Urbason 250 mg powder and solvent for solution for injection or for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Urbason 250 mg powder and solvent for injectable solution or for infusion

methylprednisolone

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

1. What Urbason is and what it is used for

Methylprednisolone 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 cases of such severity that they require immediate acute treatment, or when administration of Urbason tablets is not possible, including:

• Severe asthma attacks.
• Anaphylactic shock (severe allergic reaction) and clinical situations that may pose a life-threatening risk, such as angioedema (generalized hives accompanied by swelling of feet, hands, throat, lips, and airways), laryngeal edema (swelling of the throat area due to fluid accumulation).
• Accidental poisonings, such as insect bites, 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 after the injury occurred).
• Addisonian crisis (a disorder affecting the adrenal glands located just above each of the two kidneys, requiring 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 Urbason

Do not use Urbason

• 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 or emergency treatments, do not use Urbason 250 mg 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 (eye disease),
• if you have herpetic keratitis (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 (fungal infection disseminated throughout the body),
• in patients with poliomyelitis (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 tuberculosis is merely suspected,
• 8 weeks before vaccination and 2 weeks after vaccination.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Urbason:

• 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,
• Urbason 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 consult your doctor immediately. Your doctor will decide whether further diagnostic measures or treatment are needed,
• if you have any infection, as this medicine may reduce your body's defenses, potentially leading to new infections or reactivation of existing ones. In severe infections, Urbason should only be used alongside appropriate anti-infective treatment,
• contact your doctor if you experience blurred vision or other visual disturbances,
• in patients receiving high-dose intravenous pulse therapy with Urbason, 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 herpes zoster. If you are exposed to these infections during treatment with Urbason, contact a doctor immediately, even if you have no symptoms,
• if you are using Urbason, it is recommended that you do not get vaccinated,
• if you 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 treatment, a low initial dose of Urbason 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,
• 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 can occur in patients with hyperthyroidism treated with methylprednisolone. You may need additional treatment to relieve this condition.

• treatment should 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 corticosteroid treatment may lead to 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 advise you to regularly monitor your blood pressure and urine,
• if you have kidney problems or high levels of uric acid in the blood before starting treatment with Urbason,
• inform your doctor if you experience any symptoms of tumor lysis syndrome, such as muscle cramps, muscle weakness, confusion, visual disturbances, difficulty breathing, seizures, irregular heartbeat, or kidney failure (decreased urine output or dark urine), especially if you have malignant hematological neoplasia (see section 4. “Possible side effects”),
• use of Urbason during pregnancy and breastfeeding is not recommended,
• unless prescribed by a doctor, administration of Urbason 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 take several weeks or longer. In most reported cases, adverse reactions resolved after discontinuation of treatment. Therefore, adequate monitoring is required.

Use in athletes

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

Other medicines and Urbason

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

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

Urbason may interfere with the following medicines:

• Amphotericin B, clarithromycin, erythromycin (antibiotics).

• Cyclosporine.

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

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

• Antidiabetic agents.

• 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 lower cholesterol and triglyceride levels).

• Salicylates.

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

• 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 test results.

Use of Urbason with food and drinks

Avoid consuming large amounts of grapefruit juice, as it may interfere with Urbason.

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.

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

Only use Urbason during the first trimester of pregnancy after discussing with your doctor the potential benefits and risks for you and the fetus of different treatment options. This is because Urbason may increase the risk of having a baby born with cleft lip and/or cleft palate (clefts 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 Urbason with your doctor.

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

Driving and use of machines

During treatment with Urbason, 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 Urbason

This medicine contains less than 23 mg (1 mmol) of sodium per vial; hence, it is essentially “sodium-free.”

3. How to use Urbason

Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Urbason 250 mg may be administered by intravenous injection. The intravenous injection must be given slowly. It may also be administered by intravenous infusion. Depending on the clinical condition and response achieved, the injection may be repeated during the first hours of treatment.

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 daily dose of 20 to 40 mg is recommended for adults and 8 to 16 mg daily 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 feel that the effect of Urbason 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 injectable presentations of Urbason (8 mg, 20 mg, or 40 mg) may need to be used.

The following are the recommended doses according to the different indications:

Acute asthma exacerbations: 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 crises: 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 crises: up to 30 mg of methylprednisolone/kg body weight.

In cases of cerebral edema, status asthmaticus, and immunological crises, treatment should be continued with oral Urbason tablets, gradually reducing the dose.

Urbason is used as an adjunct to standard therapy (e.g., fluid volume replacement, cardiac and circulatory treatment, administration of antibodies, analgesia, etc.).

Prolonged treatment with Urbason, 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 Urbason than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested or administered.

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 Urbason

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

If you stop using Urbason

Do not stop using this medicine without consulting your doctor.

After prolonged use of Urbason, if you need to discontinue treatment, follow your doctor's advice. Your doctor may instruct you to gradually reduce the dose until you stop taking the medicine completely.

Sudden discontinuation of treatment may cause:

• corticosteroid withdrawal syndrome (see section 4)
• adrenal cortical insufficiency (low cortisol levels), or
• a recurrence (return) of the underlying condition being treated.

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

4. Possible adverse effects

Like all medicines, Urbason 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 the available data.

The following adverse effects have been observed during treatment with Urbason:

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 body 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 urea levels.

Very rare: reversible accumulation of fat in the epidural canal or in the 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 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 hypokalemia.

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 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 (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, it may cause 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, tendon rupture (in individuals with prior tendon injury, diabetes, or high blood uric acid levels). When Urbason 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 increased 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 have been reported, as well as cholestasis and cellular-level damage that 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 abrupt withdrawal of Urbason 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 eye pressure, cataracts, glaucoma (an eye disease that may lead to 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, simple herpes, or shingles, your condition may 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 Urbason 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 effect, talk to 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 Urbason

Keep out of the sight and reach of children.

Store the ampoules in the outer packaging to protect them from light.

Do not use Urbason 250 mg after the expiry date 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 must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Urbason 250 mg powder and solvent for injectable solution or for infusion

• The active substance is sodium methylprednisolone hemisuccinate. Each vial contains 331.48 mg, equivalent to 250 mg of methylprednisolone.
• The other components are: disodium phosphate dihydrate, monosodium phosphate monohydrate, and water for injections.

Appearance of the product and contents of the pack

The standard pack contains 1 glass vial with lyophilisate and 1 glass vial of 5 ml with solvent.

The clinical pack contains 50 glass vials with lyophilisate and 50 glass vials of 5 ml with solvent.

The lyophilisate vial contains a white or almost white powder, and the solvent vial contains a clear, colourless liquid.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Fidia farmaceutici S.p.A.

Via Ponte della Fabbrica, 3/A

35031 Abano Terme (PD) – Italy

Manufacturer:

Sanofi S.r.l.

Via Valcanello, 4

03012 Anagni (FR)

(Italy)

Further information on this medicinal product can be requested from the local representative of the Marketing Authorisation Holder

Local representative:

Laboratorios Fidia Farmacéutica S.L.U.

Parque Empresarial de la Moraleja - Edificio Torona

Avenida de Europa, 24 - Edificio A - 1 B

28108 Alcobendas - Madrid

(Spain)

This information is intended only for healthcare professionals

Urbason 250 mg may be administered by intravenous injection.

The 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 injectable Urbason in 5 ml of water for injections, provided in the solvent vial. It may also be administered by intravenous infusion. Depending on the clinical condition and response, the injection may be repeated during the first hours of treatment.

For the preparation of an infusion solution, the contents of one vial of Urbason 250 mg should first be dissolved and then mixed with 5% glucose solution or 0.9% sodium chloride solution (physiological saline). It must not be mixed in the same syringe with other solutions except physiological saline or 5% glucose solution.

Concomitant administration of reconstituted Urbason injectable solutions with other medicinal products in the same syringe should be avoided, as precipitation may occur. Mixing with infusion solutions may also result in clouding of the solution or formation of precipitates.

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

Date of the most recent revision of this leaflet: October 2024

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