Encortolon

PATIENT INFORMATION LEAFLET

Enclosed patient information leaflet

Encortolon, 5 mg, tablets

Prednisolone

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.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

1. What is Encortolon and what is it used for

Prednisolone is a synthetic glucocorticosteroid with strong anti-inflammatory effects. It is assumed that 5 mg of prednisolone 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. Prednisolone inhibits the development of inflammation symptoms without affecting their cause. It inhibits the accumulation of macrophages, leukocytes, and other cells in the inflammatory focus. It causes a decrease in the extensibility and permeability of capillaries, leading to the inhibition of edema formation. Prednisolone has an immunosuppressive effect by inhibiting cellular immune reactions. Other effects:It inhibits the secretion of ACTH by the pituitary gland, leading to a decrease in the production of corticosteroids and androgens in the adrenal cortex. Prednisolone affects the water-electrolyte balance. It intensifies protein breakdown. It causes an increase in blood glucose levels and increases insulin resistance. It affects lipid metabolism, increasing the concentration of fatty acids in the serum. Long-term treatment may cause abnormal fat distribution. It impairs bone formation, lowers blood calcium levels, and may cause growth inhibition in children and the development of osteoporosis at any age. Indications:Endocrine disorders

• Primary (Addison's disease) and secondary adrenal insufficiency (the drugs of choice are hydrocortisone and cortisone; synthetic analogs may be used with mineralocorticoids)
• Adrenal-genital syndrome (congenital, adrenal hyperplasia); treatment is used to inhibit virilization (the occurrence of male sex characteristics in women) caused by excessive androgen production in the adrenal glands due to enzyme deficiency in the synthesis of glucocorticoids and mineralocorticoids, insufficient production of these hormones, and stimulation of the adrenal cortex by pituitary hormones. Sodium administration is recommended; in some patients, mineralocorticoid administration may also be necessary.
• Acute adrenal insufficiency
• Non-suppurative thyroiditis
• Hypercalcemia (elevated blood calcium levels) associated with malignant disease Severe allergic diseases, resistant to other treatments
• Psoriatic disease
• Drug hypersensitivity reactions
• Year-round or seasonal allergic rhinitis Collagen diseases during exacerbation or in some cases as maintenance treatment)
• Acute rheumatic heart disease
• Systemic lupus erythematosus Dermatological diseases
• Psoriasis
• Herpetic vesicular dermatitis
• Severe seborrheic dermatitis
• Severe inflammatory skin diseases
• Severe erythema multiforme (Stevens-Johnson syndrome)
• Contact dermatitis
• Atopic dermatitis
• Fungal granuloma
• Pemphigus
• Severe psoriasis Gastrointestinal diseases - during exacerbation (long-term treatment is not recommended)
• Ulcerative colitis
• Crohn's disease Hematological 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 Cancer - with concurrent anticancer or palliative treatment
• Leukemias and lymphomas in adults
• Acute or chronic leukemia 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 erythematosus. In idiopathic nephrotic syndrome, long-term treatment may be necessary to prevent frequent relapses. Neurological diseases
• Multiple sclerosis during exacerbation Eye diseases (severe acute and chronic inflammatory processes)
• Iritis
• Iridocyclitis
• Choroiditis
• Diffuse choroidal inflammation of the posterior segment of the eye
• Optic neuritis
• Sympathetic uveitis
• Anterior segment inflammation
• Allergic conjunctivitis
• Keratitis (not associated with herpes virus or fungal infection)
• Allergic marginal corneal ulceration Respiratory diseases
• Berylliosis
• Löffler's syndrome not responding to other treatments
• Aspiration pneumonia
• Symptomatic sarcoidosis
• Asthma Rheumatic diseases (as supportive treatment during exacerbation)
• Ankylosing spondylitis
• Psoriatic arthritis
• Rheumatoid arthritis
• Juvenile rheumatoid arthritis (in cases resistant to other treatments) Non-rheumatic musculoskeletal diseases
• Acute gouty arthritis
• Post-traumatic arthritis
• Synovitis in patients with arthritis
• Acute and subacute bursitis Other
• Tuberculous meningitis with subarachnoid block (concurrently with antitubercular treatment)
• Trichinosis with cardiac or nervous system involvement

2. Important information before taking Encortolon

When not to take Encortolon:

• if the patient is hypersensitive to prednisolone or any of the other ingredients of this medicine (listed in section 6)
• if the patient has systemic fungal infections (see warning about amphotericin B)
• if the patient has ocular infections - Herpes simplex infection due to the risk of corneal perforation

Warnings and precautions

Before starting treatment with Encortolon, the patient should discuss it with their doctor or pharmacist if they have: Scleroderma (an autoimmune disorder also known as systemic sclerosis), as doses of at least 15 mg per day may increase the risk of developing a serious complication called scleroderma renal crisis. Symptoms of scleroderma renal crisis include high blood pressure and decreased urine production. The treating physician may recommend regular blood pressure checks and urine output monitoring. Patients treated with prednisolone should strictly follow the doctor's instructions. Stopping 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, prednisolone has a stronger effect. Prednisolone should be used in the smallest effective doses. If possible, the dose should be gradually reduced. In patients with prothrombin deficiency, caution should be exercised during treatment with aspirin and prednisolone. The patient should inform their doctor if they have ulcerative colitis, intestinal diverticulitis, gastric or duodenal ulcer, renal insufficiency, hypertension, osteoporosis, muscle weakness, diabetes, liver insufficiency, glaucoma, or fungal or viral infections. In fungal infections treated with amphotericin B, prednisolone 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. In patients treated with glucocorticosteroids, increased stress may require an increase in the dose of a rapidly acting glucocorticosteroid. Sudden cessation of treatment may lead to adrenal insufficiency, so the prednisolone dose should be gradually reduced. Prednisolone may mask infection symptoms, reduce resistance to infection, and make it difficult to localize the infection. Long-term use of prednisolone may cause cataracts, glaucoma with possible optic nerve damage, and increased risk of secondary fungal or viral infections. If the patient experiences blurred vision or other vision disturbances, they should consult their doctor. Prednisolone in high doses may cause increased blood pressure, water and sodium retention, and increased potassium excretion. Sodium restriction in the diet and potassium supplementation may be necessary. Prednisolone also causes increased calcium excretion. Patients treated with prednisolone should not be vaccinated with live viral vaccines. Administration of inactivated viral or bacterial vaccines may not result in the expected increase in antibodies. During prednisolone treatment, psychiatric disturbances, such as euphoria, insomnia, mood swings, personality changes, severe depression, and symptoms of psychosis, may occur. Pre-existing emotional instability or psychotic tendencies may worsen during treatment. In cases of gastrointestinal perforation in patients treated with high doses of prednisolone, symptoms of peritonitis may be mild or absent.

Children and adolescents

Infants and children treated long-term should be monitored due to the risk of growth and development disorders.

Using Encortolon in patients with renal and/or hepatic impairment

Use with caution in patients with liver and kidney failure.

Using Encortolon in the elderly

No data available.

Encortolon and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Prednisolone reduces the effect of non-steroidal anti-inflammatory drugs. Concurrent use of prednisolone, non-steroidal anti-inflammatory drugs, or alcohol increases the risk of gastrointestinal ulceration and bleeding. Some medicines may enhance the effect of Encortolon, and the doctor may want to monitor the patient's condition closely (including some HIV medicines: ritonavir, cobicistat). Concurrent use of prednisolone, amphotericin B, and carbonic anhydrase inhibitors may cause hypokalemia (decreased potassium levels in the blood), cardiac hypertrophy, and congestive heart failure. Concurrent use of prednisolone and paracetamol increases: sodium levels in the blood (hypernatremia), edema, calcium excretion, the risk of hypocalcemia and osteoporosis, and the risk of liver damage. Concurrent use of anabolic steroids, androgens, and prednisolone may cause edema and acne. Concurrent use of prednisolone with anticholinergic drugs, mainly atropine, causes increased intraocular pressure. Concurrent use of prednisolone with anticoagulant drugs, coumarin derivatives, indanedione, heparin, streptokinase, and urokinase increases the risk of gastrointestinal ulceration and bleeding and may decrease or increase the effectiveness of these drugs. Tricyclic antidepressants may enhance the psychiatric disturbances associated with prednisolone. Prednisolone reduces the hypoglycemic effect of insulin and oral hypoglycemic drugs. Concurrent use of prednisolone with antithyroid drugs or thyroid hormones may alter their effect on thyroid function. Dose adjustment or discontinuation of antithyroid drugs or thyroid hormones may be necessary. Oral contraceptives containing estrogens enhance the effects of prednisolone. Prednisolone increases the risk of cardiac arrhythmias and toxicity from cardiac glycosides (digitalis glycosides). Prednisolone reduces the effect of diuretic drugs and enhances the hypokalemia (decreased potassium levels in the blood) that occurs after their use. Prednisolone may increase the need for folic acid. Concurrent use of prednisolone and immunosuppressive drugs increases the risk of infection, lymphoma, and other lymphoproliferative diseases. Prednisolone reduces the levels of isoniazid in the blood. Prednisolone accelerates the metabolism of mexiletine and reduces its levels in the blood. Hypokalemia associated with prednisolone and drugs that block the motor plate, non-depolarizing, may enhance the motor plate block, leading to prolonged respiratory depression and paralysis. Prednisolone increases the excretion of salicylates and reduces their levels in the blood, increasing the risk of gastrointestinal ulceration and bleeding. Prednisolone enhances sodium retention in the body, causing edema and increased blood pressure. Sodium restriction in the diet may be necessary. Glucocorticosteroid supplementation may sometimes require additional sodium administration. Ephedrine may accelerate the metabolism of glucocorticosteroids. Prednisolone increases the hyperglycemic effect of asparaginase. Concurrent use of live viral vaccines and immunosuppressive doses of glucocorticosteroids may lead to viral replication and the development of viral diseases. Reduced antibody production in response to vaccination. Concurrent use of prednisolone with other vaccines increases the risk of neurological complications and reduces antibody production.

Encortolon with food and drink

The medicine should be taken during meals. Tablets should not be divided.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist 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, placental insufficiency, and fetal growth inhibition. The general use of corticosteroids in women of childbearing age and pregnant women is only justified if the benefit of the medicine outweighs the potential risk to the fetus. It is believed that maternal treatment with a dose of up to 5 mg does not cause adverse effects in the child. However, the use of higher doses may cause growth inhibition or inhibition of endogenous hormone secretion in the child. Prednisolone is excreted into breast milk and may cause adverse effects in the child. If long-term treatment is necessary during breastfeeding, it is recommended to stop breastfeeding.

Driving and using machines

Some side effects (seizures, dizziness, and headaches, blurred or double vision, psychiatric disturbances) may impair the ability to drive vehicles, operate machines, and affect psychophysical fitness. In such cases, activities requiring psychophysical fitness should not be performed. Encortolon contains lactose.If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Encortolon

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their 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 effect, the dose should be gradually reduced to the smallest effective dose. Also, before planned cessation of treatment, the dose should be gradually reduced. It is recommended to take the medicine according to the daily rhythm, usually once a day, in the morning. However, in some cases, more frequent administration of prednisolone may be necessary. Usual doses: Adults: usually from 5 mg to 60 mg per day, up to a maximum of 250 mg per day. Multiple sclerosis during exacerbation: 200 mg per day for 7 days, then 80 mg per day for 1 month.

Use in children

Usually from 0.14 mg to 2 mg per kg of body weight per day, divided into three or four doses.

Taking a higher dose of Encortolon than recommended

Even very high doses of glucocorticosteroids usually do not cause symptoms of acute overdose. Long-term use of glucocorticosteroids may cause numerous disorders characteristic of excessive adrenal hormone activity, including psychiatric disorders, abnormal fat distribution, fluid retention, weight gain, excessive hair growth, acne, skin striae, increased blood pressure, immune system disorders, osteoporosis, and 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 overdose consists of supportive therapy. In case of taking a higher dose of the medicine than recommended, the patient should immediately consult their doctor or pharmacist.

Missing a dose of Encortolon

In case of a missed dose, the patient should take the medicine as soon as possible or, if the next dose is approaching, skip the missed dose. The patient should not take a double dose to make up for the missed dose.

Stopping Encortolon treatment

Stopping treatment after long-term use may cause symptoms of glucocorticosteroid withdrawal syndrome, such as fever, muscle and joint pain, and malaise. In case of any further doubts about the use of this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Encortolon can cause side effects, although not everybody gets them. Short-term use of prednisolone, like other corticosteroids, rarely causes side effects. The risk of side effects listed below mainly applies to patients receiving prednisolone long-term, but not all patients experience these effects. Side effects with unknown frequency:Scleroderma renal crisis in patients with scleroderma (an autoimmune disorder). Symptoms of scleroderma renal crisis include high blood pressure and decreased urine production. Secondary adrenal and pituitary insufficiency (in patients treated with doses above 5 mg of prednisolone per day), particularly in stressful situations, such as illness, injury, surgery, Cushing's syndrome, growth inhibition in children, menstrual disorders, decreased glucose tolerance, and increased insulin requirements in patients with diabetes. Excessive hair growth on the body. Negative nitrogen balance, increased blood glucose and urine levels, weight gain, increased appetite. Schizophrenia symptoms, mania, or delirium, which may appear within the first few weeks of treatment. These symptoms are dose-dependent. Women and patients with lupus erythematosus are most susceptible to these symptoms. Increased intracranial pressure with papilledema (pseudotumor cerebri - most common in children, usually after too rapid dose reduction, symptoms include headaches, blurred or double vision), seizures, dizziness, and headaches. Posterior subcapsular cataract, increased intraocular pressure, glaucoma, exophthalmos. Thromboembolic disorders. Gastrointestinal ulcers and their consequences: perforations, bleeding; perforations of the large or small intestine, especially in patients with inflammatory bowel disease; pancreatitis; bloating; esophageal ulcers, digestive disorders, nausea, increased appetite. Skin striae, acne, impaired wound healing, bruising and bleeding, flushing, increased sweating; allergic dermatitis; urticaria; angioedema. Muscle weakness, steroid myopathy, muscle mass loss, osteoporosis, compressive spinal fractures, aseptic necrosis of the femoral and humeral heads, pathological fractures of long bones. Blurred vision. Bradycardia.

Other side effects: Unknown(frequency cannot be determined from available data): Anaphylactic reactions and hypersensitivity, malaise, sleep disorders, water-electrolyte balance disorders (sodium and fluid retention in the body, congestive heart failure, potassium loss, hypokalemic alkalosis, hypertension). Some people may experience other side effects when taking Encortolon.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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, more information can be collected on the safety of the medicine.

5. How to store Encortolon

The medicine should be stored out of 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. The patient should ask their 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 Encortolon contains

• The active substance of the medicine is prednisolone. One tablet contains 5 mg of prednisolone
• Other excipients are: lactose monohydrate, potato starch, gelatin, magnesium stearate.

What Encortolon looks like and contents of the pack

White or almost white, round, flat tablets with one-sided engraving. The tablets are packaged in an orange glass vial with a white polyethylene cap, in a cardboard box, or in blisters of PVC/Aluminum foil in a cardboard box. 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: