Medoxa

Leaflet accompanying the packaging: 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

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

• You should keep this leaflet so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

Hormone replacement therapy

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

Rheumatic diseases:

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

Pulmonary diseases:

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

Upper respiratory tract diseases:

• severe forms of hay fever and allergic rhinitis after failure of local glucocorticosteroid therapy (SD: c),
• acute laryngeal and respiratory tract narrowing: mucous membrane edema (Quincke's edema), laryngitis and tracheitis (pseudocroup) (SD: b to a).

Skin diseases:

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

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

Blood diseases/cancer:

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

Nervous system diseases:

• certain forms of muscle paralysis (myasthenia) (the first-choice drug is azathioprine), chronic Guillain-Barré syndrome, Tolosa-Hunt syndrome, polyneuropathy in monoclonal gammopathy, multiple sclerosis (after initial intravenous administration of high doses of glucocorticosteroids in the course of an acute relapse), certain forms of seizure disorders in infants (West syndrome).

Specific forms of infectious diseases:

• toxic conditions in the course of severe infectious diseases (in combination with antibiotics or chemotherapeutic agents), e.g., tuberculous meningitis (SD: b), severe forms of pulmonary tuberculosis (SD: b).

Eye diseases (SD: b to a):

• in systemic diseases affecting the eyes and in immunological processes within the orbit and eye: optic nerve disease (optic neuritis, e.g., giant cell arteritis, related to insufficient circulation or trauma),

Behçet's disease, sarcoidosis, endocrine orbitopathy, pseudotumor of the orbit, transplant rejection, and in some forms of uveitis, such as Harada's syndrome and sympathetic uveitis. In the following diseases, the use of Medoxa is indicated only in cases where local treatment is ineffective. Inflammatory conditions of various parts of the eye:

• scleritis and adjacent scleritis, keratitis or uveitis, chronic inflammation of the part of the eye that produces intraocular fluid, allergic conjunctivitis, alkaline burns,
• keratitis occurring in autoimmune disease or syphilis (additional anti-infective treatment is required), keratitis caused by the herpes simplex virus (only if the corneal surface is intact and regular ophthalmological monitoring is ensured).

Gastrointestinal and liver diseases:

• ulcerative colitis (SD: b to c),
• Crohn's disease (SD: b),
• autoimmune hepatitis (SD: b),
• esophageal burn (SD: a).

Kidney diseases:

• certain autoimmune diseases in the kidneys: minimal change disease (SD: a), rapidly progressive glomerulonephritis (SD: treatment with high doses in pulses, usually in combination with cytostatics), reduction of the dose and termination of treatment in Goodpasture's syndrome, in all other forms long-term treatment (SD: d).

2. Important information before taking Medoxa

When not to take Medoxa:

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

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

Warnings and precautions

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

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

Medoxa should be used with caution when administered in higher doses than those used for hormone replacement therapy. In this case, Medoxa should only be used if the doctor considers it absolutely necessary.

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

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

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

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

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

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

Before starting Medoxa, the patient should discuss with their doctor if they have a suspected or known pheochromocytoma (adrenal gland tumor).

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

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

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

In patients receiving high doses of glucocorticosteroids, there may be no symptoms of peritoneal irritation after perforation of a gastrointestinal ulcer.

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

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

In principle, vaccinations with killed microorganism vaccines (inactivated vaccines) are allowed. However, it should be considered that the effectiveness of the vaccination may be reduced after taking higher doses of Medoxa.

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

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

In diabetic patients, their metabolism should be regularly checked, and the possibility of increased requirements for antidiabetic drugs (insulin or tablets) 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. The patient's potassium levels should be monitored under medical supervision.

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

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

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

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

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

During withdrawal or after possible discontinuation of long-term treatment, the following situations should be considered: exacerbation or recurrence of the underlying disease, acute adrenal insufficiency (especially in stressful situations, e.g., during infection, after accidents, during increased physical exertion), objective and subjective symptoms caused by corticosteroid withdrawal.

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

Children and adolescents

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

Elderly patients

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

Incorrect use of the medicine as a doping agent

Taking Medoxa may result in positive doping test results and may pose a risk to health if the medicine is used as a doping agent.

Medoxa and other medicines

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

Other medicines affecting Medoxa

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

Effect of Medoxa on other medicines

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

Effect on laboratory tests

Skin reactions in allergy tests may be suppressed.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

During pregnancy, this medicine should only be used if prescribed by a doctor. Therefore, if the patient is pregnant, they should inform their doctor. During long-term use of Medoxa during pregnancy, growth disorders in the unborn child cannot be ruled out. If Medoxa is used at the end of pregnancy, the newborn may experience adrenal insufficiency, which may require substitution therapy with gradual dose reduction. In animal studies, prednisone has shown harmful effects on fetuses (e.g., cleft palate). There are reports indicating an increased risk of such damage in humans due to prednisone administration during the first three months of pregnancy.

Breastfeeding

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

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

The patient should immediately contact their doctor.

Driving and using machines

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

Medoxa contains sodium

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

3. How to take Medoxa

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

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

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

Method of administration

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

Hormone replacement therapy in chronic adrenal insufficiency is lifelong. The doctor, depending on the patient's clinical condition and individual response to treatment, will assess the possibility of the patient taking the medicine every other day.

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

Replacement therapy (after the end of growth)

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

Treatment of certain diseases (pharmacotherapy)

To allow for the use of higher doses, Medoxa is available in various strengths.

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

The following tables provide an overview of general dosage guidelines:

Adults (dosing schemes a-d)

Usually, the total daily dose is taken in the morning between 6:00 and 8:00. However, depending on the disease, high daily doses can be divided into 2-4 single doses, and medium daily doses - into 2-3 single doses.

Children

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

Reducing the dose

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

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

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

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

Treatment with high and very high doses for several days, depending on the underlying disease and the patient's clinical response, may be discontinued without the need for gradual dose reduction.

In cases of hypothyroidism or liver cirrhosis, smaller doses may be sufficient, or the dose may need to be reduced.

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

Dosing scheme "e" (SD: e)

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

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

Using a higher dose of Medoxa than recommended

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

Missing a dose of Medoxa

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

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

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

Stopping Medoxa treatment

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

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

4. Possible side effects

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

If Medoxa is used to compensate for the lack of corticosteroids in the body when the body does not produce enough natural corticosteroid, the risk of side effects is low when using the recommended doses.

Side effects depend on the dose and duration of treatment. Therefore, the frequency of these side effects cannot be provided. Most side effects disappear after treatment is discontinued and are usually less severe after dose reduction.

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

• Depression, including suicidal thoughts
• Euphoric state (mania), excessive feeling of happiness or excitement (euphoria) or elevated or lowered mood, increased drive
• Feeling of anxiety or irritability, sleep disorders
• Feeling, seeing, or hearing things that do not exist (hallucinations), loss of contact with reality (psychosis)

5. How to store Medoxa

The medicinal product should be stored out of sight and reach of children.
Do not use this medicinal product after the expiry date stated on the blister and carton after:
“EXP”. The expiry date refers to the last day of the specified month.
The entry on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
1 mg: Do not store above 30°C.
Other strengths: No special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines that are no longer needed. This will help protect
the environment.

6. Package contents and other information

What 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, cornstarch, sodium stearyl fumarate (Ph.Eur.).
10 mg / 20 mg / 25 mg / 30 mg / 50 mg:
microcrystalline cellulose, cornstarch, 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 break line on one side and the number "1" embossed on the other side.
2.5 mg:
White or almost white, round tablet with a break line on one side and the number "2.5" embossed on the other side.
5 mg:
White or almost white, round tablet with a break line on one side and the number "5" embossed on the other side.
10 mg:
White or almost white, round tablet with a break line on one side and the number "10" embossed on the other side.
20 mg:
White or almost white, round tablet with a break line on one side and the number "20" embossed on the other side.
25 mg:
White or almost white, round tablet with a break line on one side and the number "25" embossed on the other side.
30 mg:
White or almost white, round tablet with a break line on one side and the number "30" embossed on the other side.
50 mg:
White or almost white, round tablet with a break line on one side and the number "50" embossed on the other side.
Tablets can be divided into equal doses.
Tablets are packaged in PVC/PVDC/Aluminum blisters.
Package sizes:
1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg, 25 mg, 30 mg, 50 mg:
Packages contain 20 or 100 tablets.
Not all package sizes may be marketed.

Marketing authorization holder

Polpharma S.A.
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 authorized in the Member States of the European Economic Area 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

Date of last revision of the leaflet: