SOFLON

PATIENT INFORMATION LEAFLET

SOFLON 5 mg tablets, 20 mg tablets, 25 mg tablets

Prednisone
Generic medicine
Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because 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 SOFLON is and what it is used for
2. What you need to know before taking SOFLON
3. How to take SOFLON
4. Possible side effects
5. How to store SOFLON
6. Contents of the pack and other information

1. What SOFLON is and what it is used for

SOFLON is a glucocorticoid (a hormone produced by the adrenal glands) that affects metabolism, electrolyte balance (salts), and tissue function.
SOFLON is used in diseases requiring systemic treatment with glucocorticoids, including the following conditions depending on type and severity (dosage table SD from a to d); see section 3 “How to take SOFLON”.
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, reduced pituitary activity) after the growth period (drugs of first choice are hydrocortisone and cortisone).
• Conditions of stress following prolonged corticosteroid treatment.

Rheumatic diseases:

• Active phases of 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 case 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 treatment (SD: a–b) in combination with methotrexate (mild forms without renal involvement) or according to 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):
• Systemic lupus erythematosus (chronic disease due to immune system dysfunction causing inflammation and tissue damage), muscle weakness and muscle pain (polymyositis)
• Inflammation of cartilage (chronic atrophic polychondritis)
• Connective tissue diseases (mixed connective tissue disease)
  • Progressive rheumatoid arthritis (SD: from a to d) with severely progressive course, e.g. rapidly destructive forms (SD: a) or forms not affecting joints (SD: b)
  • Other inflammatory rheumatic joint diseases, if clinical severity requires and non-steroidal anti-inflammatory drugs (NSAIDs) are not usable or ineffective:
  • Inflammatory diseases primarily affecting the spine (spondyloarthritides), inflammation and changes in vertebrae (ankylosing spondylitis) with involvement of other joints, e.g. arms and legs (SD: b, c), psoriatic arthritis (SD: c, d) and enteropathic arthropathy (joint disease caused by gastrointestinal inflammation) (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)
  • Unexplained joint inflammation in young people (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 disorders:

• 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 is recommended up to 10 days
• Specific lung diseases such as acute inflammation of pulmonary alveoli (alveolitis) (SD: b), hardening of lung tissue and lung 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 pulmonary function tests) (SD: b)
• Prophylaxis of respiratory distress syndrome in preterm neonates (SD: b, twice daily).

Upper respiratory tract diseases:

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

Skin diseases:
Skin and mucosal diseases that cannot be treated or cannot be adequately treated with topical glucocorticoids due to their 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 that partly destroy the skin, drug-induced rashes, erythema multiforme, toxic epidermal necrolysis (Lyell’s syndrome), generalized acute pustulosis, nodular erythema, acute febrile neutrophilic dermatosis (Sweet’s syndrome), allergic contact eczema (SD: from b to a)
• Skin rashes: e.g. allergic rashes such as atopic eczema, contact eczema, rashes caused by pathogens (e.g. nummular eczema) (SD: from b to a)
• Nodular diseases: e.g. sarcoidosis, lip inflammation (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)
• 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, pemphigoid gestationis (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 of syphilis, rapidly growing and increasing cavernous hemangioma, Behçet’s disease, pyoderma gangrenosum, eosinophilic fasciitis, exanthematic lichen ruber, hereditary epidermolysis bullosa (SD: from c to a).

Blood disorders / oncological diseases:

• Autoimmune blood diseases: 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 decrease in platelet count (intermittent thrombocytopenia) (SD: a)
• Malignant disorders 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 in underlying malignant neoplasms (SD: from c to a)
• Prevention and treatment of chemotherapy-induced nausea and vomiting (SD: from b to a)
• Palliative therapy of malignant diseases
• Note: Soflon 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 (drug of first choice 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 neuropathy (e.g. giant cell arteritis, caused by blood flow disturbances or trauma), Behçet’s disease, sarcoidosis, endocrine orbitopathy, pseudotumor of the orbit, transplant rejection, and certain choroid inflammations such as Harada’s disease and sympathetic ophthalmia. In the following conditions, Soflon administration is indicated only after topical therapy has failed. Inflammations of various eye sections:
• Inflammation of sclera and surrounding areas, cornea or choroid, chronic inflammation of the eye part producing aqueous humor, allergic conjunctivitis, alkaline burns
• Corneal inflammations occurring in autoimmune disease or syphilis (additional pathogen-specific treatment required), in case of corneal inflammation caused by Herpes simplex (only if corneal surface is intact and with regular ophthalmological monitoring).

Gastrointestinal / liver disorders:

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

Renal disorders:

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

2. What you need to know before taking SOFLON

Do not take SOFLON
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 SOFLON in life-threatening medical conditions.

Warnings and precautions
Talk to your doctor or pharmacist before taking SOFLON.
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 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).
Contact your doctor immediately if, during treatment with prednisone, you develop 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 to relieve this condition.

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

Due to suppression of the body's defenses, treatment with SOFLON 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.

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

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

When SOFLON is used concomitantly, the following conditions must be specifically monitored and treated as needed under close supervision by your doctor:

• gastrointestinal ulcers
• osteoporosis
• poorly controlled high blood pressure
• poorly controlled diabetes mellitus
• psychiatric disorders (including history of psychiatric illness or suicidal tendencies): neurological or psychiatric monitoring is recommended
• increased intraocular pressure (narrow-angle glaucoma and open-angle glaucoma); ophthalmological monitoring and concomitant therapy are recommended
• corneal wounds and ulcers; 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). Contact your doctor immediately if you experience any of these signs.
Consult your doctor before taking SOFLON if you suspect or are known to have a pheochromocytoma (adrenal gland tumor).
Contact your doctor if blurred vision or other visual disturbances occur.

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

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

Signs of peritoneal irritation after gastrointestinal ulcer perforation may not be evident in patients receiving high doses of glucocorticoids.

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

In the treatment of a specific form of muscle paralysis (myasthenia gravis), symptoms may initially worsen; therefore, SOFLON should be administered in a hospital setting.
In particular, if facial and pharyngeal symptoms are severe and breathing is impaired, treatment with SOFLON 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 impaired by high doses of SOFLON.

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

Regular medical check-ups (including ophthalmological examinations every three months) are necessary during long-term SOFLON therapy.

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 SOFLON, pay particular attention to adequate potassium intake (e.g., vegetables, bananas) and reduced salt intake. Your doctor may prescribe blood tests to monitor potassium levels.

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

If you experience particular stress conditions during SOFLON treatment (illness with fever, accidents, surgical procedures, childbirth, etc.), inform your doctor immediately, as a temporary increase in the daily dose of SOFLON may be necessary. For this reason, if you are on long-term treatment, your doctor should provide appropriate documentation that you must carry with you at all times.

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

Depending on the duration and dose of treatment, a negative effect on calcium metabolism should be considered, and osteoporosis prevention is recommended. This is particularly important in the presence of concomitant risk factors such as family history, advanced age, inadequate protein and calcium intake, 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 SOFLON therapy, the following risks may occur: recurrence or worsening of the underlying disease, reduced adrenal gland activity (especially under stress conditions, e.g., during infection, after accidents, or increased physical exertion), or corticosteroid withdrawal syndrome.

Certain viral diseases (chickenpox, measles) may have a particularly severe course in patients treated with SOFLON. If you are immunocompromised and have not had chickenpox or measles, and have been exposed to individuals with these diseases while on SOFLON treatment, contact your doctor immediately, who may initiate preventive treatment if necessary.

Children and adolescents
SOFLON 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. SOFLON therapy should be limited in duration or administered intermittently (e.g., alternate-day dosing, but with double dosage on active days [alternate therapy]).

Elderly patients
Since elderly patients have an increased risk of osteoporosis, the benefit-risk ratio of SOFLON therapy must be carefully evaluated.

For athletes: using the drug without therapeutic need constitutes doping and may lead to a positive anti-doping test.

Other medicines and SOFLON
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 SOFLON:

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

Other effects of SOFLON

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

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

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

Pregnancy
SOFLON should be taken during pregnancy only on medical advice. Inform your doctor if you are pregnant.
Long-term SOFLON treatment during pregnancy may not exclude fetal growth disturbances.
If SOFLON is taken toward the end of pregnancy, adrenal cortical atrophy may occur in the newborn, possibly requiring gradual replacement therapy. Animal studies have shown that prednisone can cause fetal damage (e.g., cleft palate). An increased risk of such effects in humans following prednisone administration during the first trimester of pregnancy is under discussion.

Breastfeeding
Prednisone passes into breast milk. No adverse effects on the infant have been reported so far. Nevertheless, the necessity of administering SOFLON 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 using machines
There is currently no evidence that SOFLON affects the ability to drive or operate machinery.

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

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

3. How to take SOFLON

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, otherwise SOFLON may not have the desired effect. If in doubt,
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 your doctor, the usual dose for hormone replacement therapy (beyond
the growth period) is:
5 to 7.5 mg of prednisone daily, divided into two doses (in the morning and at midday; in the case of adrenogenital syndrome, in the morning and evening). If necessary, your doctor may prescribe an additional 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 gradually tapered over several days.
Treatment of certain diseases (pharmacotherapy):
The following tables provide an overview of general dosage 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; medium 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, dose reduction is initiated depending on the underlying disease. When the daily dose is divided into multiple individual doses, the evening dose should first be reduced, followed by the midday dose, if applicable. Initially, the dose is reduced in larger decrements, starting from approximately 30 mg/day, and subsequently in smaller decrements (see table below). The duration of treatment depends on the course of the disease. As soon as a satisfactory treatment outcome is achieved, the dose is reduced to a maintenance dose or treatment is discontinued. For this purpose, the physician establishes a treatment regimen that must be strictly followed. The following approximate decrements may serve as guidance 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 tapering.
In cases of hypothyroidism or hepatic cirrhosis, lower dosages may be sufficient or dose reduction may be necessary.
Talk to your doctor or pharmacist if you feel that the effect of SOFLON is too strong or too weak.

Dosing schedule “e” (DS: e)
Generally, SOFLON is used as a single dose without gradual reduction until the end of treatment. In chemotherapy, the following dosing schedules 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 SOFLON than you should
In general, SOFLON is well tolerated without complications even after short-term intake of large quantities. Therefore, no special measures are required. If you notice an increase in adverse effects, contact your doctor.

If you forget to take SOFLON
Do not take a double dose to make up for the forgotten dose. Contact your doctor to find out what to do.

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

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

4. Possible adverse effects

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

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

Treatment of specific diseases with higher dosages than those used in hormone replacement therapy:
The following dose- and duration-dependent adverse effects may occur; 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).

Disorders of the blood and lymphatic system
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 disturbances in heart rhythm, bronchospasm (cramping of the smooth muscles of the bronchi), blood pressure too high or too low, circulatory collapse, cardiac arrest, weakening of immune defenses.

Endocrine disorders
Development of so-called Cushing's syndrome (typical signs are "moon face", weight gain in the upper part of the body, and facial redness), inactivity or atrophy of the adrenal cortex.

Metabolism and nutrition disorders
Weight gain, elevated blood glucose, diabetes mellitus, increased blood lipids (cholesterol and triglycerides), sodium retention with edema formation, potassium deficiency due to increased potassium excretion, increased appetite.

Psychiatric disorders
Depression, irritability, euphoria, increased libido, psychosis, mania, hallucinations, emotional lability, anxiety, sleep disturbances, suicidal tendencies.

Nervous system disorders
Increased intracranial pressure, emergence of previously unrecognized epilepsy and increased frequency of seizures in existing epilepsy.

Eye disorders
Clouding of the lens (cataract), increased intraocular pressure (glaucoma), worsening of corneal lesions, predisposition to eye inflammation caused by viruses, bacteria or fungi, blurred vision.

Cardiac disorders
Slowing of the heartbeat; frequency unknown.

Vascular disorders
Increased blood pressure, increased risk of atherosclerosis and thrombosis, inflammation of blood vessels (including withdrawal syndrome following long-term therapy), increased vessel fragility.

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

Skin and subcutaneous tissue disorders
Stretch marks (Striae rubrae), skin atrophy, dilation of skin blood vessels (telangiectasias), tendency to bruise, pinpoint or flat skin hemorrhages, increased body hair, acne, inflammatory skin changes on the face, particularly around the mouth, nose, and eyes, changes in skin pigmentation.

Musculoskeletal and connective tissue disorders
Muscle disorders, muscle weakness, muscle atrophy, and osteoporosis occurring depending on the dose and possible even after short-term use; other forms of bone deterioration (bone necrosis), tendon disorders, tendon inflammation, tendon ruptures, and fat deposits in the spine (epidural lipomatosis), growth suppression in children.
In case of too rapid dose reduction following long-term treatment, disorders such as muscle and joint pain may occur.

Renal and urinary disorders
Renal crisis caused by scleroderma in patients already suffering from scleroderma (an autoimmune disease). Signs of 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 disorders, back, shoulder or hip joint pain, psychological disturbances, blood glucose fluctuations in diabetics, or other disturbances.

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

5. How to store SOFLON

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Store below 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What SOFLON contains
The active substance is prednisone.
One tablet of SOFLON 5 mg contains 5 mg of prednisone.
One tablet of SOFLON 20 mg contains 20 mg of prednisone.
One tablet of SOFLON 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 SOFLON and the contents of the pack
SOFLON is available as 5 mg, 20 mg, and 25 mg tablets in PVC/PVDC-Al blisters.
Pack sizes: 10, 20 or 30 tablets of 5 mg.
Pack size: 20 tablets of 20 mg.
Pack sizes: 10 or 20 tablets of 25 mg.

Marketing Authorization Holder
S.F. Group Srl – via Tiburtina, 1143 – 00156 Rome

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

This leaflet was last approved in: February 2026