Predasol

Leaflet accompanying the packaging: information for the user

Predasol, 20 mg, tablets

Prednisolone

You should carefully read the contents of the leaflet before using 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.
• In case of 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.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Predasol is and what it is used for

Predasol is a glucocorticosteroid (corticosteroid) that affects metabolism, electrolyte balance, and tissue function. Predasol is indicated for the treatment of diseases that require systemic administration of glucocorticosteroids. These diseases, depending on their symptoms and severity, include [see section 3, dosing schedules (SD): from "a" to "d" and scheme "e"]:

Substitution therapy:

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

Rheumatic diseases:

• active phase of vascular diseases:
• giant cell 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 OB,
• Wegener's granulomatosis: initial treatment (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 doses) 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,
• active rheumatoid arthritis (SD: a to d) in severe, progressive form, 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 certain drugs used to treat rheumatic diseases (NSAIDs) are ineffective or cannot be used:
• inflammatory changes, especially in the spine (spondylitis), 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 form involving internal organs (Still's disease) or eyes (uveitis and iritis), which does 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 (pulmonary tissue hardening and structural changes) (SD: b), bronchiolitis obliterans with organizing pneumonia (BOOP) (SD: b, gradually reducing doses), if necessary, in combination with immunosuppressive drugs, chronic eosinophilic pneumonia (SD: b, gradually reducing doses), long-term treatment of chronic sarcoidosis in stage II and III (with shortness of breath, 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 glucocorticosteroid therapy (SD: c),
• sudden narrowing of the larynx and bronchi: swelling of the mucous membranes (angioedema), subglottic 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 administered glucocorticosteroids. These include:

• allergic, pseudoallergic, and infectious allergic diseases: e.g., acute urticaria, anaphylactoid reactions,
• severe skin disorders, some of which cause skin continuity disruption, drug rash, erythema multiforme, toxic epidermal necrolysis (Lyell's syndrome), acute generalized exanthematous pustulosis, erythema nodosum, severe febrile 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 (pityriasis versicolor) (SD: b to a),
• diseases characterized by nodule formation, e.g., sarcoidosis, cheilitis (granulomatous cheilitis) (SD: b to a),
• severe skin diseases characterized by blister formation: e.g., common pemphigus, bullous pemphigoid, benign mucous membrane pemphigoid, linear IgA dermatosis (SD: b to a),
• vasculitis: e.g., allergic vasculitis, giant cell arteritis (SD: b to a),
• immune system diseases (autoimmune): e.g., dermatomyositis, systemic sclerosis (scleroderma) (fibrotic phase), chronic discoid lupus erythematosus 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, erythroderma, including Sézary syndrome (SD: c to a),
• other severe diseases: e.g., Jarisch-Herxheimer reaction to penicillin used to treat syphilis, cavernous hemangioma with rapidly progressing exophthalmos, Behçet's disease, pyoderma gangrenosum, eosinophilic fasciitis, Sweet's syndrome, hereditary epidermolysis bullosa (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), 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 cancer (SD: c to a),
• prevention and treatment of chemotherapy-induced vomiting (SD: b to a),
• palliative therapy for cancer diseases. Note: Predasol may be used to alleviate symptoms, e.g., in the case of loss of appetite, anorexia, and general weakness in advanced cancer diseases after exhausting other treatment options.

Nervous system diseases:

• certain forms of muscle paralysis (myasthenia) (azathioprine is the first-choice drug), chronic Guillain-Barré syndrome, Tolosa-Hunt syndrome, polyneuropathy in monoclonal gammopathy, multiple sclerosis (with gradual oral dose reduction after initial parenteral administration of high doses of glucocorticosteroids during an acute relapse of the disease), certain forms of childhood epilepsy (infantile spasms - West syndrome).

Specific forms of infectious diseases:

• toxic conditions in 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 neuritis (e.g., giant cell arteritis, associated with insufficient circulation or trauma), Behçet's disease, sarcoidosis, thyroid orbitopathy, pseudo-tumor of the orbit (swelling of the tissue within the orbit), graft rejection, and in some cases of uveitis (inflammation of the middle part of the eye), such as Harada's syndrome and sympathetic ophthalmia.

In the following diseases, the use of Predasol is indicated only in cases where local therapy with glucocorticosteroids is ineffective:

• inflammation of the sclera (outer layer) and surrounding tissue, keratitis, uveitis (middle layer), chronic inflammation of the part of the eye that produces the aqueous humor, allergic conjunctivitis, alkaline burns,
• keratitis occurring in autoimmune disease or syphilis (additional anti-infective treatment is required), keratitis caused by the herpes simplex virus (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 burns with caustic substances (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), dose reduction and discontinuation in Goodpasture's syndrome, and in all other forms, long-term treatment (SD: d),
• idiopathic retroperitoneal fibrosis (SD: b).

2. Important information before taking Predasol

When not to take Predasol:

• if the patient is hypersensitive to prednisolone 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 Predasol for the treatment of life-threatening conditions.

Warnings and precautions

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

The patient has scleroderma (an autoimmune disorder also known as systemic sclerosis), as doses of at least 15 mg per day may increase the risk of a serious complication called scleroderma renal crisis. The symptoms of scleroderma renal crisis include elevated blood pressure and decreased urine production. The attending physician may recommend regular blood pressure and urine output checks.

After administering Predasol, cases of pheochromocytoma crisis (elevated blood pressure, headache, excessive sweating, palpitations, pallor) have been reported, which can be fatal. Treatment of patients with suspected or diagnosed pheochromocytoma should only be started after a thorough evaluation of the benefit-risk ratio.

Particular caution should be exercised when using Predasol in higher doses than in substitution therapy. In this case, Predasol should only be used if the doctor considers it absolutely necessary.

Due to the suppression of the body's immune system, Predasol may lead to an increased 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.

Targeted anti-infective treatment should be used in the following cases:

• 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, roundworms); in patients with suspected or confirmed strongyloidiasis, Predasol may lead to stimulation and significant multiplication of parasites;
• swollen lymph nodes after BCG vaccination (in cases of past tuberculosis - use only with anti-tuberculosis drugs);
• infectious liver disease (chronic active viral hepatitis with a positive HBsAg test result);
• Heine-Medin disease;
• during the period from approximately 8 weeks before to 2 weeks after vaccinations with live attenuated microorganisms (live vaccines);

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

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

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

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

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

The risk of tendon disorders, tendonitis, and tendon rupture is increased when fluorquinolones (a certain group of antibiotics) and Predasol are administered concomitantly.

During treatment for a certain type of muscle paralysis (myasthenia), there may be an initial worsening of symptoms. Therefore, Predasol should be administered initially in a hospital setting. Predasol should be introduced gradually, especially in cases of severe facial and throat disorders or respiratory disorders.

During Predasol treatment, bradycardia (slow heart rate) may occur.

The occurrence of bradycardia is not necessarily related to the duration of treatment.

In general, vaccinations with inactivated vaccines (containing killed microorganisms) are permissible. However, it should be considered that the effectiveness of the vaccination may be reduced when using high doses of Predasol.

During long-term administration of Predasol, 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.

During long-term use of high doses of Predasol, adequate potassium intake (e.g., vegetables, bananas) should be ensured, and salt intake should be limited. Potassium levels in the blood should be monitored under medical supervision.

Severe anaphylactic reactions (immune system overreaction) may occur.

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

During Predasol treatment, regular blood pressure checks are required, especially when using high doses and in patients with difficult-to-control hypertension.

If, during Predasol treatment, situations of particular physical stress occur, such as illness with fever, accident, surgery, childbirth, etc., the patient should immediately inform their attending physician or emergency doctor about the ongoing treatment. It may be necessary to temporarily increase the daily dose of Predasol. 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. Therefore, osteoporosis prevention is recommended. This is especially important for 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 cases of existing osteoporosis, additional pharmacological treatment should be considered.

When discontinuing or after possible discontinuation of long-term glucocorticosteroid 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), withdrawal symptoms and signs caused by cortisol withdrawal.

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

If the patient experiences blurred vision or other visual disturbances, they should consult a doctor.

Children and adolescents

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

Elderly patients

Since elderly patients are at a higher risk of osteoporosis, the benefit-risk ratio of using Predasol should be carefully considered.

Predasol and other medicines

The patient should inform their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.

Other medicines that affect the action of Predasol

• Medicines that accelerate liver metabolism, such as certain sedatives (barbiturates), antiepileptic drugs (phenytoin, carbamazepine, and primidone), and some anti-tuberculosis drugs (containing rifampicin), may weaken the action of Predasol.
• 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 Predasol may be reduced due to accelerated metabolism in the body.

The effect of Predasol on other medicines

• Predasol may increase the effect of heart-strengthening medicines (cardiac glycosides) due to potassium deficiency.
• Predasol may increase potassium excretion caused by diuretics and laxatives.
• Predasol may weaken the effect of oral antidiabetic drugs and insulin.
• Predasol 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.
• Predasol may increase the risk of stomach ulcers and gastrointestinal bleeding when used concomitantly with anti-inflammatory medicines (containing salicylates, indomethacin, or other non-steroidal anti-inflammatory drugs).
• Predasol may prolong the action of certain muscle relaxants (non-depolarizing muscle relaxants).
• Predasol may increase the effect of certain medicines (atropine and other anticholinergic medicines) that increase intraocular pressure.
• Predasol may reduce the effect of medicines used to treat parasitic diseases (containing praziquantel).
• Predasol may increase the risk of muscle disease and heart muscle disease (myopathy and cardiomyopathy) when used concomitantly with medicines used to treat malaria and rheumatic diseases (containing chloroquine, hydroxychloroquine, mefloquine).
• Growth hormone (somatotropin): its effect is reduced, especially when using high doses of Predasol.
• Predasol may reduce the effect of thyroid-stimulating hormone (TSH) after administration of protirelin (TRH - a hormone produced by a part of the brain).
• Predasol used concomitantly with immunosuppressive medicines may increase the susceptibility to infections and may worsen or trigger symptoms of previously unmanifested infections.
• Also, in the case of cyclosporin (an immunosuppressive medicine), Predasol may increase the cyclosporin blood level 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.

Predasol with food and drink

Tablets should be taken during or after a meal, preferably after breakfast, without chewing, with a sufficient amount of fluid.

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

Predasol should only be used during pregnancy if prescribed by a doctor. Therefore, if the patient is pregnant, they should inform their doctor.

During long-term use of Predasol during pregnancy, it is not possible to exclude the occurrence of growth disorders in the unborn child.

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

Breastfeeding

Prednisolone passes into breast milk. So far, no disorders have been reported in infants. However, it is necessary to carefully consider the need for treatment during breastfeeding. If higher doses are required for medical reasons, breastfeeding should be discontinued. The patient should immediately consult their doctor.

Fertility

Predasol may reduce fertility in men.

Driving and using machines

There is currently no data indicating that Predasol impairs the ability to drive vehicles or operate machines. The same applies to working without safety precautions.

Predasol contains lactose and sodium

This medicine contains lactose. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

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

Incorrect use of the medicine as a doping agent

The use of Predasol may lead to positive results in doping tests and may pose a risk to health if the medicine is used as a doping agent.

3. How to take Predasol

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 Predasol 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, preferably after breakfast, with a sufficient amount of fluid.

Substitution therapy in chronic adrenal insufficiency lasts for life.

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

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

Substitution therapy (outside of growth period)

5 to 7.5 mg of prednisolone 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 concomitantly. In cases 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 smaller doses, Predasol is also available as 5 mg and 10 mg tablets.

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

The following tables provide an overview of general dosing guidelines:

Adults (dosing schedules a-d)

Doses Dose (mg per day) Dose (mg/kg body weight per day)

a) high

• 80 – 100 (250) 1.0 – 3.0 b) medium
• 40 – 80 0.5 – 1.0 c) low
• 10 – 40 0.25 – 0.5 d) very low 1.5 – 7.5 (10) ---

e) in hematological disorders, as part of special treatment schedules (see below "Dosing schedule 'e' (SD: e)")

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

Doses Dose (mg/kg body weight per day)

high

• 2 – 3 medium
• 1 – 2 maintenance 0.25

In children, treatment should be performed with the smallest possible dose. In special cases (e.g., infantile spasms - West syndrome), this recommendation can be deviated from.

Reducing the dose

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, from a dose of about 25 mg per day.

The duration of treatment depends on the course of the disease. After achieving a satisfactory treatment result, the dose of Predasol is reduced to a maintenance dose or treatment is discontinued.

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

above 30 mg per day

reduction by 10 mg

every 2-5 days,

from 30 to 15 mg per day

reduction by 5 mg

every week,

from 15 to 10 mg per day

reduction by 2.5 mg

every 1-2 weeks,

from 10 to 6 mg per day

reduction by 1 mg

every 2-4 weeks,

below 6 mg per day

reduction by 0.5 mg

every 4-8 weeks.

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 cases of hypothyroidism or liver cirrhosis, smaller doses may be sufficient, or dose reduction may be necessary.

If the patient feels that the effect of Predasol is too strong or too weak, they should consult their doctor or pharmacist.

Dosing schedule "e" (SD: e)

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

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

Using a higher than recommended dose of Predasol

Generally, Predasol is well-tolerated even when using high doses for a short period. No special measures are required. If the patient experiences severe or unusual side effects, they should consult their doctor.

Missing a dose of Predasol

A missed dose can be taken up on the same day and treatment can be continued with the dose prescribed by the doctor at the usual time the next day. A double dose should not be taken to make up for a missed dose. If several doses are missed, the treated disease may worsen or recur. In such cases, the patient should consult their doctor, who will assess the treatment and adjust it if necessary.

Discontinuing Predasol

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

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

4. Possible side effects

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

Substitution therapy:

Low risk of side effects when following the recommended dosage.

Treatment of certain diseases, using higher doses than in substitution therapy:

The following side effects may occur, which largely depend on the dose and duration of treatment, and for which it is not possible to determine the frequency of occurrence:

Infections and infestations

Masking of infections, occurrence, worsening, or recurrence of viral, fungal, bacterial, and parasitic infections, as well as opportunistic infections, activation of strongyloidiasis.

Blood and lymphatic system disorders

Changes in blood count (increased white blood cell count or all blood cells, decreased count of certain white blood cells).

Immune system disorders

Allergic reactions (e.g., drug rash), severe anaphylactic reactions, such as cardiac arrhythmias, bronchospasm (smooth muscle contraction in the bronchi), decreased or increased blood pressure, circulatory collapse, heart attack, osteoporosis.

Endocrine disorders

Induction of Cushing's syndrome (typical symptoms: large, round face - "moon face", central obesity, and facial redness), suppression or reduction of adrenal cortex function.

Metabolic and nutritional disorders

Weight gain, increased blood glucose levels, diabetes, increased blood lipid levels (cholesterol and triglycerides), fluid retention, potassium deficiency due to increased potassium excretion, increased appetite.

Psychiatric disorders

Depression, irritability, euphoria, increased drive, psychosis, mania, hallucinations, emotional instability, anxiety, sleep disturbances, suicidal thoughts.

Nervous system disorders

Increased intracranial pressure, emergence of latent epilepsy, increased seizure propensity in epilepsy.

Eye disorders

Cataract (lens clouding), increased intraocular pressure (glaucoma), worsening of corneal ulcers, increased susceptibility to bacterial, viral, and fungal eye infections, blurred vision.

Cardiac disorders

Bradycardia (slow heart rate)

Vascular disorders

Hypertension, increased risk of atherosclerosis and thrombosis, vasculitis (also as a withdrawal syndrome after long-term treatment), increased capillary fragility.

Gastrointestinal disorders

Peptic ulcers, gastrointestinal bleeding.

Skin and subcutaneous tissue disorders

Stretch marks, skin thinning ("parchment-like skin"), dilated blood vessels, tendency to bruise, pinpoint or surface bleeding of the skin, increased body hair, acne, facial skin inflammation, especially around the mouth, nose, and eyes, changes in skin pigmentation.

Musculoskeletal and connective tissue disorders

Muscle disorders, muscle weakness, muscle atrophy, osteoporosis (bone loss) that occurs dose-dependently and is also possible during short-term use, other forms of bone degeneration (bone necrosis), tendon disorders, tendonitis, tendon rupture, growth retardation in children.

Note: After rapid dose reduction following long-term treatment, muscle and joint pain may occur.

Renal and urinary disorders

Scleroderma renal crisis in patients with scleroderma (an autoimmune disorder). The symptoms of scleroderma renal crisis include elevated blood pressure and decreased urine production.

Reproductive system and breast disorders

Disorders of sex hormone secretion (leading to absence of menstrual bleeding, male-type body hair in women - hirsutism, impotence).

General disorders and administration site conditions

Delayed wound healing.

5. How to Store Predasol

The medicinal product should be stored out of sight and reach of children.
Do not use this medicinal product after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the specified month.
Do not store above 25°C.

6. Package Contents and Other Information

What Predasol Contains

• The active substance of the medicinal product is prednisolone. 1 tablet contains 20 mg of prednisolone.
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, corn starch, hypromellose 2910, sodium croscarmellose, hydrophobic colloidal silica, talc, magnesium stearate.

What Predasol Looks Like and What the Package Contains

Predasol is white, round tablets with a cross-shaped dividing line on one side.
Tablets can be divided into equal doses.
Predasol is available in PVC/PVDC/Aluminum blisters in a cardboard box, containing 20,
30 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki

Manufacturer

mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany
SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki
Date of Last Update of the Leaflet:10.2023