Methylprednisolone Normon 40 mg powder and solvent for solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Metilprednisolona Normon 40 mg powder and solvent for injectable solution EFG

Read the entire 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 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.

Leaflet contents

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 adverse effects

5. Storage of 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 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 in replacement or emergency treatments, you must not use Metilprednisolona Normon 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 spinal cord disease),
• if you have certain viral infections (such as chickenpox, herpes, herpes zoster) (see section “Warnings and precautions”),
• if you have tuberculosis, or if you only suspect you might have it,
• 8 weeks before vaccination and 2 weeks after vaccination.

Warnings and precautions

Talk to 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, or intestinal anastomoses,
• metilprednisolone may cause gas in the intestinal wall, a condition known as intestinal pneumatosis (frequency not known, see section 4. “Possible side 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 contact your doctor immediately. Your doctor will decide whether further diagnostic measures or treatment are needed,
• if you have any infection, as it may reduce your body's defenses, leading to new infections or reactivation of existing ones. In severe infections, metilprednisolone should only be used together with treatment for the infection,
• contact your doctor if you experience blurred vision or other visual disturbances,
• in patients treated with intravenous high-dose pulses of metilprednisolone, 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 people who have chickenpox or shingles. If during treatment with metilprednisolone you are exposed to these infections, contact a doctor immediately, even if you do not have symptoms,
• if you are using metilprednisolone, vaccination is not recommended,
• if you tested positive for the tuberculin test (a test to detect tuberculosis), inform your doctor,
• if you have myasthenia gravis, particularly if receiving high-dose glucocorticoid treatment, a low initial dose of metilprednisolone 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 tapered gradually. Do not stop using this medicine without consulting your doctor (see section 4. “Possible side 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 treatment with corticosteroids 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 increased blood pressure and reduced urine output. Your doctor may recommend periodic monitoring of blood pressure and urine,
• if you have kidney problems or high levels of uric acid in the blood before starting metilprednisolone treatment,
• inform your doctor if you experience any symptoms of tumor lysis syndrome such as muscle cramps, muscle weakness, confusion, visual loss or disturbances, difficulty breathing, seizures, irregular heartbeat, or kidney failure (decreased urine output or dark urine), if you have a malignant hematological neoplasm (see section 4. “Possible side effects”),
• the use of metilprednisolone during pregnancy and breastfeeding is not recommended,
• unless prescribed by a doctor, metilprednisolone should be avoided in children,
• 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 metilprednisolone in 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 more. In most reported cases, adverse reactions resolved after discontinuation of treatment. Therefore, appropriate monitoring is required,
• if you have overactivity of the thyroid gland (hyperthyroidism).

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

Use in athletes

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

Other medicines and Metilprednisolona Normon

Tell 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 metilprednisolone, so your doctor will perform careful monitoring if you are taking these medicines (including some used for HIV: ritonavir, cobicistat).

Metilprednisolone 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, for treating myasthenia gravis, and paralytic ileus).

• Antidiabetics.

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

• Non-depolarizing muscle relaxants.

• Diltiazem (a medicine used for heart problems).

• Some diuretics (medicines used to eliminate water).

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

• Cardiotonic 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 lower cholesterol and triglyceride levels).

• Salicylates.

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

• Vaccines.

Interference with diagnostic 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

Avoid drinking large amounts of grapefruit juice, as it may interfere with metilprednisolone.

Pregnancy, breastfeeding, and fertility

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

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

Only use metilprednisolone 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 metilprednisolone may increase the risk of a baby being born with cleft lip and/or cleft palate (openings or splits in the upper lip and/or roof of the mouth). If you are pregnant or planning to become pregnant, discuss the use of metilprednisolone with your doctor.

Metilprednisolone passes into breast milk. If high doses of metilprednisolone are required, breastfeeding should be avoided.

Driving and using machines

During treatment with metilprednisolone, 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; this is essentially “sodium-free”.

3. How to use Metilprednisolona Normon

Follow exactly the instructions for administration of this medicine as given by your doctor. 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. A dose of 20 to 40 mg per day is recommended for adults and 8 to 16 mg per day for 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 consider the effect of methylprednisolone to be 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 ingredient may need to be used.

The following are the recommended doses for 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 other 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 standard 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, must not be stopped abruptly, but should be 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 Poison Information Service at telephone 91 562 04 20, stating the name of 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 bleeding, 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 you need to discontinue treatment, follow your doctor's advice. Your doctor may instruct you to gradually reduce the amount of medicine you are taking until you stop completely.

Sudden discontinuation 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:

Metabolism and nutrition disorders

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, problems with the adrenal cortex (glands located above the kidneys that produce hormones), growth retardation 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 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 through changes in blood tests such as increased levels of uric acid, potassium, or phosphorus and decreased calcium levels, and may cause symptoms such as muscle cramps, muscle weakness, confusion, visual loss or disturbances, difficulty breathing, seizures, irregular heartbeat, or renal failure (reduced urine output or dark urine). If you experience any of these 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 hypokalemia.

In patients with heart failure, pulmonary congestion may increase and hypertension may develop.

Blood vessel disorders 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 toward 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: Delayed wound healing.

Frequency not known: Elevated white blood cell count, thrombocytopenia (decreased 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, it may cause a reversible worsening of weakness, potentially leading to a myasthenic crisis.

Also, severe muscle disease (acute myopathy) due to concomitant administration of non-depolarizing muscle relaxants.

Very rare: Bone tissue death in the head of the femur or humerus (avascular necrosis), tendon rupture (in individuals with prior tendon injury, diabetes, or high blood uric acid levels).

When methylprednisolone is administered at very high doses over a long period, 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 elevated blood pressure and reduced 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 your liver; cases of hepatitis and elevated liver enzymes, cholestasis, and cellular-level liver 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 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).

Eye disorders

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

Frequency not known: Choroidal and retinal disorders, blurred vision.

Immune system disorders

Uncommon: Decreased body defenses and increased risk of infection. If you have a viral disease such as chickenpox, simple herpes, or shingles, your condition could worsen, sometimes seriously endangering your health.

Nervous system disorders

Rare: Cerebral seizures.

Frequency not known: Dizziness, headache, 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, hypotension, 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 effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Methylprednisolone Normonn

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 which is stated on the packaging after "Exp". The expiry date refers to the last day of the month indicated.

Once reconstituted, the solution must be used immediately.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Metilprednisolona Normon 40 mg powder and solvent for injectable solution EFG:

• The active substance is methylprednisolone. Each vial contains 40 mg of methylprednisolone (as sodium methylprednisolone succinate).
• The other components are: sodium hydroxide, disodium phosphate, monohydrate sodium phosphate. The solvent ampoule contains 1 ml of water for injections.

Appearance of the product and contents of the pack:

Metilprednisolona Normon 40 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 transparent 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 medicinal product can be administered by intravenous or intramuscular injection.

Intravenous injection must be given slowly (each vial over 1 or 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 precipitate formation.

Injectable solutions prepared for administration should be used as soon as possible.

Date of latest revision of this leaflet: October 2024

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