Predasol

Package Leaflet: Information for the User

Predasol, 1000 mg, Powder and Solvent for Solution for Injection/Infusion

Prednisolone Hemisuccinate

Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medication has been prescribed specifically for you. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this package leaflet, they should inform their 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 Package 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:

• Anaphylactic shock (after initial adrenaline injection);
• Pulmonary edema caused by inhaling toxic substances, such as chlorine, isocyanates, hydrogen sulfide, phosgene, nitrogen, ozone, as well as after aspiration of gastric juice or drowning;
• Severe, acute asthma attack;
• Brain edema caused by brain tumors, neurosurgical procedures, brain abscess, bacterial meningitis;
• Risk of organ rejection after kidney transplantation;
• Initial treatment of widespread, acute, severe skin diseases, such as erythroderma, pemphigus, 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 recurring symptoms, from the 5th week after myocardial infarction, and when other medications are not sufficiently effective;
• Severe infectious diseases with toxic symptoms (e.g., in the course of tuberculosis, typhoid fever), only in combination with appropriate anti-infective therapy;
• Lack or decreased adrenal cortex function (adrenal insufficiency): adrenal crisis;
• Pseudocroup (respiratory tract inflammation 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 succinate or any of the other ingredients of this medication (listed in section 6).

Warnings and Precautions

Before starting treatment with Predasol, the patient should discuss it with their 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 treating doctor 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, dyspnea (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 concurrent or developing infection, making it difficult to diagnose. It may lead to the activation of latent infections. The doctor will use additional targeted anti-infective therapy in cases of concurrent:

• 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, roundworms);
• In patients with suspected or confirmed strongyloidiasis (intestinal worm infection), Predasol may lead to the activation 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:

• Stomach and intestinal ulcers;
• Bone loss (osteoporosis);
• Severe heart failure;
• Difficult-to-control hypertension;
• Difficult-to-control diabetes;
• Mental disorders (including those that have occurred in the past), including the risk of suicide. In these cases, neurological or psychiatric supervision is recommended;
• Increased intraocular pressure (glaucoma with narrow and wide angle of filtration) - ophthalmological supervision and concomitant treatment (targeted) are recommended;
• Corneal damage and ulcers - ophthalmological supervision and concomitant treatment (targeted) are recommended.

Treatment with Predasol may lead to the so-called crisis in the course of pheochromocytoma (a rare hormone-dependent adrenal tumor), which can be life-threatening. A crisis in the course of pheochromocytoma 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, the patient should discuss it with their 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 abscessing inflammation, possible even without peritoneal irritation;
• Intestinal 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 taking Predasol. The most vulnerable are patients with weakened immune systems who have not previously had chickenpox or measles. If such patients taking Predasol come into contact with people suffering from measles or chickenpox, they should immediately contact their doctor, who will initiate appropriate preventive treatment. Essentially, vaccinations with killed microorganisms (inactivated vaccines) are permissible. However, it should be considered that the effectiveness of vaccination may be reduced after taking high 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 rate or duration of administration. During long-term treatment with 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 physical stress occurs during treatment, 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 glucocorticosteroid treatment, the risk of the following situations should be considered: exacerbation or recurrence of the underlying disease, acute adrenal insufficiency, 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 a higher risk of osteoporosis (bone loss), the benefit-risk ratio of using Predasol should be carefully considered.

Incorrect Use of the Medication 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 Medications

The patient should inform their doctor about all medications they are currently taking or have recently taken, as well as those they plan to take, including those available without a prescription. Effect on the Action of Predasol Enhancement of Action or Possible Enhancement of Adverse Reactions

• Certain female sex hormones, such as those used in oral contraceptives ("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 patient's condition when 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.

Weakening of Action

• Medications that accelerate liver metabolism, such as certain sedatives (barbiturates), antiepileptic medications (containing phenytoin, carbamazepine, and primidone), and certain anti-tuberculosis medications (containing rifampicin), may weaken the effect of corticosteroids.
• Ephedrine (which 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 Medications Enhancement of Action or Possible Enhancement of Adverse ReactionsPredasol may:

• increase the risk of changes in blood morphology when 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 stomach ulcers and gastrointestinal bleeding when used concurrently with anti-inflammatory medications (containing salicylates, indomethacin, or other non-steroidal anti-inflammatory medications).
• 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) when used concurrently with medications used to treat malaria and rheumatic diseases (containing chloroquine, hydroxychloroquine, mefloquine).
• increase the concentration of cyclosporin in the blood (a medication that reduces the activity of the immune system) and, consequently, increase the risk of seizures.

Predasol used concurrently with medications that reduce the activity of the immune system (i.e., immunosuppressive medications) may increase the 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. Weakening of ActionPredasol may:

• weaken the action of oral anti-diabetic medications and insulin.
• weaken the action of medications used to treat parasitic diseases (containing praziquantel).
• weaken the action of growth hormone (somatropin).
• weaken the action of increasing the concentration of thyrotropin (TSH) after administration of protirelin (TRH - a hormone produced by the hypothalamus).

Enhancement or Weakening of ActionPredasol may decrease or increase the effect of medications that reduce blood clotting (oral anticoagulants, coumarin derivatives). The doctor will decide whether it is necessary to adjust the dose of the medication that reduces blood clotting. Effect on Laboratory Test Results Skin reactions in allergy tests may be suppressed.

Pregnancy and Breastfeeding

If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medication. Pregnancy During pregnancy, this medication should only be used if prescribed by a doctor. Therefore, if the patient is pregnant, they should inform their doctor. During long-term treatment with 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 therapy with gradual dose reduction. In animal studies, prednisolone has shown harmful effects on fetuses (e.g., cleft palate). There are reports indicating an increased risk of such damage in humans due to prednisolone administration 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 medication during breastfeeding should be carefully considered. If higher doses are required due to the underlying disease, breastfeeding should be discontinued. The patient should immediately contact their doctor.

Driving and Operating Machinery

There is currently no data indicating that Predasol affects the ability to drive or operate machinery. The same applies to work without safety precautions.

Predasol Contains Sodium

The medication contains 59.11 mg of sodium (the main component of table salt) per vial, which corresponds to 3% of the maximum recommended daily sodium intake for adults. The medication 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 solution. To obtain accurate information about the sodium content in the solution used to dilute the medication, the patient should 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, the patient should consult their doctor or pharmacist. Generally, the doctor follows the following dosage guidelines: Anaphylactic Shock (After Initial Adrenaline Injection)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), 1000 mg of prednisolone (250 mg in children) should be administered intravenously, followed by infusion of fluids and, if necessary, artificial ventilation. Adrenaline and prednisolone injections may be repeated if necessary. Calcium preparations or digitalis should not be administered together with adrenaline. Pulmonary Edema Caused by Inhaling Toxic Substances, as Well as After Aspiration of Gastric Juice or DrowningInitial dose: 1000 mg of prednisolone intravenously in adults (10-15 mg/kg body weight in children). If necessary, repeat after 6, 12, and 24 hours. Then, 150 mg per day for 2 days and 75 mg per day for the next 2 days, administered intravenously in divided doses (in children, 2 mg/kg body weight and 1 mg/kg body weight, respectively). Then, gradually discontinue the medication, switching to inhalation therapy. Severe, Acute Asthma AttackInitial dose in adults: 100-500 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, initially administer 2 mg/kg body weight of prednisolone intravenously, then 1-2 mg/kg body weight every 6 hours until improvement is achieved. Concurrent administration of bronchodilators is recommended. Prophylaxis or Treatment of Brain EdemaInitial dose: 250-1000 mg of prednisolone intravenously (if dexamethasone phosphate cannot be used as initial parenteral treatment), then treatment with 8-16 mg of dexamethasone phosphate intravenously, in 2- to 6-hour intervals. Risk of Organ Rejection After Kidney TransplantationIn addition to basic therapy, administer 1000 mg of prednisolone in 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 Syndrome50 mg of prednisolone intravenously per day, then cautiously reduce the dose. Severe Infectious Diseases (e.g., in the Course of Tuberculosis, Typhoid Fever)100-500 mg of prednisolone per day intravenously (in combination with antibiotic therapy). Adrenal Crisis25-50 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 administer 3-5 mg/kg body weight intravenously, if necessary, repeat the dose after 2-3 hours.

Method of Administration

Predasol is administered by medical personnel intravenously or as an infusion. The medication can be administered as a direct intravenous injection or as an infusion, but the preferred method of administration is direct intravenous injection. The prepared solution for injection is intended for single use. Any unused solution should be discarded. The medication should be administered immediately after opening the vial. In exceptional cases, the prepared solution for injection can be stored for up to 24 hours at a temperature of 2-8°C (see section 5). To prepare the solution for injection, the enclosed solvent (water for injection) should be injected into the vial with the powder immediately before use and mixed until the powder is dissolved. Compatibility with Infusion SolutionsThe 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 medication should first be dissolved according to the above instructions and then mixed aseptically (sterile) with one of the listed infusion solutions. When mixing with infusion solutions, the patient should follow the instructions of the individual infusion solution manufacturers regarding compatibility, contraindications, adverse reactions, and interactions. Predasol should not be mixed with other medications. Medications 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 when used in high doses for a short period. No special measures are required. If the patient experiences enhanced or atypical adverse reactions, they should consult their doctor.

Missing a Dose of Predasol

The missed dose can be taken up during the day and treatment 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, the patient should consult their doctor, who will assess the treatment and adjust it if necessary.

Discontinuation of Predasol

The patient should always follow the dosage regimen prescribed by their doctor. The patient should never discontinue Predasol without consulting their doctor, as long-term treatment with 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 the patient has any further doubts about the use of this medication, they should consult their doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medications, 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 certain 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, and cardiac arrest. Endocrine DisordersInduction of Cushing's syndrome (typical symptoms: moon face, truncal obesity, and facial flushing), suppression or decrease 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, manifestation of latent epilepsy, increased susceptibility to seizures in epilepsy. Eye DisordersCataracts, increased intraocular pressure (glaucoma), worsening of corneal ulcers, enhancement of viral, fungal, and bacterial eye infections, blurred vision. Cardiac DisordersBradycardia Vascular DisordersHypertension, increased risk of atherosclerosis and thrombosis, vasculitis (including withdrawal syndrome after long-term treatment), increased capillary fragility. Gastrointestinal DisordersGastric and intestinal ulcers, gastrointestinal bleeding, pancreatitis. Skin and Subcutaneous Tissue DisordersStretch marks, skin thinning, telangiectasias, tendency to bruise, petechiae, acne, facial skin inflammation, especially around the mouth, nose, and eyes. Musculoskeletal and Connective Tissue DisordersMuscle disorders, muscle weakness, muscle atrophy, bone loss (osteoporosis), which may occur depending on the dose and is also possible during short-term treatment, 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. The patient should consult their doctor or pharmacist if they experience any of the above side effects or any other side effects during treatment with Predasol. The patient should never discontinue treatment without consulting their doctor. If the patient experiences gastrointestinal disorders, back, shoulder, or hip pain, psychiatric disorders, noticeable fluctuations in blood sugar levels (in patients with diabetes), or other disorders, they should immediately contact their doctor.

Reporting Side Effects

If side effects occur, including any not listed in this package leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety 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 Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medication.

5. How to Store Predasol

The medication should be stored out of sight and reach of children. There are no special storage temperature requirements for the product. The vial with powder should be stored in the outer packaging to protect it from light. Do not use this medication after the expiration date stated on the packaging after "EXP". The expiration date refers to the last day of the specified month.

Shelf Life After First Opening or Reconstitution

For microbiological reasons, the prepared solution for injection is intended for immediate use. If the product is not used immediately, the user is responsible for the storage time and conditions. In exceptional cases, the prepared solution for injection can be stored for up to 24 hours at a temperature of 2-8°C. Vials are not suitable for repeated use. Any unused solution should be discarded. In the case of infusions, 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. Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of unused medications. This will help protect the environment.

6. Contents of the Package and Other Information

What Predasol Contains

• The active substance of the medication is prednisolone sodium succinate. 1 vial with powder contains prednisolone sodium succinate equivalent to 1000 mg of prednisolone succinate, which corresponds to 782.7 mg of prednisolone.
• Other ingredients are: sodium bicarbonate, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate.

1 ampoule with solvent contains 10 ml of water for injection.

What Predasol Looks Like and Contents of the Package

Predasol consists of a white to cream-colored or yellow powder and a clear, colorless solvent. Predasol is available in packages containing: 1 vial with powder for solution for injection/infusion and 1 ampoule with solvent containing 10 ml of water for injection. 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: