Package Leaflet: Information for the Patient

Entocord 3 mg Modified Release Capsules

budesonide

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this package leaflet. See section 4.

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

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

3. How to take Entocord 3 mg Capsules

4. Possible side effects

5. Storage of Entocord 3 mg Capsules

6. Contents of the pack and additional information

Entocord (budesónida) 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 variant of collagenous and lymphocytic colitis(a chronic inflammation of the large intestine, which causes chronic watery diarrhea).

Do not take Entocord 3 mg capsules

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Entocord.

You must inform your doctor of 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), 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, temporary symptoms that may have bothered you previously may reappear, such as skin rashes, muscle and joint pain. If any of these symptoms bother you, or if you experience symptoms such as headaches, fatigue, nausea, or vomiting, please contact your doctor.

Children and adolescents

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

Other medications and Entocord 3 mg capsules

Inform your doctor, pharmacist, or nurse if you are taking, have taken recently, or may need to take any other medication.

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

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

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

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

Taking Entocord 3 mg capsules with food and drinks

During treatment with Entocord, it is recommended to 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, or think you may be pregnant, or plan to become pregnant, consult your doctor, pharmacist, or nurse before using this medication.

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

Driving and operating machinery

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

Entocord 3 mg capsules contain saccharose and sodium

Entocord contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

If you are an athlete, you should be aware that this medication contains a component that may result in a positive analytical result for doping control.

Follow exactly the administration instructions of this medication 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. Follow your doctor's instructions carefully. These instructions may be different from the information contained in this leaflet.

The administration route of Entocord is oral. Entocord capsules should be swallowed whole with water. For children and adults with difficulty swallowing, the capsules can be opened and the contents ingested after mixing it with a spoonful of apple sauce. It is essential that the contents of the capsules 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 8 years of age and older, with a body weight of over 25 kg. The dose is administered once a day, in the morning. Treatment usually lasts up to 8 weeks. Once symptoms are under control, treatment should be adjusted to the lowest effective dose. Experience in children is limited.

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

Treatment with Entocord capsules should be gradually reduced before its suspension.

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 usually achieved within 2-4 weeks. Do not forget to take Entocord doses even if you start feeling 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Entocord 3 mg capsules

If you occasionally forget to take some dose of Entocord, do not compensate for the missed dose, simply continue with the next dose as prescribed.

Do not take a double dose to compensate for missed doses.

If you have any other doubts about the use of this medication, ask your doctor, pharmacist or nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

Other possible side effects:

Frequent: may affect up to 1 in 10 people

?Stomach or intestinal pain, such as stomach pain, flatulence, diarrhea, stomach burning, and feeling unwell.

?Muscle cramps.

?Skin reactions, such as pustular 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.

Rare: may affect up to 1 in 100 people

?Uncontrollable movements or extreme restlessness, possibly accompanied by spasms or muscle twitches.

?Anxiety.

?Tremors.

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

?Alteration in the adrenal gland (a small gland near the kidney).

• Aggression.
• Opacity of the natural lens of the eye including the posterior part (cataracts).
• Glaucoma (increased intraocular pressure).
• Blurred vision.
• Alteration of skin color as a result of internal bleeding.

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

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

Unknown frequency: cannot be estimated from available data

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

Medicines like Entocord (corticosteroids) may affect the normal production of steroid hormones in your body. Effects include:

?Changes in bone mineral density (bone thinning).

?Glaucoma (increased intraocular pressure).

?Decreased growth rate in children and adolescents.

?Alteration in the adrenal gland (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 consider any of the side effects you experience to be severe or if you notice any side effect not mentioned in this prospectus, inform your doctor, pharmacist, or nurse.

Reporting of side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not appearing in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash.

Deposit the packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Entocord 3 mg capsules

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

The other components (excipients) are: ethylcellulose, acetate tributyl citrate, copolymer of methacrylic acid type C, triethyl citrate (E-1505), antifoaming agent 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), iron oxide black (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, iron oxide black (E-172),ammonium hydroxideand potassium hydroxide.

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

TILLOTTS PHARMA GMBH

Warmbacher Strasse 80

Rheinfelden DE-79618

Germany

Responsible 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 medication by contacting the local representative of the holder of the marketing authorization:

TILLOTTS PHARMA SPAIN, S.L.U.

Gran Via de les Corts Catalanes 680, 1º1ª

08010, Barcelona

Spain

Last review date of this leaflet:July 2023

Other sources of information

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/