Entocord 3 mg modified-release capsules

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

Entocord 3 mg modified-release capsules

budesonide

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Entocord 3 mg capsules are and what they are used for
2. What you need to know before taking Entocord 3 mg capsules
3. How to take Entocord 3 mg capsules
4. Possible adverse effects
5. How to store 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 (intestinal inflammation localized in 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 variants (a disease with chronic inflammation of the large intestine that causes chronic watery diarrhoea).

2. What you need to know before taking Entocord 3 mg capsules

Do not take Entocord 3 mg capsules

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, pharmacist, or nurse before starting to take Entocord.

You must always inform your doctor about the following conditions:

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

• If you currently have, have had, or contract any infection, particularly chickenpox or measles.

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

• If you have any eye disorders 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 do so.

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 instructs you to do so.

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

Children and adolescents

There are no long-term treatment data in children and adolescents; regular monitoring of 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 need to take any other medicines.

Certain medicines may interact with Entocord; in such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines.

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

Some medicines may increase the effects of Entocord, and your doctor may wish 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 suppression.

Taking Entocord 3 mg capsules with food and drink

During treatment with Entocord, you should avoid regularly consuming large amounts of grapefruit or grapefruit juice, as grapefruit intake 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 are planning to become pregnant, consult your doctor, pharmacist, or nurse before using this medicine.

Experience with Entocord in pregnant or breastfeeding women is very limited. 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 contains sucrose and sodium

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

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

If you are an athlete, you should be aware that this medicine contains a component that may lead to a positive analytical finding in doping controls.

3. How to take Entocord 3 mg capsules

Follow exactly the instructions for use of this medicine given by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse again.

Your doctor will determine how long you should take Entocord. Do not stop treatment until your doctor tells you to do so, as your doctor may wish to gradually reduce the dose.

The dosage is individualized. Carefully follow your doctor's instructions, as they may differ from the information contained in this leaflet.

The route of administration of Entocord is oral. Entocord capsules must be swallowed whole with water. For children and adults who have difficulty swallowing, the capsules may be opened and the contents taken after mixing with one tablespoon of apple sauce. It is important 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) daily. The dose is administered once daily 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 daily 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) daily in children aged 8 years and older, with a body weight of more than 25 kg. The dose is administered once daily in the morning. Treatment usually lasts up to 8 weeks. Once symptom control has been 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 the elderly is limited.

Note: Full effect is generally achieved within 2–4 weeks. Do not forget to take your doses of Entocord 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Entocord 3 mg capsules

If you occasionally forget to take a dose of Entocord, do not make up for the missed dose. Simply continue with the next dose as prescribed.

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

Other possible adverse effects:

Common: may affect up to 1 in 10 people

? Stomach or intestinal pain, such as stomach aches, flatulence, diarrhoea, heartburn and feeling unwell.

? Cramps.

? Skin reactions, such as lumpy rash and skin rash.

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

? Palpitations.

? Menstrual disorders.

? Low levels of potassium in the blood.

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

Uncommon: may affect up to 1 in 100 people

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

? Anxiety.

? Tremor.

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

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

• Aggression.
• Opacity of the eye's natural lens, including the posterior part (cataracts).
• Glaucoma (increased intraocular pressure).
• Blurred vision.
• Skin discolouration due to internal bleeding.

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

? Severe allergic reaction (called anaphylaxis) which may 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 may cause swelling of the face, especially of the eyelids, lips, tongue, or throat (angioedema).

Medicines such as Entocord (corticosteroids) can affect the normal production of steroid hormones in your body. Effects include:

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

? Glaucoma (increased eye pressure).

? Reduced growth rate in children and adolescents.

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

Most of the adverse effects listed here may also be expected with treatment using other glucocorticoids.

Do not be alarmed by this list of adverse effects. You may not experience any of them. If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not mentioned in this leaflet, inform your doctor, pharmacist, or nurse.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Entocord 3 mg capsules

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

Store the capsules in the original bottle to protect them from moisture. The bottle must be tightly closed after each 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 packaging after EXP. The expiry date refers to the last day of the month indicated.

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

Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers 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 components (excipients) are: ethylcellulose, acetyltributyl citrate, methacrylic acid copolymer type C, triethyl citrate (E-1505), antifoaming agent M, polysorbate 80 (E-433), talc (E-553b) and sugar spheres (sucrose and maize starch).

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

The printing ink consists 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 as modified-release hard capsules. Each pack 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

TILLOTTS PHARMA SPAIN, S.L.U.

Travessera de Gràcia 58, 5th floor, office 3

08006, Barcelona

Spain

Date of the most recent revision of this leaflet: July 2023

Other sources of information

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