Meprelon

Leaflet accompanying the packaging: information for the user

Meprelon, 16 mg,

powder and solvent for preparing a 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 Meprelon is and what it is 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 Meprelon is and what it is used for

Meprelon contains an active substance from the group of modified adrenal cortex hormones (glucocorticosteroids) in a highly water-soluble form. 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 medicine 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, insect bite reaction),
• initial treatment of extensive, severe skin diseases with an acute course (e.g., erythroderma, common 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 medicine of choice is hydrocortisone).

2. Important information before using Meprelon

When not to use Meprelon

Warnings and precautions

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

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. If indicated, targeted concurrent use of anti-infection medicines may be necessary:

• 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., worm infestations, nematode infestations),
• Heine-Medin disease (poliomyelitis),
• lymph node involvement after BCG vaccination,
• acute and chronic bacterial infections,
• in cases of tuberculosis in the medical history, the medicine may only be used in combination with anti-tuberculosis medicines and under close medical supervision.

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

• peptic ulcer,
• severe osteoporosis (bone mass loss),
• uncontrolled hypertension,
• uncontrolled diabetes,
• mental illness (also in the medical history),
• increased intraocular pressure (glaucoma with narrow and open-angle filtration),
• corneal ulcers and eye damage.

Due to the risk of intestinal wall perforation with peritonitis, Meprelon can only be used when there are valid reasons and under close supervision 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 of the intestine,
• immediately after certain surgical procedures on the intestines (enteroanastomosis).

In patients taking high doses of glucocorticosteroids, signs of peritoneal irritation may not occur after gastric or intestinal perforation.
Using Meprelon may cause gas accumulation in the intestinal wall, known as intestinal pneumatosis (frequency unknown, see section 4 "Possible side effects"). Intestinal pneumatosis 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. The possible need for increased doses of anti-diabetic medicines (insulin, oral medicines, etc.) should be considered.
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, 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, 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 if you have a hematological malignancy (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 pale skin, and may lead to death (see section 4 "Possible side effects"). Corticosteroids should only be administered to patients with suspected or diagnosed pheochromocytoma after careful assessment of the benefit-risk ratio.
During the use of corticosteroids, thrombosis has been reported, including venous thromboembolic disease. 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 more difficult.
Due to the weakening of the immune system, treatment with glucocorticosteroids, such as Meprelon, may lead to an increased risk of infection, including those caused by 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 supplementary treatment).
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 weakened immunity (immunosuppressed children) and patients who have not had chickenpox or measles in their medical history. If these patients come into contact with people 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), cases of cardiac arrhythmias and/or circulatory collapse and/or cardiac arrest have been reported, even in patients without previously 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 administration of the medicine.
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 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 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 a medicine 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 medicines 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 stressful 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 being taken. Temporary dose increase may be required. A patient taking the medicine for a long time should be given a special identification card by their doctor, indicating that they are taking glucocorticosteroids, which they should always carry with them.
Depending on the duration and dosage of the medicine, 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 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 activity. If osteoporosis is present, the possibility of taking additional medication should be considered.
After completing or, if necessary, discontinuing 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 discomfort caused by the steroid withdrawal syndrome (see section 4 "Possible side effects").
In cases of untreated hypothyroidism or liver cirrhosis, relatively small doses or dose reduction may be sufficient, and 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.
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 medicine when 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. Additionally, using Meprelon as a doping substance may pose a risk to health.

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
Increased effect and possible increased side effects:

• Certain female sex hormones, such as oral contraceptives ("the pill"), may enhance the effect of corticosteroids.
• Medicines that slow down the metabolism of corticosteroids in the liver, such as certain antifungal medicines (containing ketoconazole, itraconazole), may enhance the effect of corticosteroids.
• Certain medicines may enhance the effect of Meprelon, 16 mg, 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, the initial treatment period should be under medical supervision. It may be necessary to adjust the dose of methylprednisolone.

Decreased effect:

• Medicines that accelerate the metabolism of corticosteroids in the liver, such as certain sedatives (containing barbiturates), antiepileptic medicines (containing phenytoin, carbamazepine, primidone), and certain medicines used to treat tuberculosis (containing rifampicin), may reduce the effect of corticosteroids.
• 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
Increased effect and possible increased 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 effect of heart-strengthening medicines (digitalis glycosides).
• Meprelon may increase potassium excretion due to diuretics (sodium-enhancing diuretics) 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 increase the action of certain medicines (atropine and other anticholinergic medicines) that increase intraocular pressure.
• When used concurrently with medicines for 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 medicine that suppresses the body's immune system), which may increase the risk of seizures.

Decreased effect:

• Meprelon may reduce the effect of oral anti-diabetic medicines and insulin.
• Meprelon may reduce the effect of blood clotting inhibitors (oral anticoagulants, coumarin derivatives).
• Meprelon may reduce the effect of anti-parasitic medicines (praziquantel).
• Meprelon may reduce the effect of growth hormone (somatropin).
• 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
Effect 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 a 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 cases of long-term treatment with glucocorticosteroids during pregnancy, growth disturbances in the unborn child cannot be ruled out. In cases 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 reaction ability. 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 contains sodium

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

3. How to use Meprelon

Meprelon, 16 mg should always be used as directed by your doctor. Generally, Meprelon is used according to the following dosage recommendations:
In cases of acute symptom treatment, the adult dose is usually 32-64 mg of methylprednisolone (2-4 ampoules of Meprelon, 16 mg) or more. In such cases, Meprelon, 32 mg is also available. The dose for children is 8-32 mg (½ - 2 ampoules of Meprelon, 16 mg) or 1-2 mg/kg of body weight.
In the treatment of life-threatening conditions, the adult dose is 250-500 mg of methylprednisolone; and 4-8 mg/kg of body weight in 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 (2-6 ampoules of Meprelon, 16 mg) in combination with standard basic treatment or concurrent medicines. In such cases, Meprelon, 32 mg is also available. Depending on the clinical condition, this dose may be repeated every 6 hours.
In cases of severe, life-threatening asthma attacks, 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 (2-4 ampoules of Meprelon, 16 mg) is administered three times a day for several days. In such cases, Meprelon, 32 mg is also available. If necessary, the dose should be gradually reduced and switched to oral treatment.
Acute allergic reactions (e.g., angioedema, insect bite reaction)
In cases of angioedema, 96-160 mg of methylprednisolone is administered intravenously in a single dose. In cases of insect bite reactions, 96 mg of methylprednisolone or more is administered intravenously in a single dose. In such cases, Meprelon, 32 mg is more suitable. In cases of acute upper airway narrowing, a dose of 250 mg of methylprednisolone may be required. Administration of this dose may 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, common bullous pemphigoid)
In cases of skin diseases, oral methylprednisolone may be used 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 (in such cases, Meprelon, 32 mg is more suitable) 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 (in such cases, Meprelon, 32 mg is more suitable). 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, administered intravenously (1-2 ampoules of Meprelon, 16 mg). 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, this dose may 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 (2 ampoules of Meprelon, 16 mg). Subsequently, 16 mg of methylprednisolone is administered intravenously (1 ampoule of Meprelon, 16 mg) three times a day for two days. Later, the dose is gradually reduced, and treatment is switched to inhaled corticosteroids.
Addisonian crisis
The initial dose is 16-32 mg of methylprednisolone (1-2 ampoules of Meprelon, 16 mg) administered intravenously in combination with standard concurrent treatment. Subsequently, 16-32 mg of methylprednisolone (1-2 ampoules of Meprelon, 16 mg) is administered in a 24-hour intravenous infusion, after which treatment is switched to oral administration 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 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 is recommended to avoid administering the medicine together with other medicinal products mixed in a syringe, as this may cause precipitation. For the same reason, Meprelon should not be added to infusion solutions other than those listed, or injected into an infusion line.
Solutions for injection or infusion prepared by dissolving the powder should be used as soon as possible.
Medicines 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.

Using a higher dose of Meprelon than recommended

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

Discontinuing Meprelon

In case of discontinuation of treatment after long-term use of Meprelon, you should follow the doctor's instructions. The doctor may recommend gradual dose reduction until the medicine 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.

If you have any further doubts about the use of this medicine, you should 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 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 (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 circulatory 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, and pale skin in cases of pheochromocytoma; see section 2 "Warnings and precautions"), 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, you should contact your doctor immediately (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), and 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 (lens opacity), increased intraocular pressure (glaucoma), exacerbation of corneal ulcers, exacerbation of viral, fungal, and bacterial eye infections, blurred vision.
Cardiac disorders
Arrhythmias, cardiac arrest, exacerbation of pulmonary congestion in heart failure, certain heart muscle disorders in premature infants (see section 2 "Children").
Vascular disorders
Circulatory 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 a risk of perforation (e.g., with peritonitis), gastrointestinal bleeding, pancreatitis, abdominal discomfort, 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 includes 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 cases of myasthenia (muscle weakness), reversible increased muscle weakness, which may lead to myasthenic crisis, induction of acute myopathy (muscle disease) when used concurrently with non-depolarizing muscle relaxants (see also section 2 "Meprelon and other medicines"), osteoporosis (dependent on dose, possible even with short-term use), which may lead to an increased risk of bone fractures, other forms of bone destruction (aseptic bone necrosis: humeral head and femoral head), tendon rupture.
Reducing the dose too quickly after long-term treatment may cause discomfort, such as muscle pain and joint pain.
Renal and urinary disorders
Scleroderma renal crisis in patients with scleroderma (an autoimmune disorder). The symptoms of scleroderma renal crisis include increased blood pressure and decreased urine production (see section 2 "Warnings and precautions").
General disorders and administration site conditions
Intramuscular injection may cause local fat tissue atrophy.
Investigations
Weight gain.
In case of abrupt discontinuation of methylprednisolone after long-term use, the following side effects have been observed, although not in every patient:
Symptoms such as fever, loss of appetite, nausea, weakness, anxiety, 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).
If you experience gastrointestinal or intestinal disorders, back, shoulder, or hip pain, psychiatric disorders, abnormal blood glucose levels (in diabetic patients), or other disorders, you should immediately inform your 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. These measures 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.
From a microbiological point of view, the prepared 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, 16 mg contains

• The active substance is methylprednisolone.

1 vial of powder contains 20.92 mg of methylprednisolone sodium succinate, equivalent to 15.78 mg of methylprednisolone.
1 ml of the prepared solution contains 20.92 mg of methylprednisolone sodium succinate, equivalent to 15.78 mg of methylprednisolone.

• The other ingredients are: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate.

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

What Meprelon, 16 mg looks like and package contents

Meprelon, 16 mg contains a white to cream-colored powder and a clear, colorless solvent.
Meprelon, 16 mg is available in packages:
3 vials of powder for solution for injection/infusion, each containing 16 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
phone: +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:

Austria
Metasol 16 mg Powder and solvent for solution for injection/infusion
Germany
Methylprednisolut 16 mg
Poland
Meprelon
Date of last update of the leaflet:09.2024