Package leaflet: Information for the user

Demezon, 1 mg, tablets
Dexamethasonum
Please read the entire leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are similar.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Demezon is and what it is used for
Important information before taking Demezon
How to take Demezon
Possible side effects
How to store Demezon
Contents of the pack and other information

1. What Demezon is and what it is used for

Demezon is a synthetic glucocorticoid (corticosteroid) that affects metabolism,
electrolyte balance, and tissue functions.
Uses of Demezon
Demezon is used in the treatment of diseases requiring systemic administration
of glucocorticoids. Depending on symptoms and severity, these include, among others:

Cerebral edema caused by brain tumor, neurosurgical intervention, brain abscess, or bacterial meningitis.
Severe acute asthma attack.
Initial phase 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 symptoms.
Severe infectious diseases with sepsis-like symptoms (e.g. tuberculosis, typhoid fever); only in combination with anti-infective therapy.
Adjunctive treatment of malignant tumors.
Demezon is indicated in the treatment of COVID-19 in adult and adolescent patients (aged 12 years and older with body weight of at least 40 kg) who have difficulties in 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).

Warnings and precautions
Before starting treatment with Demezon, discuss this with your doctor, pharmacist, or nurse.
Do not stop taking any corticosteroid medicines unless instructed otherwise by your doctor.
General precautions regarding the use of corticosteroid medicines in certain diseases,
masking symptoms of infection, 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 therapy 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 (the adrenal cortex functions poorly, so the body does not produce sufficient glucocorticoids), which, depending on the dose and duration of treatment, may persist for several months after treatment ends, and in some cases even beyond one year.

If during glucocorticoid treatment the patient experiences significant 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 treatment has ended. During long-term treatment, the doctor should provide the patient with a steroid treatment card, which must always be carried.

Contact a doctor 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 your doctor's instructions strictly.

Demezon suppresses the body's immune system, increasing the risk of bacterial, viral, parasitic, opportunistic (infections in patients with weakened immunity), 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 organisms must be used concomitantly:

Acute viral infections (hepatitis B, chickenpox, shingles, herpes virus infections, herpes keratitis);
Chronic active hepatitis with positive HBsAg test (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 worms). In case of infection or suspected infection with strongyloidiasis (Strongyloides), Demezon may lead to activation and excessive multiplication of these parasites;
Heine-Medin disease (poliomyelitis);
Swollen lymph nodes after BCG vaccination;
If the patient has previously had tuberculosis, the medicine may be used only concomitantly 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 difficult to control,
Psychiatric disorders (including history), including suicide risk. In case of neurological or psychiatric disorders, patient supervision is recommended.
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 cause a hypertensive crisis in pheochromocytoma (Pheochromocytoma crisis), which may lead to death. Pheochromocytoma is a rare tumor of the adrenal glands. A 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 pheochromocytoma (adrenal gland tumor) is suspected or has been diagnosed.

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, with ulcerative or suppurative (pus-filled) inflammation, even without peritonitis,
Diverticulitis (inflammation of diverticula, protrusions in the wall of the large intestine),
After certain intestinal surgeries (intestinal anastomoses) immediately after surgery.

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

During Demezon treatment in diabetic patients, 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 severe heart failure should remain under careful observation.

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

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

The risk of tendon diseases, tendonitis, and tendon rupture increases in patients treated concomitantly with glucocorticoids and fluoroquinolones (a type of antibiotic).

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

Long-term use, even of 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, making diagnosis more difficult.

Vaccination with inactivated (killed) pathogen vaccines is generally possible. However, it should be noted that after administration of high doses of Demezon, vaccine efficacy may be reduced.

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

Especially 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 dose of treatment, negative effects of the medicine on calcium metabolism should be expected. Therefore, prevention of osteoporosis is recommended. This particularly applies to individuals with existing risk factors such as family history, advanced age, insufficient protein and calcium intake, heavy smoking, excessive alcohol consumption, postmenopausal period, or lack of physical activity. Prevention includes adequate calcium and vitamin D intake and physical activity. In case of existing osteoporosis, additional medication should be considered.

After ending or temporarily interrupting long-term Demezon treatment, the following risks should be considered: 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 measles or chickenpox patients 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, they should 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 distress syndrome.

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

Elderly patients
Caution should be exercised in elderly patients due to the risk of osteoporosis.

Effect of the medicine when used improperly as a doping agent
Taking Demezon may result in positive doping test results.

Demezon and other medicines
Inform your doctor about all medicines currently or recently taken, including those obtained without a prescription, and any medicines planned for future use.

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 corticosteroid metabolism in the liver, such as certain antifungal drugs (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 acid production (antacids): reduced absorption of dexamethasone may occur when magnesium hydroxide or aluminium hydroxide are used concomitantly. These medicines should be taken separately (with a two-hour interval).
Ephedrine (a component of, e.g., medicines 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

Concomitant use with certain blood pressure-lowering medicines (ACE inhibitors) carries an increased risk of blood disorders.
Due to potential potassium deficiency caused by Demezon, the effect of medicines used in heart failure treatment (cardiac glycosides) may be reduced.
Demezon increases potassium loss associated with diuretics (medicines increasing urine excretion) and laxatives.
Demezon may weaken the hypoglycemic effect (lowering blood glucose) of oral antidiabetic drugs and insulin.
Demezon may weaken or enhance the effect of anticoagulant medicines (oral anticoagulants, coumarin derivatives). The doctor will decide whether a dose adjustment 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 gastrointestinal ulceration or bleeding.
Demezon may prolong the muscle-relaxing effect of certain medicines (non-depolarizing muscle relaxants).
Demezon may enhance the effect of medicines increasing intraocular pressure (atropine and other anticholinergic drugs).
Demezon may reduce the effectiveness of medicines used to treat worm infections (praziquantel).
When used concomitantly with medicines used to treat malaria or rheumatic diseases (chloroquine, hydroxychloroquine, mefloquine), Demezon may increase the risk of muscle or heart diseases (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).
Concomitant use of Demezon with immunosuppressive medicines may increase susceptibility to infections and worsen the course of existing but latent infections.
Cyclosporine (an immunosuppressive medicine): Demezon may increase cyclosporine blood 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, especially in the first trimester, only if the benefits outweigh the risks. In case of pregnancy or suspected pregnancy, 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, the newborn may develop adrenal insufficiency (impaired adrenal function), which may require gradual replacement therapy in newborns.

Breastfeeding
Dexamethasone passes into breast milk. Harmful effects on the infant have not been reported to date. However, the necessity of administering Demezon should be carefully considered. 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 on the ability to drive vehicles and operate machinery.

3. How to use Demezon

Always take this medicine exactly as your doctor has told you. Your doctor will decide how long you should take dexamethasone. The dose will be individually determined by your doctor. You must follow these instructions, otherwise the effect of Demezon may not be optimal. If you have any doubts, consult your doctor or pharmacist again.

Unless otherwise directed by your doctor, the following doses are recommended:

Cerebral oedema: 16–24 mg (up to 48 mg) (16–24 tablets (up to 48 tablets)) daily orally, divided into 3–4 (up to 6) single doses for 4–8 days. In this indication, the patient may take fewer tablets of dexamethasone but with higher strength.
Cerebral oedema 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 (8–20 tablets), then if necessary 8 mg (8 tablets) every 4 hours. Children: 0.15–0.3 mg/kg body weight.
Acute skin diseases: depending on the type and severity of the disease, daily doses ranging from 8–40 mg (8–40 tablets), and in some cases up to 100 mg, followed by dose reduction according to clinical needs.
Systemic lupus erythematosus: 6–16 mg (6–16 tablets).
Active rheumatoid arthritis with severe, progressive course, e.g. forms rapidly leading to joint damage: rapidly progressive destructive form: 12–16 mg (12–16 tablets) daily; with extra-articular symptoms: 6–12 mg (6–12 tablets) daily.
Severe infectious diseases with symptoms resembling poisoning: 4–20 mg daily (4–20 tablets) for several days, exclusively in combination with anti-infective therapy.
Palliative treatment of malignant tumours: initially 8–16 mg daily (8–16 tablets); 4–12 mg daily (4–12 tablets) in long-term therapy.
Treatment of COVID-19: adults are recommended to take 6 mg orally once daily for up to 10 days. Use in adolescents: children and adolescents (aged 12 years and older) 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 fluid, 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 better therapeutic effect.

Duration of treatment
The duration of treatment depends on the disease and its progression. Your doctor will determine the treatment plan, which must be strictly followed. As soon as 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.

Taking more Demezon than recommended
Demezon is generally well tolerated even when high doses are taken for a short period. No special measures are usually necessary. If severe or unusual adverse effects occur, consult your doctor.

If you forget to take Demezon
A missed dose may be taken within the same day. Take the next dose the following day 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 a case, consult your doctor, who will assess and possibly adjust the treatment.

Stopping Demezon
You must strictly follow your doctor's instructions. Do not stop taking Demezon on your own. Long-term use of Demezon may lead to suppression of the body's own production of glucocorticosteroids (adrenal cortex insufficiency). Severe stress could then become life-threatening (adrenal crisis).

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Possible adverse effects
In replacement therapy, the risk of adverse effects is low when the recommended dosage is observed. However, during long-term use, especially of high doses, the medicine may cause adverse effects of varying severity. The frequency of their occurrence cannot be determined based on available data.
Infections and parasitic infestations:
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 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 lipid levels (cholesterol, triglycerides), increased sodium levels with tissue edema, potassium deficiency caused by increased potassium excretion (which may lead to cardiac arrhythmias), increased appetite.
Psychiatric disorders:
Depression, irritability, euphoria, increased drive, psychosis, mania, hallucinations, mood changes, anxiety, sleep disturbances, suicide risk.
Nervous system disorders:
Increased intracranial pressure, occurrence of symptoms of previously unobserved epilepsy and increased tendency 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 keratitis, ptosis (drooping eyelids), pupil dilation, conjunctival edema, perforation of the sclera (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 long-term treatment), increased capillary fragility.
Respiratory, thoracic and mediastinal disorders:
Hiccups
Gastrointestinal disorders:
Gastrointestinal ulcers, gastrointestinal bleeding, pancreatitis, dyspepsia.
Skin and subcutaneous tissue disorders:
Skin striae, decreased skin thickness ("parchment skin"), skin vessel dilation, tendency to bruising, petechial or extensive skin hemorrhages, hirsutism, acne, inflammatory skin changes on the face, particularly 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 long-term 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 effects listed in this leaflet occur, or any other adverse effects 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 area pain, psychiatric disturbances, marked changes in blood glucose levels or other disturbances in diabetic patients, contact your doctor immediately.
Reporting of adverse effects
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects may also be reported to the marketing authorization holder.
By reporting adverse effects, more information on the safety of the medicine can be collected.

5. How to store Demezon

Keep this medicine out of the 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 30ºC. Store 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 you no longer use. Following this advice helps protect the environment.

6. Contents of the pack and other information

What Demezon contains
The active substance is dexamethasone.
One tablet contains 1 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 1 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 "D1" on one side.
The tablet can be divided into equal doses.
Demezon 1 mg tablets are available in packs of 20, 40 and 100 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