Demezon

Package leaflet: Information for the user

Demezon, 4 mg, tablets
Dexamethasone
Please read the entire leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

1. What Demezon is and what it is used for
2. Important information before taking Demezon
3. How to take 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 is a synthetic glucocorticosteroid (corticosteroid) that affects metabolism,
electrolyte balance, and tissue functions.
Uses of Demezon
Demezon is used in the treatment of conditions requiring systemic administration of
glucocorticosteroids. Depending on symptoms and severity, these include, among others:

• Cerebral oedema caused by brain tumour, neurosurgical intervention, brain abscess, or bacterial meningitis.
• Severe acute asthma attack.
• Initial stage of treatment of extensive, severe skin diseases with acute course, such as erythroderma, pemphigus vulgaris, acute eczema.
• Treatment of systemic rheumatic diseases (rheumatic diseases that may affect the whole body), such as systemic lupus erythematosus.
• Severe progressive course of active rheumatoid arthritis, e.g. rapidly progressing destructive forms of the disease and (or) extra-articular manifestations.
• Severe infectious diseases with symptoms resembling intoxication (e.g. tuberculosis, typhoid fever); only in combination with anti-infective therapy.
• Palliative treatment of malignant tumours.
• Prevention and treatment of postoperative or cytostatic-induced nausea and vomiting as part of antiemetic therapy.
• Demezon is indicated for 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
Do not use Demezon if the patient is allergic to dexamethasone or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Demezon, discuss this with your doctor, pharmacist, or nurse.
Do not stop taking any steroid medications unless instructed otherwise by your doctor.
General precautions regarding the use of steroid medications in certain 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 outcomes in this patient group.

Treatment with glucocorticoids may lead to adrenal insufficiency (reduced function of the adrenal cortex, resulting in insufficient production of glucocorticoids by the body). Depending on the dose and duration of treatment, this condition may persist for several months after discontinuation of therapy, and in some cases even longer than one year.

If during glucocorticoid treatment the patient experiences significant physiological stress, such as feverish illness, trauma, surgery, childbirth, etc., contact the treating physician or inform emergency department staff about ongoing treatment. In some cases, a temporary increase in the daily dose of Demezon may be necessary.

Glucocorticoid administration may also be required during stressful situations when adrenal insufficiency (impaired adrenal function) persists after completion of treatment. During long-term treatment, the doctor should provide the patient with a steroid treatment card, which must always be carried on the person.

Contact a doctor immediately if the patient develops symptoms of tumor lysis syndrome, such as: muscle cramps, muscle weakness, confusion, visual disturbances or loss of vision, and rapid breathing, particularly if the patient has a hematological malignancy.

To avoid acute adrenal insufficiency (weakened adrenal function) after stopping treatment, the doctor will establish a treatment discontinuation plan involving gradual dose reduction. Follow the doctor's instructions strictly.

Demezon suppresses the body's immune system, increasing the risk of bacterial, viral, parasitic, opportunistic (infections in immunocompromised patients), and fungal infections. Symptoms of infection may be masked and therefore difficult to detect. Reactivation of latent infections may occur.

Demezon may be used in the following conditions only if the doctor considers it necessary. In some cases, antimicrobial agents with specific activity against the causative microorganisms must be administered concurrently:

• Acute viral infections (hepatitis B, chickenpox, shingles, herpes virus infections, herpes keratitis);
• Chronic active hepatitis with positive HBsAg test results (infectious hepatitis);
• Approximately 8 weeks before and up to 2 weeks after vaccination with live vaccines;
• Acute and chronic bacterial infections;
• Fungal infections involving internal organs;
• Certain parasitic diseases (infection with amoebae or helminths). In case of infection or suspected infection with strongyloidiasis (Strongyloides), Demezon may trigger activation and aggressive multiplication of these parasites;
• Poliomyelitis (Heine-Medin disease);
• Swollen lymph nodes following tuberculosis vaccination;
• If the patient has previously had tuberculosis, the drug may be used only concurrently with anti-tuberculosis agents.

During treatment with Demezon, the following conditions should be monitored:

• Gastric and duodenal ulcer disease;
• Bone mass loss (osteoporosis);
• Severe heart failure;
• Hypertension difficult to control;
• Diabetes mellitus difficult to control;
• Psychiatric disorders (including history), including suicide risk. Monitoring is recommended for patients with neurological or psychiatric disorders;
• Increased intraocular pressure (glaucoma with closed or open angle), ophthalmological monitoring and appropriate treatment are recommended;
• Corneal damage and ulcers, ophthalmological monitoring and appropriate treatment are recommended.

Use of this medicine may trigger a pheochromocytoma crisis, which can be fatal. Pheochromocytoma is a rare tumor of the adrenal gland. A pheochromocytoma crisis may present with headache, excessive sweating, palpitations, and elevated blood pressure. If any of these symptoms occur, the patient should contact a doctor immediately.

Before starting treatment with Demezon, discuss with a doctor if there is suspicion of, or a confirmed diagnosis of, pheochromocytoma (adrenal tumor).

If the patient experiences blurred vision or other visual disturbances, contact a doctor.

Due to the risk of intestinal perforation, Demezon may be used only for urgent indications and under appropriate monitoring in the following conditions:

• Severe colitis (ulcerative colitis) with risk of perforation, including ulcerative or suppurative (pus-filled) inflammation, even without peritonitis;
• Diverticulitis (inflammation of outpouchings, called diverticula, in the wall of the large intestine);
• After certain intestinal surgeries (intestinal anastomoses) immediately postoperatively.

Signs of peritoneal irritation following gastrointestinal perforation may not appear in patients receiving high doses of glucocorticoids.

During administration of Demezon to diabetic patients, metabolism should be monitored regularly, and increased requirements for antidiabetic medications (insulin, oral antidiabetic drugs) should be considered.

Patients with severe heart failure should remain under careful observation due to the risk of symptom exacerbation.

During administration of high doses of the drug, pulse rate may be lower than usual.

Severe anaphylactic reactions (hypersensitivity of the immune system) may occur.

The risk of tendon disorders, tendonitis, and tendon rupture increases in patients receiving glucocorticoids concurrently with fluoroquinolones (a class of antibiotics).

During treatment of a specific type of muscle paralysis (myasthenia gravis), symptoms may initially worsen.

Long-term use of even small amounts of dexamethasone increases the risk of infection, including by microorganisms that rarely cause infection under other circumstances (so-called opportunistic infections). Dexamethasone treatment may mask symptoms of existing or developing infections, thereby complicating diagnosis.

Vaccination with inactivated (killed) microbial vaccines is generally possible. However, it should be noted that administration of high doses of Demezon may reduce vaccine effectiveness.

During long-term administration of Demezon, regular medical check-ups (including ophthalmological examinations) are necessary.

Particularly during long-term treatment with relatively high doses of Demezon, attention should be paid to consuming sufficient potassium (e.g., vegetables, bananas) and limiting sodium intake. The doctor should monitor blood potassium levels.

Depending on the duration and dosage of treatment, a negative effect of the drug on calcium metabolism should be anticipated. Therefore, prevention of osteoporosis is recommended. This applies especially to individuals with concurrent risk factors such as family history, advanced age, inadequate protein and calcium intake, heavy smoking, excessive alcohol consumption, postmenopausal status, or lack of physical activity. Prevention includes adequate intake of calcium and vitamin D, and physical activity. In cases of existing osteoporosis, additional pharmacological treatment should be considered.

After completing or temporarily interrupting long-term treatment with Demezon, the following risks should be remembered: exacerbation of the underlying disease, acute adrenal insufficiency, and symptoms and discomfort caused by cortisone withdrawal.

In patients treated with Demezon, viral diseases (e.g., measles, chickenpox) may have a particularly severe course, especially in immunocompromised children and individuals who have never had measles or chickenpox. If such individuals come into contact with infected persons during Demezon treatment, they should immediately consult a doctor, who may initiate preventive measures if necessary.

Important information about some ingredients of Demezon
This medicine contains monohydrate lactose. If the patient has previously been diagnosed with intolerance to certain sugars, contact a doctor before taking the medicine.

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

Children and adolescents
Dexamethasone should not be routinely used in premature infants with respiratory insufficiency.

Demezon may be used in children only for absolute indications due to the risk of growth suppression. Growth should be monitored regularly. Treatment duration with Demezon should be limited or administered intermittently (e.g., every other day, but at double dose).

Elderly patients
Exercise caution in elderly patients due to the risk of osteoporosis.

Use of Demezon as a doping agent
Administration of Demezon may lead to positive results in doping tests.

Demezon and other medicines
Inform the doctor about all medicines currently or recently taken, as well as any medicines planned for use, including those available without prescription.

Medicines that affect the action of Demezon

• Some medicines may enhance the effect of Demezon, and the doctor may wish to closely monitor the patient taking such medicines (including certain HIV medications: ritonavir, cobicistat).
• Medicines that accelerate its metabolism in the liver, such as sleeping pills (barbiturates), anticonvulsants (phenytoin, carbamazepine, primidone), and certain anti-tuberculosis drugs (rifampicin), may weaken the effect of corticosteroids.
• Medicines that slow down corticosteroid metabolism in the liver, such as certain antifungal agents (containing ketoconazole, itraconazole), may enhance the effect of corticosteroids.
• Certain female sex hormones, e.g., oral contraceptives: the effect of Demezon may be increased.
• Medicines reducing gastric hydrochloric acid production (antacids): reduced absorption of dexamethasone may occur when used concomitantly with magnesium hydroxide or aluminum hydroxide. These medicines should be taken separately (with a 2-hour interval).
• Ephedrine (a component of, e.g., medications used for low blood pressure, chronic bronchitis, asthma attacks, nasal decongestants, and appetite stimulants): the effectiveness of Demezon may be reduced due to accelerated metabolism of glucocorticoids.

Effect of Demezon on other medicines

• Concurrent use with certain antihypertensive drugs (ACE inhibitors) carries an increased risk of blood disorders.
• Due to potential potassium deficiency caused by Demezon, the effectiveness of drugs used in heart failure treatment (cardiac glycosides) may be reduced.
• Demezon increases potassium loss associated with diuretics (medications increasing urine excretion) and laxatives.
• Demezon may reduce the hypoglycemic effect (blood glucose-lowering) of oral antidiabetic drugs and insulin.
• Demezon may weaken or strengthen the effect of anticoagulant drugs (oral anticoagulants, coumarin derivatives). The doctor will decide whether a dose adjustment of the anticoagulant is necessary.
• If Demezon is used concurrently with anti-inflammatory and anti-rheumatic drugs (salicylates, indomethacin, and other non-steroidal anti-inflammatory drugs), the risk of gastrointestinal ulceration or bleeding may increase.
• Demezon may prolong the muscle-relaxing effect of certain drugs (non-depolarizing muscle relaxants).
• Demezon may enhance the effect of drugs increasing intraocular pressure (atropine and other anticholinergic drugs).
• Demezon may reduce the effectiveness of drugs used to treat worm infections (praziquantel).
• Concurrent use with drugs used to treat malaria or rheumatic diseases (chloroquine, hydroxychloroquine, mefloquine) may increase the risk of muscle or heart disorders (myopathies and cardiomyopathies).
• Demezon, especially in high doses and after long-term use, may weaken the effect of growth hormone (somatotropin).
• Demezon may reduce the TSH response after protirelin (TRH, a hormone produced by the hypothalamus).
• Concurrent use of Demezon with immunosuppressive drugs may increase susceptibility to infections and worsen the course of existing but latent infections.
• Cyclosporine (an immunosuppressive drug): Demezon may increase blood cyclosporine levels and thereby increase seizure risk.
• Fluoroquinolones, a group of antibiotics, may increase the risk of tendon rupture.

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

Pregnancy and breastfeeding

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

Pregnancy
Dexamethasone crosses the placenta. Dexamethasone may be prescribed during pregnancy, particularly in the first trimester, only if the benefits outweigh the risks. If pregnant or if pregnancy occurs, consult a doctor. With long-term use of Demezon during pregnancy, impaired fetal growth cannot be ruled out. If Demezon is used in late pregnancy, neonatal adrenal insufficiency (impaired adrenal function) may occur in the newborn, which may require gradual substitution therapy in neonates.

Breastfeeding
Dexamethasone passes into breast milk. No harmful effects on infants have been reported to date. However, the necessity of administering Demezon should be carefully evaluated. If high-dose treatment is required due to illness, breastfeeding should be discontinued and the doctor consulted.

Driving and operating machinery
No studies have been conducted on the effect of Demezon on the ability to drive vehicles or operate machinery.

3. How to use Demezon

The medicine should always be used as directed by the physician. The physician decides how long dexamethasone should be administered and determines the dosage individually for each patient. It is essential to follow these instructions, as otherwise the effect of Demezon may not be appropriate. In case of any doubts, contact your doctor or pharmacist again.

Unless otherwise directed by the physician, the following doses are recommended:

• Cerebral edema: 16–24 mg (up to 48 mg) (4–6 tablets (up to 12 tablets)) daily orally, divided into 3–4 (up to 6) single doses for 4–8 days.
• Cerebral edema caused by bacterial meningitis: 0.15 mg/kg body weight every 6 hours for 4 days. Children: 0.4 mg/kg body weight every 12 hours for 2 days, starting before the first dose of antibiotic.
• Severe acute asthma attack: Adults: administer as quickly as possible 8–20 mg (2–5 tablets), then if necessary 8 mg (2 tablets) every 4 hours. Children: 0.15–0.3 mg/kg body weight.
• Acute skin diseases: depending on the type and severity, daily doses ranging from 8–40 mg (2–10 tablets), and in some cases up to 100 mg; thereafter the dose should be reduced according to clinical needs.
• Systemic lupus erythematosus: 6–16 mg (1½–4 tablets).
• Active rheumatoid arthritis with severe, progressive course, e.g. forms rapidly leading to joint damage: rapidly progressive destructive form: 12–16 mg (3–4 tablets) daily; with extra-articular symptoms: 6–12 mg (1½–3 tablets) daily.
• Severe infectious diseases with symptoms resembling intoxication: 4–20 mg daily (1–5 tablets) for several days, exclusively in combination with anti-infective therapy.
• Palliative treatment of malignant tumors: initially 8–16 mg daily (2–4 tablets); 4–12 mg daily (1–3 tablets) for long-term therapy.
• Prevention and treatment of vomiting induced by cytostatic therapy as antiemetic therapy: 10–20 mg (2½–5 tablets) of dexamethasone before chemotherapy, then if necessary 4–8 mg (1–2 tablets) 2–3 times daily for 1–3 days (moderately emetogenic chemotherapy) or up to 6 days (highly emetogenic chemotherapy).
• Prevention and treatment of postoperative vomiting: single dose of 8–20 mg (2–5 tablets) before surgery; children aged 2 years and older: 0.15–0.5 mg/kg body weight (maximum 16 mg).
• Treatment of COVID-19: adults are recommended to take 6 mg orally once daily for up to 10 days. For adolescents: children and adolescents (from 12 years of age) are recommended to take 6 mg orally once daily for up to 10 days.

Method of administration
Oral administration
The tablet should be swallowed whole (not chewed) with sufficient liquid, during or after a meal.
If possible, the entire daily dose should be taken in the morning as a single dose. However, in diseases requiring treatment with high doses, dividing the daily dose into several doses may provide a better therapeutic effect.

Duration of treatment
The duration of treatment depends on the disease and its progression. The physician will establish a treatment plan which must be strictly followed. Once a satisfactory treatment response is achieved, the dose will be reduced to a maintenance dose or treatment will be discontinued. In general, the dose should be tapered gradually.

In patients with hypothyroidism or liver cirrhosis, relatively low doses may be sufficient or dose reduction may be required.

Use of a higher than recommended dose of Demezon
Demezon is generally well tolerated even when high doses are used for short periods. No special measures are usually required. If severe or unusual adverse reactions occur, consult a physician.

Missed dose of Demezon
A missed dose may be taken during the same day. On the following day, take the next dose as usual. Do not take a double dose to make up for a missed dose.

If several doses are missed, the disease may sometimes worsen. In such cases, consult your doctor, who will assess and possibly adjust the treatment.

Stopping Demezon treatment
Follow your physician's instructions exactly. Do not stop taking Demezon on your own. Particularly prolonged use of Demezon may lead to suppression of the body's own glucocorticoid production (adrenal cortex insufficiency). Severe stress could then become life-threatening (adrenal crisis).

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Possible adverse reactions
In substitution therapy, the risk of adverse reactions is low if the recommended dosage is followed. However, during prolonged use, especially of high doses, the medicine may cause adverse reactions of varying severity. The frequency of their occurrence cannot be determined based on available data.
Infections and parasitic infections:
Masking of infection symptoms, occurrence, recurrence, and worsening of viral, fungal, bacterial, parasitic, and opportunistic infections, activation of ascariasis infection.
Blood and lymphatic system disorders:
Changes in blood morphology (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-induced rash), severe anaphylactic reactions such as cardiac arrhythmia, bronchospasm (contraction of smooth muscles of the bronchi), excessively high or low blood pressure, circulatory collapse, myocardial infarction, immunosuppression.
Endocrine disorders:
Development of so-called Cushing's syndrome (typical symptoms include moon face, central obesity, and facial redness), adrenal insufficiency or atrophy of the adrenal cortex.
Metabolism and nutrition disorders:
Weight gain, increased blood glucose levels, diabetes, increased levels of lipids (cholesterol, triglycerides), increased sodium levels with tissue edema, potassium deficiency caused by increased potassium excretion (this may lead to cardiac arrhythmias), increased appetite.
Psychiatric disorders:
Depression, irritability, euphoria, increased drive, psychosis, mania, hallucinations, mood changes, anxiety, sleep disturbances, risk of suicide.
Nervous system disorders:
Increased intracranial pressure, occurrence of symptoms of previously unobserved epilepsy and increased susceptibility to seizures in existing epilepsy.
Eye disorders:
Increased intraocular pressure (glaucoma), cataract, worsening of corneal ulcers, exacerbation of inflammation caused by viruses, bacteria, or fungi, worsening of bacterial corneal inflammation, ptosis (drooping eyelid), pupil dilation, conjunctival edema, scleral perforation (perforation of the white part of the eyeball wall), visual disturbances, vision loss, blurred vision.
Vascular disorders:
Increased arterial blood pressure, increased risk of atherosclerosis and thrombosis, vasculitis (including withdrawal syndrome after prolonged treatment), increased capillary fragility.
Respiratory, thoracic and mediastinal disorders:
Hiccups
Gastrointestinal disorders:
Gastrointestinal ulcers, gastrointestinal bleeding, pancreatitis, dyspepsia.
Skin and subcutaneous tissue disorders:
Stretch marks, decreased skin thickness ("parchment skin"), skin vessel dilation, tendency to bruising, petechial or extensive skin hemorrhages, hirsutism, acne, inflammatory skin changes on the face, especially around the mouth, nose, and eyes, skin pigmentation changes.
Musculoskeletal and connective tissue disorders:
Muscle diseases, muscle weakness, muscle atrophy, loss of bone mass (osteoporosis) dose-dependent and possible even after short-term therapy, other forms of bone degeneration (avascular necrosis), tendon disorders, tendonitis, tendon rupture, fat deposition in the spine (epidural lipomatosis), growth suppression in children.
Note:
Complications such as withdrawal syndrome may occur if, after prolonged treatment, the dose of the medicine is reduced too quickly. This may manifest as muscle and joint pain.
Reproductive system and breast disorders:
Disorders of sex hormone secretion (manifesting as irregular menstruation or absence of menstruation (amenorrhoea), male-pattern hair growth in women (hirsutism), impotence).
General disorders and administration site conditions:
Slower wound healing.
Recommendations
If any adverse reactions listed in this leaflet occur, or any other adverse reactions during the use of Demezon, inform your doctor or pharmacist. Do not discontinue treatment on your own.
In case of gastrointestinal symptoms, back pain, shoulder or hip pain, psychiatric disturbances, marked changes in blood glucose levels, or other disturbances in diabetic patients, contact your doctor immediately.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring 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 responsible entity.
By reporting adverse reactions, more information on the safety of the medicine can be collected.

5. How to store Demezon

Keep this medicine out of sight and reach of children.
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.
Storage conditions:
Store below 30°C. Keep in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Demezon contains
The active substance is dexamethasone.
One tablet contains 4 mg of dexamethasone.
The other ingredients are:
monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.

What Demezon looks like and contents of the pack
Demezon 4 mg tablets are white to almost white, round, biconvex tablets with bevelled edges, approximately 7 mm in diameter, with a division line and the engraved mark "D4" on one side.
The tablet can be divided into equal doses.
Demezon 4 mg tablets are available in packs of 10, 20 and 40 tablets.
PVC/PVDC/Aluminium blisters in a cardboard box.

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:
Cyndea Pharma S.L.
Polígono Industrial Emiliano Revilla Sanz
Avenida de Ágreda, 31
Ólvega 42110 (Soria)
Spain