Patient Information Leaflet

Dexamethasone Zentiva, 8 mg, tablets
Dexamethasonum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

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

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

Dexamethasone Zentiva contains the active substance dexamethasone, which is a
synthetic glucocorticoid (a corticosteroid hormone). It affects metabolism, the body's electrolyte balance, and tissue function.
Dexamethasone Zentiva is used in conditions requiring systemic glucocorticoid therapy. Depending on the type and severity, these include:

Cerebral oedema caused by brain tumour, neurosurgical procedures, brain abscess or bacterial meningitis
Severe acute asthma attack
Initial stage of treatment of extensive, severe skin diseases with acute course, e.g. erythroderma, pemphigus vulgaris or acute eczema
Treatment of systemic rheumatic diseases (rheumatic diseases which may affect internal organs), such as systemic lupus erythematosus
Active rheumatoid arthritis (RA) with severe progressive course, e.g. forms rapidly leading to joint destruction and (or) extra-articular tissue involvement
Severe infectious diseases with features resembling poisoning (e.g. tuberculosis, typhoid fever); only in combination with appropriate anti-infective therapy
Palliative treatment of malignant tumours
Treatment of disease caused by coronavirus 2019 (COVID-19) in adult and adolescent patients (aged 12 years and older with body weight of at least 40 kg) who have difficulty breathing and require oxygen therapy
Prevention and treatment of vomiting during cytostatic therapy
Prevention and treatment of postoperative vomiting

2. Important information before using Dexamethasone Zentiva

When not to use Dexamethasone Zentiva

if the patient is allergic to dexamethasone or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before using Dexamethasone Zentiva, discuss this with your doctor, pharmacist, or
nurse.
If the patient is taking other steroid medicines, do not stop taking them unless advised otherwise by a doctor.
General precautions regarding the use of steroid medicines in certain diseases, masking of infection symptoms, concomitant medications, etc., should be followed according to current guidelines.
Treatment with glucocorticoids may lead to adrenal insufficiency (inadequate production of glucocorticoids by the body), which depending on the dose and duration of treatment may last several months, and in some cases even more than a year after therapy has ended.
If unusual physical stress occurs during glucocorticoid treatment, such as fever, injury, surgery, childbirth, etc., inform your treating doctor or the emergency department physician about the ongoing treatment. Temporary increase in the daily dose of Dexamethasone Zentiva may be necessary. Glucocorticoid administration may also be required during stressful situations if adrenal insufficiency (impaired adrenal function) persists after treatment has ended. During long-term treatment with Dexamethasone Zentiva, the doctor should provide the patient with a card indicating corticosteroid use, which should always be carried.
To avoid acute adrenal insufficiency caused by therapy, when discontinuation of treatment is planned, 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 suppression of the body's defense mechanisms. Subjective and objective symptoms of existing or developing infections may be masked and thus difficult to detect. Inactive infections may reactivate.
Dexamethasone Zentiva may be used during the following conditions only if the doctor considers it absolutely necessary. In some cases, antimicrobial agents with specific activity must be used concomitantly:

acute viral infections (hepatitis B, chickenpox, shingles, herpes virus infections, corneal inflammation caused by Herpes viruses);
chronic active hepatitis with a positive HBsAg test (infectious hepatitis);
approximately 8 weeks before and up to 2 weeks after vaccination with vaccines containing live microorganisms;
acute and chronic bacterial infections;
fungal infections involving internal organs;
certain parasitic diseases (infection with amoebae, worms). In case of infection or suspected infection with Strongyloides (intestinal threadworm), Dexamethasone Zentiva may lead to activation and increased multiplication of these parasites;
Heine-Medin disease (polio);
lymph node inflammation after tuberculosis vaccination;
if the patient has previously had tuberculosis, the medicine may be used only concomitantly with

anti-tuberculosis agents.
During treatment with Dexamethasone Zentiva, the following diseases should be monitored:

peptic ulcer of the stomach and intestines;
bone mass loss (osteoporosis);
severe heart failure;
difficult-to-control hypertension;
difficult-to-control diabetes;
psychiatric disorders (including in medical history), including suicide risk. In such cases, neurological or psychiatric supervision is recommended.
increased intraocular pressure (glaucoma with narrow or wide filtration angle); 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 visual disturbances, contact a doctor.
Use of this medicine may cause a pheochromocytoma crisis, which may lead to death.
Pheochromocytoma is a rare tumour of the adrenal glands. A pheochromocytoma crisis may present with: headache, excessive sweating, palpitations, and increased blood pressure.
If the above symptoms occur, the patient should contact a doctor immediately.
Before starting treatment with Dexamethasone Zentiva, discuss this with your doctor if there is suspicion of or a diagnosed pheochromocytoma (adrenal tumour).
Due to the risk of intestinal perforation, Dexamethasone Zentiva may be used only for urgent indications and under appropriate monitoring in the following conditions:

Severe colitis (ulcerative colitis) with risk of perforation, including ulcerative or suppurative inflammation, even without peritonitis.
Diverticulitis.
Immediately after certain intestinal surgeries (intestinal anastomoses).

Signs of peritoneal irritation following gastrointestinal perforation may not occur in patients receiving high doses of glucocorticoids.
In patients with diabetes, metabolism should be monitored regularly. An increased requirement for antidiabetic medications (insulin, oral antidiabetic drugs) should be considered.
Patients with severe hypertension and/or severe heart failure should be carefully monitored, as there is a risk of worsening health status.
High doses may cause reduced cardiac function.
Severe anaphylactic reactions (excessive immune system response) may occur.
Concomitant administration of fluoroquinolones (a type of antibiotic) and Dexamethasone Zentiva increases the risk of tendon disorders, tendon inflammation, and tendon rupture.
At the beginning of treatment for a specific type of muscle paralysis (myasthenia gravis), symptoms may worsen.
Vaccinations
Vaccination with killed microorganisms (inactivated vaccines) is 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, even of small doses of dexamethasone, increases the risk of infection, including by microorganisms that usually rarely cause infections (so-called opportunistic infections). At the same time, symptoms of infections may be masked, making detection of existing or developing infections difficult.
In case of long-term treatment with Dexamethasone Zentiva, regular medical check-ups (including ophthalmological) are required.
Especially during long-term, high-dose treatment with 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 and dose of treatment, a negative effect of the drug on calcium metabolism should be expected; therefore, prevention of osteoporosis is recommended. This particularly applies to individuals with existing risk factors such as family history, advanced age, insufficient protein and calcium intake, heavy smoking, excessive alcohol consumption, postmenopausal period, and lack of physical activity. Prevention includes adequate intake of calcium and vitamin D and physical activity. In case of existing osteoporosis, the doctor should consider using additional medications.
When stopping or interrupting long-term glucocorticoid treatment, consider the risk of the following: exacerbation or recurrence of the underlying disease, acute adrenal insufficiency, cortisone withdrawal syndrome.

Viral diseases
Viral diseases (such as measles, chickenpox) may have a particularly severe course in patients treated with Dexamethasone Zentiva. Patients with reduced immunity who have not yet had measles or chickenpox are especially at risk. If these patients come into contact with people suffering from measles or chickenpox during treatment with Dexamethasone Zentiva, they should contact a doctor immediately, who may initiate preventive treatment if necessary.
Tumour lysis syndrome
Symptoms of tumour lysis syndrome, such as muscle cramps, muscle weakness, confusion, loss or disturbances of vision, and shortness of breath, if the patient has a haematological tumour.
Children and adolescents
Dexamethasone should not be routinely used in preterm infants with respiratory insufficiency.
In children, Dexamethasone Zentiva should be used only when there are important medical reasons due to the risk of growth retardation, and during long-term treatment, growth should be monitored regularly. The duration of treatment with Dexamethasone Zentiva should be limited or administered intermittently (e.g., every other day, but at double dose) (intermittent therapy).
Elderly patients
In elderly patients, caution should be exercised due to the risk of osteoporosis.
Doping tests
Use of Dexamethasone Zentiva may lead to positive results in drug tests.
Dexamethasone Zentiva and other medicines
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), anticonvulsants (phenytoin, carbamazepine, primidone), and some anti-tuberculosis drugs (rifampicin), may weaken the effect of corticosteroids.
Medicines that slow down corticosteroid metabolism in the liver, such as certain antifungal drugs (ketoconazole, itraconazole), may enhance the effect of corticosteroids.
Specific female sex hormones, e.g., used in contraceptives ("the pill"): may increase the effect of Dexamethasone Zentiva.
Medicines against excessive hydrochloric acid production in the stomach (antacids): reduced absorption of dexamethasone may occur when used concomitantly with magnesium hydroxide or aluminium hydroxide. These medicines should be taken separately (with a two-hour interval).
Ephedrine (may be contained, e.g., in medicines used to treat low blood pressure, chronic bronchitis, asthma attacks, and to reduce mucosal swelling in colds, or as an ingredient in appetite suppressants): The effectiveness of Dexamethasone Zentiva may be reduced due to accelerated metabolism in the body.

Inform your doctor if the patient is taking ritonavir or cobicistat, as this may increase dexamethasone blood levels.
Effect of Dexamethasone Zentiva on the action of other medicines

may increase the risk of blood morphology changes if used concomitantly with certain blood pressure-lowering medicines (ACE inhibitors)
may enhance the effect of cardiac-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 lowering blood glucose and insulin
may weaken or enhance the effect of blood-thinning medicines (oral anticoagulants, coumarins). The doctor will decide whether adjustment of the blood-thinning medicine dose is necessary.
may increase the risk of gastric ulcers and gastrointestinal bleeding if used concomitantly with anti-inflammatory and antirheumatic medicines (salicylates, indomethacin, and other non-steroidal anti-inflammatory drugs)
may prolong the muscle-relaxing effect of certain medicines (non-depolarizing muscle relaxants)
may enhance the effect of certain medicines increasing intraocular pressure (atropine and other anticholinergics)
may reduce the effectiveness of medicines used to treat worm infections (praziquantel)
may increase the risk of developing muscle diseases or heart muscle diseases (myopathies, cardiomyopathies) when used concomitantly with medicines for malaria or rheumatic diseases (chloroquine, hydroxychloroquine, mefloquine)
may weaken the effect of growth hormones (somatropin), especially during high-dose or long-term treatment
may reduce the increase in thyroid-stimulating hormone (TSH) concentration after protirelin (TRH, a hormone produced by the hypothalamus)
may increase susceptibility to infections if taken concomitantly with immunosuppressive medicines (immunosuppressive agents) and may exacerbate the course of an existing infection that may not have fully developed
may increase cyclosporine (a medicine used to suppress the body's defense mechanisms against diseases) blood levels and thus increase the risk of seizures
fluoroquinolones, a group of antibiotics, which may increase the risk of tendon rupture.

Effect on diagnostic tests
Glucocorticoids may suppress skin reactions in allergy tests.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Dexamethasone crosses the placenta. During pregnancy, especially in the first trimester, the medicine should be used only after careful assessment of benefit versus risk. Therefore, if the patient is pregnant or may be pregnant, she should inform her doctor. The possibility of fetal growth disturbances during long-term glucocorticoid use during pregnancy cannot be excluded. If glucocorticoids are administered towards the end of pregnancy, there is a risk of adrenal insufficiency in the fetus, which may require substitution therapy with gradual dose reduction in newborns.
Breastfeeding
Glucocorticoids, including dexamethasone, pass into the milk of breastfeeding women. To date, no harmful effects on infants have been reported. Nevertheless, the medicine may be used during breastfeeding only if absolutely necessary. If higher doses are required due to illness, breastfeeding should be discontinued. Contact a doctor immediately.
Driving and operating machinery
There is currently no evidence that Dexamethasone Zentiva impairs the ability to drive or operate machinery. The same applies to work under hazardous conditions.
Dexamethasone Zentiva contains lactose and sodium
If intolerance to certain sugars has previously been diagnosed in patients, the patient should contact a doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Dexamethasone Zentiva

The medicine should always be used exactly as directed by the physician. The physician decides how long dexamethasone should be used. If in doubt, consult your doctor or pharmacist.
Dexamethasone Zentiva is not suitable for all doses described below. For these doses, other medicinal products containing dexamethasone should be used. The physician will determine the dose individually for each patient. Follow the instructions carefully, as otherwise the effect of Dexamethasone Zentiva may not be optimal. In case of any doubts, contact your doctor or pharmacist.
Unless otherwise directed by the physician, the following doses are recommended:

Cerebral edema: 16 – 24 mg (up to 48 mg) per day, divided into 3 – 4 (up to 6) single doses for 4 – 8 days.
Cerebral edema due to bacterial meningitis: 0.15 mg/kg body weight every 6 hours for 4 days. Children: 0.4 mg/kg body weight every 12 hours for 2 days, starting before the first dose of antibiotic.
Severe acute asthma attack: administer as quickly 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 type and severity, daily doses ranging from 8 – 40 mg, and in some cases up to 100 mg. Subsequently, treatment should continue with gradually decreasing doses.
Systemic lupus erythematosus: 6 – 16 mg.
Severe active rheumatoid arthritis with rapidly progressive course, e.g. forms leading rapidly to joint damage or forms with extra-articular symptoms: 6 – 12 mg per day.
Severe infectious diseases with symptoms resembling sepsis: 4 – 20 mg per day for several days, only in combination with appropriate anti-infective therapy.
Palliative treatment of malignant tumours: initially 8 – 16 mg per day; in long-term therapy, 4 – 12 mg per day.
Treatment of COVID-19: Adults are recommended to take 6 mg orally once daily for up to 10 days. Adolescents (aged 12 years and older) are recommended to take 6 mg orally once daily for up to 10 days.
Prevention and treatment of nausea and vomiting during cytostatic therapy as part of antiemetic treatment planning: 10 – 20 mg before initiation of chemotherapy, followed by 4 – 8 mg 2 to 3 times daily for 1 – 3 days or, if necessary, up to 6 days.
Prevention and treatment of postoperative nausea and vomiting: Single dose of 8 – 20 mg before start of surgery; In children aged 2 years and older: 0.15 – 0.5 mg/kg body weight (maximum 16 mg).

Method of administration
Tablets for oral administration.
Tablets should be swallowed whole during or after meals with sufficient fluid.
Whenever possible, the daily dose should be administered as a single dose in the morning. However, in diseases requiring high-dose treatment to achieve maximum effect, multiple daily doses are often necessary.

Duration of treatment
The duration of treatment depends on the disease and its progression. The physician will establish a treatment plan which should be strictly followed. Once a satisfactory treatment response has been achieved, the dose will be reduced to a maintenance dose or treatment will be discontinued. Doses should generally be tapered gradually.
In patients with hypothyroidism or liver cirrhosis, relatively low doses may be sufficient or dose reduction may be required.

Use of a higher than recommended dose of Dexamethasone Zentiva
Dexamethasone Zentiva is generally well tolerated without complications, even after short-term use of high doses. No special measures are usually required. If severe or unusual adverse reactions occur, consult your doctor.

Missed 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 a missed dose.
Repeatedly missing doses may lead to worsening or exacerbation of the treated condition. In such cases, contact your doctor, who will assess and possibly adjust the treatment.

Stopping Dexamethasone Zentiva
Always follow the dosing regimen prescribed by the physician. Never discontinue Dexamethasone Zentiva on your own initiative, as prolonged treatment in particular may lead to suppression of endogenous glucocorticoid production by the body (adrenal insufficiency). A situation of severe physical stress without adequate glucocorticoid production may be life-threatening.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the adverse reactions listed below, or any other adverse reactions, occur during treatment with Dexamethasone Zentiva, consult a doctor.
Do not discontinue treatment on your own.

Possible adverse reactions
There is a small risk of adverse reactions occurring when recommended doses are used in hormone replacement therapy.
However, during long-term use, especially of high doses, the medicine may cause adverse reactions of varying severity, although the frequency of their occurrence cannot be clearly determined.

Infections and parasitic infestations
Masking of infections, occurrence and worsening of viral, fungal, bacterial, and also parasitic and opportunistic infections, reactivation of latent tuberculosis.

Blood and lymphatic system disorders
Changes in blood morphology (increased number of white blood cells or all blood cells, decreased number of certain types of white blood cells).

Immune system disorders
Hypersensitivity reactions (e.g. drug rash), severe anaphylactic reactions such as cardiac arrhythmia, bronchospasm (constriction of smooth muscles in the bronchi), abnormally high or low blood pressure, circulatory collapse, myocardial infarction, immunosuppression.

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

Metabolism and nutrition disorders
Weight gain, increased blood glucose levels, diabetes, increased levels of lipids (cholesterol and triglycerides), increased sodium concentration with tissue swelling (edema), potassium deficiency caused by increased potassium excretion (which may lead to cardiac arrhythmias), increased appetite.

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

Nervous system disorders
Increased intracranial pressure, emergence of symptoms of latent epilepsy, increased frequency of seizures in epilepsy.

Eye disorders
Increased intraocular pressure (glaucoma), lens clouding (cataract), worsening of corneal ulceration, exacerbation of eye inflammation caused by viruses, bacteria or fungi, worsening of bacterial corneal ulceration, eyelid drooping, pupil dilation, conjunctival swelling, perforation of the sclera (white outer layer of the eyeball), visual disturbances, vision loss, blurred vision.

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

Gastrointestinal disorders
Peptic ulcers of the stomach and intestines, gastrointestinal bleeding, pancreatitis, gastrointestinal discomfort.
If gastrointestinal symptoms, back, shoulder or hip joint pain, psychiatric disturbances, noticeable fluctuations in blood glucose levels in diabetics, or other disturbances occur, inform your doctor immediately.

Skin and subcutaneous tissue disorders
Skin striae, decreased skin thickness ("parchment skin"), dilated blood vessels, tendency to bruising, petechiae or extensive skin hemorrhages, hirsutism, acne, inflammatory skin conditions of the face, especially around the mouth, nose and eyes, skin pigmentation changes.

Musculoskeletal and connective tissue disorders
Muscle disorders, muscle weakness and atrophy, loss of bone mass (osteoporosis) dependent on dose and possible even after short-term therapy, other forms of bone degeneration (avascular necrosis), tendon disorders, tendonitis, tendon rupture, fat deposition in the spine (epidural lipomatosis), growth suppression in children.

Note:
If the dose is reduced too quickly after long-term treatment, 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 menstruation or absence of menstruation (amenorrhoea), male-pattern hair growth in women (hirsutism), impotence.

General disorders and administration site conditions
Delayed wound healing.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder or its representative in Poland. Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Dexamethasone Zentiva

Keep out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the blister and carton
following the abbreviation "EXP". The expiry date refers to the last day of the specified month.
There are no special storage temperature requirements for this medicinal product.
Store in the original packaging to protect from light.
Medicines must not be disposed of via the wastewater system or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help
protect the environment.

6. Contents of the pack and other information

What Dexamethasone Zentiva contains

The active substance is dexamethasone. Each tablet contains 8 mg of dexamethasone.
Other ingredients: lactose monohydrate; sodium carboxymethyl starch (type A); magnesium stearate; colloidal anhydrous silica.

What Dexamethasone Zentiva looks like and contents of the pack
White or almost white, round, flat tablet with bevelled edges, approximately 9.5 mm in diameter,
imprinted with the code ‘DX’ on one side and ‘8’ on the other side.
Aluminium/PVC/PVDC foil blister in a cardboard box.
Pack sizes: 10, 20, 30, 50, 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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 no. 50, Sector 3
Bucharest 032266
Romania

This medicinal product is authorised in the following European Economic Area countries under the following names:
Germany: Dexamethason Zentiva
Croatia: Deksametazon Zentiva
Poland: Dexamethasone Zentiva

For more detailed information, please contact the local representative of the Marketing Authorisation Holder:
Zentiva Polska Sp. z o.o.,
ul. Bonifraterska 17
00-203 Warsaw, Poland
Tel.: +48 22 375 92 00

Dexamethasone zentiva