Encorton

Leaflet accompanying the packaging: patient information

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

Read the 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 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 packaging 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 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 consumption 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 concentration of fatty acids in the blood, and after prolonged treatment, it may lead to abnormal distribution of adipose tissue. 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 adrenal insufficiency (Addison's disease) and secondary (hydrocortisone and cortisone are the drugs of choice, synthetic derivatives may be used with mineralocorticoids);
• congenital adrenal hyperplasia;
• hypercalcemia associated with cancer;
• thyroiditis (non-suppurative).

Severe allergic diseases, resistant to other treatment methods:

• contact dermatitis;
• atopic dermatitis;
• psoriasis;
• drug hypersensitivity reactions;
• perennial or seasonal allergic rhinitis.

Collagen diseases (glucocorticosteroids are indicated during exacerbations 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);
• mycosis fungoides;
• pemphigus;
• severe psoriasis.

Gastrointestinal diseases (during exacerbations; 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 erythroid system;
• secondary thrombocytopenia in adults;
• idiopathic thrombocytopenic purpura (Werlhof's disease) in adults.

Cancer (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 remission in idiopathic nephrotic syndrome without uremia or to improve renal function in patients with lupus erythematosus. 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;
• uveitis and scleritis;
• retinitis;
• diffuse choroiditis;
• optic neuritis;
• sympathetic ophthalmia;
• anterior segment inflammation;
• 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);
• bronchial 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-rheumatic inflammatory conditions of the musculoskeletal system:

• acute and subacute bursitis;
• acute gouty arthritis;
• acute non-specific tenosynovitis;
• post-traumatic arthritis;
• synovitis in patients with arthritis;
• epicondylitis.

Others:

• tuberculous meningitis with blockage of the subarachnoid space (concurrently with 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:
The patient has 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. The attending physician 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 ion concentration in the blood).
In patients treated with corticosteroids, increased stress may lead to the need for 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 much more severe in these cases.
Long-term use of prednisone may lead to cataracts, glaucoma with possible optic nerve damage, as well as 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 limit sodium intake and supplement potassium.
All corticosteroids increase calcium excretion.
Patients treated with Encorton should not be vaccinated with live viral vaccines. The administration of an inactivated viral or bacterial vaccine may not result in the expected increase in antibodies.
The patient treated with prednisone should strictly follow the doctor's instructions.
Discontinuation of treatment after long-term use may lead to symptoms of glucocorticosteroid withdrawal syndrome, such as fever, muscle and joint pain, and malaise. These symptoms may occur even if adrenal insufficiency is not diagnosed.
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 continuity), abscesses, or other purulent infections, diverticulitis, recent intestinal anastomoses, peptic ulcer, esophagitis, gastritis, hyperthyroidism, hypothyroidism, renal failure, hypertension, osteoporosis, myasthenia gravis (muscle weakness), diabetes, impaired liver function, heart diseases, congestive heart failure, recent myocardial infarction, glaucoma.
Prednisone may reveal latent strongyloidiasis. In individuals coming from tropical countries or patients with diarrhea of unknown origin, strongyloidiasis should be ruled out 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 the case of ocular herpes, it should be used with caution due to the risk of corneal perforation.
During the use of prednisone, mental 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 be exacerbated during treatment.
In the event of perforation in the gastrointestinal tract in patients treated with high doses of prednisone, symptoms of peritonitis may be slight or absent.
In patients treated with corticosteroids, adrenal function, electrolyte levels, blood glucose levels, prothrombin time (in patients receiving anticoagulant drugs from the coumarin group), ophthalmological examinations, and stool tests for occult blood should be monitored.
If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.

Children and adolescents

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

Using Encorton in patients with renal and/or hepatic impairment

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

Using 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 closely monitor your condition 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 ion deficiency in the blood), cardiac hypertrophy, congestive heart failure.
Paracetamol: hypernatremia (increased sodium ion concentration in the blood), edema, increased calcium excretion, risk of calcium deficiency and osteoporosis, increased risk of toxic paracetamol effect on the liver.
Anabolic steroids, androgens: edema, acne.
Cholinolytic 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 exacerbate mental disorders associated with prednisone use.
Oral anti-diabetic drugs, insulin: weakened anti-diabetic effect.
Medicines used in hyperthyroidism, thyroid hormones: altered thyroid function; dose adjustment or discontinuation of the medicine used in hyperthyroidism or thyroid hormone may be necessary.
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: weakened diuretic effect, hypokalemia (potassium ion deficiency in the blood).
Folic acid: increased requirement for this medicine.
Immunosuppressive drugs: increased risk of infection, development of lymphomas and other lymphoproliferative diseases.
Isoniazid: decreased isoniazid serum concentration, dose modification may be necessary.
Mexiletine: accelerated mexiletine metabolism and decreased serum concentration.
Mitotane: inhibits adrenal cortex function, during its use, glucocorticosteroids are usually necessary, but in higher doses than usual.
Sodium: edema, increased blood pressure; sodium restriction in the diet and medicines with high sodium content may be necessary; glucocorticosteroid supplementation sometimes requires additional sodium administration.
Vaccines containing live viruses: during immunosuppressive doses of glucocorticosteroids, the development of viral diseases is possible, and the effectiveness of the vaccine may be reduced.
Other vaccines: increased risk of neurological complications and reduced antibody production.
Microsomal enzyme inducers: weakened glucocorticosteroid effect.
Ephedrine may accelerate glucocorticosteroid metabolism.
Non-depolarizing muscle relaxants: hypokalemia (potassium ion deficiency in the blood) associated with prednisone use may enhance muscle relaxant effect, leading to prolonged respiratory depression and paralysis.
Salicylates: increased salicylate excretion, decreased serum concentrations, risk of gastrointestinal ulceration and bleeding.
Potassium: glucocorticosteroid use leads to decreased potassium ion concentration in the blood.

Encorton with food and drink

Should be taken with food.
Tablets should not be divided.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning 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 have caused an increased incidence of cleft palate, abortion, fetal death, and growth retardation. Although suspicions of teratogenic effects of corticosteroids in humans have not been confirmed, there are data indicating an increased risk of fetal death, low birth weight, and maternal placental insufficiency in women who have 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 adverse effects in the child. However, the use of higher doses of the medicine may cause growth retardation or inhibition of endogenous 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, mental disorders) may impair the ability to drive vehicles, operate machinery, and affect psychophysical fitness.

Encorton contains lactose

If you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking the medicine.

3. How to take Encorton

This medicine should always be taken exactly as directed by your doctor. In case of doubt, consult your doctor.
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 in 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 level of endogenous corticosteroids is secreted. 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, cancer: 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.

Taking a higher dose of Encorton than recommended

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 mental disorders, abnormal fat distribution, fluid retention, weight gain, excessive hair growth, acne, stretch marks, increased blood pressure, 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 taking a higher dose of the medicine than recommended, consult your doctor or pharmacist immediately.

Missing a 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.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Encorton

Discontinuation of treatment after long-term use may lead to symptoms of glucocorticosteroid withdrawal syndrome, such as fever, muscle and joint pain, and malaise.
In case of any further doubts regarding the use of this medicine, consult 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.
• menstrual disorders; Cushing's syndrome; growth retardation in children; secondary adrenal insufficiency and hypopituitarism, particularly in stressful situations, revelation of diabetes and increased insulin requirement 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.
• mental disorders, most commonly occurring within the first 2 weeks of treatment; symptoms of schizophrenia, mania, or delirium may occur; occur in 15 to 50% of patients; are dose-dependent, occur most commonly in patients treated with doses of 40 mg of prednisone per day; women and patients with lupus erythematosus 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 syndromes.
• 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.
• stretch marks, acne, impaired wound healing; bruising and bleeding.
• petechiae; purpura; increased sweating. 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:
Allergic 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 the 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 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 that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Encorton contains

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

What Encorton looks like and contents of the packaging

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