Urbason 16 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Urbason 16 mg tablets

methylprednisolone

Read all of 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 and must not be given to other people, even if they have the same symptoms as you. It could harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Urbason is and what it is used for

Methylprednisolone belongs to a group of medicines called corticosteroids (it acts at the cellular level by reducing the production of substances that cause inflammation or allergic reactions).

Urbason 16 mg tablets are used for:

• replacement treatment 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 autoimmune chronic active hepatitis), nephrotic syndrome, adrenogenital syndrome, blood disorders (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 organ transplantation,
• in combination with chemotherapeutic agents or radiotherapy.

2. What you need to know before taking 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, you should not use Urbason in the following cases:
• if you have gastric or duodenal ulcers,
• if you have severe bone demineralization (osteoporosis),
• if you have closed-angle or open-angle glaucoma (an eye disease),
• if you have herpetic keratitis (an eye disease),
• if you have lymphadenopathy (swollen lymph nodes) after tuberculosis vaccination,
• if you have an infection caused by amoebae (a type of infectious agent),
• if you have systemic mycosis (a fungal infection spread throughout the body),
• in patients with poliomyelitis (a 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 only suspected,
• 8 weeks before vaccination and 2 weeks after vaccination,
• if you have a history of psychiatric disorders, consult your doctor about whether it is advisable to use this medicine.

Warnings and precautions

Talk to 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, or intestinal anastomoses,
• Urbason may cause gas accumulation in the intestinal wall, a condition called intestinal pneumatosis (frequency not known, see section 4. “Possible side effects” below). The course of intestinal pneumatosis varies from a benign condition requiring no treatment to severe conditions that may require immediate treatment. If you experience persistent or worsening symptoms such as “nausea, vomiting, and abdominal pain,” you must consult your doctor immediately. Your doctor will decide whether further diagnostic measures or treatment are needed,
• if you have any infection, as Urbason may reduce your body’s defenses, potentially leading to new infections or reactivation of existing ones. In severe infections, Urbason should only be used alongside specific anti-infective treatment,
• contact your doctor if you experience blurred vision or other visual disturbances,
• except for individuals who have already had chickenpox, avoid contact with people who have chickenpox or shingles. If, during treatment with Urbason, you are exposed to these infections, contact a doctor immediately, even if you do not have symptoms,
• if you are taking Urbason, vaccination is not recommended,
• if you have tested positive for the tuberculin skin test (a test to detect tuberculosis), inform your doctor,
• if you have myasthenia gravis, particularly if you are receiving high-dose glucocorticoid therapy, a low initial dose of Urbason should be used and gradually increased,
• if you have hypothyroidism or hepatic cirrhosis. In both cases, relatively low doses may be sufficient, and dose reduction may be necessary. Your doctor will monitor you regularly,
• if you have overactivity of the thyroid gland (hyperthyroidism).

Contact your doctor immediately if you experience muscle weakness, muscle pain, cramps, or stiffness while using metilprednisolone. These may be symptoms of a condition called thyrotoxic periodic paralysis, which can occur in patients with overactive thyroid (hyperthyroidism) treated with metilprednisolone. You may require additional treatment to relieve this condition.

• treatment should not be stopped abruptly, but gradually tapered. Do not stop using this medicine without consulting your doctor (see section 4. “Possible side effects”),
• if you are diabetic, or have heart failure or very high blood pressure, your doctor will monitor you regularly,
• during long-term treatment, ensure adequate potassium intake, limit sodium intake, and monitor blood potassium levels. Additionally, your doctor will perform regular checks to prevent eye complications,
• long-term treatment with corticosteroids may lead to osteopor游戏副本

3. How to take Urbason

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

Urbason tablets should be swallowed whole, without chewing, with sufficient 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, as a single dose in the morning.

The score line must not be used to split the tablet.

In cases of shock or other serious conditions, glucocorticoids should be administered intravenously.

At the beginning of treatment, you will take the initial dose. As soon as a satisfactory response is achieved, you should switch to the standard 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 kg of body weight (but never exceeding 80 mg) in children.

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

The recommended doses for specific indications are listed below:

Replacement therapy

4 to 8 mg daily in Addison's disease, as an adjunct to mineralocorticoid therapy. In stressful situations, up to 16 mg daily.

Asthma and obstructive lung disease

Initial dose: 16 to 40 mg daily.

Maintenance dose: 4 to 8 mg daily.

Interstitial lung disorders

Initial dose: 24 to 40 mg daily.

Maintenance dose: 4 to 12 mg daily.

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 treatment should be gradually withdrawn.

Allergic reactions

Initial dose: 16 to 40 mg daily.

Maintenance dose: 4 to 8 mg daily.

Ulcerative colitis and Crohn's disease

Initial dose: 40 to 80 mg daily, followed by gradual dose reduction. In ulcerative colitis, treatment should be discontinued as soon as possible. In patients with Crohn's disease, a longer treatment duration may be necessary.

Autoimmune diseases

Initial dose: 40 to 160 mg daily, gradually reducing the dose until a maintenance dose is reached.

Hematological disorders

Initial dose: 80 to 160 mg daily, gradually reduced to the maintenance dose.

Dermatological disorders

Initial dose: 80 to 160 mg daily. Generally, the dose should be rapidly decreased until treatment is discontinued.

If you take more Urbason than you should

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

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

If you forget to take Urbason

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

Sudden discontinuation of treatment may cause:

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

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

4. Possible adverse effects

Like all medicines, Urbason may cause adverse effects, although not everyone experiences them.

The following frequency definitions have been used for classification:

Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Frequency not known: cannot be estimated from available data.

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

Metabolism and nutrition disorders

Common: abnormal fat distribution, obesity, increased blood sugar levels, changes in blood fat levels (such as cholesterol or triglycerides), absence of menstrual periods, increased hair growth, weight gain.

Rare: impotence, adrenal cortex problems (glands located above the kidneys that produce hormones), growth retardation in children, increased protein metabolism, elevated blood urea levels.

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

Frequency not known: localized accumulation of adipose tissue in specific parts of the body. Cases of tumor lysis syndrome have been reported in patients with malignant hematological neoplasms. Tumor lysis syndrome may be detected by your doctor based on changes in blood tests such as increased levels of uric acid, potassium, or phosphate and decreased calcium levels, and may cause symptoms such as muscle cramps, muscle weakness, confusion, visual loss or disturbances, difficulty breathing, seizures, irregular heartbeat, or renal failure (decreased amount or darkening of urine). If you experience such symptoms, you must inform your doctor immediately (see section “Warnings and precautions”).

Cardiac disorders

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

Vascular disorders

Common: sodium and water retention, increased potassium excretion, and possibly hypokalaemia.

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

Blood vessel 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 towards increased platelet count (thrombocytosis) and increased risk of thrombosis.

Skin and subcutaneous tissue disorders

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

Rare: allergic reactions (skin rash), including shock in rare cases after parenteral administration, especially in patients with bronchial asthma or after kidney transplantation.

Blood and lymphatic system disorders

Common: delayed wound healing.

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

Musculoskeletal and connective tissue disorders

Common: osteoporosis, which in severe cases may lead to fractures.

Rare: muscle weakness (reversible). In patients with myasthenia gravis, it may cause a reversible worsening of weakness, potentially leading to a myasthenic crisis.

Also, a severe muscle disease (acute myopathy) due to concomitant administration of non-depolarizing muscle relaxants.

Very rare: bone tissue death in the head of the femur or humerus, tendon rupture (in individuals with prior tendon injury, diabetes, or high blood uric acid levels). When Urbason is administered at very high doses over a long period, muscle disorders may occur.

Renal and urinary disorders

Frequency not known: scleroderma renal crisis in patients who already have scleroderma (an autoimmune disorder). Signs of scleroderma renal crisis include increased blood pressure and reduced urine output.

Gastrointestinal disorders

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

Frequency not known: gas in the intestinal wall (intestinal pneumatosis).

Hepatobiliary disorders

Frequency not known: increased liver enzymes.

Endocrine disorders

Frequency not known: pheochromocytoma crisis (see section “Warnings and precautions”).

The following adverse effects have been observed after sudden withdrawal of Urbason following prolonged use, although not everyone will experience them:

• Symptoms such as fever, loss of appetite, nausea, weakness, restlessness, joint pain, skin peeling, low blood pressure, and weight loss (corticosteroid withdrawal syndrome).

Eye disorders

Rare: eye damage: opaque lens, increased eye pressure, cataracts, glaucoma (an eye disease that may lead to vision loss).

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

Immune system disorders

Uncommon: decreased body defenses and increased risk of infection. If you have a viral disease such as chickenpox, simple herpes, or shingles, your condition may worsen, sometimes seriously endangering your health.

Nervous system disorders

Rare: cerebral seizures.

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

Psychiatric disorders

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

If treatment with Urbason is stopped abruptly (not gradually) after long-term therapy, muscle pain, joint pain, breathing difficulties, anorexia, nausea, vomiting, fever, low blood pressure, low blood sugar levels, and even death due to acute adrenal insufficiency may occur (see section “Warnings and precautions”).

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Urbason

Keep out of the sight and reach of children.

No special storage conditions are required.

Do not use Urbason after the expiry date stated on the container after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Urbason 16 mg tablets

• The active substance is methylprednisolone.
• The other components are monohydrate lactose, corn starch, talc, magnesium stearate, anhydrous colloidal silica.

Appearance of the product and contents of the container

Urbason 16 mg tablets are presented as round, flat, beveled, cross-scored, whitish tablets, 9 mm in diameter.

The pack contains 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:

Dragenopharm Apotheker Püschl GmbH

Göllstraße 1, 84529 Tittmoning – Germany

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 most recent revision of this leaflet: October 2024

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