Meprelon

Package Leaflet: Information for the User

Meprelon, 8 mg, Tablets

Methylprednisolone

Read the package leaflet carefully before taking 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, consult your 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, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Meprelon and what is it used for

The active substance of Meprelon is a glucocorticosteroid (adrenal cortex hormone) that affects metabolism (i.e., metabolism), water and electrolyte balance, and tissue function. Meprelon is used in diseases that require the administration of glucocorticosteroids. Depending on the symptoms and severity, these include inflammatory and systemic rheumatic diseases, autoimmune diseases, allergic conditions, anaphylactic shock, severe asthma, and transplant rejection.

• Rheumatic diseases: progressive rheumatoid arthritis in severe, progressive form, e.g., with rapid joint destruction, and extra-articular forms.
• Juvenile rheumatoid arthritis with severe course, involving internal organs (Still's syndrome) or eyes, when local treatment is ineffective (uveitis and adjacent structures).

Respiratory diseases:

• Bronchial asthma (concomitant administration of bronchodilators is recommended).
• Exacerbation of chronic obstructive pulmonary disease (recommended treatment period: up to 10 days).
• Specific lung diseases, such as acute alveolitis, pulmonary fibrosis; maintenance treatment of chronic sarcoidosis in stage II and III (with dyspnea, cough, and worsening lung function parameters).
• Severe forms of hay fever and allergic rhinitis after failure of treatment with a glucocorticosteroid nasal spray.

Skin diseases:
Diseases of the skin and mucous membranes that cannot be sufficiently treated with topical corticosteroids due to their severity and/or size or involvement of internal organs. These include:

• Allergic reactions and pseudo-allergic reactions, allergic reactions associated with infections, e.g., urticaria, anaphylactoid reactions.
• Severe skin reactions, sometimes causing skin destruction, drug rash, erythema multiforme, toxic epidermal necrolysis (Lyell's syndrome), generalized acute pustular psoriasis, nodular erythema, severe febrile neutrophilic dermatosis (Sweet's syndrome), allergic contact dermatitis.
• Immune system diseases (autoimmune diseases), e.g., dermatomyositis, discoid and subacute lupus erythematosus.

Blood diseases:

• Autoimmune blood diseases: anemia due to red blood cell destruction (acquired [autoimmune] hemolytic anemia).

Gastrointestinal diseases:

• Ulcerative colitis.
• Crohn's disease.

Replacement therapy:
Decreased or absent adrenal cortex function (adrenal insufficiency of any cause, e.g., Addison's disease, adrenogenital syndrome, postoperative adrenal removal, pituitary insufficiency) after completion of growth (hydrocortisone and cortisone are the drugs of choice).

2. Important information before taking Meprelon

When not to take Meprelon

• If you are allergic to methylprednisolone or any of the other ingredients of this medicine (listed in section 6).
• If you have systemic fungal infections. Except for allergic reactions, there are no contraindications to short-term use of Meprelon in life-threatening conditions or replacement therapy.

Warnings and precautions

Before starting to take Meprelon, discuss it with your doctor or pharmacist,

• if you have hyperthyroidism. If it is necessary to use Meprelon in doses higher than substitution (doses used to supplement the lack of corticosteroids produced by the human body), Meprelon should only be used when the doctor considers it necessary. In some cases, specific-acting drugs against disease-causing factors must be used simultaneously. This applies to the following cases:
• acute viral infections (chickenpox, shingles, herpes virus infections, herpes simplex keratitis);
• acute and chronic bacterial infections;
• fungal infections with internal organ involvement;
• certain parasitic diseases (strongyloidiasis, worm infestations);
• lymph node disease after tuberculosis vaccination (in case of tuberculosis in the history, the medicine can only be used simultaneously with anti-tuberculosis drugs);
• hepatitis (chronic active hepatitis with a positive HBsAg test result);
• poliomyelitis;
• about 8 weeks before and up to 2 weeks after vaccinations with live vaccines.

Meprelon can only be used in the course of the following diseases if the doctor considers it necessary, and the disease will be treated according to the applicable rules:

• peptic ulcer disease;
• uncontrolled hypertension;
• severe diabetes;
• osteoporosis;
• mental illnesses (also in history);
• increased intraocular pressure (glaucoma with closed or open angle filtration);
• corneal damage and ulcers.

Due to the risk of intestinal perforation and peritonitis, Meprelon can only be used with absolute indications and under proper control in the course of the following diseases:

• severe ulcerative colitis (ulcerative colitis) with risk of perforation, with abscesses or purulent inflammation;
• diverticulitis;
• after certain intestinal surgeries (intestinal anastomoses) immediately after surgery.

In patients taking high doses of glucocorticosteroids, symptoms of peritonitis after intestinal perforation may be masked.

Taking Meprelon may cause gas accumulation in the intestinal wall, called intestinal pneumatosis cystoides (see section 4 "Possible side effects"). Intestinal pneumatosis cystoides can range from a mild condition that does not require treatment to more severe conditions that may require immediate treatment.

If symptoms such as nausea, vomiting, and abdominal pain occur, which persist or worsen, you should contact your doctor immediately. The doctor will decide on the need for further diagnosis and treatment.

During treatment for a certain type of muscle paralysis (myasthenia), there may be an initial worsening of symptoms. Therefore, Meprelon should initially be administered in a hospital. Especially in the case of severe facial and throat disorders with breathing difficulties, Meprelon should be introduced gradually.

Meprelon may mask infection symptoms, making it difficult to diagnose an existing or developing infection. Long-term use of even small doses of methylprednisolone leads to an increased risk of infection with microorganisms that usually rarely cause infections.

In principle, it is possible to vaccinate with vaccines containing killed pathogens. However, it should be remembered that when taking higher doses of Meprelon, the effectiveness of the vaccination may be reduced.

In diabetic patients, metabolism (metabolism) should be regularly monitored. It is necessary to consider possible increased demand for anti-diabetic drugs (insulin, oral drugs, etc.).

Especially during long-term treatment with relatively high doses of Meprelon, attention should be paid to adequate potassium intake (e.g., vegetables, bananas) and sodium restriction. The doctor should monitor blood potassium levels.

In cases of severe hypertension or severe heart failure, the doctor should carefully monitor the patient, as there is a risk of deterioration.

Before starting to take Meprelon, discuss it with your doctor if:

Patient has scleroderma (an autoimmune disorder also known as systemic sclerosis), as doses of at least 12 mg per day may increase the risk of a serious complication called scleroderma renal crisis. Scleroderma renal crisis symptoms include high blood pressure and decreased urine production. The attending physician may recommend regular blood pressure and urine output checks.

Tell your doctor if you experience symptoms of tumor lysis syndrome, such as muscle cramps, muscle weakness, confusion, vision loss or disturbances, shortness of breath, seizures, irregular heartbeat, or kidney failure (decreased urine output or darker urine color), as well as in cases where the patient has a blood cancer (see section 4 "Possible side effects").

After administration of Meprelon, cases of pheochromocytoma crisis (high blood pressure, headache, excessive sweating, palpitations, paleness) have been reported, which can lead to death. Treatment of patients with suspected or diagnosed pheochromocytoma should only be started after careful assessment of the benefit-risk ratio.

If you experience blurred vision or other vision disturbances, contact your doctor.

During long-term administration of Meprelon, regular medical check-ups (including ophthalmological check-ups) are necessary.

In cases where the body is under special stress, e.g., diseases with fever, injuries, or surgeries, you should consult your attending physician or inform the emergency doctor about the treatment. Sometimes, a temporary increase in the daily dose of Meprelon may be necessary.

Depending on the duration of treatment and dose, there may be a negative impact on calcium metabolism. Therefore, osteoporosis prevention is recommended. This applies especially to people with existing risk factors, such as family history, advanced age, inadequate protein and calcium intake, smoking, excessive alcohol consumption, postmenopausal period, or lack of physical activity. Prevention involves adequate calcium and vitamin D intake and physical activity. In cases of existing osteoporosis, the use of medications should also be considered.

After stopping or possibly interrupting long-term use of Meprelon, remember the following types of risks: worsening or recurrence of the underlying disease, acute adrenal insufficiency (especially in stressful situations, e.g., during infection, after injuries, with increased stress), "steroid withdrawal syndrome" (see section 4 "Possible side effects").

In patients treated with Meprelon, viral diseases may have a particularly severe course, especially in children with impaired immunity and individuals who have not previously had measles or chickenpox. In cases where these individuals come into contact with people suffering from measles or chickenpox during Meprelon treatment, they should immediately consult a doctor, who may apply preventive measures if necessary.

In cases of uncontrolled hypothyroidism or liver cirrhosis, relatively small doses may be sufficient, or the dose may need to be reduced, which should be determined by the doctor.

Immediately consult a doctor if you 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.

Children

Meprelon can be used in children only if absolutely necessary, due to the risk of growth retardation. Regular growth monitoring is necessary.

After systemic treatment with glucocorticosteroids in premature infants, a specific heart muscle disease (hypertrophic cardiomyopathy) has been observed. Therefore, in infants treated systemically with glucocorticosteroids, heart function should be monitored.

Elderly

In elderly patients, caution should be exercised due to the increased risk of side effects, such as diabetes, osteoporosis, and hypertension.

Effect of the medicine when used inappropriately as a doping agent

Taking Meprelon may result in positive test results for doping substances. Additionally, using Meprelon as a doping agent can pose health risks.

Meprelon and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, including those available without a prescription.

Medicines that affect the action of Meprelon

Medicines that may enhance the effect of Meprelon

• Certain medicines may enhance the effect of Meprelon, and the doctor may want to closely monitor the patient's condition when taking such medicines (including certain HIV medicines: ritonavir, cobicistat).
• Medicines that slow down the metabolism of corticosteroids in the liver, such as certain antifungal medicines (containing ketoconazole, itraconazole), may enhance the effect of Meprelon.
• Certain female sex hormones, e.g., oral contraceptives: the effect of Meprelon may be increased.

Medicines that may weaken the effect of Meprelon

• Medicines that accelerate its breakdown in the liver (barbiturates, phenytoin, primidone, carbamazepine - antiepileptic drugs, rifampicin - anti-tuberculosis drug): the effect of Meprelon may be reduced.
• Medicines containing ephedrine, used to reduce swelling of mucous membranes, may accelerate the metabolism of glucocorticosteroids, which may reduce their effectiveness. Other potential effects
• Medicines used to treat heart diseases (e.g., diltiazem - a calcium channel blocker) may slow down the metabolism of methylprednisolone. Therefore, during the initial treatment period, it should be carried out under medical supervision. It may be necessary to adjust the dose of methylprednisolone.
• Medicines used to reduce excessive stomach acid production (antacids): in patients with chronic liver disease, it may be necessary to increase the dose of Meprelon.

Influence of Meprelon on the effect of other medicines

Enhancement of effect

• Medicines used to treat heart failure (cardiac glycosides): due to the potential induction of potassium deficiency by Meprelon, their effect may increase.
• Diuretics and laxatives: their effect is enhanced in the form of increased potassium excretion.
• Certain muscle relaxants (non-depolarizing muscle relaxants): muscle relaxation may last longer.

Weakening of effect

• Antidiabetic medicines (oral, insulin): their effect may be weakened, leading to increased blood sugar levels.
• Anticoagulant medicines (oral anticoagulants, coumarin derivatives): their blood-clotting-inhibiting effect may be weakened.
• Medicines used to treat parasitic infections (praziquantel): the effect of this medicine may be reduced.
• Growth hormones (somatotropin): their effect is weakened, especially when Meprelon is used in higher doses.
• Protirelin (pituitary hormone): the increase in thyroid-stimulating hormone (TSH) levels is weakened.

Other potential effects

• Anti-inflammatory and anti-rheumatic medicines (salicylates, indomethacin, and other non-steroidal anti-inflammatory drugs): the risk of gastrointestinal ulcers or bleeding may increase.
• Certain ophthalmic medicines (atropine) and medicines with similar effects (other anticholinergic medicines): intraocular pressure may increase further.
• Medicines used to treat malaria or rheumatic diseases (chloroquine, hydroxychloroquine, mefloquine): there is an increased risk of muscle diseases or heart muscle diseases.
• Cyclosporin (an immunosuppressive medicine): the blood level of cyclosporin increases, leading to an increased risk of seizures.
• Certain medicines used to treat hypertension (angiotensin-converting enzyme inhibitors): the risk of blood disorders increases.

Influence on test results: the skin reaction in allergy tests may be reduced.

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 medicine.

In animal studies, it has been shown that Meprelon has a fertility-impairing effect.

Until appropriate studies are conducted on the effect of Meprelon on human reproductive processes, this medicine should not be given to pregnant women unless a thorough assessment of the benefit-risk ratio for the mother and fetus has been made.

Certain corticosteroids easily cross the placental barrier. In one retrospective study, an increased incidence of low birth weight in newborns born to mothers taking corticosteroids was found. In humans, the risk of low birth weight is dose-dependent. This risk can be reduced by administering smaller doses of corticosteroids.

If there is a need to stop long-term use of Meprelon during pregnancy, it should be done gradually. In some situations (e.g., in replacement therapy for adrenal insufficiency), it may be necessary to continue treatment or even increase the dose. Children born to mothers who took Meprelon during pregnancy should be closely monitored and examined for adrenal insufficiency.

The effect of Meprelon on the course of labor is unknown.

In infants born to mothers who took Meprelon for a long time during pregnancy, cataract development has been observed.

Meprelon passes into breast milk.

This medicine can be used by breastfeeding women only after a thorough assessment of the benefit-risk ratio for the mother and infant.

Driving and using machines

Due to the occurrence of certain side effects, such as blurred vision (due to cataracts or increased intraocular pressure), dizziness, or headaches, there may be a deterioration in concentration and reaction abilities. It is possible that the patient may not be able to react quickly enough to sudden and unexpected events. This may be associated with a risk, for example, when driving a vehicle or operating machinery. The patient may unnecessarily put themselves and others at risk. Note that alcohol can increase this risk.

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Meprelon

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.

The doctor will determine the dose of Meprelon individually for each patient, depending on the type of disease and the patient's individual response. You must follow the instructions, as otherwise, the effect of Meprelon will not be correct. In case of doubts, consult your doctor or pharmacist again.

Usually, relatively high initial doses are used (from 4 mg to 48 mg). These must be clearly higher in acute, severe forms of diseases than in chronic diseases.

Depending on the course of the disease, the dose can be reduced to the smallest possible maintenance dose (usually from 4 to 12 mg of methylprednisolone per day). Especially in the treatment of chronic diseases, long-term treatment with small maintenance doses is often necessary.

Method of administration

The medicine is taken orally.

• Usually, the tablets (the entire daily dose) are taken before or after breakfast (from 6:00 to 8:00), without chewing, with a sufficient amount of liquid, e.g., with one glass of water. If the clinical condition allows, the doctor may recommend taking the medicine every other day.

Taking a higher dose of Meprelon than recommended

Usually, Meprelon is well-tolerated without complications even after short-term use in high doses. There is no need for special measures. If intensified or atypical side effects are observed, you should consult a doctor.

Missing a dose of Meprelon

A missed dose can be taken during the day. The next day, the dose is taken as usual. If several doses are missed, the disease may worsen. In such cases, consult a doctor, who will check and possibly correct the treatment.

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

Stopping Meprelon treatment

Follow the doctor's instructions carefully. Do not stop taking Meprelon on your own. The doctor may prescribe a gradual reduction in the dose of the medicine until it is completely discontinued.

In case of sudden withdrawal of Meprelon, remember the following types of risks (see also section 2 "Warnings and precautions"):

• "steroid withdrawal syndrome" (see section 4 "Possible side effects"),
• adrenal insufficiency (low cortisol levels),
• worsening or recurrence of the underlying disease.

Especially long-term use of Meprelon may lead to inhibition of the body's own glucocorticosteroid production. Severe stress on the body could be life-threatening (adrenal crisis).

If you feel that the effect of Meprelon is too strong or too weak, consult your doctor or pharmacist.

If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Meprelon can cause side effects, although not everybody gets them.

Side effects have been listed without information on their frequency. Frequency cannot be determined based on available data.

Replacement therapy:

Low risk of side effects when following the recommended dosage.

Treatment of certain diseases, using higher doses than in replacement therapy:

Depending on the duration of treatment and dose, the following side effects may occur:

Blood and lymphatic system disorders

Changes in blood morphology (increased white blood cell count, red blood cells, platelets, decreased granulocyte count).

Immune system disorders

Immunosuppression (e.g., increased risk of infections, appearance of infection symptoms in asymptomatic carriers, worsening of infection symptoms), allergic reactions.

Endocrine disorders

Pheochromocytoma crisis (high blood pressure, headache, sweating, palpitations, paleness), Cushing's syndrome (typical symptoms are moon face, central obesity, and facial flushing), adrenal insufficiency or atrophy, growth retardation in children, hormonal disorders (amenorrhea, hirsutism, erectile dysfunction).

In case of sudden withdrawal of Meprelon after long-term treatment, the following side effects have been observed, although not in every patient:

fever, loss of appetite, nausea, weakness, anxiety, drowsiness, malaise, joint pain, skin peeling, hypotension, weight loss.

Metabolic and nutritional disorders

Tumor lysis syndrome has been reported in patients with hematological malignancies. Tumor lysis syndrome can be diagnosed by the doctor based on changes in blood test results causing high levels of uric acid, potassium, or phosphates and decreased calcium levels. Symptoms include muscle cramps, muscle weakness, confusion, vision loss or disturbances, shortness of breath, seizures, irregular heartbeat, or kidney failure (decreased urine output or darker urine color). If such symptoms occur, consult a doctor immediately (see section 2 "Warnings and precautions").

Accumulation of fat tissue in certain parts of the body (supraclavicular or mediastinal lipomatosis). Increased blood sugar levels, diabetes, increased lipid levels in the blood (cholesterol and triglycerides), tissue edema, potassium deficiency due to increased potassium excretion (attention to cardiac arrhythmias), increased protein breakdown.

Psychiatric disorders

Depression, irritability, personality changes, euphoria, mood swings, increased drive and appetite, psychoses, sleep disturbances.

Nervous system disorders

Increased intracranial pressure (especially in children), appearance of symptoms of previously undiagnosed epilepsy and increased susceptibility to seizures in existing epilepsy, dizziness, headaches.

Eye disorders

Increased intraocular pressure (glaucoma), cataract, worsening of corneal ulcers, worsening of viral, bacterial, or fungal infections, blurred vision.

Retinal and choroidal disorders.

Cardiac disorders

Worsening of pulmonary congestion in heart failure, certain heart muscle disorders in premature infants (see section 2 "Children").

Vascular disorders

Increased blood pressure, increased risk of atherosclerosis and thrombosis, increased blood clotting, vasculitis (also as a withdrawal syndrome after long-term treatment).

Gastrointestinal disorders

Ulcers of the stomach or intestines with risk of perforation (e.g., peritonitis), gastrointestinal bleeding, pancreatitis, abdominal discomfort, gas accumulation in the intestinal wall (intestinal pneumatosis cystoides).

Hepatobiliary disorders

Increased liver enzyme activity.

Skin and subcutaneous tissue disorders

Stretch marks, skin thinning ("parchment-like" skin), dilation of skin blood vessels, tendency to bruise, petechiae or ecchymoses, hirsutism, acne, delayed wound healing, facial skin inflammation, especially around the mouth, nose, and eyes, skin pigmentation changes, hypersensitivity reactions, e.g., skin rash.

Musculoskeletal and connective tissue disorders

Muscle weakness and atrophy, in myasthenia (muscle weakness) reversible increased muscle weakness, which can lead to myasthenic crisis, induction of acute myopathy (muscle disease) when using non-depolarizing muscle relaxants (see also section 2 "Meprelon and other medicines"), osteoporosis (depending on the dose), which can lead to an increased risk of bone fractures, other forms of osteoporosis (aseptic bone necrosis, e.g., of the humeral or femoral head), tendon rupture.

Note: After rapid dose reduction after long-term treatment, muscle and joint pain may occur.

In patients receiving corticosteroids, Kaposi's sarcoma has been observed.

Renal and urinary disorders

Scleroderma renal crisis in patients with scleroderma (an autoimmune disorder). Scleroderma renal crisis symptoms include high blood pressure and decreased urine production.

Investigations

Weight gain.

Special instructions:

If you experience any side effects mentioned in this leaflet or other side effects while taking Meprelon, inform your doctor or pharmacist. Do not stop treatment on your own.

In case of gastrointestinal or back pain, or psychiatric disorders, or significant changes in blood sugar levels, or other disorders in diabetic patients, consult a doctor immediately.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell 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

Tel.: +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.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Meprelon

Keep the medicine out of the sight and reach of children.

Store in a temperature below 30°C.

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Meprelon contains

• The active substance of Meprelon is methylprednisolone. One tablet contains 8 mg of methylprednisolone.
• The other ingredients of the medicine are mannitol, hydroxypropyl cellulose, hypromellose (type 2910, 3 mPas), mannitol (spray-dried), microcrystalline cellulose, sodium croscarmellose, colloidal silicon dioxide, dibehenic acid glyceride, magnesium stearate.

What Meprelon looks like and contents of the pack

Meprelon 8 mg is a white to yellowish-white, round tablet with a cross-shaped score line and an oval imprint, approximately 9 mm in diameter. The medicine is available in packs of 30, 50, and 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

SUN-FARM Sp. z o.o.

ul. Dolna 21

05-092 Łomianki

tel. +48 22 350 66 69

Manufacturer

mibe GmbH Arzneimittel

Münchener Straße 15

06796 Brehna

Germany

Date of last revision of the leaflet: