Patient Information Leaflet

MEDROL, 4 mg, tablets
MEDROL, 16 mg, tablets
Methylprednisolonum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Keep this leaflet for future reference.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It 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.

Contents of the leaflet

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

1. What Medrol is and what it is used for

The active substance in Medrol, methylprednisolone, belongs to the group of glucocorticosteroids.
Medrol is intended for oral use.
Like other glucocorticosteroids, Medrol affects, among others:

inflammatory and immunological (immune) processes,
carbohydrate, protein and fat metabolism,
the circulatory system,
the cardiovascular system,
the central nervous system,
skeletal muscles,
bone tissue,
connective tissue,
skin and mucous membranes,
the endocrine system,
kidney function.

Medrol is used for symptomatic treatment, except in endocrine disorders, where it is used as replacement therapy.

Non-endocrine disorders

Rheumatic diseases
As supportive treatment for short-term use (during episodes of exacerbation or worsening of condition) in:
psoriatic arthritis;
rheumatoid arthritis, including juvenile rheumatoid arthritis (in some cases, low-dose maintenance therapy may be required);
ankylosing spondylitis;
acute and subacute tenosynovitis;
acute nonspecific tenosynovitis;
acute gouty arthritis;
traumatic degenerative joint disease;
synovitis in degenerative joint disease;
epicondylitis.

Systemic connective tissue diseases
During exacerbations or as maintenance therapy in:
systemic lupus erythematosus (and lupus nephritis);
polymyositis and dermatomyositis;
acute rheumatic carditis;
polymyalgia rheumatica;
giant cell arteritis.

Skin diseases
pemphigus;
bullous pemphigoid;
severe forms of erythema multiforme (Stevens-Johnson syndrome);
exfoliative dermatitis;
pyoderma granulomatosis;
severe psoriasis;
severe seborrheic dermatitis.

Allergic conditions
Treatment of severe allergic diseases when other treatment methods are ineffective:
seasonal or perennial (non-seasonal) allergic rhinitis;
serum sickness;
bronchial asthma;
hypersensitivity reactions to drugs;
contact dermatitis;
atopic dermatitis.

Eye diseases
Severe acute and chronic allergic and inflammatory processes affecting the eye and its adnexa, such as:
allergic corneal ulceration;
ophthalmic zoster;
anterior segment inflammation;
diffuse posterior uveitis and choroiditis;
sympathetic uveitis;
allergic conjunctivitis;
keratitis;
choroiditis and retinitis;
optic neuritis;
iritis, iridocyclitis.

Respiratory diseases
symptomatic sarcoidosis;
Loeffler's syndrome unresponsive to other drugs;
berylliosis;
fulminant or disseminated pulmonary tuberculosis, concomitantly with appropriate antituberculosis chemotherapy;
aspiration pneumonitis.

Blood disorders

idiopathic thrombocytopenic purpura in adults;
secondary thrombocytopenia in adults;
acquired (autoimmune) hemolytic anemia;
erythroblastopenia;
congenital hypoplastic anemia.

Oncological diseases
Palliative treatment:

leukemias and lymphomas in adults;
acute leukemia in children.

Edema
to induce diuresis or remission of proteinuria in nephrotic syndrome, without uremia, idiopathic or associated with systemic lupus erythematosus.

Gastrointestinal diseases
During exacerbations of:

ulcerative colitis;
Crohn's disease.

Neurological diseases

exacerbations of multiple sclerosis;
cerebral edema associated with brain tumor.

Others

organ transplantation.

Endocrine disorders
primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone are drugs of choice; if necessary, synthetic analogs may be used concomitantly with mineralocorticoids; in infants and children, supplementation with mineralocorticoids is particularly important);
congenital adrenal hyperplasia;
nontoxic thyroiditis;
hypercalcemia (elevated blood calcium levels) associated with malignancy.

2. Important information before using Medrol

When not to use Medrol

If the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
In case of systemic fungal infection.

Warnings and precautions
Immunosuppressive effect / Increased susceptibility to infections
Medrol may increase susceptibility to infections, may mask some signs of infection, worsen existing infections, or cause recurrence or exacerbation of previous, latent infections. New infections may also occur during treatment with Medrol. These infections may range from mild to severe and, in some cases, may lead to death. During treatment with Medrol, decreased immunity and inability to localize infection may occur. The physician will closely monitor the patient for the development of infection and, if necessary, may consider discontinuing or reducing the dose of the medication.
Administration of corticosteroids, either as monotherapy or in combination with other immunosuppressive drugs, may be associated with infections caused by pathogenic microorganisms, including viral, bacterial, fungal, protozoal, or parasitic diseases, affecting any part of the body. The frequency of infectious complications increases with higher corticosteroid doses. Patients taking drugs that reduce immune function are more susceptible to infections than healthy individuals. Chickenpox and measles may have a more severe course or even be fatal in children or adults lacking immunity who are receiving corticosteroids.
Administration of live or live attenuated vaccines (containing live, weakened microorganisms) is contraindicated in patients receiving immunosuppressive doses of corticosteroids (doses that suppress antibody and immune cell production).

Oral anticoagulant drugs (taken orally to prevent blood clotting) used together with Medrol may increase the risk of bleeding. In some cases, the effect of oral anticoagulants may also be reduced. During treatment with Medrol, frequent monitoring of bleeding risk by the physician through additional blood tests may be necessary. If needed, the physician may also adjust the dose of Medrol.

In patients with active tuberculosis, Medrol should be used only in fulminant or disseminated forms and in combination with other antituberculosis drugs. If Medrol must be administered to a patient with latent tuberculosis or a positive tuberculin test, close monitoring is essential, as reactivation of the disease may occur. In such patients undergoing long-term corticosteroid therapy, the physician may decide on the need for additional treatment.

Kaposi's sarcoma has been observed in patients receiving corticosteroids. Discontinuation of these drugs may lead to clinical remission.

Effect on the immune system
Allergic reactions (e.g., angioedema) may occur during treatment with Medrol. Rarely, skin reactions, anaphylactic, and/or anaphylactoid reactions have been reported in patients receiving Medrol. Before administering Medrol, the physician will take appropriate precautions, especially if the patient has previously experienced allergic reactions to any drug.

Endocrine disorders
If patients undergoing treatment with Medrol experience significant stress, the physician may recommend increasing the dose of fast-acting corticosteroids before, during, and after the stressful situation.

Adrenal insufficiency may occur during treatment with Medrol and may persist for several months after discontinuation. Inform the physician about any stressful situations occurring during this period. The physician may consider initiating hormonal therapy. The physician may also decide to gradually reduce the dose of Medrol.

Sudden withdrawal of Medrol may cause acute adrenal insufficiency, potentially leading to death. After abrupt discontinuation of Medrol, a "steroid withdrawal syndrome" may also occur, seemingly unrelated to adrenal cortex insufficiency. This syndrome includes symptoms such as: loss of appetite, nausea, vomiting, lethargy, headache, fever, joint pain, skin desquamation, muscle pain, weight loss, and/or hypotension. These effects are believed to result more from a sudden change in Medrol concentration than from low levels of the drug.

Patients with Cushing's disease should not use Medrol, as it may cause or worsen Cushing's syndrome.

If the patient has hyperthyroidism before starting Medrol, this should be discussed with the physician or pharmacist.

Medrol may have a stronger effect in patients with hypothyroidism.

Seek immediate medical advice if weakness or muscle pain, cramps, or stiffness occur during methylprednisolone treatment. These may be symptoms of thyrotoxic periodic paralysis, which may occur in patients with hyperthyroidism treated with methylprednisolone. Additional treatment may be necessary to alleviate this condition.

Metabolic and nutritional disorders
Medrol may increase blood glucose levels and worsen pre-existing diabetes. Patients on long-term Medrol therapy may be more prone to developing diabetes.

Psychiatric disorders
Psychiatric disturbances may occur during and after treatment with Medrol. They usually appear within a few days or weeks of starting treatment. Most resolve after dose reduction or discontinuation of Medrol. Patients and caregivers should consult a physician if psychiatric symptoms occur, especially if depressive mood or suicidal thoughts are suspected. Particular attention should be paid to psychiatric disturbances occurring during treatment, immediately after dose reduction, or after discontinuation of Medrol.

Effect on the nervous system
Medrol should be used with caution in patients with seizure disorders. Medrol is effective in accelerating the resolution of severe exacerbations of multiple sclerosis, but its effect on the final outcome of the disease's natural course has not been confirmed. The physician should exercise caution when using Medrol in patients with myasthenia gravis. Cases of subcapsular lipomatosis have been reported in patients receiving Medrol, usually after long-term, high-dose treatment.

Effect on the eyes
Caution is advised in patients with ocular herpes simplex or ocular zoster, or with symptoms affecting the eyeball, as treatment with Medrol may increase the risk of corneal perforation (formation of a defect).
In patients on long-term Medrol therapy, posterior subcapsular cataracts and nuclear cataracts (especially in children), exophthalmos, or increased intraocular pressure may develop, which may lead to glaucoma with potential damage to the optic nerves. Secondary fungal and viral infections of the eyeball may also occur more frequently in patients receiving Medrol.
Treatment with Medrol is associated with a risk of central serous chorioretinopathy, which may lead to retinal detachment.

If the patient experiences blurred vision or other visual disturbances, medical advice should be sought.

Effect on the heart
Medrol has adverse effects on the cardiovascular system, including dyslipidemia (abnormal fasting serum levels of one or more lipoprotein fractions or their composition) and hypertension. Therefore, patients with existing cardiovascular risk factors may be at additional risk when receiving high doses or long-term treatment with Medrol. The physician should exercise caution when using Medrol in such patients and may recommend monitoring of the cardiovascular system. The physician may recommend using Medrol in low doses and on alternate days, as this may reduce the frequency of treatment complications.

In patients with congestive heart failure, Medrol treatment should be used cautiously and only when necessary.

Effect on the vascular system
Thrombosis, including venous thromboembolic disease, has been reported during Medrol treatment. Therefore, caution is advised in patients with thromboembolic disorders or those at risk of developing them.
Medrol treatment should be used with caution in patients with hypertension.

Effect on the stomach and intestines
High doses of Medrol may cause acute pancreatitis. Medrol may mask symptoms of peptic ulcer disease, so perforations or hemorrhages may occur without accompanying severe pain. Medrol treatment may mask peritonitis or other symptoms related to gastrointestinal disorders such as perforation, constipation, or pancreatitis. The risk of gastric and intestinal ulcer disease increases when combined with nonsteroidal anti-inflammatory drugs (NSAIDs).

Medrol should be used with caution in patients with ulcerative colitis if there is a risk of perforation, abscess formation, or other suppurative infections, diverticulitis, recent intestinal anastomosis, or active or latent peptic ulcer disease.

Effect on the liver and biliary tract
Rare cases of liver and biliary tract dysfunction have been reported, most of which resolved after discontinuation of treatment. Therefore, appropriate monitoring is necessary.

Effect on the musculoskeletal system
Acute myopathy may occur during treatment with high doses of Medrol, most frequently in patients with neuromuscular transmission disorders (e.g., myasthenia) or in patients simultaneously receiving drugs that block neuromuscular transmission (e.g., pancuronium). Increased creatine kinase levels may also occur. Recovery after discontinuation of Medrol may take time, ranging from several weeks to years.

Osteoporosis may occur in patients on long-term, high-dose Medrol therapy.

Renal and urinary disorders
Caution is advised in patients with systemic sclerosis, as an increased frequency of scleroderma renal crisis has been observed with corticosteroids, including methylprednisolone.
Medrol should be used with caution in patients with renal impairment.

Diagnostic tests
Administration of medium and high doses of Medrol may increase blood pressure, sodium and water retention, and potassium excretion. Therefore, the physician may recommend limiting dietary salt (table salt) intake and potassium supplementation. All glucocorticoids, including Medrol, increase calcium excretion.

Injury, poisoning, and post-procedural complications
Medrol should not be used in the treatment of traumatic brain injury.

Other warnings
Complications of glucocorticoid therapy depend on dose size and duration of treatment. The physician will make individual decisions regarding dosage and treatment duration for each patient.
The physician will decide to use the lowest effective dose necessary to control symptoms. Dose reduction should be gradual.

Inform the physician about all medications currently or recently taken by the patient, including those available without a prescription.

Some drugs may enhance the effect of Medrol, and the physician may wish to closely monitor patients taking such drugs (including certain HIV medications: ritonavir, cobicistat).

Patients should exercise caution when using acetylsalicylic acid and nonsteroidal anti-inflammatory drugs together with Medrol.

After administration of Medrol, tumor flare in pheochromocytoma has been reported, sometimes leading to death. The physician will decide whether to use Medrol only after appropriate risk-benefit assessment in patients suspected of or diagnosed with pheochromocytoma.

Tumor lysis syndrome may occur during corticosteroid treatment for cancer. Inform the physician 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
Growth and development in infants and children undergoing long-term Medrol treatment should be closely monitored.
In children undergoing long-term Medrol treatment with divided daily doses, growth suppression may occur. The physician should limit such treatment to the most severe indications. Adverse effects can be avoided or minimized by using an intermittent dosing regimen.
Infants and children undergoing long-term Medrol treatment are particularly susceptible to increased intracranial pressure.
High doses of Medrol may cause pancreatitis in children.

Medrol and other medicines
Inform the physician about all medications currently or recently taken by the patient, as well as any medications the patient plans to use. Medrol may affect the action of other drugs, and other drugs may affect the action of Medrol.

Dose adjustment of Medrol may be necessary when used concomitantly with the following drugs or products:

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

Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a physician or pharmacist before using this medicine.
Animal studies have shown that Medrol impairs fertility. Until adequate studies on the effects of Medrol on human reproductive processes are conducted, the drug should not be administered to pregnant women unless a careful benefit-risk assessment for mother and fetus has been performed.
Some corticosteroids readily cross the placental barrier. In one retrospective study, an increased incidence of low birth weight in infants born to mothers taking corticosteroids was observed. In humans, the risk of low birth weight is dose-dependent. This risk may be reduced by administering lower corticosteroid doses.
If discontinuation of long-term Medrol treatment is necessary during pregnancy, it should be done gradually. In some cases (e.g., replacement therapy for adrenal insufficiency), continuation or even dose increase may be necessary. Infants born to mothers who received Medrol during pregnancy should be carefully observed and examined for adrenal insufficiency.
The effect of Medrol on labor is unknown.
Cataracts have been observed in infants born to mothers treated with Medrol for prolonged periods during pregnancy.
Medrol passes into breast milk.
The drug may be used by breastfeeding women only after careful benefit-risk assessment for mother and infant.

Driving and operating machinery
The effect of Medrol on the ability to drive and operate machinery has not been evaluated. During treatment with Medrol, adverse effects such as dizziness, visual disturbances, and fatigue may occur. If such symptoms occur, patients should not drive or operate machinery.

Medrol contains lactose and sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the physician before taking the medicine.
Medrol contains monohydrate lactose derived from cow's milk. Caution is advised in patients with known or suspected hypersensitivity to cow's milk or its components, or other dairy products, as the medicine may contain trace amounts of milk components.

3. How to use Medrol

This medicine should always be used exactly as your doctor has advised. If in doubt, consult your doctor or pharmacist.
Your doctor will determine the initial dose, which may range from 4 mg to 48 mg of methylprednisolone per day, depending on the disease condition. Lower doses are generally used for milder diseases, although higher doses may be required in some patients. High-dose treatment may be necessary in cases of cerebral edema (200–1,000 mg per day), organ transplantation (up to 7 mg/kg body weight per day), and multiple sclerosis. For treatment of multiple sclerosis relapses, effective oral regimens include 500 mg per day for 5 days or 1,000 mg per day for 3 days. If there is no clinical improvement, your doctor will decide to discontinue Medrol and initiate alternative therapy. If long-term treatment needs to be discontinued, a gradual dose reduction is recommended.
Once clinical improvement is achieved, your doctor will establish a maintenance dose by gradually reducing the initial dose at appropriate intervals until the lowest effective dose that maintains the desired clinical response is reached. The dose should be continuously monitored. Depending on remission or exacerbation of the disease, individual patient response to treatment, or the occurrence of stressful situations, your doctor may decide that dose adjustment is necessary. In patients exposed to stress, an increased dose of Medrol may be required during the period of stress.
The dose varies and must be individually determined according to the type of disease and the individual patient's response.

Intermittent treatment regimen
Your doctor may decide to use an intermittent treatment regimen: administering a double daily dose every other day in the morning. The aim of this regimen is to maintain the beneficial effects of corticosteroids while minimizing certain adverse effects, such as suppression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome (a clinical syndrome associated with elevated cortisol levels), growth suppression in children, and symptoms of acute corticosteroid withdrawal.

WARNING! The breakline on the tablet is not intended for splitting the tablet.

Taking more Medrol than prescribed
If you take more Medrol than recommended, contact your doctor or pharmacist immediately. There are no specific symptoms of acute Medrol overdose. There is no specific antidote for Medrol overdose. In such cases, supportive and symptomatic treatment should be administered. Chronic overdose causes typical symptoms of Cushing's syndrome. Dialysis is an effective method for removing Medrol from the body.

Missing a dose of Medrol
Do not take a double dose of Medrol to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the symptoms listed below occur, contact your doctor immediately or go to the nearest hospital:

Frequency unknown (frequency cannot be determined from available data):

opportunistic infections (infections typical in people with reduced immunity), infections, peritonitis†
leukocytosis (increased number of white blood cells in blood)
hypersensitivity reactions, anaphylactic reactions – a type of immediate allergic reaction upon re-exposure to an allergen, anaphylactoid reactions – an immediate systemic reaction that may occur even after first exposure to the drug
Cushing's syndrome, suppression of the hypothalamic-pituitary-adrenal axis, steroid withdrawal syndrome
metabolic acidosis, subcutaneous lipomatosis, sodium retention, fluid retention, hypokalemic alkalosis, dyslipidemia, impaired glucose tolerance, increased insulin requirement or need for oral antidiabetic drugs in diabetic patients, fat redistribution to 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 excitement, delusions, hallucinations, and schizophrenia), psychotic behavior, mental disturbances, personality changes, confusion, anxiety, mood changes, abnormal behavior, insomnia, irritability
increased intracranial pressure (with optic nerve disc swelling [benign intracranial hypertension]), seizures, memory loss, cognitive dysfunction, dizziness, headache
chorioretinopathy (retinal and choroidal disorders), cataract, glaucoma, exophthalmos, rarely blurred vision
vertigo of labyrinthine origin
congestive heart failure (in susceptible patients)
increased blood coagulability, arterial hypertension, hypotension, feeling of warmth and skin flushing (hot flush)
pulmonary embolism, hiccups
gastrointestinal ulcers (with possible subsequent perforation and bleeding), intestinal perforations, gastric bleeding, pancreatitis, erosive esophagitis, esophagitis, bloating, abdominal pain, diarrhea, indigestion, nausea
increased liver enzyme activity (elevated alanine aminotransferase and aspartate aminotransferase activity)
angioedema, hirsutism, petechiae, subcutaneous or cutaneous hemorrhages, skin atrophy, erythema, excessive sweating, striae, rash, pruritus, urticaria, acne
inflammation of subcutaneous fat tissue, which may cause skin hardening and the appearance of painful red nodules or skin lesions (subcutaneous panniculitis). Subcutaneous panniculitis has been reported after dose reduction or discontinuation of long-term high-dose treatment. In most cases, it resolves spontaneously.
muscle weakness, myalgia, myopathy (muscle disease), muscle atrophy, osteoporosis, avascular necrosis of bone, pathological fractures, neurogenic arthropathy, joint pain, growth suppression
irregular menstruation
impaired wound healing, peripheral edema, fatigue, malaise
increased intraocular pressure, decreased carbohydrate tolerance, decreased blood potassium concentration, increased calcium excretion in urine, increased serum alkaline phosphatase activity, increased blood urea concentration, suppression of skin test reactions
vertebral compression fractures, tendon rupture.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform 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
Phone: +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 authorization holder or its representative.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Medrol

The medicine should be stored at a temperature below 25 °C.
The medicine should be kept out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: (EXP). The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Medrol contains

The active substance is: methylprednisolone (Methylprednisolonum). One tablet of Medrol 4 mg contains 4 mg of methylprednisolone. One tablet of Medrol 16 mg contains 16 mg of methylprednisolone.
Other components are:
Tablets 4 mg: monohydrate lactose, corn starch, sucrose, calcium stearate.
Tablets 16 mg: monohydrate lactose, sucrose, liquid paraffin, calcium stearate, corn starch.

What Medrol looks like and contents of the pack
Tablets 4 mg are:
oval, white, scored tablets with an embossing of "MEDROL 4" on one side and a double break line
on the other side.
Tablets 16 mg are:
oval, convex, white tablets with an embossing of "MEDROL 16" on one side and a double break line
on the other side.
Medrol 4 mg is available in PVC/Al blisters or in high-density polyethylene (HDPE) bottles with a
polypropylene (PP) cap, aluminium/polyethylene seal, child-resistant closure, placed in a cardboard
box. The pack contains 10, 30 or 100 tablets in blisters or in a bottle.
Medrol 16 mg is available in PVC/Al blisters or in high-density polyethylene (HDPE) bottles with a
polypropylene (PP) cap, aluminium/polyethylene seal, child-resistant closure, placed in a cardboard
box. The pack contains 50 tablets in blisters or 50 tablets in a bottle.

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

Manufacturer
Pfizer Italia S.r.l.
63 100 Localitá Marino del Tronto
Ascoli Piceno
Italy

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