Patient Information Leaflet: Read this leaflet carefully before taking the 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 consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are similar.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

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

1. What Meprelon is and what it is used for

The active substance in Meprelon is a glucocorticoid (a corticosteroid hormone), which affects metabolism (i.e. the body's chemical processes), water and electrolyte balance, and tissue functions.
Meprelon is used in diseases requiring glucocorticoid therapy. Depending on symptoms and severity, these include, among others: inflammatory and systemic rheumatic diseases, autoimmune disorders, allergic conditions, anaphylactic shock, severe asthma, and transplant rejection.

Rheumatic diseases:

Progressive rheumatoid arthritis in severe, advancing forms, e.g. with rapid joint destruction, and extra-articular manifestations.
Juvenile rheumatoid arthritis with severe course involving internal organs (Still's syndrome) or affecting the eyes when local treatment is ineffective (uveitis and adjacent structures).

Respiratory system diseases:

Bronchial asthma (bronchodilators should be used concomitantly).
Acute exacerbation of chronic obstructive pulmonary disease (recommended treatment duration: up to 10 days).
Specific lung diseases such as acute alveolitis, pulmonary fibrosis; maintenance treatment of chronic sarcoidosis in stage II and III (with dyspnea, cough, and impaired lung function parameters).
Severe forms of hay fever and allergic rhinitis after failure of treatment with intranasal glucocorticoid aerosol.

Skin diseases:
Skin and mucous membrane disorders that cannot be adequately treated with topical corticosteroids due to their severity and/or extent or involvement of internal organs. These include:

Allergic and allergy-like reactions, including infection-related allergic reactions, e.g. urticaria, anaphylactoid reactions.
Severe skin reactions, sometimes causing skin necrosis, drug eruptions, erythema multiforme, toxic epidermal necrolysis (Lyell's syndrome), generalized acute exanthematous pustulosis, nodular erythema, severe febrile neutrophilic dermatosis (Sweet's syndrome), allergic contact dermatitis.

Blood disorders:

Autoimmune blood diseases: anemia due to destruction of red blood cells (acquired [autoimmune] hemolytic anemia).

Gastrointestinal diseases:

Ulcerative colitis.
Crohn's disease.

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).

2. Important information before using Meprelon

When not to use Meprelon

If the patient is allergic to methylprednisolone or any of the other ingredients of this medicine (listed in section 6).
If the patient has systemic fungal infections. Apart from allergic reactions, there are no contraindications to short-term use of Meprelon in acute life-threatening conditions or in replacement therapy.

Warnings and precautions
Before starting treatment with Meprelon, discuss this with your doctor or pharmacist if:

The patient has hyperthyroidism. If treatment with Meprelon in doses higher than replacement doses (doses used to compensate for deficient corticosteroid production by the human body) is necessary, Meprelon should only be used when deemed essential by the physician. In certain cases, specific antimicrobial therapy must be administered concomitantly. This applies to the following conditions:
Acute viral infections (chickenpox, shingles, herpes virus infections, herpes keratitis);
Acute and chronic bacterial infections;
Fungal infections involving internal organs;
Certain parasitic diseases (amoebiasis, helminth infections);
Lymph node disorders following tuberculosis vaccination (in patients with a history of tuberculosis, Meprelon may be used only if administered simultaneously with anti-tuberculosis drugs);
Hepatitis (chronic active hepatitis with positive HBsAg test);
Poliomyelitis;
Approximately 8 weeks before and up to 2 weeks after vaccination with live vaccines.

Meprelon may be used in the following conditions only if the physician considers it necessary, and the disease is treated according to established guidelines:

Peptic ulcer disease of the stomach and duodenum;
Hypertension that is difficult to control;
Severe diabetes;
Osteoporosis;
Psychiatric disorders (including in medical history);
Increased intraocular pressure (glaucoma with closed or open angle);
Corneal damage and corneal ulcers.

Due to the risk of intestinal perforation and peritonitis, Meprelon should be used only under strict indications and with appropriate monitoring in the following conditions:

Severe colitis (ulcerative colitis) with risk of perforation, abscesses, or suppurative inflammation;
Diverticulitis;
After certain intestinal surgeries (intestinal anastomoses) immediately post-operatively.

In patients receiving high doses of glucocorticoids, symptoms of peritonitis following gastrointestinal perforation may be masked.
Treatment with Meprelon may cause gas accumulation in the intestinal wall, known as pneumatosis intestinalis (see section 4, "Possible side effects"). Pneumatosis intestinalis may range from a mild condition not requiring treatment to more severe cases that may require immediate treatment.
If symptoms such as nausea, vomiting, and abdominal pain persist or worsen, contact a doctor immediately. The doctor will decide on the need for further diagnosis and treatment.
During treatment of certain types of muscle paralysis (myasthenia gravis), symptoms may initially worsen. Therefore, Meprelon should initially be administered in a hospital setting. Especially in cases of severe facial and throat disorders with breathing difficulties, Meprelon should be introduced gradually.
Meprelon may mask symptoms of infection, thereby complicating the diagnosis of existing or developing infections. Long-term use of even small doses of methylprednisolone increases the risk of infection by microorganisms that usually rarely cause disease.
Vaccination with vaccines containing inactivated pathogenic microorganisms is generally possible. However, it should be noted that administration of higher doses of Meprelon may reduce vaccine efficacy.
In diabetic patients, metabolism (material exchange) should be monitored regularly. An increased need for antidiabetic medications (insulin, oral antidiabetics, etc.) should be considered.
Particularly during long-term treatment with relatively high doses of Meprelon, attention should be paid to adequate potassium intake (e.g., vegetables, bananas) and sodium restriction. The doctor should monitor blood potassium levels.
In cases of severe hypertension or severe heart failure, the doctor should carefully monitor the patient, as there is a risk of deterioration.
Before starting treatment with Meprelon, discuss this with your doctor if:
The patient has scleroderma (an autoimmune disorder also known as systemic sclerosis), as doses of at least 12 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 output.
Inform your doctor if the patient develops symptoms of tumor lysis syndrome, such as muscle cramps, muscle weakness, confusion, vision loss or visual disturbances, shortness of breath, seizures, irregular heartbeat, or kidney failure (reduced urine output or darker urine color), especially if the patient has a hematologic malignancy (see section 4, "Possible side effects").
Cases of tumor crisis following administration of Meprelon have been reported in patients with pheochromocytoma (Pheochromocytoma crisis) (elevated blood pressure, headache, excessive sweating, palpitations, pallor), which may be fatal. Treatment of patients with suspected or diagnosed adrenal pheochromocytoma should begin only after careful assessment of benefit versus risk.
If the patient experiences blurred vision or other visual disturbances, contact a doctor.
During long-term treatment with Meprelon, regular medical check-ups (including ophthalmological examinations) are necessary.
If the patient experiences unusual physical stress during treatment with Meprelon, such as febrile illness, trauma, or surgery, contact the treating physician or inform the emergency department about the ongoing treatment. Temporary increase in the daily dose of Meprelon may sometimes be necessary.
Depending on the duration of treatment and dosage, a negative impact of the drug on calcium metabolism should be expected. Therefore, osteoporosis prevention is recommended, especially in individuals with existing risk factors such as family history, advanced age, insufficient protein and calcium intake, heavy smoking, excessive alcohol consumption, postmenopausal status, or lack of physical activity. Prevention includes adequate calcium and vitamin D intake and physical activity. In cases of existing osteoporosis, additional drug treatment should be considered.
After discontinuation or interruption of long-term Meprelon treatment, the following risks should be considered: exacerbation or recurrence of the underlying disease, acute adrenal insufficiency (especially under stress conditions, e.g., during infection, after trauma, or with increased physical stress), and "steroid withdrawal syndrome" (see section 4, "Possible side effects").
Viral infections may have a particularly severe course in patients treated with Meprelon, especially in immunocompromised children and individuals who have not previously had measles or chickenpox. If such individuals come into contact with patients suffering from measles or chickenpox during Meprelon treatment, they should immediately consult a doctor, who may initiate preventive measures if necessary.
In patients with untreated hypothyroidism or liver cirrhosis, relatively low or reduced doses may be sufficient, and dosage adjustments should be determined in consultation with the physician.
Seek immediate medical advice if weakness or muscle pain, cramps, and stiffness occur during methylprednisolone treatment. These may be symptoms of a condition called thyrotoxic periodic paralysis, which may occur in patients with hyperthyroidism treated with methylprednisolone. Additional treatment may be necessary to alleviate this condition.

Children
Meprelon should be used in children only under absolute indications due to the risk of growth suppression. The child's growth should be monitored regularly.
A specific heart muscle disease (hypertrophic cardiomyopathy) has been observed in preterm infants after systemic glucocorticoid treatment. Therefore, cardiac function should be monitored in infants receiving systemic glucocorticoids.

Elderly patients
Caution should be exercised in elderly patients due to increased risk of adverse effects, such as diabetes, osteoporosis, and hypertension.

Misuse of Meprelon as a doping agent
Use of Meprelon may lead to positive results in doping tests. Moreover, using Meprelon as a doping agent may pose health risks.

Meprelon and other medicines
Inform your doctor about all medicines currently or recently taken, including those available without prescription.

Medicines that may enhance the effect of Meprelon

Certain medicines may enhance the effect of Meprelon, and the doctor may wish to closely monitor the patient receiving such medicines (including some HIV medications: ritonavir, cobicistat).
Medicines that slow corticosteroid metabolism in the liver, such as certain antifungal agents (containing ketoconazole, itraconazole), may enhance the effect of Meprelon.
Certain female sex hormones, e.g., oral contraceptives: the effect of Meprelon may be increased.

Medicines that may reduce the effect of Meprelon

Medicines that accelerate its breakdown in the liver (barbiturates, phenytoin, primidone, carbamazepine – anticonvulsants, rifampicin – antituberculosis drug): the effect of Meprelon may be reduced.
Medicines containing ephedrine, used to reduce mucosal edema, may accelerate glucocorticoid metabolism, potentially reducing their efficacy.

Other potential interactions

Medicines used in heart disease treatment (e.g., diltiazem – calcium channel blocker) may slow methylprednisolone breakdown. Therefore, initial treatment should be under medical supervision. Dose adjustment of methylprednisolone may be necessary.
Medicines neutralizing gastric acid (antacids): in patients with chronic liver disease, an increased dose of Meprelon may be required.

Effect of Meprelon on other medicines
Enhanced effects

Medicines used in heart failure treatment (cardiac glycosides): due to potential potassium deficiency caused by Meprelon, their effect may be increased.
Diuretics and laxatives: their potassium-depleting effect may be intensified.
Certain muscle relaxants (non-depolarizing neuromuscular blockers): muscle relaxation may last longer.

Reduced effects

Antidiabetic medicines (oral, insulin): their effect may be reduced, leading to increased blood glucose levels.
Anticoagulants (oral anticoagulants, coumarin derivatives): their blood-clotting inhibition effect may be reduced.
Antiparasitic medicines (praziquantel): reduced efficacy of this medicine is possible.
Growth hormones (somatotropin): their effect may be reduced, especially during high-dose Meprelon treatment.
Protirelin (pituitary hormone): reduced increase in thyroid-stimulating hormone (TSH) concentration.

Other potential interactions

Anti-inflammatory and antirheumatic medicines (salicylates, indomethacin, and other non-steroidal anti-inflammatory drugs): increased risk of gastrointestinal ulceration or bleeding may occur.
Certain ophthalmic medicines (atropine) and similar-acting drugs (other anticholinergics): intraocular pressure may increase further.
Medicines against malaria or rheumatic diseases (chloroquine, hydroxychloroquine, mefloquine): increased risk of muscle disorders or cardiomyopathy.
Cyclosporine (an immunosuppressant): cyclosporine blood levels increase, thereby increasing the risk of seizures.
Certain antihypertensive medicines (angiotensin-converting enzyme inhibitors): increased risk of blood count abnormalities.

Effect on laboratory tests: skin reaction in allergy tests may be reduced.

Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Animal studies have shown that Meprelon impairs fertility. Until adequate studies on the effects of Meprelon on human reproductive processes are conducted, this medicine should not be given to pregnant women unless a careful benefit-risk assessment for both mother and fetus has been performed.
Some corticosteroids readily cross the placental barrier. In one retrospective study, an increased incidence of low birth weight in infants born to mothers taking corticosteroids was observed. In humans, the risk of low birth weight is dose-dependent. This risk may be reduced by using lower corticosteroid doses.
If chronic Meprelon treatment must be discontinued during pregnancy, it should be done gradually. In certain situations (e.g., replacement therapy for adrenal insufficiency), continuation or even dose increase may be necessary. Infants born to mothers who received Meprelon during pregnancy should be closely observed and tested for adrenal insufficiency.
The effect of Meprelon on labor is unknown.
Cataracts have been observed in infants born to mothers who received long-term Meprelon treatment during pregnancy.
Meprelon passes into breast milk.
This medicine may be used by breastfeeding women only after careful benefit-risk assessment for both mother and infant.

Driving and operating machinery
Due to certain possible side effects such as impaired visual acuity (due to cataracts or increased intraocular pressure), dizziness, or headache, concentration and reaction ability may rarely be impaired. The patient may not react quickly enough to sudden or unexpected events. This may pose a risk, for example, when driving or operating machinery. The patient may unnecessarily endanger themselves and others. Note that alcohol may increase this risk.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Meprelon

This medicine should always be used exactly as your doctor has instructed. If in doubt, consult your doctor or pharmacist.
Your doctor will determine the dose individually for each patient depending on the type of illness and the individual response of the patient. You must follow these instructions carefully, as otherwise the effect of Meprelon may not be optimal. If you have any doubts, contact your doctor or pharmacist again.
Relatively high initial doses (from 4 mg to 48 mg) are usually used. These doses must be clearly higher in acute, severe forms of disease than in chronic conditions.
Depending on the course of the disease, the dose may be gradually reduced to the lowest possible maintenance dose (usually from 4 to 12 mg of methylprednisolone per day). Particularly in the treatment of chronic diseases, long-term therapy with low maintenance doses is often necessary.

Method of administration
The medicine is taken orally.
Tablets (the entire daily dose) are usually taken before or after breakfast (between 6:00 a.m. and 8:00 a.m.), without chewing, with sufficient fluid, e.g., one glass of water. If the clinical condition allows, your doctor may recommend taking the medicine every other day.

Use of a higher than recommended dose of Meprelon
Meprelon is generally well tolerated even when high doses are used for short periods. No special measures are usually required. However, if pronounced or unusual adverse effects occur, consult your doctor immediately.

Missed dose of Meprelon
A missed dose may be taken during the same day. The next day, take the usual dose as scheduled. If several doses are missed, the underlying disease may sometimes worsen. In such a case, contact your doctor, who will assess and, if necessary, adjust your treatment.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Meprelon
Follow your doctor's instructions exactly. Do not stop taking Meprelon on your own. Your doctor may instruct you to gradually reduce the dose until treatment is completely discontinued.

If Meprelon is stopped abruptly, the following risks should be considered (see also section 2. "Warnings and precautions"):

steroid withdrawal syndrome (see section 4. "Possible side effects"),
adrenal insufficiency (low cortisol levels),
worsening or relapse of the underlying disease.

Prolonged use of Meprelon may lead to suppression of the body's own production of glucocorticosteroids. In such cases, significant physical stress could become life-threatening (adrenal crisis).

If you feel that the effect of Meprelon is too strong or too weak, consult your doctor or pharmacist.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although they do not occur in everyone.
Adverse effects have been listed without information on their frequency. Frequency cannot be
determined from the available data.
Substitution therapy:
Low risk of adverse effects when the recommended dosage is observed.
Treatment of specific diseases, using higher doses than in substitution therapy:
Depending on the duration of treatment and dose, the following adverse effects may occur:
Blood and lymphatic system disorders
Changes in blood morphology (increased number of white blood cells, red blood cells, platelets,
decreased number of a certain type of white blood cells – eosinophils).
Immune system disorders
Weakened immune system (e.g. increased risk of infections, appearance of infection symptoms in
individuals who were previously asymptomatic carriers, worsening of infection symptoms), allergic
reactions.
Endocrine disorders
Catecholamine crisis (elevated blood pressure, headache, sweating, palpitations, pallor), development
of so-called Cushing's syndrome (typical symptoms include moon face, central obesity and facial
flushing), adrenal insufficiency or atrophy, growth suppression in children, sex hormone disorders
(absence of menstrual bleeding, excessive hair growth, erectile dysfunction).
Following abrupt discontinuation of the medicine after long-term treatment with Meprelon, the
following adverse effects have been observed, although they do not occur in everyone:
fever, loss of appetite, nausea, weakness, restlessness, drowsiness, malaise, joint pain, skin peeling,
hypotension, weight loss.
Metabolism and nutrition disorders
Cases of tumor lysis syndrome have been reported in patients with hematological malignancies. Tumor
lysis syndrome may be diagnosed by a physician based on changes in blood test results causing high
levels of uric acid, potassium or phosphates, and decreased calcium levels. Symptoms include muscle
cramps, muscle weakness, confusion, vision loss or disturbances, shortness of breath, seizures,
irregular heartbeat, or kidney failure (reduced urine output or darker urine color). If such symptoms
occur, contact a physician immediately (see section 2 "Warnings and precautions").
Accumulation of fatty tissue in certain parts of the body (supraclavicular, mediastinal or dorsocervical
lipomatosis).
Increased blood glucose levels, diabetes, increased blood lipid levels (cholesterol and triglycerides),
tissue edema, potassium deficiency due to enhanced potassium excretion (caution regarding cardiac
arrhythmias), increased protein breakdown.
Psychiatric disorders
Depression, irritability, personality changes, euphoria, mood changes, increased drive and appetite,
psychoses, sleep disturbances.
Nervous system disorders
Increased intracranial pressure (especially in children), occurrence of symptoms of previously
undetected epilepsy and increased tendency to seizures in existing epilepsy, dizziness, headache.
Eye disorders
Increased intraocular pressure (glaucoma), lens opacification (cataract), worsening of corneal
ulceration, exacerbation of infections caused by viruses, bacteria or fungi, blurred vision.
Retinal and choroidal disorders.
Cardiac disorders
Worsening of pulmonary congestion in heart failure, certain myocardial disorders in preterm infants
(see section 2 "Children").
Vascular disorders
Increased arterial blood pressure, increased risk of atherosclerosis and thrombosis, increased blood
coagulability, vasculitis (also as withdrawal syndrome after long-term treatment).
Gastrointestinal disorders
Gastric or intestinal ulcers with risk of perforation (e.g. peritonitis), bleeding from stomach or
duodenum, pancreatitis, epigastric discomfort, gas accumulation in the intestinal wall (pneumatosis
intestinalis).
Hepatobiliary disorders
Increased liver enzyme activity.
Skin and subcutaneous tissue disorders
Skin striae, decreased skin thickness ("parchment skin"), skin vessel dilation, tendency to bruising,
petechial or superficial skin bleeding, hirsutism, acne, prolonged wound healing, inflammatory skin
changes on the face, particularly around the mouth, nose and eyes, skin pigmentation changes,
hypersensitivity reactions, e.g. skin rash.
Musculoskeletal and connective tissue disorders
Muscle weakness and muscle atrophy, in myasthenia gravis (muscle fatigue) reversible worsening of
muscle weakness potentially leading to myasthenic crisis, induction of acute myopathy (muscle disease)
when non-depolarizing skeletal muscle relaxants are administered concomitantly (see also section 2
"Meprelon with other medicines"), bone atrophy (osteoporosis) which occurs depending on dose and
may even occur with short-term use of the medicine; in severe cases leads to risk of bone fractures,
other forms of bone atrophy (avascular necrosis of bone, e.g. of humeral and femoral heads), tendon
rupture.
Note: After rapid dose reduction following long-term treatment, symptoms such as muscle and joint
pains may occur.
Kaposi's sarcoma has been observed in patients receiving corticosteroids.
Renal and urinary disorders
Scleroderma renal crisis in patients with scleroderma (an autoimmune disorder). Symptoms of
scleroderma renal crisis include elevated blood pressure and decreased urine output.
Investigations
Weight gain.
Special recommendations:
If any of the adverse effects listed in this leaflet or any other adverse effects occur during treatment
with Meprelon, inform your doctor or pharmacist. Do not stop treatment on your own.
In case of gastrointestinal symptoms, back pain, shoulder or hip area pain, psychiatric disorders,
marked changes in blood glucose levels or other disturbances in diabetic patients, contact your doctor
immediately.
Reporting of adverse effects
If any adverse symptoms occur, including any adverse symptoms 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.
By reporting adverse effects, additional information regarding the safety of the medicine can be
collected.

5. How to store Meprelon

Keep the medicine out of sight and reach of children.
Store below 30°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Meprelon contains

The active substance is methylprednisolone. One tablet contains 4 mg of methylprednisolone.
The other ingredients are mannitol, low-substituted hydroxypropylcellulose, hypromellose (type 2910, 3 mPas), spray-dried mannitol, microcrystalline cellulose, sodium croscarmellose, colloidal silicon dioxide, glycerol dibehenate, magnesium stearate.

What Meprelon looks like and contents of the pack
Meprelon 4 mg is a round tablet, white to yellowish-white in colour, with cross-scored lines and a ring-shaped imprint, approximately 9 mm in diameter.
Pack sizes of 20, 30, 50 and 100 tablets are available.
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
tel. +48 22 350 66 69

Manufacturer
mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany