Esotkaleno

Patient Information Leaflet: Read this leaflet carefully before using the medicine, as it contains important information for you.

Esotkaleno, 1 mg, tablets
Esotkaleno, 2.5 mg, tablets
Esotkaleno, 5 mg, tablets
Esotkaleno, 10 mg, tablets
Esotkaleno, 20 mg, tablets
Esotkaleno, 25 mg, tablets
Esotkaleno, 30 mg, tablets
Esotkaleno, 50 mg, tablets
Prednisonum

• Keep this leaflet for future reference.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

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

1. What is Esotkaleno and what is it used for

Esotkaleno is a glucocorticoid (a corticosteroid hormone) that affects metabolism, electrolyte balance, and tissue function.
Esotkaleno is indicated for the treatment of diseases requiring systemic glucocorticoid therapy. Depending on the symptoms and severity of the disease, these include (dosing regimens: SD: from "a" to "d" and regimen "e", see section 3. How to take Esotkaleno):

Hormone replacement therapy for:

• Adrenal insufficiency or absence of adrenal cortex function (adrenal insufficiency) of any cause (e.g., Addison's disease, adrenogenital syndrome, post-surgical adrenalectomy, pituitary insufficiency) after completion of growth (hydrocortisone and cortisone are drugs of choice),
• Stress conditions following long-term corticosteroid therapy.

Rheumatic diseases:

• Active phase of vasculitis:
• Polyarteritis nodosa (SD: a, b; in cases with hepatitis B, limit treatment duration to two weeks),
• Giant cell arteritis, muscle pain and stiffness (polymyalgia rheumatica) (SD: c),
• Temporal arteritis (giant cell arteritis) (SD: a); in cases of sudden vision loss, initial intravenous high-dose pulse glucocorticoid therapy followed by maintenance therapy with ESR monitoring,
• Granulomatosis with polyangiitis (Wegener's granulomatosis): induction therapy (SD: a–b) in combination with methotrexate (for mild forms not involving kidneys) or according to the Fauci regimen (for severe forms involving kidneys and/or lungs); maintenance of remission: (SD: d, with gradual dose reduction) in combination with immunosuppressive agents,
• Churg-Strauss syndrome: initial treatment (SD: a–b) with organ manifestation and severe forms in combination with immunosuppressive agents; maintenance of remission (SD: d),
• Active phases of rheumatic diseases with possible internal organ involvement (SD: a, b): systemic lupus erythematosus involving internal organs, muscle weakness and pain (polymyositis), cartilage inflammation (relapsing polychondritis), mixed connective tissue disease,
• Progressive forms of rheumatoid arthritis (SD: a to d) in severe, progressive cases, e.g., with rapid joint destruction (SD: a) or extra-articular manifestations (SD: b),
• Other forms of rheumatoid arthritis when necessary due to symptom severity or when certain rheumatic disease treatments (NSAIDs) are ineffective or contraindicated:
• Inflammatory changes, particularly in the spine (spondyloarthritis), ankylosing spondylitis involving other joints such as hands and feet (SD: b, c), psoriatic arthritis (SD: c, d), joint disease associated with gastrointestinal disorders with significant inflammatory activity (enteropathic arthritis) (SD: a),
• Arthritis occurring as a reaction to an underlying disease (SD: c),
• Arthritis in sarcoidosis (initially SD: b),
• Carditis in rheumatic fever, beyond 2–3 months in severe cases (SD: a),
• Juvenile arthritis of unknown cause (juvenile idiopathic arthritis), in severe forms involving internal organs (Still's disease) or eyes (uveitis) unresponsive to local treatment (SD: a).

Bronchial and lung diseases:

• Bronchial asthma (SD: c to a); bronchodilators are also recommended,
• Exacerbation of chronic obstructive pulmonary disease (COPD) (SD: b); recommended treatment duration: up to 10 days,
• Specific lung diseases such as acute alveolitis (SD: b), pulmonary fibrosis and structural lung changes (SD: b), bronchiolitis obliterans organizing pneumonia (BOOP) (SD: b, with gradual dose reduction), if necessary in combination with immunosuppressive agents, chronic eosinophilic pneumonia (SD: b, with gradual dose reduction), long-term treatment of chronic sarcoidosis in stage II and III (with dyspnea, cough, and impaired lung function) (SD: b),
• Prevention of respiratory distress syndrome in premature infants (SD: b, two single doses).

Upper respiratory tract diseases:

• Severe forms of hay fever and allergic rhinitis after failure of intranasal glucocorticoid treatment (SD: c),
• Acute laryngeal and airway obstruction: mucosal edema (Quincke's edema), laryngeal stenosis and inflammation (pseudocroup) (SD: b to a).

Skin diseases:
Skin and mucous membrane diseases that, due to severity and/or extent or internal organ involvement, cannot be adequately treated with topical glucocorticoids. These include:

• Allergic and pseudoallergic reactions, infection-related allergic reactions: e.g., acute urticaria, anaphylactoid reactions,
• Severe skin disorders, some causing skin barrier disruption, drug eruptions, erythema multiforme, toxic epidermal necrolysis (Lyell's syndrome), acute generalized exanthematous pustulosis, nodular erythema, severe febrile neutrophilic dermatosis (Sweet's syndrome), allergic contact dermatitis (SD: b to a),
• Skin rashes: e.g., allergic skin rashes such as atopic dermatitis, contact dermatitis, microorganism-induced rashes (pityriasis rosea) (SD: b to a),
• Nodular diseases: e.g., sarcoidosis, cheilitis (granulomatous cheilitis) (SD: b to a),
• Severe blistering skin diseases: e.g., pemphigus vulgaris, bullous pemphigoid, benign mucous membrane pemphigoid, linear IgA dermatosis (SD: b to a),
• Vasculitis: e.g., allergic vasculitis, polyarteritis nodosa (SD: b to a),
• Immune system (autoimmune) diseases: e.g., dermatomyositis, systemic sclerosis (sclerotic phase), chronic discoid lupus erythematosus, subacute cutaneous lupus erythematosus (SD: b to a),
• Severe skin diseases during pregnancy (see also section "Pregnancy and breastfeeding"): e.g., pemphigoid gestationis, prurigo gestationis (SD: d to a),
• Severe skin diseases with erythema and scaling: e.g., pustular psoriasis, erythema annulare centrifugum, pityriasis group (SD: c to a), erythrodermia, including Sézary syndrome (SD: c to a),
• Other severe skin diseases: e.g., Jarisch-Herxheimer reaction to penicillin used in syphilis treatment, rapidly developing cavernous hemangioma with rapid progression, Behçet's disease, pyoderma gangrenosum, eosinophilic fasciitis, erythema annulare centrifugum, hereditary epidermolysis bullosa (SD: c to a).

Blood diseases/oncological diseases:

• Autoimmune blood diseases: anemia due to destruction of red blood cells (autoimmune hemolytic anemia) (SD: c to a), idiopathic thrombocytopenic purpura (Werlhof's disease) (SD: a), acute transient decrease in platelet count (acute transient thrombocytopenia) (SD: a),
• Oncological diseases such as acute lymphoblastic leukemia (SD: e), Hodgkin's lymphoma (SD: e), non-Hodgkin's lymphoma (SD: e), chronic lymphocytic leukemia (SD: e), Waldenström's macroglobulinemia (SD: e), multiple myeloma (SD: e),
• Hypercalcemia associated with malignancy (SD: c to a),
• Prevention and treatment of chemotherapy-induced vomiting (SD: b to a),
• Palliative therapy for oncological diseases. Note: Esotkaleno may be used to alleviate symptoms, e.g., loss of appetite, excessive weight loss, and general weakness in advanced cancer after exhausting other treatment options.

Nervous system diseases:

• Certain forms of muscle paralysis (myasthenia) (azathioprine is the drug of choice), chronic Guillain-Barré syndrome, Tolosa-Hunt syndrome, neuropathy in monoclonal gammopathy, multiple sclerosis (with oral gradual dose reduction after initial high-dose intravenous glucocorticoid infusion in acute relapses), certain forms of infantile seizures (West syndrome).

Specific infectious diseases:

• Toxic states in severe infections (in combination with antibiotics or chemotherapeutic agents), e.g., tuberculous meningitis (SD: b), severe forms of pulmonary tuberculosis (SD: b).

Eye diseases (SD: b to a):

• In systemic diseases involving the eyes and immunological processes within the orbit and eye: optic nerve disease (optic neuropathy, e.g., giant cell arteritis, ischemia-related or trauma-related), Behçet's disease, sarcoidosis, endocrine orbitopathy, orbital pseudotumor, transplant rejection, and certain forms of uveitis such as Harada syndrome and sympathetic ophthalmia.

Esotkaleno is indicated only if local treatments have failed in the following conditions. Inflammatory conditions of various eye parts:

• Scleritis and episcleritis, keratitis or uveitis, chronic inflammation of the intraocular fluid-producing part of the eye, allergic conjunctivitis, alkali burns,
• Keratitis in autoimmune disease or syphilis (requires additional antimicrobial treatment), herpes simplex virus-induced keratitis (only if corneal surface is intact and regular ophthalmological monitoring is ensured).

Gastrointestinal and liver diseases:

• Ulcerative colitis (SD: b to c),
• Crohn's disease (SD: b),
• Autoimmune hepatitis (SD: b),
• Esophageal burn (SD: a).

Kidney diseases:

• Certain autoimmune kidney diseases: minimal change glomerulonephritis (SD: a), proliferative extracapillary glomerulonephritis (rapidly progressive glomerulonephritis) (SD: high-dose pulse therapy, usually in combination with cytostatics), dose reduction and discontinuation in Goodpasture's syndrome, long-term treatment in all other forms (SD: d).

2. Important information before using Esotkaleno

When not to use Esotkaleno:

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

Except for allergic reactions, there are no other contraindications for short-term use of Esotkaleno in the treatment of acute, life-threatening conditions.
Warnings and precautions
Before starting treatment with Esotkaleno, discuss this with your doctor or pharmacist if:
the patient suffers from scleroderma (an autoimmune disorder also known as systemic sclerosis), because 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 output.
Extreme caution should be exercised when using Esotkaleno at higher doses than those used in hormonal replacement therapy. In such cases, Esotkaleno should only be used if the doctor considers it absolutely necessary.
Due to suppression of the immune system, Esotkaleno may increase the risk of bacterial, viral, parasitic, opportunistic, and fungal infections. Objective and subjective signs of existing or developing infections may be masked, making them more difficult to diagnose. Latent infections such as tuberculosis or hepatitis B virus infection may be reactivated. Concomitant targeted antimicrobial therapy should be administered in the following conditions:

• acute viral infections (hepatitis B, chickenpox, shingles, herpes, herpes keratitis);
• acute and chronic bacterial infections;
• fungal infections involving internal organs;
• certain parasitic diseases (e.g. caused by amoebae, nematodes); in patients with suspected or confirmed strongyloidiasis, Esotkaleno may lead to activation and significant multiplication of parasites;
• swollen lymph nodes after BCG vaccination (in patients with a history of tuberculosis – use only with anti-tuberculosis drugs);
• infectious hepatitis (chronic active viral hepatitis with positive HBsAg test);
• Heine-Medin disease;
• during the period of approximately 8 weeks before to 2 weeks after vaccination with attenuated live microorganisms (live vaccines);

During treatment with Esotkaleno, the following conditions should be carefully monitored and appropriately treated:

• gastric and intestinal ulcers;
• difficult-to-control arterial hypertension;
• difficult-to-control diabetes;
• bone atrophy (osteoporosis);
• psychiatric disorders (current or past), including suicide risk. In such cases, supervision by a neurologist or psychiatrist is recommended;
• increased intraocular pressure (narrow-angle and open-angle glaucoma) – ophthalmological monitoring and concomitant treatment are recommended;
• corneal damage and ulcers; ophthalmological monitoring and concomitant treatment are recommended.

During treatment with this medicine, a pheochromocytoma crisis may occur, which can be fatal. Pheochromocytoma is a rare, hormone-dependent tumor of the adrenal glands. Possible symptoms of a crisis include: headache, excessive sweating, palpitations, and high blood pressure (hypertension). If any of these symptoms occur, contact a doctor immediately.
Before starting treatment with Esotkaleno, discuss this with your doctor if there is suspicion or confirmation that the patient has a pheochromocytoma (adrenal gland tumor).
If the patient experiences blurred vision or other visual disturbances, contact a doctor.
Due to the risk of intestinal perforation, Esotkaleno may be used only if there are strong medical indications and under appropriate supervision in the following cases:

• severe intestinal inflammation (ulcerative colitis) with risk of perforation, with abscesses or purulent inflammation, possibly even without peritoneal irritation;
• diverticulitis;
• immediately after certain intestinal surgeries (intestinal anastomoses).

In patients receiving high doses of glucocorticoids, symptoms of peritoneal irritation after gastrointestinal perforation may not occur.
The risk of tendon disorders, tendonitis, and tendon rupture is increased when fluoroquinolones (a certain group of antibiotics) are administered concomitantly with Esotkaleno.
During treatment of certain types of muscle paralysis (myasthenia gravis), symptoms may initially worsen; therefore, Esotkaleno should initially be administered in a hospital setting. Esotkaleno should be introduced gradually, especially if severe facial or throat disorders or breathing difficulties occur.
In principle, vaccinations using vaccines containing killed microorganisms (inactivated vaccines) are permissible. However, it should be considered that vaccine efficacy may be reduced after administration of higher doses of Esotkaleno.
During treatment with high doses of Esotkaleno, bradycardia (slow heart rate) may occur. The occurrence of bradycardia does not necessarily correlate with the duration of treatment.
During long-term administration of Esotkaleno, regular medical check-ups are necessary (including ophthalmological examination every 3 months).
In patients with diabetes, metabolism should be monitored regularly, and the possibility of increased need for antidiabetic drugs (insulin or tablets) should be considered.
During long-term use of high doses of Esotkaleno, adequate potassium intake (e.g. vegetables, bananas) should be ensured and salt intake limited. Blood potassium levels should be monitored under medical supervision.
Severe anaphylactic reactions (immune system hyperreactivity) may occur.
If the patient has high blood pressure or severe heart failure, close monitoring by a physician is required, as there is a risk of worsening.
If special physical stress situations occur during treatment with Esotkaleno, such as feverish illness, accident, surgery, childbirth, etc., the treating physician or emergency doctor should be immediately informed about ongoing treatment.
An increase in the daily dose of Esotkaleno may be necessary. During long-term treatment, the patient should receive an emergency information card from the doctor, which should always be carried.
Depending on the doses used and duration of treatment, a negative effect of the drug on calcium metabolism should be expected; therefore, osteoporosis prophylaxis is recommended. This particularly applies to individuals with existing risk factors such as family predisposition, advanced age, inadequate protein and calcium intake, heavy smoking, excessive alcohol consumption, postmenopausal period, and lack of physical activity. Prophylaxis consists of adequate calcium and vitamin D intake and physical activity. In cases of existing osteoporosis, additional pharmacological treatment should be considered.
During discontinuation or after interruption of long-term treatment, the risk of the following situations should be considered: exacerbation or recurrence of the underlying disease, acute adrenal insufficiency (especially under stress conditions, e.g. during infection, after accidents, during increased physical strain), objective and subjective symptoms caused by cortisone withdrawal.
Viral diseases (e.g. chickenpox, measles) may have a particularly severe course in patients using Esotkaleno. Patients with weakened immune systems who have not previously had chickenpox or measles are at highest risk. If such patients using Esotkaleno come into contact with individuals suffering from measles or chickenpox, they should immediately contact a doctor, who will initiate appropriate prophylactic treatment if necessary.
Children and adolescents
In children, due to the risk of growth suppression, Esotkaleno may be used only if there are strong medical indications. The child's growth should be monitored regularly. Treatment with Esotkaleno should be limited in duration or administered on an alternate-day schedule (e.g. every other day, but at double dose (alternate-day therapy)).
Elderly patients
Since elderly patients are at higher risk of osteoporosis, the benefit-risk ratio of using Esotkaleno should be carefully evaluated.
Improper use of the drug as doping
Use of Esotkaleno may lead to positive results in anti-doping controls and may pose a health risk if the drug is used as a doping agent.
Esotkaleno and other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Other medicines affecting the action of Esotkaleno

• Some medicines may enhance the effect of Esotkaleno, and the doctor may wish to closely monitor the patient taking such medicines (including certain HIV drugs: ritonavir, cobicistat).
• Medicines that slow down liver metabolism, such as certain antifungal drugs (ketoconazole, itraconazole), may increase the effect of Esotkaleno.
• Certain female sex hormones, e.g. those used in oral contraceptives ("the pill"), may increase the effect of Esotkaleno.
• Medicines that accelerate liver metabolism, such as certain sedatives (barbiturates), antiepileptic drugs (phenytoin, carbamazepine, primidone), and certain tuberculosis drugs (containing rifampicin) may weaken the effect of Esotkaleno.
• Ephedrine (e.g. may be contained in drugs used to treat low blood pressure, chronic bronchitis, asthma attacks, nasal catarrh, and as a component of appetite suppressants): the effectiveness of Esotkaleno may be reduced due to accelerated metabolism in the body.
• Drugs used for excessive gastric acid production (antacids): concomitant use of magnesium hydroxide or aluminium hydroxide may reduce prednisolone absorption. These drugs should be taken at least 2 hours apart.

Effect of Esotkaleno on the action of other medicines

• Esotkaleno may enhance the effect of cardiac glycosides (heart-strengthening drugs) due to potassium deficiency.
• Esotkaleno may increase potassium excretion caused by diuretics (saluretics) and laxatives.
• Esotkaleno may weaken the glucose-lowering effect of oral antidiabetic drugs and insulin.
• Esotkaleno may decrease or increase the effect of blood-thinning drugs (oral anticoagulants, coumarin derivatives). The doctor will decide whether dose adjustment of the blood-thinning drug is necessary.
• Esotkaleno may increase the risk of gastric ulcers and gastrointestinal bleeding if used concomitantly with anti-inflammatory and antirheumatic drugs (containing salicylates, indomethacin, or other non-steroidal anti-inflammatory drugs).
• Esotkaleno may prolong the muscle-relaxing effect of certain non-depolarizing neuromuscular blocking agents.
• Esotkaleno may increase the effect of certain drugs that increase intraocular pressure (atropine and other anticholinergic drugs).
• Esotkaleno may weaken the effect of drugs used to treat parasitic diseases (praziquantel).
• Esotkaleno may increase the risk of muscle disease and heart muscle disease (myopathy and cardiomyopathy) if taken concomitantly with drugs used to treat malaria or rheumatic diseases (chloroquine, hydroxychloroquine, mefloquine).
• Growth hormone (somatotropin): its effect is reduced, especially during administration of high doses of Esotkaleno.
• Esotkaleno may weaken the effect of thyrotropin (TSH) increase after protirelin (TRH - a hormone produced by the hypothalamus).
• Esotkaleno used concomitantly with immunosuppressive drugs (drugs that reduce immune system function) may increase susceptibility to infections and may exacerbate or trigger symptoms of previously undiagnosed infections.
• Also in the case of cyclosporine (an immunosuppressive drug): Esotkaleno may increase cyclosporine blood levels and thereby increase the risk of seizures.
• Certain blood pressure-lowering drugs (angiotensin-converting enzyme inhibitors): increased risk of blood morphology changes.
• Fluoroquinolones, a certain group of antibiotics, may increase the risk of tendon damage.

Effect on laboratory test results
Skin reactions in allergy tests may be suppressed.
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 or pharmacist before using this medicine.
Pregnancy
During pregnancy, this medicine should be used only on a doctor's recommendation. Therefore, if the patient is pregnant, she should inform her doctor. During long-term use of Esotkaleno during pregnancy, impaired fetal growth cannot be excluded.
If Esotkaleno is used towards the end of pregnancy, adrenal insufficiency may occur in the newborn, which may require replacement therapy with gradual dose reduction. Animal studies have shown that prednisone has harmful effects on fetuses (e.g. cleft palate). There are reports indicating an increased risk of such defects in humans following prednisone administration during the first three months of pregnancy.
Breastfeeding
Prednisone passes into the milk of breastfeeding women. No disorders in infants have been reported so far.
Nevertheless, the necessity of using the drug during breastfeeding should be carefully considered.
If higher doses are required for medical reasons, breastfeeding should be discontinued.
Contact a doctor immediately.
Driving and operating machinery
Currently, there are no data indicating that Esotkaleno impairs the ability to drive vehicles or operate machinery. The same applies to work without secure support.
Esotkaleno contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to use Esotkaleno

This medicine should always be used exactly as directed by the physician. The doctor will determine the dose individually for each patient.
The recommended dosage must be strictly followed, as otherwise the effect of Esotkaleno may be inadequate.
In case of doubt, consult a physician or pharmacist.
Administration method
Tablets should be taken without chewing, during or immediately after a meal, with sufficient fluid.
Hormone replacement therapy in chronic adrenal cortex insufficiency is lifelong.
Depending on the clinical condition and the individual patient's response to treatment, the physician will assess the possibility of administering the medicine every other day.
Unless otherwise directed by the physician, the usual dosage is:
Substitution therapy (outside the growth period)
5 to 7.5 mg of prednisone daily, divided into two single doses (morning and noon; in adrenogenital syndrome: morning and evening); mineralocorticoid (fludrocortisone) should be administered concomitantly if necessary. In cases of significant physical stress, such as infection with fever, trauma, surgery, or childbirth, the dose may be temporarily increased by the physician.
Stress conditions following long-term glucocorticoid therapy: up to 50 mg of prednisolone daily, administered at appropriate times. The dose should be tapered down over several days.
Treatment of certain diseases (pharmacotherapy)
To allow for higher doses, Esotkaleno is available in various strengths.
Scored lines on the tablets enable individual dose adjustment for each case.
The tables below provide an overview of general dosing guidelines:
Adults (dosing regimens a-d)

The total daily dose is usually taken early in the morning between 6:00 a.m. and 8:00 a.m.
However, depending on the disease, high daily doses may be divided into 2–4 single doses, and
medium daily doses into 2–3 single doses.
Children

In children, treatment should be conducted using the lowest possible dose. In special cases (e.g., in West syndrome), this recommendation may be departed from.
Dose reduction
Dose reduction should begin after the desired clinical effect has been achieved, depending on the underlying disease. If the daily dose is divided into several individual doses, the evening dose should be reduced first, followed by the afternoon dose, if applicable.
Dose reduction should initially proceed somewhat faster, then more slowly as the dose approaches approximately 30 mg per day.
The duration of treatment depends on the course of the disease. After achieving a satisfactory treatment outcome, the dose should be reduced to a maintenance dose or treatment may be discontinued. For this purpose, the physician establishes a treatment schedule which must be strictly followed.
The following steps, together with monitoring of disease severity, may serve as guidelines for dose tapering:

Treatment with high and highest doses lasting for several days, depending on the underlying disease and the patient's clinical response, may be discontinued without the need for gradual dose reduction.
In cases of hypothyroidism or liver cirrhosis, lower doses may be sufficient or dose reduction may be necessary.
If the patient feels that the effect of Esotkaleno is too strong or too weak, they should contact their doctor or pharmacist.

Dosing regimen "e" (DR: e)
In this case, Esotkaleno is usually administered in a single dose without the need for gradual dose tapering at the end of treatment. The following are example chemotherapy regimens:

• Non-Hodgkin's lymphoma: CHOP regimen, prednisone 100 mg/m², day 1-5; COP regimen, prednisone 100 mg/m², day 1-5
• Chronic lymphocytic leukemia: Knospe regimen, prednisone 75/50/25 mg, day 1-3
• Hodgkin's lymphoma: COPP-ABVD regimen, prednisone 40 mg/m², day 1-14
• Multiple myeloma: Alexanian regimen, prednisone 2 mg/kg body weight, day 1-4

Use of a higher than recommended dose of Esotkaleno
Esotkaleno is generally well tolerated, even with short-term use of high doses. No special measures are required. If the patient experiences severe or unusual adverse effects, medical advice should be sought.

Missed dose of Esotkaleno
Do not take a double dose to make up for a missed dose.
A missed dose may be taken during the same day, and treatment should continue with the dose prescribed by the doctor at the usual time on the following day.
If several doses are missed, a relapse or worsening of the treated disease may occur. In such cases, consult the doctor, who will assess the treatment and adjust it if necessary.

Discontinuation of Esotkaleno
Always follow the dosing regimen prescribed by the doctor. Never discontinue Esotkaleno without consulting a doctor, as prolonged use of Esotkaleno may suppress the body's natural production of glucocorticosteroids. In such cases, situations involving significant physical stress may pose a life-threatening risk (adrenal crisis).

If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If this medicine is used to compensate for a deficiency in corticosteroid levels when the body does not produce sufficient amounts of natural corticosteroids, the risk of adverse effects is low when the recommended doses are used.
Adverse effects depend on the dose and duration of treatment. Therefore, the frequency of occurrence of these adverse effects cannot be specified. Most adverse effects resolve after discontinuation of treatment and are usually less severe when the dose is reduced.
Corticosteroids, including prednisone, may cause serious mental health problems, such as those listed below. The patient should contact a doctor immediately if any of the following problems occur:

• Depressive state, including suicidal thoughts
• Feelings of depression, euforia (mania), excessive feelings of happiness or excitement (euphoria), elevated or depressed mood, increased drive
• Feelings of anxiety or irritability, sleep disturbances
• Sensing, seeing, or hearing things that are not there (hallucinations), loss of contact with reality (psychosis)

If any of the following severe adverse effects occur, contact a doctor immediately:

• Allergic reactions, such as skin rash or itching, difficulty breathing, irregular heartbeat, blood pressure too high or too low, circulatory collapse, cardiac arrest. This type of adverse reaction may be severe (anaphylactic reaction).
• Abdominal pain radiating to the back, hip, or shoulder, which may be accompanied by vomiting, shock, and loss of consciousness. This may indicate pancreatitis.
• Ulcers or bleeding in the stomach or intestines, manifested by abdominal pain, rectal bleeding, black or blood-stained stools, and/or bloody vomiting.
• Seizure in individuals without a history of epilepsy
• Scleroderma renal crisis in patients diagnosed with scleroderma (an autoimmune disorder). Symptoms of scleroderma renal crisis include elevated blood pressure and reduced urine production.

The following adverse effects have also been reported:
Infections and parasitic infestations

• Symptoms of infections may be masked
• Occurrence, recurrence, or worsening of viral, fungal, bacterial, parasitic, and opportunistic infections
• Reactivation of intestinal tuberculosis infection

Blood and lymphatic system disorders

• Changes in blood morphology (increased number of white blood cells or all blood cells, decreased number of certain types of white blood cells)

Immune system disorders

• Suppression of the immune system (increased risk of infection)

Endocrine disorders

• Cushing's syndrome (typical symptoms: large, round face – "moon face", central obesity, and facial redness)
• Symptoms of impaired adrenal function or adrenal atrophy (physical shrinkage): headache, nausea, dizziness, loss of appetite, weakness, emotional changes, apathy, inadequate response to stress

Metabolism and nutrition disorders

• Increased body weight
• Increased blood glucose levels
• Diabetes
• Increased blood lipid levels (cholesterol and triglycerides)
• Reduced sodium excretion, which may lead to fluid retention (edema)
• Increased potassium excretion, which may cause irregular heartbeat
• Increased appetite

Nervous system disorders

• Increased intracranial pressure (pseudotumor cerebri), with symptoms such as headache with vomiting, fatigue, and drowsiness
• Increased frequency and severity of seizures in patients with epilepsy

Eye disorders

• Cataract (clouding of the lens)
• Glaucoma (increased intraocular pressure)
• Worsening of pre-existing corneal ulcers
• Increased incidence of viral, fungal, and bacterial eye infections
• Blurred vision

Cardiac disorders

• Slowed heart rate

Vascular disorders

• Increased blood pressure
• Increased risk of thickening, hardening, and loss of elasticity of arterial walls (arteriosclerosis) or blood clots in blood vessels (thrombosis)
• Inflammation of the inner lining of blood vessels (vasculitis)
• Increased fragility of capillaries

Skin and subcutaneous tissue disorders

• Striae (stretch marks)
• Thinning of the skin ("parchment skin")
• Small dilated blood vessels near the skin surface or mucous membranes ("spider veins")
• Small red, purple, or blue spots on the skin caused by bleeding
• Bruising
• Increased body hair growth
• Acne
• Inflammatory skin changes on the face, especially around the mouth, nose, and eyes
• Skin pigmentation changes

Musculoskeletal and connective tissue disorders

• Muscle disorders, muscle weakness, muscle atrophy
• Bone disorders leading to increased risk of bone fractures (osteoporosis), other forms of bone degeneration (bone necrosis)
• Tendon disorders, tendonitis, tendon rupture
• Formation of fatty tissue in the spinal canal (epidural lipomatosis)

Note: After rapid dose reduction following long-term treatment, symptoms such as muscle and joint pain may occur.
Reproductive system and breast disorders

• Disorders in sex hormone secretion, resulting in absence of menstrual periods, male-pattern body hair growth in women (hirsutism), or impotence in men

General disorders and administration site conditions

• Delayed wound healing

Additional adverse effects in children and adolescents
Slowed growth may occur in children and adolescents. In such a case, inform the doctor.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to gather more information on the safety of using the medicine.

5. How to store Esotkaleno

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton following:
"EXP". The expiry date refers to the last day of the specified month.
1 mg: Do not store above 30°C.
Other strengths: This medicine does not require special storage conditions.
Medicines must not be disposed of via the sewage system or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help
protect the environment.

6. Contents of the pack and other information

What Esotkaleno contains
The active substance is prednisone.
Each tablet contains 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg, 25 mg, 30 mg or 50 mg of prednisone.
The other ingredients are:
1 mg / 2.5 mg / 5 mg:
microcrystalline cellulose, pregelatinized starch (corn), sodium stearyl fumarate (Ph.Eur.).
10 mg / 20 mg / 25 mg / 30 mg / 50 mg:
microcrystalline cellulose, pregelatinized starch (corn), poloxamer 407, sodium stearyl fumarate (Ph.Eur.), anhydrous colloidal silica.

What Esotkaleno looks like and contents of the pack
1 mg:
White or almost white, round tablet with a score line on one side and the number "1" engraved on the other side.
2.5 mg:
White or almost white, round tablet with a score line on one side and the number "2.5" engraved on the other side.
5 mg:
White or almost white, round tablet with a score line on one side and the number "5" engraved on the other side.
10 mg:
White or almost white, round tablet with a score line on one side and the number "10" engraved on the other side.
20 mg:
White or almost white, round tablet with a score line on one side and the number "20" engraved on the other side.
25 mg:
White or almost white, round tablet with a score line on one side and the number "25" engraved on the other side.
30 mg:
White or almost white, round tablet with a score line on one side and the number "30" engraved on the other side.
50 mg:
White or almost white, round tablet with a score line on one side and the number "50" engraved on the other side.

The tablets can be divided into equal doses.
The tablets are packed in PVC/PVDC - aluminium blisters.

Pack sizes:
1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg, 25 mg, 30 mg, 50 mg:
Packs contain 20 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

For further information, contact the representative of the Marketing Authorisation Holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warszawa
Tel. +48 22 737 79 20

Manufacturer
Formula Pharmazeutische und chemische Entwicklungs GmbH
Goerzallee 305b
14167 Berlin
Germany

This medicinal product is authorised for marketing in the European Economic Area under the following names:
Germany: Corten 1 mg Tabletten
Corten 2.5 mg Tabletten
Corten 5 mg Tabletten
Corten 10 mg Tabletten
Corten 20 mg Tabletten
Corten 25 mg Tabletten
Corten 30 mg Tabletten
Corten 50 mg Tabletten
Poland: Esotkaleno