URBASON 20 mg POWDER AND SOLVENT FOR INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Urbason 20 mg powder and solvent for solution for injection

methylprednisolone

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Urbason and what is it 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 those cases that, due to their severity, require immediate acute treatment or when the 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 to the patient, such as angioedema (generalized urticaria accompanied by inflammation of the feet, hands, throat, lips, and respiratory tract), laryngeal edema (swelling of the throat area due to fluid accumulation).
• In 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 that treatment is started within 8 hours after the injury occurred).
• Addisonian crisis (a disorder that affects the adrenal glands located just above each of the two kidneys and requires immediate medical treatment) and secondary shock due to adrenocortical insufficiency.
• Acute multiple sclerosis attacks.
• As an adjunct in chemotherapy.
• Treatment of acute organ transplant rejection.

2. What you need to know before you use 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 in substitution or emergency treatments, you should not use Urbason 20 mg in the following cases:

• if you have stomach or duodenal ulcers,
• if you have severe bone demineralization (osteoporosis),
• if you have a history of psychiatric disorders, consult your doctor about the convenience of using this medicine,
• if you have closed or open-angle glaucoma (eye disease),
• if you have herpetic keratitis (eye disease),
• if you have lymphadenopathy (inflammation of the lymph nodes) after tuberculosis vaccination,
• if you have an amoeba infection (a type of infectious agent),
• if you have systemic mycosis (infection caused by fungi and spread throughout the body),
• in patients with poliomyelitis (spinal cord disease),
• if you have certain viral infections (such as chickenpox, herpes, herpes zoster) (see section "Warnings and precautions"),
• if you have tuberculosis, or if it is suspected 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 gases in the intestinal wall, a disease called intestinal neumatosis (frequency not known, see section 4. "Possible side effects" below). The course of intestinal neumatosis varies from a benign disease that does not require treatment to other severe diseases that may require immediate treatment. If you experience symptoms such as "nausea, vomiting, and abdominal pain" that persist or become severe, you should consult your doctor immediately. Your doctor will decide on the need for other diagnostic measures and treatment,
• if you have any infection, as it may decrease your body's defenses, leading to new infections or reactivating existing ones. In severe infections, Urbason should only be used together with infection treatment,
• contact your doctor if you experience blurred vision or other visual disturbances,
• in patients treated with high-dose intravenous pulses of Urbason, as cardiac arrhythmias and cardiac arrest may be observed, even in patients without known cardiac abnormalities,
• except for patients who have already had chickenpox, avoid contact with people who have, for example, chickenpox 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), you should inform your doctor,
• if you have myasthenia gravis, particularly if you are receiving high-dose glucocorticoid treatment, you should use a low dose of Urbason at the start of treatment and gradually increase it,
• if you have hypothyroidism or liver cirrhosis. In both cases, relatively low doses may be sufficient, and dose reduction may be necessary. Your doctor will perform regular checks,
• if you have hyperthyroidism (overactive thyroid gland).

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 thyrotoxic periodic paralysis that can occur in patients with hyperthyroidism treated with methylprednisolone. You may need additional treatment to alleviate this condition,

• treatment should not be stopped abruptly, but 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 and very high blood pressure, your doctor will perform regular checks,
• in long-term treatments, you should ensure adequate potassium intake, limit sodium intake, and analyze blood potassium levels. Additionally, your doctor will perform regular checks to avoid eye complications,
• long-term treatment with corticosteroids can produce 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. The signs of a scleroderma renal crisis include increased blood pressure and decreased urine production. Your doctor may advise you to have your blood pressure and urine checked periodically,
• if you have kidney problems or high levels of uric acid in the 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 disturbances, breathing difficulties, seizures, irregular heartbeat, or kidney failure (decreased or darkened urine), in the case of hematological malignancies (see section 4. "Possible side effects"),
• the use of Urbason is not recommended during pregnancy and breastfeeding,
• unless prescribed by a doctor, the administration of Urbason to children should be avoided,
• in premature babies, echocardiograms should be performed to monitor the heart's condition and function,
• when administered to elderly patients, the doctor will regularly monitor the patient. Elderly patients should avoid prolonged treatment with this medicine,
• the administration of methylprednisolone in cyclic IV injection (usually in an initial dose of ? 1 g/day) may cause drug-induced liver damage, such as acute hepatitis or increased liver enzymes. Rare cases of hepatotoxicity have been reported. The time of onset of these adverse reactions may be several weeks or more. In most reported cases, the adverse reactions resolved after treatment was discontinued. Therefore, adequate follow-up is required.

Use in athletes

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

Other medicines and Urbason

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

Urbason may interfere with the following medicines:

• Amphotericin B, clarithromycin, erythromycin (antibiotics).
• Cyclosporin.
• Coumarin derivatives: oral anticoagulants (such as Sintrom).
• Anticholinesterases (such as neostigmine, pyridostigmine, medicines used for muscle spasms, to treat myasthenia gravis, and paralytic ileus).
• Antidiabetics.
• Non-steroidal anti-inflammatory drugs (acetylsalicylic acid, indomethacin) and alcohol.
• Non-depolarizing muscle relaxants.
• Diltiazem (medicine used for heart problems).
• Certain 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, barbiturics, 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 decrease cholesterol and triglyceride levels).
• Salicylates.
• Theophylline (medicine used for asthma and bronchial problems).
• Vaccines.

Interference with laboratory tests

If you are going to have skin tests "Allergy tests", inform your doctor that you are using this medicine, as it may alter the results.

Using Urbason with food and drinks

You should avoid drinking 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 are planning to have a baby, ask your doctor or pharmacist for advice 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 consulting your doctor about the potential benefits and risks for you and the fetus of the different treatment options. This is because Urbason may increase the risk of a baby being born with a cleft lip and/or palate (openings or fissures in the upper lip and/or the roof of the mouth). If you are pregnant or plan to become pregnant, consult your doctor about using Urbason.

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

Driving and using machines

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

Important information about some of the ingredients of Urbason

This medicine contains less than 23 mg (1 mmol) of sodium per ampoule; this is essentially "sodium-free".

3. How to use Urbason

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

Urbason 20 mg can be administered by intravenous or intramuscular injection.

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

In severe cases, where 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 two injections will be 30 minutes to 24 hours, depending on the severity of the patient.

If you think the action of Urbason is too strong or too weak, inform your doctor or pharmacist.

In situations that pose a life-threatening risk to the patient, 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 Urbason injectable (8 mg, 40 mg, or 250 mg).

The following doses are recommended for 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 life-threatening situations: 250 to 500 mg of methylprednisolone.

Cerebral edema: 250 to 500 mg of methylprednisolone.

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

Acute multiple sclerosis attacks: usually 1 g per day by intravenous route, for 3 to 5 days.

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

In cases of cerebral edema, status asthmaticus, and 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 basic therapy (e.g., replacement of circulating fluid volume, heart and circulation treatment, administration of antibodies, analgesia, etc.).

Prolonged treatment with Urbason, particularly with relatively high doses, should not be stopped 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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested or administered.

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

If you forget to use Urbason

Do not use a double dose to make up for forgotten 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 stop treatment, follow your doctor's advice. Your doctor may advise you to gradually reduce the amount of medicine you are taking until you stop taking it completely.

Sudden interruption of treatment may cause:

• corticosteroid withdrawal syndrome (see section 4)
• adrenocortical insufficiency (low cortisol levels) or
• there may be a recurrence (return) of the underlying condition being treated.

If you have any other 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 all people suffer from them.

The following frequency definitions have been used for classification:

Very frequent: may affect more than 1 in 10 people

Frequent: 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 Urbason:

Metabolic and Nutritional Disorders

Frequent:abnormal fat distribution, obesity, increased blood sugar levels, changes in blood fat levels (such as cholesterol or triglycerides), absence of menstrual period, excessive 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 fat accumulation in the epidural canal or thoracic cavity.

Frequency not known:accumulation of adipose tissue in localized parts of the body. Cases of tumor lysis syndrome have been reported in patients with malignant hematological neoplasms. Tumor lysis syndrome may be revealed by 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, vision loss or changes, breathing difficulties, seizures, irregular heartbeat, or kidney failure (decreased urine output or dark urine). If you experience such symptoms, you should inform your doctor immediately (see "Warnings and Precautions" section).

Cardiac Disorders

Frequency not known: myocardial disease (hypertrophic cardiomyopathy) in premature infants, arrhythmias, and cardiac arrest related to high-dose pulse therapy.

Vascular Disorders

Frequent:sodium and water retention, increased potassium excretion, and possible hypokalemia.

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

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

Frequency not known:increased blood clots.

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

Skin and Subcutaneous Tissue Disorders

Frequent:skin alterations (atrophy, striae, acne, red-purple spots due to accumulation of small amounts of blood in 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

Frequent: delayed wound healing.

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

Musculoskeletal and Connective Tissue Disorders

Frequent: osteoporosis, which can lead to fractures in severe cases.

Rare: reversible muscle weakness. 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, muscle alterations may occur.

Renal and Urinary Disorders

Frequency not known: 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:stomach or duodenal ulcers, and if they perforate, peritonitis (severe 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 increased liver enzymes, cholestasis, and cellular damage that can include acute liver failure (see "Warnings and Precautions" section).

Endocrine Disorders

Frequency not known: pheochromocytoma crisis (see "Warnings and Precautions" section).

The following adverse effects have been observed after sudden withdrawal of Urbason after 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).

Ocular Disorders

Rare: eye injuries: cataracts, increased eye pressure, glaucoma (eye disease that can cause vision loss).

Frequency not known: retinal and choroidal disease, blurred vision.

Immune System Disorders

Uncommon:decreased immune system function and increased risk of infection. If you have a viral disease such as chickenpox, herpes simplex, or herpes zoster, your condition may worsen, sometimes with serious risk to your health.

Nervous System Disorders

Rare:seizures.

Frequency not known: vertigo, 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

Atrophy of the skin may occur when injected into fatty tissue.

If treatment with Urbason is withdrawn rapidly (not gradually) after long-term treatment, muscle pain, joint pain, breathing problems, anorexia, nausea, vomiting, fever, low blood pressure, low blood sugar levels, and even death due to acute adrenocortical insufficiency may occur (see "Warnings and Precautions" section).

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 prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Urbason

Keep out of sight and reach of children.

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

Do not use Urbason 20 mg after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Urbason 20 mg Powder and Solvent for Injectable Solution

• The active ingredient is methylprednisolone sodium hemisuccinate. Each ampoule contains 26.52 mg equivalent to 20 mg of methylprednisolone.
• The other ingredients are: disodium phosphate dihydrate, monosodium phosphate monohydrate, and water for injectable preparations.

Appearance of the Product and Package Contents

The packaging contains:

• 1 glass ampoule with lyophilized powder and 1 glass ampoule of 2 ml with solvent.

The lyophilized ampoule contains a white powder, and the solvent ampoule contains a colorless and transparent liquid.

Marketing Authorization Holder and Manufacturer

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)

You can request more information about this medicine by contacting the local representative of the marketing authorization 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 20 mg can be administered by intravenous or intramuscular injection.

Intravenous injection should be administered slowly (each ampoule in 1 or 2 minutes).

Your doctor or nurse will dissolve the contents of one ampoule of Urbason injectable in 2 ml of water for injectable preparations, contained in the solvent ampoule.

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

Prepared injection solutions should be used as soon as possible.

Date of the Last Revision of this Prospectus:October 2024

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