Dexamethasone Zentiva

Package Leaflet: Information for the User

Dexamethasone Zentiva, 8 mg, Tablets

Dexamethasone

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It 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, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 glucocorticoid (adrenal cortex hormone). It affects metabolism, electrolyte balance, and tissue function.

Dexamethasone Zentiva is used in diseases that require systemic glucocorticoid 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 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 (RA) with a severe progressive course, e.g., forms that rapidly lead to joint destruction and/or involvement of tissues outside the joints
• severe infectious diseases with symptoms similar to poisoning (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
• prevention and treatment of vomiting during cytostatic therapy
• prevention and treatment of vomiting after surgical procedures

2. Important information before taking Dexamethasone Zentiva

When not to take Dexamethasone Zentiva

• if you are allergic to dexamethasone or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Dexamethasone Zentiva, discuss it with your doctor, pharmacist, or nurse.

If you are taking other steroid medicines, do not stop taking them unless your doctor tells 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 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 therapy, special physical stress conditions occur, such as fever, injuries, surgery, 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 about the use of corticosteroids, which you should always carry with you.

In order to avoid acute adrenal insufficiency caused by therapy, when treatment is planned to be discontinued, 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. Subjective and objective symptoms of existing or developing infections may be masked and thus difficult to detect. Dormant infections may recur.

Dexamethasone Zentiva can only be used in the following diseases if:

absolutely necessary, as decided by your doctor. In some cases, concomitant use of specific anti-infective medicines may be necessary:

• acute viral infections (hepatitis B, chickenpox, shingles, herpes simplex virus infections, herpes keratitis)
• chronic active hepatitis with a positive HBsAg test result (infectious hepatitis)
• about 8 weeks before vaccination 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 Strongyloides stercoralis (threadworm), Dexamethasone Zentiva may lead to activation and increased reproduction of these parasites
• poliomyelitis
• lymph node inflammation after BCG vaccination

If you have had tuberculosis in the past, the medicine can only be used in combination with anti-tuberculosis medicines.

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 (a rare tumor of the adrenal gland), which can be life-threatening.

Pheochromocytoma is a rare tumor of the adrenal gland. 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 should only be used in emergency situations and under proper control in the following diseases:

• severe ulcerative colitis (ulcerative colitis) with a risk of perforation, with ulcerative or abscessing inflammation, also without peritonitis
• diverticulitis
• immediately after certain intestinal surgeries (intestinal anastomoses)

Signs of peritoneal irritation after perforation (rupture) of the gastrointestinal tract may not occur in patients taking high doses of glucocorticoids.

In diabetic patients, metabolism should be regularly monitored. The possible need for increased doses of diabetes medicines (insulin, oral antidiabetic medicines) should be taken into account.

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 function.

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

When Dexamethasone Zentiva is administered concomitantly 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 initially worsen.

Vaccinations

Vaccinations with killed vaccines are generally possible. However, it should be noted that the immune response, and thus the response to vaccination, may be weakened by high 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 infections 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 intake of potassium (e.g., vegetables, bananas) and limitation of sodium intake. The doctor should monitor blood calcium levels.
• 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 individuals with existing risk factors, such as family history, advanced age, inadequate protein and calcium intake, smoking, excessive alcohol consumption, postmenopausal period, and lack of physical activity. Prevention involves adequate intake of calcium and vitamin D, as well as physical activity. In the case of existing osteoporosis, the doctor should consider the use of additional medicines.
• In the event of termination or interruption of long-term glucocorticoid therapy, 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 impaired immunity who have not had measles or chickenpox are particularly at risk. If these patients come into contact with individuals with measles or chickenpox during treatment with Dexamethasone Zentiva, they should immediately contact their doctor, who may initiate 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 when there are significant medical reasons, due 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.

Doping tests

Taking Dexamethasone Zentiva may lead to positive doping test results.

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 medicines (phenytoin, carbamazepine, primidone), and some anti-tuberculosis medicines (rifampicin), may weaken the effect of corticosteroids.
• Medicines that slow down the metabolism of corticosteroids in the liver, such as certain antifungal medicines (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): possible reduced absorption of dexamethasone when taken concomitantly with magnesium hydroxide or aluminum hydroxide. These medicines should be taken separately (with a 2-hour interval).
• Ephedrine (which may be contained, e.g., in medicines used to treat low blood pressure, chronic bronchitis, asthma attacks, and to reduce swelling of mucous membranes in the 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 blood level of dexamethasone.

Effect of Dexamethasone Zentiva on the action of other medicines

• may increase the risk of changes in blood morphology, if used concomitantly with certain blood pressure-lowering medicines (ACE inhibitors)
• 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 if used concomitantly with anti-inflammatory and anti-rheumatic medicines (salicylates, indomethacin, and other non-steroidal anti-inflammatory medicines)
• 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 concomitantly with malaria or rheumatic diseases medicines (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) levels after administration of protirelin (TRH, a hormone produced by the hypothalamus)

• may increase the susceptibility to infections if taken concomitantly with immunosuppressive agents and may exacerbate existing infections that have not fully developed
• may increase the blood level of cyclosporine (a medicine used to weaken the body's defense mechanisms against diseases) and thus increase the risk of seizures
• fluoroquinolones, a group of antibiotics that may increase the risk of tendon rupture

Effect on diagnostic tests

Glucocorticoids 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 evaluation of the benefit-risk ratio. If you are pregnant or may be pregnant, you should tell your doctor. The use of glucocorticoids during pregnancy may lead to fetal growth disturbances. If glucocorticoids are administered at the end of pregnancy, there is a risk of adrenal insufficiency in the fetus, which may require substitution therapy in newborns.

Breastfeeding

Glucocorticoids, including dexamethasone, pass into breast milk. So far, no harmful effects on breastfed infants have been reported. Nevertheless, the medicine may only be used during breastfeeding if absolutely necessary. If high doses are required due to the disease, breastfeeding should be discontinued. You should 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, you should contact your doctor before taking this medicine.

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

3. How to take Dexamethasone Zentiva

Always take this medicine exactly as your doctor has told you. Your doctor will decide how long you should take dexamethasone. If you are unsure, ask your doctor or pharmacist.

Dexamethasone Zentiva is not suitable for all the doses described below. For these doses, other medicinal products containing dexamethasone should be used. Your doctor will determine the dose of the medicine individually for you. You should follow the instructions in the package leaflet, as otherwise, the effect of Dexamethasone Zentiva may not be correct. If you have any doubts, ask your doctor or pharmacist.

If your doctor has not 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 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 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.
• Active rheumatoid arthritis with a severe progressive course, e.g., forms that rapidly lead to joint destruction and/or involvement of tissues outside the joints: 6 - 12 mg per day.
• Severe infectious diseases with symptoms similar to poisoning:4 - 20 mg per day for several days, only in combination with appropriate anti-infective therapy.
• Supportive 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 with a body weight of at least 40 kg) are recommended to take 6 mg orally once a day for up to 10 days.
• Prevention and treatment of vomiting during cytostatic therapy as part of antiemetic therapy planning:10 - 20 mg before the start of chemotherapy, then 4 - 8 mg 2 to 3 times a day for 1 - 3 days or up to 6 days if necessary.
• Prevention 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.

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 the case 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. Your doctor will establish a treatment plan that should be strictly followed. 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 the case of adrenal insufficiency or liver cirrhosis, relatively small doses may be sufficient, or the dose may need to be reduced.

Use of a higher than recommended dose of Dexamethasone Zentiva

Generally, Dexamethasone Zentiva is well-tolerated without complications even after short-term use of high doses. No special measures are necessary. If severe or unusual side effects occur, you should contact your doctor.

Missing a dose of Dexamethasone Zentiva

If you miss a dose, 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, you should contact your doctor, who will check and possibly adjust the treatment.

Stopping treatment with Dexamethasone Zentiva

You should 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 suppression of glucocorticoid production by the body (adrenal insufficiency or "hypofunction" of the adrenal cortex). A situation of increased physical stress without sufficient glucocorticoid production can be life-threatening.

If you have any further questions about the use of this medicine, ask 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 tell your doctor. Do not stop treatment on your own.

Possible side effects

There is a small risk of side effects after the use of recommended doses in 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 exacerbation of viral, fungal, bacterial, and parasitic infections, as well as opportunistic infections, and activation of dormant 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

Hypersensitivity 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, myocardial infarction, and immunosuppression.

Endocrine disorders

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

Metabolic and nutritional disorders

Weight gain, increased blood sugar levels, diabetes, increased levels of fats (cholesterol and triglycerides), sodium retention with tissue edema (edema), 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, increased frequency of seizures in epilepsy.

Eye disorders

Increased intraocular pressure (glaucoma), cataract (lens clouding), worsening of corneal ulcers, exacerbation of eye infections caused by viruses, bacteria, or fungi, worsening of bacterial keratitis, ptosis (drooping eyelid), mydriasis (pupil dilation), conjunctival edema, perforation of the sclera (the white part of the eyeball), vision disturbances, loss of vision, blurred vision.

Vascular disorders

Hypertension, increased risk of atherosclerosis and thrombosis, vasculitis (including as a withdrawal syndrome after long-term treatment), 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 joint pain, or psychiatric disturbances, 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), petechiae (small hemorrhages), ecchymoses (bruises), hirsutism (excessive hair growth), acne, facial inflammation, 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 duration of treatment, other forms of bone degeneration (aseptic bone necrosis), tendon diseases, tendonitis, tendon rupture, fat deposition 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 with symptoms such as muscle and joint pain.

Reproductive system and breast disorders

Disorders of sex hormone secretion, resulting in irregular or absent menstrual periods, hirsutism in women, 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 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 pack and carton after "EXP". The expiry date refers to the last day of the month.

No special storage temperature is required.

Store in the original package 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 pack and other information

What Dexamethasone Zentiva contains

• The active substance is dexamethasone. Each tablet contains 8 mg of dexamethasone.
• The other ingredients are: lactose monohydrate; sodium carboxymethylcellulose (type A); magnesium stearate; anhydrous colloidal silica.

What Dexamethasone Zentiva looks like and contents of the pack

White or almost white, round, flat tablets with beveled edges and a diameter of about 9.5 mm, with the inscription "DX" on one side and "8" on the other.

Blister pack of aluminum/PVC/PVDC 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

032266 Bucharest

Romania

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

Germany: Dexamethason Zentiva

Croatia: Deksametazon Zentiva

Poland: Dexamethasone 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

phone: +48 22 375 92 00

Date of last revision of the package leaflet: