Package leaflet: Information for the user

Meprelon, 16 mg,
powder and solvent for solution for injection/infusion
Methylprednisolonum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

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

Contents of the leaflet

What Meprelon is and what it is used for
What you need to know before you use Meprelon
How to use Meprelon
Possible side effects
How to store Meprelon
Contents of the pack and other information

1. What Meprelon is and what it is used for

Meprelon contains an active substance belonging to the group of modified adrenal cortex hormones (glucocorticoids), in a form highly soluble in water. Therefore, Meprelon is administered directly into the bloodstream in conditions requiring very rapid onset of glucocorticoid action.

Meprelon is indicated for:
All corticosteroid treatment indications where a very rapid therapeutic effect is required, or when for other reasons (e.g. vomiting or loss of consciousness) parenteral administration is necessary, particularly in the following cases:

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

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 this with your doctor, pharmacist, or
nurse,

if the patient has hyperthyroidism.

In severe infections, Meprelon should only be administered in combination with specific
antimicrobial agents.
Meprelon should be used in the following conditions only when the doctor considers it
absolutely necessary. If indicated, targeted concomitant antimicrobial therapy should be
administered:

acute viral infections (e.g. chickenpox, shingles, herpes virus infection, herpes keratitis),
infectious hepatitis (chronic active hepatitis with positive HBsAg test),
approximately 8 weeks before and up to 2 weeks after vaccination with live vaccines,
fungal infections involving internal organs,
certain parasitic diseases (e.g. protozoal infections, nematode infections),
Heine-Medin disease (poliomyelitis),
lymph node involvement after BCG vaccination,
acute and chronic bacterial infections,
if a history of tuberculosis is present, the medicine may be used only in combination with anti-tuberculosis drugs and under strict medical supervision.

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

gastrointestinal ulceration,
severe osteoporosis (loss of bone mass),
severe hypertension difficult to control,
diabetes difficult to control,
psychiatric disorders (including history),
increased intraocular pressure (glaucoma with narrow or open angle),
corneal ulcers and corneal damage.

Due to the risk of intestinal wall perforation with peritonitis, Meprelon may be used only when there are compelling reasons and under strict medical supervision in the following cases:

in patients with severe colitis (ulcerative colitis) at risk of perforation, with abscesses or suppurative inflammation,
in patients with diverticulitis,
immediately after certain intestinal surgeries (enteroanastomosis).

In patients receiving high doses of glucocorticosteroids, symptoms of peritoneal irritation after gastric or intestinal perforation may not occur.
Treatment with Meprelon may lead to gas accumulation in the intestinal wall, known as pneumatosis intestinalis (frequency unknown, see section 4 "Possible side effects"). Pneumatosis intestinalis may range from mild, asymptomatic conditions not requiring treatment to severe conditions that may require immediate surgical intervention.
If symptoms such as nausea, vomiting, and abdominal pain persist or worsen, contact a doctor immediately. The doctor will decide on the need for further diagnosis and treatment.
In patients with diabetes, metabolism (metabolic control) should be monitored regularly. An increased need for antidiabetic medications (insulin, oral antidiabetics, 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 worsening of these conditions.
Before starting treatment with Meprelon, discuss this with your doctor if:

the patient has scleroderma (an autoimmune disorder also known as systemic sclerosis), because doses of at least 12 mg methylprednisolone per day may increase the risk of a serious complication called scleroderma renal crisis. Symptoms of scleroderma renal crisis include elevated blood pressure and reduced urine output. The treating physician may recommend regular monitoring of blood pressure and urine output.
the patient has kidney disease or high blood uric acid levels before starting treatment with Meprelon.

Inform the doctor if the patient develops symptoms of tumor lysis syndrome, such as
muscle cramps, muscle weakness, confusion, vision loss or disturbances, shortness of breath, seizures,
irregular heartbeat, or kidney failure (reduced urine output or darker urine), and also if the patient has a
hematological malignancy (see section 4. "Possible side effects").
Cases of pheochromocytoma crisis have been reported after administration of glucocorticosteroids, which may manifest as elevated blood pressure with headache, sweating, tachycardia, and skin pallor, and which may be fatal (see section 4. "Possible side effects"). Corticosteroids should be administered to patients with suspected or diagnosed pheochromocytoma (most commonly a hormone-producing tumor located in adrenal gland tissue) only after careful benefit-risk assessment.
Thrombosis, including venous thromboembolic disease, has been reported during corticosteroid therapy. Inform the doctor if the patient has conditions associated with blood clot formation in blood vessels. In such cases, Meprelon should be used with caution.
During treatment with corticosteroids, initial worsening of pre-existing myasthenia (a type of muscle paralysis) may occur, progressing to myasthenic crisis.
Treatment with Meprelon may mask symptoms of coexisting or developing infections, thereby complicating diagnosis.
Due to immunosuppression, treatment with glucocorticosteroids such as Meprelon may increase the risk of infections, including those caused by microorganisms that rarely cause infections under other circumstances (so-called opportunistic pathogens).
Inactivated vaccines (vaccines containing killed pathogens) can generally be administered. However, it should be considered that immune response, and thus vaccine efficacy, may be reduced during high-dose corticosteroid therapy.
Therefore, vaccination is not recommended for patients receiving maintenance therapy with higher doses (except replacement therapy).
When high doses of Meprelon are administered, adequate potassium intake (e.g. vegetables, bananas) should be ensured and dietary salt intake limited. The doctor should monitor blood potassium levels.
Viral infections may be particularly severe and sometimes life-threatening in patients treated with Meprelon. The risk particularly affects immunocompromised children and patients without a history of chickenpox or measles. If such patients come into contact with individuals suffering from measles, chickenpox, or shingles during treatment with Meprelon, they should immediately consult a doctor, who may initiate prophylactic treatment if necessary.
After intravenous administration of high doses of methylprednisolone (over 500 mg methylprednisolone), cardiac arrhythmias and/or circulatory collapse and/or cardiac arrest have been reported, even in patients without diagnosed heart disease. Therefore, close medical monitoring is recommended during treatment and for several days after its completion.
Bradycardia (slowed heart rate) may occur during or after intravenous administration of high doses of methylprednisolone, regardless of the rate or duration of infusion.
Rare cases of drug-induced liver injury, including acute hepatitis and increased liver enzyme activity, have been reported after intravenous administration of methylprednisolone (usually at initial doses ≥ 1000 mg per day). Symptoms may appear after several weeks or later. In most cases, adverse effects resolved after discontinuation of treatment. Appropriate monitoring is therefore necessary (see section 4. "Possible side effects").
Systemic (whole-body) treatment with glucocorticosteroids may cause choroidal and retinal disorders (chorioretinopathy), which may lead to visual disturbances, including vision loss. Long-term systemic glucocorticosteroid therapy may cause chorioretinopathy even after low-dose treatment (see section 4. "Possible side effects").
If the patient experiences blurred vision or other visual disturbances, contact a doctor.
Meprelon is intended for short-term use. However, if Meprelon is not used as directed but long-term, further warnings and precautions applicable to glucocorticosteroid-containing medicines intended for long-term use should be observed.
During long-term glucocorticosteroid therapy, regular medical check-ups (including ophthalmological examinations every three months) are recommended.
In special stress situations occurring during glucocorticosteroid therapy, such as febrile illnesses, accidents, surgeries, or childbirth, the patient must immediately report to a doctor and inform them about the medication being taken. A temporary increase in daily dose may be required. Patients on long-term therapy should be issued a special identification card indicating glucocorticosteroid use, which should always be carried.
Depending on the duration and dosage of treatment, an adverse effect on calcium metabolism may be expected. Therefore, osteoporosis prevention is recommended, especially in patients with risk factors such as family history, advanced age, inadequate protein and calcium intake, heavy smoking, excessive alcohol consumption, postmenopausal status, and lack of physical activity. Prevention includes adequate calcium and vitamin D intake and physical activity. In patients with coexisting osteoporosis, additional medication should be considered.
After discontinuation or, if necessary, interruption of long-term therapy, the following risks should be considered: exacerbation or recurrence of the underlying disease, acute adrenal insufficiency (especially in stress situations, e.g. during infections, after accidents, during intense physical exertion), symptoms and discomfort due to steroid withdrawal syndrome (see section 4. "Possible side effects").
In cases of untreated hypothyroidism or liver cirrhosis, relatively low or reduced doses may be sufficient. Close medical supervision is required.
Seek immediate medical advice if muscle weakness or pain, cramps, and stiffness occur during methylprednisolone treatment. These may be symptoms of a condition called thyrotoxic periodic paralysis, which may occur in patients with hyperthyroidism treated with methylprednisolone. Additional treatment may be necessary to alleviate this condition.

Children
After systemic treatment of preterm infants with glucocorticosteroids, a specific cardiac muscle disorder (hypertrophic cardiomyopathy) has been observed. Therefore, cardiac monitoring is recommended in infants receiving systemic glucocorticoid therapy.
In children, Meprelon should be used only when there are important medical reasons, due to the risk of growth suppression. During long-term treatment with Meprelon, the child's growth should be monitored regularly.

Use of Meprelon as a doping agent
Use of Meprelon may lead to positive results in doping tests. The health consequences of using Meprelon as a doping agent cannot be predicted. Moreover, using Meprelon as a doping agent may pose a health risk.

Meprelon and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for use, including those available without prescription.

The following medicines affect the action of Meprelon
Enhanced effect and increased risk of adverse reactions:

Certain female sex hormones, e.g. contraceptive drugs ("the pill"), may enhance the effect of corticosteroids.
Medicines that inhibit corticosteroid metabolism in the liver, such as certain antifungal drugs (containing ketoconazole, itraconazole), may enhance the effect of corticosteroids.
Some medicines may enhance the effect of Meprelon 16 mg, and the doctor may wish to closely monitor the patient taking such medicines (including certain HIV drugs: ritonavir, cobicistat).
Medicines used in heart disease (e.g. diltiazem [a calcium channel blocker]) may slow down methylprednisolone metabolism. Therefore, the initial treatment period should be under medical supervision. Dose adjustment of methylprednisolone may be necessary.

Reduced effect:

Medicines that accelerate corticosteroid metabolism in the liver, such as certain sedatives (containing barbiturates), anticonvulsants (containing phenytoin, carbamazepine, primidone), and certain tuberculosis drugs (containing rifampicin), may reduce the effect of corticosteroids.
Medicines containing ephedrine, used to reduce mucosal edema, may accelerate glucocorticosteroid metabolism, potentially reducing their efficacy.

Meprelon affects the action of other medicines
Enhanced effect and increased risk of adverse reactions:

When used concomitantly with certain antihypertensive drugs (angiotensin-converting enzyme inhibitors), Meprelon may increase the risk of blood morphology changes.
Meprelon may cause potassium deficiency, which may enhance the effect of cardiac glycosides (drugs that strengthen heart contractions).
Meprelon may enhance potassium loss caused by diuretics (sodium-excreting diuretics) and laxatives.
When used concomitantly with anti-inflammatory and antirheumatic drugs (salicylates, indomethacin, and other nonsteroidal anti-inflammatory drugs), Meprelon may increase the risk of gastrointestinal ulcers and bleeding.
Meprelon may prolong the effect of certain muscle relaxants (non-depolarizing skeletal muscle relaxants) (see also section 4. "Possible side effects").
Meprelon may enhance the effect of certain drugs (atropine and other anticholinergics) in increasing intraocular pressure.
When used simultaneously with drugs used in malaria and rheumatic diseases (containing chloroquine, hydroxychloroquine, mefloquine), Meprelon may increase the risk of muscle disorders (myopathies) or heart muscle disorders (cardiomyopathies).
Meprelon may increase blood cyclosporine levels (an immunosuppressive drug). There is an increased risk of seizures.

Reduced effect:

Meprelon may reduce the glucose-lowering effect of oral antidiabetic drugs and insulin.
Meprelon may reduce the effect of anticoagulant drugs (oral anticoagulants, coumarin derivatives).
Meprelon may reduce the effect of antiparasitic drugs (praziquantel).
Meprelon may reduce the effect of growth hormone (somatotropin).
Meprelon may reduce the increase in thyroid-stimulating hormone (TSH) after protirelin (TRH, a hormone secreted by the hypothalamus).

Other possible interactions
Effect on laboratory test results:

Glucocorticosteroids may suppress skin reactions in allergy tests.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a
child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
During pregnancy, especially in the first three months, Meprelon should be used only after careful benefit-risk assessment by the doctor.
Methylprednisolone should be used in the first trimester only after discussing with the doctor the possible benefits and risks associated with different treatment options for the patient and the unborn child. This is because methylprednisolone may increase the risk of cleft lip and/or palate (an opening or cleft in the upper lip and/or palate) in the newborn. In cases of long-term glucocorticosteroid treatment during pregnancy, impaired fetal growth cannot be excluded. In cases of treatment in late pregnancy, adrenal cortical atrophy may occur in the fetus, which may require treatment after birth.
Breastfeeding
Glucocorticosteroids, including methylprednisolone, pass into breast milk. When high doses are used or treatment is prolonged, breastfeeding should be avoided.

Driving and operating machinery
Due to the occurrence of certain adverse effects such as reduced visual acuity (due to cataract or increased intraocular pressure), dizziness, or headache, in rare cases concentration or ability to concentrate and reaction may be impaired. The patient may not be able to react quickly enough to sudden and unexpected events. This may pose a risk, for example when driving a vehicle or operating machinery. The same applies to performing activities without secure anchoring. The patient may unnecessarily endanger themselves and others. 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, meaning the medicine is considered "sodium-free".

3. How to use Meprelon

Meprelon 16 mg should always be used as directed by the physician. Generally, Meprelon should be used according to the following dosing recommendations:

In the treatment of acute symptoms, the dose for adults is usually 32 mg to 64 mg of methylprednisolone (2–4 vials of Meprelon 16 mg) or more. In such cases, Meprelon 32 mg is also available. The dose for children is 8 to 32 mg (½–2 vials of Meprelon 16 mg) or 1 to 2 mg/kg body weight.

In the treatment of acute, life-threatening conditions, the dose for adults is 250–500 mg of methylprednisolone; and 4 to 8 mg/kg body weight in children. Depending on symptoms, single doses up to 30 mg/kg body weight may be required. In such cases, Meprelon 250 mg and Meprelon 1000 mg are available.

Depending on the medical condition, the interval between injections ranges from 30 minutes to 24 hours.

Unless otherwise prescribed by the physician, the dosing recommendations for individual indications are as follows:

Severe acute asthma attack
Depending on symptoms, the initial dose is 32–96 mg of methylprednisolone (2–6 vials of Meprelon 16 mg) in combination with standard basic treatment or concomitant medications. In such cases, Meprelon 32 mg is also available. Depending on the clinical condition, this dose may be repeated every 6 hours.

In severe, life-threatening asthma attacks, an initial dose of 250–500 mg of methylprednisolone is recommended. In such cases, Meprelon 250 mg is available.

Cerebral edema (caused by brain tumor or brain metastases)
In the treatment of acute or severe cerebral edema, an initial dose of 250–500 mg of methylprednisolone is administered. In such cases, Meprelon 250 mg is available.

For maintenance treatment of acute or severe cerebral edema, or mild or chronic cerebral edema, usually 32–64 mg of methylprednisolone (2–4 vials of Meprelon 16 mg) is administered three times daily for several days. In such cases, Meprelon 32 mg is also available.

If necessary, the dose should be gradually reduced and transitioned to oral therapy.

Acute hypersensitivity reactions (e.g. angioedema, insect sting reactions)
In angioedema, intravenous administration of a single dose of 96–160 mg methylprednisolone is given. In insect sting reactions, 96 mg methylprednisolone or more is administered intravenously as a single dose. In this case, Meprelon 32 mg is more suitable. In acute upper airway obstruction, a dose of 250 mg methylprednisolone may be required. This dose may be repeated after 6 and 12 hours. In such cases, Meprelon 250 mg is available.

Severe acute skin diseases (e.g. erythroderma, pemphigus vulgaris)
In skin diseases, oral methylprednisolone may be administered at a dose of 80–160 mg daily, depending on severity and progression. In initial treatment of severe cases of acute skin diseases, parenteral administration of 96–160 mg methylprednisolone is also possible (in this case, Meprelon 32 mg is more suitable). Subsequently, oral treatment is used.

Acute hematological disorders (e.g. autoimmune hemolytic anemia, acute thrombocytopenic purpura)
Initially, instead of oral therapy, 96–160 mg methylprednisolone per day is administered intravenously (in this case, 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 methylprednisolone per day (1–2 vials of Meprelon 16 mg), administered intravenously. Subsequently, oral treatment is used.

Toxic pulmonary edema caused by inhalation of irritant gas
Immediately administer 1000 mg methylprednisolone intravenously. Repeat if necessary after 6, 12, and 24 hours. In such cases, Meprelon 1000 mg is available. For the next two days, administer 32 mg methylprednisolone intravenously three times daily (2 vials of Meprelon 16 mg). Then, for the following two days, administer 16 mg methylprednisolone intravenously (1 vial of Meprelon 16 mg) three times daily. Afterwards, the dose should be gradually reduced and transitioned to inhaled corticosteroids.

Addisonian crisis
The initial dose is 16–32 mg methylprednisolone (1–2 vials of Meprelon 16 mg) administered as an intravenous infusion in combination with standard concomitant treatment. Then, administer the next 16–32 mg methylprednisolone (1–2 vials of Meprelon 16 mg) as a 24-hour intravenous infusion, followed by transition to oral treatment, if necessary in combination with mineralocorticoids.

Note:
Considering the known profile of adverse effects, administration of the first intravenous dose is recommended in a hospital setting.

Meprelon is administered by intravenous injection or intravenous infusion. Since the extent of absorption of the active substance is uncertain, intramuscular administration should only be used exceptionally when intravenous administration is not possible. Intravenous injection should be performed slowly.

To prepare the ready-to-use injection solution, inject the provided solvent (1 ml of water for injection) into the vial containing the powder immediately before use and shake until dissolved.

To prepare an infusion (drip), first dissolve the drug according to the above instructions, then mix it with 5% glucose solution, 0.9% sodium chloride solution, or Ringer's solution.

Solutions or mixtures must be prepared and administered under strictly aseptic (microorganism-free) conditions.

Avoid co-administration with other medicinal products mixed in the same syringe, as precipitation may occur. For the same reason, Meprelon should not be added to infusion solutions other than those specified, nor injected into the infusion line.

Solutions for injection or infusion prepared by dissolving the powder must be used as quickly as possible.

Parenteral medicinal products should be inspected visually before use. Only clear solutions without visible particles should be used.

The duration of treatment depends on the individual course of the disease and is determined by the physician.

After prolonged treatment, particularly with relatively high doses, Meprelon should not be discontinued abruptly, but gradually tapered.

Use of a higher than recommended dose of Meprelon
There are no known cases of acute poisoning with Meprelon. Due to its low toxicity, poisoning is not expected. In the event of severe or unusual adverse reactions, the physician will decide what measures, if any, should be taken.

Discontinuation of Meprelon treatment
If treatment is discontinued after prolonged use of Meprelon, follow the physician's instructions. The physician may recommend gradually reducing the dose until complete discontinuation. Abrupt discontinuation of treatment may result in (see also section 2, "Warnings and precautions"):

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

If you have any further questions about the use of this medicine, please consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions are listed without regard to frequency.
Frequency could not be estimated from the available data.
Depending on the duration of treatment and dose, the following adverse reactions may occur:

Blood and lymphatic system disorders
Changes in blood cell counts (i.e. blood morphology) (increased white blood cells, increased red blood cells, platelets, or decreased number of certain white blood cells and platelets).

Immune system disorders
Severe hypersensitivity reactions (anaphylactic reactions) with circulatory collapse, cardiac arrest, cardiac arrhythmias, bronchospasm and (or) decreased or increased blood pressure.
Weakened immune defence with increased risk of infection (some viral diseases such as chickenpox, herpes simplex, or – during the viraemic phase – shingles may have a severe course, sometimes even life-threatening), masking of infections, emergence of latent infections, allergic reactions.

Endocrine disorders
Catecholamine crisis in patients with phaeochromocytoma (markedly elevated blood pressure with headache, sweating, tachycardia, pallor; for phaeochromocytoma, see section 2, "Warnings and precautions"), induction of Cushing's syndrome (typical symptoms: moon face, central obesity and facial flushing), adrenal insufficiency or adrenal atrophy, steroid withdrawal syndrome, growth suppression in children, disturbances in sex hormone secretion (amenorrhoea, hirsutism, erectile dysfunction).

Metabolism and nutrition disorders
Tumour lysis syndrome has been reported in patients with haematological malignancies. Tumour lysis syndrome may be diagnosed by the physician based on changes in blood test results causing high levels of uric acid, potassium or phosphates and decreased calcium levels. Symptoms include muscle cramps, muscle weakness, confusion, visual disturbances or loss, shortness of breath, seizures, irregular heartbeat or kidney failure (reduced urine output or darker urine). If such symptoms occur, contact your doctor immediately (see section 2 "Warnings and precautions").
Accumulation of fat tissue in certain parts of the body (in the spinal canal [epidural space] or temporarily in the chest cavity [pericardium, mediastinum]).
Fluid retention due to sodium retention, increased potassium excretion which may be accompanied by hypokalaemia (which may lead to cardiac arrhythmias), increased blood glucose levels, diabetes mellitus, increased blood lipid levels (cholesterol and triglycerides), enhanced protein catabolism.

Psychiatric disorders
Severe depression, irritability, personality changes, mood swings, euphoria, increased energy and appetite, psychosis, sleep disturbances.

Nervous system disorders
Increased intracranial pressure (pseudotumour cerebri – especially in children), emergence of previously undiagnosed epilepsy and increased seizure tendency in existing epilepsy, feeling of emptiness in the head, dizziness, headache.

Eye disorders
Retinal and choroidal disorders (chorioretinopathy, see section 2 "Warnings and precautions"), lens opacity (cataract), increased intraocular pressure (glaucoma), worsening of corneal ulcer symptoms, exacerbation of viral, fungal and bacterial eye infections, blurred vision.

Cardiac disorders
Cardiac arrhythmias, cardiac arrest, worsening of pulmonary congestion in heart failure, certain myocardial disorders in preterm infants (see section 2 "Children").

Vascular disorders
Vascular collapse, arterial hypertension, increased blood coagulability (thromboembolic events), increased risk of atherosclerosis and thrombosis, vasculitis (also as withdrawal syndrome after long-term treatment).

Gastrointestinal disorders
Gastric and intestinal ulcers with risk of perforation (e.g. peritonitis), gastrointestinal bleeding, pancreatitis, epigastric discomfort, gas accumulation in the intestinal wall (pneumatosis intestinalis).

Hepatobiliary disorders
Methylprednisolone may cause liver damage. Cases of hepatitis and increased liver enzyme activity have been reported. This includes liver cell injury and cholestatic liver damage, which may lead to acute liver failure (see section 2 "Warnings and precautions").

Skin and subcutaneous tissue disorders
Skin striae, decreased skin thickness (atrophy) ("parchment skin"), dilated blood vessels in the skin (telangiectasia), increased capillary fragility ("capillary fragility"), tendency to bruising, petechiae or purpura, hirsutism, acne, delayed wound healing, facial dermatitis (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, reversible increase in muscle weakness in myasthenia gravis, which may lead to myasthenic crisis, induction of acute myopathy (muscle disease) when used concomitantly with non-depolarising neuromuscular blocking agents (see also section 2 "Meprelon and other medicines"), osteoporosis (brittle bone disease) (dose-dependent, possible even with short-term use), in severe cases leading to risk of bone fractures, other forms of bone necrosis (avascular necrosis: humeral head and femoral head), tendon rupture.
Too rapid dose reduction after long-term treatment may cause symptoms such as muscle and joint pain.

Renal and urinary disorders
Scleroderma renal crisis in patients with scleroderma (an autoimmune disorder). Symptoms of scleroderma renal crisis include elevated blood pressure and reduced urine output (see section 2 "Warnings and precautions").

General disorders and administration site conditions
Subcutaneous fat injection may cause local atrophy of fat tissue.

Investigations
Increased body weight.

The following adverse reactions have been observed after abrupt discontinuation following prolonged methylprednisolone treatment, although not everyone will experience them:
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 very rarely cause allergic reactions, even leading to anaphylactic shock, patients with a predisposition to allergies (e.g. bronchial asthma) should have immediate access to emergency treatment (e.g. adrenaline, intravenous infusion, artificial ventilation).

If gastrointestinal or intestinal disorders, back, shoulder or hip joint pain, psychiatric disturbances, abnormal blood glucose levels (in diabetic patients) or other disturbances occur, inform your doctor immediately.

Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Meprelon

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial after: EXP.
The expiry date refers to the last day of the stated month.
No special storage temperature requirements.
Store vials in the outer packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

Note on shelf-life after opening or reconstitution
For single use only. Any remaining solution must be discarded after opening the vial.
Chemical and physical in-use stability of Meprelon has been demonstrated for 24 hours at 25 °C when diluted with water for injections, and for 8 hours at 25 °C when diluted with 5% (50 mg/ml) glucose solution, 0.9% (9 mg/ml) sodium chloride solution, or Ringer's solution.
Due to microbiological concerns, 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. Contents of the pack and other information

What Meprelon 16 mg contains

The active substance is methylprednisolone.

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

Other ingredients: disodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate.

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

What Meprelon 16 mg looks like and contents of the pack

Meprelon 16 mg contains a white to creamy powder and a clear, colourless solvent.
Meprelon 16 mg is available in packs containing:
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 Authorisation Holder and Manufacturer

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

Manufacturer:
mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany

This medicinal product is authorised 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