Dexamethasone Krka

Leaflet accompanying the packaging: information for the user

Dexamethasone Krka, 0.5 mg, tablets

dexamethasone

You should carefully read the contents of the leaflet before taking 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 another person, 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 Krka and what is it used for
• 2. Important information before taking Dexamethasone Krka
• 3. How to take Dexamethasone Krka
• 4. Possible side effects
• 5. How to store Dexamethasone Krka
• 6. Contents of the packaging and other information

1 What is Dexamethasone Krka and what is it used for

Dexamethasone Krka 0.5 mg is a synthetic glucocorticosteroid(adrenal hormone) affecting metabolism, electrolyte balance, and tissue function.

Dexamethasone Krka 0.5 mg is used in such cases as

Diseases requiring systemic glucocorticoid treatment. These include, depending on the type and severity:

Neurological diseases

Brain edema caused by a brain tumor, neurosurgical intervention, bacterial meningitis, brain abscess.

Pulmonary and respiratory diseases

Severe acute asthma attack.

Dermatological diseases

Initial oral therapy for extensive, severe, acute skin diseases sensitive to glucocorticosteroids, such as erythroderma (exfoliative dermatitis), pemphigus vulgaris.

Autoimmune disorders and rheumatic diseases

Initial oral therapy for autoimmune diseases, such as systemic lupus erythematosus. Severe progressive rheumatoid arthritis, e.g., rapidly progressive destructive forms of the disease and (or) extra-articular symptoms.

Infectious diseases

Tuberculous meningitis exclusively in combination with anti-infective therapy.

Oncological diseases

Palliative care in cancer.

Endocrine diseases

Hormone replacement therapy: in reduced adrenal function or adrenal failure (adrenogenital syndrome) in adults.

2. Important information before taking Dexamethasone Krka

You should not take Dexamethasone Krka

• in case of hypersensitivity to the active substance or any of the other ingredients of this medicine (listed in section 6);

Warnings and precautions

Before taking Dexamethasone Krka, you should discuss it with your doctor or pharmacist: Before taking Dexamethasone Krka, you should discuss it with your doctor if you have or suspect a pheochromocytoma (adrenal gland tumor). Glucocorticosteroid therapy may lead to adrenal insufficiency (inadequate production of glucocorticosteroids by the body); depending on the dose and duration of treatment, it may persist for several months and in some cases even more than a year after the end of treatment. If you are taking glucocorticosteroids and experience special physical stress conditions (such as fever, injury, surgery, childbirth, etc.), you should inform your attending physician or inform the emergency doctor about the treatment you are taking. An increase in the daily dose of Dexamethasone Krka 0.5 mg may be required. In cases of prolonged adrenal insufficiency after the end of treatment, glucocorticosteroids may be necessary in physical stress conditions. Therefore, during long-term treatment with Dexamethasone Krka 0.5 mg, the doctor should provide the patient with a card informing about steroid use, which should always be carried with them. To avoid acute adrenal insufficiency caused by therapy, when treatment is planned to be discontinued, the doctor will establish a dose reduction plan, which must be strictly followed. Due to the immunosuppressive effect of Dexamethasone Krka, it may lead to an increased risk of bacterial, viral, parasitic, opportunistic, and fungal infections. Symptoms of an existing or developing infection may be masked, making diagnosis difficult. Treatment with Dexamethasone Krka should only be initiated in the most serious indications and, if necessary, with additional targeted anti-infective therapy in the following diseases:

• acute viral infections (viral hepatitis B, chickenpox, shingles, herpes, corneal herpes);
• chronic active hepatitis with the presence of the HbsAG antigen;
• approximately 8 weeks before and 2 weeks after vaccination with a live vaccine;
• acute and chronic bacterial infections;
• systemic mycoses and parasitic infections (e.g., caused by nematodes);
• certain parasitic diseases (e.g., caused by amoebas, nematodes). In patients with suspected or confirmed nematode infection, Dexamethasone Krka may lead to activation and significant multiplication of parasites;
• Heine-Medin disease (polio);
• lymph node inflammation after BCG vaccination;
• in the case of past tuberculosis (risk of reactivation), only under the protection of anti-tuberculosis drugs.

In addition, dexamethasone therapy should only be performed for compelling medical reasons, if necessary, with the use of additional specific therapy in the case of:

• gastric and intestinal ulcers;
• osteoporosis;
• severe heart failure;
• difficult-to-control hypertension;
• difficult-to-control diabetes;
• psychiatric disorders (also in history), including suicidal thoughts - neurological or psychiatric supervision is recommended;
• glaucoma with narrow and wide-angle glaucoma - ophthalmological supervision and concomitant treatment are recommended;
• corneal ulcers and damage - ophthalmological supervision and concomitant treatment are recommended.

Due to the risk of intestinal perforation, dexamethasone must be used only in urgent cases and under proper control in the case of:

• severe colitis (ulcerative colitis) with a risk of perforation, with abscesses or abscessing, possible also without peritoneal irritation);
• diverticulitis of the intestine;
• immediately after some intestinal surgeries (intestinal anastomoses).

Signs of peritoneal irritation after gastric and intestinal perforation may not occur in patients taking large doses of glucocorticosteroids. In diabetic patients, metabolism (metabolic processes) should be regularly monitored. It is necessary to consider the possible increased need for diabetes medications (insulin, oral antidiabetic drugs). In cases of severe hypertension or severe heart failure, the doctor should carefully monitor the patient, as there is a risk of worsening the condition. Large doses can cause a slowdown in heart function. Severe anaphylactic reactions (excessive immune system response) may occur. When taking fluoroquinolones and Dexamethasone Krka 0.5 mg simultaneously, the risk of tendon disorders, tendonitis, and tendon rupture is increased. During treatment for a certain type of muscle paralysis (myasthenia), symptoms may initially worsen. Long-term use of even small doses of dexamethasone can lead to an increased risk of infection with microorganisms that usually rarely cause infections. At the same time, it can mask symptoms, making it difficult to diagnose an existing or developing infection. Vaccinations (using vaccines containing killed microorganisms, inactivated vaccines) are generally allowed. However, it should be noted that the immune response, and thus the effect of vaccination, may be reduced after larger doses of corticosteroids. During long-term treatment with dexamethasone, regular medical check-ups (including ophthalmological ones) are necessary. Especially during long-term treatment with high doses of Dexamethasone Krka 0.5 mg, attention should be paid to adequate potassium intake (e.g., vegetables, bananas) and sodium restriction. The doctor should monitor potassium levels in the blood. Depending on the duration of treatment and dose, one should expect a negative impact on calcium metabolism. Therefore, osteoporosis prevention is recommended. This applies primarily to individuals with existing risk factors, such as family history, advanced age, insufficient protein and calcium intake, smoking a large number of cigarettes, excessive alcohol consumption, post-menopausal period, or lack of physical activity. Prevention involves adequate calcium and vitamin D intake and physical activity. In the case of existing osteoporosis, the use of medications should also be considered. When ending long-term glucocorticosteroid treatment, one should consider the risk of the following situations: exacerbation or recurrence of the underlying disease, acute adrenal insufficiency, cortisol withdrawal syndrome. In patients treated with Dexamethasone Krka 0.5 mg, viral diseases can have a particularly severe course, especially in children with immune disorders and individuals who have not previously had chickenpox or measles. If these individuals come into contact with people suffering from measles or chickenpox while taking Dexamethasone Krka 0.5 mg, they should immediately consult a doctor, who may use preventive treatment if necessary. Symptoms of tumor lysis syndrome, such as muscle cramps, muscle weakness, confusion, vision loss, or breathing difficulties, in the case of a hematological malignancy. If the patient experiences blurred vision or other visual disturbances, they should contact a doctor. Taking this medicine can cause a pheochromocytoma crisis, which can be fatal. Pheochromocytoma is a rare adrenal gland tumor. The crisis may manifest with the following symptoms: headaches, sweating, palpitations, and hypertension. If any of these symptoms occur, one should immediately contact a doctor.

Children and adolescents

Due to the risk of growth retardation, Dexamethasone Krka should be used in children for compelling medical reasons, and during long-term treatment, the child's growth should be regularly monitored. Treatment with Dexamethasone Krka should be limited in time or, in the case of long-term treatment, should be performed alternately (e.g., every other day, and then taking a double dose). Dexamethasone should not be used routinely in premature infants with respiratory failure.

Elderly patients

Also, in elderly patients, the benefit-to-risk ratio should be carefully considered due to the increased risk of osteoporosis.

Notes on doping

The use of Dexamethasone Krka may lead to positive results in anti-doping tests.

Dexamethasone Krka and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking or have recently taken, including those that are available without a prescription.

Medicines that affect the action of Dexamethasone Krka

• Medicines that accelerate liver metabolism, such as certain sleeping pills (barbiturates), anti-epileptic drugs (containing phenytoin, carbamazepine, and primidone), and some anti-tuberculosis drugs (containing rifampicin), may weaken the effect of corticosteroids.
• Some medicines may enhance the effect of Dexamethasone Krka, and the doctor may want to carefully monitor the patient's condition when taking such medicines (including some HIV medications: ritonavir, cobicistat).
• Medicines that slow down the metabolism of corticosteroids in the liver, such as certain antifungal drugs (ketoconazole, itraconazole), may enhance the effect of corticosteroids.
• Some female sex hormones, such as those used in oral contraceptives ("the pill"), may increase the effect of Dexamethasone Krka.
• Medicines that reduce excessive stomach acid production (antacids): Simultaneous administration of aluminum hydroxide or magnesium hydroxide may lead to reduced absorption of dexamethasone and decreased efficacy of Dexamethasone Krka. A 2-hour interval should be maintained between taking one and the other medicine.

Ephedrine (which may be contained in medicines used to treat low blood pressure, chronic bronchitis, asthma attacks, rhinitis, and as a component of appetite suppressants): the efficacy of Dexamethasone Krka may be reduced due to accelerated metabolism in the body.

Effect of Dexamethasone Krka on the action of other medicines

When taken simultaneously with certain blood pressure-lowering medicines (ACE inhibitors), Dexamethasone Krka may increase the risk of changes in blood morphology. Dexamethasone Krka may increase the effect of heart medications (cardiac glycosides) due to potassium deficiency. Dexamethasone Krka may increase potassium excretion caused by diuretics and laxatives. Dexamethasone Krka may increase blood glucose levels by weakening the effect of oral antidiabetic drugs and insulin. Dexamethasone Krka may reduce or increase the effect of blood clotting medicines (oral anticoagulants, coumarin derivatives). The doctor will decide whether it is necessary to adjust the dose of the blood clotting medicine. Dexamethasone Krka taken simultaneously with anti-inflammatory medicines (containing salicylates, indomethacin, or other non-steroidal anti-inflammatory drugs) may increase the risk of gastric ulcers and gastrointestinal bleeding. Dexamethasone Krka may prolong the action of certain muscle relaxants (non-depolarizing muscle relaxants). Dexamethasone Krka may increase the effect of certain medicines (atropine and other anticholinergic drugs) that increase intraocular pressure. Dexamethasone Krka may weaken the effect of medicines used to treat parasitic diseases (containing praziquantel). When taken simultaneously with medicines used to treat malaria and rheumatic diseases (containing chloroquine, hydroxychloroquine, mefloquine), Dexamethasone Krka may increase the risk of muscle disease (myopathy) and heart muscle disease (cardiomyopathy). Dexamethasone Krka may weaken the effect of growth hormones (somatotropin), especially when taken in high doses and for a long time. Dexamethasone Krka may weaken the effect of increasing thyrotropin (TSH) levels after administration of protirelin (TRH - a hormone produced by a part of the brain). When taken simultaneously with medicines that reduce immune system activity (i.e., immunosuppressive drugs), Dexamethasone Krka may increase the susceptibility to infections and may exacerbate or trigger symptoms of previously undiagnosed infections. Additionally, in the case of cyclosporin (an immunosuppressive drug), Dexamethasone Krka may increase the level of cyclosporin in the blood. This can lead to an increased risk of seizures. Fluoroquinolones, a certain group of antibiotics, may increase the risk of tendon damage.

Effect on laboratory test results

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 taking this medicine.

Pregnancy

Dexamethasone passes through the placenta. During pregnancy, especially in the first trimester, the medicine should only be used after careful assessment of the benefit-to-risk ratio. Therefore, if you are pregnant or may be pregnant, you should tell your doctor. It is not possible to exclude the occurrence of fetal growth disorders 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 substitution therapy with gradual dose reduction in newborns.

Breastfeeding

Glucocorticosteroids, including dexamethasone, pass into breast milk. So far, no harm has been reported in infants. Nevertheless, the medicine can be used during breastfeeding, but only if it is absolutely necessary. If higher doses are required due to the disease, breastfeeding should be discontinued.

Driving and operating machinery

No studies have been conducted on the effect of Dexamethasone Krka on the ability to drive vehicles and operate machinery in motion or without safety devices.

Dexamethasone Krka contains lactose

If you have previously been diagnosed with intolerance to certain sugars, you should contact your doctor before taking this medicine.

3. How to take Dexamethasone Krka

This medicine should always be taken according to the doctor's recommendations. The doctor will determine the dose individually. To take the dose of Dexamethasone Krka and achieve the proper effect, you should follow the instructions. If you have any doubts, you should consult your doctor or pharmacist.

If the 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. For this indication, it is recommended to use tablets with a higher strength.
• Brain edema caused by bacterial meningitis: 0.15 mg per kilogram of body weight every 6 hours for 4 days, children: 0.4 mg per kilogram of body weight every 12 hours for 2 days, starting before the first antibiotic.
• Acute asthma: adults: 8-20 mg, then, if necessary, 8 mg every 4 hours; children: 0.15-0.3 mg per kilogram of body weight.
• Acute skin diseases: depending on the type and severity of the disease, daily doses in the range of 8-40 mg, after which the dose should be reduced according to clinical needs.
• Systemic lupus erythematosus: 6-16 mg per day.
• Severe progressive rheumatoid arthritis: rapidly progressive destructive form of the disease 12-16 mg per day, with extra-articular symptoms 6-12 mg per day.
• Severe infectious diseases, toxic conditions (e.g., tuberculosis, typhoid fever): 4-20 mg for several days, only with accompanying anti-infective therapy.
• Palliative care in cancer: initial dose 8-16 mg per day, in longer therapy 4-12 mg per day.
• Hormone replacement therapy: Congenital adrenogenital syndrome in adults: 0.25-0.75 mg/day in a single dose. If necessary, add a mineralocorticoid (fludrocortisone). In case of special physical stress (e.g., infection with fever, injury, surgery, or childbirth), the doctor should temporarily increase the dose.

Tablets should not be divided to adjust the dose. If the patient needs a dose that cannot be achieved with one or more 0.5 mg tablets, another suitable form of the product should be used.

Method of administration

Oral tablets. Tablets should be taken during or after a meal. Tablets should be swallowed whole with a sufficient amount of liquid. The daily dose should be administered in a single dose in the morning. In patients who, due to their disease, require high-dose treatment, it is necessary to take multiple doses throughout the day to achieve maximum effect.

Duration of treatment

The treatment duration depends on the disease and its course. The doctor will determine the treatment regimen, which the patient should strictly follow. After achieving a satisfactory treatment result, the dose will be reduced to a maintenance dose or treatment will be discontinued. In principle, the dose should be gradually reduced. In case of hypothyroidism or liver cirrhosis, small doses may be sufficient or dose reduction may be necessary.

Use of a higher than recommended dose of Dexamethasone Krka

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

Missing a dose of Dexamethasone Krka

A missed dose can be taken on the same day, and the next day, it is recommended to take the dose according to the doctor's recommendation. A double dose should not be taken to make up for a missed dose. If many doses are missed, the disease may worsen. In such a case, you should consult a doctor, who will check and, if necessary, correct the treatment.

Discontinuation of Dexamethasone Krka

You should strictly follow the doctor's recommendations. You should not stop taking Dexamethasone Krka on your own. Especially long-term use of Dexamethasone Krka may lead to inhibition of the body's own glucocorticosteroid production. Situations of special physical stress without proper glucocorticosteroid production can be fatal. If you have any further questions about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible side effects

Hormone replacement therapy:

There is a low risk of side effects after using the recommended doses for hormone replacement therapy. In the case of long-term use, especially in high doses, side effects have been commonly reported in varying degrees, but their frequency cannot be clearly determined.

Infections and parasitic infestations:

Masking of infections, occurrence, and exacerbation of viral, fungal, bacterial, and parasitic infections, as well as opportunistic infections, activation of intestinal worm infection.

Blood and lymphatic system disorders:

Changes in blood morphology (increased white blood cell count or all blood cells, decreased count of a certain type of 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), decreased or increased blood pressure, circulatory collapse, myocardial infarction, immunosuppression.

Endocrine disorders

Induction of Cushing's syndrome (typical symptoms: large, round face - "moon face", central obesity, and facial flushing).

Metabolic and nutritional disorders:

Weight gain, increased blood glucose levels, diabetes, increased blood lipid levels (cholesterol and triglycerides), increased sodium levels with edema, potassium deficiency due to increased potassium excretion (may lead to cardiac arrhythmias), increased appetite.

Psychiatric disorders:

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

Nervous system disorders:

Increased intracranial pressure, occurrence of latent epilepsy symptoms, increased seizure susceptibility in epilepsy.

Eye disorders:

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

Vascular disorders:

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

Gastrointestinal disorders:

Gastric and intestinal ulcers, gastrointestinal bleeding, pancreatitis, dyspepsia, hiccups.

Skin and subcutaneous tissue disorders:

Stretch marks, skin thinning ("parchment-like skin"), telangiectasia, bruising, petechiae, acne, facial skin inflammation, especially around the mouth, nose, and eyes, skin pigmentation changes.

Musculoskeletal and connective tissue disorders:

Muscle disorders, muscle weakness, muscle atrophy, osteoporosis (depending on the dose and duration of treatment, possible even with short-term use), other forms of bone degeneration (bone necrosis), tendon disorders, tendonitis, tendon rupture, growth retardation in children. Note: Too rapid a reduction in the dose used after long-term treatment may cause the occurrence of symptoms such as muscle and joint pain (withdrawal syndrome).

Reproductive system and breast disorders:

Disorders of sex hormone secretion (leading to amenorrhea, hirsutism in women, impotence).

General disorders and administration site conditions:

Delayed wound healing. You should consult your doctor or pharmacist if you experience any of the above side effects or any other side effects during treatment with Dexamethasone Krka. Never stop treatment without consulting your doctor. In case of gastrointestinal symptoms, back, shoulder, or hip pain, psychiatric disorders, noticeable fluctuations in blood sugar levels (in diabetic patients), or other disorders, you should immediately contact your doctor.

Reporting 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 Monitoring of Adverse Reactions to Medicinal Products of the 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help gather more information on the safety of this medicine.

5. How to store Dexamethasone Krka

Store in a place out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging after the term "EXP". The expiry date refers to the last day of the specified month. Store in the original packaging to protect from light and moisture. There are no special recommendations for the storage temperature of the medicinal product. 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 Krka contains

• The active substance of the medicine is dexamethasone. Each tablet contains 0.5 mg of dexamethasone.
• The other ingredients of the medicine are lactose monohydrate, cornstarch, colloidal anhydrous silica, magnesium stearate. See section 2 "Dexamethasone Krka contains lactose".

What Dexamethasone Krka looks like and contents of the pack

White or almost white, round tablets with beveled edges, diameter: 4.8-5.2 mm, thickness: 1.4-2.2 mm. Blister pack of OPA/Aluminum/PVC/Aluminum foil, in a cardboard box. Pack sizes: 10, 20, 28, 30, 50, 56, 60, 90, 100, 10x1, 20x1, 28x1, 30x1, 50x1, 56x1, 60x1, 90x1, and 100x1 tablets. Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia, TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany. For more detailed information on the names of medicinal products in other EU member states, you should contact the local representative of the marketing authorization holder: KRKA-POLSKA Sp. z o.o., ul. Równoległa 5, 02-235 Warsaw, Tel. 22 57 37 500. Date of last revision of the leaflet:25.04.2022