Prexilev

PATIENT INFORMATION LEAFLET

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

Prednisone
Generic medicine
Read this entire leaflet carefully before taking this medicine because 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 others, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 taking 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 PREXILEV is and what it is used for

PREXILEV is a glucocorticoid (a hormone produced by the adrenal glands) that affects metabolism, electrolyte balance (salts), and tissue function.
PREXILEV is used in diseases requiring systemic treatment with glucocorticoids, including the following conditions depending on type and severity (dosage table SD from a to d); see section 3 “How to take PREXILEV”.

Hormone replacement therapy in case of:

• Reduced or absent adrenal function (adrenal insufficiency) of any cause (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).
• Stress conditions following prolonged corticosteroid therapy.

Rheumatic diseases:

• Active phases of vasculitis:
  • Nodular inflammation of vessel walls (polyarteritis nodosa) (SD: a, b; treatment duration limited to two weeks in case of hepatitis B infection)
  • Giant cell arteritis, muscle pain and stiffness (polymyalgia rheumatica) (SD: c)
  • Temporal arteritis (SD: a); in case of acute vision loss, initial pulse therapy with intravenous glucocorticoids is recommended, followed by continuous therapy with monitoring of erythrocyte sedimentation rate (ESR)
  • Granulomatosis with polyangiitis (Wegener’s): induction therapy (SD: a–b), combined with methotrexate (mild forms without renal involvement) or according to Faucci regimen (severe forms with kidney and/or lung involvement); maintenance of remission: (SD: d, gradual dose reduction), combined with immunosuppressants
• Churg-Strauss syndrome: initial therapy (SD: a–b), combined with immunosuppressants in case of organ involvement and severe course; maintenance of remission: (SD: d)
  • Active phases of rheumatic diseases that may affect internal organs (SD: a, b):
• Systemic lupus erythematosus (chronic disease due to immune system dysfunction causing inflammation and tissue damage), muscle weakness and muscle pain (polymyositis)
• Inflammation of cartilage (chronic atrophic polychondritis)
• Connective tissue diseases (mixed connective tissue disease)
  • Active rheumatoid arthritis (SD: from a to d) with severely progressive course, e.g. rapidly destructive forms (SD: a) or extra-articular forms (SD: b)
  • Other inflammatory rheumatic arthritides, if clinical severity warrants and non-steroidal anti-inflammatory drugs (NSAIDs) cannot be used:
• Spondyloarthritides (ankylosing spondylitis involving peripheral joints (SD: b, c), psoriatic arthritis (SD: c, d), enteropathic arthropathy with high inflammatory activity (SD: a)
• Reactive arthritides (SD: c)
• Arthritis in sarcoidosis (initially SD: b)
  • Carditis in rheumatic fever, in severe cases over 2–3 months (SD: a)
  • Juvenile idiopathic arthritis with severe systemic form (Still’s syndrome) or with iridocyclitis when local treatment is ineffective (SD: a)

Bronchial and pulmonary disorders:

• Bronchial asthma (SD: from c to a); bronchodilators should be co-administered
• Acute exacerbation of chronic obstructive pulmonary disease (COPD) (SD: b); recommended treatment duration up to 10 days
• Interstitial lung diseases such as acute alveolitis (SD: b), pulmonary fibrosis (SD: b), bronchiolitis obliterans with organizing pneumonia (BOOP) (SD: b, with gradual dose reduction until discontinuation), possibly combined with immunosuppressants, chronic eosinophilic pneumonia (SD: b, with gradual dose reduction until discontinuation), long-term treatment of chronic forms of sarcoidosis in stages II and III (in case of dyspnea, cough, and worsening pulmonary function tests) (SD: b)
• Prophylaxis of respiratory distress syndrome in preterm neonates (SD: b, twice daily)

Diseases of the upper respiratory tract:

• Severe forms of hay fever and allergic rhinitis after failure of intranasal glucocorticoid administration (SD: c)
• Acute stenosis of the larynx and trachea: Quincke’s edema, subglottic obstructive laryngitis (pseudocroup) (SD: from b to a)

Skin diseases:
Skin and mucosal 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 rash, erythema multiforme, toxic epidermal necrolysis (Lyell’s syndrome), generalized acute pustulosis, acute febrile neutrophilic dermatosis (Sweet’s syndrome), allergic contact dermatitis (SD: from b to a)
• Eczematous 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 mucosal pemphigoid, linear IgA dermatosis (SD: from b to a)
• Vasculitides: e.g. allergic vasculitis, polyarteritis nodosa (SD: from b to a)
• Autoimmune diseases: e.g. dermatomyositis, systemic scleroderma (indurative phase), chronic and subacute cutaneous lupus erythematosus (SD: from b to a)
• Gestational dermatoses (see also section 4.6): e.g. herpes gestationis, herpetiform impetigo (SD: from d to a)
• Erythematous-squamous dermatoses: e.g. pustular psoriasis, pityriasis rubra pilaris, parapsoriasis group (SD: from c to a)
• Erythroderma, including Sézary syndrome (SD: from c to a)
• Other conditions: e.g. Jarisch-Herxheimer reaction during penicillin treatment for syphilis, rapidly growing and increasing cavernous hemangioma, Behçet’s disease, pyoderma gangrenosum, eosinophilic fasciitis, exanthematic lichen ruber, hereditary bullous epidermolysis (SD: from c to a)

Blood disorders / tumour 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 lymphoma, chronic lymphocytic leukemia, Waldenström’s macroglobulinemia, multiple myeloma (SD: e)
• Hypercalcemia in underlying malignant neoplasms (SD: from c to a)
• Prophylaxis and treatment of cytostatic-induced vomiting (SD: from b to a), use in antiemetic regimens
• Palliative therapy of malignant diseases
• Note: prednisone may be used to relieve symptoms, e.g. anorexia, loss of appetite, and general weakness in advanced malignant neoplasms, after specific therapeutic options have been exhausted. For further details, consult current medical literature.

Nervous system disorders:

• Myasthenia gravis (drug of first choice is azathioprine)
• Chronic Guillain-Barré syndrome
• Tolosa-Hunt syndrome
• Polyneuropathy in monoclonal gammopathy
• Multiple sclerosis (with gradual dose reduction until discontinuation after high-dose parenteral glucocorticoid administration in the acute phase)
• West syndrome (infantile spasms)

Specific courses of infectious diseases:

• Toxic conditions associated with severe infectious diseases (in combination with antibiotics/chemotherapy), e.g. tuberculous meningitis (SD: b), severe pulmonary tuberculosis (SD: b)

Eye disorders (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, orbital pseudotumor, transplant rejection, and certain uveitides such as Harada’s disease and sympathetic ophthalmia
• Systemic administration is indicated only after unsuccessful local treatment in the following conditions: scleritis, episcleritis, keratitis, chronic cyclitis, uveitis, allergic conjunctivitis, alkali chemical burns, in combination with antimicrobial therapy in autoimmune or syphilis-associated interstitial keratitis, and in herpes simplex stromal keratitis only if corneal epithelium is intact and with regular ophthalmological monitoring

Gastrointestinal / liver disorders:

• Ulcerative colitis (SD: from b to c)
• Crohn’s disease (SD: b)
• Autoimmune hepatitis (SD: b)
• Esophageal burn (SD: a)

Renal disorders:

• Minimal change glomerulonephritis (SD: a)
• Proliferative-extracapillary glomerulonephritis (rapidly progressive glomerulonephritis) (SD: intermittent high-dose [pulse therapy], usually in combination with cytostatic agents); in Goodpasture’s syndrome, reduce and discontinue treatment; in all other forms, long-term continuation of therapy (SD: d)
• Idiopathic retroperitoneal fibrosis (SD: b)

2. What you should know before taking PREXILEV

Do not take PREXILEV
If you are allergic to the active substance (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 higher may increase the risk of scleroderma renal crisis with elevated blood pressure and reduced urine output. Your doctor may recommend regular monitoring of your blood pressure and urine
➢ you have an overactive thyroid (hyperthyroidism).

Special caution is required when taking PREXILEV at high doses for hormone replacement therapy. You should take PREXILEV only if your doctor considers it absolutely necessary.

Due to suppression of your immune defenses, treatment with PREXILEV may increase the risk of bacterial, viral, parasitic, opportunistic, and fungal infections. 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.

Contact your doctor immediately if you develop any of the following conditions:

• acute viral infections (hepatitis B, chickenpox, shingles, herpes simplex infections, viral keratitis caused by herpes virus)
• infectious inflammation of the liver (chronic active hepatitis B surface antigen-positive)
• approximately 8 weeks before to 2 weeks after vaccination with live vaccines
• fungal diseases affecting internal organs
• certain diseases caused by parasites (amebic infections, helminths)
• in patients with suspected or confirmed infections by threadworms (strongyloides), PREXILEV may lead to activation and massive multiplication of the parasites
• poliomyelitis
• lymph node disease after anti-tuberculosis vaccination (in case of history of tuberculosis, use only with concomitant anti-tuberculosis medication)
• acute and chronic bacterial infections

When receiving concomitant treatment with PREXILEV, the following conditions must be specifically monitored and treated as needed under close supervision of your doctor:

• gastrointestinal ulcer
• osteoporosis
• poorly controlled high blood pressure
• poorly controlled diabetes (diabetes mellitus)
• psychiatric disorders (including history of suicidal tendencies): neurological or psychiatric monitoring is recommended
• increased intraocular pressure (narrow-angle glaucoma and open-angle glauopenia); ophthalmological monitoring and concomitant therapy are recommended
• corneal wounds and ulcers of the eye; ophthalmological 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 blurred vision or other visual disturbances occur.

Due to the risk of intestinal perforation, PREXILEV may be taken only if your doctor considers it necessary and under strict medical supervision in the following cases:

• severe inflammation of the colon (ulcerative colitis) with risk of perforation, with abscesses or purulent inflammations possibly even without peritoneal irritation
• diverticulitis
• immediately after certain intestinal surgeries (enteroanastomosis)

Signs of peritoneal irritation after perforation of a gastrointestinal ulcer may be absent in patients receiving high doses of glucocorticoids.

The risk of tendon disorders, tendon inflammation, and tendon rupture is increased when fluorquinolones (a specific group of antibiotics) and PREXILEV are administered concomitantly.

In case of diabetes, metabolism must be monitored regularly; your doctor will assess whether an increase in antidiabetic medication (insulin or oral antidiabetics, etc.) is required.

In case of severe hypertension or severe heart failure, consult your doctor for careful monitoring, as symptoms may worsen.

When treating a specific form of muscle paralysis (myasthenia gravis), symptoms may initially worsen; therefore, PREXILEV should be administered in a hospital setting.

Particularly if facial and pharyngeal symptoms are severe and breathing is impaired, treatment with PREXILEV should be initiated gradually.

Long-term use of even low doses of prednisone increases the risk of infections, including those caused by microorganisms that rarely cause disease (so-called opportunistic infections).

Vaccinations with inactivated (killed) pathogen vaccines are generally possible. However, it should be noted that the effectiveness of vaccination may be impaired by high doses of PREXILEV.

High doses of PREXILEV may cause a slowing of the heart rate (bradycardia). The onset of bradycardia is not necessarily related to the duration of treatment.

Regular medical check-ups (including ophthalmological examinations every three months) are required during long-term treatment with PREXILEV.

During prolonged high-dose treatment with PREXILEV, pay particular attention to adequate potassium intake (e.g., vegetables, bananas) and restricted salt intake. Your doctor may prescribe blood tests to monitor your potassium levels.

If you experience particular stress conditions during treatment with PREXILEV (illness with fever, accidents, surgical procedures, childbirth, etc.), inform your doctor immediately, as a temporary increase in the daily dose of PREXILEV may be necessary. For this reason, if undergoing long-term treatment, your doctor should provide you with appropriate documentation, which you must always carry with you.

Severe anaphylactic reactions (exaggerated immune system response) may occur.

Depending on the duration and dose of treatment, a negative impact on calcium metabolism should be considered, and osteoporosis prevention is recommended. This is especially important in the presence of concurrent risk factors such as family history, advanced age, inadequate protein and calcium intake, excessive smoking, excessive alcohol consumption, post-menopausal status, and low physical activity. Prevention includes adequate calcium and vitamin D intake and regular physical activity. In case of existing osteoporosis, drug therapy should also be considered.

After ending or discontinuing long-term treatment with PREXILEV, the following risks may occur: recurrence or worsening of the underlying disease, reduced adrenal gland activity (especially under stress conditions, e.g., during infection, after accidents, or with increased physical exertion), corticosteroid withdrawal syndrome.

Certain 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 but have been exposed to individuals with these diseases while on PREXILEV treatment, preventive therapy may be necessary.

Contact your doctor immediately if, during treatment with prednisone, you experience muscle weakness, muscle pain, cramps, or stiffness. These may be symptoms of a condition called "thyrotoxic periodic paralysis," which may occur in patients with overactive thyroid (hyperthyroidism) treated with prednisone. Additional treatment may be required to manage this condition.

Children and adolescents
PREXILEV should be used in children only when strictly necessary and under medical supervision due to the risk of growth suppression, which must be monitored regularly. Treatment with PREXILEV should be time-limited or administered intermittently (e.g., one day on, one day off, but with double dosage on active days [intermittent therapy]).

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

For athletes: using the drug without therapeutic need constitutes doping and may result in a positive anti-doping test.

Other medicines and PREXILEV
Inform your doctor if you are taking, have recently taken, or might take any other medicines, including those 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 (including some HIV medications: ritonavir, cobicistat)
• Medicines that slow down liver metabolism, such as certain antifungal drugs (ketoconazole, itraconazole), may enhance the effects of PREXILEV
• Certain female sex hormones, e.g., contraceptives ("the pill"), may increase the effect of PREXILEV
• Medicines such as hypnotics (barbiturates), anticonvulsants (phenytoin, carbamazepine, primidone), and certain anti-tuberculosis drugs (rifampicin) may reduce the effect of PREXILEV
• Ephedrine (which may be contained, for example, in medicines for treating hypotension, chronic bronchitis, asthma attacks, nasal decongestion in colds, or as an anorectic component) may reduce the effectiveness of PREXILEV
• Medicines for reducing stomach acid production (antacids): concomitant administration of magnesium or aluminum hydroxide may reduce the absorption of prednisone. Therefore, these medicines should be taken at least 2 hours apart

Other effects of PREXILEV

• Due to potassium deficiency, PREXILEV may enhance the effect of medicines used to strengthen the heart (cardiac glycosides)
• PREXILEV may increase potassium loss when used with diuretics (saluretics) and laxatives
• PREXILEV may reduce the hypoglycemic effect of oral antidiabetics and insulin
• PREXILEV may decrease or increase the effect of anticoagulant medicines (oral anticoagulants, coumarin derivatives). Your doctor will decide whether a dose adjustment of anticoagulants is necessary
• When used concomitantly with anti-inflammatory and rheumatism medicines (salicylates, indomethacin, and other NSAIDs), PREXILEV may increase the risk of gastric ulcers and gastrointestinal bleeding
• PREXILEV may prolong the muscle-relaxant effect of certain medicines (non-depolarizing muscle relaxants)
• PREXILEV may enhance the intraocular pressure-increasing effect of certain medicines (atropine and other anticholinergics)
• PREXILEV may reduce the effect of anti-helminthic medicines (praziquantel)
• When used concomitantly with medicines for malaria or rheumatic diseases (chloroquine, hydroxychloroquine, mefloquine), PREXILEV may increase the risk of developing muscle diseases or heart muscle diseases (myopathies, cardiomyopathies)
• Growth hormones (somatotropin): their effect is particularly reduced by high doses of PREXILEV
• PREXILEV may reduce the increase in thyroid-stimulating hormone (TSH) following concomitant administration with protirelin (a diencephalic hormone)
• PREXILEV and concomitant use of immunosuppressive medicines may increase susceptibility to infections and worsen existing but possibly not yet apparent infections
• In addition to cyclosporine (an immunosuppressive medicine): PREXILEV may increase cyclosporine blood levels and thus the risk of seizures
• Some blood pressure-lowering medicines (ACE inhibitors): increased risk of hematological changes
• Fluoroquinolones, a group of antibiotics, may increase the risk of tendon rupture

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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
During pregnancy, PREXILEV should be taken only on medical advice. Inform your doctor if you are pregnant.
With long-term treatment with PREXILEV during pregnancy, fetal growth disturbances cannot be ruled out.
If PREXILEV is taken towards the end of pregnancy, adrenal cortical atrophy may occur in the newborn, possibly requiring gradual replacement therapy. Animal studies have shown fetal damage (e.g., cleft palate) with prednisone. An increased risk of such damage in humans following prednisone administration during the first trimester of pregnancy is under discussion.

Breastfeeding
Prednisone passes into breast milk. So far, no harm to the infant has been reported. Nevertheless, the necessity of administering PREXILEV during breastfeeding should be carefully evaluated. If higher doses are required due to your condition, you must stop breastfeeding. Contact your doctor immediately.

Driving and use of machines
There are currently no indications that PREXILEV affects the ability to drive or operate machinery.

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

3. How to take PREXILEV

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Your doctor will determine the dose individually for you.
Follow the prescribed dosing instructions carefully, as otherwise PREXILEV may not have the desired effect. If you have
any 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.
Unless otherwise prescribed by the doctor, the usual dose for hormone replacement therapy (beyond
the age of growth) is:
5 to 7.5 mg of prednisone daily, divided into two doses (in the morning and at noon; in the case of adrenogenital syndrome, in the morning and evening). If necessary, your doctor may additionally prescribe a mineralocorticoid (fludrocortisone). In special stress situations such as febrile illnesses,
accidents, surgical procedures, or childbirth, your doctor may decide to temporarily
increase the dose.
In stress situations following long-term treatment with glucocorticoids:
administration should be promptly increased up to 50 mg of prednisone per day; the dose reduction should then be carried out gradually over several days.
Treatment of certain diseases (pharmacotherapy):
The following tables provide an overview of general dosing guidelines:
Adults

In general, the entire daily dose is taken in the early morning between 6 and 8 a.m. High daily doses may be divided, depending on the disease, into 2–4 individual administrations; medium doses into 2–3 individual administrations.
Children

In children, dosages should be as low as possible. In special cases (e.g. West syndrome), this recommendation may be deviated from.
Dosage reduction
Once the desired clinical effect has been achieved, and depending on the underlying disease, dosage reduction is initiated. If the daily dose is divided into multiple individual doses, the evening dose should first be reduced, followed by the potential midday dose. The dose is initially reduced in larger decrements, starting from approximately 30 mg/day, and subsequently reduced in smaller decrements (see table below). Depending on the clinical situation, decisions are made regarding gradual dose reduction either to complete discontinuation of treatment or to the need for a maintenance dose, based on the disease. The following approximate decrements may be used for dose reduction:

High and very high doses, administered for a few days only, may be discontinued depending on the underlying disease and clinical response, without gradual tapering.

Dosing regimen “e” (DR: e)
Generally, PREXILEV is used as a single dose without gradual reduction until the end of treatment. In chemotherapy, the following dosing regimens are recognized, for example:

In case of hypothyroidism or hepatic cirrhosis, lower dosages may be sufficient or dose reduction may be required.

Speak with your doctor or pharmacist if you feel that the effect of PREXILEV is too strong or too weak.

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

If you take more PREXILEV than you should
In general, PREXILEV is well tolerated without complications even after short-term ingestion of large quantities. Therefore, no special measures are necessary. If you notice an increase in adverse effects, contact your doctor.

If you forget to take PREXILEV
Do not take a double dose to make up for the forgotten dose. Contact your doctor to find out how to proceed.

If you stop taking PREXILEV
Always follow the dosing schedule prescribed by your doctor. Do not stop taking PREXILEV abruptly. If you discontinue treatment with PREXILEV, particularly after long-term therapy, suppression of glucocorticoid production by your body may occur. Particular stress conditions may become life-threatening (Addisonian crisis).

If you have any questions 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 dose and duration of treatment.
Hormone replacement therapy:
Low risk of side effects when recommended doses are observed.
Treatment of specific diseases using higher doses than those used in hormone replacement therapy:
The following dose- and duration-dependent side effects may occur; their frequency is unknown:
Infections and infestations
Masking of infections, onset, recurrence, and worsening of viral, fungal, and bacterial infections, parasitic or opportunistic infections, activation of nematode infection (strongyloidiasis).
Disorders of the blood and lymphatic system
Changes in haematological parameters (increase in white blood cells or in all blood cells, decrease in certain white blood cells).
Immune system disorders
Hypersensitivity reactions (e.g. drug rash), severe anaphylactic reactions such as cardiac rhythm disturbances, bronchospasm (spasms of the smooth muscles of the bronchi), blood pressure too high or too low, circulatory collapse, cardiac arrest, weakening of immune defences.
Endocrine disorders
Development of so-called Cushing's syndrome (typical signs are "moon face", weight gain in the upper part of the body and facial redness), inactivity or atrophy of the adrenal cortex.
Metabolism and nutrition disorders
Weight gain, elevated blood glucose, diabetes mellitus, increased blood lipids (cholesterol and triglycerides), sodium retention with oedema formation, potassium deficiency due to increased potassium excretion, increased appetite.
Psychiatric disorders
Depression, irritability, euphoria, increased libido, psychosis, mania, hallucinations, emotional lability, anxiety, sleep disturbances, suicidal tendencies.
Nervous system disorders
Increased intracranial pressure, onset of previously unrecognized epilepsy and increased susceptibility to seizures in existing epilepsy.
Eye disorders
Lens opacity (cataract), increased intraocular pressure (glaucoma), worsening of corneal lesions, predisposition to eye inflammation caused by viruses, bacteria or fungi, blurred vision.
Cardiac disorders
Slowing of the heartbeat, frequency unknown.
Vascular disorders
Increased blood pressure, increased risk of atherosclerosis and thrombosis, inflammation of blood vessels (including withdrawal syndrome following long-term therapy), increased fragility of blood 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 blood vessels (telangiectasias), tendency to bruise, pinpoint or flat skin haemorrhages, increased body hair, acne, inflammatory skin changes on 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 occurring depending on the dose and possible even with short-term use; other forms of bone deterioration (bone necrosis), tendon disorders, tendon inflammation, tendon ruptures and fat deposits in the spine (epidural lipomatosis), growth suppression in children.
In case of too rapid dose reduction following long-term treatment, symptoms 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).
Signs of scleroderma-related renal crisis include increased blood pressure and reduced urine output.
Reproductive system and breast disorders
Disturbances in sex hormone secretion that may cause absence of menstruation (amenorrhoea), male-pattern hair distribution in women (hirsutism), impotence.
General disorders and administration site conditions
Delayed wound healing.
Inform your doctor immediately if you experience gastrointestinal disturbances, back, shoulder or hip joint pain, psychological changes, blood glucose fluctuations in diabetics, or any other disturbances.
Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the packaging. The expiry date refers to the last day of that month.
Store below 30°C.
Do not dispose of medicines via 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 substance is prednisone.
One tablet of PREXILEV 5 mg contains 5 mg of prednisone.
One tablet of PREXILEV 20 mg contains 20 mg of prednisone.
One tablet of PREXILEV 25 mg contains 25 mg of prednisone.
The other components 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 mg, 20 mg and 25 mg tablets in PVC/PVDC-Al blisters.
Carton pack containing 10, 20 or 30 tablets of 5 mg.
Carton pack containing 20 or 30 tablets of 20 mg.
Carton pack containing 10, 20 or 30 tablets of 25 mg.

Marketing Authorization 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: 02/2026