Prospect: information for the user

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

metilprednisolone

Read this prospect carefully before starting to use this medication.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you and should not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist even if they are not listed in this prospect. See section 4.

1.What is Urbason and what it is used for

2.What you need to know before starting to use Urbason

3.How to use Urbason

4.Possible adverse effects

5.Storage of Urbason

6.Contents of the package and additional information

Methylprednisolone belongs to a group of medications called corticosteroids (acts at the cellular level by reducing the production of substances that produce inflammation or allergy).

Due to its rapid onset of effect, it is especially indicated in those cases that due to their severity require immediate acute treatment or when the administration of Urbason 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, for example, angioedema (generalized urticaria accompanied by inflammation of feet, hands, throat, lips, and respiratory passages), laryngeal edema (swelling of the throat area due to accumulation of liquids).
• In accidental poisonings, such as, for example, insect bites, snake bites, to prevent anaphylactic shock.
• Cerebral edema (inflammation of the brain due to accumulation of liquid) and spinal cord injuries (provided that treatment is initiated within 8 hours after the injury occurred).
• Addisonian crisis (condition 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.
• Treatment of acute rejection of organ transplants.

No use Urbason

• If you are allergic (hypersensitive) to the active ingredient, to other glucocorticoids, or to any of the other components of this medication (listed in section 6),
• Except in emergency or substitution treatments, do not use Urbason 250 mg in the following cases:
• If you have gastric or duodenal ulcers,
• If you have severe osteoporosis,
• If you have a history of psychiatric disorders, consult your doctor about the advisability of using this medication,
• If you have glaucoma (closed or open angle),
• If you have herpetic 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 disseminated throughout the body),
• In patients with poliomyelitis (spinal cord disease),
• If you have certain viral infections (such as varicella, herpes, or herpes zoster) (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, 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, and intestinal anastomoses,
• Urbason 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, Urbason should be used only 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 Urbason, arrhythmias and cardiac arrest may be observed, even in patients with no known cardiac abnormalities,
• Except for patients who have already had varicella, avoid contact with people who have, for example, varicella or herpes zoster. If you are exposed to these infections during treatment with Urbason, you should contact a doctor immediately, even if you do not have any symptoms,
• If you are using Urbason, it is recommended that you not be vaccinated,
• If you have tested positive for the tuberculin test (test to determine tuberculosis disease), you should inform your doctor,
• If you have myasthenia gravis, particularly if you are receiving high doses of glucocorticoids, you should use a low dose of Urbason 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,
• If you have hyperthyroidism.

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

• The treatment should not be interrupted 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 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 complications in the eyes,
• 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 high blood pressure and decreased urine production. Your doctor may advise you to monitor your blood pressure and urine regularly,
• If you have kidney problems or high levels of uric acid in your blood before starting treatment with Urbason,
• You should 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 production or dark urine), in the case of malignant hematological neoplasia (see section 4. "Possible adverse effects"),
• Urbason should not be used during pregnancy and lactation,
• Except on medical prescription, administration of Urbason to children should be avoided,
• 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 methylprednisolone in intravenous cyclic IV pulses (usually at an initial dose of?1 g/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.

Use in athletes

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

Other medications and Urbason

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 Urbason, so your doctor will perform thorough checks if you are taking these medications (including some for HIV: ritonavir, cobicistat).

Urbason may interact with the following medications:

- Amphotericin B, clarithromycin, erythromycin (antibiotics).

- Cyclosporine.

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

- Anticholinesterases (such as neostigmine, pyridostigmine, medications used for muscle spasms, for myasthenia gravis, and for paralytic ileus).

- Antidiabetics.

- Nonsteroidal anti-inflammatory drugs (aspirin, indomethacin) and alcohol.

- Non-depolarizing muscle relaxants.

- Diltiazem (medication used for heart problems).

- Some diuretics (medications used to eliminate water).

- Estrogens (medications used for hormonal imbalances), oral contraceptives.

- Cardiotonic glucosides (medications used to treat heart failure).

- Enzyme inducers:

• Carbamazepine, phenytoin, barbiturates, or 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 Urbason with food and beverages

You should avoid taking large amounts of orange juice, as it may interfere with Urbason.

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.

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

Only use Urbason 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 Urbason 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 Urbason.

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

Driving and operating machines

During treatment with Urbason, 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 components of Urbason

This medication contains less than 23 mg (1 mmol) of sodium per ampoule; that is, 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.

Urbason 250 mg can be administered via intravenous injection. The intravenous injection must be applied slowly.It can also be administered by intravenous infusion. Depending on the clinical picture and the results obtained, the injection may be repeated during the first hours of treatment.

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

In severe cases, where within 30 minutes no sufficient therapeutic effect has been achieved, the injections may 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 Urbason 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 of 250 to 1000 mg of methylprednisolone in adults and 4 to 20 mg/kg of body weight in children. For this, you may need to use other presentations of injectable Urbason (8 mg, 20 mg or 40 mg).

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

Asthma exacerbations: 30 to 90 mg per day. Instatus asthmaticusit is recommended to take 250 to 500 mg of methylprednisolone.

Anaphylactic shock and situations of immediate danger to the patient's life: 250 to 500 mg of methylprednisolone.

Cerebral edema:250 to 500 mg of methylprednisolone.

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

Acute relapses of multiple sclerosis:usually 1 g per day by intravenous route, between 3 and 5 days.

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

In cases of cerebral edema,status asthmaticusand immunological crises, it is recommended to continue treatment with the oral form of Urbason tablets in gradually decreasing doses.

Urbason 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 Urbason, 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 Urbason 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.

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 Urbason

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

If you interrupt treatment with Urbason

Do not stop using this medication without consulting your doctor.

After prolonged use of Urbason, 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.

Stopping treatment abruptly may cause:

- corticosteroid withdrawal syndrome (see section 4)

- adrenal insufficiency (low cortisol levels) or

- a recurrence of the underlying condition being treated.

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

Like all medicines, Urbason 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 unknown: cannot be estimated from available data.

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

Metabolic and nutritional disorders

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

Rare:impotence, problems with the adrenal cortex (glands located above the kidneys and 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 unknown:localized fat accumulation in the body.There have been reported cases of tumor lysis syndrome in patients with malignant hematological neoplasms. Tumor lysis syndrome can be revealed by your doctor based on changes in blood tests such as increased levels of uric acid, potassium, or phosphate and decreased calcium levels, and can 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 unknown: 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 unknown: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 (skin rash) including shock 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 unknown:elevated white blood cell count, thrombocytopenia (decreased platelet count).

Musculoskeletal and connective tissue disorders

Common:osteoporosis that in severe cases can lead to fractures.

Rare:muscle weakness (reversible). In patients with myasthenia gravis, it may cause reversible worsening of weakness, which 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 Urbason is administered at very high doses for a long time, it may cause muscle changes.

Renal and urinary disorders

Frequency unknown: scleroderma renal crisis in patients who already have scleroderma (an autoimmune disorder). Signs of a scleroderma renal crisis include increased blood pressure and decreased urine production.

Gastrointestinal disorders

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

Frequency unknown:gas in the intestinal wall (intestinal pneumatosis).

Hepatobiliary disorders

Frequency unknown: methylprednisolone can damage the liver: cases of hepatitis and elevated liver enzymes, cholestasis, and cellular damage that may include acute liver failure (see "Warnings and precautions").

Endocrine disorders

Frequency unknown: phaeochromocytoma crisis (see "Warnings and precautions").

The following side effects have been observed after the sudden withdrawal of Urbason 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: cloudy cornea, increased eye pressure, cataracts, glaucoma (eye disease that can cause vision loss).

Frequency unknown: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:seizures.

Frequency unknown: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 Urbason 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 from acute adrenocortical 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 Medicines 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 out of sight and reach of children.

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

Do not use Urbason 250 mg after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Once the solution has been reconstituted, it must be used immediately.

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

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

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

Appearance of the product and contents of the package

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

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

The lyophilisate vial contains a white powder and the solvent vial contains a colorless and transparent liquid.

Holder of the marketing authorization and responsible for manufacturing

Holder:

Fidia farmaceutici S.p.A.

Via Ponte della Fabbrica, 3/A

35031 Abano Terme (PD) – Italy

Responsible for manufacturing:

Sanofi S.r.l.

Via Valcanello, 4

03012 Anagni(FR)

(Italy)

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization

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 solely for doctors or healthcare professionals

Urbason 250 mg can be administered by intravenous injection.

The intravenous injection must be applied slowly (each vial in 1 or 2 minutes).

Your doctor or nurse will dissolve thecontent of a vial of Urbason injectable in 5 ml of water for injectable preparations, contained in the solvent vial. It can also be administered by intravenous infusion. According to the clinical picture and the results obtained, the injection may be repeated during the first hours of treatment.

To prepare a solution for infusion, the content of a vial of Urbason 250 mg will be dissolved beforehand and then mixed with glucose 5% solutions or sodium chloride 0.9% (physiological serum). It should not be mixed in the same syringe with other solutions that are not physiological serum or 5% glucose solution.

It should be avoided to administer the reconstituted solutions of Urbason injectable with other medications in the same syringe, as it could produce a precipitation. The mixture with infusion solutions could also lead to a turbidity of the solution or the formation of precipitates.

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

Last review date of this leaflet:October 2024

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