Entocort

Leaflet accompanying the packaging: patient information

ENTOCORT,3 mg, prolonged-release capsules, hard
Budesonide

Please read carefully the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, please consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Entocort and what is it used for
• 2. Important information before taking Entocort
• 3. How to take Entocort
• 4. Possible side effects
• 5. How to store Entocort
• 6. Contents of the pack and other information

1. What is Entocort and what is it used for

Budesonide, the active substance of Entocort, belongs to a group of medicines called
glucocorticosteroids. Entocort has a local effect.
Indications for use:

• Mild or moderate Crohn's disease affecting the ileum and/or ascending colon. The exact mechanism of action of glucocorticosteroids in the treatment of Crohn's disease is not fully understood. It is likely to be related to their anti-inflammatory effect.
• Microscopic colitis Entocort is used to treat acute attacks of microscopic colitis (a chronic inflammatory disease of the colon, characterized by long-term watery diarrhea) and for maintenance treatment.

2. Important information before taking Entocort

When not to take Entocort:

• in patients with bacterial, fungal or viral infections,
• in patients allergic to budesonide or any of the other ingredients of the medicine.

Please inform your doctor about any worrying reactions that have occurred after taking a medicine containing budesonide or any of the ingredients listed in section 6.
Please also inform your doctor about any worrying reactions that have occurred after taking other medicines.

Warnings and precautions

Before starting treatment, please inform your doctor about all health problems, especially if you have infections such as tuberculosis, high blood pressure, diabetes, osteoporosis, stomach ulcers, psychosis, heart failure, glaucoma, cataracts, recent intestinal surgery, a family history of diabetes, glaucoma.
Particular care should be taken when treating patients who are being switched from systemic glucocorticosteroids to Entocort. In these patients, adrenal insufficiency may occur. When switching from prednisolone products to Entocort, side effects may occur (see section 4).
If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.
In case of any inflammatory conditions, please inform your doctor. When taking Entocort, patients should avoid contact with people who have chickenpox or shingles. These diseases can be more severe in people taking Entocort.
If Entocort has been prescribed to someone who has previously been treated with other glucocorticosteroid medicines, when switching to Entocort, pre-existing allergic reactions may recur, such as hay fever, rash. In such cases, the patient should consult their doctor, who may prescribe antihistamines.
Patient taking Entocort should consult their doctor before surgery or other stressful situations, as their doctor may recommend additional glucocorticosteroid therapy.
During long-term administration of budesonide in high doses, general glucocorticosteroid effects may occur, such as high cortisol levels in the blood and adrenal insufficiency (see section 4).
Entocort should not be stopped abruptly. If it is necessary to stop taking Entocort, the doctor may recommend gradually reducing the dose. During the dose reduction period, some patients may experience worsening of their condition due to symptoms such as muscle and joint pain, fatigue, headache, nausea, and vomiting. In such cases, the patient should consult their doctor, who may recommend additional medication.

Children and adolescents

Entocort can be used in children over 8 years old and with a body weight over 25 kg.
Caution should be exercised when using Entocort in patients during growth periods. It is recommended to monitor the growth of children and adolescents during treatment. If growth is slowed down, the doctor may reconsider the treatment.

Patient with liver function disorders

Liver function disorders may affect the elimination of glucocorticosteroids. There is a possibility of systemic side effects.
In patients with liver failure, the bioavailability of orally administered budesonide is increased.
In diabetic patients treated with insulin, the dose of insulin may need to be increased if glucocorticosteroids are administered at the same time.

Entocort and other medicines

Please tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Please inform your doctor about the use of the following medicines: ketoconazole and itraconazole (antifungal medicines), HIV protease inhibitors (antiviral medicines, including ritonavir, cobicistat), carbamazepine (a medicine used to treat epilepsy), cimetidine (a medicine used to treat stomach ulcers), estrogens (used to treat hormonal disorders), hormonal contraceptives, cholestyramine (used to treat high cholesterol), antacids.
Some medicines may enhance the effect of Entocort, and your doctor may want to closely monitor your condition when taking such medicines (including some HIV medicines: ritonavir, cobicistat). If concomitant use of budesonide and ketoconazole or itraconazole or an HIV protease inhibitor is unavoidable, the time interval between administration of the doses of the individual medicines should be as long as possible. Additionally, your doctor may consider reducing the dose of budesonide.
Please also inform your doctor about any worrying reactions that have occurred after taking other medicines.
Diagnostic tests of pituitary function may show falsely low values due to adrenal suppression.

Entocort with food and drink

See section 3.

Pregnancy and breastfeeding

Before taking Entocort, please consult your doctor.
During pregnancy and breastfeeding, all medicines should be used with caution.
If a woman taking Entocort becomes pregnant, she should inform her doctor as soon as possible.
Budesonide passes into breast milk. The medicine can be used in breastfeeding women only if, in the doctor's opinion, the expected benefit to the mother is greater than the risk to the baby.

Driving and using machines

Entocort does not affect the ability to drive or use machines.

Entocort contains sucrose

If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.
Entocort contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per maximum daily dose (3 tablets), i.e. the medicine is considered "sodium-free"

3. How to take Entocort

This medicine should always be taken exactly as prescribed by your doctor. In case of doubt, please consult your doctor.
The dose of Entocort is determined individually for each patient.
Entocort capsules should be swallowed whole and taken with water. They should not be chewed or crushed.
Patient who may have difficulty swallowing the capsule whole may open it and, after gently mixing the contents with a tablespoon of apple juice, drink it. Grapefruit juice should be avoided during treatment with Entocort, as it increases the bioavailability of budesonide. Other juices and fruits do not have this effect.

Most commonly recommended dosing in adults

Crohn's disease
Treatment in case of exacerbation of symptoms: the recommended dose is 9 mg (3 capsules) once a day. In most cases, this dose of the medicine is used for up to 8 weeks. Long-term treatment: the recommended dose is 6 mg per day (2 capsules). Depending on the severity of the disease, the doctor may change the dose of Entocort.
Do not stop taking the medicine without consulting your doctor, even if the symptoms of the disease have disappeared or decreased.
Microscopic colitis
In acute attack of the disease, the dose is 9 mg (3 capsules) once a day, taken in the morning, for a period of 8 weeks. It is recommended to gradually reduce the dose over the last two weeks of treatment.
Maintenance treatment may be initiated by the doctor only in case of recurrence of symptoms of microscopic colitis, not in the first episode of symptoms.
Recommended dose: 6 mg (2 capsules) once a day, taken in the morning, with the possibility of reducing the dose to 3 mg (1 capsule) in stable, asymptomatic patients.
Treatment can be continued for up to 9 months, with gradual dose reduction.

Use in children and adolescents

The recommended daily dose in mild or moderate Crohn's disease in children over 8 years old and with a body weight over 25 kg is 9 mg (3 capsules). The medicine can be used at this dose for no longer than 8 weeks. The full therapeutic effect is usually achieved within 2 to 4 weeks.
There is no experience with the use of Entocort for a period longer than 12 weeks.

Elderly patients

The same doses as for adult patients are recommended. However, clinical experience with the use of Entocort in elderly patients is limited.
Warning.If Entocort replaces another glucocorticosteroid medicine that has been used so far (e.g. prednisone, prednisolone or methylprednisolone), symptoms that have already occurred may recur, such as rash, muscle pain, joint pain. If one of these symptoms occurs or new symptoms appear, such as headache, fatigue, nausea or vomiting, the patient should contact their doctor as soon as possible.
In order to properly replace prednisolone in steroid-dependent patients, a dose of 6 mg (2 capsules) once a day is recommended. After starting Entocort, the prednisolone dose should be gradually reduced until it is completely discontinued.

Use of a higher than recommended dose of Entocort

Always follow your doctor's instructions strictly. If Entocort has been taken in a single dose higher than recommended, no worrying symptoms should occur. If Entocort is taken for a long time (a month or longer) in a dose higher than recommended, side effects may occur (see section 4). Rare cases of acute overdose or death have been reported after overdosing on glucocorticosteroids.
In case of taking a higher dose of the medicine than recommended, please consult your doctor or pharmacist immediately.

Missing a dose of Entocort

Entocort should be taken as prescribed by your doctor, regularly at the same time. If a dose of the medicine is missed, the next dose prescribed by the doctor should be taken at the usual time.
A double dose should not be taken to make up for a missed dose.
Entocort should always be taken as prescribed by your doctor.

Stopping Entocort treatment

See "Warnings and precautions" in section 2.
In case of any further doubts about the use of this medicine, please consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects occur with the following frequency:
common (less than 1 in 10 treated patients)

• irregular or rapid heartbeat (palpitations),
• suppression of adrenal hormone secretion (weakness, fatigue, weight loss, menstrual disorders),
• symptoms characteristic of Cushing's syndrome (facial and truncal obesity, purple striae),
• gastrointestinal disorders,
• decreased potassium levels in the blood,
• muscle cramps,
• behavioral changes such as nervousness, insomnia, mood changes and depression,
• menstrual disorders,
• skin reactions (hives, rash),
• reduced immunity to infections.

uncommon (less than 1 in 100 treated patients)

• tremors,
• restlessness
• motor hyperactivity,

rare (less than 1 in 1,000 treated patients):

• aggression,
• glaucoma (a disease of the eye characterized by progressive and irreversible damage to the optic nerve, leading to impaired or lost vision),
• cataract (clouding of the eye's natural lens, also the posterior part of the lens),
• purpura (small red, brown or purple spots on the skin or mucous membranes resulting from bleeding under the skin),
• blurred vision

very rare (less than 1 in 10,000 treated patients):

• growth retardation,
• anaphylactic reactions (severe allergic reactions causing difficulty breathing or dizziness).

frequency not known (frequency cannot be estimated from the available data):

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

Additionally, the following may occur: edema, hypertension, skin atrophy, impaired wound healing, sodium retention, increased gluconeogenesis, catabolic effects, osteoporosis, muscle wasting, reactivation of infections (e.g. tuberculosis), disorders of carbohydrate metabolism, exacerbation of mental disorders, glaucoma, cataracts, thrombosis, mild intracranial hypertension. The occurrence of these side effects depends on the dose, duration of treatment, and individual sensitivity.
Most of the listed side effects can also be expected during treatment with other glucocorticosteroids.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, please tell your doctor or pharmacist.
Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, Medical Devices and Biocides of the Office for Registration of Medicinal Products, Medical Devices and Biocides, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: + 48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help to gather more information on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Entocort

Keep the medicine out of the sight and reach of children.
The medicine should be stored in its original packaging. After removing a capsule, the container should be tightly closed.
Store at a temperature below 30°C.
Do not use this medicine after the expiry date stated on the packaging after EXP.
Medicines should not be disposed of via wastewater or household waste. Please ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Entocort contains

The active substance of Entocort is budesonide. One capsule contains 3 mg of budesonide.
The other ingredients of the medicine are: ethylcellulose, tributyl acetylcitrate, methacrylic acid copolymer type C, triethyl citrate, anti-caking agent, polysorbate 80, talc, sugar pellets (sucrose + corn starch), gelatin, sodium lauryl sulfate, edible oil, silicon dioxide, iron oxide red (E 172), iron oxide black (E 172), iron oxide yellow (E 172),
titanium dioxide (E 171). The composition of the ink used for printing on the capsules: shellac, iron oxide black, potassium hydroxide, ammonium hydroxide.

What Entocort looks like and contents of the pack

Prolonged-release capsule, hard, body light gray, cap pink. The cap of the capsule has a black inscription: "CIR 3 mg".
A polypropylene container containing 100 capsules, placed in a cardboard box.

Marketing authorization holder

Tillotts Pharma GmbH
Warmbacher Strasse 80
79618 Rheinfelden
Germany

Manufacturer

Astrea Fontaine
Rue des Près Potets
21121 Fontaine-lès-Dijon
France

Date of last revision of the leaflet: