Dexamethasone Zentiva

Leaflet accompanying the packaging: information for the user

Dexamethasone Zentiva, 0.5 mg, tablets

Dexamethasone Zentiva, 1 mg, tablets

Dexamethasone Zentiva, 4 mg, tablets

Dexamethasone

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your 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 using Dexamethasone Zentiva
• 3. How to use 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 therapy. 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 difficulty breathing 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 using Dexamethasone Zentiva

When not to use Dexamethasone Zentiva

Warnings and precautions

Before using Dexamethasone Zentiva, you should discuss it with your doctor, pharmacist, or nurse.

If you are taking other steroid medicines, you should not stop taking them unless your doctor advises you to do so.

General precautions for the use of steroid medicines in certain diseases, masking of infection symptoms, concomitant 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 you experience any of the following during treatment with glucocorticosteroids: fever, injuries, surgical procedures, childbirth, etc., you should inform your doctor or the emergency doctor about the treatment you are taking. It may be necessary to temporarily increase the daily dose of Dexamethasone Zentiva. 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, your doctor should provide you with a card informing you about taking corticosteroids, which you should always carry with you.

In order to avoid acute adrenal insufficiency caused by therapy, when it is planned to stop treatment, your doctor will establish a dose reduction plan, which must be strictly followed.

Treatment with Dexamethasone Zentiva may lead to an increased 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

ifyour doctor considers it absolutely necessary. In some cases, it may be necessary to use medicines with specific antimicrobial action at the same time:

• 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 you experience blurred vision or other vision disturbances, you should contact your 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 you experience any of these symptoms, you should immediately contact your doctor.

Before starting treatment with Dexamethasone Zentiva, you should discuss it with your doctor if you 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 (ulcerative colitis) with a risk of perforation, with ulcerative or abscessing inflammation, also occurring 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 increase in the 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 a slowdown in heart rate.

Severe anaphylactic reactions (excessive immune system response) may occur.

When Dexamethasone Zentiva is administered concurrently with fluoroquinolones (a type of antibiotic), the risk of tendon disorders, tendonitis, and tendon rupture is increased.

During treatment of a certain type of muscle paralysis (myasthenia), symptoms may worsen at the beginning.

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 lead to an increased risk of infection, including those caused by microorganisms that usually rarely cause infections (so-called opportunistic infections). At the same time, 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 ones) are required.
• Especially during long-term treatment with high doses of Dexamethasone Zentiva, attention should be paid to adequate intake of potassium (e.g., vegetables, bananas) and restriction of sodium intake. Your doctor should monitor calcium levels in your blood.
• Depending on the duration of treatment and dose, there may be a negative impact 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 a large number of cigarettes, excessive alcohol consumption, postmenopausal period, and lack of physical activity. Prevention involves adequate intake of calcium and vitamin D and physical activity. In the case of existing osteoporosis, your doctor should consider the use of additional medications.
• In the case of termination or interruption of long-term glucocorticosteroid treatment, the risk of the following situations should be considered: 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 weakened immunity who have not had measles or chickenpox before are especially 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 you have a hematological malignancy.

Children and adolescents

Dexamethasone should not be routinely used in premature infants with respiratory distress syndrome.

In children, Dexamethasone Zentiva should only be used when there are significant 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 should be exercised due to the risk of osteoporosis.

Dexamethasone Zentiva and other medicines

You should tell your doctor or pharmacist about all medicines you are currently 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 stomach acid production (antacids): it is possible that 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 (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.

You should inform 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 drugs that lower blood sugar levels and insulin
• may weaken or enhance the effect of blood-thinning medicines (oral anticoagulants, coumarins). Your 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 action of certain muscle relaxants (non-depolarizing muscle relaxants)
• may enhance the effect of certain medicines that increase intraocular pressure (atropine and other anticholinergic medicines)
• may reduce the effectiveness of medicines used to treat worm infections (praziquantel)
• may increase the risk of muscle diseases or heart muscle diseases (myopathies, cardiomyopathies) when used concurrently with malaria or rheumatic diseases (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 medicines that weaken the immune system (immunosuppressive agents) and may exacerbate existing infections that have not fully developed
• may increase the level of cyclosporine (a medicine used to weaken the body's immune system) 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, you should consult your doctor or pharmacist before using this medicine.

Pregnancy

Dexamethasone crosses the placenta. During pregnancy, especially in the first trimester, the medicine should only be used after careful evaluation of the benefit-risk ratio. If you are pregnant or think you may be pregnant, you should tell your doctor. It is not possible to exclude the occurrence of fetal growth disturbances during long-term use of glucocorticosteroids during pregnancy. If glucocorticosteroids are administered at the end of pregnancy, there is a risk of adrenal insufficiency in the fetus, which may require substitute 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. You should immediately contact your doctor.

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, you should contact your doctor before taking this medicine.

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to use Dexamethasone Zentiva

You should always use the medicine as directed by your doctor. Your doctor will decide how long you should use dexamethasone. If you have any doubts, you should contact your doctor or pharmacist.

Your doctor will determine the dose of the medicine individually for you. You should follow the instructions exactly, as otherwise, the effect of Dexamethasone Zentiva will not be correct.

If you have any doubts, you should contact your doctor or pharmacist.

If your doctor does not recommend 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:8 - 20 mg should be administered as soon as possible, 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 severity 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-term 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, a mineralocorticoid (fludrocortisone) should be administered. If Dexamethasone Zentiva is not available, another available dexamethasone product should be used. In case of 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: 0.15 - 0.5 mg/kg body weight (max. 16 mg).

Method of administration

Tablets for oral administration.

Tablets should be swallowed whole, during or after a meal, with a sufficient amount of liquid.

If possible, the daily dose should be administered in a single dose in the morning. However, in diseases that require treatment with high doses, it is often necessary to take multiple doses throughout the day to achieve maximum effect.

Duration of treatment

The duration of treatment depends on the disease and its progression. Your 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 reduced gradually.

In case of adrenal insufficiency or liver cirrhosis, relatively small doses may be sufficient or a dose reduction may be required.

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. If you experience severe or unusual side effects, you should contact your doctor.

Missing a dose of Dexamethasone Zentiva

If you miss a dose, you should take it as soon as possible. If it is almost time for the next dose, you should skip the missed dose. You should not take a double dose to make up for the missed dose.

Missing several doses may cause the treated disease to worsen or recur. In such cases, you should contact your doctor, who will check and possibly adjust the treatment.

Discontinuation of Dexamethasone Zentiva

You should always follow the dosage regimen recommended by your doctor. You should never stop using Dexamethasone Zentiva on your own, as prolonged treatment may lead to suppression 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.

If you have any further questions about using this medicine, you should contact 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, you should contact 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 treatment, 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 worsening 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 (smooth muscle spasm in the bronchi), high or low blood pressure, circulatory collapse, heart attack, and weakening of the immune system.

Endocrine disorders

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

Metabolic and nutritional disorders

Weight gain, increased blood sugar levels, diabetes, increased fat levels (cholesterol and triglycerides), increased sodium levels 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 corneal inflammation, ptosis (drooping eyelid), mydriasis (pupil dilation), conjunctival edema, corneal perforation, vision disturbances, vision loss.

Vascular disorders

Hypertension, increased risk of atherosclerosis and thrombosis, vasculitis (inflammation of blood vessels), and increased fragility of blood vessels.

Gastrointestinal disorders

Peptic ulcers and gastrointestinal bleeding, pancreatitis, gastrointestinal upset.

If you experience gastrointestinal upset, back pain, shoulder pain, or hip pain, mental disturbances, fluctuations in blood sugar levels in diabetics, or other disorders, you should immediately inform your doctor.

Skin and subcutaneous tissue disorders

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

Musculoskeletal and connective tissue disorders

Muscle disorders, muscle weakness and atrophy, bone loss (osteoporosis) dependent on dose and possible 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. This may manifest as symptoms such 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, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Ministry of Health, or to the marketing authorization holder. 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 expiration date stated on the blister and carton after "EXP". The expiration date refers to the last day of the month stated.

Store at 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. You should ask your pharmacist how to dispose of medicines that are no longer needed. 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, or 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 "DX" embossed on one side and "500" on the other side.

Dexamethasone Zentiva 1 mg, tablet: white or almost white, round, flat tablet with beveled edges, approximately 8 mm in diameter, with "DX" embossed on one side and "1" on the other side.

Dexamethasone Zentiva 4 mg, tablet: white or almost white, round, flat tablet with beveled edges, approximately 8 mm in diameter, with "DX" embossed on one side and "4" on the other side.

White blister with aluminum/PVC/PVDC foil in a cardboard box.

Package sizes: 10, 20, 30, 50, 100 tablets.

Not all package 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 more information, please contact your local representative of the marketing authorization holder:

Zentiva Polska Sp. z o.o.,

ul. Bonifraterska 17

00-203 Warsaw, Poland

tel.: +48 22 375 92 00

Date of last revision of the leaflet: