Meprelon

Leaflet accompanying the packaging: information for the user

Meprelon, 32 mg,

powder and solvent for solution for injection/infusion
Methylprednisolone

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, 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 them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, 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 the active substance from the group of modified adrenal cortex hormones (glucocorticosteroids) in a very soluble form in water. Therefore, Meprelon is administered directly into the bloodstream in conditions that require very rapid onset of glucocorticosteroid action.
Meprelon is used:
All indications for corticosteroid treatment in cases where rapid action of the drug is necessary or when, for other reasons (e.g., vomiting or loss of consciousness), parenteral administration is required, in particular in the following cases:

• severe acute asthma attack,
• brain edema (only in cases of symptoms of increased intracranial pressure confirmed by computed tomography) caused by a brain tumor or metastases in the brain,
• severe allergic reaction (e.g., angioedema, reaction to insect bites),
• initial treatment of extensive, severe skin diseases with an acute course (e.g., erythroderma, bullous pemphigoid),
• acute blood disorders (e.g., autoimmune hemolytic anemia, acute thrombocytopenic purpura),
• acute liver tissue disorders (e.g., acute alcoholic hepatitis),
• pulmonary edema caused by inhalation of an irritating gas (toxic pulmonary edema),
• weakness or lack of adrenal cortex activity (adrenal insufficiency): Addisonian crisis (the drug of choice is hydrocortisone).

2. Important information before using Meprelon

When not to use Meprelon

• if the patient is allergic to methylprednisolone, other glucocorticosteroids, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Meprelon, 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 drugs.
Meprelon should only be used in the following diseases when the doctor considers it absolutely necessary. If indicated, specific anti-infection drugs should be used simultaneously:

• 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 nematodes),
• Heine-Medin disease (poliomyelitis),
• lymph node involvement after BCG vaccination,
• acute and chronic bacterial infections,
• in case of a history of tuberculosis, the drug can only be used in combination with anti-tuberculosis drugs and under close medical supervision.

Furthermore, in the following diseases, Meprelon should only be used when the doctor considers it absolutely necessary and with simultaneous specific treatment:

• peptic ulcer,
• severe osteoporosis (bone mass loss),
• uncontrolled hypertension,
• 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 wall perforation with peritonitis, Meprelon can only be used when there are valid reasons and under close control in the following cases:

• in patients with severe ulcerative colitis (ulcerative colitis) with a risk of perforation, with abscesses or purulent inflammation
• in patients with diverticulitis,
• immediately after certain surgical procedures on the intestines (enteroanastomosis).

In patients taking high doses of glucocorticosteroids, symptoms of peritoneal irritation may not occur after stomach or intestinal perforation.
Using Meprelon may cause gas accumulation in the intestinal wall, called intestinal pneumatosis (frequency unknown, see section 4 "Possible side effects"). Intestinal pneumatosis can 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 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 exacerbating these conditions.
Before starting treatment with Meprelon, 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 elevated 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.

Inform your doctor if you experience 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 (decreased urine output or darker urine color), as well as in cases of hematological malignancies (see section 4 "Possible side effects").
After administering glucocorticosteroids, 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 (most often a hormone-producing tumor located in the adrenal gland tissue) after careful assessment of the benefit-risk ratio.
During the use of corticosteroids, thrombosis has been reported, including venous thromboembolic disease. 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 symptoms of concomitant or developing infections, making diagnosis difficult.
Due to immune system suppression, treatment with glucocorticosteroids, such as Meprelon, may lead to increased risk of infection, including with microorganisms that would not normally cause infection (so-called opportunistic pathogens).
In principle, vaccination with inactivated vaccines (vaccines containing killed microorganisms) is possible. However, it should be considered that the immune response, and thus the effectiveness of the 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 supportive treatment).
When administering high doses of Meprelon, 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 may administer 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 drug.
After intravenous administration of methylprednisolone (usually with an initial dose of ≥ 1000 mg per day), rare cases of drug-induced liver damage have been reported, including acute hepatitis and increased liver enzyme activity. Symptoms may occur after several weeks or later. In most cases, the adverse effects 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 with 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 a drug 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-containing drugs 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 stress situations that occur during glucocorticosteroid treatment, such as febrile illnesses, accidents, surgeries, childbirth, the patient must immediately consult a doctor and inform them about the medication they are taking. Temporary dose increase may be required. The doctor should issue a special identification card to the patient taking the drug long-term, indicating that they are taking 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 applies especially to 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 existing 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), symptoms of the disease and complaints caused by the steroid withdrawal syndrome (see section 4 "Possible side effects").
In cases of untreated hypothyroidism or liver cirrhosis, relatively small doses may be sufficient, or dose reduction may be necessary. Close medical supervision is required.
Immediately consult a doctor if, during the use of methylprednisolone, weakness or muscle pain, cramps, and stiffness occur. 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 valid medical reasons, due to the risk of growth retardation. During long-term use of Meprelon, the child's growth should be regularly checked.

Effect of the drug used improperly as a doping agent

Using Meprelon may lead to positive test results for doping substances. The health consequences of using the Meprelon product as a doping substance cannot be predicted. Moreover, using Meprelon as a doping substance may pose a risk to health.

Meprelon and other medicines

Tell your doctor or pharmacist about all medicines you are 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.
• Drugs that slow down the metabolism of corticosteroids in the liver, such as certain antifungal drugs (containing ketoconazole, itraconazole), may enhance the action of corticosteroids.
• Certain medicines may enhance the action of Meprelon, 32 mg, 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, the initial treatment period should be under medical supervision. 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), anticonvulsants (containing phenytoin, carbamazepine, primidone), and certain tuberculosis drugs (containing rifampicin), may reduce the action of corticosteroids.
• 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 blood count changes.
• Meprelon may cause potassium deficiency, which may enhance the action of heart-strengthening drugs (cardiac glycosides).
• Meprelon may enhance potassium excretion through 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 stomach and intestinal ulcers and 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 to treat malaria and rheumatic diseases (containing chloroquine, hydroxychloroquine, mefloquine), Meprelon may increase the risk of muscle diseases (myopathies) or heart muscle diseases (cardiomyopathies).
• 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 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, 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 discussing the possible benefits and risks of different treatment options for the patient and the unborn child with the doctor. 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 disorders 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, including methylprednisolone, pass into breast milk.
During treatment with high doses or long-term use, breastfeeding should be avoided.

Driving and using machines

Due to the occurrence of certain side effects, such as blurred 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 related to the risk, for example, when driving a vehicle or operating machines. The same applies to performing tasks without secure anchorage. The patient may unnecessarily put themselves and others at risk. Note that alcohol may increase this risk.

Meprelon contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per ampoule, i.e., the medicine is considered "sodium-free".

3. How to use Meprelon

Meprelon, 32 mg should always be used as directed by your doctor. In general, Meprelon is used according to the following dosage recommendations:
In case of treatment of acute symptoms, the dose for adults is usually 32-64 mg of methylprednisolone (1-2 ampoules of Meprelon, 32 mg) or more. The dose for children is 8-32 mg (up to one ampoule of Meprelon, 32 mg) or 1-2 mg/kg of body weight. In such cases, Meprelon, 16 mg is also available.
In the treatment of life-threatening conditions, the dose for adults is 250-500 mg of methylprednisolone; and 4-8 mg/kg of body weight for children. Depending on the symptoms, single doses of up to 30 mg/kg of body weight may be required. In such cases, Meprelon, 250 mg and Meprelon, 1000 mg are available.
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:
Severe acute asthma attack
Depending on the symptoms, the initial dose is 32-96 mg of methylprednisolone (1-3 ampoules of Meprelon, 32 mg) in combination with usual basic treatment or concomitant medications. Depending on the clinical condition, this dose may be repeated every 6 hours.
In case of a life-threatening asthma attack, the recommended initial dose is 250-500 mg of methylprednisolone. In such cases, Meprelon, 250 mg is available.
Brain edema (caused by a brain tumor or metastases in the brain)
Initially, 250-500 mg of methylprednisolone is administered. In such cases, Meprelon, 250 mg is available.
In the treatment of maintaining acute or severe brain edema or mild or chronic brain edema, usually 32-64 mg of methylprednisolone (1-2 ampoules of Meprelon, 32 mg) is administered three times a day for several days. If necessary, the dose should be gradually reduced and switched to oral treatment.
Acute allergic reactions (e.g., angioedema, reaction to insect bites)
Angioedema is treated with a single intravenous dose of 96-160 mg (3-5 ampoules of Meprelon, 32 mg). In case of a reaction to insect bites, a single intravenous dose of 96 mg of methylprednisolone (3 ampoules of Meprelon, 32 mg) or more is administered.
In case of acute narrowing of the upper airways, 250 mg of methylprednisolone can be administered. Administration of this dose can be repeated after 6 and 12 hours. In such cases, Meprelon, 250 mg is available.
Severe skin diseases with an acute course (e.g., erythroderma, bullous pemphigoid)
In case of skin diseases, oral methylprednisolone can be administered at a dose of 80-160 mg per day, depending on the severity and progression. In the initial treatment of severe cases of skin diseases with an acute course, parenteral administration of 96-160 mg of methylprednisolone (3-5 ampoules of Meprelon, 32 mg) is possible. Subsequently, oral treatment is used.
Acute hematologic disorders (e.g., autoimmune hemolytic anemia, acute thrombocytopenic purpura)
Initially, instead of oral therapy, 96-160 mg of methylprednisolone is administered intravenously per day (3-5 ampoules of Meprelon, 32 mg). Subsequently, oral treatment is used.
Acute liver tissue disorders (e.g., acute alcoholic hepatitis)
The initial dose is 16-32 mg of methylprednisolone per day (½-1 ampoule of Meprelon, 32 mg) administered intravenously. Subsequently, oral treatment is used.
Toxic pulmonary edema caused by inhalation of an irritating gas
1000 mg of methylprednisolone is administered intravenously immediately. If necessary, it can be repeated after 6, 12, and 24 hours. In such cases, Meprelon, 1000 mg is available. 32 mg of methylprednisolone is administered intravenously three times a day for the next two days (1 ampoule of Meprelon, 32 mg). Subsequently, 16 mg of methylprednisolone is administered intravenously (½ ampoule of Meprelon, 32 mg) three times a day for two days. In such cases, Meprelon, 16 mg is available. Later, the dose is gradually reduced and switched to inhaled corticosteroids.
Addisonian crisis
The initial dose is 16-32 mg of methylprednisolone (½-1 ampoule of Meprelon, 32 mg) administered intravenously in combination with usual concomitant treatment. Subsequently, 16-32 mg of methylprednisolone (½-1 ampoule of Meprelon, 32 mg) is administered in a 24-hour intravenous infusion, after which oral treatment is used if necessary, in combination with mineralocorticosteroids.
Note:
Considering the known side effect profile, it is recommended to administer the first intravenous dose in a hospital.
Meprelon is administered intravenously or intramuscularly. Since it is not certain to what extent the active substance will be absorbed, intramuscular administration should only be chosen exceptionally when intravenous administration is not possible. Intravenous injection should be performed slowly.
To prepare a ready-to-use solution for injection, the enclosed solvent (1 ml of water for injection) should be injected into the ampoule with the powder directly before use and shaken to dissolve.
To prepare an 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).
Concomitant administration with other medicinal products mixed in a syringe should be avoided, as this may cause precipitation. For the same reason, Meprelon should not be added to infusion solutions other than those listed, nor should it be injected into an infusion line.
Solutions for injection or infusion prepared by dissolving the powder must be used immediately.
Medicinal products intended for parenteral administration 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 discontinued abruptly but gradually.

Use of a higher than recommended dose of Meprelon

There are no known cases of acute overdose of Meprelon. 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.

Discontinuation of Meprelon

In case of discontinuation of treatment after long-term use of Meprelon, follow the doctor's instructions. The doctor may recommend gradual dose reduction until the drug is completely discontinued. Abrupt discontinuation of treatment may cause (see also section 2, "Warnings and precautions"):

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

In case of any further doubts about the use of this medicine, consult a doctor, pharmacist, or nurse.

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.
Frequency could not 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 (increased white blood cell count, increased red blood cell count, platelet count, or decreased count of certain white blood cells and platelets).
Immune system disorders
Severe allergic reactions (anaphylactic reactions) with cardiovascular collapse, cardiac arrest, arrhythmias, bronchospasm, and (or) decreased or increased blood pressure.
Endocrine disorders
Pheochromocytoma crisis (occurrence of significantly increased blood pressure with headache, sweating, rapid heart rate, pallor, in case of pheochromocytoma, see section 2 "Warnings and precautions"), induction of Cushing's syndrome (typical symptoms: moon face, central obesity, and facial flushing), adrenal insufficiency or atrophy, steroid withdrawal syndrome, growth retardation in children, disorders of sex hormone secretion (amenorrhea, hirsutism, erectile dysfunction).
Metabolic and nutritional disorders
Reports of tumor lysis syndrome 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, shortness of breath, seizures, irregular heartbeat, or kidney failure (decreased urine output or darker urine color). If such symptoms occur, immediately contact a 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 chest [in the 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), enhanced protein catabolism.
Psychiatric disorders
Severe depression, irritability, personality changes, mood swings, 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, feeling of emptiness in the head, dizziness, headache.
Eye disorders
Chorioretinopathy (see section 2 "Warnings and precautions"), cataract, increased intraocular pressure (glaucoma), worsening of corneal ulcers, worsening of viral, fungal, and bacterial eye infections, blurred vision.
Cardiac disorders
Arrhythmias, cardiac arrest, worsening of pulmonary congestion in heart failure, certain heart 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
Stomach and intestinal ulcers with a risk of perforation (e.g., with peritonitis), gastrointestinal bleeding, pancreatitis, abdominal complaints, gas accumulation in the intestinal wall (intestinal pneumatosis).
Hepatobiliary disorders
Methylprednisolone may cause liver damage. Reports of hepatitis and increased liver enzyme activity have been made. 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").
Skin and subcutaneous tissue disorders
Stretch marks, skin thinning (skin atrophy), telangiectasia, increased fragility of blood vessels ("vascular fragility"), tendency to bruise, petechiae or ecchymoses, hirsutism, acne, delayed wound healing, facial skin inflammation (especially around the mouth, nose, and eyes), skin pigmentation changes, allergic reactions, such as skin rashes.
Musculoskeletal and connective tissue disorders
Muscle weakness and atrophy, in case of myasthenia (muscle weakness), reversible increased muscle weakness, which may lead to a myasthenic crisis, induction of acute myopathy in case of concomitant administration of non-depolarizing muscle relaxants (see also section 2 "Meprelon and other medicines"), osteoporosis (dose-dependent, possible even with short-term use), which may lead to an increased risk of bone fractures, other forms of bone decay (aseptic bone necrosis: humeral head and femoral head), tendon rupture.
Too rapid dose reduction after long-term treatment may cause complaints such as muscle and joint pain.
Renal and urinary disorders
Scleroderma renal crisis in patients with scleroderma (an autoimmune disorder). The symptoms of scleroderma renal crisis include elevated blood pressure and decreased urine production (see section 2 "Warnings and precautions").
General disorders and administration site conditions
Intramuscular injection can cause local fat tissue atrophy.
Investigations
Weight gain.
In case of sudden 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 (drowsiness), malaise, joint pain, skin peeling, low blood pressure, and weight loss (steroid withdrawal syndrome).
Special warnings
Since Meprelon may rarely cause allergic reactions, even leading to anaphylactic shock, in patients with a tendency to allergies (e.g., asthma), it is necessary 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, psychiatric disorders, abnormal blood glucose levels (in diabetic patients), or other disorders, immediately inform a doctor.

5. How to Store Meprelon

The medicinal product should be stored out of sight and reach of children.
Do not use this medicinal product after the expiry date stated on the carton and ampoule after: EXP.
The expiry date refers to the last day of the given month.
There are no special storage temperature requirements .
Ampoules should be stored in the outer packaging to protect from light .
Medicines should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of medicines no longer required. 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 dilution with water for injections and for 8 hours at 25 °C after dilution with 5% (50 mg/ml) glucose solution, 0.9% (9 mg/ml) sodium chloride solution 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, 32 mg contains

• The active substance is methylprednisolone.

1 vial of powder contains 41.85 mg of methylprednisolone sodium succinate, equivalent to 31.57 mg of methylprednisolone.
1 ml of the prepared solution contains 41.85 mg of methylprednisolone sodium succinate, equivalent to 31.57 mg of methylprednisolone.

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

1 vial of solvent contains 1 ml of water for injections.

What Meprelon, 32 mg looks like and what the pack contains

Meprelon, 32 mg contains a white to cream-colored powder and a clear, colorless solvent.
Meprelon, 32 mg is available in packs of:
3 vials of powder for solution for injection/infusion, each containing 32 mg of methylprednisolone, and 3 vials of solvent, each containing 1 ml of water for injections.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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

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

The following names are used in the Member States:

Austria
Metasol 32 mg Powder and solvent for solution for injection/infusion
Germany
Methylprednisolut 32 mg
Poland
Meprelon
Date of last update of the leaflet:09.2024