hormones in your body. The effects include:

? Changes in bone mineral density (thinning of the bones).

? Glaucoma (increased eye pressure).

? Reduced growth rate in children and adolescents.

? Adrenal gland disorder (a small gland near the kidney).

Most of the side effects mentioned in this list can also be expected with treatment with other glucocorticoids.

Do not be alarmed by this list of side effects. You may not experience any of them. If you experience any side effect that is severe or if you notice any side effect not mentioned in this leaflet, tell your doctor, pharmacist, or nurse.

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Entocord 3 mg Capsules

Keep this medicine out of the sight and reach of children.

Store the capsules in the original package to protect them from moisture. The package should be closed tightly after use to protect the capsules from moisture. No special storage conditions are required.

Do not use this medicine after the expiry date stated on the package after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste.

Deposit the packages and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Entocord 3 mg Capsules

The active substance is budesonide. Each capsule contains 3 mg of budesonide.

The other ingredients (excipients) are: ethylcellulose, acetyltributyl citrate, methacrylic acid copolymer type C, triethyl citrate (E-1505), antifoam M, polysorbate 80 (E-433), talc (E-553b), and sugar spheres (sucrose and cornstarch).

The gelatin capsule is composed of: gelatin, titanium dioxide (E-171), black iron oxide (E172), sodium lauryl sulfate, colloidal silica, food-grade oil, red iron oxide (E-172), and yellow iron oxide (E-172).

The printing ink is composed of: lacquer, black iron oxide (E-172), ammonium hydroxide, and potassium hydroxide.

Appearance of the product and contents of the pack

Entocord 3 mg is presented in the form of hard, modified-release capsules. Each package contains 50 capsules.

Marketing authorization holder and manufacturer

Marketing authorization holder:

TILLOTTS PHARMA GMBH

Warmbacher Strasse 80

Rheinfelden DE-79618

Germany

Manufacturer:

AstraZeneca AB

151 85 Södertälje

Sweden

Or

Astrea Fontaine SAS

Rue des Prés Potets

21121 Fontaine-les-Dijon

France

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

TILLOTTS PHARMA SPAIN, S.L.U.

Travessera de Gràcia 58, 5º 3ª

08006, Barcelona

Spain

Date of the last revision of this leaflet:July 2023

Other sources of information

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

Online doctors for ENTOCORD 3 mg MODIFIED-RELEASE CAPSULES

Discuss questions about ENTOCORD 3 mg MODIFIED-RELEASE CAPSULES, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Doctor

Hocine Lokchiri

General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

  • fever, chills, fatigue and viral symptoms
  • cough, sore throat, nasal congestion, breathing discomfort
  • bronchitis and mild asthma flare-ups
  • nausea, diarrhoea, abdominal pain, digestive infections
  • rashes, allergic reactions, redness, insect bites
  • muscle or joint pain, mild injuries, sprains
  • headache, dizziness, migraine symptoms
  • stress-related symptoms, sleep disturbances
  • questions about test results and treatment plans
  • management of chronic conditions in stable phases
Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

Some situations are not suitable for online care. If a patient has loss of consciousness, severe chest pain, uncontrolled bleeding, seizures, major trauma or symptoms suggesting a stroke or heart attack, he will advise seeking immediate local emergency services. This improves safety and ensures patients receive the right level of care.

Dr. Lokchiri’s professional training includes:

  • Advanced Trauma Life Support (ATLS)
  • Basic and Advanced Cardiac Life Support (BLS/ACLS)
  • Pediatric Advanced Life Support (PALS)
  • Prehospital Trauma Life Support (PHTLS)
  • eFAST and critical care transthoracic echocardiography
  • aviation medicine
He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.
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Doctor

Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise:

  • Acute and chronic pain: headaches, muscle and joint pain, back pain, abdominal pain, postoperative pain. Identifying the cause, selecting treatment, and creating a care plan.
  • Internal medicine: heart, lungs, gastrointestinal tract, urinary system. Management of chronic conditions, symptom control, second opinions.
  • Pre- and postoperative care: risk assessment, decision-making support, follow-up after surgery, rehabilitation strategies.
  • General and paediatric surgery: hernias, appendicitis, congenital conditions, both planned and urgent surgeries.
  • Injuries and trauma: bruises, fractures, sprains, soft tissue damage, wound care, dressing, referral when in-person care is required.
  • Oncological surgery: diagnosis review, treatment planning, and long-term follow-up.
  • Obesity treatment and weight management: a medical approach to weight loss, including assessment of underlying causes, evaluation of comorbidities, development of a personalised plan (nutrition, physical activity, pharmacotherapy if needed), and ongoing progress monitoring.
  • Imaging interpretation: analysis of ultrasound, CT, MRI, and X-ray results, surgical planning based on imaging data.
  • Second opinions and medical navigation: clarifying diagnoses, reviewing current treatment plans, helping patients choose the best course of action.

Experience and qualifications:

  • 12+ years of clinical experience in university hospitals in Germany and Spain.
  • International education: Ukraine – Germany – Spain.
  • Member of the German Society of Surgeons (BDC).
  • Certified in radiological diagnostics and robotic surgery.
  • Active participant in international medical conferences and research.

Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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Doctor

Anna Biriukova

General medicine 6 years exp.

Dr Anna Biriukova is an internal medicine doctor with clinical experience in cardiology, endocrinology, and gastroenterology. She provides online consultations for adults, offering expert medical support for heart health, hormonal balance, digestive issues, and general internal medicine.

Cardiology – Diagnosis and treatment of:

  • High blood pressure, blood pressure fluctuations, and cardiovascular risk prevention.
  • Chest pain, shortness of breath, arrhythmias (tachycardia, bradycardia, palpitations).
  • Leg swelling, chronic fatigue, reduced exercise tolerance.
  • EKG interpretation, lipid profile evaluation, cardiovascular risk assessment (heart attack, stroke).
  • Post-COVID-19 cardiac monitoring and care.
Endocrinology – Diabetes, thyroid, metabolism:
  • Diagnosis and management of type 1 and type 2 diabetes, and prediabetes.
  • Individual treatment plans including oral medications and insulin therapy.
  • GLP-1 therapy– modern pharmacological treatment for weight management and diabetes control, including drug selection, monitoring, and safety follow-up.
  • Thyroid disorders – hypothyroidism, hyperthyroidism, autoimmune thyroid diseases (Hashimoto’s, Graves’ disease).
  • Metabolic syndrome – obesity, lipid disorders, insulin resistance.
Gastroenterology – Digestive health:
  • Abdominal pain, nausea, heartburn, gastroesophageal reflux (GERD).
  • Stomach and intestinal conditions: gastritis, irritable bowel syndrome (IBS), indigestion.
  • Management of chronic digestive disorders and interpretation of tests (endoscopy, ultrasound, labs).
General internal medicine and preventive care:
  • Respiratory infections – cough, colds, bronchitis.
  • Lab test analysis, therapy adjustments, medication management.
  • Adult vaccinations – planning, contraindications assessment.
  • Cancer prevention – screening strategies and risk assessment.
  • Holistic approach – symptom relief, complication prevention, and quality of life improvement.
Dr Biriukova combines internal medicine with specialist insight, offering clear explanations, personalised treatment plans, and comprehensive care tailored to each patient.
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€60
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Doctor

Dmytro Horobets

Family medicine 7 years exp.

Dr. Dmytro Horobets is a licensed family medicine physician in Poland, specialising in endocrinology, diabetology, obesity management, gastroenterology, pediatrics, general surgery, and pain medicine. He offers online consultations for adults and children, providing personalised medical support for a wide range of acute and chronic health concerns.

Areas of expertise:

  • Endocrinology: diabetes type 1 and type 2, prediabetes, thyroid disorders, metabolic syndrome, hormonal imbalance.
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  • Gastroenterology: acid reflux (GERD), gastritis, irritable bowel syndrome (IBS), liver and biliary conditions.
  • Pediatric care: infections, respiratory symptoms, digestive issues, growth and development monitoring.
  • General surgery support: pre- and post-surgical consultations, wound care, rehabilitation.
  • Pain management: chronic and acute pain, back pain, joint pain, post-traumatic pain syndromes.
  • Cardiovascular health: hypertension, cholesterol control, risk assessment for heart disease.
  • Preventive medicine: regular check-ups, health screenings, long-term management of chronic conditions.

Dr. Horobets combines evidence-based medicine with a patient-centred approach. He carefully evaluates each patient’s medical history and symptoms, offering clear explanations and structured treatment plans adapted to individual needs.

Whether you need help managing diabetes, tackling weight-related health issues, interpreting lab results, or receiving general family medicine support, Dr. Horobets provides professional online care tailored to your specific health goals.

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€60

Frequently Asked Questions

Is a prescription required for ENTOCORD 3 mg MODIFIED-RELEASE CAPSULES?
ENTOCORD 3 mg MODIFIED-RELEASE CAPSULES requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in ENTOCORD 3 mg MODIFIED-RELEASE CAPSULES?
The active ingredient in ENTOCORD 3 mg MODIFIED-RELEASE CAPSULES is budesonide. This information helps identify medicines with the same composition but different brand names.
How much does ENTOCORD 3 mg MODIFIED-RELEASE CAPSULES cost in pharmacies?
The average pharmacy price for ENTOCORD 3 mg MODIFIED-RELEASE CAPSULES is around 47.39 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures ENTOCORD 3 mg MODIFIED-RELEASE CAPSULES?
ENTOCORD 3 mg MODIFIED-RELEASE CAPSULES is manufactured by Tillotts Pharma Gmbh. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of ENTOCORD 3 mg MODIFIED-RELEASE CAPSULES online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether ENTOCORD 3 mg MODIFIED-RELEASE CAPSULES is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to ENTOCORD 3 mg MODIFIED-RELEASE CAPSULES?
Other medicines with the same active substance (budesonide) include ENTOCORD 2 mg TABLETS AND SOLUTION FOR RECTAL SUSPENSION, INTESTIFALK 2 mg/DOSE RECTAL FOAM, INTESTIFALK 3 mg GASTRO-RESISTANT CAPSULES. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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