DISOX 5 mg Tabletka Powlekana

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1. DISOX 5 mg tablets, 20 mg tablets, 25 mg tablets
   1. What is DISOX and what is it 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

DISOX 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell 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 you take 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 is DISOX and what is it used for

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

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).
• stress conditions after prolonged treatment with corticosteroids.

Rheumatic diseases:

• active phases of vessel inflammation:
• nodular inflammation of the 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 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 arthritis, 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 syndrome) 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 suspension), possibly in combination with immunosuppressants, chronic eosinophilic pneumonia (SD: b decreasing the dose gradually until suspension), 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 administration of glucocorticoids (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 involvement of the system.
These include:

• Allergic, pseudo-allergic and allergic-infectious diseases: e.g. acute urticaria, anaphylactoid reactions, drug exanthema, multiforme exudative erythema, 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, polyarteritis nodosa (SD: from b to a)
• Autoimmune diseases: e.g. dermatomyositis, systemic scleroderma (indurative phase), chronic cutaneous lupus erythematosus (SD: from b to a)
• Pregnancy dermatoses (see also paragraph 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, even 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 exanthematicus, hereditary bullous epidermolysis (SD: from c to a)

Blood diseases/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 macroglobulinemia, multiple myeloma (SD: e)
• Hypercalcemia in underlying malignant neoplasms (SD: from c to a)
• Prophylaxis and therapy of cytostatic-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 inappetence, 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 suspension 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, endocrinological orbitopathy, pseudotumor of the orbit, 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 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 checks

Gastrointestinal diseases / 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 interruption 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 DISOX

Do not take DISOX
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 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 even higher doses may increase the risk of a sclerodermic 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 care is required when taking DISOX at high doses in
hormone replacement therapy. You should only take DISOX if your doctor considers it absolutely
necessary.
Due to the suppression of your own defenses, treatment with DISOX 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 develop any of the following diseases at the same time:

• acute viral infections (hepatitis B, chickenpox, shingles, herpes simplex infections, corneal inflammation caused by herpes viruses)
• infectious liver inflammation (active HBsAg-positive chronic hepatitis)
• from approximately 8 weeks before to 2 weeks after vaccinations with live vaccines
• fungal diseases affecting internal organs
• certain diseases caused by parasites (amebae, worms)
• in patients with suspected or confirmed infections by dwarf nematodes (strongylids) DISOX 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 anti-tuberculosis drugs)
• acute and chronic bacterial infections

If treated with DISOX at the same time, the following diseases must be monitored specifically and
treated accordingly under close supervision 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) including suicidal tendencies: neurological or psychiatric monitoring is recommended
• increased pressure in the eye (narrow-angle glaucoma and open-angle glaucoma); ophthalmological monitoring and concomitant therapy are recommended
• wounds and ulcers of the cornea of the eye; ophthalmological monitoring and concomitant therapy are recommended

Treatment with this medicine may lead to a so-called pheochromocytoma crisis, which may 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 DISOX if you suspect or know that you 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 only be taken if your doctor considers it
necessary and under his close supervision in case of:

• severe inflammation of the large intestine (ulcerative colitis) with threat of perforation, with abscesses or purulent inflammation possibly also without peritoneal irritation
• diverticulitis
• immediately after certain operations on the intestine (enteroanastomoses)

The signs of peritoneal irritation 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 when
co-administering fluoroquinolones (certain antibiotics) and DISOX.
In case of diabetes, metabolism must be checked regularly; your doctor will assess whether an
increase in the need for medication to treat diabetes (insulin or oral antidiabetics, etc.) is necessary.
In case of severe hypertension and severe heart failure, consult your doctor for thorough 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 DISOX must take place in hospital.
In particular, if the disturbances affecting the face and pharynx are particularly severe and breathing is
compromised, treatment with DISOX must be started gradually.
Long-term use, even of low doses of prednisone, leads to an increased risk of infections, even from
microorganisms that otherwise rarely cause infections (so-called opportunistic infections).
Vaccinations with vaccines from killed pathogens (inactivated vaccines) are fundamentally possible. However, care must be taken to ensure that the success of the vaccination may be impaired by high doses of DISOX
High doses of DISOX can cause a slowing of the heartbeat (bradycardia). The onset of
bradycardia is not necessarily related to the duration of treatment.
In case of long-term treatment with DISOX, regular medical checks are necessary (including ophthalmological checks at intervals of three months).
In case of prolonged treatment at high doses with DISOX, 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 (illness with fever, accidents, surgery, childbirth, etc.) during treatment with DISOX, you must inform your doctor immediately, as a
temporary increase in the daily dose of DISOX may be necessary. For this reason, if
undergoing 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) may 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
protein 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 DISOX, 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 Disox, preventive treatment may be necessary.

Children and adolescents
DISOX should only be used in children if absolutely necessary and under the supervision of a doctor
due to the risk of growth inhibition, which must be checked regularly. Therapy with DISOX
should be limited in time or administered with alternation (e.g. one day yes and one day no, but with
double dosage (alternate therapy)).

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

For athletes:the use of the drug without therapeutic necessity constitutes doping and may
anyway result in positive doping tests.

Other medicines and DISOX
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 DISOX:

• Some medicines may increase the effects of DISOX and your doctor may want to keep you under close observation if you are taking these medicines (including some medicines for the treatment of HIV: ritonavir, cobicistat)
• Medicines that slow down liver degradation, such as some antifungal medicines (ketoconazole, itraconazole), may potentiate the effects of DISOX.
• Some female sex hormones, e.g. contraceptives (the “pill”). The effect of DISOX may be increased.
• Medicines such as hypnotics (barbiturates), medicines against convulsions (phenytoin, carbamazepine, primidone) and certain medicines against tuberculosis (rifampicin) may decrease the effect of DISOX.
• Efedrine (may be contained e.g. in medicines for treating hypotension, chronic bronchitis, asthma attacks and for decongesting the mucous membranes in colds) can decrease the effectiveness of DISOX.
• Medicines against excessive acid production in the stomach (antacids): in simultaneous administration of magnesium hydroxide or aluminum hydroxide, a decrease in the absorption of prednisone is possible. The administration of the two medicines should therefore be spaced apart in time (2 hours).

Other effects of DISOX

• Due to potassium deficiency, DISOX may increase the effect of medicines to strengthen the heart (cardiac glycosides).
• DISOX may increase potassium elimination if used in association with diuretics (saluretics) and laxatives.
• DISOX may decrease the hypoglycemic effect of oral antidiabetics and insulin.
• DISOX 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), 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 potentiate the increase in intraocular pressure of certain medicines (atropine and other anticholinergics).
• DISOX may decrease the effect of medicines against helminthiasis (praziquantel).
• In case of simultaneous use of medicines against malaria or rheumatic diseases (chloroquine, hydroxychloroquine, mefloquine), DISOX may increase the risk of developing muscle diseases or heart muscle diseases (myopathies, cardiomyopathies).
• Growth hormones (somatotropin): their effect is diminished particularly by high doses of DISOX.
• DISOX may decrease the increase in thyroid-stimulating hormone (TSH) following concomitant administration with protirelin (a diencephalic hormone).
• DISOX and the simultaneous use of medicines to reduce the body's defenses (immunosuppressants) may increase the predisposition to infections and worsen existing but perhaps not yet manifest infections.
• In addition to cyclosporine (medicine to suppress the body's defenses): DISOX may increase the level of cyclosporine in the blood and thus the risk of convulsions.
• Some drugs to lower blood pressure (ACE inhibitors): increased risk of changes in hematological status.
• 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 DISOX during pregnancy, fetal growth disorders cannot be excluded.
If DISOX is taken at the end of pregnancy, adrenal cortex atrophy may occur in the newborn, which may require gradual substitute treatment. In animal tests, prednisone has
shown fetal damage (e.g. palatoschisis). An increased risk of such damage in humans is being discussed
through the administration of prednisone during the first trimester of pregnancy.

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

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

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

3. How to take DISOX

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 DISOX 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 otherwise by the doctor, the usual dose for hormone replacement therapy is (in addition
to growth age):
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
mineralcorticoid (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 dose reduction
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 be divided, depending on the disease, also 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
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 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 DISOX 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 liver cirrhosis, lower dosages may be sufficient or a dose reduction may be necessary.
Talk to your doctor or pharmacist if you feel that the effect of DISOX 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 DISOX than you should
In general, DISOX is well tolerated even in case of short-term intake of
large quantities. Therefore, no particular measures are necessary. If you should notice an increase in side effects, contact your doctor.

If you forget to take DISOX
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 DISOX
Always follow the dosage scheme prescribed by the doctor. Do not suddenly stop taking
DISOX. If you stop treatment with DISOX, particularly 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 doses 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 (increase in white blood cells or all blood cells, decrease
of some white blood cells).

Immune system disorders
Hypersensitivity reactions (e.g. drug skin rashes), severe anaphylactic reactions such as disturbances
of 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 edema formation, potassium deficiency due to increased potassium elimination,
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 case of existing epilepsy.

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

Cardiac disorders
Slowing of the heartbeat with an unknown frequency.

Vascular disorders
Increased blood pressure, increased risk of arteriosclerosis and thrombosis, inflammation of the
vessels (also as 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 bruise, pinpoint or flat skin hemorrhages, increased body hair, acne,
inflammatory skin changes on the face, especially 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 quickly 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 those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at the address 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 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 waste water 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 DISOX contains
The active ingredient is prednisone.
One DISOX 5 mg tablet contains 5 mg of prednisone.
One DISOX 20 mg tablet contains 20 mg of prednisone.
One DISOX 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 DISOX and contents of the pack
DISOX is available in tablet form of 5, 20 and 25 mg 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)

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