Patient Information Leaflet

Predasol, 20 mg, tablets
Prednisolone
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents

What Predasol is and what it is used for
Important information before taking Predasol
How to take Predasol
Possible side effects
How to store Predasol
Contents of the pack and other information

1. What Predasol is and what it is used for

Predasol is a glucocorticoid (corticosteroid) that affects metabolism, electrolyte balance, and tissue function.
Predasol is indicated for the treatment of diseases requiring systemic administration of glucocorticoids. These diseases, depending on their symptoms and severity, include [see section 3, dosing regimens (DR): from "a" to "d" and regimen "e"]:

Substitution therapy:

Reduced or absent adrenal cortex function (adrenal insufficiency) of any cause (e.g. Addison's disease, adrenogenital syndrome, post-surgical adrenalectomy, pituitary insufficiency) after growth has ceased (hydrocortisone and cortisone are drugs of choice),
Stress states following prolonged corticosteroid therapy.

Rheumatic diseases:

Active phases of vascular diseases:
Polyarteritis nodosa (DR: a, b; in cases with hepatitis B-related liver inflammation, treatment duration should be limited to two weeks),
Giant cell arteritis, muscle pain and stiffness (polymyalgia rheumatica) (DR: c),
Temporal arteritis (inflammation primarily affecting the temporal artery) (DR: a); in cases of sudden vision loss, initial intravenous high-dose glucocorticoid pulse therapy followed by maintenance treatment with ESR monitoring,
Wegener's granulomatosis: initial treatment (DR: 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: (DR: d, with gradual dose reduction) in combination with immunosuppressive agents,
Churg-Strauss syndrome: initial treatment (DR: a-b) with organ manifestation and severe forms in combination with immunosuppressive agents, maintenance of remission (DR: d),
Active phases of rheumatic diseases, possibly involving internal organs (DR: a, b): systemic lupus erythematosus involving internal organs, muscle weakness and pain (polymyositis), cartilage inflammation (relapsing polychondritis), mixed connective tissue disease,
Active rheumatoid arthritis (DR: a to d) in severe, progressive forms, e.g. with rapid joint destruction (DR: a) or with extra-articular manifestations (DR: b),
Other forms of rheumatoid arthritis, if necessary due to severity of symptoms or when certain rheumatic disease treatments (NSAIDs) are ineffective or contraindicated:
Inflammatory changes, particularly in the spine (spondylitis), ankylosing spondylitis involving other joints, e.g. hands and feet (DR: b, c), psoriasis with joint involvement (psoriatic arthritis) (DR: c, d), joint disease associated with gastrointestinal disorders with significant inflammatory activity (enteropathic arthritis) (DR: a),
Arthritis occurring as a reaction to another underlying disease (DR: c),
Arthritis associated with sarcoidosis (DR: b initially),
Pericarditis in rheumatic fever, beyond 2–3 months in severe cases (DR: 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 (DR: a).

Bronchial and lung diseases:

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

Upper respiratory tract diseases:

Severe forms of hay fever and allergic rhinitis after failure of intranasal glucocorticoid therapy (DR: c),
Acute laryngeal and bronchial narrowing: mucosal swelling (angioedema), subglottic laryngitis (pseudocroup) (DR: b to a).

Skin diseases:
Skin and mucous membrane disorders, which due to severity and (or) extent of involvement or internal organ involvement cannot be adequately treated with topical glucocorticoids. These include:

Allergic, pseudoallergic, and infection-related allergic diseases: e.g. acute urticaria, anaphylactoid reactions,
Severe skin disorders, some causing skin discontinuity, 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 (DR: b to a),
Skin rashes: e.g. allergic skin rashes such as atopic dermatitis, contact dermatitis, rashes caused by pathogenic microorganisms (pityriasis versicolor) (DR: b to a),
Disorders with nodule formation, e.g. sarcoidosis, cheilitis (granulomatous cheilitis) (DR: b to a),
Severe blistering skin diseases: e.g. pemphigus vulgaris, bullous pemphigoid, benign mucous membrane pemphigoid, linear IgA dermatosis (DR: b to a),
Vasculitis: e.g. allergic vasculitis, polyarteritis nodosa (DR: b to a),
Immune system (autoimmune) disorders: e.g. dermatomyositis, systemic sclerosis (sclerotic phase), chronic discoid lupus erythematosus and subacute cutaneous lupus erythematosus (DR: b to a),
Severe skin diseases during pregnancy (see also section "Pregnancy and breastfeeding"): e.g. pemphigoid gestationis, herpes gestationis (DR: d to a),
Severe skin diseases with redness and scaling, e.g. pustular psoriasis, erythematous follicular psoriasis, pityriasis group (DR: c to a), erythroderma, including cases of Sézary syndrome (DR: c to a),
Other severe skin disorders: e.g. Jarisch-Herxheimer reaction to penicillin used in syphilis treatment, cavernous hemangioma with rapidly progressing proptosis, Behçet's disease, pyoderma gangrenosum, eosinophilic fasciitis, erythematous annular lichen, hereditary epidermolysis bullosa (DR: c to a).

Blood disorders / oncological diseases:

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

Nervous system disorders:

Certain forms of muscle paralysis (myasthenia) (azathioprine is the first-line treatment), chronic Guillain-Barré syndrome, Tolosa-Hunt syndrome, polyneuropathy in monoclonal gammopathy, multiple sclerosis (with oral gradual dose reduction after initial high-dose parenteral glucocorticoid administration during acute relapse), certain forms of childhood epilepsy (infantile spasms – West syndrome).

Specific infectious diseases:

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

Eye diseases (DR: b to a):

In systemic diseases involving the eyes and immunological processes within the orbit and eye: optic neuropathy (e.g. giant cell arteritis, ischemic or trauma-related), Behçet's disease, sarcoidosis, thyroid eye disease, orbital pseudotumor (tissue swelling within the orbit), transplant rejection, and certain uveitis (inflammation of the middle eye layer), such as Harada syndrome and sympathetic ophthalmia.

Predasol is indicated only if local therapy has failed in the following conditions. Inflammatory conditions of various parts of the eye:

Scleritis (outer layer) and surrounding tissues, keratitis, uveitis (middle layer), chronic inflammation of the part of the eye producing aqueous humor (eye fluid), allergic conjunctivitis, alkali burns,
Keratitis occurring in autoimmune disease or syphilis (requires additional anti-infective treatment), herpes simplex virus-induced keratitis (only if corneal surface is intact and regular ophthalmological monitoring is ensured).

Gastrointestinal and liver diseases:

Ulcerative colitis (DR: b to c),
Crohn's disease (DR: b),
Autoimmune hepatitis (DR: b),
Esophageal burns (erosions) caused by corrosive substances (DR: a).

Kidney diseases:

Certain autoimmune kidney disorders: minimal change glomerulonephritis (DR: a), extracapillary proliferative glomerulonephritis (rapidly progressive glomerulonephritis) (DR: high-dose pulse therapy, usually in combination with cytostatics), dose reduction and discontinuation in Goodpasture’s syndrome, long-term treatment in all other forms (DR: d),
Idiopathic retroperitoneal fibrosis (DR: b).

2. Important information before using Predasol

When not to use Predasol:

if the patient is allergic to prednisolone 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 Predasol in the treatment of acute, life-threatening conditions.
Warnings and precautions
Before starting treatment with Predasol, discuss 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 excretion.
Cases of pheochromocytoma crisis (Pheochromocytoma crisis) (elevated arterial pressure, headache, excessive sweating, palpitations, pallor) have been reported after administration of Predasol, which may lead to death. Treatment of patients with suspected or diagnosed pheochromocytoma should only be initiated after appropriate benefit-risk assessment.
Particular caution is required when using Predasol in higher doses than those used in replacement therapy. In such cases, Predasol should only be used if the physician considers it absolutely necessary.
Due to suppression of immune system function, Predasol 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 diagnosis more difficult. Latent infections, such as tuberculosis or hepatitis B virus infection, may be activated.
Concomitant targeted antimicrobial therapy should be used in the following conditions:

acute viral infections (hepatitis B, chickenpox, shingles, herpes simplex, herpes keratitis caused by Herpes viruses);
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, Predasol may lead to activation and significant multiplication of parasites;
swollen lymph nodes after BCG vaccination (in case of previous tuberculosis – use only with antituberculosis drugs);
infectious liver disease (chronic active viral hepatitis with positive HBsAg test);
Heine-Medin disease (poliomyelitis);
within approximately 8 weeks before and 2 weeks after vaccination with live attenuated microorganisms (live vaccines);

The following diseases should be carefully monitored and appropriately treated during treatment with Predasol:

gastric and intestinal ulcers;
difficult-to-control arterial hypertension;
difficult-to-control diabetes;
bone loss (osteoporosis);
psychiatric disorders (current or past), including suicide risk. Neurological or psychiatric supervision is recommended in these cases;
increased intraocular pressure (narrow-angle and open-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 should only be used if there are significant medical indications and under appropriate supervision in the following cases:

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

In patients receiving high doses of glucocorticoids, symptoms of peritoneal irritation may not occur following gastrointestinal perforation.
The risk of tendon disorders, tendonitis, and tendon rupture is increased when fluoroquinolones (a certain group of antibiotics) are administered concomitantly with Predasol.
During treatment of certain muscle paralysis (myasthenia gravis), symptoms may initially worsen. Therefore, Predasol should initially be administered in a hospital setting. Predasol should be introduced gradually, especially if severe facial or throat disorders or respiratory disturbances occur.
During treatment with high doses of Predasol, slow heart rate (bradycardia) may occur.
The occurrence of bradycardia does not necessarily correlate with the duration of treatment.
In principle, vaccination with inactivated vaccines (containing killed microorganisms) is permissible. However, it should be considered that vaccine efficacy may be reduced when higher doses of Predasol are used.
During long-term treatment with Predasol, regular medical check-ups are necessary (including ophthalmological examination every 3 months).
In patients with diabetes, metabolism should be regularly monitored, and the possibility of increased need for antidiabetic medications (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. Blood potassium levels should be monitored under medical supervision.
Severe anaphylactic reactions (immune system hyperreactivity) may occur.
If the patient has arterial hypertension or severe heart failure, monitoring by a physician is required, as there is a risk of worsening.
Regular monitoring of arterial blood pressure is required during treatment with Predasol, especially when high doses are used and in patients with difficult-to-control hypertension.
If special physical stress situations occur during treatment with Predasol, such as illness with fever, accident, surgery, childbirth, etc., the treating physician or emergency doctor should be immediately informed about ongoing treatment. Temporary increase in the daily dose of Predasol may be necessary. During long-term treatment, the patient should receive an emergency information card from the physician, which should always be carried.
Depending on the doses used and duration of treatment, negative effects 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 includes adequate calcium and vitamin D intake and physical activity. In cases of existing osteoporosis, additional pharmacological treatment should be considered.
During withdrawal or after interruption of long-term glucocorticoid therapy, the risk of the following situations should be considered: exacerbation or recurrence of the underlying disease, acute adrenal insufficiency (especially under stressful conditions, e.g., during infection, after accidents, during increased physical strain), and objective and subjective symptoms caused by cortisone withdrawal.
Viral diseases (e.g., chickenpox, measles) may have a particularly severe course in patients using Predasol. The most vulnerable are immunocompromised patients who have not previously had chickenpox or measles. If such patients on Predasol come into contact with individuals suffering from measles or chickenpox, they should immediately contact their physician, who will initiate appropriate prophylactic treatment if necessary.
If the patient experiences blurred vision or other visual disturbances, medical advice should be sought.
Children and adolescents
In children, due to the risk of growth suppression, Predasol should only be used if there are significant medical indications. The child's growth should be regularly monitored. Treatment with Predasol should be limited in duration or administered on an alternate-day schedule (e.g., every other day, but at double dose).
Elderly patients
Since elderly patients are at higher risk of osteoporosis, the benefit-risk ratio of using Predasol should be carefully evaluated.
Predasol and other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines planned for use, including those available without a prescription.
Other medicines affecting the action of Predasol

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

Effect of Predasol on other medicines

Predasol may enhance the effect of cardiac glycosides (heart-strengthening medicines) due to potassium deficiency.
Predasol may increase potassium loss caused by diuretics and laxatives.
Predasol may reduce the glucose-lowering effect of oral antidiabetic medicines and insulin.
Predasol may decrease or increase the effect of anticoagulant medicines (oral anticoagulants, coumarin derivatives). The doctor will decide whether dose adjustment of the anticoagulant is necessary.
Predasol may increase the risk of gastric 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 muscle-relaxing effect of certain non-depolarizing neuromuscular blocking agents.
Predasol may enhance the effect of certain medicines (atropine and other anticholinergic drugs) that increase intraocular pressure.
Predasol may reduce the effect of antiparasitic medicines (containing praziquantel).
Predasol may increase the risk of myopathy and cardiomyopathy when taken concomitantly with medicines used to treat malaria and rheumatic diseases (containing chloroquine, hydroxychloroquine, mefloquine).
Growth hormone (somatotropin): its effect is reduced, especially during high-dose Predasol treatment.
Predasol may reduce the effect of thyrotropin (TSH) stimulation after protirelin (TRH - a hormone produced by part of the brain).
Predasol used concomitantly with immunosuppressive medicines may increase susceptibility to infections and may exacerbate or trigger symptoms of previously undiagnosed infections.
Also in the case of cyclosporine (an immunosuppressive medicine): Predasol may increase cyclosporine blood levels and thereby increase the risk of seizures.
Certain blood pressure-lowering medicines (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.
Predasol with food and drink
Tablets should be taken during or after meals, preferably after breakfast, without chewing, with sufficient fluid.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
This medicine should only be used during pregnancy on medical advice. Therefore, if the patient is pregnant, she should inform her doctor.
During long-term use of Predasol in pregnancy, impaired fetal growth cannot be excluded.
If Predasol is used towards the end of pregnancy, the newborn may develop adrenal insufficiency, which may require replacement therapy with gradual dose reduction. Animal studies have shown that prednisolone has harmful effects on fetuses (e.g., cleft palate). Reports suggest an increased risk of such malformations in humans following prednisolone administration during the first three months of pregnancy.
Breastfeeding
Prednisolone passes into breast milk. No disturbances in infants have been reported so far. Nevertheless, the necessity of using the medicine during breastfeeding should be carefully considered. If higher doses are medically required, breastfeeding should be discontinued. Consult your doctor immediately.
Fertility
Predasol may reduce fertility in men.
Driving and operating machinery
There is currently no data indicating that Predasol impairs the ability to drive or operate machinery. The same applies to work without safety precautions.
Predasol contains lactose and sodium
This medicine contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".
Improper use of the medicine as doping
Use of Predasol may lead to positive results in anti-doping controls and may pose a health risk if used as a doping agent.

3. How to use Predasol

This medicine should always be used exactly as directed by the physician. The doctor will determine the dose individually for each patient. You must follow the prescribed dosage, otherwise the effect of Predasol may be inappropriate.
If in doubt, consult your doctor or pharmacist.

Method of administration
Tablets should be taken without chewing, during or immediately after a meal, preferably after breakfast, with sufficient fluid.
Substitution therapy in chronic adrenal insufficiency is lifelong.
Depending on the clinical condition and the individual patient's response to treatment, the doctor will assess whether the patient may take the medicine every other day.

Unless otherwise directed by the physician, the usual dosage is as follows:

Substitution therapy (outside the growth period)
5 to 7.5 mg prednisolone per day, divided into two single doses (morning and noon; in adrenogenital syndrome: morning and evening). If necessary, a mineralocorticoid (fludrocortisone) should also be taken concomitantly. 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 prednisolone per day, administered at the appropriate time. The dose should then be reduced gradually over several days.

Treatment of certain diseases (pharmacotherapy)
To allow for lower dosing, Predasol is also available as 5 mg and 10 mg tablets. The score lines on the tablets allow for individual dose adjustment.
The tables below provide an overview of general dosing guidelines:

Adults (dosing regimens a–d)

| Dose category | 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 haematological disorders, as part of special treatment regimens (see below "Dosing regimen 'e' (SD: e)") |

Generally, the total daily dose should be taken early in the morning between 6:00 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

| Dose category | Dose (mg/kg body weight per day) |
|-------------------|--------------------------------------|
| high | 2 – 3 |
| medium | 1 – 2 |
| maintenance | 0.25 |

In children, treatment should be conducted with the lowest possible dose. In special cases (e.g. infantile spasms – West syndrome), this recommendation may be deviated from.

Reducing the dose
Dose reduction should begin once the desired clinical effect has been achieved, depending on the underlying disease. If the daily dose is divided into several single doses, the evening dose should be reduced first, followed by the midday dose, if applicable. Dose reduction should initially proceed somewhat faster, then more slowly once the dose reaches approximately 25 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 level or treatment may be discontinued.

The following steps, along with monitoring of disease activity, may serve as guidelines for tapering:

Above 30 mg per day: reduce by 10 mg every 2–5 days,
From 30 to 15 mg per day: reduce by 5 mg weekly,
From 15 to 10 mg per day: reduce by 2.5 mg every 1–2 weeks,
From 10 to 6 mg per day: reduce by 1 mg every 2–4 weeks,
Below 6 mg per day: reduce by 0.5 mg every 4–8 weeks.

Treatment with high or maximum doses lasting only a few days may, depending on the underlying disease and clinical response, 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 Predasol is too strong or too weak, they should contact their doctor or pharmacist.

Dosing regimen "e" (SD: e)
In this case, prednisolone is usually administered as a single dose without the need for gradual tapering at the end of treatment. The following are examples of dosing regimens used in chemotherapy:

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

Use of a higher than recommended dose of Predasol
Predasol 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
A missed dose may be taken during the same day, and treatment should continue with the next prescribed dose at the usual time the following day. Do not take a double dose to make up for a missed dose. If several doses are missed, a relapse or worsening of the treated condition may occur. In such cases, consult your doctor, who will evaluate the treatment and adjust it if necessary.

Stopping Predasol
Always follow the dosing schedule prescribed by your doctor. Never stop taking Predasol without consulting your doctor, because long-term use of Predasol may suppress the body's natural production of glucocorticoids. In such cases, significant physical stress may lead to life-threatening adrenal crisis.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Substitution therapy:
Low risk of adverse reactions when the recommended dosage is observed.
Treatment of specific diseases, using higher doses than in substitution therapy:
The following adverse reactions may occur, which largely depend on the dose and duration of treatment,
and for which therefore it is not possible to determine the frequency of occurrence:
Infections and parasitic infections
Masking of infections, occurrence, worsening or recurrence of viral, fungal, bacterial,
as well as parasitic and opportunistic infections, activation of intestinal tuberculosis.
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
Hypersensitivity reactions (e.g. drug rash), severe anaphylactic reactions such as cardiac arrhythmia,
bronchospasm (constriction of smooth muscles in the bronchi), decreased or increased blood pressure,
circulatory collapse, myocardial infarction, immunosuppression.
Endocrine disorders
Induction of so-called Cushing's syndrome (typical symptoms: large, round face – "moon face", truncal
obesity and facial redness), suppression or decreased function of the adrenal cortex.
Metabolism and nutrition disorders
Increased body weight, increased blood glucose concentration, 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 lability,
anxiety, sleep disturbances, suicidal thoughts.
Nervous system disorders
Increased intracranial pressure, emergence of symptoms of latent epilepsy, increased tendency to seizures
in epilepsy.
Eye disorders
Lens opacity (cataract), increased intraocular pressure (glaucoma), worsening of corneal ulceration,
increased susceptibility to bacterial, viral and fungal eye infections, blurred vision.
Cardiac disorders
Bradycardia
Vascular disorders
Hypertension, increased risk of atherosclerosis and thrombosis, vasculitis (also as withdrawal syndrome
after long-term treatment), increased fragility of capillaries.
Gastrointestinal disorders
Gastric and intestinal ulcers, gastrointestinal bleeding, pancreatitis.
Skin and subcutaneous tissue disorders
Striae, skin thinning ("parchment skin"), dilated blood vessels, tendency to bruising, pinpoint or superficial
skin hemorrhages, increased body hair growth, acne, inflammatory skin conditions of the face, especially
around the mouth, nose and eyes, skin pigmentation changes.
Musculoskeletal and connective tissue disorders
Disorders affecting muscles, muscle weakness, muscle atrophy, osteoporosis (bone loss) which occurs
depending on dose and may also occur during short-term use, other forms of bone degeneration (bone
necrosis), disorders affecting tendons, tendonitis, tendon rupture, growth suppression in children.
Note: After rapid dose reduction following long-term treatment, symptoms such as muscle and joint pain
may occur.
Renal and urinary disorders
Scleroderma renal crisis in patients with scleroderma (autoimmune disorder). Symptoms of scleroderma
renal crisis include elevated blood pressure and reduced urine output.
Reproductive system and breast disorders
Disorders of sex hormone secretion (resulting in absence of menstrual bleeding, male pattern body hair
growth in women – hirsutism, impotence).
General disorders and administration site conditions
Delayed wound healing.
Actions to be taken
You should consult your doctor or pharmacist if any of the listed adverse reactions occur or any other
adverse reaction during use of Predasol.
Never discontinue treatment without consulting your doctor.
In case of gastrointestinal symptoms, back, shoulder or hip joint pain, psychiatric disturbances, noticeable
fluctuations in blood glucose levels (in diabetic patients) or other disturbances, contact your doctor
immediately.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your
doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring
Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store Predasol

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.

6. Contents of the package and other information

What Predasol contains

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

What Predasol looks like and contents of the pack
Predasol is white, round tablets with a cross-shaped score line on one side and an imprint
"20" on the other side.
The tablets can be divided into two or four equal doses.
Predasol is available in blister packs made of PVC/PVDC/Aluminium in cardboard boxes containing 20,
30 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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