Cortirex

PATIENT LEAFLET: INFORMATION FOR THE USER

CORTIREX 5 mg tablets, 20 mg tablets, 25 mg tablets

Prednisone
Generic medicine
Please read all of this leaflet carefully before you start 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 yours, as it may 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 taking 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 CORTIREX is and what it is used for

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

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 (first-choice drugs are hydrocortisone and cortisone).
• Conditions of stress following prolonged corticosteroid treatment.

Rheumatic diseases:

• Active phases of vascular inflammations:
  • 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 cases of acute vision loss, initial pulse therapy with intravenous glucocorticoids is recommended, followed by continuous therapy with monitoring of erythrocyte sedimentation rate (ESR)
  • Wegener's granulomatosis: induction therapy (SD: a-b) in combination with methotrexate (mild forms without renal involvement) or according to the Fausi regimen (severe forms with kidney and/or lung 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):
• Lupus erythematosus (chronic disease due to immune system dysfunction causing inflammation and tissue damage), muscle weakness and muscle pain (polymyositis)
• Inflammations of cartilage (chronic atrophic polychondritis)
• Connective tissue diseases (mixed connective tissue disease)
  • Rheumatoid arthritis (SD: from a to d) with severely progressive course, e.g., rapidly destructive forms (SD: a) or forms not involving joints (SD: b)
  • Other inflammatory rheumatic joint diseases, when clinical severity warrants it and non-steroidal anti-inflammatory drugs (NSAIDs) cannot be used or are ineffective:
• Inflammatory diseases primarily affecting the spine (spinal arthritides), inflammation and changes in vertebrae (ankylosing spondylitis involving 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 inflammations as reaction to other underlying conditions (SD: c)
• Arthritis in sarcoidosis (initially SD: b)
  • Cardiac inflammation in rheumatic fever, in severe cases over 2–3 months (SD: a)
  • Joint inflammation without identifiable cause in young individuals (juvenile idiopathic arthritis) with severe course affecting internal organs (Still's disease) or eyes (inflammation of iris and surrounding areas) (SD: a)

Bronchial and pulmonary conditions:

• Bronchial asthma (SD: from c to a); concomitant administration of bronchodilators is also recommended
• Acute exacerbation of existing chronic respiratory disease (SD: b); treatment duration up to 10 days is recommended
• Specific lung diseases such as acute inflammation of pulmonary alveoli (alveolitis) (SD: b), lung tissue hardening and remodeling (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 stages II and III (in case of shortness of breath, cough, and worsening lung function values) (SD: b)
• Prophylaxis of respiratory distress syndrome in preterm neonates (SD: b, twice)

Upper respiratory tract diseases:

• Severe forms of hay fever and allergic rhinitis after nasal sprays containing glucocorticoids have been ineffective (SD: c)
• Acute stenosis of larynx and trachea: mucosal swelling (Quincke's edema), stenosing laryngitis (pseudo-croup) (SD: from b to a)

Skin diseases:
Severe skin and mucous membrane diseases that cannot be treated or cannot be adequately treated with topical glucocorticoids due to severity and/or extent or internal organ involvement. These include:

• Allergic, pseudo-allergic, and allergo-infectious diseases: e.g., acute urticaria, anaphylactoid reactions, severe skin diseases partially destroying the skin, drug-induced rashes, erythema multiforme, toxic epidermal necrolysis (Lyell syndrome), generalized acute pustulosis, erythema nodosum, acute febrile neutrophilic dermatosis (Sweet syndrome), allergic contact eczema (SD: from b to a)

• Skin eruptions: e.g., skin eruptions such as allergic eruptions like atopic eczema, contact eczema, eruptions caused by pathogens (e.g., 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 mucosal pemphigoid, linear IgA dermatosis (SD: from b to a)

• Blood vessel inflammations (vasculitides): e.g., allergic vasculitis, polyarteritis nodosa (SD: from b to a)

• Immune system diseases (autoimmune diseases): e.g., dermatomyositis, systemic scleroderma (indurative phase), chronic discoid and subacute cutaneous lupus erythematosus (SD: from b to a)

• Severe skin diseases during pregnancy (see also “Pregnancy” and “Breast-feeding”): e.g., herpes gestationis, herpes gestationalis, herpetiform impetigo (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)

• Erythroderma, including Sézary syndrome (SD: from c to a)

• Other severe conditions: 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 exanthematicus, hereditary epidermolysis bullosa (SD: from c to a)

Blood diseases / tumor diseases:

• Autoimmune blood disorders: anemia due to autoimmune destruction of red blood cells (autoimmune hemolytic anemia) (SD: from c to a), idiopathic thrombocytopenic purpura (Werlhof's disease) (SD: a), episodic reduction in platelet count (intermittent thrombocytopenia) (SD: a)
• Malignant conditions such as: acute lymphoblastic leukemia (SD: e), Hodgkin's disease (SD: e), non-Hodgkin lymphoma (SD: e), chronic lymphocytic leukemia (SD: e), Waldenström's disease (SD: e), multiple myeloma (SD: e)
• Elevated calcium levels in blood associated with underlying malignant neoplasms (SD: from c to a)
• Prevention and treatment of chemotherapy-induced nausea and vomiting (SD: from b to a)
• Palliative therapy for malignant diseases
• Note: Cortirex may be used to relieve symptoms, e.g., loss of appetite, weight loss, and general weakness in advanced malignant neoplasms, after specific therapeutic options have been exhausted.

Nervous system disorders:

• Certain forms of muscle paralysis (myasthenia gravis (first-choice drug is azathioprine))
• Chronic Guillain-Barré syndrome
• Tolosa-Hunt syndrome
• Polyneuropathy in monoclonal gammopathy
• Multiple sclerosis (gradual dose reduction until discontinuation after high-dose parenteral glucocorticoid administration in the acute phase)
• Certain forms of epilepsy in early infancy (West syndrome – infantile spasms)

Specific courses of infectious diseases:

• Toxic states in the context of severe infectious diseases (in association 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 nerve disease (optic neuropathy, e.g., giant cell arteritis, due to circulatory disorders or trauma), Behçet's disease, sarcoidosis, endocrine orbitopathy, orbital pseudotumor, transplant rejection, and certain choroid inflammations such as Harada's disease and sympathetic ophthalmia
• Cortirex administration is indicated only after topical therapy has failed: inflammations of various eye parts: sclera and surrounding areas, cornea or choroid, chronic inflammation of the eye part producing aqueous humor, allergic conjunctivitis, alkaline burns
• Keratitis (corneal inflammations) occurring in autoimmune disease or syphilis (additional pathogen-specific treatment required); in herpes simplex-related corneal inflammation, only if corneal surface is intact and with regular ophthalmological monitoring

Gastrointestinal / liver diseases:

• Ulcerative colitis (SD: from b to c)
• Crohn's disease (SD: b)
• Autoimmune hepatitis (SD: b)
• Esophageal burn (SD: a)

Kidney disorders:

• Certain autoimmune kidney diseases: minimal lesion glomerulonephritis (SD: a)
• Proliferative-extracapillary glomerulonephritis (rapidly progressive glomerulonephritis) (SD: high-dose pulse treatment, usually in combination with cytostatic agents), Goodpasture syndrome; interruption and conclusion of treatment; in all other forms, long-term continuation of therapy (SD: d)
• Idiopathic retroperitoneal fibrosis (SD: b)

2. What you should know before taking CORTIREX

Do not take CORTIREX
If you are allergic to the active substance (prednisone) or to any of the other ingredients of this medicine
(listed in section 6).
There are no other contraindications for short-term use of CORTIREX in life-threatening medical 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 higher may increase the risk of a scleroderma renal crisis, characterized by increased blood pressure and reduced urine output. Your doctor may recommend regular monitoring of your blood pressure and urine
➢ you have an overactive thyroid (hyperthyroidism).

Special caution is required when taking CORTIREX at high doses for hormone replacement therapy. You should take CORTIREX only if your doctor considers it absolutely necessary.

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

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

• acute viral infections (hepatitis B, chickenpox, shingles, herpes simplex infections, viral keratitis)
• acute and chronic bacterial infections
• fungal diseases affecting internal organs
• certain parasitic diseases (amoebic or helminthic infections). In patients with suspected or confirmed infection by small nematodes (strongyloides), CORTIREX may lead to activation and massive multiplication of the parasites.
• lymph node inflammation after anti-tuberculosis vaccination (in case of history of tuberculosis, use only with concomitant anti-tuberculosis medication)
• infectious liver inflammation (chronic active HBsAg-positive hepatitis)
• poliomyelitis
• from approximately 8 weeks before to 2 weeks after vaccination with live vaccines

During concomitant treatment with CORTIREX, the following conditions must be specifically monitored and treated as needed under close medical supervision:

• gastrointestinal ulcers
• poorly controlled high blood pressure
• poorly controlled diabetes mellitus
• osteoporosis
• 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, rapid heartbeat (palpitations), and high blood pressure (hypertension). Seek immediate medical attention if you experience any of these symptoms.

Talk to your doctor before taking CORTIREX if you suspect or are known to have a pheochromocytoma (adrenal gland tumor).

Contact your doctor if you experience blurred vision or other visual disturbances.

Due to the risk of intestinal perforation, CORTIREX should only be taken if your doctor considers it necessary and under strict medical supervision in the following cases:

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

Signs of peritoneal irritation following 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 class of antibiotics) are taken concomitantly with CORTIREX.

In the treatment of a specific form of muscle paralysis (myasthenia gravis), symptoms may initially worsen, so administration of CORTIREX should take place in a hospital setting.

In particular, if facial and pharyngeal symptoms are severe and breathing is impaired, treatment with CORTIREX should be initiated gradually.

Vaccinations with inactivated (killed) pathogen vaccines are generally possible. However, it should be noted that the effectiveness of vaccination may be reduced by high doses of CORTIREX.

High doses of CORTIREX may cause a slowing of the heart rate (bradycardia). The onset of bradycardia is not necessarily related to the duration of treatment.

In case of long-term treatment with CORTIREX, regular medical check-ups (including ophthalmological examinations every three months) are necessary.

In case of diabetes, metabolism should be monitored regularly; your doctor will assess whether an increase in antidiabetic medication (insulin or oral antidiabetics, etc.) is needed.

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

Severe anaphylactic reactions (exaggerated immune system responses) may occur.

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

If, during treatment with CORTIREX, you experience special stress conditions (febrile illness, accidents, surgical procedures, childbirth, etc.), inform your doctor immediately, as a temporary increase in the daily dose of CORTIREX 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.

Depending on the duration and dose of treatment, a negative impact on calcium metabolism should be considered, and prevention of osteoporosis is advised. This is especially important in the presence of concomitant risk factors such as family predisposition, advanced age, insufficient protein and calcium intake, excessive smoking, excessive 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 discontinuing long-term treatment with CORTIREX, the following risks may occur: recurrence or worsening of the underlying disease, reduced adrenal gland function (particularly under stress conditions such as infection, accidents, or increased physical exertion), and corticosteroid withdrawal syndrome.

Certain 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 been exposed to individuals affected by these diseases during treatment with CORTIREX, contact your doctor immediately. Preventive treatment may be initiated if necessary.

Contact your doctor immediately if, during treatment with prednisone, you experience muscle weakness, muscle pain, cramps, or stiffness. 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.

Children and adolescents
CORTIREX should be used in children only when strictly necessary and under medical supervision due to the risk of growth suppression, which must be monitored regularly. Treatment with CORTIREX should be time-limited 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 an increased risk of osteoporosis, the benefit-risk ratio of CORTIREX therapy must be carefully evaluated.

For those engaged in sports: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

Other medicines and CORTIREX
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 CORTIREX:

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

Other effects of CORTIREX

• Due to potassium deficiency, CORTIREX may enhance the effect of heart-strengthening medicines (cardiac glycosides).
• CORTIREX may increase potassium loss when used with diuretics (saluretics) and laxatives.
• CORTIREX may reduce the hypoglycemic effect of oral antidiabetics and insulin.
• CORTIREX may decrease or increase the effect of anticoagulant medicines (oral anticoagulants, coumarin derivatives). Your doctor will decide whether a dose adjustment of anticoagulants is necessary.
• When used concomitantly with anti-inflammatory and rheumatic medicines (salicylates, indomethacin, and other NSAIDs), CORTIREX may increase the risk of gastric ulcers and gastrointestinal bleeding.
• CORTIREX may prolong the muscle-relaxing effect of certain medicines (non-depolarizing muscle relaxants).
• CORTIREX may enhance the intraocular pressure-increasing effect of certain medicines (atropine and other anticholinergics).
• CORTIREX may reduce the effect of anti-helminthic medicines (praziquantel).
• When used concomitantly with medicines for 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 may be particularly reduced by high doses of CORTIREX.
• CORTIREX may reduce the increase in thyroid-stimulating hormone (TSH) following concomitant administration with protirelin (a diencephalic hormone).
• CORTIREX and concomitant use of immunosuppressive medicines may increase susceptibility to infections and worsen existing, possibly latent, infections.
• In addition to cyclosporine (an immunosuppressive medicine): CORTIREX may increase cyclosporine blood levels and thus the risk of seizures.
• Some blood pressure-lowering medicines (ACE inhibitors): increased risk of hematological abnormalities.
• Fluoroquinolones, a group of antibiotics, may increase the risk of tendon rupture.

Effect on diagnostic tests
Skin reactions to allergy tests may be suppressed.

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

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

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

If CORTIREX is taken at the end of pregnancy, adrenal cortical atrophy may occur in the newborn, possibly requiring gradual replacement therapy. Animal studies have shown fetal damage (e.g., cleft palate) with prednisone. An increased risk of such damage in humans following prednisone administration during the first trimester of pregnancy remains under discussion.

Breastfeeding
Prednisone passes into breast milk. So far, no adverse effects on the infant have been reported. Nevertheless, the necessity of administering CORTIREX during breastfeeding should be carefully evaluated. If higher doses are required due to the underlying condition, breastfeeding should be discontinued. Contact your doctor immediately.

Driving and use of machines
There are currently no indications that CORTIREX affects the ability to drive or operate machinery.

CORTIREX contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor 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 exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Your doctor will determine the dose individually for you.
Follow the prescribed dosage instructions carefully, as otherwise CORTIREX may not produce the intended effect. If you have
any doubts, consult your doctor or pharmacist.
Method of administration
Take the tablets without chewing, with a sufficient amount of liquid, during or immediately after
a meal.
If not otherwise prescribed by the doctor, the usual dose for hormone replacement therapy (beyond
the growth period) is:
5 to 7.5 mg of prednisone daily, divided into two doses (in the morning and at midday; in cases of adrenogenital syndrome, in the morning and evening). If necessary, your doctor may prescribe an additional mineralocorticoid (fludrocortisone). In particular stress situations such as febrile illnesses, accidents, surgical procedures or childbirth, your doctor may decide to temporarily increase the dose.
In stress situations following long-term treatment with glucocorticoids: administration should be promptly increased up to 50 mg of prednisone 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 schedule a - d)

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, and average doses into 2–3 individual administrations.
Children

In children, dosages should be as low as possible. In special cases (e.g. West syndrome), this recommendation may be deviated from.
Dose reduction
Once the desired clinical effect has been achieved, and depending on the underlying disease, dose reduction is initiated. 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 by larger decrements, starting from approximately 30 mg/day, and subsequently by smaller decrements (see table below). The duration of treatment depends on the course of the disease. Once a satisfactory therapeutic outcome has been achieved, the dose is either reduced to a maintenance dose or discontinued. The physician will establish a personalized treatment regimen, which must be strictly followed. The following dose decrements may serve as a guide for dose reduction:

High and very high doses, administered for a few days, may be discontinued depending on the underlying disease and clinical response, without gradual reduction.
In cases of hypothyroidism or hepatic cirrhosis, lower dosages may be sufficient or a dose reduction may be necessary.
Talk to your doctor or pharmacist if you feel that the effect of CORTIREX is too strong or too weak.

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

• Non-Hodgkin's lymphoma: CHOP regimen, prednisone 100 mg/m², days 1–5; COP regimen, prednisone 100 mg/m², days 1–5.
• Chronic lymphocytic leukemia: Knospe regimen, prednisone 75/50/25 mg, days 1–3.
• Hodgkin's disease: COPP-ABVD regimen, prednisone 40 mg/m², days 1–14.
• Multiple myeloma: Alexanian regimen, prednisone 2 mg/kg body weight, days 1–4.

If you take more CORTIREX than you should
Generally, CORTIREX is well tolerated without complications even when large quantities are taken within a short time. Therefore, no special measures are required. If you notice an increase in adverse 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 find out how to proceed.

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

If you have any questions 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 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; their frequency is unknown:

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

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 rhythm disturbances, bronchospasm (spasms of the smooth muscles of the bronchi), blood pressure too high or too low, circulatory collapse, cardiac arrest, weakening of immune defenses.

Endocrine disorders
Development of so-called Cushing's syndrome (typical signs are "moon face", weight gain in the upper body, and facial redness), reduced activity 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
Clouding of the lens (cataract), increased intraocular pressure (glaucoma), worsening of corneal lesions, predisposition to eye infections caused by viruses, bacteria, or fungi, blurred vision.

Cardiac disorders
Slowing of the heartbeat; frequency unknown.

Vascular disorders
Increased blood pressure, increased risk of atherosclerosis and thrombosis, inflammation of blood vessels (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 vessels (telangiectasias), tendency to bruise, pinpoint or flat skin hemorrhages, increased body hair growth, acne, inflammatory skin changes on the face, especially around the mouth, nose, and eyes, changes in skin pigmentation.

Musculoskeletal and connective tissue disorders
Muscle disorders, muscle weakness, muscle atrophy, and osteoporosis, which occur depending on the dose and may also appear even after short-term use; other forms of bone deterioration (bone necrosis), tendon disorders, tendon inflammation, tendon ruptures, fat deposits in the spine (epidural lipomatosis), growth suppression in children.

With 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 who already suffer from scleroderma (an autoimmune disease). Signs of a scleroderma-related renal crisis include increased blood pressure and reduced urine output.

Reproductive system and breast disorders
Disturbances in sex hormone secretion that may cause absence of menstruation (amenorrhea), male-pattern hair distribution in women (hirsutism), impotence.

General disorders and administration site conditions
Delayed wound healing.

Inform your doctor immediately if you experience gastrointestinal disturbances, back, shoulder, or hip joint pain, psychological changes, blood glucose fluctuations in diabetics, or any other disturbances.

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

5. How to store CORTIREX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack. 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 no longer used. This will help protect the environment.

6. Package contents and other information

What CORTIREX contains
The active substance is prednisone.
One tablet of CORTIREX 5 mg contains 5 mg of prednisone.
One tablet of CORTIREX 20 mg contains 20 mg of prednisone.
One tablet of CORTIREX 25 mg contains 25 mg of prednisone.
The other components are: lactose monohydrate, sodium starch glycolate (type A), talc, hydrated colloidal silica, magnesium stearate.
Description of the appearance of CORTIREX and contents of the pack
CORTIREX 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
Farto S.r.l., Via Dei Caboto 49 – 50127 Firenze (FI)
Manufacturer
Genetic S.p.A., Contrada Canfora, 84084 Fisciano (SA)
This leaflet was last approved on: 02/2026