Package leaflet: Information for the user

Predasol, 250 mg, powder and solvent for solution for injection/infusion
Prednisoloni hemisuccinas
Please read all of this leaflet carefully before using this medicine, as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, 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 someone else 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) that affects metabolism, electrolyte balance, and tissue function.
Predasol is used in the following conditions:

Shock caused by a severe allergic reaction (anaphylactic shock) (after prior administration of adrenaline – a drug affecting the cardiovascular system);
Pulmonary edema caused by inhaling toxic substances such as chlorine, isocyanates, hydrogen sulfide, phosgene, nitrogen, ozone, as well as aspiration of gastric juice or near-drowning;
Severe acute asthma attack;
Cerebral edema due to brain tumor, 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 hemolytic anemia, acute idiopathic thrombocytopenic purpura);
Postpericardiotomy syndrome (Dressler's syndrome: chest pain with fever and inflammatory signs) in cases of severe or recurrent symptoms, starting from the 5th week after myocardial infarction, when other treatments are insufficient;
Severe infectious diseases with sepsis-like conditions (e.g., in tuberculosis, typhoid fever), only in conjunction with appropriate antimicrobial therapy;
Absent or reduced adrenal cortex function (adrenal insufficiency): adrenal crisis;
Pseudocroup (inflammation of the 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 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.

In isolated cases, severe hypersensitivity reactions (anaphylactic reactions) with circulatory failure, cardiac arrest, arrhythmias, dyspnoea (bronchospasm), and/or decreased or increased arterial blood pressure have been observed 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 B, chickenpox, shingles, herpes, 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 multiplication of parasites;
poliomyelitis (Heine-Medin disease);
swollen lymph nodes after BCG 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 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-angle and open-angle glaucoma) – ophthalmological monitoring and concomitant (targeted) treatment are recommended;
corneal damage and corneal ulcers – ophthalmological monitoring and concomitant (targeted) treatment are recommended.

Treatment with this medicine may cause a so-called crisis in pheochromocytoma (adrenal gland chromaffin tumour), which may be fatal. Pheochromocytoma is a rare hormone-dependent tumour of the adrenal glands. A pheochromocytoma crisis may present with headache, excessive sweating, palpitations and elevated blood pressure. If any of these symptoms occur, the patient should contact a doctor immediately.
Before starting treatment with Predasol, discuss this with your doctor if there is suspicion of or a confirmed diagnosis of pheochromocytoma (adrenal gland tumour).
Due to the risk of intestinal perforation, Predasol may be used only 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 treated with Predasol. Patients with a weakened immune system who have not previously 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 vaccines containing inactivated microorganisms (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, 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 long-term treatment with high doses of Predasol, an adequate intake of potassium (e.g. vegetables, bananas) should be ensured and salt intake limited. Blood potassium levels should be monitored under medical supervision.
If special physical stress occurs 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 hyperreactivity) 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 corticosteroid withdrawal syndrome.
If blurred vision or other visual disturbances occur during treatment, contact a doctor.

Children and adolescents
During periods of growth in children, the benefit-risk ratio of treatment with Predasol should be carefully evaluated.

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

Misuse 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 taken or recently taken, including those obtained without a prescription, as well as any medicines the patient plans to take.

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 effect of corticosteroids.
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 down metabolism in the liver, such as certain antifungal drugs (containing ketoconazole, itraconazole), may increase the effect of corticosteroids.

Reduced effect

Medicines that accelerate metabolism in the liver, such as certain sedatives (barbiturates), anticonvulsants (containing phenytoin, carbamazepine and primidone) and certain tuberculosis medications (containing rifampicin), may reduce the effect of corticosteroids.
Ephedrine (may be present in medicines 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 the action of 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 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 non-steroidal anti-inflammatory drugs).
prolong the muscle-relaxing effect of certain non-depolarising neuromuscular blocking agents.
enhance the effect of certain drugs (atropine and other anticholinergic drugs) 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 (i.e. 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 blood glucose-lowering effect of oral antidiabetic drugs and insulin.
reduce the effectiveness of drugs used to treat parasitic diseases (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 anticoagulant drugs (oral anticoagulants, coumarin derivatives). The doctor will decide whether adjustment of the anticoagulant dose 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 is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Predasol should be used during pregnancy only on medical advice. Therefore, if the patient is pregnant, she should inform her doctor. Long-term 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 administration of prednisolone 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 a 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 without safety precautions.

Predasol contains sodium
The medicine contains 23.94 mg of sodium (the main component of table salt) per vial. This corresponds to 1.2% of the maximum recommended daily sodium intake in the diet of adults.
The medicine 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 the sodium content of 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 trained medical personnel. If in doubt, consult your
doctor or pharmacist.
Generally, the doctor follows the dosage guidelines below:

Anaphylactic shock (after prior administration of adrenaline)
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. Then administer replacement fluids and, if necessary, apply artificial ventilation. Adrenaline and prednisolone injections may be repeated if needed. Do not administer calcium preparations or digitalis together with adrenaline.

Pulmonary oedema 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 continue for 2 days with 150 mg per day and for the next 2 days with 75 mg prednisolone per day, divided into intravenous doses (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 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 oedema
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 basic 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, up to 400 mg per day in individual cases.

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, if required in combination with a mineralocorticosteroid.

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

Method of administration
Predasol is administered by trained medical personnel into a vein (intravenous injection) or as an infusion (intravenous drip).
The medicine can be given either as a direct intravenous injection or as an infusion, but direct intravenous injection is the preferred method of administration.
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 circumstances, 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 included solvent (water for injections) directly into the vial containing the powder 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 the following standard infusion solutions:

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

When preparing an infusion, dissolve the medicine according to the above instructions and then mix aseptically with one of the listed infusion solutions.
When mixing with infusion solutions, observe 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 administration of high doses. No special measures are required. If the patient experiences severe or unusual adverse effects, 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 treatment with Predasol
Always follow the dosing regimen prescribed by the doctor. Never stop using Predasol without consulting a doctor, as long-term 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects 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,
and also parasitic and opportunistic infections, activation of intestinal schistosomiasis.
Blood and lymphatic system disorders
Changes in blood morphology (increase in number of white blood cells or all blood cells, decrease in number
of certain types 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 so-called Cushing's syndrome (typical symptoms: large, round face – "moon face",
truncal obesity and facial redness), suppression or reduction of adrenal cortex function.
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
[in the epidural space] or chest cavity [in the pericardial, mediastinal space]).
Psychiatric disorders
Depression, irritability, euphoria, increased drive, psychosis, mania, hallucinations, emotional lability,
anxiety, sleep disorders, suicidal thoughts.
Nervous system disorders
Increased intracranial pressure, emergence of symptoms of latent epilepsy, increased tendency 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.
Vascular disorders
Hypertension, increased risk of atherosclerosis and thrombosis, vasculitis (also as withdrawal syndrome after long-term treatment), increased fragility of capillaries.
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 bleeding, acne, inflammatory skin conditions of the face, especially around the mouth, nose and eyes.
Musculoskeletal and connective tissue disorders
Disorders within muscles, muscle weakness, muscle atrophy, bone loss (osteoporosis) occurring depending
on dose and possible even during short-term use, other forms of bone degeneration (bone necrosis), disorders within tendons, 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 production.
Reproductive system and breast disorders
Disorders 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 mentioned adverse effects occur, or any other adverse effect during use of 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 effects
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Adverse effects can also be reported to the responsible entity.
By reporting adverse effects, more information on the safety of the medicine can be collected.

5. How to store Predasol

Keep the medicine out of the sight and reach of children.
Do not store above 25 °C.
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 following "EXP". The expiry date refers to the last day of the stated month.
Shelf life after first opening or reconstitution
Due to microbiological concerns, the prepared injection solution is intended for immediate use. If the product is not used immediately, the user is responsible for the duration and conditions of storage. In exceptional circumstances, 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 solution should be discarded.
In the case of infusion, solutions containing 1 g of prednisolone sodium succinate 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 prednisolone sodium succinate. One vial of powder contains prednisolone sodium succinate equivalent to 250 mg of prednisolone hydrogen succinate, corresponding to 195.7 mg of prednisolone.
Other ingredients are: sodium hydrogen carbonate, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate.

One ampoule of solvent contains 5 ml of water for injections.

What Predasol looks like and contents of the pack
Predasol consists of white to creamy or yellowish 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 5 ml of water for injections,
3 vials of powder for solution for injection/infusion and 3 ampoules of solvent each containing 5 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