Demezon

Package Leaflet: Information for the User

Demezon, 4 mg, tablets

Dexamethasone

Read the package leaflet carefully before taking 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 not listed in this leaflet, they should tell 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 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 is Demezon and what is it used for

Demezon is a synthetic glucocorticosteroid(corticosteroid) that affects metabolism, electrolyte balance, and tissue function.

Use of Demezon

Demezon is used to treat diseases that require systemic administration of glucocorticosteroids. Depending on the symptoms and severity, these include:

• Brain edema caused by brain tumors, neurosurgical interventions, brain abscesses, bacterial meningitis.
• Severe acute asthma attacks.
• Initial treatment of widespread, severe skin diseases with an acute course, such as erythroderma, common pemphigus, acute eczema.
• Treatment of systemic rheumatic diseases (rheumatic diseases that can affect the whole body), such as systemic lupus erythematosus.
• Severe progressive rheumatoid arthritis, e.g., rapidly progressive destructive forms of the disease and (or) extra-articular symptoms.
• Severe infectious diseases with symptoms similar to sepsis (e.g., tuberculosis, typhoid fever); only in combination with anti-infective therapy.
• Palliative treatment of malignant tumors.
• Prophylaxis and treatment of postoperative nausea and vomiting, or nausea and vomiting caused by cytostatic therapy as part of antiemetic therapy.
• Demezon is indicated for the treatment of COVID-19 in adult patients and adolescents (aged 12 and older with a body weight of at least 40 kg) with difficulty breathing and requiring oxygen therapy.

2. Important information before taking Demezon

When not to take 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, the patient should discuss it with their doctor, pharmacist, or nurse.
Do not stop taking any steroid medicines without consulting a doctor.
General precautions for the use of steroid medicines in certain diseases, masking of infection symptoms, concurrent use of other medicines, etc., in accordance with current recommendations.
Dexamethasone should not be administered in COVID-19 patients who do not require oxygen or mechanical ventilation, due to the lack of therapeutic benefits and the risk of worsening the patient's condition in this group.
Treatment with glucocorticosteroids can lead to adrenal insufficiency (weak adrenal gland function), which, depending on the dose and duration of treatment, can last for several months after the end of therapy, and in some cases even more than a year.
In the event of a particular burden on the body during treatment with glucocorticosteroids, e.g., diseases with fever, injuries, or surgery, childbirth, etc., the patient should consult their attending physician or inform the emergency doctor about the treatment being taken. Sometimes a temporary increase in the daily dose of Demezon may be necessary.
The administration of glucocorticosteroids may also be necessary in stressful situations when adrenal insufficiency persists after the end of treatment. During long-term treatment, the doctor should provide the patient with a corticosteroid treatment card, which should always be carried with them.
The patient should consult a doctor if they experience symptoms of tumor lysis syndrome, such as muscle spasms, muscle weakness, confusion, vision disturbances, or loss of vision, and shallow breathing, if they have a hematological malignancy.
To avoid acute adrenal insufficiency after the end of treatment, the doctor will determine a plan for ending treatment that involves gradually reducing the dose. The patient should strictly follow the doctor's instructions.
Demezon suppresses the body's immune system, increasing the risk of bacterial, viral, parasitic, opportunistic (infections in patients with weakened immunity), and fungal infections. Infection symptoms may be masked and difficult to detect. There may be a recurrence of inactive infections.
Demezon can only be used in the following conditions if the doctor considers it necessary. In some cases, specific anti-infective medicines must be used concurrently:

• Acute viral infections (hepatitis B, chickenpox, shingles, herpes virus infections, herpes simplex keratitis);
• Chronic active hepatitis with a positive HBsAg test result (infectious hepatitis);
• 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 (amebiasis or worm infestations). In the case of strongyloidiasis (threadworm infection), Demezon may lead to the activation and increased reproduction of these parasites;
• Heine-Medin disease;
• Swollen lymph nodes 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 be monitored for the following diseases:

• Peptic ulcer disease of the stomach and duodenum,
• Bone loss (osteoporosis),
• Severe heart failure,
• Uncontrolled hypertension,
• Difficult-to-control diabetes,
• Mental disorders (also in the medical history), including the risk of suicide. In the case of neurological or psychiatric disorders, patient monitoring is recommended.
• Elevated intraocular pressure (glaucoma with closed or open angle), ophthalmologic monitoring and appropriate treatment are recommended,
• Corneal damage and ulcers, ophthalmologic monitoring and appropriate treatment are recommended.

Taking this medicine may cause a crisis in the course of pheochromocytoma (a rare adrenal gland tumor), which can be life-threatening. A crisis in the course of this tumor may manifest as headache, excessive sweating, palpitations, and increased blood pressure. If these 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 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 in emergencies and under appropriate control in the following conditions:

• Severe ulcerative colitis (with a risk of perforation, with ulcerative or abscessing inflammation, and without peritonitis),
• Diverticulitis (inflammation of the intestinal diverticulum),
• After certain intestinal surgeries (intestinal anastomoses) immediately after surgery.

Signs of peritoneal irritation after gastrointestinal perforation may not occur in patients taking high doses of glucocorticosteroids.
During treatment with Demezon in diabetic patients, blood sugar and insulin metabolism should be regularly monitored, and the need for increased doses of diabetes medicines (insulin, oral hypoglycemic agents) should be considered.
Due to the risk of worsening the condition, patients with severe heart failure should be closely monitored.
During the use of high doses of the medicine, the heart rate may be lower than usual.
There may be severe anaphylactic reactions (hypersensitivity of the immune system).
The risk of tendon diseases, tendonitis, and tendon rupture increases in patients treated concurrently with glucocorticosteroids and fluoroquinolones (a type of antibiotic).
During the treatment of a certain type of muscle paralysis (myasthenia), there may be an initial worsening of symptoms.
Long-term use of even small amounts of dexamethasone can lead to an increased risk of infection, including by microorganisms that rarely cause infections in other circumstances (so-called opportunistic infections). Treatment with dexamethasone may mask the symptoms of an existing or developing infection, making diagnosis more difficult.
In general, it is possible to vaccinate with killed vaccines. However, it should be noted that after taking high doses of Demezon, the effectiveness of vaccination may be reduced.
During long-term administration of Demezon, regular medical check-ups (including ophthalmological check-ups) are necessary.
Especially during long-term treatment with relatively high doses of Demezon, attention should be paid to adequate potassium intake (e.g., vegetables, bananas) and sodium restriction. The doctor should monitor blood potassium levels.
Depending on the duration of treatment and dose, there may be a negative impact on calcium metabolism. Therefore, osteoporosis prevention is recommended. This applies especially to patients with existing risk factors, such as family history, advanced age, inadequate protein and calcium intake, smoking, excessive alcohol consumption, postmenopausal period, or lack of physical activity. Prevention involves adequate calcium and vitamin D intake and physical activity. In the case of existing osteoporosis, the use of medicines should also be considered.
After the end of or possible interruption of long-term use of Demezon, the following risks should be considered: worsening of the underlying disease, acute adrenal insufficiency, symptoms and complaints caused by the cessation of cortisone action.
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 while taking Demezon, they should immediately consult a doctor, who may take preventive measures if necessary.

Important information about some ingredients of Demezon

This medicine contains lactose monohydrate. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

Children and adolescents

Dexamethasone should not be used routinely in premature infants with respiratory failure.
In children, Demezon can only be used with absolute indications, due to the risk of growth retardation. The child's growth should be regularly monitored. The duration of treatment with Demezon should be limited or the medicine should be used alternately (e.g., every other day, but in a double dose).

Elderly patients

In elderly patients, caution should be exercised due to the risk of osteoporosis.

Use of Demezon as a doping agent

Taking Demezon may cause positive results in doping tests.

Demezon and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.

Medicines that affect the action of Demezon

• Some medicines may enhance the effect of Demezon, and the doctor may want to closely monitor the patient's condition when taking such medicines (including some HIV medicines: ritonavir, cobicistat).
• Medicines that accelerate its metabolism in the liver, such as sleeping pills (barbiturates), antiepileptic drugs (phenytoin, carbamazepine, primidone), and some anti-tuberculosis medicines (rifampicin), may weaken the effect of corticosteroids.
• Medicines that slow down the metabolism of corticosteroids in the liver, such as certain antifungal medicines (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 that reduce excessive stomach acid production (antacids): it is possible that the absorption of dexamethasone may be reduced when taken together with magnesium hydroxide or aluminum hydroxide. These medicines should be taken separately (with a 2-hour interval).
• Ephedrine (an ingredient in medicines used for low blood pressure, chronic bronchitis, asthma attacks, decongestants, and appetite stimulants). The effectiveness of Demezon may be reduced due to accelerated metabolism of glucocorticosteroids.

Effect of Demezon on other medicines

• Concomitant administration with certain blood pressure-lowering medicines (ACE inhibitors) may increase the risk of blood diseases.
• Due to the potential potassium deficiency caused by Demezon, the effect of medicines used to treat heart failure (cardiac glycosides) may be reduced.
• Demezon increases potassium excretion when used with diuretics (medicines that increase urine production) and laxatives.
• Demezon may reduce the hypoglycemic effect (lowering blood sugar levels) of oral hypoglycemic agents and insulin.
• Demezon may reduce or enhance the effect of medicines that prevent blood clots (oral anticoagulants, coumarin derivatives). 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 gastrointestinal ulcers or 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 infections (praziquantel).
• When used concurrently with medicines used to treat malaria or rheumatic diseases (chloroquine, hydroxychloroquine, and mefloquine), Demezon may increase the risk of muscle or heart diseases (myopathy and cardiomyopathy).
• Demezon, especially in high doses and after long-term use, may reduce the effect of growth hormone (somatotropin).
• Demezon may reduce the increase in TSH levels after administration of protirelin (TRH, a hormone produced by the hypothalamus).
• Concomitant use of Demezon with immunosuppressive agents may increase the susceptibility to infections and worsen the course of existing, but not yet apparent, infections.
• Cyclosporine (an immunosuppressive agent): Demezon may increase cyclosporine levels in the blood, thereby increasing the risk of seizures.
• Fluoroquinolones, a group of antibiotics, may increase the risk of tendon rupture.

Effect on diagnostic tests

Glucocorticosteroids may suppress the skin reaction to 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 taking this medicine.

Pregnancy

Dexamethasone crosses the placenta. Dexamethasone may be prescribed during pregnancy, especially in the first trimester, only if the benefits of treatment outweigh the risks. In the event of pregnancy or suspected pregnancy, the patient should consult their doctor. With long-term use of Demezon during pregnancy, growth disturbances in the unborn child cannot be ruled out. If Demezon is used in the late stages of pregnancy, the newborn may experience adrenal insufficiency (adrenal gland dysfunction), which may require gradual substitution treatment in newborns.

Breastfeeding

Dexamethasone passes into breast milk. So far, no adverse effects on the infant have been reported. However, the need for Demezon administration should be carefully considered. If it is necessary to administer the medicine in high doses, breastfeeding should be discontinued, and the patient should consult their doctor.

Driving and using machines

No studies have been conducted on the effect on the ability to drive and use machines.

3. How to take Demezon

The medicine should always be taken as directed by the doctor. The doctor will decide how long to take dexamethasone. The doctor will determine the dose of the medicine individually for each 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 their doctor or pharmacist again.

If the doctor does not instruct otherwise, the following doses are recommended:

• Brain edema: 16 - 24 mg (up to 48 mg) (4 - 6 tablets (up to 12 tablets)) per day orally, divided into 3 - 4 (up to 6) single doses for 4 - 8 days.
• Brain 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 antibiotics.
• Severe acute asthma attack: adults: 8 - 20 mg (2 - 5 tablets) should be administered as soon as possible, then 8 mg (2 tablets) every 4 hours if necessary. Children: 0.15 - 0.3 mg/kg body weight.
• Acute skin diseases: depending on the type and extent of the disease, daily doses in the range of
• 8 – 40 mg (2 – 10 tablets), and in some cases up to 100 mg, after which 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., rapidly progressive destructive forms of the disease: 12 - 16 mg (3 - 4 tablets) per day, with extra-articular symptoms: 6 - 12 mg (1½ - 3 tablets) per day.
• Severe infectious diseases with symptoms similar to sepsis: 4 - 20 mg per day (1 - 5 tablets) for several days, only in combination with anti-infective therapy.
• Palliative treatment of malignant tumors: initially 8 - 16 mg per day (2 - 4 tablets);
• 4 – 12 mg per day (1 – 3 tablets) in the case of long-term therapy.
• Prophylaxis and treatment of nausea and vomiting caused by cytostatic therapy as part of antiemetic therapy: 10 - 20 mg (2½ - 5 tablets) of dexamethasone before chemotherapy, then 4 - 8 mg (1 - 2 tablets) 2 - 3 times a day for 1 - 3 days (moderately emetogenic chemotherapy) or up to 6 days (highly emetogenic chemotherapy).
• Prophylaxis and treatment of postoperative nausea and vomiting: a single dose of 8 - 20 mg (2 - 5 tablets) before surgery; children aged 2 and over: 0.15 - 0.5 mg/kg body weight (up to 16 mg).
• Treatment of COVID-19: adults are recommended to take 6 mg orally once a day for up to 10 days. For adolescents (aged 12 and over), 6 mg is recommended orally once a day for up to 10 days.

Method of administration

Oral administration
The tablet should be swallowed whole (not chewed), with a sufficient amount of liquid, during or after a meal.
If possible, the entire daily dose should be administered in the morning as a single dose. However, in diseases that require 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 doctor will determine the treatment plan, which should be followed exactly. Once a satisfactory treatment result is achieved, the dose will be reduced to a maintenance dose or treatment will be discontinued. In principle, the dose should be reduced gradually.
In the case of hypothyroidism or liver cirrhosis, relatively small doses may be sufficient, or the dose may need to be reduced.

Overdose of Demezon

Generally, Demezon is well-tolerated even after short-term use in high doses. No special measures are necessary. If severe or unusual side effects occur, the patient should consult their doctor.

Missed dose of Demezon

A missed dose can be taken during the day. The next day, the dose should be taken as usual.
A double dose should not be taken to make up for a missed dose.
If several doses are missed, the disease may worsen. In such cases, the patient should consult their doctor, who will check and correct the treatment if necessary.

Stopping treatment with Demezon

The patient should strictly follow the doctor's instructions. Do not stop taking Demezon on your own. Prolonged use of Demezon may lead to suppression of the body's own glucocorticosteroid production (adrenal insufficiency). Severe stress on the body could be life-threatening (adrenal crisis).
In case of further doubts about 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.

Possible side effects

In substitution therapy, the risk of side effects is low if the recommended dose is followed. However, during long-term use, especially with high doses, the medicine may cause side effects of varying severity. The frequency of their occurrence cannot be determined based on available data.

Infections and infestations:

Masking of infection symptoms, occurrence, recurrence, and worsening of viral, fungal, bacterial, and parasitic infections, as well as opportunistic infections, and activation of strongyloidiasis.

Blood and lymphatic system disorders:

Changes in blood morphology (increased white blood cell count or all blood cells, decreased count of certain white blood cells).

Immune system disorders:

Hypersensitivity reactions (e.g., drug-induced rash), severe anaphylactic reactions, such as arrhythmias, bronchospasm (smooth muscle spasms in the bronchi), high or low blood pressure, circulatory collapse, myocardial infarction, and adrenal insufficiency.

Endocrine disorders:

Development of Cushing's syndrome (characterized by moon face, central obesity, and purple striae), adrenal insufficiency or atrophy.

Metabolic and nutritional disorders:

Weight gain, increased blood sugar levels, diabetes, increased lipid levels (cholesterol, triglycerides), increased sodium levels with edema, potassium deficiency due to increased excretion (which may lead to arrhythmias), and increased appetite.

Psychiatric disorders:

Depression, irritability, euphoria, increased drive, psychosis, mania, hallucinations, mood changes, anxiety, sleep disturbances, and risk of suicide.

Nervous system disorders:

Increased intracranial pressure, occurrence of symptoms of previously undiagnosed epilepsy, and increased susceptibility to seizures in existing epilepsy.

Eye disorders:

Increased intraocular pressure (glaucoma), cataracts, worsening of corneal ulcers, worsening of viral, bacterial, or fungal infections, ptosis (drooping eyelid), mydriasis (pupil dilation), conjunctival edema, corneal perforation (perforation of the white part of the eyeball), vision disturbances, loss of vision, and blurred vision.

Vascular disorders:

Increased blood pressure, increased risk of atherosclerosis and thrombosis, vasculitis (including withdrawal syndrome), and increased capillary fragility.

Respiratory, thoracic, and mediastinal disorders:

Hiccup

Gastrointestinal disorders:

Gastrointestinal ulcers, gastrointestinal bleeding, pancreatitis, and dyspepsia.

Skin and subcutaneous tissue disorders:

Stretch marks, thinning of the skin ("parchment-like" skin), telangiectasia (dilation of small blood vessels), petechiae (small hemorrhages), ecchymoses (bruises), hirsutism (excessive hair growth in women), acne, facial erythema (redness), and changes in skin pigmentation.

Musculoskeletal and connective tissue disorders:

Muscle diseases, muscle weakness, muscle atrophy, osteoporosis (dependent on dose and duration of treatment, and possible even after short-term therapy), other forms of bone degeneration (aseptic bone necrosis), tendon diseases, tendonitis, and tendon rupture. Note: Complications such as withdrawal syndrome may occur if the dose of the medicine is reduced too quickly after long-term treatment. This may manifest as muscle and joint pain.

Reproductive system and breast disorders:

Disorders of sex hormone secretion (manifested as irregular menstrual cycles or amenorrhea, hirsutism in women, impotence).

General disorders and administration site conditions:

Delayed wound healing.

Recommendations

If any side effects occur, including those not listed in this leaflet, the patient should inform their doctor or pharmacist. Do not stop treatment on your own.
In case of gastrointestinal or psychiatric symptoms, back pain, shoulder or hip pain, significant changes in blood sugar levels, or other disorders in diabetic patients, the patient should immediately consult their doctor.

Reporting side effects

If any side effects occur, including those not listed in this leaflet, the patient should tell 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
Phone: +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 use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Storage conditions:
Store at a temperature below 30°C. Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of unused medicines. 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.
One tablet contains 4 mg of dexamethasone.
The other ingredients of the medicine are:
lactose monohydrate, 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, flat tablets with beveled edges, approximately 7 mm in diameter, with a dividing line and the inscription 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/Aluminum blisters in a cardboard box.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki
phone: +48 22 350 66 69

Manufacturer:

Formula Pharmazeutische und chemische Entwicklungs GmbH
Goerzallee 305 b
14167 Berlin
Germany
Cyndea Pharma S.L.
Polígono Industrial Emiliano Revilla Sanz
Avenida de Ágreda, 31
Ólvega 42110 (Soria)
Spain
Date of last revision of the leaflet:07.2023