URBASON 4 mg TABLETS

Introduction

Package Leaflet: Information for the User

Urbason 4 mg Tablets

methylprednisolone

Read all of this leaflet carefully before you start taking 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 get 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 take Urbason
3. How to take 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).

Urbason 4 mg tablets are used for:

• replacement therapy in adrenal insufficiency,
• due to its anti-inflammatory and immunosuppressive action, it is used in the treatment of severe persistent asthma, worsening of chronic obstructive pulmonary disease, sarcoidosis, severe allergic reactions, rheumatic diseases (such as rheumatoid arthritis, ankylosing spondylitis or acute gouty arthritis), vasculitis, systemic lupus erythematosus, polymyositis and dermatomyositis, ulcerative colitis, Crohn's disease, liver diseases (such as chronic active autoimmune hepatitis), nephrotic syndrome, adrenogenital syndrome, blood diseases (such as acquired hemolytic anemia and idiopathic thrombocytopenic purpura), inflammatory eye diseases (such as optic neuritis) and skin diseases (such as urticaria, severe eczema and pemphigus),
• due to its effect on the immune response, it is used as part of immunosuppressive treatment in transplants,
• together with chemotherapeutic agents or radiotherapy.

2. What you need to know before you take Urbason

Do not take 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 replacement or emergency treatments, do not use Urbason in the following cases:
• if you have stomach or duodenal ulcers,
• if you have severe bone demineralization (osteoporosis),
• 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 amoebic infection (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 chickenpox, herpes, shingles) (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,
• if you have a history of psychiatric disorders, consult your doctor about the convenience of using this medicine.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take 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 pneumatosis intestinalis (frequency not known, see section 4. "Possible side 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 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 activating 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,
• except for patients who have already had chickenpox, avoid contact with people who have, for example, chickenpox or shingles. 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 taking 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 a 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, adequate potassium intake should be ensured, sodium intake should be limited, and blood potassium levels should be analyzed. 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,
• rarely, hepatobiliary disorders have been reported, most of which were reversible after treatment withdrawal. Therefore, adequate follow-up is required,
• 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 case you have a malignant hematological neoplasm (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 condition and functioning of the heart,
• when administered to elderly patients, the doctor will regularly monitor the patient. Elderly patients should avoid prolonged treatment with this medicine.

Use in athletes

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

Other medicines and Urbason

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 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).
• 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, 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.

Taking Urbason with food and drinks

You should avoid taking 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 taking 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 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 4 mg tablets

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Urbason

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

Urbason tablets should be swallowed without chewing, with a sufficient amount of liquid (approximately half a glass of water), during or immediately after a meal.

It is recommended that the total daily dose be taken in the morning. Once the maintenance dose has been established, it is advisable to take the dose corresponding to two days, on alternate days, in the form of a single dose in the morning.

The score line should not be used to divide the tablet.

In case of shock or other serious situation, glucocorticoids should be administered intravenously.

At the beginning of treatment, you should take the initial dose. As soon as a satisfactory response is obtained, you should take the general maintenance dose. Both doses will be determined by your doctor.

The initial dose will be 12 to 80 mg per day in adults and 0.8 to 1.5 mg per day per kilogram of body weight (but never more than 80 mg) in children.

The general maintenance dose will be 4 to 8 mg per day in adults (although in short treatments, up to 16 mg per day may be taken) and 2 to 4 mg per day in children.

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

Replacement therapy

4 to 8 mg per day in Addison's disease, as a coadjuvant of mineralocorticoid therapy. In stressful situations, up to 16 mg per day.

Asthma and chronic obstructive pulmonary disease

Initial dose: 16 to 40 mg per day.

Maintenance dose: 4 to 8 mg per day.

Interstitial lung disorders

Initial dose: 24 to 40 mg per day.

Maintenance dose: 4 to 12 mg per day.

Rheumatic diseases

Initial dose: 6 to 10 mg (mild chronic polyarthritis) and 12 to 20 mg (severe chronic polyarthritis).

Maintenance dose: it is recommended not to exceed 6 mg.

Acute rheumatic fever: up to 1 mg/kg body weight, until the erythrocyte sedimentation rate remains normal for at least one week; then the treatment will be gradually withdrawn.

Allergic reactions

Initial dose: 16 to 40 mg per day.

Maintenance dose: 4 to 8 mg per day.

Ulcerative colitis and Crohn's disease

Initial dose: 40 to 80 mg per day, with a subsequent gradual reduction of the dose. In ulcerative colitis, it is recommended to finish the treatment as soon as possible. In patients with Crohn's disease, longer therapy may be necessary.

Autoimmune diseases

Initial dose: 40 to 160 mg per day, progressively reducing the dose until a maintenance dose is reached.

Hematological diseases

Initial dose: 80 to 160 mg per day, which will be gradually reduced to the maintenance dose.

Skin disorders

Initial dose: 80 to 160 mg per day. Generally, the dose should be rapidly reduced until the treatment is finished.

If you take 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 taken.

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

If you forget to take Urbason

Do not take a double dose to make up for forgotten doses.

If you stop taking Urbason

Do not stop using this medicine without consulting your doctor.

After prolonged use of Urbason, if you need to stop your treatment, follow your doctor's advice. Your doctor may indicate that you reduce the amount of medicine you are taking gradually 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 the 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 areas 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 babies.

Vascular Disorders

Frequent:sodium and water retention, increased potassium excretion, and possibly 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 changes (atrophy, stretch marks, acne, purple-red 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 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, muscle changes may occur.

Renal and Urinary Disorders

Frequency not known: scleroderma renal crisis in patients who already have scleroderma (an autoimmune disorder). The 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:increased liver enzymes.

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

Nervous System Disorders

Rare:seizures.

Frequency not known: dizziness, headache, and sleep changes.

Psychiatric Disorders

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

If treatment with Urbason is stopped quickly (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 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 below 30°C.

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

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and unused medicines in the SIGRE Point of the pharmacy. In case of 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 4 mg Tablets

• The active ingredient is methylprednisolone.
• The other ingredients are lactose monohydrate, cornstarch, talc, magnesium stearate, anhydrous colloidal silica.

Appearance of the Product and Package Contents

Urbason 4 mg tablets are presented in the form of round, flat, beveled, cross-scored, and white tablets, 8 mm in diameter.

Each package contains 10 or 30 tablets.

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.

Strada Statale 17 km 22

67019 Scoppito (AQ) (Italy)

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)

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/