Package leaflet: Information for the patient

Demezon, 8 mg/ml, solution for injection
Dexamethasoni phosphas
Please read this leaflet carefully before using this medicine, because it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Demezon is and what it is used for
Important information before using Demezon
How to use Demezon
Possible side effects
How to store Demezon
Contents of the package and other information

1. What Demezon is and what it is used for

Demezon solution for injection contains dexamethasone phosphate. Dexamethasone
is a synthetic glucocorticoid (a type of corticosteroid hormone), affecting
metabolism, electrolyte balance, and tissue function.
Demezon is indicated in clinical situations requiring the use of
glucocorticoids. Depending on symptoms and severity, these include, among others:

Cerebral edema associated with brain tumor;
Traumatic shock/prophylaxis of traumatic shock lung;
Anaphylactic shock (after initial adrenaline injection);
Demezon is indicated in the treatment of COVID-19 in adult and adolescent patients (aged 12 years and older with body weight at least 40 kg) who have difficulty breathing and require oxygen therapy.

2. Important information before using Demezon

When not to use Demezon:

if the patient is allergic to dexamethasone or any of the other ingredients of this medicine (listed in section 6). In individual cases, severe hypersensitivity reactions (anaphylactic reactions) have been observed during the use of Demezon, including circulatory collapse, cardiac arrest, cardiac arrhythmia, dyspnea (bronchospasm), and/or decreased or increased arterial blood pressure.

Warnings and precautions

Before starting treatment with Demezon, discuss this with your doctor, pharmacist, or nurse.
Do not stop taking any steroid medicines unless your doctor advises otherwise.
General precautions regarding the use of steroid medicines in specific diseases, masking of infection symptoms, concomitant medications, etc., should be followed according to current guidelines.
Dexamethasone should not be administered in COVID-19 disease in patients who do not require oxygen supplementation or mechanical ventilation, due to lack of therapeutic benefit and risk of worsening health in this patient group.
If unusual physical stress occurs during treatment with Demezon (e.g., accident, surgery, childbirth, etc.), temporary dose increase may be necessary.
Demezon may mask symptoms of existing or developing infections, making diagnosis difficult. Inactive infections may reactivate.
Treatment with Demezon should only be initiated if deemed necessary by the treating physician in the following conditions. Concomitant antimicrobial therapy may also be required:

acute viral infections (chickenpox, shingles, herpes virus infections, herpes keratitis),
chronic active hepatitis with positive HBsAg test (infectious hepatitis),
from approximately 8 weeks before to 2 weeks after vaccination with live vaccines,
acute and chronic bacterial infections,
fungal infections involving internal organs,
certain parasitic diseases (infection with amoeba or worms). In case of infection or suspected infection with nematodes, Demezon may lead to activation and massive proliferation of these parasites,
Heine-Medin disease (poliomyelitis),
lymph node disorders following BCG vaccination,
if the patient has previously had tuberculosis, the medicine should only be used concomitantly with anti-tuberculosis agents.

During treatment with Demezon, the following conditions should be carefully monitored and appropriate treatment initiated:

gastric or intestinal ulcers,
bone mass loss (osteoporosis),
hypertension difficult to control,
diabetes difficult to control,
psychiatric disorders (including past history), including suicidal tendencies. In such cases, supervision by a neurologist or psychiatrist is recommended,
increased intraocular pressure (closed-angle or open-angle glaucoma); ophthalmological supervision and appropriate treatment are recommended,
corneal damage and ulceration; ophthalmological supervision and appropriate treatment are recommended.

Use of this medicine may cause a pheochromocytoma crisis, which can be fatal. Pheochromocytoma is a rare adrenal gland tumor. A pheochromocytoma crisis may present with headache, excessive sweating, palpitations, and elevated blood pressure. If these symptoms occur, the patient should contact a doctor immediately.
Before starting treatment with Demezon, discuss with your doctor if there is suspicion of or a diagnosed pheochromocytoma (adrenal gland tumor).
If the patient experiences blurred vision or other visual disturbances, they should contact a doctor.
Due to the risk of intestinal perforation, Demezon should only be used when there are strong indications and under appropriate monitoring:

in severe colitis (ulcerative colitis) with perforation risk, with ulcerative or suppurative inflammation that may occur without peritoneal irritation,
in diverticulitis (inflammation of intestinal pouches),
after certain intestinal surgeries (intestinal anastomosis), immediately after surgery.

Signs of peritoneal irritation following gastrointestinal perforation may not appear in patients receiving high doses of glucocorticoids.
In patients with diabetes, metabolism should be monitored regularly, and increased requirements for antidiabetic medications (insulin, oral antidiabetic drugs) should be considered.
Due to the risk of exacerbation of symptoms, patients with very high blood pressure and/or severe heart failure should remain under close observation.
During administration of high doses of the medicine, pulse rate may be lower than usual.
If dexamethasone is administered to a premature infant, cardiac function and structure must be monitored.
Severe anaphylactic reactions (immune system hypersensitivity) may occur.
The risk of tendon diseases, tendonitis, and tendon rupture increases in patients treated concomitantly with fluoroquinolones (a type of antibiotic) and Demezon.
During treatment of a specific type of muscle paralysis (myasthenia gravis), symptoms may initially worsen.
Vaccination with vaccines containing killed pathogenic microorganisms (inactivated vaccines) is generally possible. However, it should be remembered that after administration of high doses of corticosteroids, immune response and thus vaccine efficacy may be reduced.
Particular attention should be paid during prolonged treatment with high doses of Demezon to ensure adequate potassium intake and restriction of salt consumption. The doctor will monitor blood potassium levels.
Viral diseases (e.g., measles, chickenpox) may have a particularly severe course in patients treated with Demezon, especially in immunocompromised children and individuals who have never had measles or chickenpox. In case of contact with persons suffering from measles or chickenpox during Demezon treatment, immediate medical consultation is required, and preventive treatment may be initiated if necessary.
Contact a doctor if the patient develops symptoms of tumor lysis syndrome, such as: muscle cramps, muscle weakness, confusion, visual disturbances, or vision loss, and shallow breathing, especially if the patient has a hematological malignancy.
Due to the possibility of transient adverse effects during too rapid administration of the medicine, such as unpleasant tingling or sensory disturbances (paresthesia), which are harmless and last up to 3 minutes, intravenous injection should be performed slowly (over 2–3 minutes).
Demezon is intended for short-term use. In case of inappropriate long-term use, additional warnings and precautions regarding prolonged therapy with glucocorticoid-containing medicines should be observed.

Children and adolescents
Routine use of dexamethasone is not recommended in premature infants with lung disorders.
This medicine should only be used in children when necessary, due to the risk of growth retardation. During long-term treatment, the child's growth should be monitored regularly.

Elderly patients
Due to the increased risk of osteoporosis, the doctor will evaluate the benefit-risk ratio of using the medicine in elderly patients.

Effects when used for doping purposes
Use of Demezon may result in positive doping test results.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Dexamethasone crosses the placenta. During pregnancy, especially during the first three months, the medicine should only be used after careful assessment of benefit versus risk. If the patient is pregnant or becomes pregnant, she should inform her doctor. With prolonged use of glucocorticosteroids during pregnancy, impaired fetal growth cannot be excluded. In cases of glucocorticosteroid use in late pregnancy, neonatal adrenal insufficiency may occur. This may require replacement therapy, which should be gradually withdrawn.

Breastfeeding
Glucocorticosteroids, including dexamethasone, pass into breast milk. Harmful effects on the infant have not been reported to date. However, the necessity of treatment during breastfeeding should be carefully considered. If high doses are required due to illness, breastfeeding should be discontinued and immediate medical consultation sought.
Before taking/using any medicine, consult a doctor or pharmacist.
Newborns of mothers who received Demezon near the end of pregnancy may have low blood sugar levels after birth.

Driving and operating machinery
There is currently no evidence that Demezon affects the ability to drive or operate machinery or perform tasks requiring balance.

Demezon with other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.

Inform your doctor if the patient is taking any of the following medicines,
as they may affect the action of Demezon:

Medicines that accelerate its metabolism in the liver, such as certain sleeping pills (barbiturates), anticonvulsants (phenytoin, carbamazepine, primidone), and certain anti-tuberculosis drugs (rifampicin), may reduce the effect of corticosteroids.
Medicines that slow down corticosteroid metabolism in the liver, such as certain antifungal drugs (ketoconazole, itraconazole), may enhance the effect of corticosteroids.
Certain female sex hormones, e.g., contraceptives (oral contraceptives): the effect of Demezon may be increased.
Ephedrine (a component of, e.g., medicines used to treat low blood pressure, chronic bronchitis, asthma attacks, nasal decongestants in colds, and appetite suppressants): the effectiveness of Demezon may be reduced due to accelerated metabolism of glucocorticosteroids.

Effect of Demezon on other medicines

Concurrent use with certain blood pressure-lowering medicines (ACE inhibitors) may increase the risk of blood morphology changes.
Demezon may enhance the effects of cardiac glycosides due to potassium deficiency.
Demezon may enhance potassium loss caused by diuretics or laxatives.
Demezon may reduce the glucose-lowering effect of oral antidiabetic drugs and insulin.
Demezon may weaken or strengthen the effect of anticoagulant medicines (oral anticoagulants, coumarins). The doctor will decide whether a dose adjustment of the anticoagulant is necessary.
If Demezon is used concomitantly with anti-inflammatory and anti-rheumatic medicines (salicylates, indomethacin, and other non-steroidal anti-inflammatory drugs), there may be an increased risk of gastric ulcers and gastrointestinal bleeding.
Demezon may prolong the muscle-relaxing effect of certain non-depolarizing muscle relaxants.
Demezon may enhance the effect of medicines that increase intraocular pressure (atropine and other anticholinergics).
Demezon may reduce the effectiveness of medicines used to treat worm infestations (praziquantel).
When used concomitantly with medicines used to treat malaria and rheumatic diseases (chloroquine, hydroxychloroquine, and mefloquine), Demezon may increase the risk of muscle or heart disorders (myopathy and cardiomyopathy).
Demezon may reduce the increase in thyrotropin (TSH) activity after protirelin (TRH, a hormone produced by the hypothalamus).
Concurrent use of Demezon with immunosuppressive medicines may increase susceptibility to infections and worsen the course of existing but not yet apparent infections.
Cyclosporine (an immunosuppressive medicine): Demezon may increase cyclosporine blood levels and thus the risk of seizures.
Fluoroquinolones (a group of antibiotics): may increase the risk of tendon rupture.

Effect on diagnostic tests
Glucocorticosteroids may suppress skin reactions in allergy tests.

Demezon contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per ampoule, meaning the medicine is considered "sodium-free."

Demezon contains propylene glycol
Demezon contains 450 mg of propylene glycol in the ampoule containing 5 ml of solution and 225 mg of propylene glycol in the ampoule containing 2.5 ml of solution, corresponding to 90 mg/ml.
Before administering the medicine to a child under 5 years of age, consult a doctor or pharmacist, especially if the child is taking other medicines containing propylene glycol or alcohol.
Women who are pregnant or breastfeeding should not take this medicine without medical advice.
The doctor may decide to perform additional tests in such patients.
Patients with impaired liver or kidney function should not take this medicine without medical advice. The doctor may decide to perform additional tests in such patients.

3. How to use Demezon

This medicine should always be used as directed by the physician. The physician decides how long
dexamethasone should be administered and determines the appropriate dose for each individual
patient. It is important to follow these instructions, as otherwise the effect of Demezon may not be
adequate.
If in doubt, consult a physician or pharmacist.

Method of administration
The medicine will be administered by intravenous injection, but may also be given by intramuscular
injection.
Demezon should be administered slowly (over 2–3 minutes) by intravenous injection (into a vein).
The medicine may be administered intramuscularly (into muscle) if intravenous access is difficult,
provided that blood circulation is normal.

Suitability for use
Only a clear solution should be used. The contents of the ampoule are intended for single use only.
Any unused portion of the solution remaining after injection must be discarded.
Immediately before administration in an infusion, the contents of the ampoule should be diluted in
isotonic sodium chloride solution or 5% glucose solution.

Unless otherwise directed by the physician, the following doses should be used:
Systemic administration:

Cerebral oedema: initially in acute conditions, depending on the cause and severity of the disease, the initial dose is 8 to 10 mg (up to 80 mg) intravenously, followed by 16 to 24 mg (up to 48 mg) per day, divided into 3–4 (up to 6) single doses for 4–8 days.
Shock following severe trauma: initial dose of 40 to 100 mg (in children: 40 mg) intravenously, repeated after 12 hours, or 16 to 40 mg every 6 hours for 2–3 days.
Anaphylactic shock: after initial intravenous administration of adrenaline, administer 40 to 100 mg (children: 40 mg) intravenously, repeat injection if necessary.
Treatment of COVID-19: adults should receive 6 mg intravenously once daily for up to 10 days. Use in adolescents Children and adolescents (aged 12 years and older) should receive 6 mg intravenously once daily for up to 10 days.

Method of administration
The duration of treatment depends on the type and course of the disease. The physician will determine
the treatment plan, which must be strictly followed. Once a satisfactory therapeutic response is
achieved, the dose will be reduced to a maintenance dose or treatment will be discontinued.
Abrupt discontinuation of treatment after approximately 10 days may result in acute adrenal
insufficiency; therefore, if treatment is to be stopped, the dose should be gradually tapered.
Relatively low doses may be sufficient, or dose reduction may be necessary, in patients with
hypothyroidism or hepatic cirrhosis.

Use of a higher than recommended dose of Demezon
Demezon is generally well tolerated, even when large amounts are administered for a short period.
No special precautions are required. If the patient experiences severe or unusual adverse effects,
medical advice should be sought.

Missed dose of Demezon
A missed dose may be taken on the same day. On the following day, resume the usual dosing
schedule. If multiple doses are missed, symptoms of the disease may recur or worsen. In such a case,
consult the physician, who will assess and, if necessary, adjust the treatment.
Do not use a double dose to make up for a missed dose.

Stopping treatment with Demezon
Follow the physician's dosing instructions exactly. Never discontinue Demezon treatment
independently, especially since prolonged use of the medicine may suppress the body's natural
production of glucocorticosteroids. Significant stress on the body could then become life-threatening.
If there are any further doubts regarding the use of this medicine, consult a physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The risk of adverse reactions with short-term treatment with dexamethasone is low.
However, short-term treatment with high doses requires monitoring of electrolyte changes, development of oedema, possible increase in blood pressure, heart failure, cardiac rhythm disturbances (arrhythmias), or seizures, and clinical signs of infection should also be anticipated. Monitoring is also required for reduced glucose tolerance as well as the occurrence of gastric and intestinal ulcers (often stress-related), which may be less apparent due to corticosteroid treatment. In very rare cases, Demezon may cause allergic reactions, even anaphylactic shock.
However, during long-term use, especially of high doses, adverse reactions of varying severity may be expected.

Infections and parasitic infections
Masking of infections, occurrence or worsening of viral, fungal, and bacterial infections, as well as parasitic infections and those caused by opportunistic pathogens, activation of Strongyloides stercoralis infection.

Blood and lymphatic system disorders
Blood morphology changes (increased number of white blood cells or all blood cells, decreased number of certain types of white blood cells).

Immune system disorders
Hypersensitivity reactions (e.g. drug rash), severe anaphylactic reactions such as cardiac arrhythmias, bronchospasm (constriction of smooth muscles of bronchi), excessively high or low arterial blood pressure, circulatory collapse, cardiac arrest, immunosuppression.

Endocrine disorders
Development of so-called Cushing's syndrome (typical symptoms include moon face, central obesity, and facial flushing), impaired function or atrophy of the adrenal cortex.

Metabolism and nutrition disorders
Weight gain, increased blood glucose concentration, diabetes, increased blood lipid levels (cholesterol and triglycerides), increased sodium concentration with tissue oedema, potassium deficiency due to increased potassium excretion (may lead to cardiac arrhythmias), increased appetite.

Psychiatric disorders
Depression, irritability, euphoria, increased drive, psychosis, mania, hallucinations, mood changes, feelings of anxiety (anxiety), sleep disturbances, suicidal thoughts (suicide risk).

Nervous system disorders
Increased intracranial pressure, emergence of symptoms of previously undiagnosed epilepsy, increased frequency of seizures in patients diagnosed with epilepsy.

Eye disorders
Increased intraocular pressure (glaucoma), cataract, worsening of corneal ulcers, occurrence or exacerbation of viral, fungal, and bacterial eye infections, worsening of bacterial corneal ulceration, ptosis (drooping eyelid), pupil dilation, conjunctival oedema, scleral perforation (white part of the eye), visual disturbances, vision loss, in rare cases reversible ocular proptosis (exophthalmos), blurred vision.

Cardiac disorders
Myocardial hypertrophy (hypertrophic cardiomyopathy) in preterm infants, which usually returns to normal after discontinuation of treatment (frequency unknown).

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

Respiratory, thoracic and mediastinal disorders
Hiccups

Gastrointestinal disorders
Gastric and intestinal ulcers, gastrointestinal bleeding, pancreatitis, epigastric discomfort.

Skin and subcutaneous tissue disorders
Striae, skin thinning ("parchment skin"), dilatation of blood vessels, tendency to bruising, very small or superficial haemorrhages, excessive hair growth, acne, inflammatory skin changes on the face, especially around the mouth, nose and eyes, skin pigmentation changes.

Musculoskeletal and connective tissue disorders
Muscle disorders, muscle weakness, muscle atrophy, and osteoporosis occur in a dose-dependent manner and are possible even during short-term use; other forms of bone degeneration (osteonecrosis), tendon disorders, tendonitis, tendon rupture, fat accumulation in the spine (epidural lipomatosis), growth suppression in children.

Note:
Disorders such as withdrawal syndrome, manifesting among others as muscle pain and joint pain, may occur if the dose is reduced too quickly after long-term treatment.

Reproductive system and breast disorders
Disturbances in sex hormone secretion leading to irregular menstrual bleeding or absence of menstrual bleeding, development of male-pattern hair growth in women (hirsutism), impotence.

General disorders and administration site conditions
Delayed wound healing.

Management
If any adverse reactions occur, whether listed in this leaflet or not, consult a doctor or pharmacist. Do not discontinue treatment without consulting a doctor.
If gastrointestinal or intestinal disturbances, back, shoulder or hip joint pain, psychiatric disturbances, noticeable changes in blood glucose concentration (in diabetic patients), or any other disturbances occur, contact a doctor immediately.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Demezon

Keep this medicine out of sight and reach of children.
Do not store at temperatures above 25 °C.
Do not store in the refrigerator or freeze.
Store in the outer packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the pack and other information

What Demezon contains

The active substance is dexamethasone phosphate (in the form of dexamethasone sodium phosphate). 1 ml of solution contains 8 mg of dexamethasone phosphate.
The other ingredients are: edetate disodium, propylene glycol, sodium hydroxide, water for injections.

What Demezon looks like and contents of the pack
Demezon is available in colourless ampoules containing 2.5 ml or 5 ml of a clear, colourless or almost colourless solution for injection, packed in a cardboard box.
Pack sizes:
1 ampoule with 2.5 ml of solution.
1 or 5 ampoules with 5 ml of solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki
tel. +48 22 350 66 69

Manufacturer
mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany

SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki

Information intended exclusively for medical professionals:

Each 2.5 ml ampoule contains 20 mg of dexamethasone phosphate (as dexamethasone sodium phosphate).
Each 5 ml ampoule contains 40 mg of dexamethasone phosphate (as dexamethasone sodium phosphate).

Route of administration:
The medicinal product Demezon should be administered by slow intravenous injection (over 2–3 minutes) or infusion, but may also be given intramuscularly if venous access is difficult, provided that blood circulation is adequate. The duration of treatment depends on the indication.
In cases of hypothyroidism or hepatic cirrhosis, lower doses may be sufficient or dose reduction may be necessary.

Guidelines on solution suitability:
Only clear solutions should be used. The contents of the ampoule are intended for single use only. Any unused portion of the injectable solution should be discarded.
Immediately before infusion, the contents of the ampoule should be diluted in isotonic sodium chloride solution or 5% glucose solution.

Storage conditions:
See section 5 "How to store Demezon".
After opening: use immediately.
When diluted in infusion fluids, the product has been shown to be chemically and physically stable for 24 hours at 25°C. Do not store in the refrigerator. From a microbiological point of view, the product should be used immediately unless the method of opening/dilution ensures protection against microbial contamination. If the product is not used immediately, the responsibility for storage conditions and duration lies with the user.