Medoxa

Package leaflet: information for the user

Medoxa, 1 mg, tablets
Medoxa, 2.5 mg, tablets
Medoxa, 5 mg, tablets
Medoxa, 10 mg, tablets
Medoxa, 20 mg, tablets
Medoxa, 25 mg, tablets
Medoxa, 30 mg, tablets
Medoxa, 50 mg, tablets
Prednisone
Please read this leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What is Medoxa and what is it used for

Medoxa is a glucocorticoid (a corticosteroid hormone) affecting metabolism,
electrolyte balance, and tissue function.
Medoxa is indicated for the treatment of diseases requiring systemic glucocorticoid therapy.
These diseases, depending on their symptoms and severity, include
(dosing regimens: SD: from "a" to "d" and regimen "e", see section 3. How to take Medoxa):

Hormone replacement 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 long-term corticosteroid therapy.

Rheumatic diseases:

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

Respiratory and lung diseases:

• Bronchial asthma (SD: c to a); concomitant use of bronchodilators is recommended,
• Acute exacerbation of chronic obstructive pulmonary disease (COPD) (SD: b); recommended treatment duration: up to 10 days,
• Specific lung diseases such as acute alveolitis (SD: b), pulmonary fibrosis and structural lung changes (SD: b), bronchiolitis obliterans organizing pneumonia (BOOP) (SD: b, with gradual dose reduction), if necessary in combination with immunosuppressive drugs, chronic eosinophilic pneumonia (SD: b, with gradual dose reduction), long-term treatment of chronic sarcoidosis stage II and III (with dyspnea, cough, and impaired lung function) (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 intranasal glucocorticoid therapy (SD: c),
• Acute laryngeal and airway obstruction: mucosal edema (Quincke's edema), laryngeal stenosis and inflammation (pseudocroup) (SD: b to a).

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

• Allergic and pseudoallergic reactions associated with infections: 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, erythema nodosum, severe febrile neutrophilic dermatosis (Sweet's syndrome), allergic contact dermatitis (SD: b to a),
• Skin rashes: e.g., allergic skin rashes such as atopic dermatitis, contact dermatitis, rashes caused by pathogenic microorganisms (pityriasis rosea) (SD: b to a),
• Diseases characterized by nodule formation, e.g., sarcoidosis, cheilitis (granulomatous cheilitis) (SD: b to a),
• Severe blistering skin diseases: e.g., pemphigus vulgaris, bullous pemphigoid, benign mucosal pemphigoid, linear IgA dermatosis (SD: b to a),
• Vasculitis: e.g., allergic vasculitis, polyarteritis nodosa (SD: b to a),
• Immune system (autoimmune) diseases: e.g., dermatomyositis, systemic sclerosis (sclerotic phase), chronic discoid lupus erythematosus and subacute cutaneous lupus erythematosus (SD: b to a),
• Severe skin diseases during pregnancy (see also section "Pregnancy and breastfeeding"): e.g., pemphigoid gestationis, prurigo gestationis (SD: d to a),
• Severe skin diseases with erythema and scaling, e.g., pustular psoriasis, erythematous follicular pityriasis, pityriasis group, erythroderma, including cases of Sézary syndrome (SD: c to a),
• Other severe skin conditions: e.g., Jarisch-Herxheimer reaction to penicillin used in syphilis treatment, rapidly developing cavernous hemangioma characterized by rapid progression, Behçet's disease, pyoderma gangrenosum, eosinophilic fasciitis, erythematous annular lichen, hereditary epidermolysis bullosa (SD: c to a).

Blood disorders/cancer:

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

Nervous system disorders:

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

Specific infectious diseases:

• Toxic states 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 immunological processes within the orbit and eye: optic neuropathy (e.g., giant cell arteritis, ischemia-related or trauma-related),

• Behçet's disease, sarcoidosis, endocrine orbitopathy, orbital pseudotumor, transplant rejection, and certain forms of uveitis such as Harada's syndrome and sympathetic ophthalmia.
  The use of Medoxa is indicated only if local treatments are ineffective in the following eye conditions. Inflammatory conditions affecting various parts of the eye:

• Scleritis and episcleritis, keratitis or uveitis, chronic inflammation of the part of the eye producing intraocular fluid, allergic conjunctivitis, alkali burns,

• Keratitis occurring in autoimmune disease or syphilis (requires additional antimicrobial therapy), herpes simplex virus-induced keratitis (only if the corneal surface is intact and regular ophthalmological monitoring is ensured).

Gastrointestinal and liver diseases:

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

Kidney diseases:

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

2. Important information before using Medoxa

When not to use Medoxa:

• if the patient is allergic to prednisone 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 Medoxa in the treatment of acute, life-threatening conditions.
Warnings and precautions
Before starting treatment with Medoxa, discuss this with your doctor or pharmacist if:
the patient suffers from 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. 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.
Extreme caution is required when using Medoxa at higher doses than those used in hormonal replacement therapy. In such cases, Medoxa should only be used if the doctor considers it absolutely necessary.
Due to suppression of the immune system, Medoxa 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 reactivated. Concomitant targeted antimicrobial therapy should be administered in the following conditions:

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

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

• gastric and intestinal ulcers;
• difficult-to-control arterial hypertension;
• difficult-to-control diabetes;
• bone loss (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 monitoring and concomitant treatment are recommended;
• corneal damage and ulcers – ophthalmological monitoring and concomitant treatment are recommended.

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

• severe intestinal inflammation (ulcerative colitis) with risk of perforation, abscesses, or suppurative 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 Medoxa.
During treatment of certain types of muscle paralysis (myasthenia gravis), symptoms may initially worsen; therefore, Medoxa should initially be administered in a hospital setting. Medoxa should be introduced gradually, especially if severe facial or throat disorders or breathing difficulties occur.
Vaccinations using inactivated (killed) microorganism vaccines are generally acceptable. However, it should be noted that vaccine efficacy may be reduced after administration of high doses of Medoxa.
During treatment with high doses of Medoxa, bradycardia (slow heart rate) may occur. The occurrence of bradycardia does not necessarily correlate with the duration of treatment.
During long-term administration of Medoxa, regular medical check-ups are required (including ophthalmological examination every 3 months).
In diabetic patients, metabolism should be monitored regularly, and the possible need for increased antidiabetic medication (insulin or oral hypoglycemic agents) should be considered.
During long-term use of high doses of Medoxa, 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 hypersensitivity) may occur.
If the patient has high blood pressure or severe heart failure, close medical monitoring is required due to the risk of worsening of these conditions.
If special physical stress situations occur during treatment with Medoxa, such as feverish illness, accident, surgery, childbirth, etc., the treating physician or emergency doctor must be informed immediately about ongoing treatment. The daily dose of Medoxa may need to be temporarily increased. During long-term treatment, the patient should receive an emergency information card from the doctor, which should always be carried.
Depending on the dose and duration of treatment, negative effects on calcium metabolism should be anticipated; therefore, osteoporosis prophylaxis is recommended. This particularly applies to individuals with additional risk factors such as family predisposition, advanced age, inadequate protein and calcium intake, heavy smoking, excessive alcohol consumption, postmenopausal status, and lack of physical activity. Prophylaxis includes adequate calcium and vitamin D intake and regular physical activity. In cases of existing osteoporosis, additional pharmacological treatment should be considered.
When discontinuing or interrupting long-term treatment, consider the risk of the following: exacerbation or recurrence of the underlying disease, acute adrenal insufficiency (especially during stressful situations, e.g., infection, accidents, increased physical strain), and objective and subjective symptoms caused by cortisone withdrawal.
Viral infections (e.g., chickenpox, measles) may have a particularly severe course in patients taking Medoxa. Patients with weakened immune systems who have not previously had chickenpox or measles are at highest risk. Such patients on Medoxa who come into contact with individuals suffering from measles or chickenpox should contact their doctor immediately for possible initiation of prophylactic treatment if necessary.
Children and adolescents
In children, due to the risk of growth suppression, Medoxa should only be used if there are strong medical indications. The child's growth should be monitored regularly. Treatment with Medoxa should be limited in duration or administered on an alternate-day schedule (e.g., every other day, but at double dose – alternate-day therapy).
Elderly patients
Since elderly patients are at higher risk of osteoporosis, the benefit-risk ratio of using Medoxa should be carefully evaluated.
Improper use of the drug as doping
Use of Medoxa may lead to positive results in anti-doping controls and may pose health risks if used as a doping agent.
Medoxa and other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines planned for future use.
Other medicines affecting the action of Medoxa

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

Effect of Medoxa on the action of other medicines

• Medoxa may enhance the effect of cardiac glycosides (heart-strengthening drugs) due to potassium deficiency.
• Medoxa may increase potassium loss caused by diuretics (saluretics) and laxatives.
• Medoxa may reduce the blood glucose-lowering effect of oral antidiabetic drugs and insulin.
• Medoxa may decrease or increase the effect of anticoagulants (oral anticoagulants, coumarin derivatives). The doctor will decide whether dose adjustment of the anticoagulant is necessary.
• Medoxa may increase the risk of gastric ulcers and gastrointestinal bleeding when used concomitantly with anti-inflammatory and antirheumatic drugs (containing salicylates, indomethacin, or other nonsteroidal anti-inflammatory drugs).
• Medoxa may prolong the muscle-relaxing effect of certain non-depolarizing neuromuscular blocking agents.
• Medoxa may enhance the effect of certain drugs that increase intraocular pressure (atropine and other anticholinergic drugs).
• Medoxa may reduce the effectiveness of antiparasitic drugs (praziquantel).
• Medoxa may increase the risk of myopathy and cardiomyopathy when taken concomitantly with drugs used to treat malaria or rheumatic diseases (chloroquine, hydroxychloroquine, mefloquine).
• Growth hormone (somatotropin): its effect is reduced, especially during high-dose Medoxa treatment.
• Medoxa may reduce the TSH-stimulating effect of protirelin (TRH – a hormone produced by the hypothalamus).
• Medoxa, when used concomitantly with immunosuppressive drugs, may increase susceptibility to infections and may exacerbate or unmask previously undiagnosed infections.
• With cyclosporine (an immunosuppressive drug): Medoxa 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.
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 if prescribed by a doctor. Therefore, if the patient is pregnant, she should inform her doctor. During long-term use of Medoxa in pregnancy, impaired fetal growth cannot be ruled out. If Medoxa is used toward the end of pregnancy, the newborn may develop adrenal insufficiency, which may require substitution therapy with gradual dose reduction. Animal studies have shown that prednisone has harmful effects on fetuses (e.g., cleft palate). Reports suggest an increased risk of such malformations in humans following prednisone administration during the first trimester of pregnancy.
Breastfeeding
Prednisone passes into breast milk. No adverse effects in infants have been reported to date.
Nevertheless, the necessity of using the drug during breastfeeding should be carefully evaluated. If higher doses are medically required, breastfeeding should be discontinued.
Contact your doctor immediately.
Driving and operating machinery
Currently, there is no data indicating that Medoxa impairs the ability to drive or operate machinery. The same applies to working without secure support.
Medoxa contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to use Medoxa

This medicine should always be used as directed by the physician. The doctor will determine the dose individually for each patient.
You must follow the recommended dosage carefully, as otherwise the effect of Medoxa may be inadequate.
If in doubt, consult your doctor or pharmacist.
Method of administration
Tablets should be taken without chewing, during or immediately after a meal, with sufficient fluid.
Hormone replacement therapy in chronic adrenal insufficiency is lifelong.
Depending on the clinical condition and the individual patient's response to treatment, the doctor may assess whether the medicine can be administered every other day.
Unless otherwise directed by the physician, the usual dosage is:
Substitution therapy (outside the growth period)
5 to 7.5 mg prednisolone daily, divided into two single doses (morning and noon; in adrenogenital syndrome: morning and evening); if necessary, a mineralocorticoid (fludrocortisone) should 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 states following long-term glucocorticoid therapy: up to 50 mg prednisolone per day, administered at appropriate times. The dose should be reduced gradually over several days.
Treatment of certain diseases (pharmacotherapy)
To allow higher doses to be administered, Medoxa is available in various strengths.
The tablet break lines enable individual dose adjustment for each case.
The tables below provide an overview of general dosing guidelines:
Adults (dosing regimens a-d)

The total daily dose is usually taken early in the morning between 6.00 a.m. and 8.00 a.m.
However, depending on the disease, high daily doses may be divided into 2–4 single doses,
and medium daily doses into 2–3 single doses.
Children

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

Treatment with high and 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, lower doses may be sufficient or dose reduction may be necessary.
If the patient feels that the effect of Medoxa is too strong or too weak, they should contact their doctor or pharmacist.
Dosing regimen "e" (DR: e)
In this case, Medoxa is usually administered as a single dose without the need for gradual dose tapering at the end of treatment. The following are example dosing regimens used in chemotherapy:

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

Use of a higher than recommended dose of Medoxa
Medoxa is generally well tolerated, even with short-term use of high doses. No special measures are required. If the patient experiences severe or unusual adverse effects, medical advice should be sought.
Missed dose of Medoxa
A double dose should not be used to make up for a missed dose.
A missed dose may be taken during the same day, and treatment should continue with the dose prescribed by the doctor at the usual time on the following day.
If several doses are missed, a relapse or worsening of the treated disease may occur. In such cases, the patient should consult their doctor, who will assess the treatment and adjust it if necessary.
Stopping treatment with Medoxa
The dosing schedule prescribed by the doctor should always be followed. Medoxa should never be discontinued without consulting a doctor, because prolonged use of Medoxa may suppress the body's natural production of glucocorticoids. In such cases, significant physical stress may pose a life-threatening risk (adrenal crisis).
If there are any further doubts regarding the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible adverse effects

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

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

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

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

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

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

Blood and lymphatic system disorders

• Changes in blood morphology (increased white blood cell count or total blood cell count, decreased count of certain types of white blood cells)

Immune system disorders

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

Endocrine disorders

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

Metabolism and nutrition disorders

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

Nervous system disorders

• Increased intracranial pressure (pseudotumor cerebri), symptoms of which include headache with vomiting, fatigue, and drowsiness
• Occurrence of seizures in patients with epilepsy, more frequently and with greater severity

Eye disorders

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

Cardiac disorders

• Slow heart rate

Vascular disorders

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

Skin and subcutaneous tissue disorders

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

Musculoskeletal and connective tissue disorders

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

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

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

General disorders and administration site conditions

• Delayed wound healing

Additional adverse effects in children and adolescents
Slowed growth may occur in children and adolescents. In such a case, inform the doctor.
Reporting adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
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 marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Medoxa

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton following:
"EXP". The expiry date refers to the last day of the specified month.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation Lot indicates the batch number.
1 mg: Do not store above 30°C.
Other strengths: No special storage instructions for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the pack and other information

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

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

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

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

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

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

This medicinal product is authorised in the European Economic Area member states under the following names:
Czech Republic: Prednison Scalepharm
Italy: BRUCORTEN
Germany: Prednison Scalepharm 1 mg Tabletten, Prednison Scalepharm 2.5 mg Tabletten, Prednison Scalepharm 5 mg Tabletten, Prednison Scalepharm 10 mg Tabletten, Prednison Scalepharm 20 mg Tabletten, Prednison Scalepharm 25 mg Tabletten, Prednison Scalepharm 30 mg Tabletten, Prednison Scalepharm 50 mg Tabletten
Poland: Medoxa