Disox

PATIENT LEAFLET: INFORMATION FOR THE USER

DISOX 5 mg tablets, 20 mg tablets, 25 mg tablets

Prednisone
Generic medicine
Please read this 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 their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What DISOX is and what it is used for

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

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 (first-choice drugs are hydrocortisone and cortisone).
• Stress conditions following prolonged corticosteroid treatment.

Rheumatic diseases:

• Active phases of vasculitis:
  • Nodular inflammation of vessel walls (polyarteritis nodosa) (SD: a, b; treatment duration limited to two weeks if hepatitis B infection is present)
  • Giant cell arteritis, muscle pain and stiffness (polymyalgia rheumatica) (SD: c)
  • Temporal arteritis (SD: a); in cases of acute vision loss, initial pulse therapy with intravenous glucocorticoids is recommended, followed by continuous therapy with monitoring of erythrocyte sedimentation rate (ESR)
  • Wegener’s granulomatosis: induction therapy (SD: a–b) in combination with methotrexate (mild forms without renal involvement) or according to Fausi’s regimen (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 course in combination with immunosuppressants; remission maintenance: (SD: d)
  • Active phases of rheumatic diseases that may affect internal organs (SD: a, b):
• Lupus erythematosus (a 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 non-articular forms (SD: b)
  • Other inflammatory rheumatic arthritides, when clinical severity warrants it 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 also be 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 in combination 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 shortness of breath, cough, and worsening pulmonary function values) (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 (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 allergo-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., vulgar pemphigus, bullous pemphigoid, benign mucous membrane 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 of syphilis, rapidly growing and expanding cavernous hemangioma, Behçet’s disease, pyoderma gangrenosum, eosinophilic fasciitis, exanthematous lichen ruber, hereditary epidermolysis bullosa (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’s lymphoma, chronic lymphocytic leukemia, Waldenström’s disease, multiple myeloma (SD: e)
• Hypercalcemia associated with 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 such as anorexia, loss of appetite, and general weakness in advanced malignant neoplasms, after specific treatment options have been exhausted. For further details, consult current medical literature.

Nervous system disorders:

• Myasthenia gravis (first-choice drug is azathioprine)
• Chronic Guillain-Barré syndrome
• Tolosa-Hunt syndrome
• Polyneuropathy in monoclonal gammopathy
• Multiple sclerosis (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 in some uveitis 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, in herpes simplex stromal keratitis only if the 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 therapy [pulse therapy], usually in combination with cytostatic agents); in Goodpasture’s syndrome, reduce and discontinue treatment; in all other forms, continue long-term therapy (SD: d)
• Idiopathic retroperitoneal fibrosis (SD: b)

2. What you should know before taking DISOX

Do not take DISOX
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 DISOX.

Warnings and precautions
Talk to your doctor or pharmacist before taking DISOX.
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 DISOX at high doses for hormone replacement therapy. You should take DISOX only if your doctor considers it absolutely necessary.

Due to suppression of the body's defenses, treatment with DISOX may increase the risk of bacterial, viral, parasitic, opportunistic, and fungal infections. Signs and symptoms of existing or developing infections may be masked and thus difficult to recognize. Subclinical infections, such as tuberculosis or hepatitis B, may be reactivated.

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

• acute viral infections (hepatitis B, chickenpox, shingles, herpes simplex infections, viral keratitis)
• infectious liver inflammation (chronic active HBsAg-positive hepatitis)
• from about 8 weeks before to 2 weeks after vaccination with live vaccines
• fungal diseases affecting internal organs
• certain parasitic diseases (amebic or worm infections)
• in patients with suspected or confirmed infection with dwarf nematodes (strongyloides), DISOX may cause 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

If you are being treated concomitantly with DISOX, the following conditions must be specifically monitored and treated as needed under close supervision of your doctor:

• gastrointestinal ulcer
• osteoporosis
• poorly controllable high blood pressure
• poorly controllable diabetes (diabetes mellitus)
• psychiatric disorders (including history of suicidal tendencies): neurological or psychiatric monitoring is recommended
• increased intraocular pressure (narrow-angle and open-angle glaucoma); 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.

Contact your doctor before taking DISOX 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, DISOX 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 gastrointestinal ulcer perforation may not be evident in patients receiving high doses of glucocorticoids.

The risk of tendon disorders, tendon inflammation, and tendon rupture is increased when fluorochinolones (certain antibiotics) and DISOX 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 worsening of the condition may occur.

In the treatment of a specific form of muscle paralysis (myasthenia gravis), symptoms may initially worsen; therefore, DISOX should be administered in a hospital setting.

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

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

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

High doses of DISOX may cause a slowing of the heartbeat (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 DISOX.

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

If you experience particular stress conditions during treatment with DISOX (illness with fever, accidents, surgical procedures, childbirth, etc.), inform your doctor immediately, as a temporary increase in the daily dose of DISOX may be necessary. For this reason, in case of long-term treatment, your doctor should provide you with appropriate documentation that 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 effect on calcium metabolism should be considered, and osteoporosis prevention is recommended. This is especially true in the presence of concomitant risk factors such as family predisposition, advanced age, insufficient protein and calcium intake, excessive smoking, excessive alcohol consumption, post-menopause, and low physical activity. Prevention includes adequate intake of calcium and vitamin D and regular physical activity. In case of existing osteoporosis, drug therapy should also be considered.

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

Contact your doctor immediately if you experience muscle weakness, muscle pain, cramps, or stiffness during prednisone treatment. 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
DISOX 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. DISOX therapy should be time-limited or administered intermittently (e.g., one day on, one day off, but with double dosage (intermittent therapy)).

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

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

Other medicines and DISOX
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 DISOX:

• Some medicines may increase the effects of DISOX, and your doctor may wish to monitor you closely if you are taking these (including certain HIV medications: ritonavir, cobicistat)
• Medicines that slow hepatic degradation, such as certain antifungal agents (ketoconazole, itraconazole), may enhance the effects of DISOX.
• Certain female sex hormones, e.g., contraceptives ("the pill"), may increase the effect of DISOX.
• Medicines such as hypnotics (barbiturates), anticonvulsants (phenytoin, carbamazepine, primidone), and certain anti-tuberculosis drugs (rifampicin) may reduce the effect of DISOX.
• Ephedrine (may be contained, e.g., in medicines for treating hypotension, chronic bronchitis, asthma attacks, nasal decongestion in colds, or as a component of anorectics); may reduce the efficacy of DISOX.
• Medicines for excessive stomach acid production (antacids): concomitant administration of magnesium or aluminum hydroxide may reduce prednisone absorption. Therefore, these medicines should be taken at different times (2 hours apart).

Other effects of DISOX

• Due to potassium deficiency, DISOX may enhance the effect of heart-strengthening medicines (cardiac glycosides).
• DISOX may increase potassium elimination when used with diuretics (saluretics) and laxatives.
• DISOX may reduce the hypoglycemic effect of oral antidiabetics and insulin.
• DISOX may decrease or increase the effect of anticoagulant medicines (oral anticoagulants, coumarin derivatives). Your doctor will decide whether dose adjustment of anticoagulants is necessary.
• When used concomitantly with anti-inflammatory and rheumatic medicines (salicylates, indomethacin, and other NSAIDs), DISOX may increase the risk of gastric ulcers and gastrointestinal bleeding.
• DISOX may prolong the muscle-relaxant effect of certain medicines (non-depolarizing muscle relaxants).
• DISOX may enhance the intraocular pressure-increasing effect of certain medicines (atropine and other anticholinergics).
• DISOX may reduce the effect of anti-helminthic medicines (praziquantel).
• When used concomitantly with medicines for malaria or rheumatic diseases (chloroquine, hydroxychloroquine, mefloquine), DISOX may increase the risk of muscle disorders or heart muscle diseases (myopathies, cardiomyopathies).
• Growth hormones (somatotropin): their effect is particularly reduced by high doses of DISOX.
• DISOX may reduce the increase in thyroid-stimulating hormone (TSH) following concomitant administration with protirelin (a diencephalic hormone).
• DISOX and concomitant use of immunosuppressive medicines may increase susceptibility to infections and worsen existing, possibly latent infections.
• In addition to cyclosporine (an immunosuppressive medicine): DISOX may increase cyclosporine blood levels and thus the risk of seizures.
• Certain 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, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
During pregnancy, DISOX should be taken only on medical advice. Inform your doctor if you are pregnant.

Long-term treatment with DISOX during pregnancy may not exclude fetal growth disturbances.

If DISOX is taken towards the end of pregnancy, adrenal atrophy may occur in the newborn, possibly requiring gradual replacement therapy. Animal studies have shown that prednisone can cause fetal damage (e.g., cleft palate). It is debated whether such risks are increased in humans by administering prednisone during the first trimester of pregnancy.

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

Driving and using machines
There is currently no indication that DISOX affects the ability to drive or operate machinery.

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

3. How to take DISOX

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 dosage instructions carefully, otherwise DISOX may not have the intended 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.
If not otherwise prescribed by the doctor, the usual dose for hormone replacement therapy (beyond
the growth period) is:
5 to 7.5 mg of prednisone per day, divided into two doses (in the morning and at midday; in cases of adrenogenital syndrome, in the morning and evening). If necessary, your doctor may prescribe an additional dose of a mineralocorticoid (fludrocortisone). In particular stress situations such as illnesses with fever, 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 dosage guidelines:
Adults

In general, the entire daily dose is taken early in the 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.
Dose reduction
Once the desired clinical effect has been achieved, dose reduction is initiated depending on the underlying disease. When the daily dose is divided into multiple individual doses, the evening dose should be reduced first, followed by the midday dose, if applicable. Initially, the dose is reduced in larger decrements, starting from approximately 30 mg/day, and subsequently in smaller decrements (see table below). Depending on the clinical situation, a decision is made regarding gradual dose reduction either to discontinuation of treatment or to the need for a maintenance dose, based on the disease. The following dose decrements may serve as guidance for dose reduction:

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

Dosing schedule “e” (DS: e)
Generally, DISOX is used as a single dose without gradual tapering until the end of treatment. In chemotherapy, the following dosing schedules are recognized, for example:

• Non-Hodgkin's lymphomas: 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.

In cases of hypothyroidism or hepatic cirrhosis, lower doses may be sufficient or dose reduction may be required.
Talk to your doctor or pharmacist if you feel the effect of DISOX is too strong or too weak.

If you take more DISOX than you should
Generally, DISOX is well tolerated even when large amounts are taken within a short time, and no special measures are required. However, if you notice an increase in adverse effects, contact your doctor.

If you forget to take DISOX
Do not take a double dose to make up for the forgotten dose. Contact your doctor for advice on how to proceed.

If you stop taking DISOX
Always follow the dosing schedule prescribed by your doctor. Do not stop taking DISOX abruptly. If you discontinue treatment with DISOX, particularly after long-term therapy, suppression of glucocorticoid production by your body may occur. Under conditions of particular stress, this may lead to life-threatening situations (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 may 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 recommended dosages are respected.

Treatment of specific diseases with higher dosages than hormone replacement therapy:
The following dose- and treatment duration-dependent side effects may occur; their frequency is unknown:

Infections and infestations
Masking of infections, occurrence, 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 blood count (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 heart rhythm disturbances, bronchospasms (spasms of the smooth muscles of the bronchi), blood pressure too high or too low, circulatory collapse, cardiac arrest, weakening of immune defenses.

Endocrine disorders
Development of 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, elevated blood glucose, diabetes mellitus, increased blood lipids (cholesterol and triglycerides), sodium retention with edema 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 seizure susceptibility in existing epilepsy.

Eye disorders
Lens opacity (cataract), increased intraocular pressure (glaucoma), worsening of corneal lesions, promotion of 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 vessel fragility.

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 bruise, pinpoint or flat skin hemorrhages, 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 disorders, muscle weakness, muscle atrophy, and osteoporosis—occurring depending on 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, disorders 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 a scleroderma-related renal crisis include increased blood pressure and reduced urine output.

Reproductive system and breast disorders
Disorders in sex hormone secretion that may cause absence of menstruation (amenorrhea), 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 disorders, back, shoulder or hip joint pain, psychological disturbances, blood glucose fluctuations in diabetics, or other disturbances.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You may 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 DISOX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Store below 30°C.
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

What DISOX contains
The active substance is prednisone.
One tablet of DISOX 5 mg contains 5 mg of prednisone.
One tablet of DISOX 20 mg contains 20 mg of prednisone.
One tablet of DISOX 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 DISOX and contents of the pack
DISOX is available as 5 mg, 20 mg and 25 mg tablets in PVC/PVDC-Al blisters.
Pack sizes of 10, 20 or 30 tablets of 5 mg.
Pack sizes of 20 or 30 tablets of 20 mg.
Pack sizes of 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