PREDASOL 25 mg Powder

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Predasol, 25 mg, Powder and Solvent for Solution for Injection/Infusion
   1. Read the Package Leaflet Carefully Before Using the Medication, 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 Medication as a Doping Agent
   6. Predasol and Other Medications
   7. Pregnancy and Breastfeeding
   8. Driving and Operating Machinery
   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 Package and Other Information
   1. What Predasol Contains
   2. What Predasol Looks Like and Contents of the Package
   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, 25 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, 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 you experience any side effects, including those not listed in this package leaflet, 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 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 inhalation of 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 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 toxic symptoms (e.g., in tuberculosis, typhoid fever), only in combination with appropriate antimicrobial therapy;
• Lack or decreased adrenal cortex function (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:

• 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, discuss 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.

During treatment with Predasol, the following have been observed in individual cases: severe hypersensitivity reactions (anaphylactic reactions) with circulatory failure, cardiac arrest, arrhythmias, shortness of breath (bronchospasm), and/or decreased or increased blood pressure.

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 apply additional targeted antimicrobial therapy in cases of:

• Acute viral infections (viral hepatitis B, chickenpox, shingles, herpes, corneal herpes);
• Chronic active viral hepatitis with a positive HBsAg test result (infectious liver disease);
• During the period from 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 the stimulation and significant multiplication of parasites;
• Chagas disease;
• Swollen lymph nodes after BCG vaccination;
• Acute and chronic bacterial infections;
• In cases of past tuberculosis, only in combination with anti-tuberculosis medications.

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

• Stomach and intestinal ulcers;
• Bone thinning (osteoporosis);
• Severe heart failure;
• Difficult-to-control high blood pressure;
• Difficult-to-control diabetes;
• Mental illnesses (including those that have occurred 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 closure) - ophthalmological supervision and concomitant treatment (targeted) are recommended;
• Corneal damage and ulcers - ophthalmological supervision and concomitant treatment (targeted) are recommended.

Treatment with this medication may lead to the occurrence of a so-called crisis in the course of a pheochromocytoma (a rare hormone-dependent adrenal gland tumor). This crisis may be life-threatening and manifest as headache, excessive sweating, palpitations, and increased blood pressure.

Before starting treatment with Predasol, discuss with your doctor if there is a suspicion or diagnosis of a pheochromocytoma (adrenal gland 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 consult a 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 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.

In cases of long-term use of high doses of Predasol, it is necessary to ensure adequate potassium intake (e.g., through vegetables, bananas) and limit salt consumption. Potassium levels in the blood should be monitored under medical supervision.

If situations of particular physical stress occur 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 therapy, 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 vision disturbances, they should consult a 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 excluded.

Predasol and Other Medications

Tell your doctor about all medications you are currently taking or have recently taken, as well as those you plan to take, including those available without a prescription.

Influence on the Effect of Predasol

Enhancement of Effect or Possible Enhancement of Adverse Effects

• Certain female sex hormones, e.g., used in oral contraceptives ("the pill"), may enhance 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 enhance the effect of corticosteroids.

Reduction of Effect

• Medications that accelerate liver metabolism, such as certain sedatives (barbiturates), antiepileptic medications (containing phenytoin, carbamazepine, and primidone), and certain tuberculosis medications (containing rifampicin), may reduce the effect of corticosteroids.
• Ephedrine (which may be contained in medications for low blood pressure, chronic bronchitis, asthma attacks, hay fever, and as an ingredient in appetite suppressants): the effectiveness of Predasol may be reduced due to accelerated metabolism in the body.

Influence of Predasol on the Effect of Other Medications

Enhancement of Effect or Possible Enhancement of Adverse Effects

• Predasol may increase the risk of changes in blood morphology when used concurrently with certain blood pressure-lowering medications (angiotensin-converting enzyme inhibitors).
• Predasol may enhance the effect of heart medications (cardiac glycosides) due to potassium deficiency.
• Predasol may increase potassium excretion caused by diuretics and laxatives.
• Predasol may increase the risk of stomach ulcers and gastrointestinal bleeding when used concurrently with anti-inflammatory medications (containing salicylates, indomethacin, or other nonsteroidal anti-inflammatory drugs).
• Predasol may prolong the effect of certain medications (non-depolarizing muscle relaxants) that cause muscle relaxation.
• Predasol may enhance the effect of certain medications (atropine and other anticholinergic medications) that increase intraocular pressure.
• Predasol may increase the risk of muscle disease (myopathy) and heart muscle disease (cardiomyopathy) when taken concurrently with medications used to treat malaria and rheumatic diseases (containing chloroquine, hydroxychloroquine, mefloquine).
• Predasol may increase the blood level of cyclosporine (an immunosuppressive medication) and thus increase the risk of seizures. Predasol used concurrently with immunosuppressive medications may increase the susceptibility to infections and may exacerbate or trigger previously unmanifested infections.

Reduction of Effect

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

Enhancement or Reduction of Effect

Predasol may decrease or increase the effect of blood thinning medications (oral anticoagulants, coumarin derivatives). The doctor will decide whether adjustment of the blood thinning medication dose is necessary.

Influence 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, consult your doctor or pharmacist before using this medication.

Pregnancy

This medication may only be used during pregnancy if prescribed by a doctor. Therefore, if you are pregnant, inform 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 replacement therapy with gradual dose reduction. In animal studies, prednisolone has shown harmful effects on the fetus (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. Consult your doctor immediately.

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 2.39 mg of sodium (the main component of table salt) per ampoule. This corresponds to 0.12% of the maximum recommended daily sodium intake 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. For accurate information on the sodium content in the solution used to dilute the medication, 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, consult a doctor or pharmacist.

Generally, the doctor follows these guidelines for dosing:

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), administer 1000 mg of prednisolone (250 mg in children) intravenously, 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 concurrently with adrenaline.

Pulmonary Edema Caused by Inhalation of Toxic Substances, as Well as After Aspiration of Gastric Juice or Drowning

Initial 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 taper off the medication, switching to inhaled treatment.

Severe, Acute Asthma Attack

Initial 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 of prednisolone per kilogram of body weight intravenously, then 1-2 mg per kilogram of body weight every 6 hours until improvement. Concurrent administration of bronchodilators is recommended.

Prophylaxis or Treatment of Brain Edema

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

Risk of Organ Rejection After Kidney Transplantation

In 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 Syndrome (Post-Myocardial Infarction Syndrome)

50 mg of prednisolone intravenously per day, then carefully reduce the dose.

Severe Infectious Diseases (e.g., in Tuberculosis, Typhoid Fever)

100-500 mg of prednisolone per day intravenously (in combination with antibiotic therapy).

Adrenal Crisis

25-50 mg of prednisolone intravenously as an initial dose; if necessary, continue treatment orally with prednisone or prednisolone, if necessary, in combination with a mineralocorticosteroid.

Pseudocroup

Severe forms: immediately 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 infusion, but the preferred method of administration is direct intravenous injection.

The ready-to-use solution for injection is intended for single use. The medication should be administered immediately after opening the ampoule. Any unused 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 Solutions

The 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 (in a germ-free environment) with one of the listed infusion solutions.

When mixing with infusion solutions, the information of the individual manufacturers regarding their infusion solutions should be observed, with respect to compatibility, contraindications, adverse effects, 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 effects, consult a doctor.

Missing a Dose of Predasol

A missed dose can be taken up on the same 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, consult a 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 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 pose a life-threatening risk (adrenal crisis).

In case of further doubts regarding the use of this medication, consult a 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 therefore not possible to determine the frequency of occurrence:

Infections and Infestations

Masking 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 Disorders

Changes in blood morphology (increased white blood cell count or all blood cells, decreased count of a certain type of white blood cells).

Immune System Disorders

Hypersensitivity reactions (e.g., drug rash), severe anaphylactic reactions, such as cardiac arrhythmias, bronchospasm, decreased or increased blood pressure, circulatory collapse, myocardial infarction, immunosuppression.

Endocrine Disorders

Induction of Cushing's syndrome (typical symptoms: moon face, truncal obesity, and facial reddening), suppression or reduction of adrenal cortex function.

Metabolic and Nutritional Disorders

Weight gain, increased blood glucose levels, diabetes, increased blood lipid levels (cholesterol and triglycerides), fluid retention, potassium deficiency due to increased potassium excretion, increased appetite.

Psychiatric Disorders

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

Nervous System Disorders

Increased intracranial pressure, occurrence of symptoms of latent epilepsy, increased susceptibility to seizures in epilepsy.

Eye Disorders

Cataracts, increased intraocular pressure (glaucoma), worsening of corneal ulcers, exacerbation of viral, fungal, and bacterial eye infections, blurred vision.

Cardiac Disorders

Bradycardia

Vascular Disorders

Hypertension, increased risk of atherosclerosis and thrombosis, vasculitis (including as a withdrawal syndrome after long-term treatment).

Gastrointestinal Disorders

Stomach and intestinal ulcers, gastrointestinal bleeding.

Skin and Subcutaneous Tissue Disorders

Stretch marks, thinning of the skin (paper-thin 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 Disorders

Muscle disorders, muscle weakness, muscle atrophy, bone loss (osteoporosis), which may occur depending on the dose and is also possible with short-term use, other forms of bone degeneration (bone necrosis), tendon disorders, tendonitis, tendon rupture, growth retardation in children.

Renal and Urinary Disorders

Scleroderma 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 Disorders

Disorders of sex hormone secretion (leading to amenorrhea, male-type body hair in women - hirsutism, impotence).

General Disorders and Administration Site Conditions

Delayed wound healing.

Consult a doctor or pharmacist if you experience any of the above side effects or any other side effects during treatment with Predasol. Never discontinue treatment without consulting a doctor.

In case of gastrointestinal, back, shoulder, or hip pain, psychiatric disturbances, noticeable fluctuations in blood sugar levels (in diabetic patients), or other disorders, immediately consult a doctor.

Reporting Side Effects

If you experience any side effects, including those not listed in this package leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 medication.

5. How to Store Predasol

Keep the medication out of the sight and reach of children.

There are no special storage temperature requirements for the product.

Store the ampoule with the powder 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

The ready-to-use solution for injection is intended for single use. The medication should be administered immediately after opening the ampoule. Any unused 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.

Do not dispose of medications in the sewage system or household waste containers. Ask your 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. One ampoule with powder contains prednisolone sodium succinate equivalent to 25 mg of prednisolone succinate, which corresponds to 19.6 mg of prednisolone.
• The other ingredients are sodium bicarbonate, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate.

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

What Predasol Looks Like and Contents of the Package

Predasol consists of a white to cream or yellow powder and a clear, colorless solvent.

Predasol is available in packages 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: