Demezon

Leaflet accompanying the packaging: patient information

Demezon, 4 mg/ml, solution for injection

Dexamethasone phosphate

Read the 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 any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Demezon and what is it used for

Demezon solution for injection contains dexamethasone phosphate. Dexamethasone is a synthetic glucocorticosteroid (a type of adrenal cortex hormone). It has a very strong and long-lasting anti-inflammatory, anti-allergic, and immunosuppressive effect. Demezon is used to treat life-threatening conditions that require the administration of glucocorticosteroids, as well as clinical situations that require the use of glucocorticosteroids to treat and/or alleviate the symptoms of the underlying disease.

2. Important information before using Demezon

When not to use Demezon:

• intramuscularly, if the patient has idiopathic thrombocytopenic purpura;
• intra-articularly, in cases where the patient has: infection in or near the joint, requiring treatment, bacterial arthritis, joint instability requiring treatment, hemorrhagic diathesis, periarticular calcification, avascular necrosis of bone, tendon rupture, Charcot's joint;
• locally, without additional causal treatment, in case of infections at the injection site. In life-threatening conditions, there are no contraindications to the use of the medicine, especially if it is expected to be administered for a short time (24-36 hours).

Warnings and precautions

During the use of Demezon, psychological disorders may occur, ranging from euphoria, insomnia, mood changes, and personality changes to severe depression and psychotic symptoms. The patient should inform their doctor about any history of emotional instability, psychotic tendencies, or past illnesses, such as depression or manic-depressive syndrome. The symptoms accompanying these conditions may worsen under the influence of Demezon. Glucocorticosteroids may mask some symptoms of inflammation, and during their use, new infections may develop. During the use of glucocorticosteroids, the body's resistance may decrease, and there may be difficulties in localizing the infection. While using Demezon, the patient should not undergo live viral vaccinations (e.g., smallpox, measles) due to the risk of neurological disorders and ineffectiveness of immunization. The patient should inform their doctor about any past infectious diseases, such as chickenpox, measles, and vaccinations received, as well as exposure to any of these diseases. During the use of dexamethasone, the patient should avoid exposure to viral diseases (chickenpox, measles), especially if they have not had these diseases in the past. Particular caution should be exercised when using Demezon in patients with the following conditions (the patient should inform their doctor about them before starting to use Demezon, even if these conditions occurred in the past):

• osteoporosis (especially in postmenopausal women),
• hypertension or congestive heart failure,
• severe mental illness (especially if they occurred after previous administration of steroid drugs) currently or in the past,
• diabetes (or a family history of diabetes),
• past tuberculosis, as glucocorticosteroids may cause a relapse of the disease,
• glaucoma (or a family history of glaucoma),
• steroid-induced muscle weakness in the past,
• liver failure,
• kidney failure,
• epilepsy,
• gastric and duodenal ulcers,
• migraine,
• certain parasitic diseases, especially amoebiasis,
• growth retardation,
• Cushing's syndrome,
• symptoms of tumor lysis syndrome, such as muscle cramps, muscle weakness, confusion, vision disturbances, or loss of vision, and shortness of breath, in case the patient has a hematological malignancy.

During the use of high doses of the medicine, the pulse may be lower than usual. After the administration of Demezon, severe allergic reactions may occur, such as laryngeal edema, urticaria, bronchospasm, especially in patients who have had allergic reactions in the past. When using Demezon locally, one should consider the possibility of side effects and interactions as in the case of systemic administration. Intra-articular administration of Demezon increases the risk of joint infections. Prolonged and repeated use of glucocorticosteroids in stressed joints may lead to worsening of degenerative joint changes. One possible cause is overloading of the affected joint after pain or other symptoms have subsided. The use of this medicine may cause a crisis in the course of pheochromocytoma (Pheochromocytoma crisis), which can be life-threatening. Pheochromocytoma is a rare adrenal gland tumor. A crisis in its course may manifest as headache, excessive sweating, palpitations, and increased blood pressure. If these symptoms occur, the patient should contact their doctor immediately. Before starting to use Demezon, the patient should discuss it with their doctor if there is a suspicion or diagnosis of pheochromocytoma (adrenal gland tumor). If the patient experiences blurred vision or other vision disturbances, they should contact their doctor. If dexamethasone is administered to a premature infant, it is necessary to monitor the heart's function and structure.

Children and adolescents

Caution should be exercised when using Demezon in children. The growth and development of children should be carefully monitored during long-term use of glucocorticosteroids. Premature infants Available data indicate the occurrence of long-term adverse events affecting the neurological development of premature infants with chronic lung disease after early treatment (within 96 hours) with an initial dose of 0.25 mg/kg body weight twice daily. Newborns Warning regarding the use of Demezon in newborns is described in the section "Demezon contains sodium and propylene glycol" at the end of this point.

Elderly patients

Side effects may be more severe in elderly patients, especially osteoporosis, hypertension, hypokalemia (low potassium levels in the blood), diabetes, susceptibility to infections, and skin thinning.

Effect of the medicine when used inappropriately as a doping agent

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

Demezon and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, including those available without a prescription. Some medicines may enhance the effect of Demezon, and the doctor may want to monitor the patient's condition closely when taking such medicines (including some HIV medicines: ritonavir, cobicistat). In particular, the patient should inform their doctor about taking any of the following medicines, due to their possible effect on Demezon or modification of the effect of these medicines by Demezon:

• phenytoin, carbamazepine, primidone, phenobarbital (medicines used to treat epilepsy),
• rifampicin, rifabutin (antibiotics used to treat tuberculosis),
• ketoconazole, itraconazole (medicines used to treat fungal infections),
• medicines used to treat diabetes, including insulin,
• antihypertensive and diuretic medicines,
• cardiac glycosides (medicines used to treat heart failure),
• anticoagulant medicines derived from coumarin (warfarin, acenocoumarol),
• oral contraceptives containing estrogen and progestogen,
• non-steroidal anti-inflammatory medicines (NSAIDs), such as acetylsalicylic acid (aspirin), ibuprofen, indomethacin,
• laxatives,
• medicines used to treat myasthenia,
• medicines used to relax muscles (non-depolarizing muscle relaxants), e.g., pancuronium,
• atropine and anticholinergic medicines (medicines used to increase intraocular pressure),
• fluoroquinolones (a group of antibiotics),
• cyclosporine (a medicine that suppresses the immune system),
• protirelin (a hormone produced by the hypothalamus in the brain),
• chloroquine, hydroxychloroquine, mefloquine (medicines used to treat malaria and rheumatic diseases),
• praziquantel (a medicine used to treat parasitic infections),
• aminoglutethimide (a medicine used to treat cancer),
• acetazolamide (a medicine used to treat glaucoma, epilepsy, etc.),
• carbenoxolone (a medicine used to treat gastric ulcers),
• ephedrine (a medicine used locally to constrict blood vessels in inflammatory conditions of the nasal mucosa).

Demezon may suppress skin reactions in allergy tests.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine. The medicine should only be used if, in the doctor's opinion, the benefits to the mother outweigh the potential risk to the fetus. Newborns born to mothers who received high doses of glucocorticosteroids during pregnancy should be monitored for the risk of adrenal insufficiency. Glucocorticosteroids pass into breast milk and may impair growth, endogenous production of glucocorticosteroids, and cause other side effects in newborns and infants. Breastfeeding mothers are advised to stop breastfeeding during the use of the medicine. In newborns of mothers who were given Demezon at the end of pregnancy, low blood sugar may occur after birth.

Driving and operating machinery

There is currently no data indicating an effect of the medicine on driving or operating machinery.

Demezon contains sodium and propylene glycol.

The medicine contains less than 1 mmol (23 mg) of sodium per ampoule, which means the medicine is considered "sodium-free". Demezon contains 20 mg of propylene glycol in a 1 ml ampoule and 40 mg of propylene glycol in a 2 ml ampoule, which corresponds to 20 mg/ml. Before administering the medicine to a child under 4 weeks of age, the patient should consult their doctor or pharmacist, especially if the child is taking other medicines containing propylene glycol or alcohol. Due to the presence of propylene glycol, the medicine may cause skin irritation.

3. How to use Demezon

This medicine should always be used as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist. The doctor will determine an individual treatment schedule for each patient, depending on the severity of the disease, the patient's response to treatment, and special situations (e.g., stress in the patient), which should be strictly followed. AdultsUnless otherwise prescribed, the recommended dose is 4 to 16 mg per day, and exceptionally up to 32 mg per day. The usual single dose is 4 to 8 mg. If necessary, this dose may be repeated at suitable intervals, several times a day. However, in life-threatening situations (e.g., anaphylactic shock, acute asthma attack), much higher doses may be required. Usually, the initial doses are higher, and after achieving the desired therapeutic effect, they are reduced to the smallest dose that allows maintaining a beneficial therapeutic effect or until the medicine is discontinued. Treatment involving local injection and infiltration usually requires a dose of 4 to 8 mg. A dose of 2 mg is sufficient in the case of injection into small joints. Use in childrenThe dosing requirements are variable and may be changed depending on the individual needs of the patient. Usually, 0.2 to 0.4 mg/kg body weight per day. Use in elderly patientsThe use of the medicine in elderly patients does not require special dosing, but when selecting a dose, the doctor will consider the greater susceptibility of elderly patients to side effects. In case of adrenal insufficiency or liver cirrhosis, relatively small doses may be sufficient or a dose reduction may be required. Abrupt discontinuation of treatment may lead to acute adrenal insufficiency. Therefore, if discontinuation of the medicine is planned, the dose should be gradually reduced.

Method and duration of administration

The medicine is administered by injection or infusion intravenously. If intravenous administration is not possible, the product may be administered intramuscularly. Intramuscular administration should be deep, into a large muscle mass. The product may also be administered locally or intra-articularly. The duration of treatment depends on the indications and is determined by the doctor.

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 their doctor.

Omission of Demezon administration

A missed dose should be administered later in the day, and the next day, the prescribed dose should be continued. If several doses have been missed, the treated disease may recur or its symptoms may worsen. In such cases, the patient should consult their doctor, who will analyze the treatment and adjust it if necessary. A double dose should not be used to make up for a missed dose.

Discontinuation of Demezon

The medicine should always be used according to the schedule prescribed by the doctor. The patient should not discontinue the use of Demezon without consulting their doctor, as abrupt discontinuation of treatment may be life-threatening. In case of any further doubts regarding the use of this medicine, the patient should consult their 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 high 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 for decreased glucose tolerance is also required, as well as the occurrence of gastric and duodenal 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 high doses, side effects of varying severity may occur. 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 intestinal worm infection. Blood and lymphatic system disordersChanges in blood morphology (increased white blood cell count or all blood cells, decreased count of certain types of white blood cells). Immune system disordersHypersensitivity reactions (e.g., drug rash), severe anaphylactic reactions, such as arrhythmias, bronchospasm (smooth muscle spasm of the bronchi), excessively high or low blood pressure, circulatory collapse, cardiac arrest, immune system weakness. 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 levels of lipids in the blood (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, 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 keratitis, ptosis, mydriasis, conjunctival edema, corneal perforation (white eye wall), vision disturbances, loss of vision; in rare cases, reversible exophthalmos (bulging eye), corneal perforation in the case of pre-existing keratitis, blurred vision. Cardiac disordersHypertrophic cardiomyopathy in premature infants, which usually returns to normal after treatment is discontinued (frequency unknown). Vascular disordersHypertension, increased risk of atherosclerosis and thrombosis, vasculitis (also as a withdrawal syndrome after long-term treatment), increased capillary fragility. Respiratory, thoracic, and mediastinal disordersHiccup Gastrointestinal disordersGastric and duodenal ulcers, gastrointestinal bleeding, pancreatitis, abdominal discomfort. Skin and subcutaneous tissue disordersStretch marks, skin thinning ("parchment-like skin"), telangiectasia, tendency to bruise, 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 may occur depending on the dose and are possible even 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 secretion disorders resulting in irregular menstrual bleeding or amenorrhea, hirsutism in women, impotence. General disorders and administration site conditionsDelayed wound healing. Local administration: Local irritation and intolerance symptoms (feeling of heat, prolonged pain) may occur.

Procedure

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

What Demezon contains

• The active substance of the medicine is dexamethasone phosphate (as dexamethasone sodium phosphate). 1 ml of the solution contains 4 mg of dexamethasone phosphate.
• The other ingredients are: sodium edetate, propylene glycol, sodium chloride, sodium hydroxide, water for injections.

What Demezon looks like and contents of the packaging

Demezon is available in colorless ampoules containing 1 ml or 2 ml of a clear, colorless or almost colorless solution for injection in a cardboard box. Packaging sizes: 10 or 20 ampoules of 1 ml solution. 10 or 20 ampoules of 2 ml solution. Not all packaging 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:

Method of administration:

The medicine is administered by injection or infusion intravenously. If intravenous administration is not possible, the product may be administered intramuscularly. Intramuscular administration should be deep, into a large muscle mass. Intra-articular administration of Demezon increases the risk of joint infections. Intra-articular injections are considered procedures on open joints and can only be performed under sterile conditions. A single intra-articular injection is usually sufficient to effectively alleviate symptoms. If a subsequent injection is necessary, it should not be administered for at least the next 3-4 weeks. The number of injections into one joint should be limited to 3-4 times. Medical examination of the joints is recommended, especially after repeated injections. Demezon is administered locally in areas with the most intense pain or tendon attachments. Note: The medicine should not be injected into tendons. Injections should be avoided at short intervals. Strict adherence to sterile conditions is necessary.

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 infusion, the contents of the ampoule are diluted in 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.