Patient Information Leaflet

Predasol, 10 mg, tablets
Prednisolonum
Please read all of 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 further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any 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 glucocorticosteroid (corticosteroid) affecting metabolism, electrolyte balance, and tissue function.
Predasol is indicated for the treatment of diseases requiring systemic administration of glucocorticosteroids. These include the following conditions, depending on their symptoms and severity [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 completion of growth (hydrocortisone and cortisone are drugs of choice),
stress conditions following prolonged corticosteroid therapy.

Rheumatic diseases:

active phases of vascular diseases:
polyarteritis nodosa (DR: a, b; in cases of hepatitis B, treatment duration should be limited to two weeks),
giant cell arteritis, muscle pain and stiffness (polymyalgia rheumatica) (DR: c),
temporal arteritis (inflammation mainly affecting the temporal artery) (DR: a); in cases of sudden vision loss, initial intravenous high-dose glucocorticosteroid pulse therapy followed by maintenance treatment with ESR monitoring,
Wegener's granulomatosis: initial treatment (DR: a-b) in combination with methotrexate (mild forms not involving kidneys) or according to Fauci regimen [severe forms involving kidneys and (or) lungs], maintenance of remission: (DR: d, gradually reducing doses) in combination with immunosuppressive drugs,
Churg-Strauss syndrome: initial treatment (DR: a-b) with organ manifestation and severe forms in combination with immunosuppressive drugs, 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 when necessary due to symptom severity or when certain drugs used in rheumatic disease treatment (NSAIDs) are ineffective or cannot be used:
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 in sarcoidosis (initially DR: b),
cardiac inflammation in rheumatic fever, beyond 2-3 months in severe cases (DR: a),
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); bronchodilators should also be administered,
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 (lung tissue hardening and structural changes) (DR: b), bronchiolitis obliterans with organizing pneumonia (BOOP) (DR: b, gradually reducing doses), if necessary in combination with immunosuppressive drugs, chronic eosinophilic pneumonia (DR: b, gradually reducing doses), long-term treatment of chronic sarcoidosis stage II and III (with dyspnea, cough, and worsening 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 glucocorticosteroid treatment (DR: c),
acute laryngeal and bronchial narrowing: mucosal edema (angioedema), subglottic laryngitis (pseudocroup) (DR: b to a).

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

allergic, pseudoallergic, and infection-related allergic diseases: e.g. acute urticaria, anaphylactoid reactions,
severe skin disorders, some causing skin integrity disruption, drug eruptions, erythema multiforme, toxic epidermal necrolysis (Lyell's syndrome), acute generalized exanthematous pustulosis, nodular erythema, severe febrile neutrophilic dermatosis (Sweet's syndrome), allergic contact dermatitis (DR: b to a),
skin rashes: e.g. allergic skin rashes such as atopic dermatitis, contact dermatitis, rashes caused by pathogenic microorganisms (pityriasis rosea) (DR: b to a),
diseases with nodule formation, e.g. sarcoidosis, lip inflammation (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) diseases: 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, prurigo 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 Sézary syndrome (DR: c to a),
other severe skin diseases: e.g. Jarisch-Herxheimer reaction to penicillin used in syphilis treatment, cavernous hemangioma with rapidly progressing exophthalmos, Behçet's disease, pyoderma gangrenosum, eosinophilic fasciitis, erythema annulare centrifugum, hereditary epidermolysis bullosa (DR: c to a).

Blood diseases/cancer:

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 transient drop in platelet count (acute transient thrombocytopenia) (DR: a),
cancer diseases such as acute lymphoblastic leukemia (DR: e), Hodgkin's lymphoma (DR: e), non-Hodgkin lymphoma (DR: e), chronic lymphocytic leukemia (DR: e), Waldenström's macroglobulinemia (DR: e), multiple myeloma (DR: e),
hypercalcemia associated with cancer (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 appetite loss, 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 drug of first choice), chronic Guillain-Barré syndrome, Tolosa-Hunt syndrome, neuropathy in monoclonal gammopathy, multiple sclerosis (with oral gradual dose reduction after prior parenteral high-dose glucocorticosteroid 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 eyes and immunological processes within the orbit and eye: optic nerve disease (optic neuropathy, e.g. giant cell arteritis, ischemia- or trauma-related), Behçet's disease, sarcoidosis, thyroid eye disease, orbital pseudotumor (orbital tissue edema), transplant rejection, and certain uveitis (inflammation of the middle eye layer).

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

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

Stomach, intestinal, 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 diseases: minimal change glomerulonephritis (DR: a), proliferative extracapillary glomerulonephritis (rapidly progressive glomerulonephritis) (DR: high-dose pulse treatment, usually combined with cytostatics), dose reduction and treatment termination in Goodpasture’s syndrome, long-term treatment in all other forms (DR: d),
idiopathic retroperitoneal fibrosis (DR: b).

2. 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).

With the exception of 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 this with your doctor or pharmacist if:
The patient suffers from scleroderma (an autoimmune disorder also known as systemic sclerosis), because doses of at least 15 mg per day may increase the risk of a serious complication called scleroderma renal crisis. Symptoms of scleroderma renal crisis include elevated blood pressure and reduced urine output. The treating physician may recommend regular monitoring of blood pressure and urine excretion.
Cases of pheochromocytoma crisis have been reported after administration of Predasol ( Pheochromocytoma crisis ) (elevated arterial pressure, headache, excessive sweating, palpitations, pallor), which may lead to death. Treatment of patients with suspected or diagnosed pheochromocytoma should only be initiated after appropriate assessment of benefit versus risk.
Extreme caution should be exercised when using Predasol in higher doses than those used for 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 infection 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 administered in the following conditions:

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

The following conditions 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 atrophy (osteoporosis);
psychiatric disorders (current or past), including suicide risk. In such cases, supervision by a neurologist or psychiatrist is recommended;
increased intraocular pressure (narrow- and wide-angle glaucoma) – ophthalmological supervision and concomitant treatment are recommended;
corneal damage and ulcers in the eye – ophthalmological supervision and concomitant treatment are recommended.

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

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

In patients receiving high doses of glucocorticoids, symptoms of peritoneal irritation may not occur following gastrointestinal tract ulcer 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 types of muscle paralysis (myasthenia gravis), symptoms may initially worsen. Therefore, Predasol should initially be administered in a hospital setting. Predasol should be introduced gradually, especially in cases of severe facial and throat disorders or respiratory disturbances.
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 administration of Predasol, regular medical check-ups are necessary (including ophthalmological examination every 3 months).
In diabetic patients, metabolism should be regularly checked, and the possibility of increased requirement 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 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, he or she should be monitored by a physician, as there is a risk of worsening.
Regular monitoring of blood pressure is required during treatment with Predasol, especially during use of high doses and in patients with difficult-to-control hypertension.
If during treatment with Predasol situations of particular physical stress occur, such as feverish illness, accident, surgery, childbirth, etc., the treating physician or emergency physician should be immediately informed about ongoing treatment. An 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 possible 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 during stressful situations, e.g., during infection, after accidents, during increased physical exertion), objective and subjective symptoms caused by cortisone withdrawal.
Viral diseases (e.g., chickenpox, measles) may have a particularly severe course in patients taking Predasol. Patients with weakened immune systems who have not previously had chickenpox or measles are most at risk. If such patients taking 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. Use of 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 with other medicines
Inform your doctor about all medicines currently or recently taken, as well as those planned for use, including over-the-counter medicines.
Other medicines affecting the action of Predasol

Medicines accelerating liver metabolism, such as certain sleeping pills (barbiturates), antiepileptic drugs (phenytoin, carbamazepine, and primidone), and certain tuberculosis drugs (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, rhinitis, and as an ingredient in appetite suppressants): The effectiveness of Predasol may be reduced due to accelerated metabolism in the body.
Medicines slowing liver metabolism, e.g., certain antifungal drugs (ketoconazole, itraconazole), may increase the effect of Predasol.
Certain female sex hormones, e.g., those used in contraceptives ("the pill"), may increase 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 drugs: ritonavir, cobicistat).

Effect of Predasol on other medicines

Predasol may enhance the effect of cardiac glycosides (medicines used to strengthen the heart) due to potassium deficiency.
Predasol may increase potassium loss caused by diuretics and laxatives.
Predasol may weaken the glucose-lowering effect of oral antidiabetic drugs and insulin.
Predasol may decrease or increase the effect of anticoagulant drugs (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 drugs (containing salicylates, indomethacin, or other nonsteroidal anti-inflammatory drugs).
Predasol may prolong the muscle-relaxing effect of certain non-depolarizing neuromuscular blocking agents.
Predasol may enhance the effect of certain drugs (atropine and other anticholinergic drugs) that increase intraocular pressure.
Predasol may weaken the effect of antiparasitic drugs (containing praziquantel).
Predasol may increase the risk of myopathy and cardiomyopathy when taken concomitantly with drugs 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 weaken the effect of thyrotropin (TSH) stimulation after protirelin (TRH - a hormone produced by part of the brain).
Predasol used concomitantly with immunosuppressive drugs (medicines reducing immune system function) may increase susceptibility to infections and may exacerbate or trigger symptoms of previously undiagnosed infections.
Also with cyclosporine (an immunosuppressive drug): Predasol may increase cyclosporine blood levels and thereby increase the risk of seizures.
Certain antihypertensive drugs (angiotensin-converting enzyme inhibitors): increased risk of blood morphology changes.
Fluoroquinolones – a certain group of antibiotics – may increase the risk of tendon damage.

Effect on laboratory test results
Skin reactions in allergy tests may be suppressed.
Predasol with food and drink
Tablets should be taken during or after a meal, preferably after breakfast, without chewing, with sufficient fluid.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, 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, neonatal adrenal insufficiency may occur, 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 drug during breastfeeding should be carefully considered. If higher doses are required for medical reasons, breastfeeding should be discontinued. Immediate medical advice should be sought.
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 working without safety protection.
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 prescribed by your doctor. The doctor will determine the dose individually for each patient. You must follow the prescribed dosage carefully, as otherwise the effect of Predasol may be inadequate.
If you have any doubts, consult your doctor or pharmacist.

Method of administration
The tablets should be taken whole, 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 patient's clinical condition and individual response to treatment, the doctor may assess the possibility of administering the medicine every other day.

Unless otherwise directed by the doctor, 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 midday; in adrenogenital syndrome: morning and evening). If necessary, a mineralocorticoid (fludrocortisone) should also be taken concurrently. In cases of significant physical stress, such as feverish infection, trauma, surgery, or childbirth, the dose may be temporarily increased by the doctor.

Stress situations following long-term glucocorticoid therapy: up to 50 mg prednisolone per day, administered at the appropriate time. The dose should then be tapered gradually over several days.

Treatment of certain diseases (pharmacotherapy)
To allow for the use of lower or higher doses, Predasol is also available as 5 mg and 20 mg tablets. Score lines on the tablets enable individual dose adjustment for each case.

The following tables provide an overview of general dosing guidelines:

Adults (dosing regimens a–d)
Dose category Daily dose (mg) Daily dose (mg/kg body weight)
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 haematopoietic disorders, as part of special treatment regimens (see below "Dosing regimen „e” (SD: e)")

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

Children
Dose category Daily dose (mg/kg body weight)
high 2 – 3
medium 1 – 2
maintenance 0.25

In children, treatment should be conducted with the lowest possible dose. In exceptional 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. Initially, the dose should be reduced 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, together with monitoring of disease activity, may serve as a guideline 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 very high doses lasting for several days may, depending on the underlying disease and clinical response, be discontinued without the need for gradual dose reduction.

In patients with 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 lymphocytic 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. However, if the patient experiences severe or unusual adverse effects, medical advice should be sought.

Missed dose of Predasol
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, the treated condition may recur or worsen. In such cases, consult your doctor, who will evaluate and adjust the treatment as necessary.

Discontinuation of Predasol
Always follow the dosing schedule prescribed by your doctor. Never discontinue Predasol without consulting your doctor, as 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Substitution therapy:
Low risk of adverse effects when the recommended dosage is followed.
Treatment of specific diseases, using higher doses than in substitution therapy:
The following adverse effects may occur, which largely depend on the dose and duration of treatment,
and for which it is therefore 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, reactivation 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", central
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.
Central 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 capillary fragility.
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, petechiae or
superficial skin hemorrhages, hirsutism, acne, inflammatory skin conditions of the face, especially around
the mouth, nose and eyes, skin pigmentation changes.
Musculoskeletal and connective tissue disorders
Muscle disorders, 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),
tendon disorders, tendinitis, tendon rupture, growth suppression in children.
Note: After rapid dose reduction following long-term treatment, symptoms such as muscle and joint
pains may occur.
Renal and urinary disorders
Scleroderma renal crisis in patients with scleroderma (an 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-type body
hair growth in women – hirsutism, impotence).
General disorders and administration site conditions
Delayed wound healing.
How to proceed
You should consult your doctor or pharmacist if any of the mentioned adverse effects occur or if any
other adverse effect occurs during treatment with 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, you should
contact your doctor immediately.
Reporting of adverse effects
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, you should
inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of
Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the responsible entity.
By reporting adverse effects, more information on the safety of the medicine can be collected.

5. How to store Predasol

Keep this medicine out of 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 instructions apply for this medicine.

6. Contents of the package and other information

What Predasol contains

The active substance is prednisolone. Each tablet contains 10 mg of prednisolone.
Other ingredients are: microcrystalline cellulose, lactose monohydrate, maize starch gelatinised, 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 embossing
"○" on the other side.
The tablets can be divided into equal doses.
Predasol is available in PVC/PVDC/Aluminium foil blisters in a cardboard box 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