Package leaflet: Information for the user

Predasol, 25 mg, powder and solvent for solution for injection/infusion
Prednisoloni hemisuccinas
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

What Predasol is and what it is used for
Important information before using Predasol
How to use Predasol
Possible side effects
How to store Predasol
Contents of the pack and other information

1. What Predasol is and what it is used for

Predasol is a glucocorticoid (corticosteroid) affecting metabolism, electrolyte balance, and tissue function.
Predasol is indicated in the following conditions:

Shock caused by severe allergic reaction (anaphylactic shock) (after prior administration of adrenaline, a drug acting on the cardiovascular system);
Pulmonary oedema caused by inhalation of toxic substances such as chlorine, isocyanates, hydrogen sulfide, phosgene, nitrogen, ozone, as well as aspiration of gastric juice or following near-drowning;
Severe acute asthma attack;
Cerebral oedema caused by brain tumour, neurosurgical procedures, brain abscess, or bacterial meningitis;
Risk of organ rejection following kidney transplantation;
Initial treatment of extensive, acute, severe skin diseases such as erythroderma, pemphigus vulgaris, acute exanthema;
Acute blood disorders (autoimmune haemolytic anaemia, acute idiopathic thrombocytopenic purpura);
Postpericardiotomy syndrome (Dressler's syndrome: chest pain with fever and inflammatory signs), in cases of severe or recurrent symptoms, from the 5th week after myocardial infarction and when other drugs are insufficiently effective;
Severe infectious diseases with sepsis-like conditions (e.g. in tuberculosis, typhoid fever), only in conjunction with appropriate concomitant antimicrobial therapy;
Absent or reduced function of the adrenal cortex (adrenal insufficiency): adrenal crisis;
Pseudocroup (inflammation of the upper airways with respiratory distress and severe cough).

2. Important information before using Predasol

When not to use Predasol:

if the patient is allergic to prednisolone or prednisolone sodium metabisulfite, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Predasol, discuss this with your doctor, pharmacist, or nurse if:

the patient suffers from scleroderma (an autoimmune disorder also known as systemic sclerosis), because doses of at least 15 mg per day may increase the risk of a serious complication called scleroderma renal crisis. Symptoms of scleroderma renal crisis include elevated blood pressure and reduced urine output. The treating physician may recommend regular monitoring of blood pressure and urine excretion.

In isolated cases, severe hypersensitivity reactions (anaphylactic reactions) with circulatory failure, cardiac arrest, arrhythmias, dyspnoea (bronchospasm), and/or decreased or increased blood pressure have been observed during treatment with Predasol.
Due to suppression of the body's immune system function, Predasol may lead to an increased risk of bacterial, viral, parasitic, opportunistic, and fungal infections. Treatment with Predasol may mask symptoms of coexisting or developing infections, thereby complicating diagnosis. Latent infections may become reactivated.
The physician will initiate additional targeted antimicrobial therapy if any of the following conditions are present:

acute viral infections (viral hepatitis B, chickenpox, shingles, herpes, herpes keratitis);
chronic active viral hepatitis with a positive HBsAg test result (infectious liver disease);
within approximately 8 weeks before to 2 weeks after vaccination with live attenuated microorganisms (live vaccines);
fungal infections involving internal organs;
certain parasitic diseases (e.g., caused by amoebae, nematodes);
in patients with suspected or confirmed strongyloidiasis (intestinal threadworm infection), Predasol may lead to activation and significant proliferation of parasites;
Heine-Medin disease (poliomyelitis);
swollen lymph nodes after tuberculosis vaccination;
acute and chronic bacterial infections;
in patients with a history of tuberculosis – use only with antituberculosis medications.

Additionally, during treatment with Predasol, the physician should monitor and appropriately treat the following conditions:

gastric and intestinal ulcers;
bone atrophy (osteoporosis);
severe heart failure;
difficult-to-control arterial hypertension;
difficult-to-control diabetes;
psychiatric disorders (including those with a history), including suicide risk. In such cases, supervision by a neurologist or psychiatrist is recommended;
increased intraocular pressure (narrow- and wide-angle glaucoma) – ophthalmological monitoring and concomitant treatment are recommended;
corneal damage and ulcers – ophthalmological monitoring and concomitant treatment are recommended.

Treatment with this medicine may cause a so-called crisis in pheochromocytoma (Pheochromocytoma crisis), which may be fatal. Pheochromocytoma is a rare hormone-dependent adrenal gland tumour. A crisis may present with headache, excessive sweating, palpitations, and elevated arterial pressure. If any of these symptoms occur, the patient should contact a doctor immediately.
Before starting treatment with Predasol, discuss with a doctor if there is suspicion of or a diagnosed pheochromocytoma (adrenal gland tumour).
Due to the risk of intestinal perforation, Predasol should only be used when there are strong medical indications and under appropriate supervision in the following cases:

severe intestinal inflammation (ulcerative colitis) with risk of perforation, with abscesses or purulent inflammation, possibly even without peritoneal irritation;
diverticulitis;
immediately after certain intestinal surgeries (intestinal anastomoses).

In patients receiving high doses of glucocorticosteroids, symptoms of peritonitis following gastrointestinal perforation may not be apparent.
The risk of tendon disorders, tendonitis, and tendon rupture is increased when fluoroquinolones (a certain group of antibiotics) are administered concomitantly with Predasol.
Viral diseases (e.g., chickenpox, measles) may have a particularly severe course in patients treated with Predasol. The most vulnerable are immunocompromised patients who have not previously had chickenpox or measles. If such patients on Predasol have contact with individuals suffering from measles or chickenpox, they should contact their doctor immediately for appropriate prophylactic treatment.
In general, vaccinations using inactivated microorganism vaccines (inactivated vaccines) are permissible. However, it should be considered that vaccine efficacy may be reduced after administration of higher doses of Predasol.
Coexisting myasthenia (a form of muscle paralysis) may initially worsen during treatment with Predasol.
In isolated cases, during or after intravenous administration of a high dose of prednisolone, bradycardia (slow heart rate) may occur, not necessarily related to the rate or duration of drug administration.
During prolonged treatment with high doses of Predasol, adequate potassium intake (e.g., vegetables, bananas) should be ensured and salt intake limited. Serum potassium levels should be monitored under medical supervision.
If physically stressful situations occur during treatment, such as illness with fever, accident, childbirth, or surgery, temporary increases in the daily corticosteroid dose may be necessary.
Severe anaphylactic reactions (immune system overreaction) may occur.
When discontinuing or interrupting long-term glucocorticosteroid therapy, the risk of the following conditions should be considered: exacerbation or recurrence of the underlying disease, acute adrenal insufficiency, or cortisone withdrawal syndrome.
If blurred vision or other visual disturbances occur during treatment, contact a doctor.

Children and adolescents
During the growth phase of children, the benefit-risk ratio of using Predasol should be carefully evaluated.

Elderly patients
Since elderly patients are at higher risk of osteoporosis (bone loss), the benefit-risk ratio of using Predasol should be carefully evaluated.

Improper use of the medicine as doping
Use of Predasol may lead to positive results in anti-doping controls. The health consequences of using Predasol as a doping agent cannot be predicted. Serious health risks cannot be excluded.

Predasol and other medicines
Inform your doctor about all medicines currently used, recently used, or planned for use, including those available without a prescription.

Effect on the action of Predasol
Increased effect or possible increased adverse effects

Certain female sex hormones, e.g., those used in contraceptives ("the pill"), may enhance corticosteroid effects.
Some medicines may enhance the effect of Predasol, and the doctor may wish to closely monitor the patient taking such medicines (including certain HIV medications: ritonavir, cobicistat).
Medicines that slow metabolism in the liver, such as certain antifungal drugs (containing ketoconazole, itraconazole), may increase corticosteroid effects.

Reduced effect

Medicines that accelerate liver metabolism, such as certain sedatives (barbiturates), anticonvulsants (containing phenytoin, carbamazepine, primidone), and certain tuberculosis medications (containing rifampicin), may reduce corticosteroid effects.
Ephedrine (may be present in medications for low blood pressure, chronic bronchitis, asthma attacks, rhinitis, or as an ingredient in appetite suppressants): the effectiveness of Predasol may be reduced due to accelerated metabolism in the body.

Effect of Predasol on other medicines
Increased effect or possible increased adverse effects
Predasol may:

increase the risk of blood morphology changes when used concomitantly with certain antihypertensive drugs (angiotensin-converting enzyme inhibitors).
enhance the effect of cardiac medications (cardiac glycosides) due to potassium deficiency.
increase potassium loss caused by diuretics and laxatives.
increase the risk of gastric ulcers and gastrointestinal bleeding when used concomitantly with anti-inflammatory drugs (containing salicylates, indomethacin, or other nonsteroidal anti-inflammatory drugs).
prolong the muscle-relaxing effect of certain non-depolarizing neuromuscular blocking agents.
enhance the effect of certain drugs (atropine and other anticholinergics) that increase intraocular pressure.
increase the risk of muscle disease (myopathy) and heart muscle disease (cardiomyopathy) when taken concomitantly with antimalarial and rheumatic disease drugs (containing chloroquine, hydroxychloroquine, mefloquine).
increase blood cyclosporine levels (an immunosuppressive drug) and thereby increase the risk of seizures.

Concomitant use of Predasol with immunosuppressive drugs may increase susceptibility to infections and may exacerbate or trigger symptoms of previously undiagnosed infections.
Fluoroquinolones – a certain group of antibiotics – may increase the risk of tendon damage.

Reduced effect
Predasol may:

reduce the glucose-lowering effect of oral antidiabetic drugs and insulin.
reduce the effectiveness of antiparasitic drugs (containing praziquantel).
reduce the effect of growth hormone (somatropin).
reduce the effect of thyrotropin-releasing hormone (TRH) on increasing thyroid-stimulating hormone (TSH) levels.

Increased or reduced effect
Predasol may decrease or increase the effect of anticoagulant drugs (oral anticoagulants, coumarin derivatives). The doctor will decide whether dose adjustment of the anticoagulant is necessary.

Effect on laboratory test results
Skin reactions in allergy tests may be suppressed.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
During pregnancy, this medicine should only be used on medical advice. Therefore, if the patient is pregnant, she should inform her doctor. Prolonged use of Predasol during pregnancy may lead to impaired fetal growth. If Predasol is used towards the end of pregnancy, the newborn may develop adrenal insufficiency, which may require substitution therapy with gradual dose reduction. Animal studies have shown that prednisolone has harmful effects on fetuses (e.g., cleft palate). There are reports suggesting an increased risk of such malformations in humans following prednisolone administration during the first three months of pregnancy.

Breastfeeding
The active substance – prednisolone – passes into breast milk. So far, no disturbances in infants have been reported. Nevertheless, the necessity of using the medicine during breastfeeding should be carefully considered. If higher doses are required due to the underlying disease, breastfeeding should be discontinued. Contact a doctor immediately.

Driving and operating machinery
Currently, there is no data indicating that Predasol affects the ability to drive vehicles or operate machinery. The same applies to working without safety protection.

Predasol contains sodium
The medicine contains 2.39 mg of sodium (the main component of table salt) per ampoule. This corresponds to 0.12% of the maximum recommended daily sodium intake in the adult diet.
The medicine can be mixed with the following solutions: 5% glucose solution, 0.9% sodium chloride solution, or Ringer's solution. The sodium content originating from the diluent should be considered when calculating the total sodium content in the prepared dilution. For precise information on the sodium content of the solution used for dilution, refer to the leaflet of the diluent used.

3. How to use Predasol

Predasol will be administered by qualified medical personnel. If in doubt, consult your
doctor or pharmacist.
Generally, the doctor follows these dosage guidelines:

Anaphylactic shock (after prior adrenaline injection)
After intravenous injection of adrenaline (1.0 ml of standard 1:1000 adrenaline solution diluted to 10 ml with physiological saline or blood, slowly injected under strict medical supervision; warning: cardiac arrhythmias), administer 1000 mg of prednisolone intravenously (250 mg in children) via an established venflon, followed by fluid replacement and, if necessary, artificial ventilation. Adrenaline and prednisolone injections may be repeated if needed. Do not administer calcium preparations or digitalis together with adrenaline.

Pulmonary edema caused by inhalation of toxic substances, following aspiration of gastric juice, or due to drowning
Initial dose: 1000 mg prednisolone intravenously in adults (in children, 10–15 mg/kg body weight). Repeat after 6, 12, and 24 hours if necessary. Then, for the next 2 days, 150 mg daily, followed by 75 mg prednisolone daily for another 2 days, given in divided doses intravenously (in children, correspondingly 2 mg/kg body weight and 1 mg/kg body weight). Then gradually discontinue the drug, switching to inhaled therapy.

Severe acute asthma attack
Initial dose in adults: 100–500 mg prednisolone intravenously, followed by further treatment with the same or lower doses approximately every 6 hours, then slowly reduce to maintenance dose. In children, initially administer 2 mg prednisolone/kg body weight intravenously, then doses of 1–2 mg/kg body weight every 6 hours until improvement. Concomitant administration of bronchodilators is recommended.

Prophylaxis or treatment of cerebral edema
Initial dose: 250–1000 mg prednisolone intravenously (if dexamethasone phosphate cannot be used as initial parenteral treatment), followed by treatment with 8–16 mg dexamethasone phosphate intravenously at 2- to 6-hour intervals.

Risk of kidney transplant rejection
In addition to basic therapy, administer 1000 mg prednisolone as intravenous pulses, depending on severity, for 3 to 7 consecutive days.

Severe skin diseases and acute blood disorders
40–250 mg prednisolone intravenously; in individual cases, up to 400 mg per day.

Dressler's syndrome (post-cardiac injury syndrome)
50 mg prednisolone intravenously per day, then carefully reduce the dose.

Severe infectious diseases (e.g., tuberculosis, typhoid fever)
100–500 mg prednisolone per day intravenously (together with antibiotic therapy).

Adrenal crisis
Initial dose: 25–50 mg prednisolone intravenously; if necessary, continue treatment orally with prednisone or prednisolone, possibly combined with a mineralocorticosteroid as needed.

Pseudocroup
Severe forms: immediately 3–5 mg/kg body weight intravenously; if necessary, repeat dose after 2–3 hours.

Method of administration
Predasol is administered by qualified medical personnel into a vein (intravenous injection) or as an infusion (drip).
The drug may be given either as a direct intravenous injection or as an infusion; however, direct intravenous injection is the preferred method of administration.
The ready-to-use injection solution is for single use only. The medicine should be administered immediately after opening the vial. Any unused portion of the solution must be discarded.
To prepare the ready-to-administer injection solution, inject the provided solvent (water for injections) into the vial containing the powder immediately before use, and rotate the vial until the powder is completely dissolved.

Compatibility with infusion fluids
The prepared injection solution is stable for at least 6 hours at room temperature when prepared using the following standard infusion solutions:

5% glucose solution
0.9% sodium chloride solution
Ringer's solution.

When preparing an infusion, dissolve the drug first according to the above instructions, then mix aseptically (under microorganism-free conditions) with one of the listed infusion solutions.
When mixing with infusion solutions, follow the individual manufacturers' information regarding their infusion solutions, concerning compatibility, contraindications, adverse effects, and interactions.
Do not mix Predasol with other medicines.
Parenteral medicines should be inspected visually before use. Only clear solutions without visible particles should be used.

Use of a higher than recommended dose of Predasol
Predasol is generally well tolerated, even with short-term use of high doses. No special measures are required. If severe or unusual adverse effects occur in the patient, consult a doctor.

Missed dose of Predasol
A missed dose may be administered during the same day, and treatment should continue with the dose prescribed by the doctor at the usual time the next day. If several doses are missed, the treated disease may recur or worsen. In such cases, consult a doctor, who will evaluate the treatment and adjust it if necessary.

Stopping Predasol treatment
Always follow the dosing regimen prescribed by the doctor. Never stop using Predasol without consulting a doctor, as prolonged use of Predasol may suppress the body's natural production of glucocorticosteroids. In such cases, significant physical stress may pose a life-threatening risk (adrenal crisis).

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur, which largely depend on the dose and duration of treatment,
and for which it is therefore not possible to determine the frequency of occurrence:

Infections and parasitic infections
Masking of infections, occurrence, worsening or recurrence of viral, fungal, bacterial,
as well as parasitic and opportunistic infections, reactivation of intestinal tuberculosis (intestinal schistosomiasis).

Blood and lymphatic system disorders
Changes in blood morphology (increase in white blood cells or all blood cells, decrease in a certain type of white blood cells).

Immune system disorders
Hypersensitivity reactions (e.g. drug rash), severe anaphylactic reactions such as cardiac arrhythmia, bronchospasm (constriction of smooth muscles in the bronchi), low or high blood pressure, circulatory collapse, myocardial infarction, immunosuppression.

Endocrine disorders
Induction of Cushing's syndrome (typical symptoms: large, round face – "moon face", central obesity and facial redness), suppression or reduced function of the adrenal cortex.

Metabolism and nutrition disorders
Weight gain, increased blood glucose levels, diabetes, increased blood lipid levels (cholesterol and triglycerides), fluid retention, potassium deficiency due to increased potassium excretion, increased appetite, temporary deposition of fatty tissue in various parts of the body (in the spinal canal [epidural space] or chest cavity [pericardial, mediastinal space]).

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

Nervous system disorders
Increased intracranial pressure, emergence of symptoms of latent epilepsy, increased susceptibility to seizures in epilepsy.

Eye disorders
Cataract, increased intraocular pressure (glaucoma), worsening of corneal ulceration, exacerbation of viral, fungal and bacterial eye infections, blurred vision.

Cardiac disorders
Bradycardia (slow heart rate).

Vascular disorders
Hypertension, increased risk of atherosclerosis and thrombosis, vasculitis (also as a withdrawal syndrome after long-term treatment), increased capillary fragility.

Gastrointestinal disorders
Peptic ulcers of the stomach and intestines, gastrointestinal bleeding, pancreatitis.

Skin and subcutaneous tissue disorders
Striae, skin thinning ("parchment skin"), dilated blood vessels, tendency to bruising, petechiae or superficial skin hemorrhages, acne, inflammatory skin conditions of the face, particularly around the mouth, nose, and eyes.

Musculoskeletal and connective tissue disorders
Muscle disorders, muscle weakness, muscle atrophy, bone loss (osteoporosis) which occurs depending on the dose and may also occur during short-term use, other forms of bone degeneration (bone necrosis), tendon disorders, tendonitis, tendon rupture, growth suppression in children.

Renal and urinary disorders
Scleroderma renal crisis in patients with scleroderma (an autoimmune disorder). Symptoms of scleroderma renal crisis include elevated blood pressure and reduced urine output.

Reproductive system and breast disorders
Disorders of sex hormone secretion (resulting in absence of menstrual bleeding, male-pattern body hair growth in women – hirsutism, impotence).

General disorders and administration site conditions
Delayed wound healing.

If any of the adverse reactions listed above occur, or any other adverse reaction during treatment with Predasol, consult a doctor or pharmacist. Never discontinue treatment without consulting a doctor.

In case of gastrointestinal symptoms, back, shoulder or hip joint pain, psychiatric disturbances, noticeable fluctuations in blood glucose levels (in diabetic patients), or other disturbances, contact a doctor immediately.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.

Reporting adverse reactions helps to gather more information on the safety of the medicine.

5. How to store Predasol

Keep the medicine out of the sight and reach of children.
There are no special requirements regarding the storage temperature of the medicinal product.
Store the vial containing the powder in the outer packaging to protect it from light.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the stated month.
Expiry date after first opening or reconstitution
The ready-to-use injection solution is intended for single use only. The medicine should be administered immediately after opening the vial. Any unused portion of the solution must be discarded.
In the case of infusion, solutions containing 1 g of prednisolone sodium metasulfobenzoate in 250 ml or 1 g in 500 ml, prepared by dissolving the powder in solvent and subsequently diluted with 5% glucose solution, 0.9% sodium chloride solution or Ringer's solution, should be administered within 6 hours.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Predasol contains

The active substance is sodium prednisolone succinate. One vial of powder contains sodium prednisolone succinate equivalent to 25 mg of prednisolone hydrogen succinate, corresponding to 19.6 mg of prednisolone.
Other ingredients: sodium hydrogen carbonate, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate.

One vial of solvent contains 2 ml of water for injections.

What Predasol looks like and contents of the pack
Predasol consists of a white to cream or yellow powder and a clear, colourless solvent.
Predasol is available in packs containing:
1 vial of powder for solution for injection/infusion and 1 vial of solvent containing 2 ml of water for injections,
3 vials of powder for solution for injection/infusion and 3 vials of solvent containing 2 ml of water for injections each.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki
tel. +48 22 350 66 69

Manufacturer
mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany