Esotkaleno

Leaflet accompanying the packaging: information for the user

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

Prednisone

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• 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 as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 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 glucocorticosteroid (adrenal cortex hormone) that affects metabolism, electrolyte balance, and tissue function. Esotkaleno is indicated for the treatment of diseases that require systemic administration of glucocorticosteroids. These diseases, depending on their symptoms and severity, include:

Hormone replacement therapy for

• reduced adrenal cortex function or lack of function (adrenal insufficiency) of any cause (e.g., Addison's disease, adrenogenital syndrome, postoperative adrenal removal, hypopituitarism) after completion of growth (hydrocortisone and cortisone are the drugs of choice),
• stressful conditions after long-term corticosteroid therapy.

Rheumatic diseases:

• active phase of vasculitis:
• nodular vasculitis (nodular arteritis) (SD: a, b, in the case of accompanying hepatitis B, the treatment duration should be limited to two weeks),
• giant cell arteritis, muscle pain and stiffness (polymyalgia rheumatica) (SD: c),
• temporal arteritis (temporal arteritis) (SD: a), in the case of sudden vision loss, initially intravenous therapy with high doses of glucocorticosteroids in pulses, and then maintenance therapy with monitoring of ESR,
• Wegener's granulomatosis: initial therapy (SD: a-b) in combination with methotrexate (mild forms not involving the kidneys) or according to the Fauci scheme (severe forms involving the kidneys and/or lungs), maintenance of remission: (SD: d, gradually reducing the dose) in combination with immunosuppressive drugs,
• Churg-Strauss syndrome: initial treatment (SD: a-b) with organ involvement and severe forms in combination with immunosuppressive drugs, maintenance of remission (SD: d),
• active phases of rheumatic diseases, with possible organ involvement (SD: a, b): systemic lupus erythematosus involving internal organs, muscle weakness and pain (polymyositis), cartilage inflammation (chronic relapsing polychondritis), mixed connective tissue disease,
• progressive forms of rheumatoid arthritis (SD: a to d) in severe, progressive forms, e.g., with rapid joint destruction (SD: a) or with extra-articular symptoms (SD: b),
• other forms of rheumatoid arthritis, if necessary due to the severity of symptoms or if certain drugs used to treat rheumatic diseases (NSAIDs) are ineffective or cannot be used:
• inflammatory changes, especially in the spine (spondyloarthritis), ankylosing spondylitis involving other joints, e.g., hands and feet (SD: b, c), psoriatic arthritis (SD: c, d), enteropathic arthritis (SD: a),
• arthritis occurring as a reaction to another underlying disease (SD: c),
• arthritis in the course of sarcoidosis (SD: b initially),
• heart inflammation in the course of rheumatic fever, for more than 2-3 months in severe cases (SD: a),
• juvenile idiopathic arthritis, in severe forms involving internal organs (Still's disease) or eyes (uveitis), which do not respond to local treatment (SD: a).

Respiratory tract and lung diseases:

• asthma (SD: c to a), simultaneously, it is recommended to administer bronchodilators,
• exacerbation of chronic obstructive pulmonary disease (COPD) (SD: b) - recommended treatment duration: up to 10 days,
• specific lung diseases, such as acute pneumonitis (SD: b), pulmonary fibrosis (SD: b), bronchiolitis obliterans organizing pneumonia (BOOP) (SD: b, gradually reducing the dose), if necessary, in combination with immunosuppressive drugs, chronic eosinophilic pneumonia (SD: b, gradually reducing the dose), long-term treatment of chronic sarcoidosis in stage II and III (with dyspnea, cough, and worsening lung function parameters) (SD: b),
• prevention of respiratory distress syndrome in preterm infants (SD: b, two single doses).

Upper respiratory tract diseases:

• severe forms of hay fever and allergic rhinitis after failure of local corticosteroid therapy (SD: c),
• acute laryngeal edema and airway obstruction: angioedema, laryngitis (pseudocroup) (SD: b to a).

Skin diseases:

Skin and mucous membrane diseases that, due to their severity and/or affected area or internal organ involvement, cannot be adequately treated with locally applied corticosteroids. These include:

• allergic and pseudoallergic reactions, allergic reactions associated with infections: e.g., acute urticaria, anaphylactoid reactions,
• severe skin disorders, some of which cause skin discontinuity, drug rash, erythema multiforme, toxic epidermal necrolysis (Lyell's syndrome), acute generalized exanthematous pustulosis, erythema nodosum, severe febrile neutrophilic dermatosis (Sweet's syndrome), allergic contact dermatitis (SD: b to a),
• skin rash: e.g., allergic skin rash, such as atopic dermatitis, contact dermatitis, rash caused by pathogenic microorganisms (impetigo) (SD: b to a),
• diseases characterized by nodule formation, e.g., sarcoidosis, cheilitis (granulomatous cheilitis) (SD: b to a),
• severe blistering skin diseases: e.g., common pemphigus, bullous pemphigoid, benign pemphigoid of mucous membranes, linear IgA dermatosis (SD: b to a),
• vasculitis: e.g., allergic vasculitis, nodular arteritis (SD: b to a),
• immune system diseases (autoimmune): e.g., dermatomyositis, systemic sclerosis (scleroderma) (fibrotic phase), chronic discoid and subacute cutaneous lupus erythematosus (SD: b to a),
• severe skin diseases occurring during pregnancy (see also "Pregnancy and breastfeeding"): e.g., pemphigoid gestationis, papular dermatitis (SD: d to a),
• severe skin diseases with redness and scaling, e.g., pustular psoriasis, red lichen planus, pityriasis group (SD: c to a), erythroderma, including Sézary syndrome (SD: c to a),
• other severe diseases: e.g., Jarisch-Herxheimer reaction to penicillin used to treat syphilis, rapidly spreading hemangioma, characterized by rapid migration, Behçet's disease, pyoderma gangrenosum, eosinophilic fasciitis, red lichen planus, hereditary blistering skin separation (SD: c to a).

Blood diseases/cancer:

• autoimmune blood diseases: hemolytic anemia (autoimmune hemolytic anemia) (SD: c to a), idiopathic thrombocytopenic purpura (Werlhof's disease) (SD: a), acute transient thrombocytopenia (SD: a),
• cancer diseases, such as acute lymphoblastic leukemia (SD: e), malignant 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 cancer (SD: c to a),
• prevention and treatment of chemotherapy-induced nausea and vomiting (SD: b to a),
• palliative therapy for cancer. Note: Esotkaleno may be used to alleviate symptoms, e.g., in the case of loss of appetite, excessive weight loss, and general weakness in advanced cancer after other treatment options have been exhausted.

Nervous system diseases:

• certain forms of muscle paralysis (myasthenia) (the first-choice drug is azathioprine), chronic Guillain-Barré syndrome, Tolosa-Hunt syndrome, polyneuropathy in monoclonal gammopathy, multiple sclerosis (with gradual oral dose reduction after initial intravenous high-dose glucocorticosteroid pulses), certain forms of seizure disorders in infants (West syndrome).

Specific forms of infectious diseases:

• toxic conditions in the course of severe infectious diseases (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 in immunological processes within the orbit and eye: optic nerve disease (optic neuritis, e.g., giant cell arteritis, associated with insufficient circulation or trauma), Behçet's disease, sarcoidosis, endocrine orbitopathy, pseudo-tumor of the orbit, graft rejection, and in some forms of uveitis, such as Harada's syndrome and sympathetic uveitis.

In the following diseases, the use of Esotkaleno is indicated only in the case of ineffective local treatment with corticosteroids. Inflammatory conditions of various parts of the eye:

• scleritis and adjacent scleritis, keratitis or uveitis, chronic uveitis, allergic conjunctivitis, alkaline burns,
• keratitis occurring in autoimmune disease or syphilis (additional anti-infective treatment is required), herpes simplex virus keratitis (only if the 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 diseases in the kidneys: minimal change disease (SD: a), rapidly progressive glomerulonephritis (SD: treatment with high doses in pulses, usually in combination with cytostatics), reduction of dose and termination of treatment in Goodpasture's syndrome, in all other forms long-term treatment (SD: d).

2. Important information before taking Esotkaleno

When not to take Esotkaleno:

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

Except for allergic reactions, there are no other contraindications in the case of short-term use of Esotkaleno for the treatment of life-threatening conditions.

Warnings and precautions

Before starting Esotkaleno, the patient should discuss with their doctor or pharmacist if they:

have systemic sclerosis (an autoimmune disorder also known as systemic scleroderma), 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 high blood pressure and reduced urine production. The attending physician may recommend regular blood pressure and urine output checks.

should be cautious when taking Esotkaleno in higher doses than for replacement therapy. In this case, Esotkaleno should only be used if the doctor considers it absolutely necessary.

due to the suppression of the body's immune system, Esotkaleno may increase the risk of bacterial, viral, parasitic, opportunistic, and fungal infections. The objective and subjective symptoms of an existing or developing infection may be masked, making it more difficult to diagnose. There may be activation of latent infections, such as tuberculosis or viral hepatitis B.

should use targeted anti-infective treatment in the following situations:

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

During Esotkaleno treatment, the following diseases should be carefully monitored and treated:

• gastric and intestinal ulcers;
• difficult-to-control hypertension;
• difficult-to-control diabetes;
• osteoporosis;
• mental disorders (currently or in the past), including the risk of suicide. In these cases, supervision by a neurologist or psychiatrist is recommended;
• increased intraocular pressure (glaucoma with narrow and wide angle of filtration) - ophthalmological supervision and concomitant treatment are recommended;
• corneal damage and ulcers; ophthalmological supervision and concomitant treatment are recommended.

During treatment with this medicine, a crisis of pheochromocytoma may occur, which can be fatal. Pheochromocytoma is a rare, hormone-dependent tumor of the adrenal gland. Possible symptoms of a crisis include headache, excessive sweating, palpitations, and high blood pressure (hypertension). If any of these symptoms are noticed, the patient should immediately contact their doctor.

Before starting Esotkaleno, the patient should discuss with their doctor if they have or suspect they have pheochromocytoma (adrenal gland tumor).

If the patient experiences blurred vision or other visual disturbances, they should contact their doctor.

Due to the risk of intestinal perforation, Esotkaleno can only be used if there are significant medical indications and under proper supervision in the following cases:

• severe colitis (ulcerative colitis) with a risk of perforation, with abscesses or abscessing, possible also without peritoneal irritation;
• diverticulitis of the intestine;
• immediately after some intestinal surgeries (intestinal anastomoses).

In patients receiving high doses of glucocorticosteroids, there may not be symptoms of peritoneal irritation after perforation of a gastrointestinal ulcer.

The risk of tendon disorders, tendonitis, and tendon rupture is increased in the case of concomitant administration of fluoroquinolones (a certain group of antibiotics) and Esotkaleno.

During treatment for a certain type of muscle paralysis (myasthenia), there may initially be an exacerbation of symptoms, so Esotkaleno should initially be administered in a hospital. Esotkaleno should be introduced gradually, especially in the case of severe facial and throat disorders or respiratory disorders.

Essentially, vaccinations with killed microorganism vaccines (inactivated vaccines) are permissible. However, it should be considered that the effectiveness of the vaccination may be reduced after taking higher doses of Esotkaleno.

During high-dose Esotkaleno treatment, bradycardia (slow heart rate) may occur. The occurrence of bradycardia does not have to be related to the duration of treatment.

During long-term administration of Esotkaleno, regular medical check-ups (including ophthalmological check-ups every 3 months) are necessary.

In diabetic patients, their metabolism should be regularly checked, and the possibility of increased demand for antidiabetic drugs (insulin or tablets) should be considered.

In the case of long-term use of high doses of Esotkaleno, adequate potassium intake (e.g., vegetables, bananas) should be ensured, and salt intake should be limited. The patient's potassium levels should be monitored under medical supervision.

Severe anaphylactic reactions (hypersensitivity of the immune system) may occur.

If the patient has high blood pressure or severe heart failure, they should be closely monitored by a doctor, as there is a risk of worsening these conditions.

If the patient experiences situations of particular physical stress, such as illness with fever, accident, surgery, childbirth, etc., they should immediately inform their attending doctor or emergency doctor about their ongoing treatment.

It may be necessary to temporarily increase the daily dose of Esotkaleno. During long-term treatment, the patient should receive an emergency card from their doctor, which they should always carry with them.

Depending on the doses used and the duration of treatment, one should expect a negative impact on calcium metabolism, so osteoporosis prevention is recommended. This applies especially to individuals with existing risk factors, such as family predisposition, older age, inadequate protein and calcium intake, smoking a large number of cigarettes, excessive alcohol consumption, postmenopausal period, and lack of physical activity. Prevention involves adequate calcium and vitamin D intake and physical activity. In the case of existing osteoporosis, additional pharmacological treatment should be considered.

During withdrawal or after possible discontinuation of long-term treatment, one should consider the risk of:

• worsening or recurrence of the underlying disease,
• acute adrenal insufficiency (especially in stressful situations, e.g., during infection, after accidents, during increased physical exertion),
• objective and subjective symptoms caused by corticosteroid withdrawal.

The course of viral diseases (e.g., chickenpox, measles) may be particularly severe in patients taking Esotkaleno. The most vulnerable are patients with weakened immune systems who have not had chickenpox or measles before. If such patients, who are taking Esotkaleno, come into contact with people suffering from measles or chickenpox, they should immediately contact their doctor, who will initiate appropriate preventive treatment if necessary.

Children and adolescents

In children, due to the risk of growth retardation, Esotkaleno should only be used if there are significant medical indications. The child's growth should be regularly monitored. The use of Esotkaleno should be limited in time or performed in an alternating scheme (e.g., every other day, but in a 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 considered.

Incorrect use of the medicine as a doping agent

The use of Esotkaleno may result in positive doping control results and may pose a risk to health if the medicine is used as a doping agent.

Esotkaleno and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Other medicines affecting the action of Esotkaleno

• Some medicines may enhance the effect of Esotkaleno, and the doctor may want to closely monitor the patient's condition when taking such medicines (including some HIV medicines: ritonavir, cobicistat).
• Medicines that slow down liver metabolism, such as some antifungal medicines (ketoconazole, itraconazole), may increase the effect of Esotkaleno.
• Certain female sex hormones, e.g., used in oral contraceptives ("the pill"), may increase the effect of Esotkaleno.
• Medicines that accelerate liver metabolism, such as some sedatives (barbiturates), antiepileptic drugs (phenytoin, carbamazepine, and primidone), and some anti-tuberculosis drugs (containing rifampicin), may weaken the effect of Esotkaleno.
• Ephedrine (e.g., may be contained in medicines used to treat low blood pressure, chronic bronchitis, asthma attacks, rhinitis, and as a component of appetite suppressants): the effectiveness of Esotkaleno may be reduced due to accelerated metabolism in the body.
• Medicines used to treat excessive stomach acid production (antacids): when taking magnesium hydroxide or aluminum hydroxide simultaneously, the absorption of prednisolone may be reduced. These medicines should be taken at a 2-hour interval.

Influence of Esotkaleno on the action of other medicines

• Esotkaleno may increase the effect of heart-strengthening medicines (cardiac glycosides) due to potassium deficiency.
• Esotkaleno may increase potassium excretion caused by diuretics (saluretics) and laxatives.
• Esotkaleno may weaken the effect of oral antidiabetic medicines and insulin.
• Esotkaleno may decrease or increase the effect of anticoagulant medicines (oral anticoagulants, coumarin derivatives). The doctor will decide whether it is necessary to adjust the dose of the anticoagulant medicine.
• Esotkaleno may increase the risk of stomach ulcers and gastrointestinal bleeding when used concomitantly with anti-inflammatory and anti-rheumatic medicines (containing salicylates, indomethacin, or other non-steroidal anti-inflammatory drugs).
• Esotkaleno may prolong the action of some muscle relaxants (non-depolarizing muscle relaxants).
• Esotkaleno may increase the effect of certain medicines that increase intraocular pressure (atropine and other anticholinergic medicines).
• Esotkaleno may weaken the effect of medicines used to treat parasitic diseases (praziquantel).
• Esotkaleno may increase the risk of muscle disease and heart muscle disease (myopathy and cardiomyopathy) when taken concomitantly with medicines used to treat malaria or rheumatic diseases (chloroquine, hydroxychloroquine, mefloquine).
• Growth hormone (somatotropin): its effect is reduced, especially when taking high doses of Esotkaleno.
• Esotkaleno may weaken the effect of thyrotropin-releasing hormone (TRH) after administration of protirelin (TRH - a hormone produced by the hypothalamus).
• Esotkaleno used concomitantly with immunosuppressive medicines may increase the susceptibility to infections and may worsen or trigger previously unmanifested infections.
• Also, in the case of cyclosporine (an immunosuppressive medicine), Esotkaleno may increase the blood level of cyclosporine and thus increase the risk of seizures.
• Certain blood pressure-lowering medicines (angiotensin-converting enzyme inhibitors): increased risk of blood count changes.
• Fluoroquinolones, a certain group of antibiotics, may increase the risk of tendon damage.

Influence on laboratory test results

Skin reactions in allergy tests may be suppressed.

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.

Pregnancy

During pregnancy, this medicine should only be used if prescribed by a doctor. Therefore, if the patient is pregnant, they should inform their doctor. During long-term use of Esotkaleno during pregnancy, it cannot be excluded that there may be growth disorders in the unborn child.

If Esotkaleno is used at the end of pregnancy, the newborn may experience adrenal insufficiency, which may require substitution treatment with gradual dose reduction. In animal studies, prednisone showed harmful effects on fetuses (e.g., cleft palate). There are reports indicating an increased risk of such damage in humans due to prednisone administration during the first three months of pregnancy.

Breastfeeding

Prednisone passes into breast milk in nursing mothers. So far, no disorders have been reported in infants.

However, the need for treatment during breastfeeding should be carefully considered. If higher doses are required for medical reasons, breastfeeding should be stopped.

The patient should immediately contact their doctor.

Driving and operating machinery

So far, there is no data indicating that Esotkaleno impairs the ability to drive vehicles and operate machinery. The same applies to work without safe support.

Esotkaleno contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means the medicine is considered "sodium-free".

3. How to take Esotkaleno

This medicine should always be taken as directed by the doctor. The doctor will determine the dose individually for the patient.

The recommended dose should be followed, as otherwise, the effect of Esotkaleno may be inappropriate.

In case of doubts, the patient should consult their doctor or pharmacist.

Method of administration

Tablets should be taken without chewing during or immediately after a meal, with a sufficient amount of liquid.

Replacement therapy in chronic adrenal insufficiency is lifelong.

The doctor, depending on the patient's clinical condition and individual response to treatment, will assess the possibility of the patient taking the medicine every other day.

Unless the doctor has prescribed otherwise, the dosage is usually:

Replacement therapy (after completion of growth)

From 5 to 7.5 mg of prednisone per day, divided into two single doses (in the morning and at noon; in adrenogenital syndrome: in the morning and evening); if necessary, a mineralocorticoid (fludrocortisone) should be taken simultaneously. In case of particular physical stress, such as infection with fever, injury, surgery, or childbirth, the dose may be temporarily increased by the doctor.

Treatment of certain diseases (pharmacotherapy)

To enable the use of higher doses, Esotkaleno is available in various strengths.

The lines on the tablets allow for individual dose adjustment for each case.

The following tables provide an overview of general dosage guidelines:

Adults (dosing schemes a-d)

Usually, the total daily dose is taken in the morning between 6:00 and 8:00.

However, depending on the disease, high daily doses can be divided into 2-4 single doses, and medium daily doses - into 2-3 single doses.

Children

In children, treatment should be carried out with the lowest possible dose. In special cases (e.g., West syndrome), this recommendation can be deviated from.

Dose reduction

Dose reduction begins after achieving the desired clinical effect, depending on the underlying disease. If the daily dose is divided into several single doses, the evening dose should be reduced first, then the noon dose, if applicable.

Dose reduction should be performed initially somewhat faster, then slower than the dose of about 30 mg per day.

The duration of treatment depends on the course of the disease. After achieving a satisfactory treatment result, the dose of Esotkaleno is reduced to a maintenance dose or treatment is discontinued. For this purpose, the doctor determines a treatment schedule that should be strictly followed.

The following stages, along with monitoring the severity of the disease, can serve as guidelines for dose reduction:

Treatment with high and very high 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 the case of hypothyroidism or liver cirrhosis, smaller 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 scheme "e" (SD: e)

In this case, Esotkaleno is usually administered in a single dose without the need for gradual dose reduction at the end of treatment. The following exemplary dosing schemes are known in chemotherapy:

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

Use of a higher than recommended dose of Esotkaleno

Usually, Esotkaleno is well-tolerated even in the case of short-term use of high doses. No special measures are required. If the patient experiences intensified or atypical side effects, they should consult their doctor.

Missing a dose of Esotkaleno

A double dose should not be taken to make up for a missed dose.

A missed dose can be taken up during the day and treatment can be continued with the dose prescribed by the doctor at the usual time the next day.

If several doses are missed, there may be a recurrence of the treated disease or its worsening. In such cases, the patient should consult their doctor, who will assess the treatment and adjust it if necessary.

Discontinuation of Esotkaleno

The patient should always follow the dosing schedule prescribed by their doctor. Esotkaleno should never be discontinued without consulting a doctor, as especially long-term use of Esotkaleno may suppress the production of glucocorticosteroids in the body. In such cases, situations of significant physical stress may pose a risk to life (adrenal crisis).

In case of further doubts regarding the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Esotkaleno can cause side effects, although not everybody gets them.

If this medicine is used to compensate for the difference in corticosteroid levels when the body does not produce enough natural corticosteroid, the risk of side effects is low after taking the recommended doses.

Side effects depend on the dose and duration of treatment. Therefore, it is not possible to provide the frequency of these side effects.

Most side effects disappear after discontinuation of treatment and are usually less severe after dose reduction.

Glucocorticosteroids, including prednisone, can cause serious mental health problems, such as those listed below. The patient should immediately contact their doctor if they notice any of the following problems:

• Depression, including suicidal thoughts
• Mania (feeling extremely happy or irritable), excessive feeling of well-being or excitement (euphoria) or elevated or lowered mood, increased drive
• Feeling anxious or agitated, sleep disorders
• Seeing, hearing, or feeling things that do not exist (hallucinations), loss of contact with reality (psychosis)

5. How to store Esotkaleno

Store in the original package to protect from moisture.

Do not store above 25°C.

Keep out of the reach and sight of children.

6. Contents of the pack and other information

What Esotkaleno contains:

The active substance is prednisone.

The other ingredients are:

Tablet core: lactose monohydrate, potato starch, microcrystalline cellulose, talc, magnesium stearate.

Tablet coating: hypromellose, titanium dioxide (E 171), macrogol 6000, iron oxide yellow (E 172), iron oxide red (E 172).

What Esotkaleno looks like and contents of the pack:

Esotkaleno 1 mg tablets are yellow, round, biconvex tablets with a score line on one side.

Esotkaleno 2.5 mg tablets are pink, round, biconvex tablets with a score line on one side.

Esotkaleno 5 mg tablets are white, round, biconvex tablets with a score line on one side.

Esotkaleno 10 mg tablets are blue, round, biconvex tablets with a score line on one side.

Esotkaleno 20 mg tablets are red, round, biconvex tablets with a score line on one side.

Esotkaleno 25 mg tablets are brown, round, biconvex tablets with a score line on one side.

Esotkaleno 30 mg tablets are purple, round, biconvex tablets with a score line on one side.

Esotkaleno 50 mg tablets are green, round, biconvex tablets with a score line on one side.

Packaging:

Blisters: 10, 20, 30, 50, 60, 100 tablets.

Bottles: 100, 500 tablets.

5. How to store Esotkaleno

The medicine should be stored out of sight and out of reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after:
“EXP”. The expiry date refers to the last day of the month stated.
1 mg: Do not store above 30°C.
Other strengths: This medicinal product does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. You should ask
your pharmacist how to dispose of medicines that are no longer needed. This will help protect
the environment.

6. Package contents 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, corn starch, sodium stearyl fumarate (Ph.Eur.).
10 mg / 20 mg / 25 mg / 30 mg / 50 mg:
microcrystalline cellulose, corn starch, poloxamer 407, sodium stearyl fumarate (Ph.Eur.), colloidal anhydrous 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" embossed 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" embossed on
the other side.
5 mg:
White or almost white, round tablet with a score line on one side and the number "5" embossed on
the other side.
10 mg:
White or almost white, round tablet with a score line on one side and the number "10" embossed on
the other side.
20 mg:
White or almost white, round tablet with a score line on one side and the number "20" embossed on
the other side.
25 mg:
White or almost white, round tablet with a score line on one side and the number "25" embossed on
the other side.
30 mg:
White or almost white, round tablet with a score line on one side and the number "30" embossed on
the other side.
50 mg:
White or almost white, round tablet with a score line on one side and the number "50" embossed on
the other side.
Tablets can be divided into equal doses.
Tablets are packaged in PVC/PVDC - aluminum blisters.
Pack sizes:
1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg, 25 mg, 30 mg, 50 mg:
Packages contain 20 and 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
To obtain more detailed information, please contact the representative of the marketing authorization holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Tel. +48 22 737 79 20

Manufacturer

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

This medicinal product is authorized in the Member States of the European Economic

Area under the following names:

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
Esotkaleno

Date of last revision of the leaflet:

Germany
Poland