Metipred

Leaflet attached to the packaging: patient information

Metypred, 4 mg, tablets

Metypred, 16 mg, tablets

Methylprednisolone

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Metypred and what is it 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 packaging and other information

1. What is Metypred and what is it used for

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

Metypred is used as symptomatic treatment, except for endocrine disorders, when it is used as substitution (replacement) treatment.
Disorders other than endocrine disorders
Rheumatic diseases
Supportive treatment for short-term use (during an episode of exacerbation or worsening 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 degenerative joint disease;
• synovitis in the course of degenerative joint disease;
• epicondylitis.

Systemic connective tissue diseases
During exacerbation or as maintenance treatment in the course of:

• systemic lupus erythematosus (and kidney inflammation in the course of lupus);
• polymyositis and dermatomyositis;
• acute rheumatic myocarditis;
• polymyalgia rheumatica;
• giant cell arteritis.

Dermatological diseases

• pemphigus;
• pemphigoid blistering skin disease;
• severe form of erythema multiforme (Stevens-Johnson syndrome);
• exfoliative dermatitis;
• fungoid granuloma;
• severe form of psoriasis;
• severe form of seborrheic dermatitis.

Allergic diseases
Treatment of severe allergic diseases, in cases where other treatment methods are ineffective:

• seasonal or perennial (non-seasonal) allergic rhinitis;
• serum sickness;
• bronchial 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 of the posterior segment of the eye and uveitis;
• sympathetic uveitis;
• allergic conjunctivitis;
• keratitis;
• uveitis and retinitis;
• optic neuritis;
• iritis, iridocyclitis.

Respiratory diseases

• sarcoidosis;
• Loeffler's syndrome not responding to other medications;
• berylliosis;
• fulminant or disseminated pulmonary tuberculosis, simultaneously with appropriate anti-tuberculosis 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 production) or remission of proteinuria (proteinuria) in nephrotic syndrome, without uremia, idiopathic or in the course of lupus.

Gastrointestinal diseases
In exacerbation:

• ulcerative colitis;
• Crohn's disease.

Nervous system diseases

• exacerbation in the course of multiple sclerosis;
• brain edema associated with the presence of a brain tumor.

Other

• organ transplantation.

Endocrine disorders

• primary or secondary adrenal cortex 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 Metypred

When not to take Metypred

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

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

Warnings and precautions

Before starting to take Metypred, you should discuss it with your doctor or pharmacist.

Immunosuppressive action/Increased susceptibility to infections

Metypred may increase susceptibility to infections and may mask some symptoms of infection. During its use, new infections may occur. While taking Metypred, there may be a decrease in the body's immunity 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 Metypred 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.
Live vaccines should not be administered to patients taking immunosuppressive doses of corticosteroids.
In patients with active tuberculosis, Metypred should only be used in cases of fulminant or disseminated disease, in combination with other anti-tuberculosis medications. If it is necessary to administer Metypred to a patient with latent or positive tuberculin test tuberculosis, 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 treatment with Metypred, allergic reactions (e.g., angioedema) may occur.
In patients taking Metypred, rare cases of skin and anaphylactic reactions and (or) anaphylactoid reactions have been reported. Before administering Metypred, the doctor will take appropriate precautions, especially if the patient has a history of allergic reactions to any medication.

Endocrine disorders

If a patient undergoing treatment with Metypred experiences severe stress, the doctor may recommend increasing the dose of rapidly acting corticosteroids before, during, and after the stressful situation.
During treatment with Metypred, adrenal insufficiency may occur, which may persist for several months after discontinuation of treatment. You should inform your 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 Metypred.
Sudden discontinuation of Metypred may cause acute adrenal insufficiency, leading to death.
After sudden discontinuation of Metypred, 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 Metypred concentration rather than its low concentration.
Patients with Cushing's syndrome should not take Metypred, as it may cause or exacerbate Cushing's syndrome.
Metypred may have a stronger effect in patients with hypothyroidism.
You should immediately consult a doctor if you have hyperthyroidism and 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

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

Psychiatric disorders

During treatment with Metypred and after its discontinuation, psychiatric disorders may occur.
They usually occur within a few days or weeks of starting treatment with Metypred.
Most of them disappear after reducing the dose or discontinuing Metypred. Patients and their caregivers should consult a doctor if the patient experiences psychiatric symptoms, especially if they suspect depressive mood or suicidal thoughts.
Patients and their 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.
In patients with myasthenia, the doctor will exercise caution when using Metypred.
There have been reports of exophthalmos in patients taking Metypred, usually with long-term use of high doses.

Effect on the eyes

Caution should be exercised in patients with ocular herpes or herpes zoster, with symptoms from the eyeball, as treatment with Metypred may increase the risk of corneal perforation.
In patients taking Metypred 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 Metypred may also be more likely to develop secondary fungal or viral eye infections.
Treatment with Metypred is associated with the risk of central serous chorioretinopathy, which can lead to retinal detachment.
If a patient experiences blurred vision or other visual disturbances, they should contact a doctor.

Effect on the heart

Metypred 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 and long-term treatment with Metypred. In these patients, the doctor will exercise caution when using Metypred and may recommend monitoring the cardiovascular system. The doctor may recommend using Metypred in a low dose and in an alternate-day regimen, as this may reduce the frequency of treatment complications.
In patients with congestive heart failure, treatment with Metypred should be used with caution and only when necessary.

Effect on the vascular system

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

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 bleeding may occur without significant pain. Treatment with Metypred 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, Metypred should be used with caution, especially if there is a risk of perforation, abscess, or other forms of purulent infection, diverticulitis, recent intestinal anastomosis, or 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.
In patients with liver cirrhosis, the effect of Metypred may be increased.

Effect on the musculoskeletal system

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

Renal and urinary disorders

Before starting to take Metypred, you should discuss it with your doctor or pharmacist if you have scleroderma (an autoimmune disorder also known as systemic sclerosis), as doses of at least 15 mg per day may increase the risk of developing a serious complication called scleroderma renal crisis. The symptoms of scleroderma renal crisis include increased blood pressure and decreased urine production. The attending physician may recommend regular blood pressure and urine output checks.
Metypred should be used with caution in patients with renal insufficiency.

Diagnostic tests

The use of medium and high doses of Metypred 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 Metypred, increase calcium excretion.

Injuries, poisoning, and post-procedure complications

Metypred 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 be cautious when taking aspirin and non-steroidal anti-inflammatory drugs (NSAIDs) with Metypred.
After administration of Metypred, a crisis in the course of pheochromocytoma has been reported, sometimes fatal. The doctor will decide on the use of Metypred only after careful assessment of the risk-benefit ratio in patients suspected of having or diagnosed with pheochromocytoma.
During corticosteroid therapy for cancer, tumor lysis syndrome may occur. You should inform your doctor if you 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 Metypred should be closely monitored for growth and development.
In children undergoing long-term treatment with Metypred, in daily divided doses, growth retardation may occur. The doctor should limit this type of treatment to the most severe indications. Adverse reactions can be avoided or minimized by using an intermittent treatment regimen.
Infants and children undergoing long-term treatment with Metypred are particularly susceptible to increased intracranial pressure.
High doses of Metypred may cause pancreatitis in children.
After administration of Metypred in premature infants, hypertrophic cardiomyopathy (thickening of the heart muscle) may develop. The doctor will perform appropriate tests and monitor heart function and structure.

Metypred and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan 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, so the doctor may want to closely monitor the patient's condition when taking such medicines. It may be necessary to adjust the dose of Metypred when used in combination with the following medicines:

• antibacterial agents: isoniazid
• anti-tuberculosis antibiotic: rifampicin
• oral anticoagulants. Concomitant use with Metypred may decrease or increase the effect of anticoagulants. Blood coagulation tests should be monitored to ensure adequate anticoagulant effect
• antiepileptic drugs: carbamazepine, phenobarbital, phenytoin
• anticholinergic agents: blocking neuromuscular transmission. During concomitant use of high doses of Metypred and anticholinergic agents, e.g., neuromuscular blocking agents, reports of acute myopathy have been made. Muscle relaxants, e.g., pancuronium, vecuronium: Metypred may partially inhibit neuromuscular blockade caused by muscle relaxants
• anticholinesterases: Metypred may reduce the effect of anticholinesterases in patients with myasthenia
• antidiabetic drugs: in diabetic patients, it may be necessary to adjust the dose of antidiabetic drugs, as Metypred may increase blood glucose levels
• antiemetic agents: aprepitant, fosaprepitant
• antifungal agents: itraconazole, ketoconazole
• certain HIV drugs: indinavir, ritonavir, cobicistat
• calcium channel blocker: diltiazem
• oral contraceptives: ethinyl estradiol/norethindrone
• grapefruit juice
• immunosuppressive agent: cyclosporine. When cyclosporine and Metypred are used concomitantly, there is mutual inhibition of metabolism, which may increase the concentration of one or both drugs in the blood. As a result, there is a possibility that concomitant administration may increase the risk of adverse reactions associated with taking one of the drugs. Seizures have been reported during concomitant use
• immunosuppressive agents: cyclophosphamide, tacrolimus
• macrolide antibacterial agents: clarithromycin, erythromycin, troleandomycin
• non-steroidal anti-inflammatory drugs (NSAIDs): high doses of aspirin (acetylsalicylic acid) may increase the frequency of gastrointestinal bleeding and ulceration
• potassium-lowering agents. When Metypred is used concomitantly with potassium-lowering agents (e.g., diuretics), patients should be monitored for the development of hypokalemia (a condition where the potassium ion concentration in the blood is below the laboratory norm). During concomitant use of Metypred 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, you should consult a doctor or pharmacist before taking this medicine.
Before taking this medicine in pregnant or breastfeeding women, or women of childbearing age, the potential benefits of corticosteroid therapy for the mother should be weighed against the potential risks of adverse reactions in the fetus or breastfed child.
In some animal studies, it has been shown that corticosteroids administered to pregnant mothers in high doses may cause fetal developmental abnormalities.
Metypred should be used in pregnant women only when absolutely necessary.
If there is a need to discontinue chronic use of Metypred during pregnancy, it should be done gradually. In some situations (e.g., replacement therapy for adrenal insufficiency), it may be necessary to continue treatment or even increase the dose. Children born to mothers who took Metypred during pregnancy should be closely monitored and tested for adrenal insufficiency.
The effect of Metypred on the course of labor is unknown.
In infants born to mothers who were treated with Metypred for a long time during pregnancy, cataracts have been observed.
Metypred passes into breast milk, so it should not be used in breastfeeding women.
Animal studies have shown that Metypred has a detrimental effect on fertility.

Driving and using machines

The effect of Metypred on the ability to drive and use machines has not been evaluated.
During treatment with Metypred, adverse reactions such as dizziness, visual disturbances, and fatigue are possible. If such symptoms are observed, patients should not drive vehicles or operate machines.

Metypred contains lactose

One 4 mg tablet contains 70 mg of lactose monohydrate, and one 16 mg tablet contains 131 mg of lactose monohydrate. If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Metypred

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, you should consult your doctor or pharmacist.
Take orally.
The tablet can be divided into equal doses.
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 the case 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 multiple sclerosis (200 mg per day), brain 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 use another treatment. In cases where discontinuation of long-term treatment is necessary, it is recommended to gradually reduce the dose.
In the event of clinical improvement, the doctor will establish a maintenance dose by gradually reducing the initial dose at appropriate intervals until the smallest dose that maintains the beneficial clinical effect is achieved. The dose should be constantly monitored. In the event of remission or exacerbation of the disease, individual patient response to treatment, or stressful situations, the doctor may decide to modify the dose. In patients exposed to stress, it may be necessary to increase the dose of Metypred during the stressful situation.
The dose is variable and must be determined individually, depending on the type of disease and the patient's individual response.
Intermittent treatment regimen
The doctor may decide to use an intermittent treatment regimen: administering a double daily dose every other day in the morning. The purpose of this treatment regimen is to ensure the beneficial effect of corticosteroids while minimizing some adverse reactions, such as:

Use of a higher than recommended dose of Metypred

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

Missing a dose of Metypred

You should not take a double dose of Metypred to make up for a missed dose.
If you have any further doubts about the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Metypred can cause side effects, although not everybody gets them.
If you experience any of the following symptoms, you should immediately inform your doctor or go to the nearest hospital:
Frequency not known (frequency cannot be estimated from the available data)

• opportunistic infections (infections characteristic of individuals with reduced immunity), 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 involving the entire body, which can occur after the first contact with the medicine
• 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 agents 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, amnesia, cognitive impairment, dizziness, headache
• central serous chorioretinopathy (retinal and choroidal disorders), posterior subcapsular cataracts, glaucoma, exophthalmos, rarely - blurred vision
• vertigo of labyrinthine origin
• congestive heart failure (in patients with increased risk)
• increased blood coagulability, hypertension, hypotension, feeling of heat and flushing
• pulmonary embolism, hiccups
• peptic ulcers (with possible subsequent perforation and bleeding), intestinal perforations, gastrointestinal bleeding, pancreatitis, esophagitis, esophageal ulcer, abdominal distension, abdominal pain, diarrhea, dyspepsia, nausea
• increased liver enzyme activity (increased alanine aminotransferase and aspartate aminotransferase activity)
• angioedema, excessive hair growth, purpura, subcutaneous or soft tissue hemorrhages, skin atrophy, rash, excessive sweating, striae, urticaria, pruritus, acne
• muscle weakness, muscle pain, myopathy (muscle disease), muscle atrophy, osteoporosis, bone necrosis, pathological fractures, neuropathic arthropathy, arthralgia, growth retardation
• irregular menstrual cycles
• scleroderma renal crisis in patients with scleroderma (an autoimmune disorder). The symptoms of scleroderma renal crisis include increased blood pressure and decreased urine production
• wound healing disorders, peripheral edema, fatigue, malaise
• increased intraocular pressure, impaired glucose tolerance, hypokalemia, hypercalcemia in the urine, increased alkaline phosphatase activity in the blood, increased urea levels in the blood, suppression of skin test responses
• 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, you should tell your doctor or pharmacist. Side effects can be reported directly to the marketing authorization holder or to the Department of Adverse Reaction Monitoring of 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
Side effects can also be reported to the representative of the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Metypred

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label after EXP.
The expiry date refers to the last day of the month.
Store at a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This 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 methylprednisolone;
excipients: lactose monohydrate (70 mg), cornstarch, gelatin, magnesium stearate, talc.
One Metypred 16 mg tablet contains
active substance: 16 mg methylprednisolone;
excipients: lactose monohydrate (131 mg), cornstarch, gelatin, magnesium stearate, talc.

What Metypred looks like and contents of the pack

4 mg: White or almost white, round, flat tablets with a dividing line, 7 mm in diameter.
16 mg: White or almost white, round, flat tablets with a dividing line, 9 mm in diameter, marked with "ORN 346" on one side.
Available packs: 30 or 100 tablets

Marketing authorization holder and manufacturer

Marketing authorization 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
To obtain more detailed information about this medicine, you should contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o.o.
[email protected]

Date of last revision of the leaflet: