Encorton: detailed information

Package leaflet: information for the patient

Encorton, 1 mg, tablets
Encorton, 5 mg, tablets
Encorton, 10 mg, tablets
Encorton, 20 mg, tablets
Prednisone
Please read this leaflet carefully before using the medicine, as it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

What Encorton is and what it is used for
Important information before taking Encorton
How to take Encorton
Possible side effects
How to store Encorton
Contents of the pack and other information

1. What Encorton is and what it is used for

Prednisone is a synthetic glucocorticoid, an analogue of cortisol. It is an inactive compound, and its clinical significance lies in prednisolone, the metabolite of prednisone formed in the liver, which is a glucocorticoid with strong anti-inflammatory activity. It is generally accepted that 5 mg of prednisone exerts anti-inflammatory activity equivalent to 4 mg of methylprednisolone or triamcinolone, 0.75 mg of dexamethasone, 0.6 mg of betamethasone, and 20 mg of hydrocortisone. Its mineralocorticoid activity amounts to approximately 60% of hydrocortisone's activity.

Prednisolone suppresses the development of inflammatory symptoms without affecting the underlying cause. It inhibits the accumulation of cells at the inflammatory site, reduces capillary distensibility and permeability, thereby preventing edema formation.

Immunosuppressive action:
The mechanisms of immunosuppressive action are not fully understood, but prednisolone may prevent or suppress cellular immune reactions as well as specific mechanisms related to the immune response.

Effect on water-electrolyte balance:
Through its action on the distal tubule, prednisolone enhances sodium reabsorption, potassium and hydrogen ion excretion, and water retention.

Other effects:
Prednisolone inhibits the secretion of adrenocorticotropic hormone (ACTH) by the pituitary gland, leading to reduced production of corticosteroids and androgens in the adrenal cortex.
Prednisolone enhances protein catabolism and induces enzymes involved in amino acid metabolism, potentially resulting in a negative nitrogen balance.
Prednisolone increases glucose availability by inducing hepatic gluconeogenic enzymes, stimulating protein catabolism, and reducing glucose utilization in peripheral tissues. This leads to increased glycogen storage in the liver and elevated blood glucose levels.
Prednisolone enhances the release of free fatty acids from adipose tissue, increasing plasma free fatty acid concentration; prolonged treatment may lead to abnormal fat distribution.
Prednisolone reduces serum calcium levels, which may inhibit bone growth in children and adolescents and contribute to osteoporosis development at any age.
Prednisolone potentiates the effects of endogenous and exogenous catecholamines.

Therapeutic indications:

Endocrine disorders:

Primary adrenal insufficiency (Addison's disease) and secondary adrenal insufficiency (hydrocortisone and cortisone are drugs of choice; synthetic derivatives may be used with mineralocorticoids);
Congenital adrenal hyperplasia;
Hypercalcemia associated with malignancy;
Nonsuppurative thyroiditis.

Severe allergic conditions resistant to other treatments:

Contact dermatitis;
Atopic dermatitis;
Serum sickness;
Drug hypersensitivity reactions;
Perennial or seasonal allergic rhinitis.

Collagen diseases (glucocorticoids are indicated during exacerbations or, in some cases, as maintenance therapy):

Acute rheumatic fever;
Dermatomyositis (in children, glucocorticoids may be the drug of choice);
Systemic lupus erythematosus.

Skin and mucous membrane disorders:

Exfoliative dermatitis;
Bullous pemphigoid;
Severe seborrheic dermatitis;
Severe erythema multiforme (Stevens-Johnson syndrome);
Granuloma faciale;
Pemphigus;
Severe psoriasis.

Gastrointestinal diseases (during exacerbations; long-term treatment is not recommended):

Ulcerative colitis;
Crohn's disease.

Hematological disorders:

Acquired hemolytic anemia (autoimmune);
Congenital aplastic anemia;
Anemia due to pure red cell aplasia;
Secondary thrombocytopenia in adults;
Idiopathic thrombocytopenic purpura (Werlhof's disease) in adults.

Neoplastic diseases (as palliative treatment, in combination with appropriate anticancer therapy):

Leukemias and lymphomas in adults;
Acute leukemia in children.

Nephrotic syndrome:
Glucocorticoids are indicated to induce diuresis or achieve remission in idiopathic nephrotic syndrome without uremia, or to improve renal function in patients with lupus nephritis. In idiopathic nephrotic syndrome, long-term treatment may be necessary to prevent frequent relapses.

Neurological disorders:

Multiple sclerosis during exacerbations.

Ophthalmic diseases (severe acute and chronic allergic and inflammatory conditions):

Iritis;
Iridocyclitis;
Choroiditis and retinitis;
Diffuse posterior uveitis;
Optic neuritis;
Sympathetic ophthalmia;
Anterior segment inflammation;
Allergic conjunctivitis;
Keratitis (not associated with herpes simplex virus infection or fungal infection);
Allergic marginal corneal ulceration.

Respiratory diseases:

Berylliosis;
Löffler's syndrome;
Aspiration pneumonitis;
Symptomatic sarcoidosis;
Fulminant or disseminated pulmonary tuberculosis (concomitant antituberculous treatment required);
Bronchial asthma.

Rheumatic diseases (as adjunctive therapy during exacerbations):

Ankylosing spondylitis;
Psoriatic arthritis;
Rheumatoid arthritis, juvenile rheumatoid arthritis (in cases resistant to other treatments).

Other non-rheumatic musculoskeletal inflammatory conditions:

Acute and subacute bursitis;
Acute gouty arthritis;
Acute nonspecific tenosynovitis;
Traumatic inflammation of bones and joints;
Synovitis in patients with bone and joint inflammation;
Epicondylitis.

Other:

Tuberculous meningitis with subarachnoid block (concomitant antituberculous treatment required);
Trichinosis with myocardial or nervous system involvement.

2. Important information before using Encorton

When not to take Encorton:

if the patient is allergic to prednisone or any of the other ingredients of this medicine (listed in section 6)
if the patient has systemic fungal infections.

Warnings and precautions
Before starting treatment with Encorton, discuss with your doctor or pharmacist if:
The patient suffers from scleroderma (an autoimmune disorder also known as systemic sclerosis), as doses of at least 15 mg per day may increase the risk of a serious complication called scleroderma renal crisis. Symptoms of scleroderma renal crisis include elevated blood pressure and reduced urine output. The treating physician may recommend regular monitoring of blood pressure and urine excretion.
Prednisone is contraindicated in patients with systemic fungal infections due to the risk of worsening the infection. However, in fungal infections treated with amphotericin B, prednisone may occasionally be used to reduce its adverse effects; in such cases, however, it may cause congestive heart failure, cardiac enlargement, and severe hypokalemia (reduced potassium ion concentration in blood).
In patients treated with corticosteroids, increased stress may necessitate administration of a higher dose of a fast-acting glucocorticoid.
Sudden discontinuation of treatment may lead to adrenal insufficiency; therefore, the prednisone dose should be tapered gradually.
Prednisone may mask symptoms of infection, reduce resistance to infection, and impair the body's ability to localize infections. Patients receiving corticosteroids should avoid exposure to chickenpox and measles, as infections with these diseases may have a significantly more severe course.
Long-term use of prednisone may cause cataracts, glaucoma with potential optic nerve damage, and increases the risk of secondary fungal or viral infections.
Prednisone affects water-electrolyte balance. Moderate and high doses may cause increased arterial blood pressure, sodium and water retention, and increased potassium excretion. Dietary sodium restriction and potassium supplementation may then be necessary.
All corticosteroids increase calcium excretion.
Patients treated with prednisone should not be vaccinated with live viral vaccines. Administration of inactivated viral or bacterial vaccines may not produce the expected rise in antibody levels.
The patient treated with prednisone should strictly follow the doctor's instructions.
Discontinuation of treatment after long-term use may cause symptoms of glucocorticoid withdrawal syndrome, such as fever, muscle and joint pain, and malaise. These symptoms may occur even in the absence of adrenal insufficiency.
Prednisone has enhanced effects in patients with hypothyroidism or liver cirrhosis.
Prednisone should be used at the lowest effective doses.
Caution is required when treating with acetylsalicylic acid together with prednisone in patients with hypoprothrombinemia (deficiency of prothrombin in blood).
Prednisone should be used cautiously in ulcerative colitis when there is a risk of perforation (rupture of intestinal wall), abscesses or other purulent infections, intestinal diverticulosis, recent intestinal anastomoses, active or latent peptic ulcer, esophagitis, gastritis, hyperthyroidism or hypothyroidism, renal insufficiency, arterial hypertension, osteoporosis, myasthenia gravis (muscle weakness), diabetes, impaired liver function, heart disease, congestive heart failure, recent myocardial infarction, or glaucoma.
Contact your doctor immediately if, during prednisone treatment, the patient develops muscle weakness, muscle pain, cramps, or stiffness. These may be symptoms of a condition called thyrotoxic periodic paralysis, which may occur in patients with hyperthyroidism treated with prednisone. Additional treatment may be necessary to alleviate this condition.
Prednisone may unmask latent amoebiasis. In individuals arriving from tropical countries or patients with diarrhea of unknown origin, infection with Entamoeba histolytica should be ruled out before initiating glucocorticoid therapy.
Administration of prednisone to patients with active tuberculosis should be limited to cases of disseminated or fulminant tuberculosis and only when combined with antituberculosis therapy.
Use with caution in ophthalmic zoster due to the risk of corneal perforation.
Psychiatric disturbances such as euphoria, insomnia, sudden mood swings, personality changes, severe depression, or psychotic symptoms may occur during prednisone treatment. Pre-existing emotional instability or psychotic tendencies may be exacerbated during therapy.
In patients treated with high doses of prednisone, symptoms of peritonitis may be mild or absent in case of gastrointestinal perforation.
In patients treated with corticosteroids, adrenal function, electrolyte concentrations, blood glucose levels, and prothrombin time (in patients receiving coumarin anticoagulants) should be monitored. Ophthalmological examinations and fecal occult blood testing should also be performed.
If the patient experiences blurred vision or other visual disturbances, contact a doctor.

Children and adolescents
Children receiving long-term treatment should be monitored for growth and developmental disturbances.

Use of Encorton in patients with impaired kidney and/or liver function
The medicine should be used with caution in patients with impaired liver or kidney function.

Use of Encorton in elderly patients
In elderly patients, due to the potential development of arterial hypertension and osteoporosis, the medicine should be used with caution.

Encorton and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use.
Some medicines may enhance the effect of Encorton, and the doctor may wish to closely monitor the patient taking such medicines (including certain HIV medications: ritonavir, cobicistat).
Nonsteroidal anti-inflammatory drugs, alcohol: increased risk of gastrointestinal ulceration and bleeding.
Amphotericin B, carbonic anhydrase inhibitors: hypokalemia (reduced potassium ion concentration in blood), cardiac hypertrophy, congestive heart failure.
Paracetamol: hypernatremia (increased sodium ion concentration in blood), edema, increased calcium excretion, risk of calcium deficiency and osteoporosis, increased risk of paracetamol hepatotoxicity.
Anabolic steroids, androgens: edema, acne.
Cholinolytic drugs, mainly atropine: increased intraocular pressure.
Anticoagulants, coumarin derivatives, indandione derivatives, heparins, streptokinase, urokinase: reduced or, in some patients, increased effectiveness; increased risk of gastrointestinal ulceration and bleeding.
Tricyclic antidepressants may exacerbate psychiatric disturbances associated with prednisone use.
Oral antidiabetic drugs, insulin: reduced antidiabetic effect.
Medicines used in hyperthyroidism, thyroid hormones: altered thyroid function; dose adjustment or discontinuation of the medicine used for hyperthyroidism or thyroid hormone may be necessary.
Asparaginase: enhanced hyperglycemic effect (increased blood glucose) of asparaginase.
Oral contraceptives containing estrogens: estrogens enhance the effect of prednisone.
Cardiac glycosides: increased risk of cardiac arrhythmias and glycoside toxicity.
Diuretics: reduced diuretic effect, hypokalemia (reduced potassium ion concentration in blood).
Folic acid: increased requirement for this medicine.
Immunosuppressive drugs: increased risk of infection, development of lymphomas and other lymphoproliferative disorders.
Isoniazid: reduced isoniazid plasma concentration; dose modification may be necessary.
Mexiletine: accelerated mexiletine metabolism and reduced plasma concentration.
Mitotane: inhibits adrenal cortex function; during mitotane treatment, glucocorticoid administration is usually necessary, but in higher than usual doses.
Sodium: edema, elevated arterial blood pressure; sodium restriction and avoidance of sodium-rich medications may be necessary; glucocorticoid supplementation sometimes requires additional sodium administration.
Vaccines containing live viruses: during immunosuppressive doses of glucocorticoids, viral diseases may develop and vaccine efficacy may be reduced.
Other vaccines: increased risk of neurological complications and reduced antibody production.
Enzyme-inducing agents: reduced potency of glucocorticoids.
Ephedrine may accelerate glucocorticoid metabolism.
Non-depolarizing neuromuscular blocking agents: hypokalemia associated with prednisone use may exacerbate neuromuscular blockade, leading to prolonged respiratory depression and paralysis.
Salicylates: increased salicylate excretion, reduced plasma concentrations, risk of gastrointestinal ulceration and bleeding.
Potassium: glucocorticoid use causes reduced potassium ion concentration in blood.

Encorton with food and drink
Take during meals.
Do not divide tablets.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor before using this medicine.
There are no adequately sized, controlled studies in humans. Animal studies have shown corticosteroids to increase the incidence of cleft palate, miscarriage, placental insufficiency, and fetal growth retardation. Although suspicions about teratogenic effects of corticosteroids in humans have not been confirmed, data indicate increased risk of placental insufficiency, low birth weight, and fetal death in women who received glucocorticoids during pregnancy. General use of corticosteroids in pregnant women is acceptable only when the benefit outweighs the potential risk to the fetus.
Treatment with prednisone doses up to 5 mg per day is considered not to cause adverse effects in the child. However, higher doses may cause growth retardation or suppression of endogenous adrenal hormone secretion in the child. If higher doses are required during lactation, breastfeeding should be discontinued.

Driving and operating machinery
Some adverse effects (seizures, dizziness and headaches, blurred or double vision, psychiatric disturbances) may impair the ability to drive, operate machinery, or affect psychophysical performance.

Encorton contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Encorton

This medicine should always be used according to the doctor's instructions. In case of doubt, consult your doctor.
The doctor determines the dose individually, depending on the type of disease and response to treatment. After achieving the desired therapeutic effect, the dose should be gradually reduced to the lowest effective dose. The dose should also be tapered gradually before planned discontinuation. In cases of long-term high-dose treatment, tapering may begin by reducing the dose by 1 mg monthly; in short-term treatment, by 2–5 mg every 2–7 days. Prednisone administered at doses up to 40 mg per day for less than 7 days can be discontinued without risk of hypothalamic-pituitary-adrenal axis suppression.
To minimize the risk of hypothalamic-pituitary-adrenal axis suppression, the medicine is recommended to be taken once daily in the morning, as endogenous corticosteroid secretion is highest in the morning. However, in some cases, more frequent administration of prednisone may be necessary.

Typical doses:
Adults and adolescents: 5 mg to 60 mg per day, as a single dose or divided doses, up to a maximum of 250 mg per day.
Children: usual doses in children: 2 mg per kg body weight per day, in divided doses every 6 or 8 hours, or as a single daily dose.

Multiple sclerosis during relapse: Adults: 200 mg per day for 7 days, then 80 mg every other day for 1 month.
Nephrotic syndrome: Children up to 18 months: dose not established.
Children aged 18 months to 4 years: initially 7 mg to 10 mg four times daily.
Children aged 4 to 10 years: initially 15 mg four times daily.
Children over 10 years: initially 20 mg four times daily.
Rheumatic fever, leukemia, tumors: Children: for the first 2 or 3 weeks: 0.5 mg per kg body weight or 15 mg per m² body surface area four times daily; then 0.375 mg per kg body weight or 11.25 mg per m² body surface area four times daily for 4 to 6 weeks.
Tuberculosis (with concomitant antituberculosis treatment): Children: 0.5 mg per kg body weight or 15 mg per m² body surface area four times daily for two months. The medicine should be tapered off gradually.

Taking more Encorton than recommended
Even very high doses of corticosteroids do not usually cause symptoms of acute overdose. Reports of acute poisoning with these substances are lacking. Long-term use of corticosteroids may cause numerous disturbances characteristic of excessive adrenal cortex hormone activity, including psychiatric disturbances, abnormal fat deposition, fluid retention, weight gain, hirsutism, acne, striae, elevated blood pressure, immune disturbances, osteoporosis, and peptic ulcer. In acute overdose, gastric emptying via emesis or lavage is recommended. There is no specific antidote. Treatment of acute overdose consists of supportive care to maintain vital functions.
If more than the recommended dose has been taken, seek medical advice immediately from a doctor or pharmacist.

Missed dose of Encorton
If a dose is missed, take the medicine as soon as possible. If the next dose is approaching, skip the missed dose. Do not take a double dose to make up for a missed dose.

Stopping Encorton treatment
Discontinuation of treatment after long-term use may cause symptoms of glucocorticoid withdrawal syndrome, such as fever, muscle and joint pain, and malaise.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Short-term use of prednisone, as with other corticosteroids, rarely leads to adverse reactions.
The risk of the adverse reactions listed below primarily concerns patients receiving long-term prednisone treatment.
The frequency of occurrence of adverse reactions has been defined as follows:
Frequency unknown (cannot be estimated from available data):

Renal crisis in patients with scleroderma (an autoimmune disorder). Symptoms of scleroderma renal crisis include elevated blood pressure and reduced urine production.
Menstrual cycle disturbances; Cushing's syndrome; growth suppression in children; secondary adrenal and pituitary insufficiency, particularly under stressful conditions; onset of diabetes mellitus and increased insulin requirement and oral antidiabetic drugs in patients with overt diabetes; hirsutism (excessive male-pattern hair growth in women).
Negative nitrogen balance, increased blood and urinary glucose levels, increased body weight, increased appetite.
Psychiatric disturbances, most commonly occurring within the first 2 weeks of treatment; symptoms such as schizophrenia, mania or delirium may occur; observed in 15 to 50% of patients; dose-dependent, most frequently seen in patients treated with 40 mg prednisone per day; women and patients with systemic lupus erythematosus are most susceptible to these symptoms.
Seizures; increased intracranial pressure with optic disc swelling; dizziness and headache.
Cataract; increased intraocular pressure; glaucoma (usually after at least 1 year of treatment); exophthalmos, blurred vision.
Thromboembolic events.
Peptic ulcer and its complications: perforations, hemorrhages; perforation of the large or small intestine, particularly in patients with intestinal inflammatory conditions; pancreatitis; abdominal distension; erosive esophagitis; digestive disturbances.
Skin striae, acne, impaired wound healing; petechiae and hemorrhages.
Hemorrhages; erythema; excessive sweating. Other skin reactions: allergic dermatitis, urticaria, angioedema.
Muscle weakness, steroid myopathy, loss of muscle mass, osteoporosis, compression fractures of the spine, pathological fractures of long bones, aseptic necrosis of the femoral and humeral heads.
Bradycardia.

Other adverse reactions:
Hypersensitivity reactions; nausea; malaise; sleep disturbances, sodium and fluid retention,
congestive heart failure, potassium loss, hypokalemic alkalosis (increased blood pH due to potassium deficiency), hypertension.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49-21-301, fax: +48 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Encorton

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Store below 25°C. Keep in the original packaging to protect from light and moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Encorton contains

The active substance is prednisone. Each tablet contains 1 mg, 5 mg, 10 mg, or 20 mg of prednisone, respectively.
The other ingredients are: monohydrate lactose, potato starch, magnesium stearate, gelatin.

What Encorton looks like and contents of the pack
Encorton 1 mg: white or almost white, smooth, uniformly surfaced, round, biconvex tablets with the imprint "∆" on one side. The pack contains 20 tablets.
Encorton 5 mg: white or almost white, smooth, uniformly surfaced, round, biconvex tablets with the imprint "∆" on one side. The pack contains 20 or 100 tablets.
Encorton 10 mg: white or almost white, smooth, uniformly surfaced, round, biconvex tablets with the imprint "─" on one side. The pack contains 20 or 40 tablets.
Encorton 20 mg: white or almost white, smooth, uniformly surfaced, round, biconvex tablets with the imprint "+" on one side. The pack contains 20 tablets.

Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Tel: +48 22 732 77 00

Manufacturer
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów