КОРТИРЕКС 5 мг Коированные таблетки

Содержание инструкции

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

CORTIREX 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 their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is CORTIREX and what is it used for

CORTIREX is a glucocorticoid (hormone produced by the adrenal glands) with an effect on metabolism, on
electrolyte balance (of salts) and on tissue function.
CORTIREX 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 CORTIREX”).

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 period of growth (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 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)
• 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 joint diseases, if the severity of the clinical picture requires it and non-steroidal anti-inflammatory drugs (NSAIDs) cannot be used or are ineffective:
• inflammatory diseases especially of the spine (spondylarthritides), inflammation and alteration of the vertebrae (ankylosing spondylitis with involvement of other joints e.g. arms and legs (SD: b, c), psoriatic arthritis (SD: c, d), enteropathic arthropathy (joint disease caused by gastrointestinal inflammation) (SD: a) to (SD: a)
• joint inflammation as a reaction to other underlying diseases (SD: c)
• arthritis in sarcoidosis (SD: b initially)
• heart inflammation in case of rheumatic fever, in severe cases within 2-3 months (SD: a)
• joint inflammation occurring without a recognizable cause in young people (juvenile idiopathic arthritis) with a severe course affecting internal organs (Still's disease) or the eyes (inflammation of the iris and surrounding areas) (SD: a)

Bronchial and pulmonary diseases:

• Bronchial asthma (SD: from c to a), bronchodilator drugs are also recommended
• Acute worsening of an existing chronic respiratory disease (SD: b), a treatment duration of up to 10 days is recommended
• Specific lung diseases such as acute inflammation of the pulmonary alveoli (alveolitis) (SD: b), hardening of lung tissue and remodeling of the lung (pulmonary fibrosis) (SD: b), obliterating bronchiolitis with 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 the long-term treatment of chronic forms of sarcoidosis in stages II and III (in case of shortness of breath, cough and worsening 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 hay fever and allergic rhinitis after nasal sprays containing glucocorticoids have not been effective (SD: c)
• Acute stenosis of the larynx and trachea: swelling of the mucous membranes (Quincke's edema), laryngeal stenosis (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 internal organs. These
include:

• Allergic, pseudo-allergic and allergic-infectious diseases: e.g. acute urticaria, anaphylactoid reactions Severe skin diseases that partially destroy the skin rashes caused by drugs, erythema exudativum multiforme, toxic epidermal necrolysis (Lyell's syndrome), pustulosis
• acute generalized, nodular erythema, acute febrile neutrophilic dermatosis (Sweet's syndrome),
  allergic contact eczema (SD: from b to a)
• rash: e.g. rash e.g. allergic rashes such as atopic eczema, contact eczema, rash caused by pathogens (such as nummular eczema) (SD: from b to a)
• Nodular diseases e.g. sarcoidosis, inflammation of the lips (granulomatous cheilitis) (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)
• inflammation of blood vessels (vasculitis): e.g. allergic vasculitis, polyarteritis nodosa (SD: from b to a)
• diseases of the immune system (autoimmune diseases: e.g. dermatomyositis, systemic scleroderma (indurative phase), chronic discoid and subacute cutaneous lupus erythematosus (SD: from b to a)
• severe skin diseases in pregnancy (see also “Pregnancy” and “Breastfeeding”): for example herpes gestationis, impetigo herpetiformis (SD: from d to a)
• severe skin diseases with inflammatory redness and scaling: 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 severe diseases: e.g. Jarisch-Herxheimer reaction during penicillin treatment for syphilis, 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 blood diseases: anemia caused by autoimmune destruction of red blood cells (Autoimmune hemolytic anemia) (SD: from c to a), idiopathic thrombocytopenic purpura (Werlhof's disease) (SD: a), episodic reduction of platelet count (intermittent thrombocytopenia) (SD: a)
• Malignant diseases such as: Acute lymphoblastic leukemia (SD: e), Hodgkin's disease (SD: e), non-Hodgkin's lymphoma (SD: e),, chronic lymphocytic leukemia (SD: e),, Waldenström's macroglobulinemia (SD: e), multiple myeloma (SD: e)
• Elevated calcium levels in the blood in the presence of underlying malignant neoplasms (SD: from c to a)
• Prevention and treatment of chemotherapy-induced vomiting (SD: from b to a
• Palliative therapy for malignant diseases
• Note: Cortirex can be used to relieve symptoms, such as loss of appetite, weight loss and general weakness in advanced neoplasms, after specific therapeutic options have been exhausted.

Diseases of the nervous system:

• some forms of muscle paralysis (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-dose glucocorticoids parenterally in the acute phase)
• Some forms of epilepsy in early childhood (West syndrome - infantile spasms)

Particular courses of infectious diseases:

• States of intoxication in the context of 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 nerve disease (optic neuropathy, e.g. giant cell arteritis, due to circulatory disorders or trauma) Behçet's disease, sarcoidosis, endocrine orbitopathy, pseudotumor of the orbit, transplant rejection and in some inflammations of the choroid such as Harada's disease and sympathetic ophthalmia
• The administration of Cortirexis only indicated after topical therapy has been unsuccessful Inflammation of different sections of the eye: inflammation of the sclera and surrounding parts, of the cornea or choroid, chronic inflammation of the part of the eye that forms the aqueous humor, allergic inflammation of the conjunctiva, alkaline burns
• keratitis (inflammation of the cornea) occurring in the context of an autoimmune disease or syphilis (additional treatment against the pathogen is necessary), in case of corneal inflammation caused by herpes simplex only if the corneal surface is intact and with regular eye examinations

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:

• certain autoimmune diseases affecting the kidneys: Minimal change glomerulonephritis (SD: a)
• Proliferative-extracapillary glomerulonephritis (rapidly progressive glomerulonephritis) (SD: high-dose shock treatment, usually in association with cytostatic agents), Goodpasture's syndrome interruption and completion 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 CORTIREX

Do not take CORTIREX
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 CORTIREX in life-threatening pathological conditions.

Warnings and precautions
Talk to your doctor or pharmacist before taking CORTIREX.
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 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 CORTIREX at high doses in hormone replacement therapy. You should only take CORTIREX if your doctor considers it
absolutely necessary.
Due to the suppression of your own defenses, treatment with CORTIREX 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.
Contact your doctor immediately if you develop any of the following conditions:

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

In case of concomitant treatment with CORTIREX, the following diseases must be monitored in a
targeted manner and treated accordingly under strict control of your doctor:

• gastrointestinal ulcer
• high blood pressure that is difficult to control
• diabetes that is difficult to control (diabetes mellitus)
• osteoporosis
• mental illnesses (including a history of mental illness) 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, rapid heartbeat (palpitations) and high blood pressure
(hypertension). Contact your doctor immediately if you notice any of these signs.
Talk to your doctor before taking CORTIREX 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, CORTIREX can only be taken if your doctor considers it
necessary and under his strict control in case of:

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

The signs of irritation of the peritoneum 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 in case of
concomitant administration of fluoroquinolones (certain antibiotics) and CORTIREX.
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 CORTIREX must take place in hospital.
In particular, if the disorders affecting the face and pharynx are particularly severe and breathing is
compromised, treatment with CORTIREX must be started gradually.
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 CORTIREX
High doses of CORTIREX 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 therapy with CORTIREX, regular medical checks are necessary (including ophthalmological checks at intervals of three months).
In case of diabetes, metabolism must be monitored regularly; the doctor will assess whether an
increase in the need for drugs to treat diabetes (insulin or oral antidiabetics, etc.) is necessary.
In case of prolonged treatment with high doses of CORTIREX, 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.
Severe anaphylactic reactions (exaggerated immune system reaction) may occur.
In case of severe hypertension and severe heart weakness, consult your doctor for accurate checks as
you may experience a worsening.
If, during treatment with CORTIREX, you experience particular stressful conditions (illnesses with fever,
accidents, operations, childbirth, etc.), you must inform your doctor immediately because a
temporary increase in the daily dose of CORTIREX may be necessary. For this reason, in case of long-term treatment, your doctor must give you appropriate documentation that you must always carry with you.
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, drug therapy should also be considered.
At the end or after interruption of a long-term therapy with CORTIREX, the following risks may occur:
recurrence or worsening of the underlying disease, reduced activity of the adrenal glands (in
particular 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 CORTIREX. If you are immunocompromised and have not had chickenpox or measles and have come
into contact with people suffering from these diseases while being treated with Cortirex, you must contact
your doctor immediately, who, if necessary, may start preventive treatment.

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

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

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

Other medicines and CORTIREX
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 CORTIREX:

• Some medicines can increase the effects of CORTIREX 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 CORTIREX.
• Some female sex hormones, e.g. contraceptives (the “pill”). The effect of CORTIREX 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 CORTIREX.
• Ephedrine (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); may decrease the effectiveness of CORTIREX.
• Medicines against excessive acid production by the stomach (antacids): in case of concomitant 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 distance in time (2 hours).

Other effects of CORTIREX

• Due to potassium deficiency, CORTIREX may increase the effect of medicines to strengthen the heart (cardiac glycosides).
• CORTIREX may increase potassium excretion if used in association with diuretics (saluretics) and laxatives.
• CORTIREX may decrease the hypoglycemic effect of oral antidiabetics and insulin.
• CORTIREX 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 anticoagulants is necessary.
• In case of concomitant use of medicines against inflammation and rheumatism (salicylates, indometacin and other NSAIDs), CORTIREX may increase the risk of gastric ulcers and gastrointestinal bleeding.
• CORTIREX may prolong the muscle relaxant effect of certain medicines (non-depolarizing muscle relaxants).
• CORTIREX may potentiate the pressure-increasing effect in the eye of certain medicines (atropine and other anticholinergics).
• CORTIREX may decrease the effect of medicines against helminthiasis (praziquantel).
• In case of concomitant use of medicines against malaria or rheumatic diseases (chloroquine, hydroxychloroquine, mefloquine), CORTIREX may increase the risk of muscle diseases or heart muscle diseases (myopathies, cardiomyopathies).
• Growth hormones (somatotropin): their effect is diminished particularly by high doses of CORTIREX.
• CORTIREX may decrease the increase in thyroid-stimulating hormone (TSH) following concomitant administration with protirelin (a diencephalic hormone).
• CORTIREX and the concomitant use of medicines to reduce the body's defenses (immunosuppressants) may increase the predisposition to infections and worsen already present but possibly not yet manifest infections.
• In addition to cyclosporine (medicine to suppress the body's defenses): CORTIREX 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 a pregnancy, or if you are breastfeeding with breast milk,
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 the case of long-term treatment with CORTIREX during pregnancy, fetal growth disorders cannot be excluded.
If CORTIREX is taken at the end of pregnancy, adrenal cortical atrophy may occur in the newborn, which may require gradual replacement therapy. In animal tests, prednisone has shown fetal damage (e.g. cleft palate). 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 CORTIREX during breastfeeding must be carefully assessed. If higher doses are necessary due to the illness, you must stop breastfeeding. Contact your doctor immediately.

Driving and operating machinery
So far, there are no indications that CORTIREX affects the ability to drive or operate machinery.

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

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

3. How to take CORTIREX

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 prescribed dosage, as otherwise CORTIREX 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 otherwise prescribed 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: 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 (Dosage scheme a - d)
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 be
possible to deviate from this recommendation.

Dose reduction
Once the desired clinical effect is achieved and depending on the underlying disease, dose reduction begins.
In case of distribution of the daily dose into multiple single doses, the evening dose is reduced first, then
the possible midday dose. The dose is first reduced with larger decreases, starting from about
30 mg/day and then with smaller decreases (see table below). The duration of
treatment depends on the course of the disease. Once a satisfactory therapeutic result is achieved,
the dose is reduced to a maintenance dose or discontinued. The doctor will establish a personalized therapeutic
scheme, which must be followed scrupulously. The following approximate decreases can be used for dose reduction:
High and very high doses, which are administered for a few days, can be discontinued, depending
on the underlying disease and the clinical response, without progressive reduction.
In case of thyroid insufficiency or liver cirrhosis, lower dosages may be sufficient or a reduction in dose may be necessary.
Talk to your doctor or pharmacist if you feel that the effect of CORTIREX is too strong or too
weak.

Dosage scheme “e” (DS: e)
Generally CORTIREXis used as a single dose without gradual reduction until the end of
treatment. In chemotherapy, for example, the following dosage schemes are recognized:

• Non-Hodgkin lymphomas: CHOP scheme, prednisone 100 mg/m , days 1-5; COP scheme, prednisone 100 mg/m , 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/m , days 1-14.
• Multiple myeloma: Alexanian scheme, prednisone 2 mg/kg of body weight, days 1-4.

If you take more CORTIREX than you should
In general, CORTIREX is well tolerated even in case of taking large quantities in a short time.
Therefore, no particular measures are necessary. If you notice an increase in side effects
contact your doctor.

If you forget to take CORTIREX
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 CORTIREX
Always follow the dosage scheme prescribed by the doctor. Do not suddenly stop taking
CORTIREX. If you stop treatment with CORTIREX, especially 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 everyone will experience 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 dosages 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
Cataracts, increased internal eye pressure (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 changes of the skin of the face,
particularly around the mouth, nose and eyes, changes in
skin pigmentation.

Musculoskeletal and connective tissue disorders
Muscle diseases, muscle weakness, muscle atrophy and osteoporosis 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
Disturbances 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, fluctuations in blood sugar in diabetics or other disorders.

Reporting of side effects
If you experience any side effects, including 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 CORTIREX

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 the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What CORTIREX contains
The active ingredient is prednisone.
One CORTIREX 5 mg tablet contains 5 mg of prednisone.
One CORTIREX 20 mg tablet contains 20 mg of prednisone.
One CORTIREX 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 CORTIREX and contents of the pack
CORTIREX 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
Farto S.r.l., Via Dei Caboto 49 – 50127 Florence (FI)

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

This leaflet was last approved on: