Demezon

Package Leaflet: Information for the User

Demezon, 1 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 those 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 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, pemphigus, acute eczema.
• Treatment of systemic rheumatic diseases (rheumatic diseases that can affect the entire 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.
• Supportive treatment of malignant tumors.
• Demezon is indicated for the treatment of COVID-19 in adult patients and adolescents (aged 12 and older, weighing at least 40 kg) with breathing difficulties 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 administration 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 condition in this patient group. Treatment with glucocorticosteroids can lead to adrenal insufficiency (weak adrenal gland function), which, depending on the dose and duration of treatment, may last for several months after the end of therapy, and in some cases even more than a year. In the event of a particular strain 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 department about the treatment. 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. If the patient experiences symptoms of tumor lysis syndrome, such as muscle cramps, muscle weakness, confusion, vision disturbances, or loss of vision, and shortness of breath, and has a hematological malignancy, they should immediately contact their doctor. To avoid acute adrenal insufficiency after the end of treatment, the doctor will establish a plan for the end of treatment, which 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 administered concurrently:

• Acute viral infections (hepatitis B, chickenpox, shingles, herpes simplex virus infections, herpes virus 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;
• Guillain-Barré syndrome;
• Swollen lymph nodes after BCG vaccination;
• If the patient has had tuberculosis in the past, the medicine can only be used in combination with anti-tuberculosis medicines.

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

• Peptic ulcer disease and duodenal ulcer,
• Bone loss (osteoporosis),
• Severe heart failure,
• Uncontrolled hypertension,
• Difficult-to-control diabetes,
• Mental illnesses (including those in the medical history), including the risk of suicide. In the case of neurological or mental illnesses, patient monitoring is recommended.
• Elevated 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.

Taking this medicine can cause a crisis in the course of pheochromocytoma (a rare adrenal gland tumor), which can lead to death. 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 they suspect or have been diagnosed with 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 should only be used in emergencies and under proper 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. When administering Demezon to diabetic patients, blood sugar metabolism should be regularly monitored, and the increased need for 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 administration of high doses of the medicine, the pulse may be lower than usual. Serious anaphylactic reactions (hypersensitivity of the immune system) may occur. The risk of tendon diseases, tendonitis, and tendon rupture increases in patients treated 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 those caused by microorganisms that rarely cause infections under other circumstances (so-called opportunistic infections). Dexamethasone treatment 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 administering high doses of Demezon, the effectiveness of the vaccination may be reduced. During long-term administration of Demezon, regular medical check-ups (including ophthalmological ones) are necessary. Especially during long-term treatment with relatively high doses of Demezon, attention should be paid to consuming sufficient amounts of potassium (e.g., vegetables, bananas) and limiting sodium intake. The doctor should monitor blood potassium levels. Depending on the duration of treatment and dose, the medicine may have a negative impact on calcium metabolism. Therefore, osteoporosis prevention is recommended, especially for individuals with existing risk factors, such as family history, advanced age, insufficient protein and calcium intake, smoking, excessive alcohol consumption, postmenopausal period, or lack of physical activity. Prevention involves sufficient 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 remembered: 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) can have a particularly severe course, especially in children with impaired immunity and individuals who have not had measles or chickenpox before. If these individuals come into contact with people suffering from 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 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 administered 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.

Effect of the medicine when used inappropriately as a doping agent

Taking Demezon can cause positive test results for doping substances.

Demezon and other medicines

The patient should inform their doctor about all medicines they are currently taking or have recently taken, as well as those 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 breakdown in the liver, such as sleeping pills (barbiturates), anti-epileptic medicines (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 stomach acid production (antacids): the absorption of dexamethasone may be reduced when taken with magnesium hydroxide or aluminum hydroxide. These medicines should be taken separately (with a 2-hour interval).
• Ephedrine (a component of 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 the action of 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 the potassium excretion caused by 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 weaken 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 medicines), the risk of stomach or intestinal ulcers and bleeding may increase.
• 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 weaken 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 disorders in the unborn child cannot be ruled out. When Demezon is used in the late stages of pregnancy, the newborn may experience adrenal insufficiency (weak adrenal gland function), which may require gradual substitution treatment in newborns.

Breastfeeding

Dexamethasone passes into breast milk. No harmful effects on the infant have been reported to date. However, the need for Demezon administration should be carefully considered. If it is necessary to administer the medicine due to the disease, breastfeeding should be discontinued, and the patient should consult their doctor.

Driving and using machines

No studies have been conducted on the effects of Demezon 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 decides 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.

Unless the doctor instructs otherwise, the following doses are recommended:

• Brain edema: 16 - 24 mg (up to 48 mg) (16 - 24 tablets) per day orally, divided into 3 - 4 (up to 6) single doses for 4 - 8 days. In this indication, the patient may take a smaller number of Demezon tablets, but with a higher strength.
• 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 administration of the first dose of antibiotics.
• Severe acute asthma attack: adults: 8 - 20 mg (8 - 20 tablets) should be administered as soon as possible, then 8 mg (8 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 (8 - 40 tablets), and in some cases up to 100 mg, followed by a reduction in dose according to clinical needs.
• Systemic lupus erythematosus: 6 - 16 mg (6 - 16 tablets).
• Rheumatoid arthritis with severe, progressive course, e.g., rapidly progressive destructive forms of the disease: 12 - 16 mg (12 - 16 tablets) per day, with extra-articular symptoms: 6 - 12 mg (6 - 12 tablets) per day.
• Severe infectious diseases with symptoms similar to sepsis: 4 - 20 mg per day (4 - 20 tablets) for several days, only in combination with anti-infective therapy.
• Palliative treatment of malignant tumors: initially 8 - 16 mg per day (8 - 16 tablets);
• 4 - 12 mg per day (4 - 12 tablets) in the case of long-term therapy.
• 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 older), 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 the case of 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 establish a treatment plan that 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 gradually reduced. In the case of hypothyroidism or liver cirrhosis, relatively small doses may be sufficient, or the dose may need to be reduced.

Use of a higher than recommended dose of Demezon

Generally, Demezon is well-tolerated without complications 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 review and possibly adjust the treatment.

Discontinuation of Demezon

The patient should strictly follow the doctor's instructions. Do not stop taking Demezon on your own. Especially long-term use of Demezon can lead to suppression of the body's own glucocorticosteroid production (adrenal insufficiency). Severe stress on the body could be life-threatening (adrenal crisis). If the patient has any further doubts about the use of this medicine, they 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 when 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 cell count (increased white blood cell count or all blood cells, decreased count of certain types of white blood cells).

Immune system disorders:

Hypersensitivity reactions (e.g., drug-induced rash), severe anaphylactic reactions, such as cardiac arrhythmias, bronchospasm (smooth muscle spasm 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 levels of lipids (cholesterol, triglycerides), increased sodium levels with tissue edema, potassium deficiency due to increased excretion (which may lead to cardiac 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, vision disturbances, and loss of vision.

Vascular disorders:

Increased blood pressure, increased risk of atherosclerosis and thrombosis, vasculitis (including as a withdrawal syndrome after long-term treatment), and increased fragility of blood vessels.

Respiratory, thoracic, and mediastinal disorders:

Hiccup.

Gastrointestinal disorders:

Peptic ulcers, gastrointestinal bleeding, pancreatitis, and dyspepsia.

Skin and subcutaneous tissue disorders:

Stretch marks, thinning of the skin (paper-like skin), telangiectasia (spider veins), bruising, petechiae (small hemorrhages), hirsutism (excessive hair growth), acne, facial erythema (redness), and changes in skin pigmentation.

Musculoskeletal and connective tissue disorders:

Muscle diseases, muscle weakness, muscle atrophy, bone loss (osteoporosis) dependent on dose and duration of treatment, 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 the event of gastrointestinal or mental health symptoms, back pain, arm or hip pain, significant changes in blood sugar levels, or other disorders in diabetic patients, the patient should immediately consult their doctor. If any side effects occur, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, 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 use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month. Storage conditions: Store 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 medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Demezon contains

The active substance of the medicine is dexamethasone. One tablet contains 1 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, 1 mg, tablets are white to almost white, round, flat tablets with beveled edges, approximately 7 mm in diameter, with a score line and the inscription 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/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, tel. +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