Leaflet: information for the user

Methylprednisolone Normon 20 mg powder and solvent for injection EFG

Read this leaflet carefully before you start using this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

4. Possible side effects

5. Storage of Methylprednisolone Normon

6.Contents of the pack and additional information

Metilprednisolona belongs to a group of medications known as corticosteroids (acts at the cellular level by reducing the production of substances that cause inflammation or allergy).

Due to its rapid onset of effect, it is especially indicated in cases that require immediate acute treatment or when the administration of metilprednisolona tablets is not possible, including:

• Severe asthma crises.
• Anaphylactic shock (severe allergic reaction) and clinical situations that may pose a risk to the patient's life, such as generalized urticaria accompanied by inflammation of the feet, hands, throat, lips, and respiratory pathways, or laryngeal edema (swelling of the throat area due to fluid accumulation).
• In accidental poisonings, such as insect bites or snake bites, to prevent anaphylactic shock.
• Cerebral edema (inflammation of the brain due to fluid accumulation) and spinal cord injuries (provided that treatment is initiated within 8 hours of the injury occurring).
• Addisonian crisis (a disorder affecting the adrenal glands located above each kidney that requires immediate medical treatment) and secondary shock due to adrenal cortical insufficiency.
• Acute exacerbations of multiple sclerosis.
• Adjuvant in chemotherapy.

- Acute rejection treatment of organ transplants.

Do not use Metilprednisolona Normon

• if you are allergic (hypersensitive) to the active ingredient, to other glucocorticoids, or to any of the other components of this medicine (listed in section 6),
• except in emergency or substitution treatments, do not use metilprednisolona in the following cases:
• if you have stomach ulcers or duodenal ulcers,
• if you have severe osteoporosis,
• if you have a history of psychiatric disorders, consult your doctor about the suitability of using this medicine,
• if you have glaucoma (closed or open angle),
• if you have herpes keratitis (eye disease),
• if you have lymphadenopathy (inflammation of the lymph nodes) after tuberculosis vaccination,
• if you have an infection caused by amoebas (a type of infectious agent),
• if you have systemic mycosis (infection caused by fungi and spread throughout the body),
• in patients with poliomyelitis (spinal cord disease),
• if you have certain viral infections (such as chickenpox, herpes, or shingles) (see "Warnings and precautions"),
• if you have tuberculosis, or if you only suspect that you may have it,
• 8 weeks before vaccination and 2 weeks after vaccination.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Metilprednisolona Normon:

• if you have or have recently had intestinal diseases due to the risk of intestinal perforation with peritonitis, such as severe ulcerative colitis (with risk of perforation, abscesses, or purulent inflammation), diverticulitis, and intestinal anastomoses,
• metilprednisolona may produce gas in the intestinal wall, a disease called pneumatosis intestinalis (unknown frequency, see section 4. "Possible adverse effects" below). The course of pneumatosis intestinalis varies from a benign disease that does not require treatment to other serious diseases that may require immediate treatment. If you experience symptoms such as "nausea, vomiting, and abdominal pain" that persist or worsen, you should consult your doctor immediately. Your doctor will decide on the need for other diagnostic measures and treatment,
• if you have an infection, as it may decrease your body's defenses, leading to new infections or activating existing ones. In severe infections, metilprednisolona should only be used in conjunction with treatment for the infection,
• contact your doctor if you experience blurred vision or other visual disturbances.
• in patients treated with high-dose intravenous pulses of metilprednisolona, as arrhythmias and cardiac arrest may occur, even in patients with no known cardiac abnormalities,
• except for patients who have already had chickenpox, avoid contact with people who have chickenpox or shingles. If you are exposed to these infections during treatment with metilprednisolona, contact a doctor immediately, even if you do not have any symptoms,
• if you are using metilprednisolona, it is recommended that you not be vaccinated,
• if you have tested positive for the tuberculin test (test to determine tuberculosis disease), inform your doctor,
• if you have myasthenia gravis, especially if you are receiving high-dose glucocorticoid treatment, use a low dose of metilprednisolona at the beginning of treatment and gradually increase it,
• if you have hypothyroidism or liver cirrhosis. In both cases, relatively low doses may be sufficient, and a dose reduction may be necessary. Your doctor will perform regular checks,
• do not interrupt treatment abruptly, but rather gradually. Do not stop using this medication without consulting your doctor (see section 4. "Possible adverse effects"),
• if you are diabetic, or if you have heart failure and very high blood pressure, your doctor will perform regular checks,
• in long-term treatments, ensure adequate potassium intake, limit sodium intake, and analyze blood potassium levels. Your doctor will also perform regular checks to prevent eye complications,
• long-term treatment with corticosteroids may cause osteoporosis,
• in patients with suspected or diagnosed phaeochromocytoma,
• if you have scleroderma (also known as systemic sclerosis, an autoimmune disorder) because daily doses of 12 mg or more may increase the risk of a severe complication called scleroderma renal crisis. Signs of scleroderma renal crisis include high blood pressure and decreased urine production. Your doctor may advise you to monitor blood pressure and urine production regularly,

• if you have kidney problems or high levels of uric acid in your blood before starting treatment with metilprednisolona,
• inform your doctor if you have any symptoms of tumor lysis syndrome such as muscle cramps, muscle weakness, confusion, vision loss or changes, difficulty breathing, seizures, irregular heartbeat, or kidney failure (decreased urine output or dark urine) in the case of malignant hematological neoplasia (see section 4. "Possible adverse effects"),

• do not use metilprednisolona during pregnancy and lactation, except on medical prescription,
• except on medical prescription, avoid administering metilprednisolona to children,
• in premature babies, echocardiograms should be performed to monitor heart function and status,
• when administered to elderly patients, your doctor will monitor you regularly. Elderly patients should avoid prolonged treatment with this medication,
• the administration of metilprednisolona in IV cyclic injection (usually at an initial dose of ≥ 1g/day) may cause drug-induced liver injury, such as acute hepatitis or increased liver enzymes. Rare cases of hepatotoxicity have been reported. The time of appearance of these adverse reactions may be several weeks or more. In most reported cases, resolution of adverse reactions was observed after discontinuation of treatment. Therefore, adequate follow-up is required,
• if you have hyperactivity of the thyroid gland (hyperthyroidism).

Contact your doctor immediately if you experience muscle weakness, muscle pain, cramps, and stiffness while using metilprednisolona. These may be symptoms of a disease called periodic paralysis that can occur in patients with hyperactivity of the thyroid gland (hyperthyroidism) treated with metilprednisolona. You may need additional treatment to alleviate this condition.

Use in athletes

This medication contains metilprednisolona, which may produce a positive result in doping control tests.

Other medications and Metilprednisolona Normon

Inform your doctor or pharmacist if you are taking or have recently taken other medications, including those purchased without a prescription.

Some medications may increase the effects of metilprednisolona, so your doctor will perform thorough checks if you are taking these medications (including some for HIV: ritonavir, cobicistat).

Metilprednisolona Normon may interact with the following medications:

• Amphotericin B, clarithromycin, erythromycin (antibiotics).
• Ciclosporina.
• Coumarin derivatives: oral anticoagulants (such as Sintrom).
• Anticholinesterases (such as neostigmine, pyridostigmine, medications used for muscle spasms, to treat myasthenia gravis, and paralytic ileus).
• Antidiabetics.
• Non-steroidal anti-inflammatory drugs (aspirin, indomethacin) and alcohol.
• Non-depolarizing muscle relaxants.
• Diltiazem (medication used for heart problems).
• Some diuretics (medications used to eliminate water).
• Estradiols (medications used for hormonal imbalances), oral contraceptives.
• Cardiotonic glucosides (medications used to treat heart failure).
• Enzyme inducers:

• Carbamazepine, phenytoin, primidone (medications used to treat epilepsy).
• Rifampicin, rifabutin (antibiotics).

• Enzyme inhibitors such as ketoconazole (used for fungal infections).
• Ion exchange resins (such as cholestyramine, colestipol, medications used to lower cholesterol and triglyceride levels).
• Salicylates.
• Theophylline (medication used for asthma and bronchial problems).
• Vaccines.

Interference with analytical tests

If you are to undergo skin tests ("allergy tests"), inform your doctor that you are using this medication, as it may alter the results.

Use of Metilprednisolona Normon with food and drinks

Avoid taking large amounts of grapefruit juice, as it may interfere with metilprednisolona.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Metilprednisolona, like most medications, should not be administered during pregnancy or lactation, except on medical prescription.

Only use metilprednisolona during the first trimester of pregnancy after consulting with your doctor about the benefits and potential risks for you and the fetus of the different treatment options. This is because metilprednisolona may increase the risk of the baby being born with cleft lip and/or palate (openings or clefts in the upper lip and/or roof of the mouth). If you are pregnant or planning to become pregnant, consult your doctor about the use of metilprednisolona.

Metilprednisolona passes into breast milk. If high doses of metilprednisolona are necessary, breastfeeding should be avoided.

Driving and operating machines

During treatment with metilprednisolona, do not drive or operate tools or machines. Some adverse effects (visual disturbances, dizziness, headache) may impair your ability to concentrate and react.

Important information about some of the components of Metilprednisolona Normon

This medication contains less than 23 mg (1 mmol) of sodium per vial; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

This medication can be administered via intravenous or intramuscular injection.

The dose will be individual for each patient and may be modified by your doctor depending on the severity of the condition and the patient's response. It is recommended to administer20 to40 mg per day in adults and8 to16 mg per day in children.

In severe cases, where within 30 minutes a sufficient therapeutic effect has not been achieved, injections can be repeated, up to a maximum recommended dose of 80 mg. The intervals between two injections will be 30 minutes to 24 hours, depending on the severity of the patient.

If you estimate that the action of methylprednisolone is too strong or too weak, inform your doctor or pharmacist.

In situations that pose a threat to the patient's life, it is recommended to start treatment with single doses of250 to1000 mg of methylprednisolone in adults and4 to20 mg/kg of body weight in children. For this, you may need to use other commercial presentations with methylprednisolone as the active ingredient.

The following are the recommended doses for the different indications:

Acute exacerbations of asthma:30 to90 mg per day. Instatus asthmaticus, it is recommended to administer250 to500 mg of methylprednisolone.

Anaphylactic shock and situations of immediate danger to the patient's life:250 to500 mg of methylprednisolone.

Cerebral edema:250 to500 mg of methylprednisolone.

Addisonian crises:16 to32 mg by infusion, followed by other 16 mg over 24 hours. In these crises and in Waterhouse-Friderichsen syndrome, the simultaneous administration of mineralocorticoids is indicated.

Acute relapses of multiple sclerosis: generally1 gper day via intravenous injection, between 3 and 5 days.

Transplant rejection crises: up to30 mg of methylprednisolone/kg of body weight.

In cases of cerebral edema,status asthmaticus, and immunological crises, it is recommended to continue treatment with oral presentations of methylprednisolone at gradually lower doses.

Methylprednisolone is used in addition to the base therapy (e.g., replacement of circulating fluid volume, heart and circulation treatment, administration of antibodies, analgesia, etc.).

A prolonged treatment with methylprednisolone, particularly with relatively high doses, should not be interrupted abruptly, but gradually (and if necessary, under additional treatment with adrenocorticotropic hormone, ACTH).

If you use more Methylprednisolone Normon than you should

In case of overdose or accidental ingestion,consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested or administered. It is recommended to bring the package insert and packaging to the healthcare professional.

Overdose may cause anxiety, depression, mental confusion, spasms, or gastrointestinal hemorrhages, increased glucose levels (hyperglycemia), elevated blood pressure (hypertension), and edema.

If you forgot to use Methylprednisolone Normon

Do not use a double dose to compensate for the missed doses.

If you interrupt treatment with Methylprednisolona Normon

Do not stop using this medication without consulting your doctor.

After prolonged use of methylprednisolone, if you need to interrupt your treatment, follow your doctor's advice. Your doctor may recommend that you gradually reduce the amount of medication you are taking until you stop taking it completely.

Abrupt interruption of treatment may cause:

- Corticosteroid withdrawal syndrome (see section 4).

- Adrenal insufficiency (low cortisol levels).

- There may be a recurrence of the underlying condition being treated.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Metilprednisolona Normon can cause side effects, although not everyone will experience them.

To classify them, the following definitions of frequencies have been used:

Very common: can affect more than 1 in 10 people

Common: can affect up to 1 in 10 people

Uncommon: can affect up to 1 in 100 people

Rare: can affect up to 1 in 1,000 people

Very rare: can affect up to 1 in 10,000 people

Frequency not known: cannot be estimated from available data

The following side effects have been observed during treatment with Metilprednisolona Normon:

Metabolic and nutritional disorders

Common:Abnormal fat distribution, obesity, increased blood sugar levels, changes in blood lipid levels (such as cholesterol or triglycerides), amenorrhea, hirsutism, weight gain.

Rare:Impotence, problems with the adrenal cortex (glands located above the kidneys that produce hormones), delayed growth in children, increased protein metabolism, elevated urea levels.

Very rare:Reversible accumulation of fat in the epidural canal or thoracic cavity.

Frequency not known:Localized accumulation of adipose tissue. Cases of tumor lysis syndrome have been reported in patients with malignant hematological neoplasms. Tumor lysis syndrome may be revealed by your doctor based on changes in blood tests such as increased uric acid, potassium, or phosphate levels and decreased calcium levels, and may cause symptoms such as muscle cramps, muscle weakness, confusion, vision loss or changes, difficulty breathing, seizures, irregular heartbeat, or renal insufficiency (decreased urine output or dark urine). If you experience such symptoms, you should inform your doctor immediately (see "Warnings and precautions").

Cardiac disorders

Frequency not known:Cardiomyopathy (hypertrophic cardiomyopathy) in premature babies, arrhythmias, and cardiac arrest related to high-dose intravenous pulse therapy.

Vascular disorders

Common:Sodium and water retention, increased potassium excretion, and possibly hypokalemia. In patients with heart failure, it may increase pulmonary congestion and develop hypertension.

Vascular disorders including vasculitis (allergic inflammation of blood vessels), increased intracranial pressure with optic nerve inflammation.

Frequency not known:Increased blood coagulation.

Other effects include a tendency to increase platelet count (thrombocytosis) and an increased risk of thrombosis.

Skin and subcutaneous tissue disorders

Common:Skin changes (atrophy, striae, acne, red-violet patches due to small amounts of blood accumulation in the skin, small red patches).

Rare:Allergic reactions (including skin rash) including anaphylaxis in rare cases after parenteral administration, especially in patients with asthma or after renal transplantation.

Haematological and lymphatic system disorders

Common:Delayed wound healing.

Frequency not known:Elevated white blood cell count, thrombocytopenia (decreased platelet count).

Musculoskeletal and connective tissue disorders

Common:Osteoporosis that in severe cases may lead to fractures.

Rare:Muscle weakness (reversible). In patients with myasthenia gravis, it may cause reversible worsening of weakness that could lead to a myasthenic crisis. Also, a severe muscle disease (acute myopathy) due to the concomitant administration of non-depolarizing muscle relaxants.

Very rare:Death of bone tissue in the head of the femur or humerus, tendon rupture (in people with a previous tendon injury, diabetes, or high uric acid levels in the blood)

When metilprednisolona is administered at very high doses for a long time, it may cause muscle changes.

Renal and urinary disorders

Frequency not known:Scleroderma renal crisis in patients who already have scleroderma (an autoimmune disorder). Signs of scleroderma renal crisis include increased blood pressure and decreased urine production.

Gastrointestinal disorders

Rare:Stomach or duodenal ulcers, and if these perforate, peritonitis (severe gastrointestinal infection), pancreatitis (inflammation of the pancreas), or abdominal discomfort.

Frequency not known:Gas in the intestinal wall (neumatosis intestinal).

Hepatobiliary disorders

Frequency not known:Metilprednisolona may damage your liver; cases of hepatitis and increased liver enzymes have been reported, cholestasis, and cellular damage that may include acute liver failure (see "Warnings and precautions").

Endocrine disorders

Frequency not known:Phaeochromocytoma crisis (see "Warnings and precautions").

The following side effects have been observed after the sudden withdrawal of metilprednisolona after prolonged use, although not everyone will experience them:

• Symptoms such as fever, loss of appetite, nausea, weakness, restlessness, joint pain, skin peeling, low blood pressure, and weight loss (corticosteroid withdrawal syndrome).

Ocular disorders

Rare:Eye damage: opaque lens, increased eye pressure, cataracts, glaucoma (eye disease that may cause vision loss).

Frequency not known:Retinal and choroidal membrane disease, blurred vision.

Immune system disorders

Uncommon:Decreased body defenses and increased risk of infection. If you have a viral disease such as chickenpox, herpes simplex, or herpes zoster, your condition may worsen, in some cases with a serious risk to your health.

Nervous system disorders

Rare:Cerebral seizures,

Frequency not known:Dizziness, headache, and sleep disturbances.

Psychiatric disorders

Rare:Development or worsening of psychiatric problems that the patient had before starting treatment (euphoria, mood changes, personality changes, depression, psychosis).

General disorders and administration site conditions

It may cause skin atrophy when injected into fatty tissue.

If metilprednisolona treatment is withdrawn quickly (not gradually) after long-term treatment, it may cause muscle pain, joint pain, respiratory problems, anorexia, nausea, vomiting, fever, low blood pressure, and even in some cases, death due to acute adrenal insufficiency (see "Warnings and precautions").

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after “Exp”. The expiration date is the last day of the month indicated.

Once the solution is reconstituted, it must be used immediately.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Metilprednisolona Normon 20 mg powder for injectable solution EFG:

• The active ingredient is methylprednisolone. Each vial contains 20 mg of methylprednisolone (in the form of methylprednisolone sodium succinate).
• The other components are: sodium hydroxide, disodium phosphate, monohydrated sodium phosphate. The ampoule solvent contains 1 ml of water for injectable preparations.

Appearance of the product and content of the packaging:

Metilprednisolona Normon 20 mg is presented in powder and injectable solution form. The vial contains a white or almost white, porous lyophilisate, and the ampoule contains a colorless and transparent liquid. Each package contains 1 vial and 1 ampoule.

Holder of the marketing authorization and responsible for manufacturing:

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid, Spain

This information is intended solely for doctors or healthcare professionals

This medication can be administered via intravenous or intramuscular injection.

Intravenous injection should be applied slowly (each vial in 1 or 2 minutes).

Your doctor or nurse will dissolve the contents of a vial of Metilprednisolona Normon in 1 ml of water for injectable preparations contained in the ampoule of solvent.

Concurrent administration of reconstituted methylprednisolone solutions with other medications in the same syringe should be avoided, as precipitation may occur. Mixing with infusion solutions may also lead to turbidity of the solution or the formation of precipitates.

Solutions prepared for injection should be used as soon as possible.

Last review date of this leaflet : October 2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/