Methylprednisolone Normon 20 mg powder and solvent for solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Metilprednisolona Normon 20 mg powder and solvent for injectable solution EFG

Read all of 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Metilprednisolona Normon is and what it is used for
2. What you need to know before using Metilprednisolona Normon
3. How to use Metilprednisolona Normon
4. Possible side effects
5. How to store Metilprednisolona Normon
6. Contents of the pack and other information

1. What Metilprednisolona Normon is and what it is used for

Metilprednisolona belongs to a group of medicines called corticosteroids (it acts at the cellular level by reducing the production of substances that cause inflammation or allergic reactions).

Due to its rapid onset of action, it is especially indicated in severe cases requiring immediate acute treatment or when oral administration of methylprednisolone tablets is not possible, including:

• Severe asthma attacks.

• Anaphylactic shock (severe allergic reaction) and other life-threatening clinical conditions, such as angioedema (generalized hives accompanied by swelling of the feet, hands, throat, lips, and airways) or laryngeal edema (swelling of the throat area due to fluid accumulation).

• Accidental poisonings, such as insect or snake bites, to prevent anaphylactic shock.

• Cerebral edema (brain inflammation due to fluid accumulation) and spinal cord injuries (provided treatment is initiated within 8 hours of the injury).

• Addisonian crisis (a disorder affecting the adrenal glands, located just above each of the two kidneys, which requires immediate medical treatment) and shock secondary to adrenocortical insufficiency.

• Acute relapses of multiple sclerosis.

• As an adjunct in chemotherapy.

• Treatment of acute organ transplant rejection.

2. What you need to know before using Metilprednisolona Normon

Do not use Metilprednisolona Normon

• if you are allergic (hypersensitive) to the active substance, to other glucocorticoids, or to any of the other components of this medicine (listed in section 6),
• except for replacement therapy or emergency treatment, you must not use methylprednisolone in the following cases:
• if you have gastric or duodenal ulcers,
• if you have severe bone demineralization (osteoporosis),
• if you have a history of psychiatric disorders, consult your doctor about the advisability of using this medicine,
• if you have closed-angle or open-angle glaucoma (an eye disease),
• if you have herpetic keratitis (an eye disease),
• if you have lymphadenopathy (swollen lymph nodes) after tuberculosis vaccination,
• if you have an infection caused by amoebae (a type of infectious agent),
• if you have systemic mycosis (a fungal infection disseminated throughout the body),
• in patients with poliomyelitis (a disease of the spinal cord),
• if you have certain viral infections (such as chickenpox, herpes, herpes zoster) (see section “Warnings and precautions”),
• if you have tuberculosis, or if it is only suspected,
• 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,
• methylprednisolone may cause gas in the intestinal wall, a condition known as intestinal pneumatosis (frequency not known, see section 4. “Possible adverse effects” below). The course of intestinal pneumatosis varies from a benign condition requiring no treatment to severe conditions that may require immediate treatment. If you experience persistent or worsening symptoms such as “nausea, vomiting, and abdominal pain,” you must consult your doctor immediately. Your doctor will decide whether further diagnostic measures or treatment are necessary,
• if you have any infection, as methylprednisolone may reduce your body's defenses, potentially leading to new infections or reactivating existing ones. In severe infections, methylprednisolone should only be used in conjunction with specific anti-infective treatment,
• contact your doctor if you experience blurred vision or other visual disturbances,
• in patients receiving high-dose intravenous pulse therapy with methylprednisolone, cardiac arrhythmias and cardiac arrest may occur, even in patients without known cardiac abnormalities,
• except for patients who have already had chickenpox, avoid contact with individuals who have chickenpox or shingles. If you are exposed to these infections during treatment with methylprednisolone, contact a doctor immediately, even if you do not have symptoms,
• if you are using methylprednisolone, it is recommended that you do not get vaccinated,
• if you have tested positive for the tuberculin test (a test to detect tuberculosis), inform your doctor,
• if you have myasthenia gravis, particularly if you are receiving high-dose glucocorticoid therapy, a low initial dose of methylprednisolone should be used and gradually increased,
• if you have hypothyroidism or hepatic cirrhosis. In both cases, relatively low doses may be sufficient, and dose reduction may be necessary. Your doctor will perform regular monitoring,
• treatment must not be stopped abruptly, but should be tapered gradually. Do not stop using this medicine without consulting your doctor (see section 4. “Possible adverse effects”),
• if you are diabetic, or have heart failure or very high blood pressure, your doctor will perform regular monitoring,
• during long-term treatment, ensure adequate potassium intake, limit sodium intake, and monitor blood potassium levels. Additionally, your doctor will perform regular monitoring to prevent eye complications,
• long-term corticosteroid treatment may cause osteoporosis,
• in patients with suspected or diagnosed pheochromocytoma,
• 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 serious complication called scleroderma renal crisis. Signs of scleroderma renal crisis include elevated blood pressure and reduced urine output. Your doctor may advise you to monitor your blood pressure and urine output regularly,
• if you have kidney problems or high levels of uric acid in the blood before starting methylprednisolone treatment,
• you must inform your doctor if you experience symptoms of tumor lysis syndrome such as muscle cramps, muscle weakness, confusion, vision loss or disturbances, difficulty breathing, seizures, irregular heartbeat, or kidney failure (decreased urine output or dark urine), especially if you have a malignant hematological neoplasm (see section 4. “Possible adverse effects”),
• the use of methylprednisolone during pregnancy and breastfeeding is not recommended,
• unless prescribed by a doctor, administration of methylprednisolone to children should be avoided,
• in premature infants, echocardiograms should be performed to monitor heart status and function,
• when administered to elderly patients, the doctor will monitor the patient regularly. Elderly patients should avoid prolonged treatment with this medicine,
• administration of methylprednisolone via cyclic IV injection (usually at an initial dose of ≥1 g/day) may cause drug-induced liver injury, such as acute hepatitis or elevated liver enzymes. Rare cases of hepatotoxicity have been reported. The onset of these adverse reactions may occur after several weeks or longer. In most reported cases, adverse reactions resolved after discontinuation of treatment. Therefore, adequate monitoring is required,
• if you have hyperactivity of the thyroid gland (hyperthyroidism).

Contact your doctor immediately if you experience muscle weakness, muscle pain, cramps, or stiffness while using methylprednisolone. These may be symptoms of a condition called thyrotoxic periodic paralysis, which may occur in patients with hyperthyroidism treated with methylprednisolone. You may require additional treatment to relieve this condition.

Use in athletes

This medicine contains methylprednisolone, which may result in a positive doping test.

Other medicines and Metilprednisolona Normon

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

Some medicines may increase the effects of methylprednisolone, so your doctor will perform careful monitoring if you are taking these medicines (including some used for HIV: ritonavir, cobicistat).

Metilprednisolona Normon may interfere with the following medicines:

• Amphotericin B, clarithromycin, erythromycin (antibiotics).

• Cyclosporine.

• Cumarin derivatives: oral anticoagulants (such as Sintrom).

• Anticholinesterases (such as neostigmine, pyridostigmine, medicines used for muscle spasms, treatment of myasthenia gravis, and paralytic ileus).

• Antidiabetic medicines.

• Non-steroidal anti-inflammatory drugs (acetylsalicylic acid, indomethacin) and alcohol.

• Non-depolarizing muscle relaxants.

• Diltiazem (a medicine used for heart conditions).

• Some diuretics (medicines used to eliminate water).

• Estrogens (medicines used for hormonal disorders), oral contraceptives.

• Cardiac glycosides (medicines used to treat heart failure).

• Enzyme inducers:

• Carbamazepine, phenytoin, barbiturates, or primidone (medicines used to treat epilepsy).

• Rifampicin, rifabutin (antibiotics).

• Enzyme inhibitors such as ketoconazole (used for fungal infections).

• Ion-exchange resins (such as cholestyramine, colestipol, medicines used to reduce cholesterol and triglyceride levels).

• Salicylates.

• Theophylline (a medicine used for asthma and bronchial conditions).

• Vaccines.

Interference with laboratory tests

If you are undergoing skin tests (“allergy tests”), inform your doctor that you are using this medicine, as it may alter the results.

Use of Metilprednisolona Normon with food and drinks

You should avoid consuming large amounts of grapefruit juice, as it may interfere with methylprednisolone.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Methylprednisolone, like most medicines, should not be administered during pregnancy or breastfeeding unless your doctor considers it essential.

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

Methylprednisolone passes into breast milk. If high-dose methylprednisolone is required, breastfeeding should be avoided.

Driving and using machines

During treatment with methylprednisolone, do not drive or operate tools or machinery. 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 medicine contains less than 23 mg (1 mmol) of sodium per vial; hence, it is essentially “sodium-free”.

3. How to use Metilprednisolona Normon

Follow exactly the instructions given by your doctor for administering this medicine. If in doubt, consult your doctor or pharmacist again.

This medicine can be administered by intravenous or intramuscular injection.

The dose will be individual for each patient and may be adjusted by your doctor depending on the severity of the condition and the patient's response. The recommended dose is 20 to 40 mg per day in adults and 8 to 16 mg per day in children.

In severe cases, if a sufficient therapeutic effect has not been achieved within half an hour, injections may be repeated up to a maximum recommended dose of 80 mg. The intervals between injections will range from 30 minutes to 24 hours, depending on the severity of the patient's condition.

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

In life-threatening situations, treatment should be initiated with single doses of 250 to 1000 mg of methylprednisolone in adults and 4 to 20 mg/kg body weight in children. For this purpose, other commercial formulations containing methylprednisolone as the active substance may need to be used.

The following are the recommended doses according to different indications:

Acute exacerbations of asthma: 30 to 90 mg per day. In status asthmaticus, 250 to 500 mg of methylprednisolone is recommended.

Anaphylactic shock and immediately life-threatening situations: 250 to 500 mg of methylprednisolone.

Cerebral edema: 250 to 500 mg of methylprednisolone.

Addisonian crisis: 16 to 32 mg by infusion, followed by another 16 mg over 24 hours. In these crises and in Waterhouse-Friderichsen syndrome, simultaneous administration of mineralocorticoids is indicated.

Acute relapses of multiple sclerosis: generally 1 g per day intravenously for 3 to 5 days.

Rejection crisis: up to 30 mg of methylprednisolone/kg body weight.

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

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

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

If you use more Metilprednisolona Normon than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, stating the medicine and the amount ingested or administered. It is recommended to bring the package leaflet and container to the healthcare professional.

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

If you forget to use Metilprednisolona Normon

Do not use a double dose to make up for missed doses.

If you stop using Metilprednisolona Normon

Do not stop using this medicine without consulting your doctor.

After prolonged use of methylprednisolone, if treatment must be discontinued, follow your doctor's advice. Your doctor may instruct you to gradually reduce the amount of medicine you are taking until you completely stop.

Sudden interruption of treatment may cause:

• Corticosteroid withdrawal syndrome (see section 4).
• Adrenocortical insufficiency (low cortisol levels).
• A recurrence (return) of the underlying condition being treated.

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

4. Possible adverse effects

Like all medicines, Metilprednisolona Normon can cause adverse effects, although not everyone experiences them.

The following frequency definitions have been used for classification:

Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Frequency not known: cannot be estimated from available data

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

Disorders of metabolism and nutrition

Common: Abnormal fat distribution, obesity, increased blood sugar levels, changes in blood fat levels (such as cholesterol or triglycerides), absence of menstrual periods, increased hair growth, weight gain.

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

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

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

Cardiac disorders

Frequency not known: Myocardial disease (hypertrophic cardiomyopathy) in premature infants, arrhythmias and cardiac arrest associated with high-dose intravenous pulse therapy.

Vascular disorders

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

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

Frequency not known: Increased blood clotting.

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

Skin and subcutaneous tissue disorders

Common: Skin changes (atrophy, striae, acne, red-purple spots due to accumulation of small amounts of blood under the skin, small red spots).

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

Blood and lymphatic system disorders

Common: Slowed wound healing.

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

Musculoskeletal and connective tissue disorders

Common: Osteoporosis, which in severe cases may lead to fractures.

Rare: Muscle weakness (reversible). In patients with myasthenia gravis, reversible worsening of weakness may occur, potentially leading to a myasthenic crisis. Also, severe muscle disease (acute myopathy) may occur when non-depolarizing muscle relaxants are administered concomitantly.

Very rare: Avascular necrosis of the femoral head or humeral head, tendon rupture (in individuals with prior tendon injury, diabetes, or high blood uric acid levels).

When methylprednisolone is administered at very high doses for prolonged periods, muscle disorders may occur.

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 output.

Gastrointestinal disorders

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

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

Hepatobiliary disorders

Frequency not known: Methylprednisolone may damage the liver; cases of hepatitis and elevated liver enzymes, cholestasis, and cellular-level damage have been reported, which may include acute liver failure (see section “Warnings and precautions”).

Endocrine disorders

Frequency not known: Pheochromocytoma crisis (see section “Warnings and precautions”).

The following adverse effects have been observed after sudden withdrawal of methylprednisolone following prolonged use, although not everyone experiences them:

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

Eye disorders

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

Frequency not known: Retinal and choroidal disorders, 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, sometimes seriously endangering your health.

Nervous system disorders

Rare: Cerebral seizures.

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

Psychiatric disorders

Rare: Development or worsening of pre-existing psychiatric problems (euphoria, mood changes, personality changes, depression, psychosis).

General disorders and administration site conditions

Skin atrophy may occur when injected into fatty tissue.

If treatment with methylprednisolone is stopped abruptly (not gradually) after long-term use, muscle pain, joint pain, breathing difficulties, anorexia, nausea, vomiting, fever, low blood pressure, low blood sugar levels, and even death due to acute adrenal insufficiency may occur (see section “Warnings and precautions”).

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Metilprednisolona Normon

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the container following “Exp”. The expiry date refers to the last day of the month indicated.

Once reconstituted, the solution must be used immediately.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and any empty containers to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and containers. This will help protect the environment.

6. Contents of the pack and other information

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

• The active substance is methylprednisolone. Each vial contains 20 mg of methylprednisolone (as methylprednisolone sodium succinate).
• The other components are: sodium hydroxide, disodium phosphate, monosodium phosphate monohydrate. The solvent ampoule contains 1 ml of water for injections.

Appearance of the product and pack contents:

Metilprednisolona Normon 20 mg is presented as powder and solvent for injectable solution. The vial contains a white or almost white lyophilized powder with a porous appearance, and the ampoule contains a colorless and clear liquid. Each pack contains 1 vial and 1 ampoule.

Marketing Authorization Holder and Manufacturer:

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid, Spain

This information is intended for healthcare professionals only.

This medicine can be administered by intravenous or intramuscular injection.

Intravenous injection should be given slowly (each vial over 1 to 2 minutes).

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

Concomitant administration of reconstituted methylprednisolone solutions with other medicines in the same syringe should be avoided, as precipitation may occur. Mixing with infusion solutions may also result in cloudiness or formation of precipitates.

Reconstituted solutions for injection should be used as soon as possible.

Date of latest review of this package leaflet: October 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/