Encorton

Package Leaflet: Information for the Patient

Encorton, 1 mg, 5 mg, 10 mg or 20 mg, tablets
Prednisonum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet:

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

1. What is Encorton and what is it used for

Prednisone is a synthetic glucocorticosteroid, an analogue of cortisol. It is an inactive compound, and its clinical significance is due to the metabolite of prednisone produced in the liver - prednisolone, a glucocorticosteroid with strong anti-inflammatory action. It is assumed that 5 mg of prednisone has an anti-inflammatory effect equivalent to 4 mg of methylprednisolone or triamcinolone, 0.75 mg of dexamethasone, 0.6 mg of betamethasone, and 20 mg of hydrocortisone. Its mineralocorticosteroid action is about 60% of the activity of hydrocortisone. Prednisolone inhibits the development of inflammation symptoms without affecting its cause. It inhibits the accumulation of cells in the inflammatory focus. It causes a decrease in the extensibility and permeability of blood vessels, leading to the inhibition of edema formation. Immunosuppressive action: The mechanisms of immunosuppressive action are not fully understood, but prednisolone may prevent or inhibit cellular immune responses as well as specific mechanisms related to the immune response. Effect on water and electrolyte balance: Prednisolone, by acting on the distal tubule, increases sodium reabsorption, potassium and hydrogen ion excretion, and water retention. Other actions: Prednisolone inhibits the secretion of adrenocorticotropic hormone (ACTH) by the pituitary gland, leading to a decrease in the production of corticosteroids and androgens in the adrenal cortex. Prednisolone enhances protein breakdown and induces enzymes involved in amino acid metabolism, which may lead to a negative nitrogen balance. Prednisolone increases glucose availability by inducing gluconeogenic enzymes in the liver, stimulating protein catabolism, and reducing glucose uptake in peripheral tissues. This leads to increased glycogen accumulation in the liver and increased blood glucose levels. Prednisolone enhances the release of fatty acids from adipose tissue, which increases the level of fatty acids in the blood, and after long-term treatment, it may lead to abnormal fat distribution. Prednisolone reduces blood calcium levels, leading to inhibition of bone growth in children and adolescents and the development of osteoporosis at any age. Prednisolone enhances the action of endogenous and exogenous catecholamines. Indications: Endocrine disorders:

• Primary (Addison's disease) and secondary adrenal insufficiency (hydrocortisone and cortisone are the drugs of choice, synthetic derivatives may be used with mineralocorticoids);
• Congenital adrenal hyperplasia;
• Hypercalcemia associated with malignant disease;
• Thyroiditis (non-suppurative).

Severe allergic diseases, resistant to other treatment methods:

• Contact dermatitis;
• Atopic dermatitis;
• Psoriasis;
• Drug hypersensitivity reactions;
• Year-round or seasonal allergic rhinitis.

Collagen diseases (glucocorticosteroids are indicated in periods of exacerbation or as maintenance therapy in some cases):

• Acute rheumatic heart disease;
• Dermatomyositis (in children, glucocorticosteroids may be the drug of choice);
• Systemic lupus erythematosus.

Skin and mucous membrane diseases:

• Psoriatic erythroderma;
• Herpes simplex;
• Severe seborrheic dermatitis;
• Severe erythema multiforme (Stevens-Johnson syndrome);
• Granuloma fungoides;
• Pemphigus;
• Severe psoriasis.

Gastrointestinal diseases (in periods of exacerbation; long-term treatment is not recommended):

• Ulcerative colitis;
• Crohn's disease.

Blood system diseases:

• Acquired hemolytic anemia (autoimmune);
• Congenital aplastic anemia;
• Anemia due to selective hypoplasia of the red blood cell system;
• Secondary thrombocytopenia in adults;
• Idiopathic thrombocytopenic purpura (Werlhof's disease) in adults.

Oncological diseases (as palliative treatment, including appropriate anti-cancer treatment):

• Leukemias and lymphomas in adults;
• Acute leukemia in children.

Nephrotic syndrome. Glucocorticosteroids 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 diseases:

• Multiple sclerosis during exacerbations.

Eye diseases (severe, acute, and chronic allergic and inflammatory processes):

• Uveitis;
• Iritis and iridocyclitis;
• Choroiditis;
• Diffuse posterior uveitis;
• Optic neuritis;
• Sympathetic uveitis;
• Anterior uveitis;
• Allergic conjunctivitis;
• Keratitis (not associated with herpes simplex virus or fungal infection);
• Allergic marginal keratitis.

Respiratory diseases:

• Berylliosis;
• Löffler's syndrome;
• Aspiration pneumonia;
• Symptomatic sarcoidosis;
• Fulminant or disseminated pulmonary tuberculosis (with concurrent anti-tuberculosis treatment);
• Asthma.

Rheumatic diseases (as supportive treatment during exacerbations):

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

Other non-rheumatological inflammatory conditions of the musculoskeletal system:

• Acute and subacute bursitis;
• Acute gouty arthritis;
• Acute non-specific tenosynovitis;
• Post-traumatic arthritis and arthrosis;
• Synovitis in patients with arthritis;
• Epicondylitis.

Others:

• Tuberculous meningitis with blockage of the subarachnoid space (with concurrent anti-tuberculosis treatment);
• Trichinosis with cardiac or nervous system involvement.

2. Important Information Before Taking Encorton

When Not to Take Encorton:

• If the patient is allergic to prednisone or any other component of this medicine (listed in section 6)
• If the patient has a systemic fungal infection.

Warnings and Precautions

Before starting treatment with Encorton, discuss with your doctor or pharmacist if: You have 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. The symptoms of scleroderma renal crisis include increased blood pressure and decreased urine production. Your doctor may recommend regular blood pressure and urine output checks. Prednisone is contraindicated in patients with systemic fungal infections, due to the risk of exacerbating the infection. In fungal infections treated with amphotericin B, it may sometimes be used to reduce its side effects, but in these cases, it may cause congestive heart failure and cardiac enlargement, as well as severe hypokalemia (decreased potassium levels in the blood). In patients treated with corticosteroids, increased stress may require the administration of an increased dose of a rapidly acting glucocorticosteroid. Sudden discontinuation of treatment may lead to adrenal insufficiency, so the prednisone dose should be gradually reduced. Prednisone may mask infection symptoms, reduce immunity to infection, and the ability to localize it. Patients treated with corticosteroids should avoid exposure to chickenpox and measles, as the course of these diseases is significantly more severe. Long-term use of prednisone may lead to cataracts, glaucoma with possible optic nerve damage, and increased risk of secondary fungal or viral infections. Prednisone affects water and electrolyte balance. Medium and high doses of the medicine may cause increased blood pressure, sodium and water retention, and increased potassium excretion. It may then be necessary to restrict sodium intake and supplement potassium. All corticosteroids increase calcium excretion. Patients treated with prednisone should not be vaccinated with live viral vaccines. The administration of inactivated viral or bacterial vaccines may not result in the expected increase in antibodies. Patients treated with prednisone should strictly follow the doctor's instructions. Discontinuation of treatment after long-term use may cause symptoms of glucocorticosteroid withdrawal syndrome, such as fever, muscle and joint pain, and malaise. These symptoms may occur even if adrenal insufficiency is not detected. In patients with hypothyroidism or liver cirrhosis, prednisone has a stronger effect. Prednisone should be used in the smallest effective doses. Caution should be exercised when treating with acetylsalicylic acid together with prednisone in patients with hypoprothrombinemia (prothrombin deficiency in the blood). Caution should be exercised when using prednisone in non-specific ulcerative colitis if there is a risk of perforation (disruption of the intestinal wall), abscesses, or other purulent infections, diverticulitis, recent intestinal anastomoses, peptic ulcer, esophagitis, gastritis, hyperthyroidism, hypothyroidism, renal insufficiency, hypertension, osteoporosis, myasthenia gravis (muscle weakness), diabetes, impaired liver function, heart diseases, congestive heart failure, recent myocardial infarction, glaucoma. Prednisone may reveal latent peptic ulcer disease. In patients from tropical countries or patients with diarrhea of unknown origin, it is necessary to exclude parasitic infection before treatment with glucocorticosteroids. The administration of prednisone to patients with active tuberculosis should be limited to cases of disseminated or fulminant tuberculosis and only with concurrent anti-tuberculosis treatment. In cases of ocular herpes, it should be used with caution due to the risk of corneal perforation. During treatment with prednisone, psychiatric disorders may occur, such as euphoria, insomnia, sudden mood changes, personality disorders, severe depression, symptoms of psychosis. Pre-existing emotional instability or psychotic tendencies may worsen during treatment. In cases of perforation in the gastrointestinal tract in patients treated with high doses of prednisone, symptoms of peritonitis may be mild or absent. In patients treated with corticosteroids, it is necessary to monitor adrenal function, electrolyte levels, blood glucose levels, prothrombin time (in patients receiving anticoagulant drugs from the coumarin group), perform ophthalmological examinations, and test stool for occult blood. If the patient experiences blurred vision or other visual disturbances, they should contact their doctor.

Children and Adolescents

Children treated long-term should be monitored for growth and development disorders.

Use of Encorton in Patients with Renal and/or Hepatic Impairment

In patients with impaired liver or kidney function, the medicine should be used with caution.

Use of Encorton in the Elderly

In elderly patients, due to the possibility of developing hypertension and osteoporosis, the medicine should be used with caution.

Encorton and Other Medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. Some medicines may enhance the effect of Encorton, and your doctor may want to monitor your condition closely when taking such medicines (including some HIV medicines: ritonavir, cobicistat). Non-steroidal anti-inflammatory drugs, alcohol: increased risk of gastrointestinal ulceration and bleeding. Amphotericin B, carbonic anhydrase inhibitors: hypokalemia (potassium deficiency in the blood), cardiac hypertrophy, congestive heart failure. Paracetamol: hypernatremia (increased sodium levels in the blood), edema, increased calcium excretion, risk of calcium deficiency and osteoporosis, increased risk of toxic paracetamol effects on the liver. Anabolic steroids, androgens: edema, acne. Anticholinergic drugs, mainly atropine: increased intraocular pressure. Anticoagulant drugs, coumarin derivatives, indandione, heparin, streptokinase, urokinase: decreased, and in some patients increased, efficacy; increased risk of gastrointestinal ulceration and bleeding. Tricyclic antidepressants may enhance the psychiatric disorders associated with prednisone. Oral anti-diabetic drugs, insulin: reduced anti-diabetic effect. Medicines used in hyperthyroidism, thyroid hormones: altered thyroid function; it may be necessary to change the dose or discontinue the medicine used in hyperthyroidism or thyroid hormone. Asparaginase: enhanced hyperglycemic effect (increasing blood glucose levels) of asparaginase. Oral contraceptives containing estrogens: estrogens enhance the effect of prednisone. Digitalis glycosides: increased risk of cardiac arrhythmias and digitalis toxicity. Diuretics: reduced diuretic effect, hypokalemia (potassium deficiency in the blood). Folic acid: increased demand for this medicine. Immunosuppressive drugs: increased risk of infection, development of lymphomas, and other lymphoproliferative diseases. Isoniazid: decreased isoniazid levels in the blood, dose modification may be necessary. Mexiletine: accelerated metabolism of mexiletine and decreased levels in the blood. Mitotane: inhibits adrenal cortex function, during its use, glucocorticosteroids are usually necessary, but in higher doses than usual. Sodium: edema, increased blood pressure; it may be necessary to restrict sodium intake and sodium-containing medicines; glucocorticosteroid supplementation sometimes requires additional sodium administration. Live virus vaccines: during immunosuppressive doses of glucocorticosteroids, there is a risk of developing viral diseases and reduced vaccine efficacy. Other vaccines: increased risk of neurological complications and reduced antibody production. Enzyme inducers: reduced glucocorticosteroid effect. Ephedrine may accelerate glucocorticosteroid metabolism. Non-depolarizing muscle relaxants: hypokalemia (potassium deficiency in the blood) associated with prednisone may enhance muscle relaxant effect, leading to prolonged respiratory depression and paralysis. Salicylates: increased salicylate excretion, decreased blood levels, risk of gastrointestinal ulceration and bleeding. Potassium: glucocorticosteroid use leads to decreased potassium levels in the blood.

Encorton with Food and Drink

Take with food. Do not divide the tablets.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor for advice before taking this medicine. There are no adequate and well-controlled studies in humans. In animal studies, corticosteroids caused an increased incidence of cleft palate, miscarriages, fetal growth restriction, and osteoporosis. Although suspicions of teratogenic effects of corticosteroids in humans have not been confirmed, there are data indicating an increased risk of fetal growth restriction, low birth weight, and fetal death in women who received glucocorticosteroids during pregnancy. The general use of corticosteroids in pregnant women is only justified when the benefit of the medicine outweighs the potential risk to the fetus. It is believed that treatment of the mother with a dose of up to 5 mg of prednisone per day does not cause side effects in the child. However, the use of higher doses of the medicine may cause growth restriction or suppression of endogenous adrenal hormone secretion in the child. If it is necessary to use higher doses of the medicine in breastfeeding women, it is recommended to discontinue breastfeeding.

Driving and Using Machines

Some side effects (seizures, dizziness, and headaches, blurred or double vision, psychiatric disorders) may impair the ability to drive, operate machinery, and affect psychophysical fitness.

Encorton Contains Lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to Take Encorton

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist. The dose is determined individually by the doctor, depending on the type of disease and response to treatment. After achieving the desired therapeutic effect, it is recommended to gradually reduce the dose to the smallest effective dose. Also, before planned discontinuation of the medicine, the dose should be gradually reduced. In the case of long-term treatment with high doses, discontinuation of the medicine can be started by reducing the dose by 1 mg per month, and in the case of short-term treatment, by 2-5 mg every 2-7 days. Prednisone administered at a dose of up to 40 mg per day for a period of less than 7 days can be discontinued without the risk of adrenal cortex suppression. To minimize the risk of adrenal cortex suppression, it is recommended to administer the medicine once a day, in the morning, as this is when the highest levels of endogenous corticosteroids are produced. However, in some cases, more frequent administration of prednisone may be necessary. Usual doses: Adults and adolescents: 5 mg to 60 mg per day, as a single dose or in divided doses up to 250 mg per day. Children: usual doses in children: 2 mg/kg body weight per day in divided doses every 6 or 8 hours or as a single dose.

• Multiple sclerosis during exacerbations: Adults: 200 mg per day for 7 days, then 80 mg every other day for 1 month.
• Nephrotic syndrome: Children under 18 months: the dose has not been established. Children from 18 months to 4 years: initially 7-10 mg four times a day. Children from 4 to 10 years: initially 15 mg four times a day. Children over 10 years: initially 20 mg four times a day.
• Rheumatic heart disease, leukemia, tumors: Children: for the first 2-3 weeks: 0.5 mg/kg body weight or 15 mg/m2 body surface area four times a day; then 0.375 mg/kg body weight or 11.25 mg/m2 body surface area four times a day for 4-6 weeks.
• Tuberculosis (with concurrent anti-tuberculosis treatment): Children: 0.5 mg/kg body weight or 15 mg/m2 body surface area four times a day for 2 months. The medicine should be gradually discontinued.

Overdose of Encorton

Even very high doses of corticosteroids usually do not cause symptoms of acute overdose. There are no reports of acute poisoning with these compounds. Long-term use of corticosteroids may lead to numerous disorders characteristic of excessive adrenal hormone activity, including psychiatric disorders, abnormal fat distribution, fluid retention, weight gain, excessive hair growth, acne, striae, hypertension, immune system disorders, osteoporosis, peptic ulcer. In case of acute overdose, it is recommended to empty the stomach by vomiting or lavage. There is no specific antidote. Treatment of acute overdose is based on maintaining vital functions.

In case of overdose, contact your doctor or pharmacist immediately.

Missed Dose of Encorton

If you miss a dose, take it as soon as possible or, if the next dose is approaching, skip the missed dose. Do not take a double dose at the same time. Do not take a double dose to make up for a missed dose.

Discontinuation of Encorton

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

4. Possible Side Effects

Like all medicines, Encorton can cause side effects, although not everybody gets them. Short-term use of prednisone, like other corticosteroids, rarely leads to side effects. The risk of side effects listed below mainly applies to patients receiving prednisone long-term. The frequency of side effects has been determined as follows: Side effects with unknown frequency (frequency cannot be estimated from available data):

• Scleroderma renal crisis in patients with scleroderma (an autoimmune disorder). The symptoms of scleroderma renal crisis include increased blood pressure and decreased urine production.
• Disorders of the menstrual cycle; Cushing's syndrome; growth restriction in children; secondary adrenal insufficiency and pituitary insufficiency, particularly in stressful situations, revelation of diabetes and increased insulin requirements and oral anti-diabetic drugs in patients with existing diabetes; hirsutism (excessive hair growth in women).
• Negative nitrogen balance, increased blood glucose and urine levels, weight gain, increased appetite.
• Psychiatric disorders, most often occurring within the first 2 weeks of treatment; may include symptoms of schizophrenia, mania, or delirium; occur in 15 to 50% of patients; are dose-dependent, most common in patients treated with doses of 40 mg of prednisone per day; women and patients with lupus are most susceptible to these symptoms.
• Seizures; increased intracranial pressure with optic nerve edema; dizziness and headaches.
• Cataracts; increased intraocular pressure; glaucoma (usually after treatment lasting at least 1 year); exophthalmos, blurred vision.
• Thromboembolic disorders.
• Peptic ulcer and its consequences: perforations, bleeding; perforations of the large or small intestine, especially in patients with inflammatory bowel disease; pancreatitis; bloating; esophagitis; gastrointestinal disorders.
• Striae, acne, impaired wound healing; petechiae and purpura. Other skin reactions: allergic dermatitis, urticaria, angioedema.
• Muscle weakness, steroid myopathy, muscle mass loss, osteoporosis, compressive spinal fractures, pathological fractures of long bones, aseptic necrosis of the femoral and humeral heads.
• Bradycardia

Other side effects: Hypersensitivity reactions; nausea; malaise; sleep disorders, sodium and fluid retention, congestive heart failure, potassium loss, hypokalemic alkalosis (increased blood pH due to potassium deficiency), hypertension.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this 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 which is stated on the packaging. The expiry date refers to the last day of the month. Store in a temperature below 25°C. Store in the original packaging to protect from light and moisture. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

What Encorton Contains

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

What Encorton Looks Like and Contents of the Pack

Encorton 1 mg: white or almost white, smooth, with a uniform surface, round, and flat on both sides, with the marking "∆" embossed on one side. The pack contains 20 tablets. Encorton 5 mg: white or almost white, smooth, with a uniform surface, round, and flat on both sides, with the marking "∆" embossed on one side. The pack contains 20 or 100 tablets. Encorton 10 mg: white or almost white, smooth, with a uniform surface, round, and flat on both sides, with the marking "─" embossed on one side. The pack contains 20 or 40 tablets. Encorton 20 mg: white or almost white, smooth, with a uniform surface, round, and flat on both sides, with the marking "+" embossed on one side. The pack contains 20 tablets.

Marketing Authorization Holder

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

Manufacturer

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

Date of Last Revision of the Leaflet: