Meprelon

Package Leaflet: Information for the User

Meprelon, 250 mg,

Meprelon, 1000 mg,

powder and solvent for solution for injection/infusion Methylprednisolone

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• You should keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

• 1. What Meprelon is and what it is used for
• 2. Before you use Meprelon
• 3. How to use Meprelon
• 4. Possible side effects
• 5. How to store Meprelon
• 6. Contents of the pack and other information

1. What Meprelon is and what it is used for

Meprelon contains the active substance from the group of modified adrenal cortex hormones (glucocorticosteroids) in a large dose and in a form that is slightly soluble in water. Therefore, Meprelon is administered directly into the bloodstream in life-threatening acute conditions that require glucocorticosteroid treatment.

Meprelon is used in life-threatening acute conditions such as:

• shock resulting from a severe general allergic reaction (anaphylactic shock) after previous treatment with adrenaline (a drug that affects the cardiovascular system),
• brain edema (only in cases of symptoms of increased intracranial pressure confirmed by computed tomography) caused by a brain tumor, neurosurgical procedures, brain abscess, bacterial meningitis,
• persistent shock lung (adult respiratory distress syndrome, ARDS) after the acute phase,
• severe acute asthma attack,
• severe general bacterial infection with adrenal insufficiency (Waterhouse-Friderichsen syndrome),
• risk of organ rejection after transplantation,
• fluid accumulation in lung tissue after inhalation of toxic gases (toxic pulmonary edema).

In these indications, Meprelon is used in combination with appropriate basic treatment (e.g., fluid volume supplementation, treatment of cardiovascular disorders, administration of antibiotics, pain treatment, etc.). In the treatment of Waterhouse-Friderichsen syndrome, concurrent administration of mineralocorticosteroids is recommended.

Meprelon may also be used for short-term treatment in exacerbations of multiple sclerosis. Meprelon may shorten the duration of exacerbations, but it has no effect on their frequency or progression of disability.

2. Before you use Meprelon

When not to use Meprelon

• if you are allergic to methylprednisolone sodium succinate, other glucocorticosteroids, or any of the other ingredients of Meprelon (listed in section 6).

Warnings and precautions

Before starting treatment with Meprelon, discuss it with your doctor, pharmacist, or nurse,

• if you have hyperthyroidism.

In cases of severe infections, Meprelon should only be administered in combination with specific anti-infection drugs.

Meprelon should only be used in the following diseases when the doctor considers it absolutely necessary, and with concurrent use of specific anti-infection treatment:

• acute viral infections (e.g., chickenpox, shingles, herpes virus infection, herpes simplex keratitis),
• infectious hepatitis (chronic active hepatitis with a positive HBsAg test result),
• about 8 weeks before and up to 2 weeks after vaccination with live vaccines,
• fungal infections with internal organ involvement,
• certain parasitic diseases (e.g., helminthic infections, nematode infections),
• Heine-Medin disease (poliomyelitis),
• lymph node involvement after BCG vaccination,
• acute and chronic bacterial infections,
• in case of a history of tuberculosis, the drug may only be used in combination with anti-tuberculosis drugs and under close medical supervision.

Before starting short-term treatment in exacerbations of multiple sclerosis, infection should be ruled out.

In the following diseases, Meprelon should only be used when the doctor considers it absolutely necessary and with concurrent use of specific treatment:

• peptic ulcer (gastric and intestinal ulcers),
• severe osteoporosis (bone mass loss),
• uncontrolled high blood pressure,
• uncontrolled diabetes,
• psychiatric disorders (also in history),
• increased intraocular pressure (glaucoma with narrow and open angle),
• corneal ulcers and damage.

Due to the risk of intestinal perforation with peritonitis, Meprelon can only be used when there are significant reasons and under close medical supervision in the following cases:

• severe ulcerative colitis (ulcerative colitis) with risk of perforation, with abscesses or purulent inflammatory conditions,
• diverticulitis of the intestine,
• enteric fistulas (immediately after surgical procedures).

In patients taking large doses of glucocorticosteroids, objective signs of peritoneal irritation may not occur after gastric or intestinal perforation.

The use of Meprelon may cause gas accumulation in the intestinal wall, called pneumatosis cystoides intestinalis (frequency unknown, see section 4 "Possible side effects"). Pneumatosis cystoides intestinalis may range from a mild condition that does not require treatment to more severe conditions that may require immediate surgical treatment.

If symptoms such as nausea, vomiting, and abdominal pain occur, which persist or worsen, you should contact your doctor immediately. The doctor will decide on the need for further diagnosis and treatment.

In diabetic patients, metabolism (metabolism) should be regularly monitored. It is necessary to consider possible increased demand for anti-diabetic drugs (insulin, oral drugs, etc.).

In cases of high blood pressure or severe heart failure, the doctor should carefully monitor the patient, as there is a risk of worsening these conditions.

Before starting treatment with Meprelon, discuss it with your doctor if:

• You have scleroderma (an autoimmune disorder also known as systemic sclerosis), as doses of at least 12 mg of methylprednisolone per day may increase the risk of a serious complication called scleroderma renal crisis. The symptoms of scleroderma renal crisis include increased blood pressure and decreased urine production. The attending physician may recommend regular blood pressure and urine output checks.
• You have kidney disease or high uric acid levels in the blood before starting treatment with Meprelon.

You should inform your doctor if you experience symptoms of tumor lysis syndrome, such as muscle cramps, weakness, confusion, vision loss or disturbances, shortness of breath, seizures, irregular heartbeat, or kidney failure (decreased urine output or darker urine color), as well as in case of hematological malignancy (see section 4 "Possible side effects").

After administration of corticosteroids, cases of pheochromocytoma crisis have been reported, which may manifest as increased blood pressure with headache, sweating, rapid heart rate, and pallor, and may lead to death (see section 4 "Possible side effects"). Corticosteroids should only be administered to patients with suspected or diagnosed pheochromocytoma (usually a hormone-producing tumor located in the adrenal gland tissue) after careful assessment of the benefit-risk ratio.

During corticosteroid treatment, thromboembolic events and venous thromboembolism have been reported. You should inform your doctor if you have diseases related to blood clot formation in blood vessels. In such cases, Meprelon should be used with caution.

During the use of Meprelon, initial worsening of concomitant myasthenia (a type of muscle paralysis) may occur, leading to a myasthenic crisis.

Treatment with Meprelon may mask the symptoms of concomitant or developing infections, making diagnosis difficult.

Due to immunosuppression, treatment with glucocorticosteroids, such as Meprelon, may lead to an increased risk of infection, including opportunistic pathogens.

In principle, it is possible to vaccinate with inactivated vaccines (vaccines containing killed microorganisms). However, it should be considered that the immune response, and thus the effectiveness of vaccination, may be reduced during treatment with high doses of corticosteroids. Therefore, vaccination is not recommended for patients receiving maintenance treatment with higher doses (except for replacement therapy).

When administering high doses of Meprelon, it is necessary to ensure adequate potassium intake (e.g., vegetables, bananas) and limited salt consumption. The doctor should monitor blood potassium levels.

Viral diseases may have a particularly severe course, sometimes life-threatening, in patients treated with Meprelon. The risk is especially high for children with impaired immunity (children in immunosuppression) and patients who have not had a history of chickenpox and measles. In case of contact with people sick with measles, chickenpox, or shingles during treatment with Meprelon, they should immediately consult a doctor who will provide preventive treatment if necessary.

After intravenous administration of high doses of methylprednisolone (over 500 mg of methylprednisolone), cardiac arrhythmias and/or cardiovascular collapse and/or cardiac arrest have been reported, even in patients without diagnosed heart disease. Therefore, close medical supervision is recommended during treatment and for several days after its completion.

During or after intravenous administration of high doses of methylprednisolone, bradycardia (slow heart rate) may occur, not necessarily related to the speed or duration of drug administration.

After intravenous administration of methylprednisolone (usually in an initial dose of ≥ 1000 mg per day), rare cases of drug-induced liver damage, including acute hepatitis and increased liver enzyme activity, have been reported. Symptoms may occur after several weeks or later. In most cases, adverse reactions disappeared after discontinuation of treatment. Therefore, appropriate monitoring is necessary (see section 4 "Possible side effects").

Systemic treatment with glucocorticosteroids may cause chorioretinopathy, leading to vision disturbances, including vision loss. Long-term systemic treatment with glucocorticosteroids may cause chorioretinopathy even at low doses (see section 4 "Possible side effects").

If you experience blurred vision or other vision disturbances, you should contact your doctor.

Meprelon is intended for short-term use. However, if Meprelon is not used as recommended but for a long time, you should follow additional warnings and precautions described for products containing glucocorticosteroids intended for long-term use.

During long-term treatment with glucocorticosteroids, regular medical check-ups (including ophthalmological examinations every three months) are recommended.

In special situations of physical stress, such as febrile illnesses, accidents, operations, or childbirth, during treatment with glucocorticosteroids, you should immediately consult a doctor and inform them about the medication you are taking. It may be necessary to temporarily increase the daily dose of glucocorticosteroids. The doctor should issue a special identification card indicating the use of glucocorticosteroids, which the patient should always carry with them.

Depending on the duration and dosage of the drug, an unfavorable effect on calcium metabolism can be expected. Therefore, osteoporosis prevention is recommended. This is especially important for patients with a history of risk factors, such as family history, advanced age, insufficient protein and calcium intake, smoking, excessive alcohol consumption, postmenopausal period, and lack of physical exercise. Prevention includes consuming sufficient amounts of calcium and vitamin D and engaging in physical activity. In case of existing osteoporosis, it is necessary to consider additional medication.

After completion or, if necessary, discontinuation of long-term treatment, the following risks should be considered: exacerbation or recurrence of the underlying disease, acute adrenal insufficiency (especially in stressful situations, e.g., during infections, after accidents, during intense physical exertion), objective symptoms of the disease, and symptoms caused by steroid withdrawal syndrome (see section 4 "Possible side effects").

In cases of uncontrolled hypothyroidism or liver cirrhosis, relatively small doses may be sufficient, or the dose may need to be reduced. Close medical supervision is necessary.

You should immediately consult a doctor if you experience weakness or muscle pain, cramps, and stiffness during treatment with methylprednisolone. These may be symptoms of a condition called thyrotoxic periodic paralysis, which can occur in patients with hyperthyroidism treated with methylprednisolone. Additional treatment may be necessary to alleviate this condition.

Children

After systemic treatment of premature infants with glucocorticosteroids, a specific heart muscle disorder (hypertrophic cardiomyopathy) has been observed. Therefore, the heart of infants treated systemically with glucocorticosteroids should be monitored.

In children, Meprelon should only be used when there are significant medical reasons, due to the risk of growth inhibition. During long-term treatment with glucocorticosteroids, the child's growth should be regularly monitored.

Use of the drug as a doping agent

The use of Meprelon may lead to positive results in anti-doping tests. The health consequences of using Meprelon as a doping agent cannot be predicted. Serious health risks cannot be excluded.

Meprelon and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription.

The following medicines affect the action of Meprelon

Enhancement of action and possibility of enhancement of side effects:

• Certain female sex hormones, such as oral contraceptives ("the pill"), may enhance the action of corticosteroids.
• Drugs that slow down the metabolism of corticosteroids in the liver, such as certain antifungal drugs (containing ketoconazole, itraconazole), may enhance their action.
• Certain medicines may enhance the action of Meprelon, and the doctor may want to closely monitor the condition of the patient taking such medicines (including certain HIV drugs: ritonavir, cobicistat).
• Drugs used to treat heart diseases (e.g., diltiazem [calcium channel blocker]) may slow down the breakdown of methylprednisolone. Therefore, treatment should be carried out under medical supervision in the initial period. It may be necessary to adjust the dose of methylprednisolone.

Reduction of action:

• Drugs that accelerate the metabolism of corticosteroids in the liver, such as certain sedatives (containing barbiturates), antiepileptic drugs (containing phenytoin, carbamazepine, primidone), and certain drugs used in tuberculosis (containing rifampicin), may reduce their action.
• Drugs containing ephedrine, used to reduce swelling of mucous membranes, may accelerate the metabolism of glucocorticosteroids, which may reduce their effectiveness.

Meprelon affects the action of other medicines

Enhancement of action and possibility of enhancement of side effects:

• When used concurrently with certain blood pressure-lowering drugs (angiotensin-converting enzyme inhibitors), Meprelon may increase the risk of changes in blood morphology.
• Meprelon may cause potassium deficiency, which may enhance the action of heart-strengthening drugs (cardiac glycosides).
• Meprelon may enhance the potassium-excreting effect of diuretics (sodium-excreting drugs) and laxatives.
• When used concurrently with anti-inflammatory and anti-rheumatic drugs (salicylates, indomethacin, and other non-steroidal anti-inflammatory drugs), Meprelon may increase the risk of ulcers and gastrointestinal bleeding.
• Meprelon may prolong the action of certain muscle relaxants (non-depolarizing muscle relaxants) (see also section 4 "Possible side effects").
• Meprelon may enhance the action of certain drugs (atropine and other anticholinergic drugs) that increase intraocular pressure.
• When used concurrently with drugs used in malaria and rheumatic diseases (chloroquine, hydroxychloroquine, mefloquine), Meprelon may increase the risk of muscle diseases or heart muscle diseases (myopathy, cardiomyopathy).
• Meprelon may increase the blood level of cyclosporine (a drug that suppresses the body's immune system). There is an increased risk of seizures.

Reduction of action:

• Meprelon may reduce the action of oral anti-diabetic drugs and insulin.
• Meprelon may reduce the action of blood-thinning drugs (oral anticoagulants, coumarin derivatives).
• Meprelon may reduce the action of anti-parasitic drugs (praziquantel).
• Meprelon may reduce the action of growth hormone (somatotropin).
• Meprelon may reduce the increase in thyroid-stimulating hormone (TSH) levels after administration of protirelin (TRH, a hormone released from the hypothalamus).

Other possible interactions

Influence on laboratory test results:

• Glucocorticosteroids may suppress skin reactions in allergy tests.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a child, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

During pregnancy, especially in the first three months, Meprelon should only be used after careful assessment of the benefit-risk ratio by the doctor.

Methylprednisolone should only be used in the first trimester of pregnancy after discussion with the doctor about the possible benefits and risks of different treatment options for the patient and the unborn child. This is because methylprednisolone may increase the risk of the child being born with a cleft lip and/or palate (a hole or cleft in the upper lip and/or palate).

In case of long-term treatment with glucocorticosteroids during pregnancy, growth disturbances in the unborn child cannot be excluded. In case of treatment in the late pregnancy period, the fetus may experience adrenal cortex atrophy, which may require treatment after birth.

Breastfeeding

Glucocorticosteroids pass into breast milk. During treatment with higher doses or long-term treatment, breastfeeding should be avoided.

Driving and using machines

Due to the occurrence of certain side effects, such as impaired vision (due to cataracts or increased intraocular pressure), dizziness, or headaches, in rare cases, there may be a decrease in concentration or ability to concentrate and react. It is possible that the patient may not be able to react quickly enough to sudden and unexpected events. This may be associated with a risk, for example, when driving a vehicle or operating machinery. The same applies to performing tasks without secure anchorage. The patient may unnecessarily expose themselves and others to risk. Note that alcohol may increase this risk.

Meprelon 250 mg contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per vial, which means it is essentially "sodium-free".

Meprelon 1000 mg contains sodium

This medicine contains 67.6 mg of sodium (the main component of common salt) per vial, which corresponds to 3.4% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Meprelon

Meprelon should always be used exactly as your doctor has told you. The usual recommendations for dosing are as follows:

At the beginning of treatment, depending on the indication and clinical situation, the single dose for the treatment of life-threatening acute conditions is 250-1000 mg of methylprednisolone (1-4 vials of Meprelon, 250 mg) and above in adults and 4-20 mg per kilogram of body weight in children.

At the beginning of treatment, depending on the indication and clinical situation, the single dose for the treatment of life-threatening acute conditions is 250-1000 mg of methylprednisolone (up to 1 vial of Meprelon, 1000 mg) and above in adults and 4-20 mg per kilogram of body weight in children. Meprelon, 250 mg is more suitable for this treatment.

In some indications (e.g., immune rejection of transplanted organs), doses up to 30 mg per kilogram of body weight are recommended.

Depending on the disease, the intervals between injections are 30 minutes to 24 hours.

Unless otherwise prescribed by the doctor, the recommended dosages for individual indications are as follows:

Anaphylactic shock

• 250-500 mg of methylprednisolone (1-2 vials of Meprelon, 250 mg) in combination with standard basic treatment and/or concomitant medications.
• 250-500 mg of methylprednisolone in combination with standard basic treatment and/or concomitant medications. Meprelon, 250 mg is more suitable for this treatment.

Severe acute asthma attack

• 250-500 mg of methylprednisolone (1-2 vials of Meprelon, 250 mg) in combination with standard basic treatment and/or concomitant medications.
• 250-500 mg of methylprednisolone in combination with standard basic treatment and/or concomitant medications. Meprelon, 250 mg is more suitable for this treatment.

Brain edema (caused by brain tumor, neurosurgical procedures, brain abscess, bacterial meningitis)

In the treatment of acute or severe brain edema, initially 250-500 mg of methylprednisolone (1-2 vials of Meprelon, 250 mg).

In the treatment of acute or severe brain edema, initially 250-500 mg of methylprednisolone. Meprelon, 250 mg is more suitable for this treatment.

In the treatment of maintaining acute or severe brain edema or mild or chronic brain edema, usually 32-64 mg of methylprednisolone is administered three times a day for several days. Meprelon, 32 mg is available for this purpose. If necessary, the dose should be gradually reduced and switched to oral treatment.

Risk of organ rejection after transplantation

Inject doses up to 30 mg of methylprednisolone per kilogram of body weight for several days in combination with standard basic treatment. Meprelon, 1000 mg is more suitable for this treatment.

Inject doses up to 30 mg of methylprednisolone per kilogram of body weight (corresponding to 1-2 vials of Meprelon, 1000 mg for adults with a body weight between 60-70 kg) for several days in combination with standard basic treatment.

Waterhouse-Friderichsen syndrome

Initially, 30 mg of methylprednisolone per kilogram of body weight; administration is repeated in 4-6 doses over 24-72 hours in combination with intensive basic treatment.

Adult respiratory distress syndrome (ARDS)

After the acute phase of persistent ARDS, doses of 1-2 mg of methylprednisolone per kilogram of body weight per day are administered in 4 divided doses up to a dose of 250 mg of methylprednisolone every 6 hours for several days to weeks, with gradual dose reduction depending on the course of the disease.

Toxic pulmonary edema caused by inhalation of irritating gas

Inject 1000 mg of methylprednisolone intravenously immediately. If necessary, repeat after 6, 12, and 24 hours. Meprelon, 1000 mg is more suitable for this treatment. 32 mg of methylprednisolone is administered intravenously three times a day for the next two days. Then, 16 mg of methylprednisolone is administered intravenously three times a day for the next two days. Meprelon, 16 mg and Meprelon, 32 mg are available for this purpose. Later, the dose is gradually reduced and switched to inhaled corticosteroids.

Inject 1000 mg of methylprednisolone intravenously immediately (1 vial of Meprelon, 1000 mg). If necessary, repeat after 6, 12, and 24 hours. 32 mg of methylprednisolone is administered intravenously three times a day for the next two days. Then, 16 mg of methylprednisolone is administered intravenously three times a day for the next two days. Meprelon, 16 mg and Meprelon, 32 mg are available for this purpose. Later, the dose is gradually reduced and switched to inhaled corticosteroids.

Short-term treatment in exacerbations of multiple sclerosis

1000 mg of methylprednisolone per day for 3 to 5 days, administered intravenously. Treatment should be started within 3 to 5 days of the onset of exacerbation and should include stomach protection and anti-thrombotic prophylaxis. Close medical supervision of blood pressure, blood sugar levels, and electrolyte levels in the blood is necessary. The drug should be administered in the morning, as this reduces the likelihood of sleep disturbances.

After completion of treatment with intravenous methylprednisolone, the doctor will decide whether it is necessary to use the drug in tablet form to gradually reduce the dose. In such cases, treatment usually starts with a dose of 80 mg of methylprednisolone or an equivalent dose and ends after 14 days, during which the dose is gradually reduced.

Note:

Considering the known side effect profile, it is recommended to administer the first dose in a hospital.

Meprelon is administered intravenously or intravenously by infusion. Due to uncertain absorption conditions, intramuscular administration should only be chosen exceptionally when intravenous administration is not possible. Intravenous injection should be performed slowly.

To prepare the ready-to-use solution for injection, the supplied solvent (water for injection) should be injected into the vial with the powder directly before use and shaken to dissolve.

To prepare the infusion, the drug should first be dissolved according to the above instructions and then mixed with a 5% glucose solution, 0.9% sodium chloride solution, or Ringer's solution.

Solutions or mixtures should be prepared and injected under strictly aseptic conditions (free from microorganisms).

It is necessary to avoid administering other drugs mixed in a syringe, as this may cause precipitation. For the same reason, Meprelon should not be added to infusion solutions other than those specified, nor should it be injected into an infusion line.

Solutions for injection/infusion prepared by dissolving the powder must be used as soon as possible.

Medicines intended for administration outside the digestive tract should be inspected before use.

Only clear solutions without visible particles should be used.

The duration of treatment depends on the individual progress of the disease and is determined by the doctor.

After long-term treatment, especially with relatively high doses, the use of Meprelon should not be stopped abruptly but gradually.

Overdose of Meprelon

No cases of Meprelon overdose are known. Due to its low toxicity, overdose is not expected to occur. In case of severe or atypical side effects, the doctor will decide what measures to take if necessary.

4. Possible Side Effects

Like all medicines, Meprelon can cause side effects, although not everybody gets them. The following side effects have been reported without regard to frequency. The frequency cannot be estimated from the available data. Depending on the duration of treatment and the dose, the following side effects may occur:
Blood and lymphatic system disorders
Changes in blood cell count (i.e., morphology) such as increased white blood cell count, red blood cell count, or platelet count, decreased count of certain types of white blood cells or platelets.
Immune system disorders
Severe hypersensitivity reactions (anaphylactic reactions) with circulatory collapse, cardiac arrest, arrhythmias, bronchospasm, and/or hypotension or hypertension.
Immunosuppression with increased risk of infection (some viral diseases, such as chickenpox, herpes, or shingles during viremia, may have a severe course and sometimes be life-threatening), masking of infections, latent infections becoming apparent, allergic reactions.
Endocrine disorders
Cushing's syndrome (typical symptoms: moon face, central obesity, and purple striae), adrenal insufficiency, steroid withdrawal syndrome, growth suppression in children, disorders of sex hormone secretion (amenorrhea, hirsutism, impotence).
Metabolic and nutritional disorders
Tumor lysis syndrome has been reported in patients with hematological malignancies. Tumor lysis syndrome may be diagnosed by the doctor 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, dyspnea, seizures, irregular heartbeat, or renal failure (decreased urine output or darker urine color). If such symptoms occur, the patient should contact the doctor immediately (see section 2, "Warnings and precautions").
Accumulation of fat tissue in certain parts of the body (in the spinal canal or temporarily in the thorax).
Fluid retention due to sodium retention - sodium retention, increased potassium excretion, which may be accompanied by hypokalemia (may lead to arrhythmias), increased blood glucose levels, diabetes, increased blood lipid levels (cholesterol and triglycerides), increased protein catabolism.
Psychiatric disorders
Severe depression, irritability, personality changes, mood changes, euphoria, increased energy and appetite, psychoses, sleep disturbances.
Nervous system disorders
Increased intracranial pressure (pseudotumor cerebri, especially in children), appearance of previously unrecognized seizure symptoms, and increased seizure tendency in existing epilepsy, dizziness, headache.
Eye disorders
Retinal and choroidal disorders (central serous retinopathy, see section 2, "Warnings and precautions"), cataract, increased intraocular pressure (glaucoma), worsening of corneal ulcers, exacerbation of viral, fungal, and bacterial eye infections, blurred vision.
Cardiac disorders
Arrhythmias, cardiac arrest, worsening of congestive heart failure, certain muscle disorders in premature infants (see section 2, "Children").
Vascular disorders
Vascular collapse, hypertension, increased blood coagulability (thromboembolic events), increased risk of atherosclerosis and thrombosis, vasculitis (also as a withdrawal syndrome after long-term treatment).
Gastrointestinal disorders
Ulcers of the stomach and intestines with risk of perforation (e.g., peritonitis), gastrointestinal bleeding, pancreatitis, abdominal discomfort, gas accumulation in the intestinal wall (pneumatosis cystoides intestinalis).
Hepatobiliary disorders
Methylprednisolone may cause liver damage. There have been reports of hepatitis and increased liver enzyme activity. This also applies to liver cell damage and liver damage with bile stasis, which may lead to acute liver failure (see section 2, "Warnings and precautions").

• 2, section "Warnings and precautions").

Skin and subcutaneous tissue disorders
Stretch marks, thinning of the skin (skin atrophy), telangiectasia, increased fragility of blood vessels ("vascular fragility"), tendency to bruising, petechiae or ecchymoses, hirsutism, acne, delayed wound healing, facial skin inflammation (especially around the mouth, nose, and eyes), skin pigmentation changes, hypersensitivity reactions, such as skin rashes.
Musculoskeletal and connective tissue disorders
Muscle weakness and atrophy, in the case of myasthenia (significant muscle weakness associated with exertion) reversible increase in muscle weakness, which may lead to myasthenic crisis, induction of acute myopathy (muscle disease) in the case of concurrent administration of non-depolarizing muscle relaxants (see also section 2, "Meprelon and other medicines"), osteoporosis (dose-dependent, also possible during short-term use), which may lead to an increased risk of bone fractures, other forms of bone necrosis (aseptic bone necrosis: head of the humerus and head of the femur), tendon rupture.
Rapid dose reduction after long-term treatment may cause symptoms such as muscle and joint pain.
Renal and urinary disorders
Scleroderma renal crisis in patients with scleroderma (autoimmune disorder). Scleroderma renal crisis symptoms include hypertension and decreased urine output (see section 2, "Warnings and precautions").
General disorders and administration site conditions
Injection into fatty tissue may cause local fat atrophy.
Investigations
Weight gain.
In the event of abrupt discontinuation after long-term use of methylprednisolone, the following side effects have been observed, although not in every patient:
Symptoms such as fever, loss of appetite, nausea, weakness, restlessness, apathy (lethargy), malaise, joint pain, skin peeling, hypotension, and weight loss (steroid withdrawal syndrome).
Special warnings
Since Meprelon may rarely cause allergic reactions, even leading to anaphylactic shock, in patients with a history of allergies (e.g., asthma), it is recommended to ensure easy access to emergency treatment (e.g., adrenaline, intravenous infusion, artificial ventilation).
In case of gastrointestinal or intestinal disorders, back, shoulder, or hip pain, depressive mood, abnormal blood glucose levels (in diabetic patients), or other disorders, the patient should immediately inform the doctor.

Reporting of Side Effects

If any side effects occur, including those not listed in this leaflet, the patient should inform the doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Pharmacovigilance 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the drug.

5. How to Store Meprelon

The drug should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the vial after: EXP.
The expiry date refers to the last day of the month stated.
Store the vial in the outer packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. The patient should ask the pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
Note on the shelf life after opening or reconstitution
For single use only. Discard any remaining amounts after opening the vial.
Chemical and physical stability of Meprelon has been demonstrated for 24 hours at 25 °C after reconstitution with water for injection and for 8 hours at room temperature (20 - 25 °C) after dilution with 5% (50 mg/mL) glucose solution for injection, 0.9% (9 mg/mL) sodium chloride solution for injection, and Ringer's solution.
From a microbiological point of view, the reconstituted solution should be used immediately. If the ready-to-use solution is not administered immediately, the user is responsible for the storage time and conditions.

6. Package Contents and Other Information

What Meprelon, 250 mg Contains

• The active substance is methylprednisolone. One vial of powder contains 331.48 mg of methylprednisolone sodium succinate, equivalent to 250 mg of methylprednisolone.

1 mL of the reconstituted solution contains 66.3 mg of methylprednisolone sodium succinate, equivalent to 50 mg of methylprednisolone.

• Other ingredients are: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate.

1 ampoule of solvent contains 5 mL of water for injection.

What Meprelon, 1000 mg Contains

• The active substance is methylprednisolone.

1 vial of powder contains 1325.92 mg of methylprednisolone sodium succinate, equivalent to 1000 mg of methylprednisolone.
1 mL of the reconstituted solution contains 132.59 mg of methylprednisolone sodium succinate, equivalent to 100 mg of methylprednisolone.

• Other ingredients are: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate.

1 ampoule of solvent contains 10 mL of water for injection.

What Meprelon, 250 mg Looks Like and Package Contents

Meprelon, 250 mg contains white to cream-colored powder and a clear, colorless solvent.
Meprelon, 250 mg is available in the following packages:
1 vial of powder for solution for injection/infusion containing 250 mg of methylprednisolone and 1 ampoule of solvent with 5 mL of water for injection.
3 vials of powder for solution for injection/infusion containing 250 mg of methylprednisolone each and 3 ampoules of solvent with 5 mL of water for injection each.
5 vials of powder for solution for injection/infusion containing 250 mg of methylprednisolone each and 5 ampoules of solvent with 5 mL of water for injection each.
10 vials of powder for solution for injection/infusion containing 250 mg of methylprednisolone each and 10 ampoules of solvent with 5 mL of water for injection each.

What Meprelon, 1000 mg Looks Like and Package Contents

Meprelon, 1000 mg contains white to cream-colored powder and a clear, colorless solvent.
Meprelon, 1000 mg is available in the following packages:
1 vial of powder for solution for injection/infusion containing 1000 mg of methylprednisolone and 1 ampoule of solvent with 10 mL of water for injection.
3 vials of powder for solution for injection/infusion containing 1000 mg of methylprednisolone each and 3 ampoules of solvent with 10 mL of water for injection each.
5 vials of powder for solution for injection/infusion containing 1000 mg of methylprednisolone each and 5 ampoules of solvent with 10 mL of water for injection each.
10 vials of powder for solution for injection/infusion containing 1000 mg of methylprednisolone each and 10 ampoules of solvent with 10 mL of water for injection each.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki
phone: +48 22 350 66 69

Manufacturer:

mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany
SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria

Metasol 250 mg Powder and solvent for solution for injection/infusion
Germany
Methylprednisolut 250 mg
Poland
Meprelon
Austria
Metasol 1000 mg Powder and solvent for solution for injection/infusion
Germany
Methylprednisolut 1000 mg
Poland
Meprelon
Date of last revision of the leaflet:09.2024