Package leaflet: Information for the user

SOLU-MEDROL, 40 mg, powder and solvent for solution for injection
SOLU-MEDROL, 125 mg, powder and solvent for solution for injection
SOLU-MEDROL, 500 mg, powder and solvent for solution for injection
SOLU-MEDROL, 1000 mg, powder and solvent for solution for injection
Methylprednisolone
Please read this leaflet carefully before using this medicine, because it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

What SOLU-MEDROL is and what it is used for
Important information before using SOLU-MEDROL
How to use SOLU-MEDROL
Possible side effects
How to store SOLU-MEDROL
Contents of the pack and other information

1. What SOLU-MEDROL is and what it is used for

The active substance in SOLU-MEDROL, methylprednisolone, belongs to a group of medicines called glucocorticoids. Glucocorticoids penetrate cell membranes and bind to specific receptors located in the cytoplasm. These complexes then enter the cell nucleus, stimulating the synthesis of various enzymes, which are likely responsible for the numerous effects of glucocorticoids observed after systemic administration. In addition to their significant influence on inflammatory and immunological processes, glucocorticoids also affect carbohydrate, protein, and fat metabolism. They also act on the cardiovascular system, skeletal muscles, and central nervous system.

SOLU-MEDROL is used as symptomatic treatment, except in endocrine disorders, where it is used as replacement therapy, in the following conditions:

Endocrine disorders

Primary or secondary adrenocortical insufficiency (in certain circumstances, in combination with mineralocorticoids)
Acute adrenocortical insufficiency (mineralocorticoids may be required)
Treatment of shock due to adrenocortical insufficiency, or shock unresponsive to conventional therapy, when adrenocortical insufficiency is confirmed or suspected (in cases where mineralocorticoids are not indicated)
Before surgical procedures and in cases of severe illness or trauma, in patients with diagnosed adrenocortical insufficiency or reduced adrenal hormone levels
Congenital adrenal hyperplasia
Nonthyroidal illness syndrome (nonthyroidal illness)
Hypercalcemia associated with malignancy

Rheumatic diseases
As adjunctive therapy for short-term use during episodes of exacerbation or worsening of the condition in:

Traumatic degenerative joint disease
Osteoarthritis with synovitis
Rheumatoid arthritis, including juvenile rheumatoid arthritis
Acute and subacute bursitis
Epicondylitis
Acute nonspecific tenosynovitis
Acute gouty arthritis
Psoriatic arthritis
Ankylosing spondylitis

Systemic connective tissue diseases
During exacerbations or as maintenance therapy in:

Systemic lupus erythematosus (including lupus nephritis)
Acute rheumatic carditis
Polyarteritis nodosa and dermatomyositis
Goodpasture's syndrome

Dermatological diseases

Pemphigus
Severe forms of erythema multiforme (Stevens-Johnson syndrome)
Exfoliative dermatitis
Severe psoriasis
Bullous pemphigoid
Severe seborrheic dermatitis
Granuloma fungoides

Allergic conditions
Treatment of severe allergic conditions when other treatment methods are ineffective:

Bronchial asthma
Contact dermatitis
Atopic dermatitis
Serum sickness
Drug hypersensitivity reactions
Transfusion anaphylactoid reactions
Acute noninfectious laryngeal edema (epinephrine is the first-line treatment)

Ophthalmic diseases
Severe, acute, and chronic allergic and inflammatory processes involving the eye and its adnexa, such as:

Ocular herpes zoster
Iridocyclitis
Choroiditis and retinitis
Diffuse posterior uveitis and choroiditis
Optic neuritis
Sympathetic ophthalmia
Anterior segment inflammation
Allergic conjunctivitis
Allergic marginal corneal ulcers
Keratitis

Gastrointestinal diseases
As systemic treatment during exacerbations of:

Ulcerative colitis
Crohn's disease

Respiratory diseases

Symptomatic sarcoidosis
Berylliosis
Fulminating or disseminated pulmonary tuberculosis, concomitantly with appropriate antituberculosis chemotherapy
Loeffler's syndrome unresponsive to other treatments
Aspiration pneumonitis
Moderate to severe Pneumocystis jiroveci pneumonia in patients with AIDS (as adjunctive therapy, when administered within the first 72 hours of initial anti-Pneumocystis treatment)

Hematological diseases

Acquired (autoimmune) hemolytic anemia
Idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated)
Secondary thrombocytopenia in adults
Erythroblastopenia
Congenital hypoplastic anemia

Neoplastic diseases
Palliative treatment:

Leukemias and lymphomas in adults
Acute leukemia in children
Improvement of quality of life in patients with advanced-stage cancer

Edema
To induce diuresis or remission of proteinuria in nephrotic syndrome without uremia

Nervous system

Cerebral edema associated with primary or metastatic tumors and (or) related to surgical or radiation therapy
Exacerbations of multiple sclerosis
Acute spinal cord injury. Treatment should be initiated within eight hours of injury.

Other indications

Tuberculous meningitis with or at risk of subarachnoid block, in conjunction with appropriate antituberculosis therapy
Trichinellosis with central nervous system or myocardial involvement
Organ transplantation
Prevention of nausea and vomiting associated with cancer chemotherapy

2. Important information before using SOLU-MEDROL

When not to use SOLU-MEDROL

if the patient is allergic to methylprednisolone or any of the other ingredients of this medicine (listed in section 6)
if the patient has systemic fungal infections
for intrathecal administration
for epidural administration
in premature infants and newborns.

Administration of live or live attenuated vaccines is contraindicated during treatment with SOLU-MEDROL at doses causing immunosuppressive effects.

Warnings and precautions

Patients with the following conditions require special medical supervision during treatment with SOLU-MEDROL, and therapy should be as short as possible. Before starting this medicine, discuss with your doctor or pharmacist if the patient has any of the following conditions:

Infectious diseases, such as tuberculosis and certain viral diseases (e.g. herpes simplex and herpes zoster with ocular involvement).
Treatment with SOLU-MEDROL in active tuberculosis should be limited to fulminant or disseminated pulmonary tuberculosis, in which SOLU-MEDROL is used as part of the treatment regimen along with antituberculosis therapy. During prolonged treatment with SOLU-MEDROL, patients with latent tuberculosis or a positive tuberculin test require careful monitoring, as the disease may reactivate.
In patients with ocular infection caused by Herpes simplex virus receiving SOLU-MEDROL, there is a risk of corneal perforation.

Diabetes
Treatment with SOLU-MEDROL may reveal latent diabetes or increase insulin requirements or the need for oral glucose-lowering agents.

Hypertension
Treatment with SOLU-MEDROL may exacerbate arterial hypertension.

Psychiatric disorders, current or past
SOLU-MEDROL may worsen existing emotional instability or psychotic tendencies. Psychiatric disorders may occur during treatment, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression to severe psychotic disorders.

Severe stress
In patients exposed to severe stress, it may be necessary to increase the dose of rapidly acting glucocorticoids before, during, and after the stressful event.

Allergy to any medicines
If an allergic reaction occurred after taking any medicine, inform your doctor before starting treatment with SOLU-MEDROL.

Hypothyroidism
The effect of SOLU-MEDROL is enhanced in patients with hypothyroidism.

Liver cirrhosis
The effect of SOLU-MEDROL is enhanced in patients with liver cirrhosis.

Head injury
Ulcerative colitis, when there is a risk of perforation, abscess, or other suppurative infection
Diverticulitis
Recent intestinal anastomosis
Active or latent peptic ulcer
Renal insufficiency
Osteoporosis
Myasthenia gravis (an acquired chronic disease characterized by rapid muscle fatigue and skeletal muscle weakness)

If the patient experiences blurred vision or other visual disturbances, contact a doctor.

Immunosuppressive effect, increased susceptibility to infections
SOLU-MEDROL may increase susceptibility to infections and may mask some signs of infection. New infections may develop during its use. During treatment with SOLU-MEDROL, reduced immunity and inability to control infection development may occur. The risk of infection with pathogens such as viruses, bacteria, fungi, protozoa, or parasites increases with higher doses.
Patients receiving SOLU-MEDROL are more susceptible to infections than healthy individuals. For example, in children lacking immunity or in adults receiving SOLU-MEDROL, chickenpox and measles may have a more severe course or even be fatal.
During treatment with SOLU-MEDROL at immunosuppressive doses, administration of certain vaccines is contraindicated. Inactivated vaccines may be administered, but the response may be diminished or the vaccines may be ineffective. Patients receiving SOLU-MEDROL at doses without immunosuppressive effects may receive all required vaccinations.
Kaposi's sarcoma has been observed in patients treated with SOLU-MEDROL. Discontinuation of treatment may lead to remission of the disease.

Effect on the immune system
Allergic reactions may occur in patients. Skin reactions and anaphylactic/pseudoanaphylactic reactions have been reported rarely in patients receiving SOLU-MEDROL.

Endocrine disorders
Prolonged treatment with SOLU-MEDROL may result in adrenal insufficiency, which may persist for several months after discontinuation of treatment.
Your doctor may decide to gradually reduce the dose of SOLU-MEDROL. Inform your doctor about any stressful situations occurring during this period. Your doctor may consider initiating hormonal therapy.
Sudden withdrawal of SOLU-MEDROL may cause acute adrenal insufficiency, potentially leading to death.
Sudden discontinuation of SOLU-MEDROL may also result in a "steroid withdrawal syndrome" including symptoms such as anorexia, nausea, vomiting, lethargy, headache, fever, joint pain, desquamation, muscle pain, weight loss, and/or hypotension.
SOLU-MEDROL may cause or exacerbate Cushing's syndrome; therefore, patients with Cushing's disease should not use this medicine.
The effect of SOLU-MEDROL is enhanced in patients with hypothyroidism.

Psychiatric disorders
Psychiatric disorders may occur during and after treatment with SOLU-MEDROL. They usually appear within a few days or weeks after starting treatment. Most resolve after dose reduction or discontinuation of SOLU-MEDROL. Patients and caregivers should consult a doctor if psychological symptoms develop, especially if depressive mood or suicidal thoughts are suspected. Patients and caregivers should pay particular attention to psychiatric disorders that may occur during treatment or immediately after dose reduction or discontinuation of SOLU-MEDROL.

Effect on the nervous system
SOLU-MEDROL should be used with caution in patients with seizure disorders.
In patients receiving SOLU-MEDROL, usually after prolonged use of high doses, cases of benign intracranial hypertension have been reported.

Effect on the eye
Long-term use of SOLU-MEDROL may lead to development of posterior subcapsular cataracts and nuclear cataracts (especially in children), exophthalmos, or increased intraocular pressure, which may lead to glaucoma with potential optic nerve damage. Patients receiving SOLU-MEDROL may also be more prone to secondary fungal and viral infections of the eye.
Visual disturbances may occur with both systemic and local use of the medicine. If such disturbances occur, the patient should contact a doctor to determine possible causes, including cataract, glaucoma, or rare conditions such as central serous chorioretinopathy.
Central serous chorioretinopathy may lead to retinal detachment.
Use of SOLU-MEDROL has been associated with central serous retinopathy, which may lead to retinal detachment.

Effect on the heart
When high doses are used for prolonged treatment with SOLU-MEDROL in patients with cardiovascular risk factors, caution is required, and additional monitoring of the cardiovascular system may be necessary. The frequency of adverse events associated with SOLU-MEDROL use may be reduced by using low doses and alternate-day dosing.
Rapid intravenous administration of high doses of SOLU-MEDROL may cause cardiac arrhythmias and/or circulatory collapse and/or cardiac arrest.
In patients with congestive heart failure, SOLU-MEDROL should be administered with caution and only if necessary.

Effect on the vascular system
Thrombosis, including venous thromboembolic disease, has been reported during treatment with SOLU-MEDROL. Therefore, caution is required in patients with thromboembolic disorders or those who may be susceptible to their occurrence.

Effect on the stomach and intestines
Acute pancreatitis may occur after administration of high doses of SOLU-MEDROL.
Treatment with SOLU-MEDROL may mask symptoms of peptic ulcers, which may result in perforation or hemorrhage without significant preceding pain. Glucocorticoid treatment may mask peritonitis or other signs associated with gastrointestinal disturbances such as perforation, constipation, or pancreatitis.
The risk of developing gastric and intestinal ulcer disease increases when used concomitantly with nonsteroidal anti-inflammatory drugs (NSAIDs).

Effect on the liver and biliary system
Cyclic, pulsed intravenous administration of methylprednisolone may cause drug-induced liver injury, such as acute hepatitis. Acute hepatitis may occur within several weeks or longer. Resolution of this adverse event has been observed after discontinuation of treatment.

Effect on the musculoskeletal system
Acute myopathy may occur during administration of high doses of SOLU-MEDROL, particularly in patients with neuromuscular transmission disorders (e.g. in myasthenia gravis) or in patients receiving concomitant anticholinergic drugs, including neuromuscular blocking agents (e.g. pancuronium). Myopathy may involve ocular and respiratory muscles and may lead to quadriparesis. Increased creatine kinase activity may occur. Clinical improvement or complete recovery after discontinuation of SOLU-MEDROL may take several weeks or even years.

Effect on the kidneys and urinary tract
Caution is required in patients with systemic sclerosis, as increased incidence of scleroderma renal crisis has been observed with corticosteroids, including methylprednisolone.
SOLU-MEDROL should be used with caution in patients with renal insufficiency.

Diagnostic tests
In patients, use of medium to high doses of SOLU-MEDROL may increase blood pressure, sodium and water retention, and potassium excretion. Therefore, dietary sodium restriction and potassium supplementation may be necessary. All glucocorticoids, including SOLU-MEDROL, increase calcium excretion.

Injuries, poisoning, and post-procedural complications
SOLU-MEDROL should not be used in the treatment of traumatic brain injury.

Other
Complications of corticosteroid therapy depend on dose and duration of treatment. The doctor will decide on dosage and duration of treatment individually for each patient.
Patients should exercise caution when using acetylsalicylic acid and nonsteroidal anti-inflammatory drugs concomitantly with SOLU-MEDROL.
After administration of SOLU-MEDROL, cases of pheochromocytoma crisis have been reported, sometimes fatal. In patients with suspected or diagnosed pheochromocytoma, the doctor will decide on use of SOLU-MEDROL only after appropriate benefit-risk assessment.
Tumor lysis syndrome may occur during corticosteroid treatment for malignancies. Inform the doctor if the patient has cancer and experiences symptoms of tumor lysis syndrome such as muscle cramps, muscle weakness, confusion, irregular heartbeat, vision loss or disturbances, and shortness of breath.

Use in children
In children receiving long-term treatment with SOLU-MEDROL in divided daily doses, growth suppression may occur. This treatment regimen should be limited to the most severe indications, and treatment with SOLU-MEDROL should be as short as possible. Patients should remain under close medical supervision.
Infants and children receiving long-term SOLU-MEDROL are particularly susceptible to increased intracranial pressure.
Pancreatitis may develop in children after administration of high doses of SOLU-MEDROL.
After administration of SOLU-MEDROL in premature infants, hypertrophic cardiomyopathy (thickening of the heart muscle) may develop.

Other warnings
Inform the doctor about all medicines currently or recently taken, including those available without prescription.
Some medicines may enhance the effect of SOLU-MEDROL, and the doctor may wish to closely monitor the patient receiving such medicines (including some HIV medications: ritonavir, cobicistat).
Corticosteroid therapy may affect the results of many tests and biological parameters (e.g. skin tests, thyroid hormone measurements).
SOLU-MEDROL should not be administered by intramuscular injection into the deltoid muscle due to frequent occurrence of subcutaneous atrophy.
Use of SOLU-MEDROL in patients with liver function disorders
The effect of SOLU-MEDROL is particularly enhanced in patients with liver cirrhosis.
Caution is required when using SOLU-MEDROL in patients with liver function disorders.
Use of SOLU-MEDROL in patients with hypothyroidism
The effect of SOLU-MEDROL is particularly enhanced in patients with hypothyroidism.

SOLU-MEDROL with other medicines
The patient should inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for use. SOLU-MEDROL may affect the action of other medicines, and other medicines may affect the action of SOLU-MEDROL. Dose adjustment of SOLU-MEDROL may be necessary when used concomitantly with the following medicines:

antibacterial agents: isoniazid
antituberculosis antibiotic: rifampicin
anticoagulants (oral): concomitant use with SOLU-MEDROL may decrease or increase anticoagulant effect. Coagulation parameters should be monitored to ensure adequate anticoagulation
anticonvulsants: carbamazepine, phenobarbital, phenytoin
anticholinergic agents: neuromuscular blocking agents. Acute myopathy has been reported with concomitant use of high doses of SOLU-MEDROL and anticholinergic agents, e.g. neuromuscular blocking agents
muscle relaxants, e.g. pancuronium, vecuronium: SOLU-MEDROL may partially inhibit neuromuscular blockade induced by muscle relaxants
anticholinesterases: SOLU-MEDROL may reduce the effect of anticholinesterases in patients with myasthenia
antidiabetic agents: in diabetic patients, dose adjustment of antidiabetic agents may be necessary, as SOLU-MEDROL may increase blood glucose levels
antiemetics: aprepitant, fosaprepitant
antifungal agents: itraconazole, ketoconazole
antiviral agents – HIV protease inhibitors: indinavir and ritonavir
aromatase inhibitor: aminoglutethimide
calcium channel blocker: diltiazem
oral contraceptives: ethinylestradiol/norethisterone
grapefruit juice
immunosuppressants: cyclosporine. Concomitant use of cyclosporine and SOLU-MEDROL results in mutual inhibition of metabolism, potentially increasing plasma concentrations of one or both drugs. This may increase the risk of adverse effects associated with either drug. Seizures have been reported during concomitant use.
immunosuppressants: cyclophosphamide, tacrolimus
macrolide antibacterial agents: clarithromycin, erythromycin, troleandomycin
nonsteroidal anti-inflammatory drugs (NSAIDs): high-dose aspirin (acetylsalicylic acid). Concomitant use of anti-inflammatory drugs with SOLU-MEDROL may increase the frequency of gastrointestinal bleeding and ulceration. Caution is required when using aspirin in combination with SOLU-MEDROL
potassium-depleting agents: patients should be monitored for development of hypokalemia (a condition in which blood potassium levels are below laboratory reference values) when SOLU-MEDROL is used concomitantly with potassium-depleting agents (e.g. diuretics). The risk of hypokalemia increases when SOLU-MEDROL is used concomitantly with amphotericin B, xanthines, or beta2 agonists.

Pregnancy, breastfeeding, and fertility

Fertility
Animal studies have shown that SOLU-MEDROL has an adverse effect on fertility.

Pregnancy
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Some animal studies have shown that corticosteroids administered to pregnant mothers in high doses may cause fetal developmental abnormalities. However, SOLU-MEDROL administered to pregnant women does not appear to cause congenital malformations in the fetus. Until adequate studies on the effect of SOLU-MEDROL on human reproduction are conducted, this medicine should not be given to pregnant women unless a careful benefit-risk assessment for mother and fetus has been performed.
SOLU-MEDROL crosses the placenta. In one retrospective study, an increased incidence of low birth weight in infants born to mothers who received corticosteroids was observed. In humans, the risk of low birth weight is dose-dependent. This risk may be reduced by using lower doses of corticosteroids.
Although neonatal adrenal insufficiency is rare in infants exposed to SOLU-MEDROL in utero, infants born to mothers who received high doses of SOLU-MEDROL during pregnancy must be carefully monitored and evaluated for adrenal insufficiency.
The effect of SOLU-MEDROL on labor is unknown.
Cataracts have been observed in infants born to mothers treated with SOLU-MEDROL for prolonged periods during pregnancy.
SOLU-MEDROL 500 mg, 1000 mg, powder and solvent for solution for injection contains benzyl alcohol (see section 2 "SOLU-MEDROL 500 mg and 1000 mg contains benzyl alcohol").

Breastfeeding
SOLU-MEDROL passes into human milk.
In breastfed infants, SOLU-MEDROL that has passed into breast milk may inhibit growth and affect endogenous glucocorticoid production. This medicine may be used by breastfeeding women only after careful benefit-risk assessment for mother and infant.
SOLU-MEDROL 500 mg, 1000 mg, powder and solvent for solution for injection contains benzyl alcohol (see section 2 "SOLU-MEDROL 500 mg and 1000 mg contains benzyl alcohol").

Driving and using machines
The effect of SOLU-MEDROL on the ability to drive and use machines has not been studied.
Patients experiencing dizziness, visual disturbances, or fatigue during treatment with SOLU-MEDROL should not drive or operate machinery.

SOLU-MEDROL 500 mg and 1000 mg contains benzyl alcohol
SOLU-MEDROL 500 mg and 1000 mg, as powder and solvent for solution for injection, contains 9 mg of benzyl alcohol in each 1 ml of solution, equivalent to 9 mg/1 ml benzyl alcohol. Benzyl alcohol may cause allergic reactions. Administration to neonates and young children is associated with risk of severe adverse reactions, including respiratory disorders. Do not use SOLU-MEDROL containing benzyl alcohol in newborns (up to 4 weeks of age) and do not use the medicine in young children (under 3 years of age) for longer than one week without medical advice. Consult a doctor or pharmacist if the patient has liver or kidney disease, or if the woman is pregnant or breastfeeding, as large amounts of benzyl alcohol may accumulate in the body and cause adverse effects such as increased blood acid levels (metabolic acidosis).

SOLU-MEDROL contains sodium
SOLU-MEDROL 40 mg and 125 mg, powder and solvent for solution for injection, contains less than 1 mmol (23 mg) of sodium per vial, meaning the medicine is considered "sodium-free".
SOLU-MEDROL 500 mg, powder and solvent for solution for injection, contains 58.3 mg of sodium (main component of table salt) per vial, equivalent to 2.92% of the maximum recommended daily sodium intake in adults.
SOLU-MEDROL 1000 mg, powder and solvent for solution for injection, contains 116.8 mg of sodium (main component of table salt) per vial, equivalent to 5.84% of the maximum recommended daily sodium intake in adults.

3. How to use SOLU-MEDROL

This medicine should be used according to the doctor's instructions, who will individually adjust the dose for the patient. If in doubt, consult a doctor.
During treatment with SOLU-MEDROL, as well as when discontinuing long-term therapy, the patient should remain under close medical supervision.
SOLU-MEDROL may be administered as an intravenous or intramuscular injection, or as an intravenous infusion. The dose may be reduced in infants and children, but should be based on the patient's condition and response to treatment, rather than age or body weight (should not be less than 0.5 mg/kg body weight/24h).
Dosage requirements vary and must be individually adjusted depending on the disease being treated, its severity, and the patient's response to treatment throughout the therapy period. A benefit-risk assessment must be continuously re-evaluated in each individual case.
The lowest effective corticosteroid dose that controls the disease should be used for the shortest possible duration. The appropriate maintenance dose should be established by gradually reducing the initial dose at appropriate intervals until the lowest dose providing an adequate clinical response is reached.
If treatment needs to be discontinued after prolonged use, this medicine must be withdrawn gradually; abrupt cessation is not permitted.
After an initial period of use in emergency situations, consideration should be given to switching to treatment with an injectable long-acting formulation or an oral corticosteroid.
If used as supportive treatment in life-threatening conditions, it should be administered intravenously at a dose of 30 mg/kg body weight for at least 30 minutes. The dose may be repeated every 4 to 6 hours for up to 48 hours.
Intravenous pulse therapy with methylprednisolone at doses of 250 mg/day or higher for several days (usually ≤ 5 days) may be effective in treating acute exacerbations or diseases unresponsive to standard therapy. These include: rheumatic diseases, systemic lupus erythematosus, edematous conditions such as glomerulonephritis or lupus nephropathy. In patients with multiple sclerosis who have not responded to standard therapy (or during relapses), 30-minute intravenous pulses of 500 mg/day or 1000 mg/day should be administered for 3 or 5 days.
When used as supportive treatment for other conditions, the initial intravenous dose will range from 10 to 500 mg, depending on the patient's clinical condition. Higher doses may be required for short-term treatment of severe, acute conditions. Initial doses not exceeding 250 mg should be administered intravenously over at least 5 minutes, while higher doses should be given over at least 30 minutes. Subsequent doses may be administered intravenously or intramuscularly at intervals determined by the patient's response and clinical status.
During prolonged therapy, routine laboratory tests should be performed regularly, including urinalysis, postprandial glucose levels, blood pressure and body weight measurements, and a chest X-ray. Upper gastrointestinal radiographs are required in patients with a history of peptic ulcers or significant dyspepsia.
If the effect of SOLU-MEDROL seems too strong or too weak, consult a doctor.

Use of a higher than recommended dose of SOLU-MEDROL
If an excessive amount of SOLU-MEDROL has been administered, seek immediate advice from a doctor or pharmacist. There are no clinical symptoms of acute overdose with SOLU-MEDROL.
Chronic overdose causes typical symptoms of Cushing's syndrome. Dialysis is an effective method for removing SOLU-MEDROL from the body.

Missed dose of SOLU-MEDROL
Do not use a double dose to make up for a missed dose.

Discontinuation of SOLU-MEDROL
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions have been reported for the following routes of administration:
intrathecal/intracisternal: meningitis, gastrointestinal or bladder dysfunction, headache, meningoencephalitis, transverse myelopathy/paraplegia, seizures, sensory disturbances.

If any of the symptoms listed below occur, contact a doctor immediately or go to the nearest hospital:

Frequency unknown (frequency cannot be estimated from the available data)

opportunistic infections, infections, peritonitis
leukocytosis (increased number of white blood cells in blood)
hypersensitivity reactions, anaphylactic reactions, anaphylactoid reactions
Cushing's syndrome, hypothalamic-pituitary-adrenal axis suppression, steroid withdrawal syndrome
metabolic acidosis, subcutaneous lipomatosis, sodium retention, fluid retention, hypokalemic alkalosis, dyslipidemia, impaired glucose tolerance, increased insulin requirement (or oral antidiabetic drugs in diabetic patients), fat redistribution in certain parts of the body, increased appetite (which may lead to weight gain)
affective disorders (including depressive mood, euphoric mood, emotional instability, drug dependence, suicidal thoughts), psychotic disorders (including manic state, delusions, hallucinations and schizophrenia), mental disturbances, personality changes, confusion, anxiety, mood changes, abnormal behaviour, insomnia, irritability
increased intracranial pressure (with optic nerve disc swelling [benign intracranial hypertension]), seizures, memory impairment, cognitive dysfunction, dizziness, headache
chorioretinopathy (retinal and choroidal disorders), cataract, glaucoma, exophthalmos, rarely blurred vision
congestive heart failure (in susceptible patients), arrhythmia
increased blood coagulability, hypotension, hypertension
pulmonary embolism, hiccups
peptic ulcers (with possible subsequent perforation and bleeding), intestinal perforation, gastric bleeding, pancreatitis, erosive esophagitis, esophagitis, bloating, abdominal pain, diarrhoea, dyspepsia, nausea
methylprednisolone may cause liver damage. Cases of hepatitis and increased liver enzyme activity (increased alanine aminotransferase and aspartate aminotransferase activity) have been reported
angioedema, hirsutism, petechiae, subcutaneous or extravasated haemorrhages, skin atrophy, flushing, hyperhidrosis, striae, rash, pruritus, urticaria, acne, skin depigmentation
muscle weakness, myalgia, myopathy, muscle atrophy, osteoporosis, avascular necrosis, pathological fractures, neurogenic arthropathy, joint pain, growth suppression
irregular menstruation
impaired wound healing, peripheral oedema, fatigue, malaise, injection site reactions
increased intraocular pressure, decreased carbohydrate tolerance, decreased blood potassium concentration, increased urinary calcium excretion, increased serum alkaline phosphatase activity, increased blood urea concentration, suppression of response to skin tests
vertebral compression fractures, tendon rupture

†Hepatitis has been reported with intravenous administration (see section 2).
≠ Peritonitis may be the first clinical sign of gastrointestinal disorders such as perforation, bowel obstruction or pancreatitis (see section 4.4 Special warnings and precautions for use).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 can also be reported to the marketing authorisation holder or its representative.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store SOLU-MEDROL

SOLU-MEDROL, 40 mg, 125 mg, 500 mg, 1000 mg:
No special storage instructions for the medicinal product.
SOLU-MEDROL, 40 mg:
After reconstitution, the medicinal product should be stored below 25°C and used immediately or stored at 2°C - 8°C and used within 48 hours.
After reconstitution and further dilution with other infusion solutions, the medicinal product should be stored at 20°C - 25°C and used within 3 hours or stored at 2°C - 8°C and used within 24 hours.
SOLU-MEDROL, 125 mg, 500 mg, 1000 mg:
After reconstitution, the medicinal product should be stored below 25°C and used within 12 hours or stored at 2°C - 8°C and used within 48 hours.
After reconstitution and further dilution with other infusion solutions, the medicinal product should be stored at 20°C - 25°C and used within 3 hours or stored at 2°C - 8°C and used within 24 hours.
From a microbiological point of view, the solution should be used immediately unless the product has been opened and diluted under controlled and validated aseptic conditions.
If the prepared solution is not used immediately, the user is responsible for the storage conditions and duration.
Further information on storage of reconstituted and diluted solutions can be found in the section: "Information intended exclusively for medical professionals".
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 after: (EXP). The expiry date refers to the last day of the stated month.
Medicinal products must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What SOLU-MEDROL contains
SOLU-MEDROL, 40 mg, powder and solvent for solution for injection

The active substance is methylprednisolone sodium succinate.
The other excipients are: sucrose, monosodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous (see section 2 "SOLU-MEDROL contains sodium"). Solvent: water for injections.

SOLU-MEDROL, 125 mg, powder and solvent for solution for injection

The active substance is methylprednisolone sodium succinate.
The other excipients are: monosodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous (see section 2 "SOLU-MEDROL contains sodium"). Solvent: water for injections.

SOLU-MEDROL, 500 mg, 1000 mg, powder and solvent for solution for injection

The active substance is methylprednisolone sodium succinate.
The other excipients are: monosodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous (see section 2 "SOLU-MEDROL contains sodium"). Solvent: benzyl alcohol (E1519) (see section 2 "SOLU-MEDROL 500 mg and 1000 mg contains benzyl alcohol"), water for injections.

What SOLU-MEDROL looks like and contents of the pack
SOLU-MEDROL is a white, compact powder and a clear, colourless solvent.
Pack contents:
SOLU-MEDROL, 40 mg
One double-chamber vial made of colourless glass containing powder and solvent, 1 ml, in a cardboard box.
SOLU-MEDROL, 125 mg
One double-chamber vial made of colourless glass containing powder and solvent, 2 ml, in a cardboard box.
SOLU-MEDROL, 500 mg
One vial made of colourless glass containing powder and one vial containing solvent, 8 ml, in a cardboard box.
SOLU-MEDROL, 1000 mg
One vial made of colourless glass containing powder and one vial containing solvent, 16 ml, in a cardboard box.

Marketing Authorisation Holder
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Manufacturer
Pfizer Manufacturing Belgium NV
Rijksweg 12
2870 Puurs
Belgium

For further information, contact the local representative of the Marketing Authorisation Holder:
Pfizer Polska Sp. z o.o.
tel. 22 335 61 00

Information intended exclusively for medical professionals

Pharmaceutical incompatibilities
Sodium succinate methylprednisolone should be administered separately from other intravenous compounds to avoid compatibility or stability issues. Drugs that are physically incompatible in solution with sodium succinate methylprednisolone include, but are not limited to: sodium allopurinol, doxapram hydrochloride, tigecycline, diltiazem hydrochloride, calcium gluconate, vecuronium bromide, rocuronium bromide, cisatracurium besylate, glycopyrrolate, and propofol.

The compatibility and stability of intravenous solutions of sodium succinate methylprednisolone, alone or in combination with other agents, depend on the solution's pH, concentration, time, temperature, and the solubility of methylprednisolone in the given solution. Therefore, whenever possible, sodium succinate methylprednisolone should be administered separately, either as an intravenous bolus, intravenous infusion, or via "piggy-back" infusion.

To administer SOLU-MEDROL as a bolus, intravenous infusion, or "piggy-back" infusion, prepare the solution according to the following instructions.

PREPARATION OF THE SOLUTION
Under aseptic conditions, add the solvent to the vial containing the sterile powder. Use only the solvent specifically provided for this purpose. Treatment may begin by administering the reconstituted sodium succinate methylprednisolone solution intravenously over at least 5 minutes (doses up to 250 mg) or over at least 30 minutes (doses of 250 mg and higher than 250 mg). Subsequent doses may be administered similarly.

SOLU-MEDROL, 40 mg:
After reconstitution, store the solution at 2°C - 8°C and use within 48 hours. If stored below 25°C, use immediately.

SOLU-MEDROL, 125 mg, 500 mg, 1000 mg:
After reconstitution, store the solution below 25°C and use within 12 hours, or store at 2°C - 8°C and use within 48 hours.

If necessary, the reconstituted solution may be further diluted in the following solutions:

5% dextrose in water for injection
0.9% sodium chloride solution (normal saline)
5% dextrose in 0.45% sodium chloride solution
5% dextrose in 0.9% sodium chloride solution

SOLU-MEDROL, 40 mg:
After reconstitution and further dilution, the solution is chemically and physically stable when stored at 2°C - 8°C for 24 hours. If stored at 20°C - 25°C, it must be used within 3 hours.

SOLU-MEDROL, 125 mg, 500 mg, 1000 mg:
After reconstitution and further dilution, the solution is chemically and physically stable for 3 hours when stored at 20°C - 25°C, or for 24 hours when stored at 2°C - 8°C.

From a microbiological standpoint, the solution should be used immediately unless the product has been opened and diluted under controlled and validated aseptic conditions.
If the prepared solution is not used immediately, the user is responsible for ensuring appropriate storage conditions and duration.

INSTRUCTIONS FOR PREPARING THE SOLUTION IN DUAL-CHAMBER VIALS
(SOLU-MEDROL, 40 mg and SOLU-MEDROL, 125 mg)

Press the plastic activator to release the solvent into the lower chamber.
Gently shake to obtain a solution.
Remove the plastic cover protecting the center of the stopper.
Disinfect the top of the stopper with an appropriate bactericidal agent. Note: Steps 1 to 4 must be performed before drawing up the medication.
Insert the needle straight through the center of the stopper until the tip is visible.
Invert the vial and withdraw the required dose.

Parenteral medications should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Solu-medrol