PREXILEV 5 мг Коированная таблетка

Содержание инструкции

1. PREXILEV 5 mg tablets, 20 mg tablets, 25 mg tablets
   1. What is PREXILEV and what is it used for
   2. What you need to know before taking PREXILEV
   3. How to take PREXILEV
   4. Possible side effects
   5. How to store PREXILEV
   6. Contents of the pack and other information

PREXILEV 5 mg tablets, 20 mg tablets, 25 mg tablets

Prednisone
Equivalent medicine
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 doubts, ask your doctor or pharmacist.
• This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any undesirable effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet:
• 1. What PREXILEV is and what it is used for
• 2. What you need to know before you take PREXILEV
• 3. How to take PREXILEV
• 4. Possible side effects
• 5. How to store PREXILEV
• 6. Contents of the pack and other information

1. What is PREXILEV and what is it used for

PREXILEV is a glucocorticoid (hormone produced by the adrenal glands) with an effect on metabolism,
electrolyte balance (of salts) and tissue function.
PREXILEV is used in cases of diseases that require systemic treatment with
glucocorticoids including the following based on type and severity (dosage table SD from a to d), see
paragraph 3 “How to take PREXILEV”).

Hormone replacement therapy in case of

• decreased or absent adrenal function (adrenal insufficiency) of any nature (e.g. Addison's disease, adrenogenital syndrome, surgical removal of the adrenal glands, reduced pituitary activity) after the growth period (drugs of first choice are hydrocortisone and cortisone).
• stressful conditions following prolonged treatment with corticosteroids.

Rheumatic diseases:

• active phases of vascular inflammation:
• nodular inflammation of the vessel walls (polyarteritis nodosa) (SD: a, b, treatment duration limited to two weeks in the presence of hepatitis B infection)
• giant cell arteritis, muscle pain and muscle stiffness (polymyalgia rheumatica) (SD: c)
• inflammation of the temporal artery (SD: a); in case of acute vision loss, initial shock treatment with glucocorticoids intravenously and continuous therapy with erythrocyte sedimentation rate (ESR) monitoring is recommended
• Wegener's granulomatosis: induction treatment (SD: a-b) in combination with methotrexate (mild forms without kidney involvement) or according to the Fausi scheme (severe forms with kidney and/or lung involvement), remission maintenance: (SD: d, gradual dose reduction) in combination with immunosuppressants
• Churg-Strauss syndrome: initial therapy (SD: a-b), with organ involvement and severe courses in combination with immunosuppressants, remission maintenance: (SD: d)
• active phases of rheumatic diseases that can affect internal organs (SD: a, b):
• lupus erythematosus (chronic disease due to an alteration of the immune system that causes inflammation and tissue damage), muscle weakness and muscle pain (polymyositis)
• inflammation of the cartilage (chronic atrophic polychondritis)
• connective tissue diseases (mixed collagen disease)
• active rheumatoid arthritis (SD: from a to d) with a severely progressive course, e.g. forms that progress rapidly and destructively (SD: a) or forms that do not affect the joint (SD: b)
• other inflammatory rheumatic arthritides, if the severity of the clinical picture requires it and non-steroidal anti-inflammatory drugs (NSAIDs) cannot be used:
• spondyloarthropathies (ankylosing spondylitis involving peripheral joints (SD: b, c), psoriatic arthritis (SD: c, d), enteropathic arthropathy with high inflammatory activity (SD: a)
• reactive arthritis (SD: c)
• arthritis in sarcoidosis (SD: b initially)
• carditis in rheumatic fever, in severe cases within 2-3 months (SD: a)
• juvenile idiopathic arthritis with severe systemic form (Still's disease) or with iridocyclitis when local treatment is ineffective (SD: a) Bronchial and pulmonary diseases:
• Bronchial asthma (SD: from c to a), at the same time the administration of bronchodilators is recommended
• Acute exacerbation of chronic obstructive bronchopneumopathy COPD (SD: b), recommended duration of therapy up to 10 days
• Interstitial lung diseases such as acute alveolitis (SD: b), pulmonary fibrosis (SD: b), obliterating bronchiolitis organizing pneumonia (BOOP) (SD: b decreasing the dose gradually until discontinuation), possibly in combination with immunosuppressants, chronic eosinophilic pneumonia (SD: b decreasing the dose gradually until discontinuation), for long-term treatment of chronic forms of sarcoidosis in stages II and III (in case of shortness of breath, cough and deterioration of pulmonary function values) (SD: b)
• Prophylaxis of respiratory distress syndrome in premature infants (SD: b, twice)

Diseases of the upper respiratory tract:

• Severe forms of pollinosis and allergic rhinitis after failure of intranasal glucocorticoid administration (SD: c)
• Acute stenosis of the larynx and trachea: Quincke's edema, subglottic obstructive laryngitis (pseudo-croup) (SD: from b to a) Skin diseases:Skin and mucous membrane diseases that cannot be treated or cannot be adequately treated with topical glucocorticoids due to their severity and/or extent or systemic involvement. These include:
• Allergic, pseudo-allergic and allergic-infectious diseases: e.g. acute urticaria, anaphylactoid reactions, drug eruption, erythema exudativum multiforme, toxic epidermal necrolysis (Lyell's syndrome), acute generalized pustulosis, nodular erythema, acute febrile neutrophilic dermatosis (Sweet's syndrome), allergic contact dermatitis (SD: from b to a)
• Eczema diseases: e.g. atopic eczema, contact eczema, microbial eczema (nummular) (SD: from b to a)
• Granulomatous diseases: e.g. sarcoidosis, granulomatous cheilitis (monosymptomatic Melkersson-Rosenthal syndrome) (SD: from b to a)
• Bullous dermatoses: e.g. pemphigus vulgaris, bullous pemphigoid, benign mucous membrane pemphigoid, linear IgA dermatosis (SD: from b to a)
• Vasculitis: e.g. allergic vasculitis, nodular polyarteritis (SD: from b to a)
• Autoimmune diseases: e.g. dermatomyositis, systemic scleroderma (induration phase), chronic and subacute cutaneous lupus erythematosus (SD: from b to a)
• Pregnancy dermatoses (see also section 4.6): for example herpes gestationis, impetigo herpetiformis (SD: from d to a)
• Erythematous-squamous dermatoses: e.g. pustular psoriasis, pityriasis rubra pilaris, parapsoriasis group (SD: from c to a)
• Erythrodermia, also in Sézary syndrome (SD: from c to a)
• Other pathologies: e.g. Jarisch-Herxheimer reaction with penicillin treatment of Lues, rapidly growing and increasing cavernous hemangioma, Behçet's disease, pyoderma gangrenosum, eosinophilic fasciitis, lichen ruber planus, hereditary bullous epidermolysis (SD: from c to a) Blood diseases/tumor diseases:
• Autoimmune hemolytic anemia (SD: from c to a), idiopathic thrombocytopenic purpura (Werlhof's disease) (SD: a), acute intermittent thrombocytopenia (SD: a)
• Acute lymphoblastic leukemia, Hodgkin's disease, non-Hodgkin's lymphoma, chronic lymphocytic leukemia, Waldenström's macroglobulinemia, multiple myeloma (SD: e)
• Hypercalcemia in underlying malignant neoplasms (SD: from c to a)
• Prophylaxis and therapy of cytotoxic-induced vomiting (SD: from b to a), use in antiemetic regimens
• Palliative therapy for malignant diseases
• Note: prednisone can be used to relieve symptoms, such as loss of appetite, anorexia and general weakness in advanced malignancies, after specific therapeutic options have been exhausted. For more details, consult current medical literature. Diseases of the nervous system:
• Myasthenia gravis (drug of first choice is azathioprine)
• Chronic Guillain-Barré syndrome.
• Tolosa-Hunt syndrome
• Polineuropathy in monoclonal gammopathy
• Multiple sclerosis (decreasing the dose gradually until discontinuation after administering high doses of glucocorticoids parenterally in the acute phase)
• West syndrome (infantile spasms)

Particular courses of infectious diseases:

• Toxic conditions associated with severe infectious diseases (in association with antibiotics/chemotherapy), e.g. tuberculous meningitis (SD: b), severe pulmonary tuberculosis (SD: b) Eye diseases (SD: from b to a):
• In systemic diseases involving the eye and immunological processes in the orbit and eye: optic neuropathy (e.g. giant cell arteritis, anterior ischemic optic neuropathy (AION), traumatic optic neuropathy), Behçet's disease, sarcoidosis, endocrine orbitopathy, pseudotumor of the orbit, transplant rejection and in some uveitis such as Harada disease and sympathetic ophthalmia
• Systemic administration is indicated only after unsuccessful local treatment in the following diseases: scleritis, episcleritis, keratitis, chronic cyclitis, uveitis, allergic conjunctivitis, chemical burns from alkalis, in association with antimicrobial therapy in autoimmune or syphilitic interstitial keratitis, in herpes simplex stromal keratitis only if the corneal epithelium is intact and regular eye controls Gastrointestinal/liver diseases:
• Ulcerative colitis (SD: from b to c)
• Crohn's disease (SD: b)
• Autoimmune hepatitis (SD: b)
• Esophageal burn (SD: a)

Kidney diseases:

• Minimal change glomerulonephritis (SD: a)
• Proliferative-extracapillary glomerulonephritis (rapidly progressive glomerulonephritis) (SD: intermittent [pulse therapy] high-dose, usually in association with cytotoxic agents), in Goodpasture's syndrome reduction and discontinuation of treatment, in all other forms long-term continuation of therapy (SD: d)
• Idiopathic retroperitoneal fibrosis (SD: b)

2. What you need to know before taking PREXILEV

Do not take PREXILEV
If you are allergic to the active ingredient (prednisone) or to any of the other ingredients of this medicine
(listed in section 6).
There are no other contraindications for short-term use of PREXILEV.

Warnings and precautions
Talk to your doctor or pharmacist before taking PREXILEV.
You must inform your doctor if:

• you suffer from scleroderma (also known as systemic sclerosis, an autoimmune disease), as daily doses of 15 mg or even higher doses may increase the risk of a scleroderma renal crisis with increased blood pressure and reduced urine production. Your doctor may advise you to have regular checks of your blood pressure and urine. Particular caution is necessary when taking PREXILEV at high doses in hormone replacement therapy. You should only take PREXILEV if your doctor considers it absolutely necessary. Due to suppression of your own defenses, treatment with PREXILEV may lead to an increased risk of bacterial, viral, parasitic, opportunistic and fungal infections. The signs and symptoms of an existing or developing infection may be masked and therefore difficult to recognize. Subclinical infections, such as tuberculosis or hepatitis B, may be reactivated. Consult your doctor immediately if you experience any of the following diseases at the same time:
• acute viral infections (hepatitis B, chickenpox, herpes zoster, herpes simplex infections, corneal inflammation caused by herpes viruses)
• infectious inflammation of the liver (active chronic hepatitis B antigen positive)
• from about 8 weeks before to 2 weeks after vaccinations with live vaccines
• fungal diseases affecting internal organs
• certain diseases caused by parasites (amebae, worm infections)
• in patients with suspected or confirmed infections by dwarf nematodes (strongylids) PREXILEV may lead to activation and mass multiplication of the parasites.
• poliomyelitis
• lymph node disease after vaccination against tuberculosis (in case of tuberculosis in the medical history, use only with simultaneous administration of drugs against tuberculosis)
• acute and chronic bacterial infections. If treated simultaneously with PREXILEV, the following diseases must be monitored specifically and treated accordingly under strict control of your doctor:
• gastrointestinal ulcer
• osteoporosis
• high blood pressure that is difficult to regulate
• diabetes that is difficult to regulate (diabetes mellitus)
• mental illnesses (including a history of them) including suicidal tendencies: neurological or psychiatric monitoring is recommended
• increased pressure in the eye (narrow-angle glaucoma and open-angle glaucoma); ophthalmic monitoring and concomitant therapy are recommended
• wounds and ulcers of the cornea of the eye; ophthalmic monitoring and concomitant therapy are recommended. Treatment with this medicine may lead to a so-called pheochromocytoma crisis, which can be fatal. Pheochromocytoma is a rare hormone-dependent tumor of the adrenal gland. Possible symptoms of a crisis include headache, sweating, palpitations and high blood pressure (hypertension). Contact your doctor immediately if you notice any of these signs. Talk to your doctor before taking PREXILEV if you suspect or are known to have a pheochromocytoma (adrenal gland tumor). Contact your doctor if you experience blurred vision or other visual disturbances. Due to the risk of intestinal perforation, PREXILEV can only be taken if your doctor considers it necessary and under his strict control in case of:
• severe inflammation of the large intestine (ulcerative colitis) with threat of perforation, with abscesses or purulent inflammation possibly also without irritation of the peritoneum
• diverticulitis
• immediately after certain operations on the intestine (enteroanastomoses). The signs of irritation of the peritoneum after perforation of a gastrointestinal ulcer may not be present in patients receiving high doses of glucocorticoids. The risk of tendon disorders, tendon inflammation and tendon rupture is increased in case of simultaneous administration of fluoroquinolones (certain antibiotics) and PREXILEV. In case of diabetes, metabolism must be checked regularly; your doctor will assess whether an increase in the need for diabetes medication (insulin or oral antidiabetics, etc.) is necessary. In case of severe hypertension and severe heart failure, consult your doctor for accurate checks as a worsening may occur. In the treatment of a particular form of muscle paralysis (myasthenia gravis), a worsening of symptoms may occur at the beginning, so the administration of PREXILEV should take place in hospital. In particular, if the disturbances affecting the face and pharynx are particularly severe and breathing is compromised, treatment with PREXILEV should be started gradually. Long-term use, even of low doses of prednisone, leads to an increased risk of infections, even by microorganisms that otherwise rarely cause infections (so-called opportunistic infections). Vaccinations with vaccines from killed pathogens (inactivated vaccines) are fundamentally possible. However, attention should be paid to the fact that the success of the vaccination may be impaired by high doses of PREXILEV. High doses of PREXILEV can cause a slowing of the heartbeat (bradycardia). The onset of bradycardia is not necessarily related to the duration of treatment. Regular medical checks (including ophthalmic checks at intervals of three months) are necessary in case of long-term therapy with PREXILEV.

In case of prolonged treatment at high doses with PREXILEV, pay particular attention to sufficient
intake of potassium (e.g. vegetables, bananas) and limited intake of salt. Your doctor may prescribe
tests to check your blood potassium levels.
If you experience particular stressful conditions (illnesses with fever,
accidents, surgeries, childbirth, etc.) during treatment with PREXILEV, you should inform your doctor immediately because a
temporary increase in the daily dose of PREXILEV may be necessary. For this reason, in case of
long-term treatment, your doctor should provide you with appropriate documentation that you should always
carry with you.
Severe anaphylactic reactions (exaggerated immune system reaction) can occur.
Depending on the duration and dose of treatment, a negative influence on
calcium metabolism must be taken into account, and therefore prevention against osteoporosis is recommended. This is especially true in
case of concomitant risk factors, such as family predisposition, advanced age, insufficient intake of
proteins and calcium, excessive smoking, excessive alcohol consumption, after menopause and in case of poor
physical activity. Prevention consists of sufficient intake of calcium and vitamin D and physical activity. In
case of existing osteoporosis, medication therapy should also be considered.
At the end or after discontinuation of long-term therapy with PREXILEV, the following risks may occur:
recurrence or worsening of the underlying disease, reduced activity of the adrenal glands
(particularly in stressful situations, e.g. during an infection, after accidents, in case of
increased physical exertion), cortisone withdrawal syndrome.
Particular viral diseases (chickenpox, measles) may have a particularly severe course in patients
treated with glucocorticoids. If you are immunocompromised and have not had chickenpox or measles and have come into
contact with people affected by these diseases while being treated with Prexilev, preventive treatment may be necessary.

Children and adolescents
PREXILEV should only be used in children in case of actual necessity and under the control of the doctor
due to the risk of growth inhibition, which must be checked regularly. Therapy with
PREXILEV should be limited in time or administered with alternation (e.g. one day yes and one day no, but
with double dosage (alternating therapy)).

Elderly patients
Since elderly patients have a greater risk of osteoporosis, the benefit-risk ratio of a
therapy with PREXILEV must be carefully evaluated.

For athletes:the use of the drug without therapeutic need constitutes doping and can
still result in positive doping tests.

Other medicines and PREXILEV
Tell your doctor if you are taking or have recently taken or may take any other
medicines, including those available without a prescription.
Some medicines may increase or decrease the effects of PREXILEV:

• Some medicines may increase the effects of PREXILEV and your doctor may want to monitor you closely if you are taking these medicines (including some medicines for the treatment of HIV: ritonavir, cobicistat)
• Medicines that slow down liver degradation, such as some antifungal medicines (ketoconazole, itraconazole), may potentiate the effects of PREXILEV.
• Some female sex hormones, e.g. contraceptives (the “pill”). The effect of PREXILEV may be increased.
• Medicines such as hypnotics (barbiturates), anti-convulsant medicines (phenytoin, carbamazepine, primidone) and certain medicines against tuberculosis (rifampicin) may decrease the effect of PREXILEV.
• Efedrine (may be contained, for example, in medicines for treating hypotension, chronic bronchitis, asthma attacks and for decongesting the mucous membranes in colds) can decrease the effectiveness of PREXILEV.
• Medicines against excessive acid production by the stomach (antacids): in simultaneous administration of magnesium hydroxide or aluminum, a decrease in the absorption of prednisone is possible. Taking the two medicines should therefore be spaced apart in time (2 hours). Other effects of PREXILEV
• Due to potassium deficiency, PREXILEV may increase the effect of medicines to strengthen the heart (cardiac glycosides).
• PREXILEV may increase the elimination of potassium if used in association with diuretics (saluretics) and laxatives.
• PREXILEV may decrease the hypoglycemic effect of oral antidiabetics and insulin.
• PREXILEV may decrease or increase the effect of medicines to inhibit coagulation (oral anticoagulants, coumarin derivatives). Your doctor will decide whether an adjustment of the dose of anticoagulant medicines is necessary.
• In case of simultaneous use of medicines against inflammation and rheumatism (salicylates, indometacin and other NSAIDs), PREXILEV may increase the risk of gastric ulcers and gastrointestinal bleeding.
• PREXILEV may prolong the muscle-relaxing effect of certain medicines (non-depolarizing muscle relaxants).
• PREXILEV may potentiate the pressure-increasing effect in the eye of certain medicines (atropine and other anticholinergics).
• PREXILEV may decrease the effect of medicines against helminthiasis (praziquantel).
• In case of simultaneous use of medicines against malaria or rheumatic diseases (chloroquine, hydroxychloroquine, mefloquine), PREXILEV may increase the risk of muscle diseases or heart muscle diseases (myopathies, cardiomyopathies).
• Growth hormones (somatotropin): their effect is diminished particularly by high doses of PREXILEV.
• PREXILEV may decrease the increase in thyroid-stimulating hormone (TSH) following concomitant administration with protirelin (a diencephalon hormone).
• PREXILEV and the simultaneous use of medicines to reduce the body's defenses (immunosuppressants) may increase the predisposition to infections and worsen already present but perhaps not yet manifest infections.
• In addition to cyclosporine (medicine to suppress the body's defenses): PREXILEV may increase the level of cyclosporine in the blood and thus the risk of seizures.
• Some drugs to lower blood pressure (ACE inhibitors): increased risk of hematological condition changes.
• Fluoroquinolones, a group of antibiotics, may increase the risk of tendon rupture.

Influence on diagnostic tests
Skin reactions to allergy tests may be suppressed.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
During pregnancy, intake should only take place on the advice of a doctor. Inform your doctor if
you are pregnant.
In case of long-term treatment with PREXILEV during pregnancy, fetal growth disorders cannot be excluded.
If PREXILEV is taken at the end of pregnancy, the newborn may experience adrenal cortex atrophy, which may require gradual replacement therapy. In animal tests, prednisone has shown fetal damage (e.g. cleft palate). An increased risk of such
damage in humans through the administration of prednisone during the first trimester of pregnancy is under discussion.

Breastfeeding
Prednisone passes into breast milk. No harm to the infant is known so far. Nevertheless, the need to administer PREXILEV during breastfeeding should be carefully considered.
If higher doses are necessary due to the illness, you should stop breastfeeding. Contact your doctor immediately.

Driving and operating machinery
So far, there is no evidence that PREXILEV affects the ability to drive or operate
machinery.

PREXILEV contains lactose.
If your doctor has diagnosed you with intolerance to certain sugars, contact them before taking this
medicine.

3. How to take PREXILEV

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
The dose will be established individually for you by the doctor.
Respect the prescription instructions, as otherwise PREXILEV may not have the correct effect. If you have
doubts, consult your doctor or pharmacist.

Method of administration
Take the tablets without chewing with a sufficient amount of liquid during or immediately after
a meal.

If not prescribed differently by the doctor, the usual dose for hormone replacement therapy is (beyond
the age of growth):
from 5 to 7.5 mg of prednisone per day, divided into two administrations (in the morning and at noon, in case
of adrenogenital syndrome in the morning and in the evening). If necessary, you will be prescribed an additional dose of a
mineralocorticoid (fludrocortisone). In case of particular stressful conditions such as illnesses with fever,
accidents, surgeries or childbirth, the doctor may decide to temporarily increase the dose.
In case of stressful situations following long-term glucocorticoid treatment: the
administration will be promptly up to 50 mg of prednisone per day; the reduction of the dose
must occur over several days.

Treatment of certain diseases (pharmacotherapy):
The following tables give an overview of the general guidelines for dosage:

Adults

In general, the entire daily dose is taken in the early morning between 6 and 8 am. High daily
doses can also be divided, depending on the disease, into 2-4 single administrations, medium doses into 2-3 single administrations.

Children
In children, dosages should be as low as possible. In particular cases (e.g. West syndrome) it may be
possible to deviate from this recommendation.

Dose reduction
Once the desired clinical effect is achieved and depending on the underlying disease, the dose reduction is started. In case of distribution of the daily dose into multiple single doses, the evening dose is reduced first, then
the possible noon dose. The dose is first reduced with larger decreases, starting from
about 30 mg/day and subsequently with smaller decreases (see table below). Based on the
clinical situation, it is decided regarding the gradual reduction of the dose until the interruption of
treatment or the need for a maintenance dose, based on the disease. The following approximate decreases can be used for dose reduction:
High and very high doses, which are administered for a few days, can be interrupted, depending on
the underlying disease and the clinical response, without progressive decrease.

Dosage scheme “e” (SD: e)
Generally PREXILEV is used as a single dose without gradual decrease until the end of
treatment. In chemotherapy, the following dosage schemes are recognized, for example:
In case of thyroid insufficiency or hepatic cirrhosis, lower dosages may also be sufficient or a dose reduction may be necessary.
Talk to your doctor or pharmacist if you feel that the effect of PREXILEV is too strong or
too weak.

• Non-Hodgkin lymphomas: CHOP scheme, prednisone 100 mg/m², days 1-5; COP scheme, prednisone 100 mg/m², days 1-5.
• Chronic lymphocytic leukemia: Knospe scheme, prednisone 75/50/25 mg, days 1-3.
• Hodgkin's disease: COPP-ABVD scheme, prednisone 40 mg/m², days 1-14.
• Multiple myeloma: Alexanian scheme, prednisone 2 mg/kg of body weight, days 1-4.

If you take more PREXILEV than you should
In general, PREXILEV is well tolerated even in case of taking large quantities for a short time.
Therefore, no particular measures are necessary. If you should notice an increase in side effects, contact your doctor.

If you forget to take PREXILEV
Do not take a double dose to make up for the missed dose. Contact your doctor to know
how to behave.

If you stop taking PREXILEV
Always follow the dosage scheme prescribed by the doctor. Do not suddenly stop taking
PREXILEV. If you stop treatment with PREXILEV, especially in cases of long-term treatment, a suppression of the production of glucocorticoids by your
body may occur. Particular stressful conditions may be life-threatening (Addisonian crisis).
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency and severity of the side effects listed below depend on the dosage and duration of
treatment.

Hormone replacement therapy:
Low risk of side effects if the recommended dosages are respected.

Treatment of specific diseases with higher dosages than hormone replacement therapy:
The following side effects may occur, which depend on the dose and duration of treatment and whose frequency is unknown:

Infections and infestations
Masking of infections, appearance, recurrence and worsening of viral, fungal and
bacterial infections, parasitic or opportunistic infections, activation of a nematode infection (strongyloidiasis).

Blood and lymphatic system disorders
Changes in the blood picture (increased white blood cells or all blood cells, decrease
of some white blood cells).

Immune system disorders
Hypersensitivity reactions (e.g. drug rashes), severe anaphylactic reactions such as disturbances
of the heart rhythm, bronchospasm (cramps of the smooth muscles of the bronchi), blood pressure too
high or too low, circulatory collapse, cardiac arrest, weakening of the immune defenses.

Endocrine disorders
Onset of a so-called Cushing's syndrome (typical signs are "moon face", weight gain
in the upper body and facial redness), inactivity or atrophy of the adrenal cortex.

Metabolism and nutrition disorders
Weight gain, high blood sugar, diabetes mellitus, increased fats in the blood (cholesterol and triglycerides)
and sodium retention with formation of edema, potassium deficiency due to increased elimination of
potassium, increased appetite.

Psychiatric disorders
Depression, irritability, euphoria, increased desire, psychosis, mania, hallucinations, emotional lability, anxiety,
sleep disorders, suicidal tendency

Nervous system disorders
Increased intracranial pressure, onset of epilepsy that was not previously recognized and increased
predisposition to seizures in cases of existing epilepsy.

Eye disorders
Opacity of the lens (cataract), increased pressure inside the eye (glaucoma), worsening of
corneal lesions, favoring eye inflammation caused by viruses, bacteria or fungi, blurred vision.

Cardiac disorders
Slowing of the heartbeat whose frequency is unknown.

Vascular disorders
Increased blood pressure, increased risk of arteriosclerosis and thrombosis, inflammation of the
vessels (also as a withdrawal syndrome following long-term therapy), increased fragility of the vessels.

Gastrointestinal disorders
Gastrointestinal ulcers, gastrointestinal bleeding, inflammation of the pancreas.

Skin and subcutaneous tissue disorders
Stretch marks (Striae rubrae), skin atrophy, dilation of skin vessels (telangiectasias),
tendency to form bruises, pinpoint or flat skin hemorrhages, increased body hair, acne,
inflammatory changes of the skin of the face, particularly around the mouth, nose and eyes, changes
in skin pigmentation.

Musculoskeletal and connective tissue disorders
Muscle diseases, muscle weakness, muscle atrophy and osteoporosis occur depending on the dose
and are also possible even with short-term use, other forms of bone degradation (bone necrosis),
tendon disorders, tendon inflammation, tendon rupture and fat deposits in the spine
(epidural lipomatosis), inhibition of growth in children.
If the dose is reduced too rapidly following long-term treatment, disturbances such as muscle and joint pain may occur.

Renal and urinary disorders
Renal crisis caused by scleroderma in patients already suffering from scleroderma (an autoimmune disease).
The signs of a renal crisis caused by scleroderma include increased blood pressure and reduced
urine production.

Reproductive system and breast disorders
Disorders of the secretion of sex hormones that can cause absence of menstruation (amenorrhea),
distribution of hair in typically male areas in women (hirsutism), impotence.

Systemic disorders and conditions related to the site of administration
Delayed wound healing
Immediately inform your doctor if you experience gastrointestinal disturbances, back, shoulder or
hip joint pain, mental changes, blood sugar fluctuations in diabetics or other disturbances.

Reporting of side effects
If you get any side effects, even if 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 help provide more information on the safety of
this medicine.

5. How to store PREXILEV

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 pack. The expiry date refers to the last day of that month.
Store at a temperature below 30°C.
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. Contents of the pack and other information

What PREXILEV contains
The active ingredient is prednisone.
One PREXILEV 5 mg tablet contains 5 mg of prednisone.
One PREXILEV 20 mg tablet contains 20 mg of prednisone.
One PREXILEV 25 mg tablet contains 25 mg of prednisone.
The other ingredients are: lactose monohydrate, sodium starch glycolate (type A), talc, hydrated colloidal silica,
magnesium stearate .
Description of the appearance of PREXILEV and contents of the pack
PREXILEV is available as 5, 20 and 25 mg tablets in PVC/PVDC-Al blisters.
Pack of 10, 20 or 30 tablets of 5 mg.
Pack of 20 or 30 tablets of 20 mg.
Pack of 10, 20 or 30 tablets of 25 mg.

Marketing Authorisation Holder
Genetic S.p.A., Via Della Monica n. 26, 84083 Castel San Giorgio (SA)

Manufacturer
Genetic S.p.A., Contrada Canfora, 84084 Fisciano (SA)

This leaflet was last approved on: