Cison: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

CISON 5 mg tablets, 20 mg tablets, 25 mg tablets

Prednisone
Generic medicine
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 they have the same symptoms as you, because it could be harmful.
If any adverse reaction occurs, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What CISON is and what it is used for
What you need to know before taking CISON
How to take CISON
Possible side effects
How to store CISON
Contents of the pack and other information

1. What CISON is and what it is used for

CISON is a glucocorticoid (a hormone produced by the adrenal glands) that affects metabolism, electrolyte balance (salts), and tissue function.
CISON 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 CISON”.

Hormone replacement therapy in cases of:

Reduced or absent adrenal function (adrenal insufficiency) of any cause (e.g. Addison’s disease, adrenogenital syndrome, surgical removal of the adrenal glands, decreased pituitary activity) after the growth period (drugs of first choice are hydrocortisone and cortisone).
Conditions of stress 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 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 granulomatosis): induction therapy (SD: a–b) in combination with methotrexate (mild forms without renal involvement) or according to Fausi regimen (severe forms with renal and/or pulmonary involvement); maintenance of remission: (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; 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, when clinical severity warrants 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 arthritides (SD: c)
Arthritis in sarcoidosis (initially SD: b)
- Carditis in rheumatic fever, in severe cases over a period of 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 sarcoidosis in stages II and III (in case of dyspnea, cough, and deterioration in 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 (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 exanthema, 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 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, pemphigoid 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 / oncological 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 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 in malignant diseases
Note: prednisone may be used to relieve symptoms, such as loss of appetite, anorexia, and general weakness in advanced malignant neoplasms, after specific therapeutic options have been exhausted. For further details, consult current medical literature.

Disorders of the nervous system:

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, in herpes simplex stromal keratitis only if corneal epithelium is intact and with regular ophthalmological monitoring

Gastrointestinal diseases / 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: high-dose intermittent 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 CISON

Do not take CISON
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 the short-term use of CISON.

Warnings and precautions
Talk to your doctor or pharmacist before taking CISON.
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 a scleroderma renal crisis, characterized by increased blood pressure and reduced urine production. Your doctor may recommend regular monitoring of your blood pressure and urine
➢ you have an overactive thyroid (hyperthyroidism).

Particular caution is required when taking CISON at high doses for hormone replacement therapy. You should take CISON only if your doctor considers it absolutely necessary.
Due to suppression of the body's natural defenses, treatment with CISON 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)
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 diseases caused by parasites (amebic or worm infections)
in patients with suspected or confirmed infection by threadworms (strongyloides), CISON may lead to activation and massive multiplication of the parasites
poliomyelitis
lymph node disease after anti-tuberculosis vaccination (in case of a history of tuberculosis, use only with concomitant anti-tuberculosis medication)
acute and chronic bacterial infections

During concomitant treatment with CISON, the following conditions must be specifically monitored and treated as needed under close supervision by 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). Seek immediate medical attention if you experience any of these signs.
Consult your doctor before taking CISON 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, CISON may be taken only if your doctor considers it necessary and under strict supervision in the following cases:

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

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

The risk of tendon disorders, tendon inflammation, and tendon rupture is increased when fluorochinolones (a group of antibiotics) and CISON are used 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 needed.

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

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

Particularly if facial and pharyngeal symptoms are severe and breathing is impaired, treatment with CISON 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 infections otherwise (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 CISON.

High doses of CISON 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 CISON.

During prolonged high-dose treatment with CISON, 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 special stress conditions during CISON treatment (illness with fever, accidents, surgical procedures, childbirth, etc.), you must inform your doctor immediately, as a temporary increase in the daily dose of CISON 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 impact on calcium metabolism should be considered, and osteoporosis prevention is recommended. This is especially important in the presence of concomitant risk factors such as family history, advanced age, insufficient protein and calcium intake, excessive smoking, high 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 interrupting long-term treatment with CISON, 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 increased physical exertion), and cortisone withdrawal syndrome.

Certain viral diseases (chickenpox, measles) may have a particularly severe course in patients treated with glucocorticoids. If you are immunosuppressed and have not had chickenpox or measles, and have been exposed to individuals with these diseases during CISON 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 hyperthyroidism treated with prednisone. Additional treatment may be required to manage this condition.

Children and adolescents
CISON should be used in children only when absolutely necessary and under medical supervision due to the risk of growth suppression, which must be monitored regularly. CISON therapy should be limited in duration or administered intermittently (e.g., one day on, one day off, but with double dosage on treatment days—intermittent therapy).

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

For athletes:
Using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

Other medicines and CISON
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 CISON:

Some medicines may increase the effects of CISON, and your doctor may want to monitor you closely if you are taking these (including some HIV treatments: ritonavir, cobicistat)
Medicines that slow down liver metabolism, such as some antifungal agents (ketoconazole, itraconazole), may enhance the effects of CISON
Some female sex hormones, e.g., contraceptives ("the pill"), may increase the effect of CISON
Medicines such as hypnotics (barbiturates), anticonvulsants (phenytoin, carbamazepine, primidone), and certain tuberculosis medications (rifampicin) may reduce the effect of CISON
Ephedrine (which may be contained, for example, in medicines for hypotension, chronic bronchitis, asthma attacks, nasal decongestion in colds, or as an ingredient in anorectics) may reduce the effectiveness of CISON
Medicines for excessive 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 CISON

Due to potassium deficiency, CISON may enhance the effect of heart-strengthening medicines (cardiac glycosides)
CISON may increase potassium loss when used with diuretics (saluretics) and laxatives
CISON may reduce the hypoglycemic effect of oral antidiabetics and insulin
CISON may decrease or increase the effect of anticoagulant medicines (oral anticoagulants, coumarin derivatives). Your doctor will decide whether dose adjustment is necessary
When used concomitantly with anti-inflammatory and rheumatism medicines (salicylates, indomethacin, and other NSAIDs), CISON may increase the risk of gastric ulcers and gastrointestinal bleeding
CISON may prolong the muscle-relaxing effect of certain medicines (non-depolarizing muscle relaxants)
CISON may enhance the intraocular pressure-increasing effect of certain medicines (atropine and other anticholinergics)
CISON may reduce the effect of medicines against helminth infections (praziquantel)
When used concomitantly with medicines for malaria or rheumatic diseases (chloroquine, hydroxychloroquine, mefloquine), CISON may increase the risk of muscle diseases or heart muscle diseases (myopathies, cardiomyopathies)
Growth hormones (somatotropin): their effect is particularly reduced by high doses of CISON
CISON may reduce the increase in thyroid-stimulating hormone (TSH) following concomitant administration with protirelin (a diencephalic hormone)
CISON and concomitant use of immunosuppressive medicines may increase susceptibility to infections and worsen existing, possibly latent, infections
In addition to cyclosporine (an immunosuppressive medicine): CISON 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 in allergy tests may be suppressed.

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

Pregnancy
During pregnancy, CISON should be taken only on medical advice. Inform your doctor if you are pregnant.
Long-term treatment with CISON during pregnancy may not exclude fetal growth disturbances.
If CISON is taken towards the end of pregnancy, adrenal cortex 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 administration of prednisone during the first trimester of pregnancy increases the risk of such damage in humans.

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

Driving and using machines
There are currently no indications that CISON affects the ability to drive or use machinery.

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

CISON contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially "sodium-free".

3. How to take CISON

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 individual dose for you.
Follow the instructions for use carefully, as otherwise CISON 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.
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 daily, divided into two doses (in the morning and at midday; in the case of adrenogenital syndrome, in the morning and evening). If necessary, your doctor may prescribe an additional dose of a mineralocorticoid (fludrocortisone). In special stress situations such as febrile illness, accidents, surgical procedures, or childbirth, your doctor may decide to temporarily increase the dose.
In stress situations following long-term treatment with glucocorticoids: administration may be increased up to 50 mg of prednisone daily; 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

Dosage	Dose in mg/day	Dose in mg/kg body weight/day
a) high	80 - 100 (250)	1.0 - 3.0
b) medium	40 - 80	0.5 - 1.0
c) low	10 - 40	0.25 - 0.5
d) very low	1.5 - 7.5 (10)	./.
e) combination chemotherapy, see dosing schedule "e" (SD: e)

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

Dosage	Dose in mg/kg of body weight/day
High	2 - 3
Medium	1 - 2
Maintenance dose	0.25

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. If the daily dose is divided into multiple individual doses, the evening dose should be reduced first, followed by the midday dose, if applicable. The dose is initially 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 decrement guidelines may be used for dose reduction:

more than 30 mg daily	Reduce by	10 mg	every 2 - 5 days
from 30 to 15 mg daily	Reduce by	5 mg	every week
from 15 to 10 mg daily	Reduce by	2.5 mg	every 1 - 2 weeks
from 10 to 6 mg daily	Reduce by	1 mg	every 2 - 4 weeks
less than 6 mg daily	Reduce by	0.5 mg	every 4 - 8 weeks

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)
CISON is generally used as a single dose without gradual reduction until the end of treatment. In chemotherapy, the following dosing regimens are recognized, for example:

In cases of thyroid insufficiency or hepatic cirrhosis, lower doses may be sufficient or dose reduction may be necessary.

Speak with your doctor or pharmacist if you feel that the effect of CISON 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 lymphatic 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 CISON than you should
Generally, CISON is well tolerated without complications even after short-term ingestion of large quantities. Therefore, no special measures are required. If you notice an increase in adverse effects, contact your doctor.

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

If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
The frequency and severity of the adverse effects listed below depend on the dosage and duration of treatment.

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

Treatment of specific diseases with higher dosages than hormone replacement therapy:
The following dose- and duration-dependent adverse 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).

Blood and lymphatic system disorders
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 cardiac arrhythmias, 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 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 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 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 heart rate; frequency unknown.

Vascular disorders
Increased blood pressure, increased risk of atherosclerosis and thrombosis, inflammation of blood vessels (also as 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 blood 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 deposition in the spine (epidural lipomatosis), growth inhibition 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 renal crisis due to scleroderma include increased blood pressure and reduced urine output.

Reproductive and breast disorders
Disorders of 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 disturbances, back, shoulder, or hip joint pain, psychiatric changes, blood glucose fluctuations in diabetics, or other disturbances.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report adverse effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. How to store CISON

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. Pack contents and other information

What CISON contains
The active substance is prednisone.
One tablet of CISON 5 mg contains 5 mg of prednisone.
One tablet of CISON 20 mg contains 20 mg of prednisone.
One tablet of CISON 25 mg contains 25 mg of prednisone.
The other components are: monohydrate lactose, sodium starch glycolate (type A), talc, hydrated colloidal silica,
magnesium stearate.
Description of the appearance of CISON and pack contents
CISON 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 size of 20 tablets of 20 mg.
Pack sizes of 10 or 20 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