Leaflet: information for the user

Urbason 16 mg tablets

metilprednisolona

Read this leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Urbason and what it is used for

2.What you need to know before you start taking Urbason

3.How to take Urbason

4.Possible side effects

5.Storage of Urbason

6.Contents of the pack and additional information

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

Urbason 16 mg tablets are used for:

• the treatment of substitution in adrenal insufficiency,
• due to its anti-inflammatory and immunosuppressive action, it is used in the treatment of severe persistent asthma, exacerbation 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 active autoimmune chronic 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 action on the immune response, it is used as part of the immunosuppressive treatment in transplants,
• along with chemotherapy medications or radiation therapy.

Do not take 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 cases of emergency or substitution treatment, do not use Urbason in the following cases:
• if you have stomach ulcers or duodenal ulcers,
• if you have severe bone demineralization (osteoporosis),
• if you have glaucoma (closed or open angle),
• if you have herpes 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 spread throughout the body),
• in patients with poliomyelitis (spinal cord disease),
• if you have certain viral infections (such as chickenpox, herpes, or shingles) (see "Warnings and precautions"),
• if you have tuberculosis, or if you suspect 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 suitability of using this medication.

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 cause gas in the intestinal wall, a disease called pneumatosis intestinalis (unknown frequency, see section 4. "Possible side effects"). 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 further diagnostic measures and treatment,
• if you have an infection, as it may weaken your body's defenses, leading to new infections or activating existing ones. In severe infections, Urbason should only be used in conjunction with treatment for the infection,
• 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 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 taking methylprednisolone. These may be symptoms of a disease called periodic paralysis that 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 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, ensure adequate potassium intake, limit sodium intake, and analyze blood potassium levels. Your doctor will also perform regular checks to prevent eye complications,
• long-term treatment with corticosteroids may cause osteoporosis,
• in patients with suspected or diagnosed phaeochromocytoma,
• in rare cases, hepatobiliary disorders have been reported, which are usually 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. 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 output or dark urine) in the case of malignant hematological neoplasia (see section 4. "Possible side effects"),
• Urbason should not be used during pregnancy and lactation, unless your doctor considers it necessary,
• except on medical prescription, Urbason should not be administered to children,
• in premature babies, echocardiograms should be performed to monitor the heart's condition and function,
• when administered to elderly patients, your doctor will monitor you regularly. Elderly patients should avoid prolonged treatment with this medication.

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.

Taking Urbason with food and drinks

You should avoid taking large amounts of grapefruit 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 necessary.

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 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 using 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 side effects (visual disturbances, dizziness, headache) may impair your ability to concentrate and react.

Important information about some components of Urbason 16 mg tablets

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

Follow exactly the administration instructions of this medication 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 corresponding dose for two days, in alternate days, in the form of a single morning dose.

The groove should not be used to break the tablet.

In case of shock or other serious situation, corticosteroids 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 recommended doses are specified for the different indications:

Treatment of substitution

4 to 8 mg per day in Addison's disease, as an adjuvant to mineralocorticoid therapy. In situations of stress, 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.

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 per kilogram of body weight, until the erythrocyte sedimentation rate remains normal, for at least a 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 subsequent gradual dose reduction. In ulcerative colitis, it is recommended to end treatment as soon as possible. In patients with Crohn's disease, prolonged therapy may be necessary.

Autoimmune diseases

Initial dose: 40 to 160 mg per day, gradually reducing the dose to reach a maintenance dose.

Hematological disorders

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

Dermatological disorders

Initial dose: 80 to 160 mg per day. Generally, the dose should be quickly reduced to end treatment.

If you take 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.

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

If you forget to take Urbason

Do not take 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 indicate 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: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

Rare: may affect up to 1 in 1,000 people

Very rare: may affect up to 1 in 10,000 people

Frequency not known: cannot be estimated from available data.

The following 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 lipid 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), growth retardation in children, increased protein metabolism, elevated urea levels.

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

Frequency not known:localized fat accumulation in the body.Cases of tumor lysis syndrome have been reported in patients with hematological malignancies.Tumor lysis syndrome may be revealed by your doctor based on changes in blood tests such as increased levels of uric acid, potassium, or phosphate and decreased levels of calcium, andmay cause symptoms such as muscle cramps, muscle weakness, confusion, loss or visual disturbances, difficulty breathing, seizures, irregular heartbeat, or renal insufficiency (decreased urine production or dark urine). If you experience such symptoms, you should inform your doctor immediately (see "Warnings and precautions").

Cardiac disorders

Frequency not known: myocardial disease (hypertrophic cardiomyopathy) in premature babies.

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 not known:increased blood clotting.

Other effects include a tendency to increase the number of platelets (thrombocytosis) and the risk of thrombosis.

Skin and subcutaneous tissue disorders

Common:skin changes (atrophy, striae, acne, red-purple spots due to small amounts of blood accumulation in the skin, small red spots).

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

Musculoskeletal and connective tissue disorders

Common:osteoporosis that in severe cases may 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 alterations.

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:gastric or duodenal ulcers, and if these 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: 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: opaque cornea, increased eye pressure, cataracts, glaucoma (eye disease that can cause 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, 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 not known: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).

If Urbason treatment is withdrawn suddenly (not gradually) after long-term treatment, it may cause muscle pain, joint pain, breathing 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.

No special storage conditions are required.

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 drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Urbason 16 mg tablets

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

Appearance of the product and content of the packaging

Urbason 16 mg tablets are presented in the form of round, flat, bisected, cross-scored, and white tablets, 9 mm in diameter.

The packaging contains 30 tablets.

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.

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)

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/