SOFLON 5 mg Coated Tablet

Зміст інструкції

1. SOFLON 5 mg tablets, 20 mg tablets, 25 mg tablets
   1. What is SOFLON and what is it 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

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

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What SOFLON is and what it is used for
• 2. What you need to know before you take 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 is SOFLON and what is it used for

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

Hormone replacement therapy in case of

• decreased or absent adrenal function (adrenal insufficiency) of any nature (e.g. Addison's disease, adrenogenital syndrome, surgical removal of the adrenal glands, reduced pituitary activity) after the growth period (drugs of first choice are hydrocortisone and cortisone).
• stress conditions after prolonged treatment with corticosteroids.

Rheumatic diseases:

• active phases of inflammation of the vessels:
• 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)
• progressive 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 (spondyloarthropathies), 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) and enteropathic arthropathy (joint disease caused by gastrointestinal inflammation) (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), treatment duration up to 10 days is recommended
• Specific lung diseases such as acute inflammation of the lung 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)

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 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, skin rashes caused by drugs, exudative erythema multiforme, toxic epidermal necrolysis (Lyell's syndrome), acute generalized pustulosis, nodular erythema, acute febrile neutrophilic dermatosis (Sweet's syndrome), allergic contact eczema (SD: from b to a)
• Rashes: 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 the 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 (induration 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, also in Sézary syndrome (SD: from c to a)
• Other severe diseases: e.g. Jarisch-Herxheimer reaction in the treatment of syphilis with penicillin, 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 decrease in the number of platelets (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)
• high levels of calcium in the blood in 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: Soflon 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.

Nervous system diseases:

• 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 neuropathy (e.g. giant cell arteritis, caused by impaired blood supply or injuries), Behçet's disease, sarcoidosis, endocrinopathy of the orbit, pseudotumor of the orbit, transplant rejection and in some inflammations of the choroid such as Harada's disease and sympathetic ophthalmia In the following diseases, the administration of Soflon is indicated only after topical therapy has been unsuccessful. Inflammation of different sections of the eye:
• inflammation of the sclera and surrounding parts, the cornea or the choroid, chronic inflammation of the part of the eye that forms the aqueous humor, allergic inflammation of the conjunctiva, alkaline burns
• inflammation of the cornea that occurs 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 surface of the cornea is intact and with regular ophthalmological checks)

Gastrointestinal diseases / liver diseases:

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

Kidney diseases:

• some autoimmune diseases affecting the kidneys: Minimal change glomerulonephritis (SD: a)
• Proliferative-extracapillary glomerulonephritis (rapidly progressive glomerulonephritis) (SD: high-dose shock therapy, usually in association with cytostatic agents), in Goodpasture's 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 need to know before taking SOFLON

Do not take SOFLON
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 the short-term use of SOFLON in pathological situations that are
life-threatening..

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 even higher doses may increase the risk of sclerodermic 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 SOFLON at high doses
in hormone replacement therapy. You should only take SOFLON if your doctor considers it absolutely
necessary.
Due to the suppression of your own defenses, treatment with SOFLON 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.
Consult your doctor immediately if you experience any of the following conditions at the same time:

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

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

• gastrointestinal ulcer
• osteoporosis
• high blood pressure that is difficult to regulate
• diabetes that is difficult to regulate (diabetes mellitus)
• mental illnesses (including a history of suicidal tendencies): neurological or psychiatric monitoring is recommended
• increased pressure in the eye (narrow-angle 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). See your doctor immediately if you notice any of these signs.
See your doctor before taking SOFLON if you suspect or know you have a pheochromocytoma (adrenal gland tumor).
Contact your doctor if you experience blurred vision or other visual disturbances.
Due to the risk of intestinal perforation, SOFLON may only be taken if your doctor considers it
necessary and under his strict control in case of:

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

The signs of peritoneal irritation after perforation of a gastrointestinal ulcer may not be
present in patients receiving high doses of glucocorticoids.
The risk of tendon disorders, tendon inflammation and tendon rupture is increased in case of
simultaneous administration of fluoroquinolones (certain antibiotics) and SOFLON.
In the treatment of a particular form of muscle paralysis (myasthenia gravis), a worsening of symptoms may occur at the beginning, so the intake of SOFLON must take place in hospital.
Especially if the disturbances affecting the face and pharynx are particularly severe and breathing is
compromised, treatment with SOFLON should be started gradually.
Vaccinations with vaccines from killed pathogens (inactivated vaccines) are fundamentally possible. However, it must be
noted that the success of the vaccination may be impaired by high doses of SOFLON
High doses of SOFLON can cause a slowing of the heartbeat (bradycardia). The onset of
bradycardia is not necessarily related to the duration of treatment.
Regular medical check-ups (including ophthalmological check-ups at intervals of three months) are necessary in case of long-term therapy with SOFLON.
In case of diabetes, metabolism must be checked regularly; the doctor will assess whether an
increase in the need for medication to treat diabetes (insulin or oral antidiabetics, etc.) is necessary. In case of
prolonged treatment with high doses of SOFLON, pay particular attention to sufficient intake of
potassium (e.g. vegetables, bananas) and limited intake of salt. The doctor may prescribe you tests to
check your blood potassium levels.
In case of severe hypertension and severe heart failure, consult your doctor for accurate checks as
a worsening may occur.
If you experience particular stressful conditions (illnesses with fever, accidents, surgeries, childbirth, etc.) during treatment with SOFLON, you must inform your doctor immediately because a temporary increase in the daily dose of SOFLON may be necessary. For this reason, in case of long-term
treatment, your doctor must provide you with appropriate documentation that you must always carry with you.
Severe anaphylactic reactions (exaggerated immune system reaction) can occur.
Depending on the duration and dose of treatment, a negative influence on
calcium metabolism must be taken into account, and therefore prevention against osteoporosis is recommended. This is especially true in
case of concomitant risk factors, such as family predisposition, advanced age, insufficient intake of
proteins and calcium, excessive smoking, excessive alcohol consumption, after menopause and in case of poor
physical activity. Prevention consists of sufficient intake of calcium and vitamin D and physical activity. In
case of existing osteoporosis, medication therapy should also be considered.
At the end or after discontinuation of long-term therapy with SOFLON, 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 Soflon. If you are immunocompromised and have not had chickenpox or measles and have come into contact
with people affected by these diseases while being treated with Soflon, you should see your doctor immediately, who, if necessary, may start preventive treatment.

Children and adolescents
SOFLON should only be used in children if absolutely necessary and under the control of the doctor
due to the risk of growth inhibition, which must be checked regularly. Therapy with SOFLON
should be limited in time or administered with alternation (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 SOFLON 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 SOFLON
Tell your doctor if you are taking or have recently taken or may take any other medicines,
including those without a prescription.
Some medicines may increase or decrease the effects of SOFLON:

• Some medicines can increase the effects of SOFLON 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 hepatic degradation, such as some antifungal medicines (ketoconazole, itraconazole), can potentiate the effects of SOFLON.
• Some female sex hormones, e.g. contraceptives (the “pill”). The effect of SOFLON may be increased.
• Medicines such as hypnotics (barbiturates), medicines against convulsions (phenytoin, carbamazepine, primidone) and certain medicines against tuberculosis (rifampicin) can decrease the effect of SOFLON.
• Efedrine (may be contained, for example, in medicines for treating hypotension, chronic bronchitis, asthma attacks and for decongesting the mucous membranes in colds and as a component of anorectics); may decrease the effectiveness of SOFLON.
• Medicines against excessive acid production by the stomach (antacids): in case of simultaneous administration of magnesium hydroxide or aluminum, a decrease in the absorption of prednisone is possible. The intake of the two medicines should therefore be spaced apart in time (2 hours).

Other effects of SOFLON

• Due to potassium deficiency, SOFLON may increase the effect of medicines to strengthen the heart (cardiac glycosides).
• SOFLON may increase the elimination of potassium if used in association with diuretics (saluretics) and laxatives.
• SOFLON may decrease the hypoglycemic effect of oral antidiabetics and insulin.
• SOFLON 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 simultaneous use of medicines against inflammation and rheumatism (salicylates, indometacin 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 potentiate the pressure-increasing effect of certain medicines (atropine and other anticholinergics) on the eye.
• SOFLON may decrease the effect of medicines against helminthiasis (praziquantel).
• In case of simultaneous use of medicines against malaria or rheumatic diseases (chloroquine, hydroxychloroquine, mefloquine), SOFLON may increase the risk of developing muscle diseases or heart muscle diseases (myopathies, cardiomyopathies).
• Growth hormones (somatotropin): their effect is diminished particularly by high doses of SOFLON.
• SOFLON may decrease the increase in thyroid-stimulating hormone (TSH) following concomitant administration with protirelin (a diencephalic hormone).
• SOFLON and the simultaneous use of medicines to reduce the body's defenses (immunosuppressants) may increase the predisposition to infections and worsen existing but possibly not yet manifest infections.
• In addition to cyclosporine (medicine for suppressing the body's defenses): SOFLON 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, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
During pregnancy, intake should only take place on the advice of a doctor. Inform your doctor if
you are pregnant.
In case of long-term treatment with SOFLON during pregnancy, fetal growth disorders cannot be excluded.
If SOFLON is taken at the end of pregnancy, adrenal insufficiency may occur in the newborn, which may require gradual replacement therapy. Prednisone has shown fetal damage (e.g. cleft palate) in animal tests. An increased risk of such damage in humans through the administration of prednisone during the first trimester of pregnancy is under discussion.

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

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

SOFLON contains lactose.
If your doctor has diagnosed you with intolerance to certain sugars, contact them 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 following exactly the instructions of your doctor or pharmacist. If you have doubts
consult your doctor or pharmacist. The dose will be established individually for you by the doctor.
Respect the prescribed dosage, as otherwise SOFLON may not have the correct effect. If you have doubts,
consult your doctor or pharmacist.

Method of administration
Take the tablets without chewing with sufficient 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):
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: the administration
will be promptly up to 50 mg of prednisone per day; the decrease in dose must occur over
several days.

Treatment of certain diseases (pharmacotherapy):
The following tables give an overview of 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 must be as low as possible. In particular cases (e.g. West syndrome) it may
deviate from this recommendation.

Dose reduction
Once the desired clinical effect is achieved and depending on the underlying disease, the dose reduction begins.
In case of distribution of the daily dose into multiple single doses, the evening dose is reduced first, then
the possible midday dose. The dose is first reduced with larger decreases, starting from about
30 mg/day and subsequently with smaller decreases (see table below). The duration of treatment
is guided by the course of the disease. As soon as a satisfactory result of the
treatment is achieved, the dose is reduced to a maintenance dose or the treatment is discontinued. For this, the
doctor establishes a treatment scheme, which must be respected. The following indicative 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 decrease.
In case of thyroid insufficiency or liver 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 SOFLON is too strong or too
weak.

Dosage scheme “e” (DS: e)

Generally SOFLON is used as a single dose without gradual decrease 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 SOFLON than you should
In general SOFLON is well tolerated even in case of taking large quantities in a short time.
Therefore, no particular measures are necessary. If you should notice an increase in side effects, contact your doctor.

If you forget to take SOFLON
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 SOFLON
Always follow the dosage scheme prescribed by the doctor. Do not suddenly stop taking
SOFLON. If you stop treatment with SOFLON, 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 everybody gets them.
The frequency and severity of the side effects listed below depend on the dosage and duration of
treatment.

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

Treatment of specific diseases with higher 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 rashes), severe anaphylactic reactions such as disturbances of the
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 formation of edema, potassium deficiency due to increased elimination of
potassium, increased appetite.

Psychiatric disorders
Depression, irritability, euphoria, increased desire, psychosis, mania, hallucinations, emotional lability, anxiety,
sleep disturbances, suicidal tendency

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 (lens opacity), increased intraocular 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 a withdrawal syndrome following long-term therapy), increased fragility of the vessels.

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

Skin and subcutaneous tissue disorders
Stretch marks (Striae rubrae), skin atrophy, dilation of skin vessels (telangiectasias), tendency
to bruise, pinpoint or flat skin hemorrhages, increased body hair, acne, inflammatory 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
Disorders of the secretion of sex hormones that can cause absence of menstruation (amenorrhea),
distribution of hair in typically male areas in women (hirsutism), impotence.

Systemic disorders and conditions related to the site of administration
Delayed wound healing
Immediately inform your doctor if you experience gastrointestinal disorders, back pain, shoulder pain or
hip joint pain, mental changes, fluctuations in blood sugar in diabetics or other disorders.

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

5. How to store SOFLON

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

6. Contents of the pack and other information

What SOFLON contains
The active ingredient is prednisone.
One SOFLON 5 mg tablet contains 5 mg of prednisone.
One SOFLON 20 mg tablet contains 20 mg of prednisone.
One SOFLON 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 SOFLON and contents of the pack
SOFLON is available in the form of 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
S.F. Group Srl – via Tiburtina, 1143 – 00156 Roma

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

This leaflet was last approved on: