Meprelon

Leaflet accompanying the packaging: information for the user

Meprelon, 250 mg,

Meprelon, 1000 mg,

powder and solvent for solution for injection/infusion
Methylprednisolone

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

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

Table of contents of the leaflet

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

1. What is Meprelon and what is it used for

Meprelon contains an active substance from the group of modified adrenal cortex hormones (glucocorticosteroids), in a large dose and in a form that is poorly 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 medicine 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 respiratory distress syndrome (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 of exacerbations of multiple sclerosis. Meprelon may shorten the duration of exacerbations, but it does not affect their frequency or progression of disability.

2. Important information before using Meprelon

When not to use Meprelon

• if the patient is 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, you should discuss it with your doctor, pharmacist, or nurse,

• if the patient has hyperthyroidism.

In cases of severe infections, Meprelon should only be administered in combination with specific anti-infection medicines.
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., infestations with worms, infestations with roundworms),
• Heine-Medin disease (poliomyelitis),
• lymph node involvement after BCG vaccination,
• acute and chronic bacterial infections,
• in case of a history of tuberculosis, the medicine may only be used with concurrent anti-tuberculosis treatment and under close medical supervision.

Before starting short-term treatment of multiple sclerosis exacerbations, infection should be ruled out.
Furthermore, in the following diseases, Meprelon should only be used when the doctor considers it absolutely necessary and with concurrent specific treatment:

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

Due to the risk of intestinal wall 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 a 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 that persist or worsen occur, you should contact your doctor immediately. The doctor will decide on the need for further diagnosis and treatment.
In patients with diabetes, metabolism (metabolic processes) should be regularly monitored. It is necessary to consider possible increased demand for anti-diabetic medicines (insulin, oral medicines, 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, you should discuss it with your doctor if:

• The patient has 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.
• the patient has 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 malignancies (see section 4 "Possible side effects").
After administration of corticosteroids, cases of pheochromocytoma crisis have been reported, which can manifest as increased blood pressure with headache, sweating, rapid heart rate, and pallor, and can lead to death (see section 4 "Possible side effects"). Corticosteroids should only be administered to patients with suspected or diagnosed pheochromocytoma (most often 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 thromboembolic disease 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 immune system suppression, treatment with glucocorticosteroids, such as Meprelon, may lead to an increased risk of infection, including with opportunistic pathogens (pathogens that rarely cause infections in other circumstances).
In principle, it is possible to vaccinate with inactivated vaccines (vaccines containing killed pathogens). 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 chickenpox or measles in their history. If these patients come into 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 pre-existing 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 administration of the medicine.
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, the adverse effects disappeared after discontinuation of treatment. For this reason, appropriate monitoring is necessary (see section 4 "Possible side effects").
Systemic treatment with glucocorticosteroids may cause choroidoretinopathy, leading to vision disturbances, including vision loss. Long-term systemic treatment with glucocorticosteroids may cause choroidoretinopathy even at low doses (see section 4 "Possible side effects").
If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.
Meprelon is intended for short-term use. However, if Meprelon is not used as recommended but for a long time, the following warnings and precautions should be observed, as described for glucocorticosteroid products 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 medicine being taken. It may be necessary to temporarily increase the daily dose of glucocorticosteroids. The doctor should issue a special identification card to the patient taking the medicine long-term, indicating the use of glucocorticosteroids, which the patient should always carry with them.
Depending on the duration and dosage of the medicine, an unfavorable effect on calcium metabolism can be expected. For this reason, 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 a large number of cigarettes, excessive alcohol consumption, postmenopausal period, and lack of physical exercise. Prevention includes consuming sufficient amounts of calcium and vitamin D and engaging in physical exercise. In case of concomitant osteoporosis, consideration should be given to taking 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 the 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 while taking 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.
Children should only be treated with Meprelon when there are significant medical reasons, due to the risk of growth retardation. During long-term treatment with glucocorticosteroids, the child's growth should be regularly monitored.

Action of the medicine used improperly 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 ruled out.

Meprelon and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available 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.
• Medicines that slow down the metabolism of corticosteroids in the liver, such as certain antifungal medicines (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 medicines: ritonavir, cobicistat).
• Medicines used to treat heart diseases (e.g., diltiazem [a 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.
  Weakening of action:

Medicines that accelerate the metabolism of corticosteroids in the liver, such as certain sedatives (containing barbiturates), anticonvulsants (containing phenytoin, carbamazepine, primidone), and certain medicines used in tuberculosis (containing rifampicin), may weaken their action.

• Medicines 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 medicines (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 medicines (cardiac glycosides).
• Meprelon may enhance the excretion of potassium by diuretics (sodium-excreting medicines) and laxatives.
• When used concurrently with anti-inflammatory and anti-rheumatic medicines (salicylates, indomethacin, and other non-steroidal anti-inflammatory medicines), 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 medicines (atropine and other anticholinergic medicines) that increase intraocular pressure.
• When used concurrently with medicines 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 level of cyclosporine (a medicine that suppresses the body's immune system) in the blood. There is an increased risk of seizures.

Weakening of action:

• Meprelon may weaken the action of oral anti-diabetic medicines and insulin.
• Meprelon may weaken the action of blood-thinning medicines (oral anticoagulants, coumarin derivatives).
• Meprelon may weaken the action of anti-parasitic medicines (praziquantel).
• Meprelon may weaken the action of growth hormone (somatropin).
• Meprelon may weaken the increase in thyroid-stimulating hormone (TSH) levels after administration of protirelin (TRH, a hormone released by 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 plan to have a child, you should consult your doctor or pharmacist 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 ruled out. In case of treatment in late pregnancy, 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 put themselves and others at risk. It should be noted 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 that the medicine is considered "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 as directed by your doctor. In general, Meprelon is used according to the following dosage recommendations:
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 crises), doses of 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 the doctor has prescribed otherwise, the dosage recommendations 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 medicines.
• 250-500 mg of methylprednisolone in combination with standard basic treatment and/or concomitant medicines. 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 medicines.
• 250-500 mg of methylprednisolone in combination with standard basic treatment and/or concomitant medicines. 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.
Threat of organ rejection after transplantation
Inject doses of 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 of 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 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 of multiple sclerosis exacerbations
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 the 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 medicine 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 medicine 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 the hospital.
Meprelon is administered intravenously or intravenously by infusion. Due to uncertain absorption conditions, intramuscular administration should only be chosen in exceptional cases when intravenous administration is not possible. Intravenous injection should be performed slowly.
To prepare the ready-to-use solution for injections, the enclosed solvent (water for injections) should be injected into the vial with the powder directly before use and shaken to dissolve.
To prepare the infusion, the medicine 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 should be avoided to administer other medicines mixed in the 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 the infusion line.
Solutions for injections/infusions 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.

Use of a higher than recommended dose 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 their frequency. The frequency cannot be estimated from the available data. Depending on the duration of treatment and dose, the following side effects may occur:
Blood and lymphatic system disorders
Changes in blood cell count (i.e., morphology) (increased white blood cell count, red blood cells, or platelets, 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, dyspnea (bronchospasm), and/or hypotension/hypertension.
Immunosuppression with increased risk of infection (some viral diseases, such as chickenpox, herpes, or - during viremia - shingles, may have a severe course and sometimes even be life-threatening), masking of infections, revelation of latent infections, allergic reactions.
Endocrine disorders
Cushing's syndrome (typical symptoms: moon face, central obesity, and facial erythema), decreased or absent adrenal cortical activity, steroid withdrawal syndrome, growth retardation in children, disorders of sex hormone secretion (amenorrhea, hirsutism, erectile dysfunction).
Metabolic and nutritional disorders
Tumor lysis syndrome has been reported in patients with hematological malignancies. Tumor lysis syndrome can 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, you should immediately contact your doctor (see section 2, "Warnings and precautions").
Accumulation of fat tissue in certain parts of the body (in the spinal canal (epidurally) or temporarily in the thorax (in the pericardium, mediastinum).
Edema due to sodium retention in tissues - 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), occurrence of previously undiagnosed epilepsy symptoms, and increased seizure susceptibility 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 pulmonary congestion in heart failure, certain muscle disorders in premature infants (see section 2, "Children").
Vascular disorders
Vascular collapse, hypertension, increased blood coagulability (thrombotic 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., with peritonitis), gastrointestinal bleeding, pancreatitis, abdominal discomfort, gas accumulation in the intestinal wall (pneumatosis cystoides intestinalis).
Hepatobiliary disorders
Methylprednisolone may cause liver damage. Cases of hepatitis and increased liver enzyme activity have been reported. This also applies to liver cell damage and liver damage with bile stasis and may lead to acute liver failure (see section 2, "Warnings and precautions").

• 2, section "Warnings and precautions").

Skin and subcutaneous tissue disorders
Stretch marks, skin thinning (atrophy) ("parchment-like skin"), telangiectasia, increased fragility of blood vessels ("vascular fragility"), tendency to bruising, petechiae or ecchymoses, hirsutism, acne, delayed wound healing, facial erythema (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 cases 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 cases of concurrent administration of non-depolarizing muscle relaxants (see also section 2, "Meprelon and other medicines"), osteoporosis (disease of brittle bones) (dose-dependent, also possible during short-term use), which may lead to an increased risk of bone fractures in severe cases, other forms of bone degeneration (aseptic bone necrosis: head of the humerus and head of the femur), tendon rupture.
Too rapid reduction of the dose 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). Symptoms of scleroderma renal crisis include hypertension and decreased urine production, (see section 2, "Warnings and precautions").
General disorders and administration site conditions
Injection into fatty tissue may cause local fat tissue 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, anxiety, apathy (lethargy), malaise, joint pain, skin peeling, hypotension, and weight loss (steroid withdrawal syndrome).
Special warnings
Given that Meprelon may, in very rare cases, cause allergic reactions, even leading to anaphylactic shock, in patients with a tendency to allergies (e.g., bronchial asthma), it is necessary to ensure easy access to emergency treatment (e.g., adrenaline, intravenous infusion, artificial ventilation).
In the event of gastrointestinal or intestinal disorders, back, shoulder, or hip pain, depressive mood, abnormal blood glucose levels (in diabetic patients), or other disorders, you should immediately inform your doctor.

Reporting of Side Effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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 to gather more information on the safety of the medicine.

5. How to Store Meprelon

The medicine 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. You should ask your 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 preparation of the solution 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.
For microbiological reasons, the prepared solution should be used immediately. If the ready-to-use solution is not administered immediately, the user is responsible for the duration and conditions of storage.

6. Package Contents and Other Information

What Meprelon, 250 mg Contains

• The active substance of the medicine is methylprednisolone. 1 vial of powder contains 331.48 mg of methylprednisolone sodium succinate, equivalent to 250 mg of methylprednisolone.

1 mL of the prepared 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 of the medicine is methylprednisolone.

1 vial of powder contains 1325.92 mg of methylprednisolone sodium succinate, equivalent to 1000 mg of methylprednisolone.
1 mL of the prepared 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