PREDASOL 50 mg Powder

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Predasol, 50 mg, powder and solvent for solution for injection/infusion
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet
3. What is Predasol and what is it used for
   1. Predasol is used in the following cases:
4. Important information before using Predasol
   1. When not to use Predasol:
   2. Warnings and precautions
   3. Children and Adolescents
   4. Elderly Patients
   5. Incorrect Use of the Medicine as a Doping Agent
   6. Predasol and Other Medicines
   7. Pregnancy and Breastfeeding
   8. Driving and Using Machines
   9. Predasol Contains Sodium
5. How to Use Predasol
   1. Method of Administration
   2. Use of a Higher Than Recommended Dose of Predasol
   3. Missing a Dose of Predasol
   4. Discontinuation of Predasol
6. Possible Side Effects
   1. Reporting Side Effects
7. How to Store Predasol
   1. Shelf Life After First Opening or Reconstitution
8. Contents of the Pack and Other Information
   1. What Predasol Contains
   2. What Predasol Looks Like and Contents of the Pack
   3. Marketing Authorization Holder and Manufacturer
   4. Marketing Authorization Holder
   5. Manufacturer
   6. Date of Last Revision of the Package Leaflet

Package Leaflet: Information for the User

Predasol, 50 mg, powder and solvent for solution for injection/infusion

Prednisolone hemisuccinate

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package 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 you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Predasol and what is it used for
• 2. Important information before using Predasol
• 3. How to use Predasol
• 4. Possible side effects
• 5. How to store Predasol
• 6. Contents of the pack and other information

1. What is Predasol and what is it used for

Predasol is a glucocorticosteroid (corticosteroid) that affects metabolism, electrolyte balance, and tissue function.

Predasol is used in the following cases:

• Shock caused by a severe allergic reaction (anaphylactic shock) (after initial injection of adrenaline - a medicine that affects the cardiovascular system);
• Pulmonary edema caused by inhalation of toxic substances, such as chlorine, isocyanates, hydrogen sulfide, phosgene, nitrogen, ozone, as well as a result of aspiration of gastric juice into the lungs or as a result of drowning (submersion);
• Severe, acute asthma attack;
• Brain edema caused by a brain tumor, neurosurgical procedures, brain abscess, bacterial meningitis;
• Risk of organ rejection after kidney transplantation;
• Initial treatment of extensive, acute, severe skin diseases, such as erythroderma, bullous pemphigoid, acute eczema;
• Acute blood diseases (autoimmune hemolytic anemia, acute thrombocytopenic purpura);
• Dressler's syndrome (post-myocardial infarction syndrome: chest pain with fever and inflammation) in cases of severe or recurrent symptoms, from the 5th week after myocardial infarction, and when other medications are not sufficiently effective;
• Severe infectious diseases with symptoms similar to poisoning (e.g., in the course of tuberculosis, typhoid fever), only in combination with additional appropriate antimicrobial therapy;
• Lack or decreased function of the adrenal cortex (adrenal insufficiency): adrenal crisis;
• Pseudocroup (respiratory tract inflammation with shortness of breath and severe cough).

2. Important information before using Predasol

When not to use Predasol:

Warnings and precautions

Before starting treatment with Predasol, discuss it with your doctor, pharmacist, or nurse if:

• the patient has scleroderma (an autoimmune disorder also known as systemic sclerosis), as doses of at least 15 mg per day may increase the risk of a serious complication called scleroderma renal crisis. The symptoms of scleroderma renal crisis include increased blood pressure and decreased urine production. The attending physician may recommend regular blood pressure and urine output checks.

In individual cases, during treatment with Predasol, severe hypersensitivity reactions (anaphylactic reactions) with circulatory failure, cardiac arrest, arrhythmias, shortness of breath (bronchospasm), and/or decreased or increased blood pressure have been observed. Due to the suppression of the body's immune system, Predasol may lead to an increased risk of bacterial, viral, parasitic, opportunistic, and fungal infections. Treatment with Predasol may mask the symptoms of a concomitant or developing infection, making it difficult to diagnose. It may lead to the activation of latent infection. The doctor will use additional targeted antimicrobial therapy in cases of concurrent conditions such as:

• acute viral infections (viral hepatitis B, chickenpox, shingles, herpes, corneal herpes);
• chronic active viral hepatitis with a positive HBsAg test result (infectious liver disease);
• within approximately 8 weeks before to 2 weeks after vaccinations with live attenuated microorganisms (live vaccines);
• fungal infections affecting internal organs;
• certain parasitic diseases (e.g., caused by amoebas, worms);
• in patients with suspected or confirmed strongyloidiasis (intestinal worm infection), Predasol may lead to stimulation and significant multiplication of parasites;
• Guillain-Barré syndrome;
• swollen lymph nodes after BCG vaccination;
• acute and chronic bacterial infections;
• in cases of past tuberculosis - use only with anti-tuberculosis medications.

Additionally, during treatment with Predasol, the doctor will monitor and treat the following conditions:

• gastric and intestinal ulcers;
• bone loss (osteoporosis);
• severe heart failure;
• difficult-to-control hypertension;
• difficult-to-control diabetes;
• mental disorders (also occurring in the past), including the risk of suicide. In these cases, supervision by a neurologist or psychiatrist is recommended;
• increased intraocular pressure (glaucoma with narrow and wide angle of filtration) - ophthalmologic supervision and concomitant treatment (targeted) are recommended;
• corneal damage and ulcers - ophthalmologic supervision and concomitant treatment (targeted) are recommended.

Treatment with this medicine may lead to the so-called crisis in the course of pheochromocytoma (a rare hormone-dependent adrenal tumor), which can be life-threatening. Pheochromocytoma crisis may manifest as headache, excessive sweating, palpitations, and increased blood pressure. If these symptoms occur, the patient should immediately contact their doctor. Before starting treatment with Predasol, discuss it with your doctor if there is a suspicion or diagnosis of pheochromocytoma (adrenal tumor). Due to the risk of intestinal perforation, Predasol can only be used if there are significant medical indications and under appropriate supervision in the following cases:

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

In patients receiving high doses of glucocorticosteroids, symptoms of peritonitis may not occur after perforation of a gastrointestinal ulcer. The risk of tendon disorders, tendonitis, and tendon rupture is increased when fluoroquinolones (a certain group of antibiotics) and Predasol are administered concurrently. The course of viral diseases (e.g., chickenpox, measles) may be particularly severe in patients using Predasol. The most vulnerable are patients with weakened immune systems who have not previously had chickenpox or measles. If such patients, who are using Predasol, come into contact with people suffering from measles or chickenpox, they should immediately contact their doctor, who will initiate appropriate preventive treatment. In principle, vaccinations with killed microorganisms (inactivated vaccines) are permissible. However, it should be taken into account that the effectiveness of vaccination may be reduced after using higher doses of Predasol. Concomitant myasthenia (a form of muscle paralysis) may initially worsen during treatment with Predasol. In individual cases, during or after intravenous administration of a high dose of prednisolone, bradycardia (slow heart rate) may occur, not necessarily related to the speed or duration of administration of the medicine. In cases of long-term use of high doses of Predasol, it is necessary to ensure adequate potassium intake (e.g., vegetables, bananas) and limit salt consumption. Potassium levels in the blood should be monitored under medical supervision. If situations of particular physical stress occur, such as illness with fever, accident, childbirth, or surgery, it may be necessary to temporarily increase the daily dose of corticosteroids. Severe anaphylactic reactions (hypersensitivity of the immune system) may occur. During the termination or after possible discontinuation of long-term treatment with glucocorticosteroids, it should be taken into account that there is a risk of worsening or recurrence of the underlying disease, acute adrenal insufficiency, or corticosteroid withdrawal syndrome. If the patient experiences blurred vision or other visual disturbances, they should contact their doctor.

Children and Adolescents

During the growth phase of children, the benefit-risk ratio of using Predasol should be carefully considered.

Elderly Patients

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

Incorrect Use of the Medicine as a Doping Agent

Using Predasol may lead to positive results in anti-doping tests. The health consequences of using Predasol as a doping agent cannot be predicted. Serious health risks cannot be ruled out.

Predasol and Other Medicines

Tell your doctor about all medicines you are currently taking, or have recently taken, and about medicines you plan to take, including those available without a prescription. Effect on the action of Predasol Enhancement of action or possible enhancement of side effects

• Certain female sex hormones, e.g., used in contraceptive medications ("the pill"), may increase the effect of corticosteroids.
• Certain medications may enhance the effect of Predasol, and the doctor may want to closely monitor the condition of the patient taking such medications (including certain HIV medications: ritonavir, cobicistat).
• Medications that slow down liver metabolism, such as certain antifungal medications (containing ketoconazole, itraconazole), may increase the effect of corticosteroids.

Reduced effect

• Medications that accelerate liver metabolism, such as certain sedatives (barbiturates), medications used to treat epilepsy (containing phenytoin, carbamazepine, and primidone), and certain medications used to treat tuberculosis (containing rifampicin), may reduce the effect of corticosteroids.
• Ephedrine (may be contained in medications used to treat low blood pressure, chronic bronchitis, asthma attacks, rhinitis, and as a component of 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 Enhancement of action or possible enhancement of side effectsPredasol may:

• increase the risk of changes in blood morphology if used concurrently with certain blood pressure-lowering medications (angiotensin-converting enzyme inhibitors).
• increase the effect of heart medications (cardiac glycosides) due to potassium deficiency.
• increase potassium excretion caused by diuretics and laxatives.
• increase the risk of gastric ulcers and gastrointestinal bleeding if used concurrently with anti-inflammatory medications (containing salicylates, indomethacin, or other non-steroidal anti-inflammatory drugs).
• prolong the action of certain medications (non-depolarizing muscle relaxants) that cause muscle relaxation.
• increase the effect of certain medications (atropine and other anticholinergic medications) that increase intraocular pressure.
• increase the risk of muscle disease (myopathy) and heart muscle disease (cardiomyopathy) if taken concurrently with medications used to treat malaria and rheumatic diseases (containing chloroquine, hydroxychloroquine, mefloquine).
• increase the blood concentration of cyclosporin (an immunosuppressive medication) and thus increase the risk of seizures.

Predasol used concurrently with immunosuppressive medications (i.e., medications that reduce the activity of the immune system) may increase the susceptibility to infections and may worsen or trigger symptoms of previously undiagnosed infections. Fluoroquinolones - a certain group of antibiotics - may increase the risk of tendon damage. Reduced effectPredasol may:

• reduce the effect of oral antidiabetic medications and insulin.
• reduce the effect of medications used to treat parasitic diseases (containing praziquantel).
• reduce the effect of growth hormone (somatropin).
• reduce the effect of increasing the concentration of thyroid-stimulating hormone (TSH) after administration of protirelin (TRH - a hormone produced by the brain).

Enhancement or reduction of effectPredasol may decrease or increase the effect of blood thinning medications (oral anticoagulants, coumarin derivatives). The doctor will decide whether it is necessary to adjust the dose of the blood thinning medication. Effect on laboratory test results Skin reactions in allergy tests may be suppressed.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using this medicine. Pregnancy During pregnancy, this medicine should only be used if prescribed by a doctor. Therefore, if you are pregnant, tell your doctor. During long-term use of Predasol during pregnancy, fetal growth disturbances may occur. If Predasol is used at the end of pregnancy, the newborn may experience adrenal insufficiency, which may require substitution treatment with gradual dose reduction. In animal studies, prednisolone showed harmful effects on fetuses (e.g., cleft palate). There are reports indicating an increased risk of such damage in humans due to the administration of prednisolone during the first three months of pregnancy. Breastfeeding The active substance - prednisolone - passes into breast milk. So far, no disturbances have been reported in infants. Nevertheless, the need to use the medicine 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 Using Machines

So far, there is no data indicating that Predasol affects the ability to drive vehicles and operate machinery. The same applies to work without safety measures.

Predasol Contains Sodium

The medicine contains 4.68 mg of sodium (the main component of common salt) per ampoule. This corresponds to 0.23% of the maximum recommended daily intake of sodium in the diet for adults. The medicine can be mixed with the following solutions: 5% glucose solution, 0.9% sodium chloride solution, or Ringer's solution. The sodium content from the diluent should be taken into account when calculating the total sodium content in the prepared dilution of the product. To obtain accurate information about the sodium content in the solution used to dilute the medicine, refer to the package leaflet of the diluent used.

3. How to Use Predasol

Predasol will be administered by medical personnel. In case of doubts, ask your doctor or pharmacist. Generally, the doctor follows these guidelines for dosing: Anaphylactic shock (after initial injection of adrenaline)After intravenous injection of adrenaline (1.0 ml of standard adrenaline solution 1:1000 diluted to 10 ml with physiological saline or blood and slowly injected under close medical supervision; warning: cardiac arrhythmias), administer 1000 mg of prednisolone intravenously (in children 250 mg), and then administer fluids and, if necessary, use artificial ventilation. Adrenaline and prednisolone injections may be repeated if necessary. Do not administer calcium preparations or digitalis concurrently with adrenaline. Pulmonary edema caused by inhalation of toxic substances, as well as a result of aspiration of gastric juice or drowningInitial dose: 1000 mg of prednisolone intravenously in adults (in children from 10 to 15 mg/kg body weight). If necessary, repeat after 6, 12, and 24 hours. Then, for 2 days, 150 mg per day, and for the next 2 days, 75 mg of prednisolone per day, administered intravenously in divided doses (in children, respectively, 2 mg/kg body weight and 1 mg/kg body weight). Then, gradually discontinue the medicine, switching to inhalation therapy. Severe, acute asthma attackInitial dose in adults: from 100 to 500 mg of prednisolone intravenously, followed by further treatment with the same or lower doses at approximately 6-hour intervals, then gradual reduction of the dose to a maintenance dose. In children, in the initial phase, administer 2 mg of prednisolone per kilogram of body weight intravenously, followed by a dose of 1 to 2 mg per kilogram of body weight every 6 hours until improvement is achieved. Concurrent administration of bronchodilators is recommended. Prophylaxis or treatment of brain edemaInitial dose from 250 to 1000 mg of prednisolone intravenously (if dexamethasone phosphate cannot be used as initial parenteral treatment), then treatment with a dose of 8 to 16 mg of dexamethasone phosphate intravenously, at 2- to 6-hour intervals. Risk of organ rejection after kidney transplantationIn addition to basic therapy, administer 1000 mg of prednisolone in the form of intravenous pulses, depending on the severity of the case, for 3 to 7 consecutive days. Acute, severe skin diseases and acute blood diseases

• 40 - 250 mg of prednisolone intravenously, in individual cases up to 400 mg per day.

Dressler's syndrome (post-myocardial infarction syndrome)50 mg of prednisolone intravenously per day, then carefully reduce the dose. Severe infectious diseases (e.g., in the course of tuberculosis, typhoid fever)From 100 to 500 mg of prednisolone per day intravenously (in combination with antibiotic therapy). Adrenal crisisFrom 25 to 50 mg of prednisolone intravenously as an initial dose; if necessary, continue treatment orally with prednisone or prednisolone, if necessary, in combination with a mineralocorticosteroid. PseudocroupSevere forms: immediately from 3 to 5 mg/kg body weight intravenously, if necessary, repeat the dose after 2-3 hours.

Method of Administration

Predasol is administered by medical personnel intravenously (into a vein) or as an infusion (drip). The medicine can be administered as a direct intravenous injection or as an infusion, but the preferred method of administration is direct intravenous injection. The ready-to-use solution for injection is intended for single use. The medicine should be administered immediately after opening the ampoule. Any unused remainder of the solution should be discarded. To prepare the ready-to-use solution for injection, the supplied solvent (water for injection) should be injected into the ampoule with the powder immediately before use, and the ampoule should be shaken until the powder is dissolved. Compatibility with infusion fluidsThe prepared solution for injection 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

In the case of preparing an infusion, the medicine should first be dissolved according to the above instructions and then mixed aseptically (in a sterile environment) with one of the listed infusion solutions. When mixing with infusion solutions, the information of the individual manufacturers of the infusion solutions should be followed regarding compatibility, contraindications, side effects, and interactions. Predasol should not be mixed with other medicines. Medicines intended for parenteral administration should be inspected before use. Only clear solutions without visible particles should be used.

Use of a Higher Than Recommended Dose of Predasol

Generally, Predasol is well tolerated even in cases of short-term use of high doses. No special measures are required. If the patient experiences enhanced or atypical side effects, they should consult their doctor.

Missing a Dose of Predasol

A missed dose can be made up for on the same day, and treatment can be continued with the dose prescribed by the doctor at the usual time the next day. If several doses are missed, the treated disease may worsen or recur. In such cases, consult your doctor, who will assess the treatment and adjust it if necessary.

Discontinuation of Predasol

Always follow the dosing schedule prescribed by your doctor. Never discontinue the use of Predasol without consulting your doctor, as long-term use of Predasol may suppress the production of glucocorticosteroids in the body. In such cases, situations of significant physical stress may be life-threatening (adrenal crisis). If you have any further doubts about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medicines, Predasol can cause side effects, although not everybody gets them. The following side effects may occur, which to a large extent depend on the dose and duration of treatment, and for which it is not possible to determine the frequency of occurrence: Infections and infestationsMasking of infections, occurrence, worsening, or recurrence of viral, fungal, bacterial, and parasitic infections, as well as opportunistic infections, activation of intestinal worm infection. Blood and lymphatic system disordersChanges in blood morphology (increased white blood cell count or all blood cells, decreased count of a certain type of white blood cells). Immune system disordersHypersensitivity reactions (e.g., drug rash), severe anaphylactic reactions, such as cardiac arrhythmias, bronchospasm, decreased or increased blood pressure, circulatory collapse, myocardial infarction, weakened immune system. Endocrine disordersInduction of Cushing's syndrome (typical symptoms: large, round face - "moon face", central obesity, and facial flushing), suppression or reduction of adrenal cortex function. Metabolic and nutritional disordersWeight gain, increased blood glucose levels, diabetes, increased blood lipid levels (cholesterol and triglycerides), fluid retention, potassium deficiency due to increased potassium excretion, increased appetite. Psychiatric disordersDepression, irritability, euphoria, increased drive, psychosis, mania, hallucinations, emotional instability, anxiety, sleep disturbances, suicidal thoughts. Nervous system disordersIncreased intracranial pressure, occurrence of symptoms of latent epilepsy, increased susceptibility to seizures in epilepsy. Eye disordersCataract, increased intraocular pressure (glaucoma), worsening of corneal ulcers, increased risk of viral, fungal, and bacterial eye infections, blurred vision. Cardiac disordersBradycardia Vascular disordersHypertension, increased risk of atherosclerosis and thrombosis, vasculitis (also as a withdrawal syndrome after long-term treatment), increased fragility of blood vessels. Gastrointestinal disordersGastric and intestinal ulcers, gastrointestinal bleeding. Skin and subcutaneous tissue disordersStretch marks, thinning of the skin ("parchment-like skin"), widened blood vessels, tendency to bruise, pinpoint or surface bleeding of the skin, acne, facial skin inflammation, especially around the mouth, nose, and eyes. Musculoskeletal and connective tissue disordersMuscle disorders, muscle weakness, muscle atrophy, bone loss (osteoporosis) that occurs depending on the dose and is also possible during short-term use, other forms of bone degeneration (bone necrosis), tendon disorders, tendonitis, tendon rupture, growth retardation in children. Renal and urinary disordersScleroderma renal crisis in patients with scleroderma (an autoimmune disorder). The symptoms of scleroderma renal crisis include increased blood pressure and decreased urine production. Reproductive system and breast disordersHormonal disorders (leading to amenorrhea, hirsutism in women, impotence). General disorders and administration site conditionsDelayed wound healing. If you experience any of the above side effects or any other side effect during treatment with Predasol, contact your doctor or pharmacist. Never stop treatment without consulting your doctor. If you experience gastrointestinal symptoms, back, shoulder, or hip pain, psychiatric disorders, noticeable fluctuations in blood sugar levels (in patients with diabetes), or other disorders, contact your doctor immediately.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Predasol

Keep the medicine out of the sight and reach of children. There are no special recommendations for the storage temperature of the medicinal product. Store the ampoule with 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 month stated.

Shelf Life After First Opening or Reconstitution

The ready-to-use solution for injection is intended for single use. The medicine should be administered immediately after opening the ampoule. Any unused remainder of the solution should be discarded. In the case of an infusion, solutions containing 1 g of prednisolone sodium succinate in 250 ml or 1 g in 500 ml prepared by dissolving the powder in the solvent and then diluting with 5% glucose solution, 0.9% sodium chloride solution, or Ringer's solution should be administered within 6 hours. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What Predasol Contains

• The active substance of the medicine is prednisolone sodium succinate. 1 ampoule with powder contains prednisolone sodium succinate in an amount equivalent to 50 mg of prednisolone sodium succinate, which corresponds to 39.1 mg of prednisolone.
• The other ingredients are: sodium bicarbonate, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate.

1 ampoule with solvent contains 2 ml of water for injection.

What Predasol Looks Like and Contents of the Pack

Predasol consists of a white to cream-colored or yellow powder and a clear, colorless solvent. Predasol is available in packs containing: 1 ampoule with powder for solution for injection/infusion and 1 ampoule with solvent containing 2 ml of water for injection, 3 ampoules with powder for solution for injection/infusion and 3 ampoules with solvent containing 2 ml of water for injection each. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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

Date of Last Revision of the Package Leaflet