Dexamethasone zentiva

Poland
Brand name Dexamethasone zentiva
Form tablets
Active substance / Dosage
Prescription type Prescription only
ATC code
Registration number 100459170
Manufacturer S.C. Zentiva S.A.

Package leaflet: Information for the user

Dexamethasone Zentiva, 0.5 mg, tablets
Dexamethasone Zentiva, 1 mg, tablets
Dexamethasone Zentiva, 4 mg, tablets
Dexamethasonum
Please read 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 them, even if their symptoms are the same as yours.
  • If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

  1. What Dexamethasone Zentiva is and what it is 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 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 glucocorticosteroid (a corticosteroid hormone). It affects metabolism, the body's electrolyte balance, and tissue function.
Dexamethasone Zentiva is used in conditions requiring systemic treatment with glucocorticosteroids. 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 that 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 sepsis-like symptoms (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 at least 40 kg) who require oxygen support

Dexamethasone Zentiva 0.5 mg, 1 mg is additionally used in:

  • Hormone replacement therapy in adrenal insufficiency or absence of adrenal function (adrenogenital syndrome) in adults

Dexamethasone Zentiva 1 mg, 4 mg is additionally used in:

  • 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 to 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, they should 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 observed 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 for several months, and in some cases even more than a year after the end of therapy.
If during glucocorticoid treatment special physical stress conditions occur, such as fever, trauma, surgery, childbirth, etc., inform the attending physician or inform the emergency department staff about the ongoing treatment. A temporary increase in the daily dose of Dexamethasone Zentiva may be necessary. Glucocorticoid administration may also be required in stressful situations when adrenal insufficiency (impaired adrenal function) persists after discontinuation of treatment. During long-term treatment with Dexamethasone Zentiva, the doctor should provide the patient with an information card indicating corticosteroid use, which should always be carried on the person.
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 lead to an increased risk of bacterial, viral, parasitic, opportunistic and fungal infections due to suppression of the body's defense mechanisms. Signs and 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 when the
physician 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, herpes-induced keratitis);
  • chronic active hepatitis with positive HBsAg test result (infectious hepatitis);
  • approximately 8 weeks before and up to 2 weeks after vaccination with live vaccines;
  • acute and chronic bacterial infections;
  • fungal infections involving internal organs;
  • certain parasitic diseases (amebic infection, helminths). In case of infection or suspected infection with Strongyloides, Dexamethasone Zentiva may lead to activation and intensified 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 course of the following conditions should
be monitored:

  • peptic ulcer disease of the stomach and intestines;
  • bone mass loss (osteoporosis);
  • severe heart failure;
  • difficult-to-control arterial 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, they should contact a
doctor.
Use of this medicine may cause a crisis in pheochromocytoma ( Pheochromocytoma crisis ), which may be fatal.
Pheochromocytoma is a rare tumor of the adrenal gland. A crisis may occur with the following symptoms: headache, excessive sweating, palpitations, and increased arterial pressure. If any of the above symptoms occur, the patient should contact a doctor immediately.
Before starting treatment with Dexamethasone Zentiva, discuss this with the doctor if there is suspicion of or a diagnosed pheochromocytoma (adrenal tumor).
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, with ulcerative or suppurative inflammation, occurring also without peritonitis.
  • Diverticulitis.
  • Immediately after certain intestinal surgeries (intestinal anastomoses).

Signs of peritoneal irritation after gastrointestinal perforation may not occur in patients
receiving high doses of glucocorticoids.
In diabetic patients, metabolism should be monitored regularly. An increased requirement for antidiabetic medications (insulin, oral antidiabetics) should be considered.
Patients with severe arterial hypertension and/or severe heart failure should be carefully
monitored, as there is a risk of worsening health status.
High doses may cause cardiac depression.
Severe anaphylactic reactions (excessive immune system response) may occur.
When fluorquinolones (a type of antibiotic) are administered concomitantly with Dexamethasone Zentiva, the risk of tendon disorders, tendon inflammation, and tendon rupture is increased.
During treatment of a specific type of muscle paralysis (myasthenia gravis), symptoms may initially worsen.
Vaccinations
Vaccinations with inactivated microorganism vaccines (killed 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, even of small doses of dexamethasone, leads to an increased risk of infection, including by microorganisms that usually rarely cause infections (so-called opportunistic infections). At the same time, symptoms of infection may be masked, making detection of existing or developing infection difficult.
  • In case of long-term treatment with Dexamethasone Zentiva, regular medical check-ups (including ophthalmological) are required.
  • Especially during long-term treatment with high doses of Dexamethasone Zentiva, attention should be paid to consuming sufficient potassium (e.g., vegetables, bananas) and limiting sodium intake. The doctor should monitor blood calcium levels.
  • Depending on the duration of treatment and dose, 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 calcium and vitamin D intake and physical activity. In case of existing osteoporosis, the doctor should consider using additional medications.
  • When ending or interrupting long-term glucocorticoid treatment, the risk of the following situations should be considered: 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 previously had measles or chickenpox are especially at risk. If such patients have contact with individuals suffering from measles or chickenpox during treatment with Dexamethasone Zentiva, they should contact a doctor immediately, who may initiate preventive treatment if necessary.
Tumor lysis syndrome
Symptoms of tumor lysis syndrome, such as muscle cramps, muscle weakness, confusion, loss or visual disturbances, and dyspnea, may occur in patients with hematological tumors.
Children and adolescents
Dexamethasone should not be routinely used in premature infants with respiratory insufficiency.
In children, Dexamethasone Zentiva should be used only when there are important medical reasons, considering the risk of growth retardation, and during long-term treatment, growth should be monitored regularly. The duration of treatment with Dexamethasone Zentiva should be minimized or administered intermittently (e.g., every other day, but at double dose) (intermittent therapy).
Elderly patients
In elderly patients, caution is advised due to the risk of osteoporosis.
Dexamethasone Zentiva and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as about medicines the patient plans to take.
Medicines that affect the action of Dexamethasone Zentiva

  • Medicines that accelerate its metabolism in the liver, such as sleeping pills (barbiturates), anticonvulsants (phenytoin, carbamazepine, primidone), and certain 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., those 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 magnesium hydroxide or aluminum hydroxide are taken concomitantly. 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 the 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 enhance the effect of cardiac stimulants (cardiac glycosides) due to potassium deficiency
  • may increase potassium loss caused by diuretics (saluretics) or laxatives
  • may weaken the effect of oral antidiabetic drugs lowering blood glucose and insulin
  • may weaken or enhance the effect of anticoagulant drugs (oral anticoagulants, coumarins). The doctor will decide whether adjustment of the anticoagulant dose is necessary.
  • may increase the risk of gastric ulcers and gastrointestinal bleeding when used concomitantly with anti-inflammatory and anti-rheumatic drugs (salicylates, indomethacin, and other non-steroidal anti-inflammatory drugs)
  • may prolong the muscle-relaxing effect of certain drugs (non-depolarizing muscle relaxants)
  • may enhance the effect of certain drugs increasing intraocular pressure (atropine and other anticholinergics)
  • may reduce the effectiveness of drugs used to treat worm infections (praziquantel)
  • may increase the risk of developing muscle diseases or heart muscle diseases (myopathies, cardiomyopathies) when used concomitantly with drugs 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) level after protirelin administration (TRH, a hormone produced by the hypothalamus)
  • may increase susceptibility to infections when taken concomitantly with immunosuppressive drugs (immunosuppressive agents) and may exacerbate the course of an existing infection that may not have fully developed
  • may increase blood levels of cyclosporine (a drug used to suppress the body's immune defenses against diseases), thereby increasing 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 plans to become
pregnant, 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 may be used only after careful assessment of benefit versus risk; therefore, if the patient is pregnant or may be pregnant, she should inform the doctor. Impaired fetal growth cannot be excluded during long-term use of glucocorticoids during pregnancy. If glucocorticoids are administered towards the end of pregnancy, there is a risk of adrenal insufficiency in fetuses, 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
vehicles or operate machinery. The same applies to work under hazardous conditions.
Dexamethasone Zentiva contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should
consult 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 as directed by the physician. The physician decides how long dexamethasone should be used. If in doubt, consult your doctor or pharmacist.
The doctor will determine the dose individually for each patient. It is important to follow the instructions precisely, as otherwise the effect of Dexamethasone Zentiva may not be optimal.
If you have any doubts, contact your doctor or pharmacist.
Unless otherwise directed by the physician, the following doses are recommended:

  • Cerebral oedema: 16 – 24 mg (up to 48 mg) daily, divided into 3 – 4 (up to 6) single doses for 4 – 8 days.
  • Cerebral oedema 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 daily.
  • Active rheumatoid arthritis with severe, progressive course, e.g. forms rapidly leading to joint damage or with extra-articular manifestations: 6 – 12 mg daily.
  • Severe infectious diseases with symptoms resembling intoxication: 4 – 20 mg daily for several days, only in combination with appropriate anti-infective therapy.
  • Palliative treatment of malignant tumours: initially 8 – 16 mg daily; in long-term therapy, 4 – 12 mg daily.
  • Treatment of COVID-19: Adults are recommended to take orally 6 mg once daily for up to 10 days. Adolescents (aged 12 years and older) are recommended to take orally 6 mg once daily for up to 10 days.

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

  • Hormone replacement therapy: Congenital adrenal hyperplasia in adults: 0.25 – 0.75 mg/day as a single dose. Mineralocorticoid (fludrocortisone) should be administered if required. If Dexamethasone Zentiva cannot be administered, another available dexamethasone-containing medicinal product should be used. During periods of significant physical stress such as feverish infection, trauma, surgery or childbirth, the dose should be temporarily increased according to the physician's instructions.

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

  • Prevention and treatment of 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 vomiting: Single dose of 8 – 20 mg before 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.
Tablets should be swallowed whole during or after meals, with sufficient fluid.
If possible, the daily dose should be taken as a single dose in the morning. However, in diseases requiring high-dose treatment, multiple daily doses are often necessary to achieve maximum effect.
Duration of treatment
The duration of treatment depends on the disease and its progression. The physician will establish a treatment plan which must be strictly followed. Once a satisfactory treatment response is 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 effects 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, consult your doctor, who will assess and possibly adjust the treatment.
Stopping Dexamethasone Zentiva
Always follow the dosing regimen prescribed by your doctor. Never stop taking Dexamethasone Zentiva on your own, as prolonged treatment in particular may suppress the body's natural production of glucocorticosteroids (adrenal insufficiency). A situation of severe physical stress without adequate glucocorticosteroid 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the adverse effects listed below occur, or any other adverse effects not mentioned here, consult a doctor.
Do not stop treatment on your own.

Possible adverse effects
There is a low risk of adverse effects occurring after administration of the recommended doses in hormone replacement therapy.
However, during long-term use, especially of high doses, this medicine may cause adverse effects of varying severity, although the frequency of their occurrence cannot be clearly determined.

Infections and parasitic infections
Masking of infections, occurrence and worsening of viral, fungal, bacterial, as well as parasitic and opportunistic infections; reactivation of latent dwarf tapeworm infection.

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 (contraction of smooth muscles in the bronchi), abnormally high or low blood pressure, circulatory collapse, myocardial infarction, immunosuppression.

Endocrine disorders
Development 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 due to 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 seizure susceptibility in epilepsy.

Eye disorders
Increased intraocular pressure (glaucoma), lens clouding (cataract), worsening of corneal ulceration, exacerbation of viral, bacterial or fungal eye infections, worsening of bacterial corneal inflammation, ptosis (drooping eyelid), pupil dilation, conjunctival edema, 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
Gastric and intestinal ulcers, gastrointestinal bleeding, pancreatitis, gastrointestinal discomfort.

If gastrointestinal symptoms, back or shoulder pain, hip joint pain, psychiatric disturbances, noticeable fluctuations in blood glucose levels in diabetics, or other disturbances occur, inform the doctor immediately.

Skin and subcutaneous tissue disorders
Skin striae, decreased skin thickness ("parchment skin"), dilated blood vessels, tendency to bruising, petechial 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, dose-dependent bone mass loss (osteoporosis) which may occur 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 in sex hormone secretion resulting in: irregular menstrual cycles 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 effects
If any adverse effects occur, including those not listed in this leaflet, inform a doctor or pharmacist. Adverse effects 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 effects can also be reported to the marketing authorization holder or its representative in Poland. Reporting adverse effects helps to collect additional 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 medicine after the expiry date stated on the blister pack and carton after "EXP". The expiry date refers to the last day of the specified month.
Store below 25°C. Keep in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such 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 0.5 mg, 1 mg, or 4 mg of dexamethasone.
  • Other ingredients: monohydrate lactose; sodium carboxymethyl starch (type A); magnesium stearate; colloidal anhydrous 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 bevelled edges, approximately 8 mm in diameter, embossed with 'DX' on one side and '500' on the other side.
Dexamethasone Zentiva 1 mg tablet: white or almost white, round, flat tablet with bevelled edges, approximately 8 mm in diameter, embossed with 'DX' on one side and '1' on the other side.
Dexamethasone Zentiva 4 mg tablet: white or almost white, round, flat tablet with bevelled edges, approximately 8 mm in diameter, embossed with 'DX' on one side and '4' on the other side.
White aluminium/PVC/PVDC foil blister in a cardboard carton.
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 nr 50
Sector 3, Bucharest 032266
Romania

This medicinal product is authorised in the European Economic Area member states under the following names:
Germany: Dexamethason Zentiva
Croatia: Deksametazon Zentiva
Czech Republic, Denmark, Norway, Poland, Sweden: Dexamethasone Zentiva
Romania: Dexametazonă Zentiva

For further 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