Metypred

Package leaflet: Information for the patient

Metypred, 4 mg, tablets
Metypred, 16 mg, tablets
Methylprednisolonum
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

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

Table of contents of the leaflet

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

1. What Metypred is and what it is used for

The active substance in Metypred, methylprednisolone, belongs to the group of glucocorticosteroids.
Metypred is intended for oral administration.
Like other glucocorticosteroids, Metypred 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.

Metypred is used as symptomatic treatment, except in endocrine disorders, when it is used as replacement therapy.
Non-endocrine disorders
Rheumatic diseases
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 exacerbation 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 form of erythema multiforme (Stevens-Johnson syndrome);
• exfoliative dermatitis;
• granuloma fungoides;
• severe psoriasis;
• severe seborrheic dermatitis.

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

• seasonal or perennial (non-seasonal) allergic rhinitis;
• serum sickness;
• bronchial asthma;
• drug hypersensitivity reactions;
• contact dermatitis (allergic contact dermatitis);
• atopic dermatitis.

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

• allergic marginal corneal ulcers;
• herpes zoster ophthalmicus;
• inflammation of the anterior segment of the eye;
• diffuse posterior uveitis and choroiditis;
• sympathetic ophthalmia;
• allergic conjunctivitis;
• keratitis;
• uveitis and retinochoroiditis;
• 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 pneumonia.

Blood disorders

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

Neoplastic diseases
Palliative treatment:

• leukemias and lymphomas in adults;
• acute leukemia in children.

Edema

• to induce diuresis (urine excretion) or remission of proteinuria in nephrotic syndrome, without uremia, idiopathic or associated with systemic lupus erythematosus.

Gastrointestinal diseases
During exacerbation of:

• ulcerative colitis;
• Crohn's disease.

Neurological diseases

• exacerbation in multiple sclerosis;
• cerebral edema associated with brain tumor.

Others

• organ transplantation.

Endocrine disorders

• primary or secondary adrenal insufficiency (hydrocortisone or cortisone are drugs of choice; if necessary, synthetic analogs may be used concomitantly with mineralocorticoids; in infants and children, mineralocorticoid supplementation is particularly important);
• congenital adrenal hyperplasia;
• non-suppurative thyroiditis;
• hypercalcemia (increased calcium concentration in blood) associated with neoplastic disease.

2. Important information before taking Metypred
When not to use Metypred

• 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.

Administration of live or live attenuated vaccines (containing live, weakened microorganisms) is contraindicated in patients receiving immunosuppressive doses of corticosteroids (i.e., doses that suppress antibody and immune cell production).
Warnings and precautions
Before starting Metypred, discuss this with your doctor or pharmacist.
Immunosuppressive effect/Increased susceptibility to infections
Metypred may increase susceptibility to infections and may mask some signs of infection. New infections may occur during treatment. During treatment with Metypred, there may be decreased immunity and inability to contain localized infections. Patients may develop infections caused by any pathogen, including viral, bacterial, fungal, protozoal or parasitic infections, in any part of the body. These infections may be mild or severe, sometimes fatal. The frequency of infectious complications increases with increasing doses of corticosteroids.
Patients taking Metypred are more susceptible to infections than healthy individuals; for example, chickenpox and measles may have a more severe course or even be fatal in children or adults without immunity.
Vaccination with live, attenuated viruses is contraindicated in patients receiving immunosuppressive doses of corticosteroids.
Metypred should be used in patients with active tuberculosis only in fulminant or disseminated forms, in combination with other antituberculosis drugs. If Metypred must be administered to a patient with latent tuberculosis or a positive tuberculin test, close monitoring is required, as reactivation of the disease may occur. In these patients receiving long-term corticosteroid therapy, the doctor will decide on the need for additional treatment.
Kaposi's sarcoma has been reported 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 Metypred.
Rarely, skin reactions and anaphylactic and/or anaphylactoid reactions have been reported in patients taking Metypred. Before administering Metypred, the doctor will take appropriate precautions, especially if the patient has previously experienced allergic reactions to any drug.
Endocrine disorders
If patients undergoing treatment with Metypred experience significant stress, the doctor may recommend increasing the dose of fast-acting corticosteroids before, during, and after the stressful situation.
Adrenal insufficiency may occur during treatment with Metypred and may persist for several months after discontinuation. Inform your doctor of any stressful situations occurring during this period. The doctor may consider initiating hormonal therapy. The doctor may also decide to gradually reduce the dose of Metypred.
Sudden withdrawal of Metypred may cause acute adrenal insufficiency, leading to death.
After abrupt discontinuation of Metypred, a "steroid withdrawal syndrome" may also occur, seemingly unrelated to adrenal 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 Metypred concentration than from low concentration.
Patients with Cushing's disease should not use Metypred, as it may cause or worsen Cushing's syndrome.
Metypred may have a stronger effect in patients with hypothyroidism.
Seek immediate medical advice if the patient has hyperthyroidism and develops weakness or muscle pain, cramps, and stiffness during treatment with methylprednisolone. These may be symptoms of a condition called thyrotoxic periodic paralysis, which may occur in patients with hyperthyroidism treated with methylprednisolone. Additional treatment may be necessary to alleviate this condition.
Metabolic and nutritional disorders
Metypred may increase blood glucose levels and worsen pre-existing diabetes. Patients on long-term Metypred therapy may be more prone to developing diabetes.
Psychiatric disorders
Psychiatric disorders may occur during and after treatment with Metypred. They usually appear within a few days or weeks after starting treatment. Most resolve after dose reduction or discontinuation of Metypred. Patients and caregivers should consult a doctor if psychiatric symptoms occur, especially if depressive mood or suicidal thoughts are suspected.
Patients and caregivers should pay particular attention to psychiatric disorders that may occur during treatment, immediately after dose reduction, or after discontinuation of Metypred.
Effect on the nervous system
Metypred should be used with caution in patients with seizure disorders.
Metypred is effective in accelerating the resolution of severe exacerbations of multiple sclerosis, but its effect on the final outcome of the natural course of the disease has not been confirmed.
The doctor should exercise caution when using Metypred in patients with myasthenia.
Cases of subcapsular cataracts have been reported in patients taking Metypred, usually after long-term use of high doses.
Effect on the eyes
Caution is required in patients with ocular herpes simplex or herpes zoster ophthalmicus with ocular symptoms, as treatment with Metypred may increase the risk of corneal perforation (defect formation).
Long-term use of Metypred may lead to the 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 taking Metypred may also develop secondary fungal and viral eye infections more frequently.
Treatment with Metypred 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, contact a doctor.
Effect on the heart
Metypred has an adverse effect 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 from the cardiovascular system when receiving high doses and long-term treatment with Metypred. The doctor will exercise caution when using Metypred and may recommend monitoring of the cardiovascular system if necessary. The doctor may recommend using Metypred in a low dose and an alternate-day regimen, as this may reduce the frequency of treatment complications.
Treatment with Metypred should be used cautiously and only when necessary in patients with congestive heart failure.
Effect on the vascular system
Thrombosis, including venous thromboembolic disease, has been reported during treatment with Metypred. Therefore, caution is required in patients with thromboembolic disorders or those who may be susceptible to their occurrence.
Treatment with Metypred should be used with caution in patients with hypertension.
Effect on the stomach and intestines
High doses of Metypred may cause acute pancreatitis. Metypred may mask symptoms of peptic ulcer disease, so perforations or hemorrhages may occur without accompanying severe pain. Treatment with Metypred may mask peritonitis or other symptoms related to gastrointestinal disorders, such as: perforation, constipation, or pancreatitis. The risk of developing gastric and intestinal ulcer disease increases when combined with nonsteroidal anti-inflammatory drugs (NSAIDs).
Metypred should be used cautiously in patients with ulcerative colitis if there is a risk of perforation, abscess formation or other forms of suppurative infection, diverticulitis, recent intestinal anastomosis, 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. Appropriate monitoring is therefore necessary.
The effect of Metypred may be enhanced in patients with liver cirrhosis.
Effect on the musculoskeletal system
Acute myopathy may occur during treatment with high doses of Metypred, most frequently in patients with neuromuscular transmission disorders (e.g., myasthenia) or in patients simultaneously taking drugs that block neuromuscular transmission (e.g., pancuronium). Increased creatine kinase levels may also occur. Recovery after discontinuation of Metypred may take time and can last from several weeks to years.
Osteoporosis may occur in patients on long-term, high-dose Metypred therapy.
Kidney and urinary tract disorders
Before starting Metypred, discuss this with your doctor or pharmacist if the patient has scleroderma (an autoimmune disorder also known as systemic sclerosis), as doses of at least 15 mg per day may increase the risk of a serious complication called scleroderma renal crisis. Symptoms of scleroderma renal crisis include elevated blood pressure and decreased urine output. The treating doctor may recommend regular monitoring of blood pressure and urine output.
Metypred should be used with caution in patients with renal insufficiency.
Diagnostic tests
Use of medium and high doses of Metypred may increase blood pressure, sodium and water retention, and potassium excretion. Therefore, the doctor may recommend limiting dietary salt (table salt) intake and potassium supplementation. All glucocorticosteroids, including Metypred, increase calcium excretion.
Injury, poisoning and post-procedural complications
Metypred should not be used in the treatment of traumatic brain injury.
Others
Complications of glucocorticosteroid therapy depend on dose and duration of treatment. The doctor will decide on dosage and duration of treatment individually for each patient.
The doctor will decide to use the lowest effective dose necessary to control symptoms. Dose reduction should be gradual.
Patients should exercise caution when using acetylsalicylic acid and nonsteroidal anti-inflammatory drugs concomitantly with Metypred.
After administration of Metypred, pheochromocytoma crisis has been reported, sometimes fatal. The doctor will decide on using Metypred 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 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
Growth and development of infants and children on long-term Metypred therapy should be closely monitored.
Growth suppression may occur in children on long-term Metypred therapy with divided daily doses. The doctor should limit such treatment to the most severe indications. Adverse effects can be avoided or minimized by using an intermittent treatment regimen.
Infants and children on long-term Metypred therapy are particularly susceptible to increased intracranial pressure.
High doses of Metypred may cause pancreatitis in children.
Hypertrophic cardiomyopathy (thickening of the heart muscle) may develop in preterm infants after administration of Metypred. The doctor will perform appropriate tests and monitor heart function and structure.
Metypred with other medicines
Tell your doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take, including those available without a prescription.
Metypred may affect the action of other medicines, and some medicines may enhance the effect of Metypred. The doctor may wish to closely monitor the patient taking such medicines. Dose adjustment of Metypred may be necessary when used concomitantly with the following medicines:

• antibacterial drugs: isoniazid
• antituberculosis antibiotic: rifampicin
• anticoagulants (oral). Concomitant use with Metypred may decrease or increase the effect of anticoagulants. Coagulation parameters should be monitored to ensure adequate anticoagulant effect
• anticonvulsants: carbamazepine, phenobarbital, phenytoin
• anticholinergic drugs: neuromuscular blocking agents. Acute myopathy has been reported during concomitant use of high doses of Metypred and anticholinergic drugs, e.g., neuromuscular blocking agents. Muscle relaxants, e.g., pancuronium, vecuronium: Metypred may partially inhibit neuromuscular blockade induced by muscle relaxants
• anticholinesterases: Metypred may reduce the effect of anticholinesterases in patients with myasthenia
• antidiabetic drugs: in diabetic patients, dose adjustment of antidiabetic drugs may be necessary, as Metypred may increase blood glucose levels
• antiemetics: aprepitant, fosaprepitant
• antifungal drugs: itraconazole, ketoconazole
• some HIV drugs: indinavir, ritonavir, cobicistat
• calcium channel blocker: diltiazem
• oral contraceptives: ethinylestradiol/norethisterone
• grapefruit juice
• immunosuppressive drug: cyclosporine. When cyclosporine and Metypred are used concomitantly, mutual inhibition of metabolism may occur, increasing the concentration of one or both drugs in plasma. Therefore, there is a possibility that concomitant administration may increase the risk of adverse effects associated with taking 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-dose aspirin (acetylsalicylic acid) may increase the frequency of gastrointestinal bleeding and ulceration
• drugs that decrease potassium levels. When Metypred is used concomitantly with drugs that decrease potassium levels (e.g., diuretics), patients should be monitored for the development of hypokalemia (a condition in which potassium ion concentration in blood is below laboratory reference values). The risk of hypokalemia increases when Metypred 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 plans to have a child, she should consult her doctor or pharmacist before using this medicine.
Before using this medicine in pregnant or breastfeeding women or women of reproductive age, the potential benefits of corticosteroid treatment for the mother should be weighed against the potential risks to the embryo, fetus, or breastfed infant.
In some animal studies, corticosteroids given in high doses to pregnant mothers have been shown to cause fetal developmental abnormalities.
Metypred should be used in pregnant women only if absolutely necessary.
If chronic use of Metypred must be discontinued during pregnancy, it should be done gradually. In some situations (e.g., replacement therapy for adrenal insufficiency), continuation or even dose increase may be necessary. Infants born to mothers who took Metypred during pregnancy should be carefully observed and examined for adrenal insufficiency.
The effect of Metypred on labor is unknown.
Cataracts have been observed in infants born to mothers treated with Metypred for a prolonged period during pregnancy.
Metypred passes into breast milk; therefore, it should not be used in breastfeeding women.
Animal studies have shown that Metypred has harmful effects on fertility.
Driving and operating machinery
The effect of Metypred on the ability to drive and operate machinery has not been evaluated.
During treatment with Metypred, adverse reactions such as dizziness, visual disturbances, and fatigue may occur. If such symptoms occur, patients should not drive or operate machinery.
Metypred contains lactose
One 4 mg tablet contains 70 mg of monohydrate lactose, and one 16 mg tablet contains 131 mg of monohydrate lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine.

3. How to use Metypred

This medicine should always be used as prescribed by the doctor. In case of doubts, consult
your doctor or pharmacist.
Administer orally.
The tablet may be divided into equal doses.
The 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 necessary for some patients. High-dose therapy is used in cases of: multiple sclerosis (200 mg per day), cerebral edema (200–1000 mg per day), and organ transplantation (up to 7 mg/kg body weight per day). If there is no clinical improvement, the doctor will decide
to discontinue treatment with Metypred and initiate alternative therapy. When long-term treatment needs to be discontinued, a gradual dose reduction is recommended.
Once clinical improvement is achieved, the doctor will establish a maintenance dose by gradually reducing the initial dose at appropriate intervals until the lowest dose that maintains the desired clinical effect is reached. The dose should be continuously monitored. In cases of remission or exacerbation of the disease, individual patient response to treatment, or stressful situations, the doctor may decide that dose adjustment is necessary. In patients exposed to stress, an increase in the dose of Metypred may be required during the period of stress.
The dose varies and must be individually determined according to the type of disease and the patient's individual response.
Intermittent therapy regimen
The doctor may decide to use an intermittent therapy regimen: administering a double daily dose every other 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 cluster of symptoms associated with elevated cortisol levels), growth suppression in children, and symptoms of sudden corticosteroid withdrawal.
Use of a higher than recommended dose of Metypred
If an excessive amount of Metypred is taken, seek immediate medical advice from a doctor or pharmacist. There are no clinical symptoms of acute Metypred overdose. There is no specific antidote for Metypred 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 Metypred from the body.
Missed dose of Metypred
Do not take a double dose of Metypred to make up for a missed dose.
If you have any further doubts regarding 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 will experience them.
If any of the symptoms listed below occur, contact your doctor immediately or go to the nearest hospital:

Frequency unknown (frequency cannot be estimated from the 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 upon first contact with the drug
• Cushing's syndrome, suppression of the hypothalamic-pituitary-adrenal axis, steroid withdrawal syndrome
• Metabolic acidosis, hypertrophic interstitial 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 behaviour,
  mental disturbances, personality changes, confusion, anxiety, mood changes, abnormal behaviour, insomnia, irritability
• Increased intracranial pressure (with optic disc swelling [benign intracranial hypertension]), seizures, memory impairment, cognitive dysfunction, dizziness, headache
• Central serous chorioretinopathy (disorders of retina and choroid), posterior subcapsular cataract, glaucoma, exophthalmos, rarely blurred vision
• Labyrinthine vertigo
• Congestive heart failure (in patients at increased risk)
• Increased blood coagulability, arterial hypertension, arterial 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, diarrhoea, dyspepsia, nausea
• Increased liver enzyme activity (elevated alanine aminotransferase and aspartate aminotransferase activity)
• Angioedema, hirsutism, petechiae, subcutaneous or tissue haemorrhages, skin atrophy, erythema, excessive sweating, striae, rash, pruritus, urticaria, acne
• Muscle weakness, myalgia, myopathy (muscle disease), muscle atrophy, osteoporosis, avascular necrosis of bone, pathological fractures, neuropathic arthropathy, joint pain, growth suppression
• Irregular menstruation
• Scleroderma renal crisis in patients with scleroderma (an autoimmune disorder). Symptoms of scleroderma renal crisis include elevated blood pressure and reduced urine output
• Impaired wound healing, peripheral edema, fatigue, malaise
• Increased intraocular pressure, reduced carbohydrate tolerance, decreased blood potassium concentration, increased calcium excretion in urine, increased serum alkaline phosphatase activity, increased blood urea concentration, suppression of response in skin tests
• Vertebral compression fractures, tendon rupture

Peritonitis may be the first sign of gastrointestinal disorders such as perforation,
constipation, or pancreatitis.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Marketing Authorisation Holder or to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: 22 49 21 301, fax: 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the representative of the Marketing Authorisation Holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Metypred

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label following EXP.
The expiry date refers to the last day of the specified month.
Store below 25°C.
Medicines should 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 packaging and other information

What Metypred contains

One Metypred 4 mg tablet contains:
Active substance: 4 mg of methylprednisolone;
Excipients: monohydrate lactose (70 mg), maize starch, gelatin, magnesium stearate, talc.

One Metypred 16 mg tablet contains:
Active substance: 16 mg of methylprednisolone;
Excipients: monohydrate lactose (131 mg), maize starch, gelatin, magnesium stearate, talc.

What Metypred looks like and contents of the pack

4 mg: White or almost white, round, flat tablets with a score line, 7 mm in diameter.
16 mg: White or almost white, round, flat tablets with a score line, 9 mm in diameter, marked "ORN 346" on one side.

Available pack sizes: 30 or 100 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Orion Corporation
Orionintie 1
02200 Espoo
Finland

Manufacturer:
Orion Corporation
Orionintie 1
02200 Espoo
Finland
Orion Corporation
Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]