Package leaflet: Information for the user

Predasol, 1000 mg, powder and solvent for solution for injection/infusion
Prednisoloni hemisuccinas
Please read all of this leaflet carefully before use, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any further questions, please consult 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 package 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 used in the following conditions:

Shock caused by severe allergic reaction (anaphylactic shock) (after prior administration of adrenaline – a drug affecting the cardiovascular system);
Pulmonary edema caused by inhalation of toxic substances such as chlorine, isocyanates, hydrogen sulfide, phosgene, nitrogen, ozone, as well as by aspiration of gastric juice into the lungs or following near-drowning;
Severe acute asthma attack;
Cerebral edema caused by brain tumour, neurosurgical procedures, brain abscess, or bacterial meningitis;
Risk of organ rejection after kidney transplantation;
Initial treatment of extensive, acute, severe skin diseases such as erythroderma, pemphigus vulgaris, acute exanthema;
Acute blood disorders (autoimmune hemolytic anemia, acute idiopathic thrombocytopenic purpura);
Postpericardiotomy syndrome (Dressler's syndrome: chest pain with fever and inflammatory signs) in severe or recurrent cases, 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 additional antimicrobial therapy;
Absent or reduced function of the adrenal cortex (adrenal insufficiency): adrenal crisis;
Pseudocroup (inflammation of the airways with dyspnea and severe cough).

2. Important information before using Predasol

When not to use Predasol:

if the patient is allergic to prednisolone or prednisolone sodium metasulfobenzoate, 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.

Severe hypersensitivity reactions (anaphylactic reactions) with circulatory failure, cardiac arrest, arrhythmias, dyspnea (bronchospasm), and/or decreased or increased blood pressure have been observed in isolated cases during treatment with Predasol.
Due to suppression of 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 making diagnosis more difficult. It may also lead to reactivation of latent infections.
The physician will initiate additional targeted antimicrobial therapy if any of the following conditions are present concurrently:

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

Additionally, during treatment with Predasol, the physician will 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 in the patient's 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 targeted treatment are recommended;
corneal damage and ulcers – ophthalmological monitoring and concomitant targeted 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 tumor. A pheochromocytoma crisis may manifest as headache, excessive sweating, palpitations, and elevated arterial blood pressure. If any of these symptoms occur, the patient should contact a physician immediately.
Before starting treatment with Predasol, discuss this with your doctor if pheochromocytoma (an adrenal gland tumor) is suspected or has been diagnosed.
Due to the risk of intestinal perforation, Predasol may 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 suppurative 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 receiving Predasol. Patients with weakened immune systems who have never had chickenpox or measles are at highest risk. If such patients receiving Predasol come into contact with individuals suffering from measles or chickenpox, they should contact their doctor immediately for appropriate prophylactic treatment.
In general, vaccinations using inactivated vaccines (containing killed microorganisms) are permissible. However, it should be noted 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, bradycardia (slow heart rate) may occur during or after intravenous administration of a high dose of prednisolone, regardless of the rate or duration of infusion.
During prolonged treatment with high doses of Predasol, an adequate intake of potassium (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 febrile illness, 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, and cortisone withdrawal syndrome.
If blurred vision or other visual disturbances occur during treatment, contact your doctor.

Children and adolescents
During periods of growth in 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 drug 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 ruled out.

Predasol and other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines planned for future 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 contraceptive drugs ("the pill"), may enhance the effects of corticosteroids.
Some drugs may enhance the effect of Predasol, and the physician may wish to closely monitor the patient taking such drugs (including certain HIV medications: ritonavir, cobicistat).
Drugs that inhibit liver metabolism, such as certain antifungal agents (containing ketoconazole, itraconazole), may increase corticosteroid effects.

Reduced effect

Drugs that accelerate liver metabolism, such as certain sedatives (barbiturates), anticonvulsants (containing phenytoin, carbamazepine, primidone), and certain anti-tuberculosis drugs (containing rifampicin), may reduce corticosteroid effects.
Ephedrine (may be present in drugs used to treat 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 count abnormalities when used concomitantly with certain antihypertensive drugs (angiotensin-converting enzyme inhibitors).
enhance the effects of cardiac glycosides (heart medications) 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 non-steroidal anti-inflammatory drugs).
prolong the muscle-relaxing effect of certain non-depolarizing neuromuscular blocking agents.
enhance the effects 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 drugs used to treat malaria and rheumatic diseases (containing chloroquine, hydroxychloroquine, mefloquine).
increase blood levels of cyclosporine (an immunosuppressive drug) and thereby increase the risk of seizures.

Concomitant use of Predasol with immunosuppressive drugs (drugs that reduce immune system function) 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 protirelin (TRH – a hormone produced by the brain) in increasing thyrotropin (TSH) levels.

Increased or reduced effect
Predasol may decrease or increase the effect of oral anticoagulants (coumarin derivatives). The physician will decide whether dosage 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 her doctor or pharmacist before using this medicine.

Pregnancy
Predasol should only be used during pregnancy if prescribed by a doctor. 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. No adverse effects in infants have been reported to date. Nevertheless, the necessity of using the drug during breastfeeding should be carefully considered. If higher doses are required due to the underlying disease, breastfeeding should be discontinued. Contact your doctor immediately.

Driving and operating machinery
There are currently no data indicating that Predasol affects the ability to drive or operate machinery. The same applies to working at heights without safety protection.

Predasol contains sodium
The medicine contains 59.11 mg of sodium (the main component of table salt) per vial. This corresponds to 3% of the maximum recommended daily sodium intake in the diet of adults.
The product may 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 taken into account when calculating the total sodium content in the prepared dilution. For precise information on sodium content in the solution used to dilute the medicine, 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
physician or pharmacist.
Generally, the physician follows the dosage guidelines below:

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 as required 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 as 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 to 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 intravenous doses (in children, 2 mg/kg body weight and 1 mg/kg body weight, respectively). Then gradually discontinue the drug, switching to inhaled therapy.

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

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

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

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

Post-pericardiotomy syndrome (Dressler's syndrome)
50 mg prednisolone intravenously per day, then cautiously reduce the dose.

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

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

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

Method of administration
Predasol is administered by qualified medical personnel into a vein (intravenous injection) or as an infusion.
The medicine may be given as a direct intravenous injection or as an infusion, but direct intravenous injection is the preferred method.
The ready-to-use injection solution is for single use only. Any unused portion must be discarded.
The medicine should be administered immediately after opening the vial. In exceptional cases, the prepared injection solution may be stored for up to 24 hours at 2–8°C (see section 5).
To prepare the ready-to-administer injection solution, inject the supplied solvent (water for injection) into the vial containing the powder immediately before use, and mix the contents until the powder is completely dissolved.

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

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

When preparing an infusion, dissolve the medicine first according to the above instructions, then aseptically mix it 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.
Predasol must not be mixed with other medicines.
Parenteral medicines should be inspected visually before administration. Only clear solutions free from visible particles should be used.

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

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

Discontinuation of Predasol
Always follow the dosing regimen prescribed by the physician. Never discontinue Predasol without consulting a physician, as prolonged use of Predasol may suppress the body's natural production of glucocorticosteroids. In such cases, significant physical stress may lead to life-threatening adrenal crisis.

If you have any further doubts regarding the use of this medicine, consult your physician, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following side effects may occur, which largely depend on the dose and duration of treatment, and
therefore their frequency cannot be estimated:

Infections and parasitic infections
Masking of infections, occurrence, worsening, or recurrence of viral, fungal, bacterial, and parasitic
infections, as well as opportunistic infections; activation of intestinal tuberculosis.

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 (contraction of smooth muscles in the bronchi), decreased or increased blood pressure,
circulatory collapse, myocardial infarction, immunosuppression.

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

Metabolism and nutrition disorders
Increased body weight, increased blood glucose concentration, 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 (including as a withdrawal
syndrome after long-term treatment), increased capillary fragility.

Gastrointestinal disorders
Gastric and intestinal ulcers, 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 (osteonecrosis),
tendon disorders, tendonitis, tendon rupture, growth retardation 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 production.

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

General disorders and administration site conditions
Delayed wound healing.

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

Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Predasol

The medicine should be stored out of 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 its original 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
For microbiological reasons, the prepared injection solution is intended for immediate use. If the product is not used immediately, the user is responsible for the storage duration and conditions. In exceptional cases, the ready-to-use injection solution may be stored for up to 24 hours at 2–8°C.
Vials are not suitable for reuse. Any unused portion of the solution must be discarded.
For infusion purposes, 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. Such measures will help protect the environment.

6. Contents of the pack and other information

What Predasol contains

The active substance is prednisolone sodium metasulfobenzoate. One vial of powder contains prednisolone sodium metasulfobenzoate equivalent to 1000 mg of prednisolone metasulfobenzoate sodium, corresponding to 782.7 mg of prednisolone.
Other ingredients: sodium hydrogen carbonate, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate.

One ampoule of solvent contains 10 ml of water for injections.
What Predasol looks like and contents of the pack
Predasol consists of white to creamy 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 ampoule of solvent containing 10 ml of water for injections.
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