Medrol

Package Leaflet: Information for the Patient

MEDROL, 4 mg, tablets

MEDROL, 16 mg, tablets

Methylprednisolone

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

Keep this leaflet, you may need to read it again.
In case of any doubts, consult your doctor or pharmacist.
This medicine has been prescribed specifically for you; do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Medrol and what is it used for
• 2. Important information before taking Medrol
• 3. How to take Medrol
• 4. Possible side effects
• 5. How to store Medrol
• 6. Contents of the pack and other information

1. What is Medrol and what is it used for

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

• inflammatory and immune processes (resistance),
• 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 as symptomatic treatment, except in cases of endocrine disorders, when it is used as replacement therapy (substitution).
Disorders other than endocrine

Rheumatic diseases
Supportive treatment for short-term use (during an episode of exacerbation or deterioration of health) in the course of:
psoriatic arthritis;
rheumatoid arthritis, including juvenile rheumatoid arthritis (in some cases, low-dose maintenance therapy may be required);
ankylosing spondylitis;
acute and subacute bursitis;
acute non-specific tenosynovitis;
acute gouty arthritis;
post-traumatic osteoarthritis;
synovitis in osteoarthritis;
epicondylitis.
Systemic connective tissue diseases
During exacerbation or as maintenance therapy in the course of:
systemic lupus erythematosus (and kidney inflammation in lupus);
polymyositis and dermatomyositis;
acute rheumatic myocarditis;
polymyalgia rheumatica;
giant cell arteritis.
Dermatological diseases
pemphigus;
pemphigoid blistering skin inflammation;
severe form of erythema multiforme (Stevens-Johnson syndrome);
exfoliative dermatitis;
fungal granuloma;
severe form of psoriasis;
severe form of seborrheic dermatitis.
Allergic diseases
Treatment of severe allergic diseases, when other treatment methods are ineffective:
seasonal or year-round (non-seasonal) allergic rhinitis;
urticaria;
asthma;
drug hypersensitivity reactions;
contact dermatitis (contact eczema);
atopic dermatitis.
Ophthalmic diseases
Severe acute and chronic allergic and inflammatory processes affecting the eye and its appendages, such as:
allergic marginal corneal ulcers;
herpes zoster ophthalmicus;
inflammation in the anterior segment of the eye;
diffuse choroiditis and choroiditis;
sympathetic ophthalmia;
allergic conjunctivitis;
keratitis;
chorioretinitis and retinitis;
optic neuritis;
uveitis and uveitis of the ciliary body.
Respiratory system diseases
symptomatic sarcoidosis;
Loeffler's syndrome not responding to other medications;
berylliosis;
fulminant or disseminated pulmonary tuberculosis, in combination with appropriate antitubercular chemotherapy;
aspiration pneumonia.
Blood diseases

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

Oncological diseases
Palliative treatment:

• leukemia and lymphoma in adults;
• acute leukemia in children.

Edema
to induce diuresis (urine excretion) or remission of proteinuria (proteinuria) in nephrotic syndrome, without uremia, idiopathic or in the course of systemic lupus erythematosus.
Gastrointestinal diseases
In exacerbation:

• ulcerative colitis;
• Crohn's disease.

Nervous system diseases

• exacerbation in multiple sclerosis;
• brain edema associated with brain tumors.

Other

• organ transplantation.

Endocrine disorders

• primary or secondary adrenal insufficiency (hydrocortisone or cortisone are the drugs of choice; if necessary, synthetic analogs may be used simultaneously with mineralocorticosteroids; in infants and children, additional administration of mineralocorticosteroids is particularly important);
• congenital adrenal hyperplasia;
• non-suppurative thyroiditis;
• hypercalcemia (increased calcium levels in the blood) in the course of cancer.

2. Important information before taking Medrol

When not to take Medrol

• If you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• In the case of systemic fungal infections.

In patients taking immunosuppressive doses of corticosteroids (i.e., suppressing antibody production and immune cells), live or live attenuated vaccines are contraindicated (these vaccines contain live microorganisms with weakened pathogenic properties).

Warnings and precautions

Immunosuppressive action/Increased susceptibility to infections

Medrol may increase susceptibility to infections and may mask some symptoms of infection.
During its use, new infections may occur. While taking Medrol, there may be a decrease in the body's resistance and inability to limit local infections.
Patients may experience infections with any pathogen, including viral, bacterial, fungal, protozoal, or parasitic infections, in any part of the body. These infections can be mild, but also severe, sometimes fatal. The frequency of infectious complications increases with increasing doses of corticosteroids.
Patients taking Medrol are more susceptible to infections than healthy individuals, e.g., chickenpox and measles can have a more severe course or even be fatal in children or adults with impaired immunity.
The use of live vaccines is contraindicated in patients taking immunosuppressive doses of corticosteroids.
In patients with active tuberculosis, Medrol should only be used in cases of fulminant or disseminated tuberculosis, in combination with other antitubercular medications. If it is necessary to administer Medrol to a patient with latent or positive tuberculin test, close monitoring of the patient is required, as reactivation of the disease may occur. In these patients, during long-term corticosteroid therapy, the doctor will decide on the need for additional treatment.
Kaposi's sarcoma has been reported in patients taking corticosteroids. Discontinuation of these drugs may lead to clinical remission.

Effect on the immune system

During Medrol treatment, allergic reactions (e.g., angioedema) may occur.
In patients taking Medrol, rare cases of skin and anaphylactic reactions and (or) anaphylactoid reactions have been reported. Before administering Medrol, the doctor will take appropriate precautions, especially if the patient has had allergic reactions to any medication in the past.
Medrol contains lactose monohydrate derived from cow's milk. Caution should be exercised 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.

Endocrine disorders

If a patient undergoing Medrol treatment experiences severe stress, the doctor may recommend increasing the dose of rapidly acting corticosteroids before, during, and after the stressful situation.
During Medrol treatment, adrenal insufficiency may occur, which may persist for several months after discontinuation of treatment. Patients should inform their doctor about any stressful situations that occur during this period. The doctor will consider initiating hormone therapy. The doctor may also decide to gradually reduce the dose of Medrol.
Sudden discontinuation of Medrol may cause acute adrenal insufficiency, leading to death.
After sudden discontinuation of Medrol, a "steroid withdrawal syndrome" may also occur, which appears to be unrelated to adrenal insufficiency. This syndrome includes symptoms such as loss of appetite, nausea, vomiting, lethargy, headache, fever, joint pain, skin peeling, muscle pain, weight loss, and (or) hypotension. It is believed that these effects result from the sudden change in Medrol concentration rather than its low concentration.
Patients with Cushing's syndrome should not take Medrol, as it may cause or exacerbate Cushing's syndrome.
If a patient has hyperthyroidism before starting Medrol, they should discuss this with their doctor or pharmacist.
Medrol may have a stronger effect in patients with hypothyroidism.
Patients should immediately consult their doctor if they experience weakness or muscle pain, cramps, and stiffness while taking methylprednisolone. These may be symptoms of a condition called thyrotoxic periodic paralysis, which can occur in patients with hyperthyroidism treated with methylprednisolone. Additional treatment may be necessary to alleviate this condition.

Metabolic and nutritional disorders

Medrol may increase blood glucose levels and worsen existing diabetes.
Patients taking Medrol for a long time may be more likely to develop diabetes.

Psychiatric disorders

During Medrol treatment and after its discontinuation, psychiatric disorders may occur.
They usually occur within a few days or weeks of starting Medrol treatment.
Most of them resolve after dose reduction or discontinuation of Medrol. Patients and their caregivers should consult their doctor if they experience any psychiatric symptoms, especially if they suspect depressive mood or suicidal thoughts.
Patients and their caregivers should be aware of psychiatric disorders that may occur 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 multiple sclerosis relapses, but its effect on the final outcome of the natural course of the disease has not been confirmed.
In patients with myasthenia gravis, the doctor will exercise caution when using Medrol.
There have been reports of tibial periostitis in patients taking Medrol, usually with long-term use of high doses.

Effect on the eyes

Caution should be exercised in patients with ocular herpes or ocular zoster, with symptoms affecting the eyeball, as Medrol treatment may increase the risk of corneal perforation.
In patients taking Medrol for a long time, posterior subcapsular cataracts and nuclear cataracts (especially in children) may develop, as well as exophthalmos or increased intraocular pressure, which can lead to glaucoma with potential optic nerve damage. Patients taking Medrol may also be more likely to develop secondary fungal or viral eye infections.
Medrol treatment is associated with an increased risk of central serous chorioretinopathy, which can lead to retinal detachment.
If a patient experiences blurred vision or other visual disturbances, they should consult their doctor.

Effect on the heart

Medrol has an unfavorable effect on the cardiovascular system, including dyslipidemia (abnormal serum lipid levels) and hypertension, so patients with existing cardiovascular risk factors may be at increased risk of cardiovascular effects when taking high doses of Medrol for a long time. In these patients, the doctor will exercise caution when using Medrol and may recommend monitoring the cardiovascular system. The doctor may recommend using Medrol in a low dose and in an alternate-day regimen, as this may reduce the frequency of Medrol-related complications.
In patients with congestive heart failure, Medrol treatment should be used with caution and only when necessary.

Effect on the vascular system

During Medrol treatment, thrombosis, including venous thromboembolic disease, has been reported. Therefore, caution should be exercised in patients with thromboembolic disorders or those who may be prone to their occurrence.
In patients with hypertension, Medrol treatment should be used with caution.

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 bleeding may occur without significant pain. Medrol treatment may mask peritonitis or other symptoms related to gastrointestinal disorders, such as perforation, obstruction, or pancreatitis. In combination with non-steroidal anti-inflammatory drugs (NSAIDs), the risk of developing peptic ulcer disease of the stomach and intestines increases.
In patients with non-specific ulcerative colitis, Medrol should be used with caution, especially if there is a risk of perforation, abscess, or other forms of purulent infection, diverticulitis, recent intestinal anastomosis, active or latent peptic ulcer disease.

Effect on the liver and bile ducts

Rare cases of liver and bile duct disorders have been reported, most of which resolved after discontinuation of treatment. Therefore, monitoring is necessary.

Effect on the musculoskeletal system

During Medrol treatment, acute myopathy may occur, most commonly in patients with neuromuscular transmission disorders (e.g., myasthenia gravis) or those taking drugs that block this transmission (e.g., pancuronium). Elevated creatine kinase levels may also occur. Recovery after discontinuation of Medrol may take time and can last from several weeks to years.
In patients taking high doses of Medrol for a long time, osteoporosis may occur.

Renal and urinary disorders

Caution should be exercised 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

The use of medium to high doses of Medrol may increase blood pressure, sodium and water retention, and potassium excretion. Therefore, the doctor may recommend restricting salt intake in the diet and supplementing potassium. All glucocorticosteroids, including Medrol, increase calcium excretion.

Injuries, poisoning, and complications after procedures

Medrol should not be used to treat traumatic brain injury.

Other

The complications of glucocorticosteroid therapy depend on the dose and duration of treatment. The doctor will decide on the dosage and duration of treatment individually for each patient.
The doctor will decide on the use of the smallest effective dose necessary to control symptoms. Dose reduction should be gradual.
Patients should inform their doctor about all medications they are currently taking or have recently taken, including those available without a prescription.
Some medications may enhance the effect of Medrol, and the doctor may want to monitor the patient's condition closely when taking such medications (including certain HIV medications: ritonavir, cobicistat).
Patients should exercise caution when taking aspirin and non-steroidal anti-inflammatory drugs (NSAIDs) with Medrol.
After taking Medrol, a crisis in the course of a pheochromocytoma has been reported, sometimes fatal. The doctor will decide on the use of Medrol only after careful assessment of the risk-benefit ratio in patients suspected of having a pheochromocytoma.
Tumor lysis syndrome may occur during corticosteroid treatment for cancer. Patients should inform their doctor if they have cancer and experience symptoms of tumor lysis syndrome, such as muscle cramps, weakness, confusion, irregular heartbeat, vision loss, or shortness of breath.

Use in children

Infants and children who are undergoing long-term treatment with Medrol should be closely monitored for growth and development.
In children undergoing long-term treatment with Medrol, in daily divided doses, growth retardation may occur. The doctor should limit this type of treatment to the most severe indications. Adverse effects can be avoided or minimized by using an intermittent treatment regimen.
Infants and children undergoing long-term treatment with Medrol are particularly susceptible to increased intracranial pressure.
High doses of Medrol may cause pancreatitis in children.

Medrol and other medications

Patients should inform their doctor about all medications they are currently taking or plan to take. Medrol may affect the action of other medications, and other medications may affect the action of Medrol.
It may be necessary to adjust the dose of Medrol when used in combination with the following medications:
antibacterial medications: isoniazid
antitubercular antibiotic: rifampicin

• anticoagulant medications (oral). Concomitant use with Medrol may decrease or increase the effect of anticoagulant medications. Monitoring of blood coagulation parameters is necessary to ensure adequate anticoagulant effect. antiepileptic medications: carbamazepine, phenobarbital, phenytoin anticholinergic medications: blocking neuromuscular transmission. During concomitant use of high doses of Medrol and anticholinergic medications, such as neuromuscular blocking agents, reports of acute myopathy have been made. Muscle relaxants, such as pancuronium, vecuronium: Medrol may partially inhibit neuromuscular blockade caused by muscle relaxants anticholinesterases: Medrol may reduce the effect of anticholinesterases in patients with myasthenia gravis
• antidiabetic medications: in diabetic patients, it may be necessary to adjust the dose of antidiabetic medications, as Medrol may increase blood glucose levels antiemetic medications: aprepitant, fosaprepitant antifungal medications: itraconazole, ketoconazole antiviral medications - HIV protease inhibitors: indinavir and ritonavir calcium channel blocker: diltiazem oral contraceptives: ethinyl estradiol/norethindrone grapefruit juice immunosuppressive medication: cyclosporine. When cyclosporine and Medrol are used concomitantly, mutual inhibition of metabolism may occur, which may increase the concentration of one or both medications in the blood. Therefore, there is a possibility that the risk of adverse effects associated with taking one of the medications may increase. During concomitant use, reports of seizures have been made immunosuppressive medications: cyclophosphamide, tacrolimus macrolide antibacterial medications: clarithromycin, erythromycin, troleandomycin
• non-steroidal anti-inflammatory medications (NSAIDs): high doses of aspirin may increase the frequency of bleeding and peptic ulcer disease
• potassium-lowering medications. When Medrol is used concomitantly with medications that lower potassium levels (e.g., diuretics), patients should be monitored for the development of hypokalemia (a condition where the potassium level in the blood is below the laboratory norm). During concomitant use of Medrol with amphotericin B, xanthines, or beta2 agonists, the risk of hypokalemia increases aromatase inhibitor: aminoglutethimide.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medication.
In animal studies, Medrol has been shown to have a detrimental effect on fertility.
Until appropriate studies are conducted on the effect of Medrol on human reproductive processes, this medication should not be given to pregnant women unless a thorough assessment of the risk-benefit ratio for the mother and fetus has been made.
Some corticosteroids easily cross the placental barrier. In one retrospective study, an increased frequency of low birth weight in newborns born to mothers taking corticosteroids was found. In humans, the risk of low birth weight appears to be dose-dependent. This risk may be reduced by administering lower doses of corticosteroids.
If it is necessary to discontinue chronic Medrol treatment during pregnancy, it should be done gradually. In some situations (e.g., replacement therapy for adrenal insufficiency), it may be necessary to continue or even increase the dose. Children born to mothers who took Medrol during pregnancy should be closely monitored and examined for adrenal insufficiency.
The effect of Medrol on the course of labor is unknown.
In infants born to mothers who took Medrol for a long time during pregnancy, cataract development has been observed.
Medrol passes into breast milk.
This medication can be used by breastfeeding women only after a thorough assessment of the risk-benefit ratio for the mother and infant.

Driving and using machines

The effect of Medrol on the ability to drive and use machines has not been evaluated.
During Medrol treatment, side effects such as dizziness, visual disturbances, and fatigue are possible. If such symptoms occur, patients should not drive or operate machinery.

Medrol contains lactose and sucrose

If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking this medication.

3. How to take Medrol

Always take this medication exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
The doctor will decide on the initial dose, which may range from 4 mg to 48 mg of methylprednisolone per day, depending on the disease. In cases of milder diseases, smaller doses are usually used, but in some patients, higher doses may be necessary. High-dose treatment is used in cases of: brain edema (200-1000 mg/day) and organ transplantation (up to 7 mg/kg body weight per day) and multiple sclerosis. In the treatment of multiple sclerosis relapses, the following regimens have been effective: oral doses of 500 mg/day for 5 days or 1000 mg/day for 3 days. If there is no improvement in the clinical condition, the doctor will decide to discontinue Medrol treatment and use other treatment. In case of need to discontinue long-term treatment, it is recommended to gradually reduce the dose.
WARNING! The line on the tablet is not intended for breaking the tablet.

Overdose of Medrol

In case of overdose, consult your doctor or pharmacist immediately. There are no clinical symptoms of acute Medrol overdose. There is no specific antidote in case of Medrol overdose. In such cases, supportive and symptomatic treatment is used. Chronic overdose leads to typical symptoms of Cushing's syndrome. Dialysis is an effective method of removing Medrol from the body.

Missed dose of Medrol

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

4. Possible side effects

Like all medications, Medrol can cause side effects, although not everybody gets them.
In case of any of the following symptoms, consult your doctor or go to the nearest hospital immediately:
Frequency not known (frequency cannot be estimated from the available data)

• opportunistic infections (infections characteristic of immunocompromised individuals), infections, peritonitis†
• leukocytosis (increased white blood cell count)
• hypersensitivity reactions, anaphylactic reactions - a type of immediate allergic reaction after re-exposure to the allergen, anaphylactoid reactions - an immediate reaction affecting the entire body, which can occur after the first contact with the medication
• Cushing's syndrome, suppression of the hypothalamic-pituitary-adrenal axis, steroid withdrawal syndrome
• metabolic acidosis, lipomatosis, sodium retention, fluid retention, hypokalemic alkalosis, dyslipidemia, impaired glucose tolerance, increased insulin requirements or oral hypoglycemic medications in diabetic patients, fat accumulation in certain parts of the body, increased appetite (which can 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 disorders, personality changes, confusion, anxiety, mood changes, abnormal behavior, insomnia, irritability
• increased intracranial pressure (with papilledema [benign intracranial hypertension]), seizures, memory impairment, cognitive function disorders, dizziness, headache
• chorioretinopathy (retina and choroid disorders), cataracts, glaucoma, exophthalmos, increased intraocular pressure, which can lead to glaucoma with potential optic nerve damage, rarely - blurred vision
• vertigo of labyrinthine origin
• congestive heart failure (in susceptible patients)
• increased blood coagulability, hypertension, hypotension, feeling of heat and skin flushing (hot flashes)
• pulmonary embolism, hiccups
• peptic ulcers (with possible subsequent perforation and bleeding), intestinal perforation, gastrointestinal bleeding, pancreatitis, esophagitis, esophageal ulceration, abdominal distension, abdominal pain, diarrhea, dyspepsia
• increased liver enzyme activity (increased alanine aminotransferase and aspartate aminotransferase activity)
• angioedema, excessive hair growth, bruising, subcutaneous or skin hemorrhages, skin thinning, rash, itching, urticaria, acne
• muscle weakness, muscle pain, myopathy (muscle disease), muscle atrophy, osteoporosis, bone necrosis, pathological fractures, neuropathic arthropathy, joint pain, growth retardation
• menstrual irregularities
• wound healing disorders, peripheral edema, fatigue, malaise
• increased intraocular pressure, impaired glucose tolerance, hypokalemia (potassium level in the blood below the laboratory norm), increased urine calcium levels, increased blood alkaline phosphatase activity, increased blood urea levels, suppression of skin test reactions
• vertebral compression fractures, tendon rupture

Peritonitis may be the first symptom of gastrointestinal disorders, such as perforation, obstruction, or pancreatitis.
Reporting side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
Side effects can also be reported to the marketing authorization holder or its representative.
By reporting side effects, you can help provide more information on the safety of this medication.

5. How to store Medrol

Store in a temperature below 25°C.
Store in a place out of sight and reach of children.
Do not use this medication after the expiry date stated on the carton (EXP). The expiry date refers to the last day of the month.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Medrol contains

• The active substance of Medrol 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 ingredients are: tablets 4 mg: lactose monohydrate, cornstarch, sucrose, calcium stearate. tablets 16 mg: lactose monohydrate, sucrose, liquid paraffin, calcium stearate, cornstarch.

What Medrol looks like and contents of the pack

Tablets 4 mg are:
half-oval, elliptical, white tablets with the inscription "MEDROL 4" on one side and a double dividing line on the other side.
Tablets 16 mg are:
elliptical, convex, white tablets with the inscription "MEDROL 16" on one side and a double dividing line on the other side.
Medrol 4 mg is available in PVC/Al blisters or a high-density polyethylene (HDPE) bottle with a polypropylene (PP) cap with an aluminum/polyethylene seal, a child-resistant closure, and a cardboard box. The pack contains 10, 30, 100 tablets in blisters or a bottle.
Medrol 16 mg is available in PVC/Al blisters or a high-density polyethylene (HDPE) bottle with a polypropylene (PP) cap with an aluminum/polyethylene seal, a child-resistant closure, and a cardboard box. The pack contains 50 tablets in blisters or 50 tablets in a bottle.

Marketing authorization holder

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Manufacturer

Pfizer Italia S.r.l.
63 100 Localitá Marino del Tronto
Ascoli Piceno
Italy
To obtain more detailed information about this medication, please contact the local representative of the marketing authorization holder:
Pfizer Polska Sp. z o.o.
phone: 22 335 61 00

Date of last revision of the leaflet: