Demezon

Package Leaflet: Information for the Patient

Demezon, 8 mg/ml, Solution for Injection

Dexamethasone phosphate

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• 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 those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What Demezon is and what it is used for

Demezon solution for injection contains dexamethasone phosphate. Dexamethasone is a synthetic glucocorticosteroid (a type of adrenal cortex hormone) that affects metabolism, electrolyte balance, and tissue function. Demezon is used in clinical situations that require the use of glucocorticosteroids. Depending on the symptoms and severity, these include:

• brain edema caused by a brain tumor;
• traumatic shock/prophylaxis of traumatic shock lung;
• anaphylactic shock (after initial adrenaline injection);
• Demezon is indicated for the treatment of COVID-19 in adult patients and adolescents (aged 12 years and older with a body weight of at least 40 kg) with breathing difficulties and requiring 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, during the use of Demezon, severe hypersensitivity reactions (anaphylactic reactions) with circulatory collapse, cardiac arrest, arrhythmia, dyspnea (bronchospasm), and/or decreased or increased blood pressure have been observed.

Warnings and precautions

Before starting treatment with Demezon, the patient should discuss it with their doctor, pharmacist, or nurse. The patient should not stop taking any steroid medicines without their doctor's advice. General precautions for the use of steroid medicines in certain diseases, masking of infection symptoms, concurrent administration of other medicines, etc., in accordance with current recommendations. Dexamethasone should not be administered in COVID-19 disease in patients who do not require oxygen or mechanical ventilation, due to the lack of therapeutic benefits and the risk of worsening the condition in this group of patients. If special physical stress situations occur during treatment with Demezon (accident, surgery, childbirth, etc.), it may be necessary to temporarily increase the dose. Demezon may mask the symptoms of an existing or developing infection, making diagnosis difficult. Inactive infections may recur. In the circumstances listed below, treatment with Demezon can only be initiated when the attending physician considers it necessary. If necessary, other medicines with antimicrobial activity should also be taken:

• acute viral infections (chickenpox, shingles, herpes virus infections, corneal inflammation caused by herpes viruses),
• chronic active hepatitis with a positive HBsAg test result (infectious hepatitis),
• from about 8 weeks before and up to 2 weeks after vaccinations with live vaccines,
• acute and chronic bacterial infections,
• fungal infections with internal organ involvement,
• certain parasitic diseases (amebic or worm infestations). In the case of infestation or suspected infestation with roundworms, Demezon may lead to activation and massive multiplication of these parasites,
• Heine-Medin disease,
• lymph node disorders after BCG vaccination,
• if the patient has had tuberculosis in the past, the medicine can only be used concurrently with anti-tuberculosis agents.

During treatment with Demezon, the patient should carefully monitor the course of the following diseases and apply appropriate treatment:

• gastric or intestinal ulcers,
• bone loss (osteoporosis),
• difficult-to-treat hypertension,
• difficult-to-treat diabetes,
• mental disorders (also in the past), including suicidal tendencies. In such cases, neurological or psychiatric supervision is recommended,
• increased intraocular pressure (glaucoma with closed or open angle); ophthalmological supervision and appropriate treatment are recommended,
• corneal damage; ophthalmological supervision and appropriate treatment are recommended.

Treatment with this medicine may cause the occurrence of a crisis in the course of a pheochromocytoma (a rare adrenal gland tumor), which can lead to death. A crisis in the course of a pheochromocytoma may manifest as headache, excessive sweating, palpitations, and increased blood pressure. If the above symptoms occur, the patient should immediately contact their doctor. Before starting treatment with Demezon, the patient should discuss it with their doctor if there is a suspicion or diagnosis of a pheochromocytoma (adrenal gland tumor). If the patient experiences blurred vision or other vision disturbances, they should contact their doctor. Due to the risk of intestinal perforation, Demezon can only be used when there are valid reasons and under appropriate control:

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

Signs of peritoneal irritation after gastrointestinal perforation may not occur in patients receiving large doses of glucocorticosteroids. In diabetic patients, it is necessary to regularly monitor metabolism and consider the increased need for diabetes medications (insulin, oral hypoglycemic agents). Due to the risk of worsening the condition, patients with very high blood pressure and/or severe heart failure should be under close observation. During the use of large doses of the medicine, the pulse may be lower than usual. If dexamethasone is administered prematurely to a newborn, it is necessary to monitor the heart's function and structure. Severe anaphylactic reactions (hypersensitivity of the immune system) may occur. The risk of tendon diseases, tendonitis, and tendon rupture increases in patients treated concurrently with fluoroquinolones (a type of antibiotic) and Demezon. During the treatment of a certain type of muscle paralysis (myasthenia), symptoms may initially worsen. Vaccination with vaccines containing killed microorganisms (inactivated vaccines) is generally possible. However, it should be noted that after the administration of large doses of corticosteroids, the immune response may be weakened, and thus the effectiveness of the vaccine. Especially during long-term treatment with large doses of Demezon, attention should be paid to adequate potassium intake and salt consumption restriction. The doctor will monitor the potassium level in the blood. In patients treated with Demezon, viral diseases (e.g., measles, chickenpox) may have a particularly severe course, especially in children with impaired immunity and individuals who have not previously had measles or chickenpox. If these individuals come into contact with people with measles or chickenpox during treatment with Demezon, they should immediately consult a doctor, who may administer preventive treatment if necessary. The patient should consult a doctor if they experience symptoms of tumor lysis syndrome, such as muscle cramps, muscle weakness, confusion, vision disturbances, or loss of vision, and shortness of breath, if they have a hematological malignancy. Due to the possibility of transient side 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 improper use of the medicine for a long time, it is necessary to familiarize yourself with additional warnings and precautions regarding long-term therapy with glucocorticosteroid-containing medicines.

Children and Adolescents

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

Elderly Patients

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

Effects of Use for Doping

Taking Demezon may result in positive test results for doping substances.

Pregnancy and Breastfeeding

If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine.

Pregnancy

Dexamethasone passes through the placenta. During pregnancy, especially in the first three months, the medicine should only be used after a thorough assessment of the benefit-to-risk ratio. If the patient becomes pregnant or suspects they may be pregnant, they should inform their doctor. In case of long-term use of glucocorticosteroids during pregnancy, it is not possible to exclude the occurrence of growth disorders in the unborn child. In case of glucocorticosteroid use in the late stages of pregnancy, the newborn may experience adrenal insufficiency, which may require replacement therapy, which should be gradually discontinued.

Breastfeeding

Glucocorticosteroids, including dexamethasone, pass into breast milk. So far, no harmful effects on the infant have been reported. However, it is necessary to carefully consider the need for treatment during breastfeeding. If high doses are necessary due to illness, breastfeeding should be discontinued, and the doctor should be consulted immediately. Before taking/using any medicine, the patient should consult a doctor or pharmacist. In newborns of mothers who received Demezon at the end of pregnancy, low blood sugar levels may occur after birth.

Driving and Using Machines

So far, there is no evidence that Demezon affects the ability to drive and use machines or perform work that requires balance.

Demezon and Other Medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

The patient should inform their doctor if they are taking any of the following medicines, as they may affect the action of Demezon:

• Medicines that accelerate its breakdown in the liver, such as certain sleeping pills (barbiturates), antiepileptic drugs (phenytoin, carbamazepine, primidone), and some anti-tuberculosis drugs (rifampicin), may weaken the effect of corticosteroids.
• Medicines that slow down the metabolism of corticosteroids in the liver, such as certain antifungal agents (ketoconazole, itraconazole), may enhance the effect of corticosteroids.
• Certain female sex hormones, e.g., contraceptives (pills): the effect of Demezon may be increased.

Demezon may be increased.

• Ephedrine (is a component of, for example, medicines used to treat low blood pressure, chronic bronchitis, asthma attacks, nasal decongestants, and appetite suppressants): the effectiveness of Demezon may be reduced due to accelerated glucocorticosteroid metabolism.

Effect of Demezon on Other Medicines

• Concomitant use with certain blood pressure-lowering medicines (ACE inhibitors) may increase the risk of changes in blood morphology.
• Demezon may enhance the effects of glycoside medicines, due to potassium deficiency.
• Demezon may enhance potassium loss caused by diuretics or laxatives.
• Demezon may reduce the effect of oral hypoglycemic agents and insulin.
• Demezon may weaken or enhance the effect of anticoagulant medicines (oral anticoagulants, coumarin). The doctor will decide whether a change in the dose of the anticoagulant is necessary.
• If Demezon is used concurrently 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 effect of certain muscle relaxants (non-depolarizing muscle relaxants).
• Demezon may enhance the effect of medicines that increase intraocular pressure (atropine and other anticholinergic medicines).
• Demezon may reduce the effectiveness of medicines used to treat worm infestations (praziquantel).
• During concurrent use with medicines used to treat malaria and rheumatic diseases (chloroquine, hydroxychloroquine, and mefloquine), Demezon may increase the risk of muscle or heart diseases (myopathy and cardiomyopathy).
• Demezon may weaken the increase in thyrotropin (TSH) activity after the administration of protirelin (TRH, a hormone produced by the hypothalamus).
• Concurrent use with immunosuppressive agents may increase the susceptibility to infections and enhance the course of existing infections that may not have been diagnosed yet.
• Cyclosporine (an immunosuppressive agent): Demezon may increase the cyclosporine level in the blood 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, which means the medicine is considered "sodium-free".

Demezon Contains Propylene Glycol

Demezon contains 450 mg of propylene glycol in a 5 ml ampoule and 225 mg of propylene glycol in a 2.5 ml ampoule, which corresponds to 90 mg/ml. Before administering the medicine to a child under 5 years of age, the doctor or pharmacist should be consulted, especially if the child is taking other medicines containing propylene glycol or alcohol. Pregnant or breastfeeding women should not take this medicine without a doctor's recommendation. The doctor may decide to perform additional tests on such patients. Patients with liver or kidney function disorders should not take this medicine without a doctor's recommendation. The doctor may decide to perform additional tests on such patients.

3. How to Use Demezon

This medicine should always be used as directed by the doctor. The doctor decides how long to use dexamethasone. The doctor will determine the dose of the medicine suitable for the patient. The patient should follow the instructions, as otherwise, the effect of Demezon will not be correct. In case of doubts, the patient should consult a doctor or pharmacist.

Method of Administration

The medicine will be administered by intravenous injection, but it can also be administered intramuscularly. Demezon should be administered slowly (over 2-3 minutes) by intravenous injection (into a vein). The medicine can be administered intramuscularly (into a muscle) if there are difficulties with accessing a vein, but 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 remaining solution for injection should be discarded. Before administration in an infusion, the contents of the ampoule are diluted in an isotonic sodium chloride solution or 5% glucose solution.

If the doctor does not recommend otherwise, the following doses should be used:

Systemic Administration:

• Brain edema: 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, then 16 to 24 mg (up to 48 mg) per day, divided into 3-4 (up to 6) single doses for 4-8 days.
• Traumatic shock: the initial dose is 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, 40 to 100 mg (in children 40 mg) intravenously, repeat the injection if necessary.
• COVID-19 treatment: adults are recommended to receive 6 mg intravenously once a day for up to 10 days. Use in adolescentsChildren and adolescents (from 12 years of age) are recommended to receive 6 mg intravenously once a day for up to 10 days.

Method of Administration

The duration of treatment depends on the type of disease and its course. The doctor will determine the treatment plan, which should be strictly followed. As soon as a satisfactory treatment result is achieved, the dose will be reduced to a maintenance dose or treatment will be discontinued. Abrupt discontinuation of treatment after about 10 days may cause acute adrenal insufficiency, so if treatment is to be discontinued, the dose should be gradually reduced. In case of hypothyroidism or liver cirrhosis, small doses may be sufficient or the dose may need to be reduced.

Use of a Higher than Recommended Dose of Demezon

Demezon is generally well-tolerated even when used in large quantities for a short time. No special precautions are required. If the patient notices the occurrence of intensified or atypical side effects, they should consult a doctor.

Missing a Dose of Demezon

A missed dose of the medicine can be taken on the same day. The next day, the dose is taken as usual. If the patient misses several doses of the medicine, the disease symptoms may recur or worsen. In such a case, the patient should consult a doctor, who will check and possibly correct the treatment. The patient should not take a double dose to make up for a missed dose.

Discontinuation of Demezon

The patient should carefully follow the doctor's instructions regarding dosing. The patient should never discontinue taking Demezon on their own, especially since long-term use of the medicine may lead to inhibition of the body's own glucocorticosteroid production. Increased stress on the body could be life-threatening. In case of any further doubts related to the use of this medicine, the patient should consult a doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Demezon can cause side effects, although not everybody gets them. During short-term treatment with dexamethasone, the risk of side effects is low. However, short-term treatment with large doses requires monitoring of electrolyte changes, edema, possible increased blood pressure, heart failure, arrhythmias, or seizures, as well as expected clinical symptoms of infection. Monitoring of glucose tolerance is also required, as well as the occurrence of gastric and intestinal ulcers (often associated with stress), which may be less pronounced due to corticosteroid treatment. In very rare cases, Demezon may cause allergic reactions, including anaphylactic shock. However, during long-term use, especially with large doses, side effects of varying severity can be expected. Infections and InfestationsMasking of infections, occurrence or worsening of viral, fungal, and bacterial infections, as well as parasitic infections and those caused by opportunistic pathogens, stimulation of roundworm infestation. Blood and Lymphatic System DisordersChanges in blood morphology (increased white blood cell count or all blood cell counts, decreased count of certain white blood cells). Immune System DisordersHypersensitivity reactions (e.g., drug rash), severe anaphylactic reactions, such as arrhythmias, bronchospasm, excessively high or low blood pressure, circulatory collapse, cardiac arrest, weakening of the immune system. Endocrine DisordersDevelopment of Cushing's syndrome (typical symptoms include moon face, central obesity, and facial flushing), decreased adrenal cortex function. Metabolic and Nutritional DisordersWeight gain, increased blood glucose levels, diabetes, increased blood lipid levels (cholesterol and triglycerides), increased sodium levels with tissue edema, potassium deficiency due to increased potassium excretion (may lead to arrhythmias), increased appetite. Psychiatric DisordersDepression, irritability, euphoria, increased drive, psychosis, mania, hallucinations, mood changes, feeling of anxiety (anxiety), sleep disturbances, suicidal thoughts (suicide risk). Nervous System DisordersIncreased intracranial pressure, occurrence of previously undiagnosed epilepsy symptoms, increased frequency of seizures in patients with diagnosed epilepsy. Eye DisordersIncreased intraocular pressure (glaucoma), cataract, worsening of corneal ulcers, occurrence or worsening of viral, fungal, and bacterial eye infections, worsening of bacterial corneal inflammation, ptosis, mydriasis, conjunctival edema, corneal perforation, vision disturbances, loss of vision, in rare cases, reversible exophthalmos. Cardiac DisordersHypertrophic cardiomyopathy in premature infants, which usually returns to normal after treatment discontinuation (frequency unknown). Vascular DisordersHypertension, increased risk of atherosclerosis and thrombosis, vasculitis (including withdrawal syndrome after long-term treatment), increased capillary fragility. Respiratory, Thoracic, and Mediastinal DisordersHiccup. Gastrointestinal DisordersGastric and intestinal ulcers, gastrointestinal bleeding, pancreatitis, abdominal complaints. Skin and Subcutaneous Tissue DisordersStretch marks, skin thinning, telangiectasia, bruising, very small or superficial hemorrhages, excessive hair growth, acne, facial skin inflammation, especially around the mouth, nose, and eyes, skin pigmentation changes. Musculoskeletal and Connective Tissue DisordersMuscle disorders, muscle weakness, muscle atrophy, and osteoporosis, which occur depending on the dose and are also possible during short-term use; other forms of bone degeneration (bone necrosis), tendon disorders, tendonitis, tendon rupture, fat accumulation in the spine (epidural lipomatosis), growth retardation in children. Note: Disorders such as withdrawal syndrome, manifested by muscle pain and joint pain, may occur if the dose is reduced too quickly after long-term treatment. Reproductive System and Breast DisordersHormonal disorders leading to irregular menstrual bleeding or amenorrhea, hirsutism in women, impotence. General Disorders and Administration Site ConditionsDelayed wound healing.

Procedure

If any side effects occur, including those not listed in the leaflet, the patient should consult a doctor or pharmacist. The patient should not discontinue treatment without consulting a doctor. If gastrointestinal or joint disorders, back or shoulder pain, mental disorders, noticeable changes in blood glucose levels (in diabetic patients), or any other disorders occur, the patient should immediately consult a doctor.

Reporting Side Effects

If any side effects occur, including those not listed in this leaflet, the patient should inform their doctor or pharmacist. 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 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 medicine.

5. How to Store Demezon

The medicine should be stored out of sight and reach of children. Do not store 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 specified month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What Demezon Contains

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

What Demezon Looks Like and Contents of the Pack

Demezon is available in colorless ampoules containing 2.5 ml or 5 ml of a clear, colorless, or almost colorless solution for injection in a cardboard box. Pack sizes: 1 ampoule of 2.5 ml solution. 1 or 5 ampoules of 5 ml solution. 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 SUN-FARM Sp. z o.o. ul. Dolna 21 05-092 Łomianki

Date of Last Revision of the Leaflet:

Information Intended for Healthcare Professionals Only:

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

Method of Administration:

Demezon should be administered slowly (over 2-3 minutes) by intravenous injection or infusion, but it can also be administered intramuscularly if there are difficulties with accessing a vein, but blood circulation is normal. The duration of treatment depends on the indications. In case of hypothyroidism or liver cirrhosis, small doses may be sufficient or the dose may need to be reduced.

Instructions for Use

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

Storage Conditions:

See section 5 "How to Store Demezon". After opening: use immediately. After dilution in infusion fluids, chemical and physical stability has been demonstrated for 24 hours at 25°C. Do not store in the refrigerator. For microbiological reasons, the product should be used immediately, unless the opening/dilution method prevents the possibility of microbial contamination. If the product is not used immediately, the user is responsible for the storage time and conditions.