Patient Information Leaflet

Urbason 4 mg Tablets

methylprednisolone
Please read this leaflet carefully before taking this medicine as it contains
important information for you.

Keep this leaflet. 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 other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Urbason is and what it is used for
What you need to know before taking Urbason
How to take Urbason
Possible side effects
How to store Urbason
Contents of the pack and other information

1. What Urbason is and what it is used for

Urbason contains the active substance methylprednisolone, which belongs to a class of medicines called corticosteroids. Corticosteroids are hormones naturally produced by the human body that have anti-inflammatory activity.
Urbason is indicated for the treatment of:

acute inflammatory disease affecting the joints and other organs (acute rheumatic arthritis, rheumatic fever);
chronic inflammation of more than 4 joints simultaneously (chronic polyarthritis);
manifestations of chronic inflammatory disease affecting internal organs, blood vessels, eyes, skin, and blood (rheumatic and rheumatoid manifestations);
deposition of uric acid crystals in the joints, causing inflammation and progressive joint destruction over time (gouty arthritis);
inflammatory joint disease associated with skin disease (psoriatic arthropathy);
a disease characterized by narrowing of the bronchi causing breathing difficulties (bronchial asthma);
allergic rhinitis commonly known as “hay fever”;
serum sickness, a reaction similar to an allergic response to medications;
various types of allergic reactions;
urticaria;
inflammatory skin diseases with widespread redness and various disturbances (generalized eczema and dermatitis);
a skin disease characterized by widespread redness and scaling (erythroderma);
a chronic autoimmune disease causing inflammation and tissue damage (disseminated erythematodes or systemic lupus erythematosus);
an autoimmune disease affecting skin and muscles (dermatomyositis);
an autoimmune disease affecting the skin and mucous membranes (pemphigus);
inflammatory skin disease with desquamation (exfoliative dermatitis);
severe reduction in the number of white blood cells in the blood (agranulocytosis);
reduced number of blood platelets (thrombocytopenia);
severe reduction in red blood cells due to destruction of red blood cells (acquired hemolytic anemia);
a disease characterized by excessive production of abnormal white blood cells by the bone marrow (myeloblastosis);
a disease caused by abnormal proliferation of cells in lymphatic tissue, which may affect lymph nodes and various other organs (lymphadenosis and lymphogranulomatosis);
liver disease (hepatitis);
intestinal inflammation (ulcerative colitis);
a disorder affecting the genital system due to excessive hormone production by the adrenal glands (adrenogenital syndrome);
kidney disorders (nephrotic syndrome), even when used in combination with diuretic medicines that promote urine production, such as furosemide.

2. What you should know before taking Urbason

Do not take Urbason:

if you are allergic to methylprednisolone, to other glucocorticoids, or to any of the other ingredients of this medicine (listed in section 6).

Urbason must not be used, except for replacement or emergency therapy:

if you suffer from stomach or intestinal lesions (gastric or duodenal ulcers);
if you have severe thinning of the bones (osteoporosis);
if you suffer from mental disorders;
if you have increased pressure inside the eye (open-angle and closed-angle glaucoma);
if you have viral infections of the cornea (herpetic keratitis);
if you suffer from certain viral diseases such as: chickenpox, herpes simplex, and herpes zoster;
if you have tuberculosis, a bacterial infection that usually affects the lungs, or if you have previously unrecognized tuberculosis, or even if you only suspect you may have tuberculosis (risk of developing previously undetected disease or worsening of existing disease);
if you have swollen lymph glands (lymphadenopathy) after vaccination against tuberculosis;
if you are affected by parasitic infection of the colon (amebiasis);
if you have systemic fungal infections (systemic mycoses);
if you suffer from viral inflammation of the spinal cord (poliomyelitis, except for the bulbar encephalitic form affecting cranial nerves);
if you are due to receive or have recently received vaccinations, do not take Urbason for approximately 8 weeks before and 2 weeks after vaccination.

During treatment with glucocorticoids, including Urbason, do not undergo vaccinations
(unless otherwise advised by your doctor), as your immune response may be
inadequate or you may develop nervous system disorders.
Warnings and precautions
Talk to your doctor or pharmacist before taking Urbason.
If you have kidney problems or high levels of uric acid in the blood, contact your doctor before
starting treatment with Urbason.
If you suffer from hematological neoplasia, inform your doctor if you experience symptoms of
Tumor Lysis Syndrome such as muscle cramps, muscle weakness, confusion, loss or disturbances
of vision, shortness of breath, seizures, irregular heartbeat, or kidney failure
(reduced urine output or dark urine) (see section "Possible side effects").
Taking Urbason may reduce your ability to fight infections. Therefore, there is an
increased risk of developing infections. Moreover, if an infection develops, it may
be more difficult to detect during treatment with Urbason.
If you have severe infections, your doctor will prescribe Urbason together with specific therapy.
Take Urbason only when strictly necessary and under medical supervision if:

you suffer from severe inflammatory bowel disease (severe ulcerative colitis) with risk of intestinal wall rupture (perforation), accumulation of infected fluid and pus in the abdomen (abscesses), or pus-producing inflammations (purulent inflammations);
you suffer from diverticulitis, i.e. inflammation of one or more small pouches forming in the intestinal lining that bulge outward (diverticula);
you have recently undergone surgery for intestinal reconstruction (intestinal anastomosis) following removal of part of the intestine, as intestinal wall rupture (intestinal perforation) may occur, leading to inflammation of the membrane covering the inner abdominal wall (peritonitis).

If you have never had chickenpox, avoid contact with people who have chickenpox or
herpes zoster. If you are exposed to these infections while taking Urbason, contact
your doctor immediately, even if you have no symptoms. Indeed, after treatment with
glucocorticoids, these diseases can become severe.
If you tested positive for tuberculosis (tuberculin reactivity), during prolonged treatment
with glucocorticoids including Urbason, undergo careful medical monitoring and
preventive antibiotic treatment (chemoprophylaxis), as the disease may reactivate.
If you suffer from a disease characterized by severe muscle weakness (myasthenia gravis),
especially if you are taking high doses of glucocorticoids including Urbason, there is a
risk that the condition may worsen, usually within the first two weeks of starting
glucocorticoid therapy. At the beginning of treatment with Urbason, low doses will be
prescribed, which your doctor may gradually increase.
If you have high blood sugar levels (diabetes), your doctor must monitor your blood glucose levels and, if necessary, adjust the dose of your diabetes medications.
After prolonged treatment with high doses of Urbason, you may experience fluid
retention (water retention) and sodium accumulation in the body. In this case, take an adequate amount of
potassium, whose blood levels should be monitored, and reduce sodium intake.
If you have high blood pressure (hypertension) and heart disease, undergo careful medical monitoring during treatment with Urbason, as your condition may worsen.
During prolonged treatment with glucocorticoids including Urbason, your doctor will perform
periodic check-ups, including eye examinations.
Contact your doctor if you experience blurred vision or other visual disturbances.
If your thyroid gland is underactive (hypothyroidism) or you have chronic liver disease (hepatic cirrhosis), undergo careful medical monitoring. It may be necessary to reduce the dose of Urbason.
If you suffer from a condition called scleroderma (also known as systemic sclerosis, an autoimmune disease), talk to your doctor before taking Urbason.
Indeed, daily doses of 12 mg or more of methylprednisolone may increase the risk of a serious complication called scleroderma renal crisis. Signs of scleroderma renal crisis include increased blood pressure and reduced urine output. Your doctor may recommend regular monitoring of blood pressure and urine output.
High doses of corticosteroids, the class of medicines to which Urbason belongs, may
cause a disease of the pancreas (acute pancreatitis).
After administration of corticosteroids, worsening of a tumor-related condition called pheochromocytoma may occur, which can be fatal. If you suffer from or suspect you may have pheochromocytoma, your doctor will evaluate whether to administer Urbason (see
"Side effects").
Urbason may cause gas in the intestinal wall, a condition called intestinal pneumatosis (frequency unknown, see section 4 "Possible side effects" below). The course of intestinal pneumatosis varies from a benign condition requiring no treatment to more serious conditions requiring immediate treatment. If symptoms such as "nausea, vomiting, and abdominal pain" persist or become severe, you must consult your doctor immediately. Your doctor will decide whether further diagnostic or therapeutic measures are needed.
Children
In children, Urbason should be administered only when strictly necessary and under
medical supervision due to the risk of growth disturbances.
High doses of corticosteroids, the class of medicines to which Urbason belongs, may
cause inflammation of the pancreas (pancreatitis) in children.
In premature infants, a heart muscle disease characterized by thickening of the heart walls (hypertrophic cardiomyopathy) has been reported. Your doctor will monitor the infant with echocardiograms to assess the structure and function of the heart muscle.
Other medicines and Urbason
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
The effects of Urbason may be influenced by or may influence the following medicines:

heart medications (digitalis glycosides): potential potassium deficiency in the blood (hypokalaemia) caused by Urbason may enhance the effects of these medicines;
medications that promote urine production (diuretics): increased potassium loss may occur;
medications for high blood sugar levels (antidiabetics): their effect may be reduced;
blood-thinning medications (coumarin derivatives): their effects may be reduced;
medication for treating infections (rifampicin), medication for treating epilepsy (phenytoin), and medications for treating depression and anxiety (barbiturates): may decrease the effect of Urbason (see "Possible side effects");
muscle-relaxing agents (non-depolarizing neuromuscular blockers): muscle relaxation may be prolonged;
hormonal contraceptive therapy containing female sex hormones (estrogens), such as oral contraceptives: concomitant use of estrogens may alter the effect of corticosteroids including Urbason;
non-steroidal anti-inflammatory drugs (NSAIDs): increase the risk of gastrointestinal bleeding;
medication to prevent organ transplant rejection (cyclosporine): altered effect and increased risk of seizures;
laboratory allergy tests to verify and confirm possible allergies (allergy testing): concomitant use of Urbason may suppress skin reactions to allergy tests, thus falsifying results;
medication for treating heart conditions (diltiazem): alters the effect of Urbason. Undergo medical monitoring when starting treatment with Urbason. Dose adjustment of Urbason may also be necessary;
some medications may increase the effects of Urbason, and your doctor may wish to monitor you closely if you are taking these medicines (including certain HIV treatments: ritonavir, cobicistat).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.
Pregnancy
Use Urbason during the first trimester of pregnancy only after discussing with your doctor the potential benefits and risks for you and your unborn child from different treatment options. This is because Urbason may increase the risk of a child being born with cleft lip and/or cleft palate (openings or splits in the upper lip and/or palate). If you are pregnant or planning a pregnancy, talk to your doctor about using Urbason.
Breastfeeding
If you are breastfeeding, take Urbason only if strictly necessary and under medical supervision, as the medicine passes into breast milk. In case of high-dose Urbason administration, breastfeeding should be discontinued.
Driving and using machines
When using this medicine, you may experience the following side effects: reduced vision, development of lens clouding causing blurred vision, increased eye pressure, dizziness, and headache (migraine), which may impair your concentration and reaction ability. If this occurs, do not drive vehicles or operate machinery.
Urbason contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
For those engaged in sports
Using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to take Urbason

Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
In general, treatment will be started with a dose that your doctor will gradually reduce over the course of treatment (at intervals of one to several days) down to the lowest dose necessary to achieve a satisfactory response (maintenance dose).

Treatment of bronchial asthma and allergic diseases
The recommended initial dose is: 16–40 mg per day.
The maintenance dose is: 4–16 mg per day.

Treatment of inflammation affecting multiple joints (chronic polyarthritis)
The recommended initial dose is:

for mild cases: 8–16 mg per day
for severe cases: 16–40 mg per day.
The maintenance dose is: 4–16 mg per day.

Treatment of acute rheumatic fever
The recommended initial dose is 40–80–120 mg per day (in children under 14 years: 1.2–1.6 mg per kg of body weight). This dose should be continued until blood tests show that inflammatory markers have been normal for at least one week; thereafter, your doctor will gradually reduce the dose.

Treatment of systemic lupus erythematosus, acute erythematodes, pemphigus, and various blood disorders
The recommended initial dose is: 100 mg per day or more, according to your doctor's instructions.

Switching from prednisone or prednisolone to Urbason
The recommended maintenance dose is: 80% of the previously administered dose of prednisone or prednisolone; that is, 1 tablet of Urbason 4 mg corresponds to 1 tablet of prednisone or prednisolone 5 mg.

Your doctor will decide how to divide the daily dose and the duration of treatment, depending on the severity of your condition and your response to therapy. It is recommended that the daily dose be taken in the early morning, but not on an empty stomach.

If you take more Urbason than you should
In case of accidental ingestion or overdose of Urbason, contact your doctor immediately or go to the nearest hospital.

If you forget to take Urbason
Do not take a double dose to make up for the missed tablet.

If you stop taking Urbason
After long-term use of Urbason, if treatment needs to be discontinued, follow your doctor’s advice. Your doctor may gradually reduce the dose until you stop completely.
Sudden discontinuation of treatment may cause:

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

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody experiences them.
During the use of Urbason, especially with prolonged treatment and high doses, the following side effects may occur:

Common side effects (may affect up to 1 in 10 people):

abnormal distribution of body fat, such as abnormal fat accumulation in the face, particularly in the cheekbone area, giving the face a typical rounded appearance (moon face);
sleep disturbances;
dizziness;
headache;
muscle pain if the dose is reduced too quickly after prolonged treatment;
weight gain.

Uncommon side effects (may affect up to 1 in 100 people):

severe depression;
high blood pressure (hypertension);
abdominal discomfort;
joint pain if the dose is reduced too quickly after prolonged treatment;
increased blood sugar levels.

Side effects with unknown frequency (frequency cannot be estimated from the available data):

abnormal distribution of body fat and excessive accumulation of fat in the body (obesity);
accumulation of fatty tissue in the chest cavity (epicardial, mediastinal lipomatosis);
sodium retention and fluid accumulation in tissues;
increased excretion of potassium, possibly leading to low potassium levels in the blood (hypokalaemia);
increased blood volume in the lung vessels (pulmonary congestion) in patients who have had a heart attack;
disturbances in the secretion of sex hormones, possible absence of menstruation (amenorrhoea), reduced sexual potency;
suspension or suppression of adrenal gland activity;
worsening of a disease caused by a tumour called phaeochromocytoma, which mainly manifests with high blood pressure, headache, sweating, palpitations, anxiety, and hot flushes (see "Warnings");
growth retardation in children;
heart muscle disease in premature newborns, characterised by thickening of the heart walls (hypertrophic cardiomyopathy);
diabetes caused by excessive levels of steroid hormones (steroid-induced diabetes);
changes in blood lipid levels;
rupture of the Achilles tendon, especially in patients with conditions such as high levels of urea in the blood (uraemia) or high blood sugar levels (diabetes mellitus);
muscle weakness;
in patients with a disease causing severe muscle weakness (myasthenia gravis), worsening of muscle weakness and respiratory failure with difficulty in swallowing and speaking, and worsening of reduced muscle strength in arms and legs (severe myasthenic crisis). The use of certain muscle relaxants (non-depolarising relaxants) may worsen certain muscle diseases (acute myopathies);
severe thinning of the bones (osteoporosis with risk of bone fractures), severe degeneration of bone tissue (osteonecrosis), particularly of the femoral or humeral head;
development of stomach and intestinal lesions (gastric and duodenal ulcers);
rupture of the stomach or intestinal wall (gastric and duodenal perforations), with inflammation of the membrane lining the abdominal wall (peritonitis);
blood disorders;
delayed healing of injuries and wounds (impaired wound healing);
increased protein metabolism with elevated urea levels;
skin rashes and skin changes such as reduced skin thickness with loss of elasticity and firmness (atrophy);
stretch marks (striae);
acne and bleeding;
increased hair growth;
allergic reactions and skin rashes. Allergic reactions may also include shock, which may occur after injection, particularly in patients with bronchial asthma or after kidney transplantation;
reduced body defences (immunosuppression) and increased risk of infections. Certain viral diseases such as chickenpox, herpes simplex, and herpes zoster may become severe;
seizures;
increased pressure inside the skull (papilloedema, pseudotumour cerebri);
development or worsening of psychiatric disorders such as unjustified feelings of happiness (euphoria), mood changes, personality changes, or manifestation of mental illnesses affecting behavioural control and actions (psychosis);
tendency for increased platelet count in the blood (thrombocytosis);
increased risk of blood clot formation in blood vessels (thrombosis);
decreased number of platelets in the blood (thrombocytopenia);
clouding of the lens;
increased eye pressure;
scleroderma renal crisis in patients already affected by scleroderma (an autoimmune disease). Signs of scleroderma renal crisis include increased blood pressure and reduced urine production;
increased liver enzymes;
increased white blood cells (leucocytosis);
accumulation of fatty tissue in specific body areas (epidural lipomatosis);
increased blood clotting (thrombotic events);
hiccups;
disease of the retina and choroid membrane (chorioretinopathy);
blurred vision;
disease of the pancreas (pancreatitis);
Tumour Lysis Syndrome has been reported in patients with haematological neoplasia. Tumour Lysis Syndrome may be detected by the doctor based on blood test changes 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, vision loss or disturbances, shortness of breath, seizures, irregular heartbeat, or kidney failure (reduced urine output or dark urine). If you experience any of these symptoms, inform your doctor immediately (see section "Warnings and precautions");
gas in the intestinal wall (intestinal pneumatosis);
although not all people experience them, the following side effects have been observed after sudden discontinuation of Urbason following prolonged use: symptoms such as fever, loss of appetite, nausea, weakness, restlessness, joint pain, skin peeling, low blood pressure, and weight loss (steroid withdrawal syndrome).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Urbason

Do not store above 30°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

The active substance is methylprednisolone. One tablet contains 4 mg of methylprednisolone. The other ingredients are lactose, maize starch, talc, colloidal silicon dioxide and magnesium stearate.

Description of the appearance of Urbason and package contents
Urbason is available as round tablets, imprinted with the code "IVD" on one side and
the brand "Hoechst" on the other.
Pack sizes of 10 tablets of 4 mg in blister packs are available.
Marketing Authorization Holder
Fidia Farmaceutici S.p.A. - Via Ponte della Fabbrica, 3/A - 35031 Abano Terme (PD)
Manufacturer
Sanofi S.r.l. - SS n. 17, km. 22 – 67019 Scoppito (AQ)