Predasol

Leaflet accompanying the packaging: information for the user

Predasol, 250 mg, powder and solvent for solution for injection/infusion

Prednisolone hemisuccinate

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

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What Predasol is and what it is 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 packaging and other information

1. What Predasol is and what it is 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 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 widespread, acute, severe skin diseases, such as erythroderma, pemphigus vulgaris, 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 symptoms similar to poisoning (e.g., in the course of tuberculosis, typhoid fever), only in combination with additional 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 medicine (listed in section 6).

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.

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

• Stomach and intestinal ulcers;
• Osteoporosis (bone loss);
• 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, supervision by a neurologist or psychiatrist is recommended;
• Increased intraocular pressure (glaucoma with narrow and wide angle filtration) - ophthalmologic supervision and concomitant treatment (targeted) are recommended;
• Corneal damage and ulcers - ophthalmologic supervision and concomitant treatment (targeted) are recommended.

Predasol may increase the risk of infections, as it suppresses the body's immune system. 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 a latent infection.

• Acute viral infections (viral hepatitis B, chickenpox, shingles, herpes, corneal herpes);
• Chronic active viral hepatitis with a positive test result for HBsAg (infectious liver disease);
• During the period from about 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 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.

In addition, during treatment with Predasol, the doctor will monitor the patient's condition and adjust the treatment as needed.

• Stomach and intestinal ulcers;
• Osteoporosis (bone loss);
• 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, supervision by a neurologist or psychiatrist is recommended;
• Increased intraocular pressure (glaucoma with narrow and wide angle filtration) - ophthalmologic supervision and concomitant treatment (targeted) are recommended;
• Corneal damage and ulcers - ophthalmologic supervision and concomitant treatment (targeted) are recommended.

The use of 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. 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, 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 abscessing, 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 fluorquinolones (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, who are taking Predasol, come into contact with people suffering from measles or chickenpox, they should immediately contact their doctor, who will start appropriate preventive treatment.

Essentially, vaccinations with killed microorganisms (inactivated vaccines) are allowed. However, it should be taken into account 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 rate or duration of administration of the medicine.

In the case of long-term use of high doses of Predasol, it is necessary to ensure adequate potassium intake (e.g., vegetables, bananas) and limit salt intake. 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 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 higher 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 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, as well as any medicines you plan to take, including those available without a prescription.

Influence on the effect of Predasol

Enhancement of effect or possible enhancement of side effects

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

Weakening of effect

• Medicines that accelerate liver metabolism, such as certain sedatives (barbiturates), antiepileptic medications (containing phenytoin, carbamazepine, and primidone), and certain antituberculosis medications (containing rifampicin), may weaken 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.

Influence of Predasol on the effect of other medicines

Enhancement of effect or possible enhancement of side 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 increase 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 increase 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 used concurrently with medications used to treat malaria and rheumatic diseases (containing chloroquine, hydroxychloroquine, mefloquine).
• Predasol may increase the concentration of cyclosporin in the blood (a medication that reduces the activity of the immune system) 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 exacerbate or trigger symptoms of previously undiagnosed infections.

Fluorquinolones - a certain group of antibiotics - may increase the risk of tendon damage.

Weakening of effect

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

Enhancement or weakening of effect

Predasol may decrease or increase the effect of anticoagulant medications (oral anticoagulants, coumarin derivatives). The doctor will decide whether it is necessary to adjust the dose of the anticoagulant medication.

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 medicine.

Pregnancy

This medicine should only be used during pregnancy 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 therapy 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. Consult your doctor immediately.

Driving and operating machinery

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

Predasol contains sodium

The medicine contains 23.94 mg of sodium (the main component of common salt) per vial, which is 1.2% 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 solution. For accurate information on the sodium content in the solution used to dilute the product, refer to the 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 intravenously (in children 250 mg), and then administer fluids and, if necessary, apply 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 drowning

Initial 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 in divided intravenous 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 attack

Initial dose in adults: 100 to 500 mg of prednisolone intravenously, followed by further treatment with the same or lower doses at approximately 6-hour intervals, then gradual dose reduction 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. It is recommended to administer bronchodilators concurrently.

Prophylaxis or treatment of brain edema

Initial dose: 250 to 1000 mg of prednisolone intravenously (if fosfomycin dexamethasone 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 transplantation

In 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 to 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)

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

Adrenal crisis

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.

Pseudocroup

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

Method of administration

Predasol is administered by medical personnel intravenously or as an infusion. 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 prepared solution for injection is intended for single use. Any unused remainder of the solution should be discarded.

The medicine should be administered immediately after opening the vial. In exceptional cases, the prepared solution for injection can be stored for a maximum of 24 hours at a temperature of 2 to 8 °C (see section 5).

To prepare the solution for injection, the supplied solvent (water for injection) should be injected directly into the vial with the powder before use and mixed until the powder is dissolved.

Compatibility with infusion fluids

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 medicine 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 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 dose of Predasol than recommended

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 side effects, they should consult a 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 a doctor, who will assess the treatment and adjust it if necessary.

Discontinuation of Predasol

Always follow the dosing schedule prescribed by the doctor. Never discontinue the use of Predasol without consulting a 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).

In case of any further doubts regarding the use of this medicine, consult a 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 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 (smooth muscle spasm in the bronchi), decreased or increased blood pressure, circulatory collapse, heart attack, stroke.

Endocrine disorders

Induction 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 disorders

Weight gain, increased blood glucose levels, diabetes, increased levels of fats in the blood (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 (slow heart rate)

Vascular disorders

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

Gastrointestinal disorders

Stomach and intestinal ulcers, gastrointestinal bleeding, pancreatitis.

Skin and subcutaneous tissue disorders

Stretch marks, thinning of the skin ("parchment-like skin"), dilated blood vessels, tendency to bruise, pinpoint or superficial 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 during 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 absence of menstrual bleeding, 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 symptoms, back, shoulder, or hip pain, psychiatric disorders, noticeable fluctuations in blood sugar levels (in patients with diabetes), or other disorders, immediately contact a doctor.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Jerozolimskie Avenue 181C, 02-222 Warsaw, phone: +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.

Do not store above 25 °C.

Store the powder vial 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

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 a maximum of 24 hours at a temperature of 2 to 8 °C.

The vials are not suitable for reuse. Any unused remainder of the 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.

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 packaging and other information

What Predasol contains

• The active substance of the medicine is prednisolone sodium succinate. One vial of powder contains prednisolone sodium succinate equivalent to 250 mg of prednisolone succinate, which corresponds to 195.7 mg of prednisolone.
• The other ingredients are: sodium bicarbonate, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate.

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

What Predasol looks like and contents of the packaging

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

Predasol is available in packaging containing:

1 vial of powder for solution for injection/infusion and 1 ampoule of solvent containing 5 ml of water for injection,

3 vials of powder for solution for injection/infusion and 3 ampoules of solvent containing 5 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., Dolna 21, 05-092 Łomianki, phone: +48 22 350 66 69

Manufacturer

mibe GmbH Arzneimittel, Münchener Straße 15, 06796 Brehna, Germany

Date of last revision of the leaflet: