Prednisone Pensà: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

Prednisone Pensa 5 mg tablets, 20 mg tablets, 25 mg tablets

Prednisone
Generic medicine
Please 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 others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Prednisone Pensa is and what it is used for
What you need to know before taking Prednisone Pensa
How to take Prednisone Pensa
Possible side effects
How to store Prednisone Pensa
Contents of the pack and other information

1. What Prednisone Pensa is and what it is used for

Prednisone Pensa is a glucocorticoid (a hormone produced by the adrenal glands) that affects
metabolism, electrolyte balance (salts), and tissue function.
Prednisone Pensa 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 Prednisone Pensa”).
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).
Stress conditions 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 high-dose intravenous glucocorticoid therapy 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 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)
- Active rheumatoid arthritis (SD: from a to d) with severely progressive course, e.g. rapidly destructive forms (SD: a) or extra-articular forms (SD: b)
- Other inflammatory rheumatic arthritides, when clinical severity warrants it and non-steroidal anti-inflammatory drugs (NSAIDs) cannot be used:
Spondyloarthritides (ankylosing spondylitis involving peripheral joints (SD: b, c), psoriatic arthritis (SD: c, d), enteropathic arthropathy with high inflammatory activity (SD: a)
Reactive arthritides (SD: c)
Arthritis in sarcoidosis (initially SD: b)
- Carditis in rheumatic fever, in severe cases over 2–3 months (SD: a)
- Juvenile idiopathic arthritis with severe systemic form (Still's syndrome) or with iridocyclitis when local treatment is ineffective (SD: a)

Bronchial and pulmonary disorders:

Bronchial asthma (SD: from c to a); bronchodilators should be administered concomitantly
Acute exacerbation of chronic obstructive pulmonary disease (COPD) (SD: b); recommended treatment duration up to 10 days
Interstitial lung diseases such as acute alveolitis (SD: b), 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 forms of sarcoidosis in stages II and III (in case of dyspnea, cough, and worsening pulmonary function values) (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 failure of intranasal glucocorticoid administration (SD: c)
Acute stenosis of larynx and trachea: Quincke's edema, subglottic obstructive laryngitis (pseudocroup) (SD: from b to a)

Skin diseases:
Skin and mucous membrane disorders that cannot be treated or cannot be adequately
treated with topical glucocorticoids due to their severity and/or extent or systemic involvement.
These include:

Allergic, pseudo-allergic, and allergo-infectious diseases: e.g. acute urticaria, anaphylactoid reactions, drug exanthema, erythema multiforme, toxic epidermal necrolysis (Lyell's syndrome), generalized acute pustulosis, acute febrile neutrophilic dermatosis (Sweet's syndrome), allergic contact dermatitis (SD: from b to a)
Eczematous diseases: e.g. atopic eczema, contact eczema, microbial (nummular) eczema (SD: from b to a)
Granulomatous diseases: e.g. sarcoidosis, granulomatous cheilitis (monosymptomatic Melkersson-Rosenthal syndrome) (SD: from b to a)
Bullous dermatoses: e.g. pemphigus vulgaris, bullous pemphigoid, benign mucous membrane pemphigoid, linear IgA dermatosis (SD: from b to a)
Vasculitides: e.g. allergic vasculitis, polyarteritis nodosa (SD: from b to a)
Autoimmune diseases: e.g. dermatomyositis, systemic scleroderma (indurative phase), chronic and subacute cutaneous lupus erythematosus (SD: from b to a)
Gestational dermatoses (see also section 4.6): e.g. herpes gestationis, herpetiform impetigo (SD: from d to a)
Erythematous-squamous dermatoses: e.g. pustular psoriasis, pityriasis rubra pilaris, parapsoriasis group (SD: from c to a)
Erythroderma, including Sézary syndrome (SD: from c to a)
Other disorders: e.g. Jarisch-Herxheimer reaction during penicillin treatment of syphilis, rapidly growing and enlarging cavernous hemangioma, Behçet's disease, pyoderma gangrenosum, eosinophilic fasciitis, exanthematous lichen ruber, hereditary bullous epidermolysis (SD: from c to a)

Blood disorders/cancer diseases:

Autoimmune hemolytic anemia (SD: from c to a), idiopathic thrombocytopenic purpura (Werlhof's disease) (SD: a), acute intermittent thrombocytopenia (SD: a)
Acute lymphoblastic leukemia, Hodgkin's disease, non-Hodgkin lymphoma, chronic lymphocytic leukemia, Waldenström's disease, multiple myeloma (SD: e)
Hypercalcemia in underlying malignant neoplasms (SD: from c to a)
Prophylaxis and treatment of cytostatic-induced vomiting (SD: from b to a), use in antiemetic regimens
Palliative therapy of malignant diseases
Note: prednisone may be used to relieve symptoms, e.g. loss of appetite, anorexia, and general weakness in advanced malignant neoplasms, after specific therapeutic options have been exhausted. For further details, consult current medical literature.

Nervous system disorders:

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)
West syndrome (infantile spasms)

Specific courses of infectious diseases:

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

Eye 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, anterior ischemic optic neuropathy (AION), traumatic optic neuropathy), Behçet's disease, sarcoidosis, endocrine orbitopathy, orbital pseudotumor, transplant rejection, and in some uveitides such as Harada's disease and sympathetic ophthalmia
Systemic administration is indicated only after unsuccessful local treatment in the following conditions: scleritis, episcleritis, keratitis, chronic cyclitis, uveitis, allergic conjunctivitis, alkali chemical burns, in combination with antimicrobial therapy in autoimmune or syphilis-associated interstitial keratitis, in herpes simplex stromal keratitis only if corneal epithelium 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)

Kidney disorders:

Minimal change glomerulonephritis (SD: a)
Proliferative-extracapillary glomerulonephritis (rapidly progressive glomerulonephritis) (SD: intermittent high-dose [pulse therapy], usually in combination with cytostatic agents); in Goodpasture's syndrome, reduce and discontinue treatment; in all other forms, long-term continuation of therapy (SD: d)
Idiopathic retroperitoneal fibrosis (SD: b)

2. What you should know before taking Prednisone Pensa

Do not take Prednisone Pensa
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 Prednisone Pensa.

Warnings and precautions
Talk to your doctor or pharmacist before taking Prednisone Pensa.
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 with elevated 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 Prednisone Pensa at high doses for hormone replacement therapy. You should take Prednisone Pensa only if your doctor considers it absolutely necessary.

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

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

acute viral infections (hepatitis B, chickenpox, shingles, herpes simplex infections, viral keratitis)
infectious inflammation of the liver (active chronic hepatitis B surface antigen-positive)
approximately 8 weeks before to 2 weeks after vaccination with live vaccines
fungal diseases affecting internal organs
certain diseases caused by parasites (amebic or worm infections)
in patients with suspected or confirmed infection by threadworms (strongyloides), Prednisone Pensa 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 medication)
acute and chronic bacterial infections

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

gastrointestinal ulcer
osteoporosis
poorly controllable high blood pressure
poorly controllable diabetes (diabetes mellitus)
psychiatric disorders (including history of 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, palpitations, and high blood pressure (hypertension). Contact your doctor immediately if you notice any of these signs.
Consult your doctor before taking Prednisone Pensa if you suspect or are known to have pheochromocytoma (adrenal gland tumor).

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

Contact your doctor if blurred vision or other visual disturbances occur.

Due to the risk of intestinal perforation, Prednisone Pensa may be taken only if your doctor considers it necessary and under close 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 following perforation of a gastrointestinal ulcer may be absent in patients receiving high doses of glucocorticoids.

The risk of tendon disorders, tendon inflammation, and tendon rupture is increased when fluorquinolones (a group of antibiotics) are administered concomitantly with Prednisone Pensa.

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.

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

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

Particularly if facial and pharyngeal symptoms are severe and breathing is impaired, treatment with Prednisone Pensa should be initiated gradually.

Long-term use of even low doses of prednisone increases the risk of infections, including those caused by microorganisms that rarely cause infections otherwise (so-called opportunistic infections).

Vaccinations with killed pathogens (inactivated vaccines) are generally possible. However, it should be noted that the effectiveness of vaccination may be impaired by high doses of Prednisone Pensa.

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

Regular medical check-ups (including ophthalmological examinations every three months) are required during long-term treatment with Prednisone Pensa.

During prolonged treatment with high doses of Prednisone Pensa, pay particular attention to adequate potassium intake (e.g., vegetables, bananas) and restricted salt intake. Your doctor may order blood tests to monitor your potassium levels.

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

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

Depending on the duration and dose of treatment, negative effects on calcium metabolism should be considered, and osteoporosis prevention is recommended. This is especially important in the presence of concomitant risk factors such as family predisposition, advanced age, inadequate 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 Prednisone Pensa, 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 with increased physical exertion), corticosteroid withdrawal syndrome.

Certain viral diseases (chickenpox, measles) may have a particularly severe course in patients treated with glucocorticoids. If you are immunosuppressed and have not had chickenpox or measles, and have been exposed to individuals with these diseases while being treated with Prednisone Pensa, preventive treatment may be necessary.

Children and adolescents
Prednisone Pensa should be used in children only when absolutely necessary and under medical supervision due to the risk of growth suppression, which should be monitored regularly. Treatment with Prednisone Pensa should be limited in duration or administered intermittently (e.g., alternate days with double dosage on active days [intermittent therapy]).

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

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

Other medicines and Prednisone Pensa
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 Prednisone Pensa:

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

Other effects of Prednisone Pensa

Due to potassium deficiency, Prednisone Pensa may enhance the effect of heart-strengthening medicines (cardiac glycosides).
Prednisone Pensa may increase potassium loss when used concomitantly with diuretics (saluretics) and laxatives.
Prednisone Pensa may reduce the blood sugar-lowering effect of oral antidiabetics and insulin.
Prednisone Pensa may decrease or increase the effect of anticoagulant medicines (oral anticoagulants, coumarin derivatives). Your doctor will decide whether adjustment of anticoagulant dose is necessary.
When used concomitantly with anti-inflammatory and rheumatic medicines (salicylates, indomethacin, and other NSAIDs), Prednisone Pensa may increase the risk of gastric ulcers and gastrointestinal bleeding.
Prednisone Pensa may prolong the muscle-relaxant effect of certain medicines (non-depolarizing muscle relaxants).
Prednisone Pensa may enhance the intraocular pressure-increasing effect of certain medicines (atropine and other anticholinergics).
Prednisone Pensa may reduce the effect of anti-helminthic medicines (praziquantel).
When used concomitantly with medicines for malaria or rheumatic diseases (chloroquine, hydroxychloroquine, mefloquine), Prednisone Pensa may increase the risk of muscle diseases or heart muscle diseases (myopathies, cardiomyopathies).
Growth hormones (somatotropin): their effect is particularly reduced by high doses of Prednisone Pensa.
Prednisone Pensa may reduce the increase in thyroid-stimulating hormone (TSH) following concomitant administration with protirelin (a diencephalic hormone).
Prednisone Pensa and concomitant use of immunosuppressive medicines may increase susceptibility to infections and worsen existing, possibly still unmanifested infections.
In addition to cyclosporine (an immunosuppressive medicine): Prednisone Pensa 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
During pregnancy, Prednisone Pensa should be taken only on medical advice. Inform your doctor if you become pregnant.
Long-term treatment with Prednisone Pensa during pregnancy may not exclude disturbances in fetal growth.
If Prednisone Pensa is taken towards 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 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 Prednisone Pensa during breastfeeding should be carefully evaluated. If higher doses are required due to the underlying disease, breastfeeding should be discontinued. Contact your doctor immediately.

Driving and using machines
There are currently no indications that Prednisone Pensa affects the ability to drive or use machinery.

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

3. How to take Prednisone Pensa

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 individual dose for you.
Follow the prescribed dosage instructions carefully, otherwise Prednisone Pensa may not have the desired 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 replacement hormone 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 additionally prescribe a 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	Dose in mg/day	Dose in mg/kg body weight/day
a) high	80 - 100 (250)	1.0 - 3.0
b) medium	40 - 80	0.5 - 1.0
c) low	10 - 40	0.25 - 0.5
d) very low	1.5 - 7.5 (10)	./.
e) combination chemotherapy, see dosing schedule "e" (SD: e)

In general, the entire daily dose is taken early in the morning between 6 and 8 a.m. High daily doses may be divided, depending on the disease, into 2–4 individual doses; medium doses into 2–3 individual doses.
Children

Dosage	Dose in mg/kg body weight/day
High	2 - 3
Medium	1 - 2
Maintenance dose	0.25

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. When the daily dose is divided into multiple individual doses, the evening dose should be reduced first, 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). Depending on the clinical situation, decisions are made regarding gradual dose reduction, either leading to discontinuation of treatment or to the need for a maintenance dose, based on the disease. The following indicative decrements may be used for dose reduction:

more than 30 mg daily	Reduce by	10 mg	every 2 - 5 days
from 30 to 15 mg daily	Reduce by	5 mg	every week
from 15 to 10 mg daily	Reduce by	2.5 mg	every 1 - 2 weeks
from 10 to 6 mg daily	Reduce by	1 mg	every 2 - 4 weeks
less than 6 mg daily	Reduce by	0.5 mg	every 4 - 8 weeks

High and very high doses, when administered for only a few days, may be discontinued depending on the underlying disease and clinical response, without the need for gradual tapering.

Dosing regimen “e” (DR: e)
Prednisone Pensa is generally used as a single dose without gradual reduction until the end of treatment. In chemotherapy, the following dosing regimens are recognized, for example:
In cases of thyroid insufficiency or hepatic cirrhosis, lower doses may be sufficient or dose reduction may be required.
Speak with your doctor or pharmacist if you feel that the effect of Prednisone Pensa is too strong or too weak.

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 Prednisone Pensa than you should
Prednisone Pensa is generally well tolerated without complications, even if large quantities are taken within a short period. Therefore, no special measures are usually required. However, if you notice an increase in adverse effects, contact your doctor.

If you forget to take Prednisone Pensa
Do not take a double dose to make up for the forgotten dose. Contact your doctor to determine how to proceed.

If you stop taking Prednisone Pensa
Always follow the dosing schedule prescribed by your doctor. Do not stop taking Prednisone Pensa abruptly. If you discontinue treatment with Prednisone Pensa, 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 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 will experience them.
The frequency and severity of the side effects listed below depend on the dosage and duration of treatment.

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

Treatment of specific diseases with higher dosages than those used in hormone replacement therapy:
The following dose- and duration-dependent side effects may occur; their frequency is unknown:

Infections and infestations
Masking of infections, onset, 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 parameters (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 include "moon face", weight gain in the upper 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 susceptibility to seizures in existing epilepsy.

Eye disorders
Lens opacity (cataract), increased intraocular pressure (glaucoma), worsening of corneal lesions, promotion of 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 dose and possible even with short-term use—other forms of bone deterioration (bone necrosis), tendon disorders, tendon inflammation, tendon ruptures, and fat deposition in the spine (epidural lipomatosis), growth inhibition 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 already suffering from scleroderma (an autoimmune disease).
Signs of 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 experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may 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 Prednisone Pensa

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 Prednisone Pensa contains
The active substance is prednisone.
One tablet of Prednisone Pensa 5 mg contains 5 mg of prednisone.
One tablet of Prednisone Pensa 20 mg contains 20 mg of prednisone.
One tablet of Prednisone Pensa 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 Prednisone Pensa and contents of the pack
Prednisone Pensa 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 sizes of 20 or 30 tablets of 20 mg.
Pack sizes of 10, 20 or 30 tablets of 25 mg.

Marketing Authorization Holder
Towa Pharmaceutical S.p.A., Via Enrico Tazzoli, 6 – 20154 Milan, Italy

Manufacturer
Genetic S.p.A., Via Della Monica n. 26, 84083 Castel San Giorgio (SA), Italy

This leaflet was last approved in: March 2026.