URBASON 4 mg Coated Tablet

Зміст інструкції

1. Urbason 4 mg tablets
   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. Package contents and other information

Urbason 4 mg tablets

methylprednisolone

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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Urbason is and what it is used for
• 2. What you need to know before you take 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

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

• acute inflammatory disease affecting joints and other organs (acute rheumatic fever, 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, which become inflamed and over time undergo destruction (gouty arthritis);
• inflammatory disease of the joints associated with skin disease (psoriatic arthropathy);
• disease characterized by narrowing of the bronchi that causes difficulty breathing (bronchial asthma);
• allergic rhinitis commonly known as “hay fever”;
• reaction similar to an allergy to medicines (serum sickness);
• allergic reactions of various types;
• urticaria;
• inflammatory skin diseases with widespread redness and various disorders (generalized eczema and dermatitis);
• skin disease characterized by widespread redness and scaling (erythrodermia);
• chronic disease of the body's defense system that causes inflammation and tissue damage (disseminated erythematodes or disseminated lupus erythematosus);
• disease of the defense system that affects skin and muscles (dermatomyositis);
• disease of the defense system that affects the skin and mucous membranes (pemphigus);
• inflammation of the skin with scaling (exfoliative dermatitis);
• severe reduction in the number of white blood cells in the blood (agranulocytosis);
• reduction in the number of platelets in the blood (thrombocytopenia);
• severe reduction of red blood cells due to red blood cell breakdown (acquired hemolytic anemia);
• disease characterized by an elevated production of abnormal white blood cells by the bone marrow (myeloblastosis);
• disease caused by abnormal multiplication of cells of the lymphatic tissue that can affect the lymph nodes and various other organs (lymphadenosis and lymphogranulomatosis);
• liver disease (hepatitis);
• inflammation of the intestine (ulcerative colitis);
• disease characterized by disorders affecting the genital apparatus caused by excessive production of hormones by the adrenal glands (adrenogenital syndrome);
• kidney alteration (nephrotic syndrome) even with the combined use of medicines that promote urine production, such as furosemide.

2. What you need to 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 should not be used, except in replacement and emergency therapies:

• if you suffer from lesions of the stomach or intestine (gastric or duodenal ulcers);
• if you suffer from severe thinning of the bones (osteoporosis);
• if you suffer from mental disorders;
• if you have increased pressure inside the eye (open and closed-angle glaucoma);
• if you suffer from corneal infections due to viruses (herpetic keratitis);
• if you suffer from certain diseases caused by viruses such as: chickenpox, herpes simplex and herpes zoster;
• if you have tuberculosis, a bacterial infection that usually affects the lungs, or show a previously unknown tuberculosis or even suspect you have tuberculosis (risk of the disease appearing up to that time unknown or worsening of the ongoing disease);
• if you have enlarged lymph nodes (lymphadenopathy) after vaccination against tuberculosis;
• if you are affected by infection from intestinal parasites (amebiasis);
• if you have widespread fungal infections (systemic mycoses);
• if you suffer from inflammation of the spinal cord caused by a virus (poliomyelitis, except for the bulbous encephalitic form, which affects the cranial nerves);
• if you are going to have or have had vaccinations, do not take Urbason for about 8 weeks before and 2 weeks after.

During treatment with glucocorticoids including Urbason, do not undergo vaccinations
(unless otherwise advised by your doctor) because the response of your immune system may be
inadequate or you may develop disorders affecting the nervous system.

Warnings and precautions
Talk to your doctor or pharmacist before taking Urbason.
If you have kidney problems or high levels of uric acid in your blood, contact your doctor before
starting therapy with Urbason.
If you suffer from hematological neoplasm, you must tell your doctor if you have symptoms of Tumor
Lysis Syndrome such as muscle cramps, muscle weakness, confusion, loss or disturbances
of vision, shortness of breath, convulsions, irregular heartbeat or kidney failure
(reduced amount of urine 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. In addition, if an infection is developing, it may be
more difficult to detect during therapy with Urbason.
If you are affected by severe infections, your doctor will prescribe Urbason together with specific therapy .
Take Urbason only when absolutely necessary and under medical supervision if:

• you suffer from severe inflammatory bowel disease (severe ulcerative colitis) with a risk of rupture of the intestinal wall (perforation), collection of infected fluid and pus in the abdomen (abscesses) or inflammation that produces pus (purulent inflammations);
• you are affected by diverticulitis, that is, inflammation of one or more small pouches that form in the lining of the intestine and swell outwards (diverticula);
• you have recently undergone surgery to reconstruct the intestine (intestinal anastomoses) following removal of part of the intestine, because rupture of the intestinal wall (intestinal perforations) with inflammation of the membrane lining the inner wall of the abdomen (peritonitis) may occur.

If you have not already had chickenpox, avoid contact with people affected by chickenpox or
herpes zoster. If you are exposed to these infections while taking Urbason, contact
your doctor immediately, even in the absence of symptoms. Following treatment with
glucocorticoids, these diseases may in fact become severe.
If you have tested positive for the tuberculosis test (tuberculin reactivity), during prolonged therapy
with glucocorticoids including Urbason, undergo careful medical monitoring and
prophylactic antibiotic treatment (chemoprophylaxis) because the disease may reactivate.
If you suffer from a disease characterized by severe muscle weakness (myasthenia gravis) in
particular if you are taking high doses of glucocorticoids including Urbason, there is
a risk that the disease will worsen, usually within the first two weeks of starting
therapy with the glucocorticoid. At the beginning of therapy with Urbason you will be prescribed low doses
that your doctor may gradually increase.
If you have high blood sugar levels (diabetes), your doctor must check the amount of
sugar and, if necessary, adjust the dose of diabetes medications.
After prolonged treatment with high doses of Urbason, you may suffer from fluid retention
(water retention) and sodium in the body. In this case, take an adequate amount of
potassium, the amount of which in the blood must be checked, and reduce sodium intake.
If you have high blood pressure (hypertension) and suffer from heart disease, undergo careful medical monitoring during
therapy with Urbason because your condition may
worsen.
During prolonged treatment with glucocorticoids including Urbason, your doctor will subject you
to periodic checks including eye examinations.
Contact your doctor if you experience blurred vision or other visual disturbances.
If your thyroid gland is not sufficiently active (hypothyroidism) or if you have a chronic disease of the liver (hepatic cirrhosis), undergo careful medical monitoring. It may be
necessary to reduce the dose of Urbason.
If you suffer from a disease called scleroderma (also known as systemic sclerosis, an
autoimmune disease), talk to your doctor before taking Urbason.
In fact, daily doses of 12 mg or more of methylprednisolone may increase the risk of
a serious complication called scleroderma renal crisis. The signs of scleroderma renal crisis include increased blood pressure and decreased urine production.
Your doctor may advise you to regularly check your blood pressure and
urine production.
High doses of corticosteroids, the class of medicines to which Urbason belongs, can
develop a disease of the pancreas (acute pancreatitis).
After the administration of corticosteroids, a worsening of a disease due to a tumor called pheochromocytoma may occur, which can lead to death. If you suffer or
suspect you suffer from pheochromocytoma, your doctor will assess whether to administer Urbason to you (see
“Side effects”).
Urbason can cause gas in the intestinal wall, a condition called intestinal pneumatosis
(frequency not known, see paragraph 4 "Possible side effects"). The
course of intestinal pneumatosis ranges from a benign disease that does not require
treatment to more serious conditions 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. The doctor will decide on the need for
further diagnostic and treatment measures.

Children
In children, Urbason should only be administered when absolutely necessary and under
medical supervision, due to the risk of growth disorders.
High doses of corticosteroids, the class of medicines to which Urbason belongs, can
develop inflammation of the pancreas (pancreatitis) in children.
In premature infants, a disease of the heart muscle characterized by an
increase in the thickness of the heart walls (hypertrophic cardiomyopathy) has been reported. The doctor
will subject the newborn to checks with the performance of echocardiograms to monitor the
structure and function of the heart muscle.

Other medicines and Urbason
Tell your doctor or pharmacist if you are taking, have recently taken or could
take any other medicines, including over-the-counter medicines.
The effects of Urbason may be affected by or affect the following medicines:

• heart medications (digitalis glycosides): the possible potassium deficiency in the blood (hypokalemia) caused by Urbason may increase the action of these medicines;
• medicines that promote urine production (diuretics): increased elimination of potassium is possible;
• medicines to treat high blood sugar levels (antidiabetics): their effect may be reduced;
• medicines to thin the blood (coumarin derivatives): their effects may be reduced;
• medicine to treat infections (rifampicin), medicine to treat epilepsy (phenytoin) and medicines to treat depression and anxiety (barbiturates): may decrease the effect of Urbason (see “Possible side effects”);
• medicines that act on the muscles reducing their tension (non-depolarizing muscle relaxants): muscle relaxation may be prolonged;
• contraceptive therapy containing female sex hormones (estrogens) such as the pill: concomitant use of estrogens may alter the effect of corticosteroids including Urbason;
• non-steroidal anti-inflammatory drugs (NSAIDs): increase the risk of bleeding from the stomach and intestines;
• medicine to prevent organ rejection (cyclosporine): alteration of the effect and increased risk of convulsions;
• laboratory tests to check and confirm the presence of any allergies (allergy tests): the concomitant use of Urbason may cancel the skin reactions to allergy tests, thus falsifying their results;
• medicine to treat heart disease (diltiazem): alters the effect of Urbason. Undergo medical supervision when you start therapy with Urbason. Adjustment of the dose of Urbason may also be necessary;
• some medicines may increase the effects of Urbason and your doctor may want to keep you under close observation if you are taking these medicines (including some medicines for the treatment of HIV: ritonavir, cobicistat).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.

Pregnancy
Use Urbason only during the first trimester of pregnancy after discussing with your
doctor the potential benefits and risks to you and the unborn child of the different treatment options. This is because Urbason may increase the risk that a baby is born with
cleft lip and/or palate (openings or splits in the upper lip and/or palate). If
you are pregnant or planning a pregnancy, talk to your doctor about the use of 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 administrations of
Urbason, breastfeeding should be discontinued.

Driving and using machines
With the use of this medicine you may experience the following side effects: reduced
vision, appearance of clouding of the lens that causes blurred vision, increased
pressure in the eye, dizziness and headache that can
decrease your ability to concentrate and react. If this happens, do not drive
vehicles and do not use machinery.

Urbason contains lactose
If your doctor has diagnosed you with intolerance to some sugars, contact him before
taking this medicine.

For those who play sports
The use of the medicine without therapeutic need constitutes doping and may nevertheless result in
positive doping tests.

3. How to take Urbason

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
In general, treatment will be started with doses that the doctor will reduce during the treatment gradually (at intervals of one to several days) until the minimum dose necessary to obtain a satisfactory result (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 of multiple joints (chronic polyarthritis)
The recommended initial dose is:

• for mild cases: 8-16 mg per day
• for severe cases: 16-40 mg. 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 must be taken until blood tests show that the indices of inflammation are normal for at least one week; subsequently the doctor will reduce the dose gradually.

Treatment of lupus erythematosus, acute erythematodes, pemphigus and various blood diseases
The recommended initial dose is: 100 mg per day and more, as directed by your doctor.

Switching from treatment with prednisone or prednisolone to Urbason
The recommended maintenance dose is: 80% of the previously administered dose of prednisone or prednisolone, i.e. 1 Urbason 4 mg tablet corresponds to 1 prednisone or prednisolone 5 mg tablet.
The doctor will decide how to divide the dose during the day and the duration of treatment, based on the severity of your illness and your response to treatment. It is recommended that the single daily dose be taken early in the morning, but not on an empty stomach.

If you take more Urbason than you should
In case of accidental ingestion/intake of an excessive dose of Urbason, immediately notify your doctor 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 the treatment needs to be stopped, follow your doctor's advice. The doctor may gradually reduce the amount of medicine you are taking until you stop taking it altogether.
Sudden discontinuation of treatment can cause:

• steroid withdrawal syndrome (see section 4)
• adrenocortical insufficiency (low levels of cortisol) or
• a relapse (return) of the underlying condition being treated may occur. If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
During the use of Urbason, especially in case of prolonged treatments and with high doses,
the following side effects can occur:
Common side effects (may affect up to 1 in 10 people):

• abnormal distribution of body fat, such as in the case of abnormal fat accumulation on the face, especially at the level of the cheekbones, which gives the face a typical rounded shape (moon face);
• sleep disorders;
• dizziness;
• headache; muscle pain if the dose is reduced too rapidly after prolonged treatment; increased body weight.

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 rapidly after prolonged treatment;
• increased blood sugar.

Side effects with unknown frequency (frequency cannot be estimated on the basis of the available data):

• abnormal distribution of body fat and excessive fat accumulation in the body (obesity);
• accumulation of adipose tissue in the chest cavity (epicardial, mediastinal lipomatosis);
• sodium retention and water accumulation in the tissues;
• increased elimination of potassium with possible reduction of potassium in the blood (hypokalemia);
• increased blood volume in the pulmonary blood vessels (pulmonary congestion) in patients with heart attack;
• alteration in the secretion of sex hormones, possible absence of menstruation (amenorrhea), decreased sexual potency;
• suspension or suppression of the activity of the adrenal glands;
• worsening of a disease due to a tumor called pheochromocytoma, which mainly manifests with high blood pressure, headache, sweating, palpitations, anxiety and flushing (see “Warnings”);
• growth retardation in children;
• heart muscle disease in premature infants characterized by an increase in the thickness of the heart walls (hypertrophic cardiomyopathy);
• diabetes caused by an excessive amount of steroid hormones (steroid diabetes);
• changes in blood fats;
• rupture of the Achilles tendon, especially in patients with disorders such as: significant amounts of urea in the blood (uremia) or high blood sugar levels (diabetes mellitus);
• muscle weakness;
• in the case of a disease that causes severe muscle weakness (myasthenia gravis), worsening of muscle weakness and respiratory failure with difficulty swallowing and speaking and worsening of the reduction of strength in the muscles of legs and arms (severe myasthenic crises) can occur. The use of a type of muscle relaxants (non-depolarizing relaxants) can worsen some muscle diseases (acute myopathies);
• severe thinning of the bones (osteoporosis with risk of bone fractures), severe degeneration of bone tissue (osteonecrosis) especially of the femoral head or humerus;
• development of lesions of the stomach and intestines (gastric and duodenal ulcers);
• rupture of the wall of the stomach or intestines (gastric and duodenal perforations), with inflammation of the membrane lining the inner wall of the abdomen (peritonitis);
• blood diseases;
• delays in the repair of lesions and wounds (cicatrization);
• increased protein metabolism with increased urea;
• skin rashes and skin changes such as decreased skin thickness with loss of elasticity and consistency (atrophy);
• stretch marks (striae);
• acne and bleeding;
• increased hair growth;
• allergic reactions and skin rashes. Allergic reactions can also include shock, which can occur after injection and especially in the presence of bronchial asthma or after a kidney transplant;
• decreased defenses of the body (immune) and increased risk of infections. Some diseases caused by viruses such as: chickenpox, herpes simplex and herpes zoster can become severe;
• convulsions;
• increased pressure inside the skull (papilledema, pseudotumor cerebri);
• development or worsening of mental disorders such as: unjustified feeling of happiness (euphoria), mood changes, personality changes, manifestation of mental illnesses that alter the control of behavior and actions (psychoses);
• tendency to increase platelets 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 (cataract);
• increased pressure in the eye;
• scleroderma renal crisis in patients already affected by scleroderma (an autoimmune disease). The signs of scleroderma renal crisis include increased blood pressure and decreased urine production.
• increased liver enzymes;
• increased white blood cells (leukocytosis);
• accumulation of adipose tissue in localized parts of the body (epidural lipomatosis);
• increased blood coagulation (thrombotic events);
• hiccups;
• retinal and choroidal disease (chorioretinopathy);
• blurred vision;
• pancreatic disease (pancreatitis);
• Tumor Lysis Syndrome has been reported in patients with hematological malignancies. Tumor Lysis Syndrome can be discovered by the doctor based on changes in blood tests such as increased levels of uric acid, potassium or phosphorus, and decreased levels of calcium, and can cause symptoms such as muscle cramps, muscle weakness, confusion, loss or disturbances of vision, shortness of breath, convulsions, irregular heartbeat or kidney failure (reduced amount of urine or dark urine). If such symptoms occur, you must tell your doctor immediately (see the section "Warnings and precautions");
• gas in the intestinal wall (pneumatosis intestinalis);
• although not everyone will 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 flaking, low blood pressure and weight loss (steroid withdrawal syndrome).

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

5. How to store Urbason

Do not store at a temperature above 30°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the blister
after “Exp.”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in 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 ingredient is methylprednisolone. One tablet contains 4 mg of methylprednisolone. The other ingredients are lactose, corn starch, talc, colloidal silicon dioxide and magnesium stearate.

Description of the appearance of Urbason and package contents
Urbason is presented in the form of round tablets with the letters “IVD” imprinted on one side and
the “Hoechst” brand on the other.
Packs of 10 tablets of 4 mg are available in blisters.

Marketing authorisation holder
Fidia Farmaceutici S.p.A. - Via Ponte della Fabbrica, 3/A - 35031 Abano Terme (PD)

Manufacturer
Sanofi S.r.l. - S.S. n. 17, km. 22 – 67019 Scoppito (AQ)