CISON 5 mg Coated Tablet

Зміст інструкції

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

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

Prednisone
Equivalent 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is CISON and what is it used for

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

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 vascular inflammation:
• nodular inflammation of the vessel walls (polyarteritis nodosa) (SD: a, b, treatment duration limited to two weeks in the presence of hepatitis B infection)
• giant cell arteritis, muscle pain and muscle stiffness (polymyalgia rheumatica) (SD: c)
• inflammation of the temporal artery (SD: a); in case of acute vision loss, initial shock treatment with glucocorticoids intravenously and continuous therapy with erythrocyte sedimentation rate (ESR) monitoring is recommended
• Wegener's granulomatosis: induction treatment (SD: a-b) in combination with methotrexate (mild forms without kidney involvement) or according to the Fausi scheme (severe forms with kidney and/or lung involvement), remission maintenance: (SD: d, gradual dose reduction) in combination with immunosuppressants
• Churg-Strauss syndrome: initial therapy (SD: a-b), with organ involvement and severe courses in combination with immunosuppressants, remission maintenance: (SD: d)
• active phases of rheumatic diseases that can affect internal organs (SD: a, b):
• lupus erythematosus (chronic disease due to an alteration of the immune system that causes inflammation and tissue damage), muscle weakness and muscle pain (polymyositis)
• inflammation of the cartilage (chronic atrophic polychondritis)
• connective tissue diseases (mixed collagen disease)
• active rheumatoid arthritis (SD: from a to d) with a severely progressive course, e.g. forms that progress rapidly and destructively (SD: a) or forms that do not affect the joint (SD: b)
• other inflammatory rheumatic 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 disease) or with iridocyclitis when local treatment is ineffective (SD: a)

Bronchial and pulmonary diseases:

• Bronchial asthma (SD: from c to a), bronchodilators are also recommended
• Acute exacerbation of chronic obstructive bronchopneumopathy COPD (SD: b), recommended duration of therapy up to 10 days
• Interstitial lung diseases such as acute alveolitis (SD: b), pulmonary fibrosis (SD: b), obliterating bronchiolitis organizing pneumonia (BOOP) (SD: b decreasing the dose gradually until discontinuation), possibly in combination with immunosuppressants, chronic eosinophilic pneumonia (SD: b decreasing the dose gradually until discontinuation), for long-term treatment of chronic forms of sarcoidosis in stages II and III (in case of shortness of breath, cough and deterioration of pulmonary function values) (SD: b)
• Prophylaxis of respiratory distress syndrome in preterm 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 systemic involvement. 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. vulgaris pemphigus, bullous pemphigoid, benign mucous membrane pemphigoid, linear IgA dermatosis (SD: from b to a)
• Vasculitis: e.g. allergic vasculitis, nodular polyarteritis (SD: from b to a)
• Autoimmune diseases: e.g. dermatomyositis, systemic scleroderma (indurative phase), chronic and subacute 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, also in Sézary syndrome (SD: from c to a)
• Other pathologies: e.g. Jarisch-Herxheimer reaction with penicillin treatment of Lues, rapidly growing and increasing cavernous hemangioma, Behçet's disease, pyoderma gangrenosum, eosinophilic fasciitis, lichen ruber planus, hereditary bullous epidermolysis (SD: from c to a)

Blood diseases/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 treatment 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 loss of appetite, anorexia and general weakness in advanced malignancies, after specific therapeutic options have been exhausted. For more details, consult current medical literature.

Nervous system diseases:

• Myasthenia gravis (drug of first choice is azathioprine)
• Chronic Guillain-Barré syndrome.
• Tolosa-Hunt syndrome
• Polineuropathy in monoclonal gammopathy
• Multiple sclerosis (decreasing the dose gradually until discontinuation after administering high doses of glucocorticoids parenterally in the acute phase)
• West syndrome (infantile spasms)

Particular courses of infectious diseases:

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

Eye diseases (SD: from b to a):

• In systemic diseases involving the eye and immunological processes in the orbit and eye: optic neuropathy (e.g. giant cell arteritis, anterior ischemic optic neuropathy (AION), traumatic optic neuropathy), Behçet's disease, sarcoidosis, endocrinopathy orbitopathy, pseudotumor of the orbit, transplant rejection and in some uveitis such as Harada disease and sympathetic ophthalmia
• Systemic administration is indicated only after unsuccessful local treatment in the following diseases: scleritis, episcleritis, keratitis, chronic cyclitis, uveitis, allergic conjunctivitis, chemical burns from alkalis, in association with antimicrobial therapy in autoimmune or syphilitic interstitial keratitis, in herpes simplex stromal keratitis only if the corneal epithelium is intact and regular eye 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 cytostatic agents), in Goodpasture's syndrome reduction and discontinuation of treatment, in all other forms long-term continuation of therapy (SD: d)
• Idiopathic retroperitoneal fibrosis (SD: b)

2. What you need to know before taking CISON

Do not take CISON
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 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 even higher doses may increase the risk of a scleroderma renal crisis with increased blood pressure and reduced urine production. Your doctor may advise you to have regular checks of your blood pressure and urine.

Particular caution is necessary when taking CISON at high doses in
hormone replacement therapy. You should only take CISON if your doctor considers it absolutely necessary.
Due to the suppression of your own defenses, treatment with CISON can lead to an increased 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 diseases at the same time:

• acute viral infections (hepatitis B, chickenpox, herpes zoster, herpes simplex infections, corneal inflammation caused by herpes viruses)
• infectious inflammation of the liver (active chronic hepatitis B positive HBsAg)
• from approximately 8 weeks before to 2 weeks after vaccinations with live vaccines
• fungal diseases affecting internal organs
• certain diseases caused by parasites (amebe infections, worms)
• in patients with suspected or confirmed infections by dwarf nematodes (strongylids) CISON may lead to activation and mass multiplication of the parasites.
• poliomyelitis
• lymph node disease after vaccination against tuberculosis (in case of tuberculosis in the medical history use only with simultaneous administration of drugs against tuberculosis)
• acute and chronic bacterial infections

If treated with CISON 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 in the medical history) including suicidal tendencies: neurological or psychiatric monitoring is recommended
• increased pressure in the eye (narrow-angle glaucoma and open-angle glaucoma); ophthalmic monitoring and concomitant therapy are recommended
• wounds and ulcers of the cornea of the eye; ophthalmic monitoring and concomitant therapy are recommended

Treatment with this medicine can lead to a so-called pheochromocytoma crisis, which can be
fatal. Pheochromocytoma is a rare hormone-dependent tumor of the adrenal gland. Possible symptoms of
a crisis include headache, sweating, palpitations and high blood pressure (hypertension). Contact
your doctor immediately if you notice any of these signs.
Talk to your doctor before taking CISON if you suspect or know 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, CISON can 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 who are given high doses of glucocorticoids.
The risk of tendon disorders, tendon inflammation and tendon rupture is increased in case of
simultaneous administration of fluoroquinolones (certain antibiotics) and CISON.
In case of diabetes, metabolism must be monitored 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 accurate checks as
a worsening may occur.
In the treatment of a particular form of muscle paralysis (myasthenia gravis), symptoms may worsen at the beginning, so the administration of CISON must take place in hospital.
In particular, if the disorders affecting the face and pharynx are particularly severe and breathing is
compromised, treatment with CISON 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, attention must be paid to the fact that the success of the vaccination may be impaired by high doses of CISON
High doses of CISON can 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 eye examinations at intervals of three months) are necessary in case of long-term treatment with CISON.
In case of prolonged treatment with high doses of CISON, 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 level.
If you experience particular stressful conditions (illnesses with fever,
accidents, surgeries, childbirth, etc.) during treatment with CISON, you should inform your doctor immediately because a temporary increase in the daily dose of CISON may be necessary. For this reason, in case of long-term
treatment, your doctor must provide you with appropriate documentation that you should always carry with you.
Severe anaphylactic reactions (exaggerated immune system reaction) can occur.
Depending on the duration and dose of treatment, a negative influence on
calcium metabolism must be taken into account, and therefore prevention against osteoporosis is recommended. This is especially true in
case of concomitant risk factors, such as family predisposition, advanced age, insufficient intake of
proteins and calcium, excessive smoking, excessive alcohol consumption, after menopause and in case of poor
physical activity. Prevention consists of sufficient intake of calcium and vitamin D and physical activity. In
case of existing osteoporosis, medication therapy should also be considered.
At the end or after discontinuation of long-term therapy with CISON, 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
effort), cortisone withdrawal syndrome.
Particular viral diseases (chickenpox, measles) can 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 Cison, preventive treatment may be necessary.

Children and adolescents
CISON 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 CISON should
be limited in time or administered with alternation (e.g. one day yes and one day no, but with double dosage).

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

For athletes:the use of the drug without therapeutic need constitutes doping and can
determine positive results in doping tests anyway.

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

• Some medicines can increase the effects of CISON 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), can potentiate the effects of CISON.
• Some female sex hormones, e.g. contraceptives (the “pill”). The effect of CISON may be increased.
• Medicines such as hypnotics (barbiturates), medicines against convulsions (phenytoin, carbamazepine, primidone) and certain medicines against tuberculosis (rifampicin) can decrease the effect of CISON.
• Efedrine (may be contained, for example, in medicines for treating hypotension, chronic bronchitis, asthma attacks and for decongesting the mucous membranes in colds and as a component of anorectics); can decrease the effectiveness of CISON.
• 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 two medicines should therefore be taken at a time interval (2 hours).

Other effects of CISON

• Due to potassium deficiency, CISON can increase the effect of medicines to strengthen the heart (cardiac glycosides).
• CISON can increase the elimination of potassium if used in association with diuretics (saluretics) and laxatives.
• CISON can decrease the hypoglycemic effect of oral antidiabetics and insulin.
• CISON can 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 anticoagulants is necessary.
• In case of simultaneous use of medicines against inflammation and rheumatism (salicylates, indometacin and other NSAIDs), CISON can increase the risk of gastric ulcers and gastrointestinal bleeding.
• CISON can prolong the muscle relaxant effect of certain medicines (non-depolarizing muscle relaxants).
• CISON can potentiate the pressure-increasing effect in the eye of certain medicines (atropine and other anticholinergics).
• CISON can decrease the effect of medicines against helminthiasis (praziquantel).
• In case of simultaneous use of medicines against malaria or rheumatic diseases (chloroquine, hydroxychloroquine, mefloquine), CISON can increase the risk of muscle diseases or heart muscle diseases (myopathies, cardiomyopathies).
• Growth hormones (somatotropin): their effect is diminished particularly by high doses of CISON.
• CISON can decrease the increase of thyroid-stimulating hormone (TSH) following concomitant administration with protirelin (a diencephalic hormone).
• CISON and the simultaneous use of medicines to reduce the body's defenses (immunosuppressants) can increase the predisposition to infections and worsen already present but perhaps not yet manifest infections.
• In addition to cyclosporine (medicine for suppressing the body's defenses): CISON can 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 condition.
• Fluoroquinolones, a group of antibiotics, can 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, 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 CISON during pregnancy, fetal growth disorders cannot be excluded.
If CISON is taken at the end of pregnancy, adrenal insufficiency may occur in the newborn, which may require gradual replacement therapy. Prednisone has shown fetal damage (e.g. palatoschisis) in animal tests. An increased risk of such damage in humans through the administration of prednisone during the first trimester of pregnancy is under discussion.

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

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

CISON contains lactose.
If your doctor has diagnosed you with intolerance to some sugars, contact them 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 following exactly the instructions of your doctor or pharmacist. If you have any doubts
consult your doctor or pharmacist. The dose will be established individually for you by the doctor.
Respect the dosage instructions, as otherwise CISON may not have the correct 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 prescribed differently by the doctor, the usual dose for hormone replacement therapy is (in addition
to the age of growth):
from 5 to 7.5 mg of prednisone per day, divided into two administrations (in the morning and at noon, in case
of adrenal genital 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: 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 early in the morning between 6 and 8 am. High daily
doses can also be divided, depending on the disease, into 2-4 single administrations, medium doses into 2-
3 single administrations.

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

Dose reduction
Once the desired clinical effect is achieved and depending on the underlying disease, the dose reduction begins.
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, a decision is made regarding the gradual reduction of the dose until the end of treatment or the
need for a maintenance dose, based on the disease. The following guidelines 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 gradual reduction.

Dosage scheme “e” (SD: e)
Generally CISON is used as a single dose without gradual reduction until the end of
treatment. In chemotherapy, for example, the following dosage schemes are recognized:
In case of thyroid insufficiency or liver cirrhosis, even 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 CISON 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 CISON than you should
In general, CISON is well tolerated even in case of taking large
quantities in a short time. Therefore, no particular measures are necessary. If you should notice an increase in side
effects, contact your doctor.

If you forget to take CISON
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 CISON
Always follow the dosage schedule prescribed by the doctor. Do not suddenly stop taking
CISON. If you stop treatment with CISON, 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 their
frequency is unknown:

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

Blood and lymphatic system disorders
Changes in the blood picture (increased white blood cells or all blood cells, decreased
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 libido, psychosis, mania, hallucinations, emotional lability, anxiety,
sleep disorders, suicidal tendencies

Nervous system disorders
Increased intracranial pressure, onset of epilepsy that was previously unrecognized and increased
predisposition to seizures in cases of existing epilepsy.

Eye disorders
Clouding 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 whose frequency is unknown.

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

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

Skin and subcutaneous tissue disorders
Stretch marks (Striae rubrae), skin atrophy, dilation of skin vessels (telangiectasias), tendency
to 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 rapidly following long-term treatment, disturbances may occur
such as muscle and joint pain.

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 disorders, back pain, shoulder pain or
hip joint pain, mental changes, blood sugar fluctuations in diabetics or other disorders.

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
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you can contribute to providing more information on the safety of this medicine.

5. How to store CISON

Keep this medicine out of 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 CISON contains
The active ingredient is prednisone.
One CISON 5 mg tablet contains 5 mg of prednisone.
One CISON 20 mg tablet contains 20 mg of prednisone.
One CISON 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 CISON and contents of the pack
CISON is available as 5, 20 and 25 mg tablets in PVC/PVDC-Al blisters.
Pack of 10, 20 or 30 tablets of 5 mg.
Pack of 20 tablets of 20 mg.
Pack of 10 or 20 tablets of 25 mg.

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

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

This leaflet was last approved on: