Dexamethasone Zentiva

Leaflet attached to the packaging: information for the user

Dexamethasone Zentiva, 0.5 mg, tablets

Dexamethasone Zentiva, 1 mg, tablets

Dexamethasone Zentiva, 4 mg, tablets

Dexamethasone

Read the 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 further 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 tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Dexamethasone Zentiva and what is it used for
• 2. Important information before taking Dexamethasone Zentiva
• 3. How to take Dexamethasone Zentiva
• 4. Possible side effects
• 5. How to store Dexamethasone Zentiva
• 6. Contents of the packaging and other information

1. What is Dexamethasone Zentiva and what is it used for

Dexamethasone Zentiva contains the active substance dexamethasone, which is a synthetic glucocorticosteroid (adrenal cortex hormone). It affects metabolism, electrolyte balance, and tissue function. Dexamethasone Zentiva is used in diseases that require systemic glucocorticosteroid treatment. Depending on the type and severity, these include:

• brain edema caused by brain tumors, neurosurgical operations, brain abscess, or bacterial meningitis
• severe acute asthma attack
• initial stage of treatment of widespread, severe skin diseases with an acute course, such as erythroderma, pemphigus, or acute eczema
• treatment of systemic rheumatic diseases (rheumatic diseases that can affect internal organs), such as systemic lupus erythematosus
• active rheumatoid arthritis with a severe, progressive course, e.g., forms that quickly lead to joint destruction and/or involvement of tissues outside the joints
• severe infectious diseases with symptoms similar to sepsis (e.g., tuberculosis, typhoid fever); only in combination with appropriate anti-infective therapy
• supportive treatment of malignant tumors
• treatment of coronavirus disease 2019 (COVID-19) in adult and adolescent patients (aged 12 years and older with a body weight of at least 40 kg) with breathing difficulties and requiring oxygen therapy

Dexamethasone Zentiva 0.5 mg, 1 mg is also used during:

• Hormone replacement therapy in cases of adrenal insufficiency (adrenogenital syndrome) in adults.

Dexamethasone Zentiva 1 mg, 4 mg is also used during:

• Prophylaxis and treatment of vomiting during chemotherapy
• Prophylaxis and treatment of vomiting after surgical procedures

2. Important information before taking Dexamethasone Zentiva

When not to take Dexamethasone Zentiva

Warnings and precautions

Before taking Dexamethasone Zentiva, discuss it with your doctor, pharmacist, or nurse. If the patient is taking other steroid medicines, they should not stop taking them unless their doctor advises them to do so. General precautions for the use of steroid medicines in certain diseases, masking of infection symptoms, concurrent use of other medicines, etc. should be taken in accordance with current recommendations. Treatment with glucocorticosteroids may lead to adrenal insufficiency (insufficient production of glucocorticosteroids by the body), which, depending on the dose and duration of treatment, may last for several months, and in some cases, even more than a year after the end of therapy. If, during glucocorticosteroid treatment, special physical stress conditions occur, such as fever, injuries, surgical procedures, childbirth, etc., the patient should inform their doctor or the emergency department about the treatment they are taking. It may be necessary to temporarily increase the daily dose of Dexamethasone Zentiva. The administration of glucocorticoids may also be necessary in stressful situations when adrenal insufficiency persists after the end of treatment. During long-term treatment with Dexamethasone Zentiva, the doctor should provide the patient with a card informing about the use of corticosteroids, which should always be carried with them. To avoid acute adrenal insufficiency caused by therapy, when treatment is planned to be discontinued, the doctor will establish a dose reduction plan, which must be strictly followed. Treatment with Dexamethasone Zentiva may increase the risk of bacterial, viral, parasitic, opportunistic, and fungal infections due to the weakening of the body's defense mechanisms. Signs and symptoms of existing or developing infections may be masked and therefore difficult to detect. Latent infections may recur.

Dexamethasone Zentiva can only be used in the following conditions

ifthe doctor considers it absolutely necessary. In some cases, specific anti-infective medicines must be used 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, worm infestations). In the case of infection or suspected infection with threadworms (Strongyloides), Dexamethasone Zentiva may lead to activation and increased reproduction of these parasites;
• Heine-Medin disease (polio);
• lymph node inflammation after BCG vaccination;

During treatment with Dexamethasone Zentiva, the following diseases should be monitored:

• peptic ulcer disease;
• bone loss (osteoporosis);
• severe heart failure;
• difficult-to-control hypertension;
• difficult-to-control diabetes;
• mental disorders (also in history), including the risk of suicide. In such cases, neurological or psychiatric supervision is recommended.
• increased intraocular pressure (glaucoma with narrow or wide angle of filtration), ophthalmological supervision and appropriate treatment are recommended;
• corneal damage and ulcers; ophthalmological supervision and treatment are recommended.

If the patient experiences blurred vision or other vision disturbances, they should contact their doctor. Taking this medicine may cause a crisis in the course of a pheochromocytoma (adrenal gland tumor), which can be life-threatening. Pheochromocytoma is a rare adrenal gland tumor. A crisis in its course may occur with the following symptoms: headache, excessive sweating, palpitations, and increased blood pressure. If these symptoms occur, the patient should immediately contact their doctor. Before starting treatment with Dexamethasone Zentiva, the patient should discuss it with their doctor if they suspect or have been diagnosed with a pheochromocytoma (adrenal gland tumor).

Due to the risk of intestinal perforation, Dexamethasone Zentiva can only be used in emergency situations 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 of the intestine;
• immediately after certain intestinal surgeries (intestinal anastomoses).

Signs of peritoneal irritation after gastrointestinal perforation may not occur in patients taking high doses of glucocorticosteroids. In diabetic patients, metabolism should be regularly monitored. It is necessary to consider the possible increased need for diabetes medications (insulin, oral antidiabetic drugs). Patients with severe hypertension and/or severe heart failure should be closely monitored, as there is a risk of worsening their condition. High doses may cause cardiac arrhythmias. Severe anaphylactic reactions (excessive immune system response) may occur. When fluoroquinolones (a type of antibiotic) and Dexamethasone Zentiva are administered concurrently, the risk of tendon disorders, tendonitis, and tendon rupture is increased. During treatment of a certain type of muscle paralysis (myasthenia), the symptoms may initially worsen.

Vaccinations

Vaccinations with killed microorganism vaccines (inactivated vaccines) are generally possible. However, it should be noted that the immune response, and thus the response to vaccination, may be weakened with higher doses of corticosteroids.

Long-term treatment

• Long-term use of even small doses of dexamethasone can increase the risk of infection, including those caused by microorganisms that usually rarely cause infections (so-called opportunistic infections). At the same time, the symptoms of infection may be masked, making it difficult to detect existing or developing infections.
• During long-term treatment with Dexamethasone Zentiva, regular medical check-ups (including ophthalmological check-ups) are required.
• Particularly during long-term treatment with high doses of Dexamethasone Zentiva, attention should be paid to adequate potassium intake (e.g., vegetables, bananas) and sodium restriction. The doctor should monitor blood calcium levels.
• Depending on the duration of treatment and dose, one should expect a negative impact of the medicine on calcium metabolism, so osteoporosis prevention is recommended. This applies especially to people with existing risk factors, such as family history, advanced age, insufficient protein and calcium intake, smoking, excessive alcohol consumption, postmenopausal period, and lack of physical activity. Prevention involves adequate calcium and vitamin D intake and physical activity. In the case of existing osteoporosis, the doctor should consider the use of additional medications.
• In the case of termination or interruption of long-term glucocorticosteroid treatment, one should consider the risk of occurrence of the following situations: exacerbation or recurrence of the underlying disease, acute adrenal insufficiency, corticosteroid withdrawal syndrome.

Viral diseases

Viral diseases (such as measles, chickenpox) may have a particularly severe course in patients treated with Dexamethasone Zentiva. Patients with impaired immunity who have not had measles or chickenpox are particularly at risk. If these patients come into contact with people with measles or chickenpox during treatment with Dexamethasone Zentiva, they should immediately contact their doctor, who may start preventive treatment if necessary.

Tumor lysis syndrome

Symptoms of tumor lysis syndrome, such as muscle cramps, muscle weakness, confusion, vision loss or disturbances, and shortness of breath, if the patient has a hematological malignancy.

Children and adolescents

Dexamethasone should not be routinely used in premature infants with respiratory failure. In children, Dexamethasone Zentiva should only be used if there are valid medical reasons related to the risk of growth retardation, and during long-term treatment, growth should be regularly monitored. The duration of treatment with Dexamethasone Zentiva should be limited or the medicine should be used alternately (e.g., every other day, but in a double dose) (alternate-day therapy).

Elderly patients

In elderly patients, caution is necessary due to the risk of osteoporosis.

Dexamethasone Zentiva and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Medicines that affect the action of Dexamethasone Zentiva

• Medicines that accelerate its breakdown in the liver, such as sleeping pills (barbiturates), antiepileptic drugs (phenytoin, carbamazepine, primidone), and some anti-tuberculosis drugs (rifampicin), may weaken the effect of corticosteroids.
• Medicines that slow down the metabolism of corticosteroids in the liver, such as certain antifungal drugs (ketoconazole, itraconazole), may enhance the effect of corticosteroids.
• Certain female sex hormones, e.g., used in contraceptives ("the pill"): may increase the effect of Dexamethasone Zentiva.
• Medicines that reduce excessive stomach acid production (antacids): it is possible that the absorption of dexamethasone may be reduced when taken concurrently with magnesium hydroxide or aluminum hydroxide. These medicines should be taken separately (with a 2-hour interval).
• Ephedrine (which may be contained in medicines used to treat low blood pressure, chronic bronchitis, asthma attacks, and to reduce swelling of mucous membranes in case of a cold, as well as a component of appetite suppressants): the effectiveness of Dexamethasone Zentiva may be reduced due to accelerated metabolism in the body.

Tell your doctor if you are taking ritonavir or cobicistat, as this may increase the level of dexamethasone in your blood.

Effect of Dexamethasone Zentiva on the action of other medicines

• may enhance the effect of heart-strengthening medicines (cardiac glycosides) due to potassium deficiency
• may increase potassium excretion caused by diuretics (saluretics) or laxatives
• may weaken the effect of oral antidiabetic medicines that lower blood sugar levels and insulin
• may weaken or enhance the effect of blood-thinning medicines (oral anticoagulants, coumarins). The doctor will decide whether it is necessary to adjust the dose of the blood-thinning medicine.
• may increase the risk of stomach ulcers and gastrointestinal bleeding when used concurrently with anti-inflammatory and anti-rheumatic medicines (salicylates, indomethacin, and other non-steroidal anti-inflammatory drugs)
• may prolong the effect of certain muscle relaxants (non-depolarizing muscle relaxants)
• may enhance the effect of certain medicines that increase eye pressure (atropine and other anticholinergic medicines)
• may reduce the effectiveness of medicines used to treat worm infections (praziquantel)
• may increase the risk of muscle or heart muscle diseases (myopathies, cardiomyopathies) when used concurrently with malaria or rheumatic disease medicines (chloroquine, hydroxychloroquine, mefloquine)
• may weaken the effect of growth hormones (somatropin), especially when used in high doses or during long-term treatment
• may reduce the level of thyroid-stimulating hormone (TSH) after administration of protirelin (TRH, a hormone produced by the hypothalamus)
• may increase the susceptibility to infections when used concurrently with immunosuppressive agents and may exacerbate existing infections that have not fully developed
• may increase the level of cyclosporin (a medicine used to weaken the body's defense mechanisms) in the blood, thereby increasing the risk of seizures
• fluoroquinolones, a group of antibiotics that may increase the risk of tendon rupture

Effect on diagnostic tests

Glucocorticosteroids may suppress skin reactions in allergy tests.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine. Pregnancy Dexamethasone crosses the placenta. During pregnancy, especially in the first trimester, the medicine should only be used after careful consideration of the benefit-risk ratio. If you are pregnant or think you may be pregnant, tell your doctor. Long-term use of glucocorticosteroids during pregnancy may cause fetal growth disturbances. If glucocorticosteroids are administered at the end of pregnancy, there is a risk of adrenal insufficiency in the fetus, which may require substitution treatment with gradual dose reduction in newborns. Breastfeeding Glucocorticosteroids, including dexamethasone, pass into breast milk. So far, no cases of harmful effects on infants have been reported. Nevertheless, the medicine can be used during breastfeeding only if it is absolutely necessary. If higher doses are required due to the disease, breastfeeding should be discontinued. Contact your doctor immediately.

Driving and using machines

So far, there is no evidence that Dexamethasone Zentiva impairs the ability to drive or use machines. The same applies to work in hazardous conditions.

Dexamethasone Zentiva contains lactose and sodium

If you have been diagnosed with intolerance to some sugars, contact your doctor before taking this medicine. This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Dexamethasone Zentiva

Always take this medicine exactly as your doctor has told you. The doctor will decide how long you should take dexamethasone. In case of doubts, consult your doctor or pharmacist. The doctor will determine the dose of the medicine individually for each patient. You should follow the instructions exactly, as otherwise, the effect of Dexamethasone Zentiva will not be correct. In case of any doubts, consult your doctor or pharmacist.

Unless the doctor has prescribed otherwise, the following doses are recommended:

• Brain edema:16 - 24 mg (up to 48 mg) per day, 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 administration of the first dose of antibiotics.
• Severe acute asthma attack:administer as soon as possible 8 - 20 mg, then if necessary, 8 mg every 4 hours. Children: 0.15 - 0.3 mg/kg body weight.
• Acute skin diseases:depending on the type and extent of the disease, daily doses of 8 - 40 mg, and in some cases up to 100 mg. Then, treatment with gradually decreasing doses.
• Systemic lupus erythematosus:6 - 16 mg per day
• Active rheumatoid arthritis with a severe, progressive course, e.g., forms that quickly lead to joint destruction and/or involvement of tissues outside the joints: 6 - 12 mg per day.
• Severe infectious diseases with symptoms similar to sepsis:4 - 20 mg per day for several days, only in combination with appropriate anti-infective therapy.
• Palliative treatment of malignant tumors:initially 8 - 16 mg per day, in longer therapy 4 - 12 mg per day.
• COVID-19 treatment:Adults are recommended to take 6 mg orally once a day for up to 10 days. Adolescents (aged 12 and older) are recommended to take 6 mg orally once a day for up to 10 days.

Dexamethasone Zentiva 0.5 mg, 1 mg is also used during:

• Hormone replacement therapy:Congenital adrenogenital syndrome in adults: 0.25 - 0.75 mg/day, taken in a single dose. If necessary, administer a mineralocorticoid (fludrocortisone). If Dexamethasone Zentiva is not available, another available dexamethasone product should be used. In case of special physical stress, such as infection with fever, injury, surgical procedure, or childbirth, the dose should be temporarily increased according to the doctor's instructions.

Dexamethasone Zentiva 1 mg, 4 mg is also used during:

• Prophylaxis and treatment of vomiting during chemotherapy:10 - 20 mg before the start of chemotherapy, then if necessary, 4 - 8 mg 2 to 3 times a day for 1 - 3 days or up to 6 days if necessary.
• Prophylaxis and treatment of vomiting after surgical procedures:A single dose of 8 - 20 mg before the start of surgery; In children from 2 years of age: 0.15 - 0.5 mg/kg body weight (maximum 16 mg).

Method of administration

Tablets for oral administration. The tablets should be swallowed whole, during or after meals, with a sufficient amount of liquid. If possible, the daily dose should be administered in a single dose in the morning. However, in cases of diseases that require treatment with high doses, it is often necessary to take multiple doses throughout the day.

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. As soon as 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 case of adrenal insufficiency or liver cirrhosis, relatively small doses may be sufficient or a dose reduction may be necessary.

Use of a higher than recommended dose of Dexamethasone Zentiva

Generally, Dexamethasone Zentiva is well-tolerated without complications even after short-term use of high doses. There is no need for special measures. In case of severe or unusual side effects, consult a doctor.

Missing a dose of Dexamethasone Zentiva

If a dose is missed, take it as soon as possible. If it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for the missed dose. Missing several doses may cause the treated disease to worsen or exacerbate. In such cases, consult a doctor, who will check and possibly adjust the treatment.

Discontinuation of Dexamethasone Zentiva

Always follow the dosage regimen prescribed by your doctor. Never stop taking Dexamethasone Zentiva on your own, as especially long-term treatment may lead to inhibition of glucocorticosteroid production by the body (adrenal insufficiency or "hypofunction" of the adrenal cortex). A situation of increased physical stress without sufficient glucocorticosteroid production can be life-threatening. In case of any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any of the following side effects, or any other side effects not listed in this leaflet, tell your doctor or pharmacist. Do not stop treatment on your own.

Possible side effects

There is a low risk of side effects when using the recommended doses for hormone replacement therapy. However, during long-term use, especially with high doses, the medicine may cause side effects of varying severity, but the frequency of their occurrence cannot be determined.

Infections and infestations

Masking of infections, occurrence and exacerbation of viral, fungal, bacterial, and parasitic infections, as well as opportunistic infections, and reactivation of latent infections.

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

Allergic reactions (e.g., drug rash), severe anaphylactic reactions, such as cardiac arrhythmias, bronchospasm (bronchial muscle spasm), high or low blood pressure, circulatory collapse, myocardial infarction, and immunosuppression.

Endocrine disorders

Induction of Cushing's syndrome (typical symptoms are moon face, central obesity, and facial flushing), adrenal insufficiency or atrophy.

Metabolic and nutritional disorders

Weight gain, increased blood sugar levels, diabetes, increased cholesterol and triglyceride levels, sodium retention with tissue edema (swelling), potassium deficiency due to increased excretion (which may lead to cardiac arrhythmias), increased appetite.

Psychiatric disorders

Depression, irritability, euphoria, increased drive, psychosis, mania, hallucinations, emotional instability, anxiety, sleep disturbances, suicidal tendencies.

Nervous system disorders

Increased intracranial pressure, occurrence of symptoms of latent epilepsy (epilepsy), increased susceptibility to seizures in epilepsy.

Eye disorders

Increased intraocular pressure (glaucoma), cataract (lens clouding), worsening of corneal ulcers, worsening of viral, bacterial, or fungal eye infections, worsening of bacterial keratitis, ptosis (drooping eyelid), mydriasis (pupil dilation), conjunctival edema, vision disturbances, vision loss, blurred vision.

Vascular disorders

Hypertension, increased risk of atherosclerosis and thrombosis, vasculitis (including vasculitis as a withdrawal syndrome after long-term treatment), and increased capillary fragility.

Gastrointestinal disorders

Peptic ulcers and gastrointestinal bleeding, pancreatitis, gastrointestinal upset. If gastrointestinal upset, back pain, hip pain, joint pain, psychiatric disturbances, fluctuations in blood sugar levels in diabetics, or other disturbances occur, immediately inform your doctor.

Skin and subcutaneous tissue disorders

Stretch marks, skin thinning ("parchment-like" skin), telangiectasias (dilated blood vessels), bruising, petechiae (small hemorrhages), hirsutism (excessive hair growth), acne, facial skin inflammation, especially around the mouth, nose, and eyes, pigmentation changes.

Musculoskeletal and connective tissue disorders

Muscle disorders, muscle weakness and atrophy, bone loss (osteoporosis) dependent on dose and duration of treatment, possibly even after short-term therapy, other forms of bone degeneration (aseptic bone necrosis), tendon diseases, tendonitis, tendon rupture, fat accumulation in the spine (lipomatosis), growth retardation in children. Note: If the dose is reduced too quickly after long-term treatment, a withdrawal syndrome may occur, which may manifest as muscle and joint pain.

Reproductive system and breast disorders

Disorders of sex hormone secretion, resulting in: irregular or absent menstrual periods (amenorrhea), hirsutism in women (male pattern hair growth), impotence.

General disorders and administration site conditions

Delayed wound healing

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, tell your 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 or its representative in Poland. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dexamethasone Zentiva

Keep out of the sight and reach of children. Do not use this medicine after the expiry date stated on the blister and carton after "EXP". The expiry date refers to the last day of the month. Store in a temperature below 25°C. Store in the original packaging to protect from light. Medicines should 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 packaging and other information

What Dexamethasone Zentiva contains

• The active substance is dexamethasone. Each tablet contains 0.5 mg, 1 mg, 4 mg of dexamethasone.
• Other ingredients: lactose monohydrate; sodium carboxymethylcellulose (type A); magnesium stearate; anhydrous colloidal silica.

What Dexamethasone Zentiva looks like and contents of the pack

Dexamethasone Zentiva, 0.5 mg, tablet: white or almost white, round, flat tablet with beveled edges, approximately 8 mm in diameter, with the inscription "DX" on one side and "500" on the other. Dexamethasone Zentiva, 1 mg, tablet: white or almost white, round, flat tablet with beveled edges, approximately 8 mm in diameter, with the inscription "DX" on one side and "1" on the other. Dexamethasone Zentiva, 4 mg, tablet: white or almost white, round, flat tablet with beveled edges, approximately 8 mm in diameter, with the inscription "DX" on one side and "4" on the other. White blister with aluminum/PVC/PVDC foil in a cardboard box. Pack size: 10, 20, 30, 50, 100 tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva, k.s. U kabelovny 130 Dolní Měcholupy 102 37 Prague 10 Czech Republic

Importer

S.C. Zentiva S.A. B-dul Theodor Pallady nr 50 Sector 3, Bucharest 032266 Romania

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: Dexamethason Zentiva Croatia: Deksametazon Zentiva Czech Republic, Denmark, Norway, Poland, Sweden: Dexamethasone Zentiva Romania: Dexametazonă Zentiva

For further information, contact your local representative of the marketing authorization holder:

Zentiva Polska Sp. z o.o. ul. Bonifraterska 17 00-203 Warsaw, Poland phone: +48 22 375 92 00

Date of last revision of the leaflet: