ENTOCORD 3 mg MODIFIED-RELEASE CAPSULES

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).

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.

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/