Package leaflet: Information for the user

Meprelon, 16 mg, tablets
Methylprednisolonum
Please read this leaflet carefully before taking 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 further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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 glucocorticosteroid (a corticosteroid hormone), which affects
metabolism (i.e. the body's metabolic processes), water and electrolyte balance, and tissue functions.
Meprelon is used in diseases requiring treatment with glucocorticosteroids.
Depending on symptoms and severity, these include, among others: inflammatory and systemic rheumatic diseases,
autoimmune diseases, 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 diseases:

Bronchial asthma (bronchodilators should be used concomitantly).
Exacerbation of chronic obstructive pulmonary disease (recommended duration of treatment: 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 nasal glucocorticosteroid aerosol.

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

Allergic and allergy-like reactions, including those associated with infections, 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.
Immunological diseases (autoimmune diseases), e.g. dermatomyositis, discoid lupus erythematosus, subacute cutaneous lupus erythematosus.

Blood disorders:
Autoimmune blood disorders: anemia due to red blood cell destruction
(acquired [autoimmune] hemolytic anemia).
Gastrointestinal disorders:

Ulcerative colitis.
Crohn's disease.

Substitution therapy:
Reduced or absent adrenal cortex function (adrenal insufficiency of any cause, e.g. Addison's disease, adrenogenital syndrome, post-adrenalectomy state, 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 to take Meprelon, discuss this with your doctor or pharmacist if:

The patient has hyperthyroidism. If treatment with Meprelon is necessary in doses higher than replacement doses (doses used to compensate for corticosteroid deficiency in the human body), Meprelon should be used only if the doctor considers it necessary. 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-induced keratitis);
Acute and chronic bacterial infections;
Fungal infections involving internal organs;
Certain parasitic diseases (amoebiasis, helminthic infestations);
Lymph node disease following tuberculosis vaccination (in patients with a history of tuberculosis, the medicine may be used only if administered concomitantly 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 during the following conditions only if the doctor considers it necessary, and the disease is treated according to established principles:

Peptic ulcer 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 injuries and ulcers.

Due to the risk of intestinal perforation and peritonitis, Meprelon may 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 after surgery.

In patients receiving high doses of glucocorticoids, symptoms of peritonitis following gastrointestinal perforation may be masked.
Use of Meprelon may lead to 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 diagnostics and treatment.
During treatment of a specific type 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 involvement 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 inactivated (killed) pathogen vaccines is generally possible. However, it should be noted that administration of higher doses of Meprelon may reduce vaccine efficacy.
In patients with diabetes, 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 restriction of sodium intake. 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 worsening.
Before starting 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 the doctor if the patient develops symptoms of tumor lysis syndrome, such as 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), especially if the patient has a hematologic malignancy (see section 4, "Possible side effects").
After administration of Meprelon, cases of pheochromocytoma crisis have been reported, which may be fatal. Symptoms include elevated blood pressure, headache, excessive sweating, palpitations, and pallor. Treatment of patients with suspected or diagnosed 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) are necessary.
If the patient experiences significant stress during treatment with Meprelon, such as feverish illness, trauma, or surgery, contact the treating physician or inform emergency department staff about ongoing treatment. A temporary increase in the daily dose of Meprelon may sometimes be necessary.
Depending on the duration of treatment and dosage, a negative effect of the drug on calcium metabolism should be expected. Therefore, osteoporosis prevention is recommended. This particularly applies to individuals with existing risk factors such as family history, advanced age, inadequate 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 regular physical activity. In cases of existing osteoporosis, additional medication should also 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, e.g., during infection, after trauma, or increased physical strain), and "steroid withdrawal syndrome" (see section 4, "Possible side effects").
In patients treated with Meprelon, viral diseases may have a particularly severe course, especially in immunocompromised children and individuals who have not previously had measles or chickenpox. In case of exposure to measles or chickenpox during Meprelon treatment, immediate medical consultation is required, and preventive measures may be initiated if necessary.
In cases of untreated hypothyroidism or liver cirrhosis, relatively low or reduced doses may be sufficient, and dosage adjustments should be determined in consultation with the doctor.
Seek immediate medical attention if muscle weakness, pain, cramps, or 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 required 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.
After systemic glucocorticoid treatment in preterm infants, a specific heart muscle disease (hypertrophic cardiomyopathy) has been observed. Therefore, cardiac function should be monitored in infants receiving systemic glucocorticoids.

Elderly patients
In elderly patients, caution is advised due to an 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 serious health risks.

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

Medicines that affect the action of Meprelon

Liquids 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 taking such medicines (including some HIV medications: ritonavir, cobicistat).
Medicines that slow the metabolism of corticosteroids in the liver, such as certain antifungal drugs (containing ketoconazole, itraconazole), may enhance the effect of Meprelon.
Certain female sex hormones, e.g., oral contraceptives: the effect of Meprelon may be increased.

Liquids 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 to treat heart conditions (e.g., diltiazem – a calcium channel blocker) may slow the breakdown of methylprednisolone. Therefore, initial treatment should be under medical supervision. Dose adjustment of methylprednisolone may be necessary.
Medicines used to reduce gastric acid production (antacids): in patients with chronic liver disease, the dose of Meprelon may need to be increased.

Effect of Meprelon on other medicines

Enhanced effects

Medicines used to treat heart failure (cardiac glycosides): due to potential potassium deficiency caused by Meprelon, their effects may be enhanced.
Diuretics and laxatives: their potassium-depleting effects 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 anticoagulant 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) levels.

Other potential interactions

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

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

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Animal studies have shown that Meprelon impairs fertility. Until adequate human studies on the effect of Meprelon on reproductive processes are conducted, this medicine should not be given to pregnant women unless a careful benefit-risk assessment for 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 discontinuation of long-term Meprelon treatment is necessary during pregnancy, it should be done gradually. In certain situations (e.g., replacement therapy for adrenal insufficiency), continuation or even dose increase may be required. Infants born to mothers who took Meprelon during pregnancy should be carefully monitored 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 mother and infant.

Driving and operating machinery
Due to certain side effects such as impaired visual acuity (due to cataracts or increased intraocular pressure), dizziness, or headache, concentration and reaction ability may be impaired in rare cases. 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 told you. 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 in doubt, contact your doctor or pharmacist again.
Relatively high initial doses (from 4 mg to 48 mg) are usually used. These 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 and 8:00 a.m.), without chewing, with sufficient liquid, e.g. a 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 large doses are used for short periods. No special measures are usually required. However, if severe or unusual adverse effects occur, consult your doctor.

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, consult your doctor, who will review and possibly adjust your treatment.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Meprelon
You must strictly follow your doctor's instructions. 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 suddenly, 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 stress on the body 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 reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
The adverse reactions listed below are provided without information on their frequency of occurrence. Frequency
cannot be determined from the available data.
Substitution therapy:
Low risk of adverse reactions 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 reactions may occur:
Blood and lymphatic system disorders
Changes in blood morphology (increased number of white blood cells, red blood cells, platelets in blood, 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
Crisis in pheochromocytoma (elevated arterial blood pressure, headache, sweating, palpitations, pallor), development of so-called Cushing's syndrome (typical symptoms include moon face, central obesity, and facial flushing), adrenal cortex insufficiency or atrophy, growth suppression in children, disturbances in sex hormones (absence of menstruation, excessive hair growth, erectile dysfunction).
In cases of abrupt discontinuation of the drug after long-term treatment with Meprelon, the following adverse reactions have been observed, although they may 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 (supratrochanteric, mediastinal, or retrosternal 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, psychosis, sleep disturbances.
Nervous system disorders
Increased intracranial pressure (especially in children), emergence of symptoms of previously undiagnosed epilepsy and increased susceptibility to seizures in existing epilepsy, dizziness, headaches.
Eye disorders
Increased intraocular pressure (glaucoma), lens opacity (cataract), worsening of corneal ulcers, 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 premature infants (see section 2 "Children").
Vascular disorders
Increased arterial blood pressure, increased risk of atherosclerosis and thrombosis, increased blood coagulability, vasculitis (also as a withdrawal syndrome after long-term treatment).
Gastrointestinal disorders
Gastric or intestinal ulcers with risk of perforation (e.g. peritonitis), bleeding from the 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, pinpoint or superficial skin hemorrhages, excessive hair growth, 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 atrophy, in myasthenia gravis reversible worsening of muscle weakness potentially leading to myasthenic crisis, induction of acute myopathy (muscle disease) when co-administered with non-depolarizing skeletal muscle relaxants (see also section 2 "Meprelon with other medicines"), bone atrophy (osteoporosis) occurring depending on dose, possible even with short-term use, in severe cases leading to risk of bone fractures, other forms of bone atrophy (avascular bone necrosis, e.g. of the humeral or femoral head), tendon rupture.
Note: After rapid dose reduction following long-term treatment, symptoms such as muscle and joint pain may occur.
Kaposi's sarcoma has been reported 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 reduced urine production.
Investigations
Weight gain.
Special recommendations:
If any of the adverse reactions listed in this leaflet or any other adverse reactions occur during treatment with Meprelon, inform your doctor or pharmacist. Do not discontinue treatment on your own.
In case of gastrointestinal symptoms, back pain, shoulder or hip area pain, psychiatric disturbances, marked changes in blood glucose levels, or other disturbances in diabetic patients, contact your doctor immediately.
Reporting of adverse reactions
If any symptoms of adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to gather more information on the safety of the medicine.

5. How to store Meprelon

Keep the medicine out of sight and reach of children.
Store below 25°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 in use. Following this advice helps protect the environment.

6. Contents of the pack and other information

What Meprelon contains

The active substance is methylprednisolone. One tablet contains 16 mg of methylprednisolone.
The other ingredients are mannitol, low-substituted hydroxypropylcellulose, hypromellose (type 2910, 3 mPa·s), spray-dried mannitol, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, glycerol dibehenate, magnesium stearate.

What Meprelon looks like and contents of the pack
Meprelon 16 mg is a white to yellowish-white, round tablet with cross-scored lines, approximately 8 mm in diameter.
Available pack sizes contain 20, 30, 50, and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki
tel. +48 22 350 66 69
Manufacturer
mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany