Package leaflet: Information for the user

Dexamethasone Krka, 0,5 mg, tablets
dexamethasonum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet as 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 other people, 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.

Contents of the leaflet

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

1. What Dexamethasone Krka is and what it is 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 the following conditions:
Diseases requiring systemic glucocorticoid treatment. These include, depending on
type and severity:
Neurological diseases
Cerebral edema caused by brain tumor, neurosurgical intervention, bacterial meningitis, brain abscess.
Lung and respiratory tract diseases
Severe acute asthma attack.
Dermatological diseases
Oral therapy in the initial phase of treatment of extensive, severe, acute skin diseases
sensitive to glucocorticosteroids, e.g. erythroderma (exfoliative dermatitis), pemphigus vulgaris.
Autoimmune disorders and rheumatic diseases
Oral therapy in the initial phase of treatment of autoimmune diseases such as systemic lupus erythematosus.
Severe progressive course of active 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 diseases.
Endocrinological diseases
Hormone replacement therapy: in decreased adrenal function or adrenal failure (adrenogenital syndrome) in adults.

2. Important information before taking Dexamethasone Krka

Do not take Dexamethasone Krka

if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);

Warnings and precautions
Before taking Dexamethasone Krka, discuss this with your doctor or pharmacist:
Before taking Dexamethasone Krka, discuss this with your doctor if the patient
has or is suspected of having a pheochromocytoma (adrenal gland tumor).
Glucocorticosteroid treatment may lead to adrenal cortex suppression
(insufficient glucocorticoid production by the body); depending on the dose and duration of treatment, this may persist for several months and in some cases even more than a year after treatment ends.
If during glucocorticosteroid treatment special physical stress conditions occur (such as fever, injury, surgery, childbirth, etc.), inform your treating doctor or inform the emergency room doctor about the ongoing treatment. An increase in the daily dose of Dexamethasone Krka 0.5 mg may be required. In cases of prolonged adrenal insufficiency after treatment ends, glucocorticosteroids may be necessary during physical stress. Therefore, during long-term treatment with Dexamethasone Krka 0.5 mg, your doctor should provide you with a steroid alert card, which you should always carry with you.
To avoid acute adrenal insufficiency caused by therapy, when discontinuation of treatment is planned, your doctor will establish a dose reduction plan which must be strictly followed.
Due to the immunosuppressive effect, Dexamethasone Krka may lead to an increased risk of bacterial, viral, parasitic, opportunistic, and fungal infections. Symptoms of existing or developing infections 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 (hepatitis B, chickenpox, shingles, herpes simplex, herpes keratitis);
chronic active hepatitis with presence of HBsAg antigen;
approximately 8 weeks before to 2 weeks after vaccination with a live vaccine;
acute and chronic bacterial infections;
systemic fungal infections and parasitic infections (e.g. caused by nematodes);
certain parasitic diseases (e.g. caused by amoebae, nematodes). In patients with suspected or confirmed nematode infection, Dexamethasone Krka may lead to activation and significant multiplication of parasites;
Heine-Medin disease (polio);
lymphadenitis after BCG vaccination;
in case of previous tuberculosis (risk of reactivation), use only under cover of anti-tuberculosis drugs.

Furthermore, dexamethasone treatment should only be carried out in cases of absolute
medical indications, if necessary with additional specific treatment in the case of:

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

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

severe intestinal inflammation (ulcerative colitis) with risk of perforation, with abscesses or purulent inflammation, possible even without peritoneal irritation;
diverticulitis;
immediately after certain intestinal surgeries (intestinal anastomoses).

Signs of peritoneal irritation after perforation of the stomach and intestines may not occur in patients
receiving high doses of glucocorticosteroids.
In diabetic patients, metabolism (material exchange) should be regularly monitored. Consider possible increased need for antidiabetic medications (insulin, oral antidiabetics).
In cases of severe hypertension or severe heart failure, the doctor should carefully monitor the patient, as there is a risk of worsening health.
High doses may cause slowing of heart function.
Severe anaphylactic reactions (excessive immune system response) may occur.
When fluorochinolones and Dexamethasone Krka 0.5 mg are administered simultaneously,
the risk of tendon disorders, tendon inflammation, and tendon rupture is increased.
At the beginning of treatment for a certain type of muscle paralysis (myasthenia gravis), symptoms may worsen.
Long-term use, even of small doses of dexamethasone, leads to an increased risk of infection with microorganisms that usually rarely cause infections. At the same time, it may mask symptoms and thus make diagnosis of existing or developing infection difficult.
In principle, vaccinations (using vaccines containing killed microorganisms (inactivated vaccines)) are permissible. However, it should be noted that the immunological response, and thus the effect of vaccination, may be reduced after higher doses of corticosteroids.
During long-term dexamethasone treatment, regular medical check-ups (including ophthalmological) are necessary.
Especially during long-term treatment with high doses of Dexamethasone Krka 0.5 mg, attention should be paid to consuming sufficient potassium (e.g. vegetables, bananas) and limiting sodium intake. The doctor should monitor blood potassium levels.
Depending on the duration and dose of treatment, a negative effect of the drug on calcium metabolism should be expected. Therefore, osteoporosis prevention 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, post-menopausal period, or lack of physical activity. Prevention includes adequate calcium and vitamin D intake and physical activity. In case of existing osteoporosis, additional use of medications should be considered.
At the end of long-term glucocorticosteroid treatment, the risk of the following situations should be considered: exacerbation or recurrence of the underlying disease, acute adrenal insufficiency, cortisone withdrawal syndrome.
In patients treated with Dexamethasone Krka 0.5 mg, viral diseases may have a particularly severe course, especially in children with immune disorders and in individuals who have not previously had measles or chickenpox. In case of contact of these individuals during treatment with Dexamethasone Krka 0.5 mg with persons suffering from measles or chickenpox, immediate medical consultation is required, and if necessary, preventive treatment should be applied.
Tumor lysis syndrome symptoms such as muscle cramps, muscle weakness, confusion, vision loss or disturbances, and shallow breathing in patients with hematological tumors.
If the patient experiences blurred vision or other visual disturbances, contact the doctor.
Taking this medicine may cause pheochromocytoma crisis, which can be fatal. Pheochromocytoma is a rare adrenal gland tumor. The crisis may manifest with the following symptoms: headache, sweating, palpitations, and hypertension. If any of these symptoms occur, contact the doctor immediately.
Children and adolescents
Due to the risk of growth suppression, Dexamethasone Krka should be used in children only for important medical reasons; during long-term treatment, the child's growth should be regularly monitored. Treatment with Dexamethasone Krka should be limited in time or, in case of long-term treatment, should be administered intermittently (e.g. every other day, then using double dose).
Dexamethasone should not be routinely used in preterm infants with respiratory distress syndrome.
Elderly patients
In elderly patients as well, the benefit-risk ratio should be carefully considered due to the higher risk of osteoporosis.
Doping-related information
Use of Dexamethasone Krka may lead to positive results in anti-doping controls.
Dexamethasone Krka and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those obtained without a prescription.
Medicines affecting the action of Dexamethasone Krka

Medicines accelerating metabolism in the liver, such as some sleeping pills (barbiturates), antiepileptic drugs (containing phenytoin, carbamazepine, and primidone), and some tuberculosis drugs (containing rifampicin), may weaken the action of corticosteroids.
Some medicines may enhance the effect of Dexamethasone Krka, and the doctor may wish to closely monitor the patient taking such medicines (including some HIV drugs: ritonavir, cobicistat).
Medicines slowing corticosteroid metabolism in the liver, such as some antifungal drugs (ketoconazole, itraconazole), may enhance the action of corticosteroids.
Some female sex hormones, e.g. those used in contraceptive drugs ("the pill"), may increase the effect of Dexamethasone Krka.
Drugs against excessive hydrochloric acid production in the stomach (antacids): simultaneous administration of aluminum hydroxide or magnesium hydroxide may lead to reduced absorption of dexamethasone and reduced effectiveness of Dexamethasone Krka. A two-hour interval should be maintained between taking one and the other medicine.

Ephedrine (may be contained in medicines used to treat low blood pressure,
chronic bronchitis, asthma attacks, nasal catarrh, and as a component of appetite-reducing agents): the effectiveness of Dexamethasone Krka may be reduced due to accelerated metabolism in the body.
Effect of Dexamethasone Krka on the action of other medicines
When used simultaneously with some blood pressure-lowering medicines
(angiotensin-converting enzyme inhibitors), Dexamethasone Krka may increase the risk of
changes in blood morphology.
Dexamethasone Krka may enhance the effect of heart disease medicines
(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 action of oral antidiabetic drugs and insulin.
Dexamethasone Krka may decrease or increase the effect of anticoagulant medicines (oral anticoagulants, coumarin derivatives). The doctor will decide whether adjustment of the anticoagulant dose is necessary.
Dexamethasone Krka used 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 effect of some medicines causing muscle relaxation (non-depolarizing skeletal muscle relaxants).
Dexamethasone Krka may enhance the effect of some medicines (atropine and other anticholinergics) that increase intraocular pressure.
Dexamethasone Krka may weaken the action 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 action of growth hormones (somatotropin), especially when used in high doses and long-term.
Dexamethasone Krka may weaken the effect of increasing thyrotropin (TSH) concentration after administration of protirelin (TRH – a hormone produced by part of the brain).
When taken simultaneously with medicines reducing immune system function (i.e. immunosuppressive medicines), Dexamethasone Krka may increase susceptibility to infections and may exacerbate or trigger symptoms of previously undiagnosed infections.
Additionally, in the case of cyclosporine (a medicine reducing immune system function), Dexamethasone Krka may increase cyclosporine blood concentration. This leads 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 are planning to have a child, you should consult your doctor or pharmacist before using this medicine.
Pregnancy
Dexamethasone crosses the placenta. During pregnancy, especially in the first trimester, the medicine should be used only after careful assessment of benefit versus risk. Therefore, if you are pregnant or may be pregnant, you should inform your doctor. The occurrence of fetal growth disorders during long-term glucocorticosteroid use in pregnancy cannot be excluded. If glucocorticosteroids 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
Glucocorticosteroids, including dexamethasone, pass into breast milk. So far, no damage has been known in infants. Nevertheless, the medicine may be used during breastfeeding only if absolutely indicated. If higher doses are required due to illness, breastfeeding should be discontinued.
Driving and using machines
No studies have been conducted on the effect of Dexamethasone Krka on the ability to drive motor vehicles and operate mechanical equipment in motion or work without safeguards.
Dexamethasone Krka contains lactose
If intolerance to certain sugars has been previously diagnosed in patients, the patient should contact the doctor before taking this medicine.

3. How to use Dexamethasone Krka

This medicine should always be used as directed by the doctor. The doctor will determine the dose individually.
To take the correct dose of Dexamethasone Krka and achieve the desired effect, follow the instructions carefully.
If in doubt, consult a doctor or pharmacist.
Unless otherwise advised by the doctor, 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. For this indication, tablets with higher strength are recommended.
Cerebral edema caused by bacterial meningitis: 0.15 mg per kilogram of body weight every 6 hours for 4 days; in children: 0.4 mg per kilogram of body weight every 12 hours for 2 days, starting before the first antibiotic dose.
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 extent of the disease, daily doses ranging from 8 to 40 mg, followed by dose reduction according to clinical needs.
Systemic lupus erythematosus: 6–16 mg per day.
Active rheumatoid arthritis with severe, progressive course: rapidly progressive destructive form 12–16 mg per day, with extra-articular manifestations 6–12 mg per day.
Severe infectious diseases, toxic states (e.g. tuberculosis, typhoid fever): 4–20 mg for several days, only with concomitant anti-infective therapy.
Palliative care in neoplastic diseases: initial dose 8–16 mg per day, in long-term therapy 4–12 mg per day.
Hormone replacement therapy: Congenital adrenal hyperplasia in adults: 0.25–0.75 mg/day as a single dose. Mineralocorticoid (fludrocortisone) may be added if needed. In cases of significant physical stress (e.g. infection with fever, trauma, surgical procedure or childbirth), the doctor should temporarily increase the dose.

The tablets should not be divided to adjust the dose. If the patient requires a dose that cannot be achieved with one or more 0.5 mg tablets, another suitable formulation of the product should be used.
Method of administration
Tablets for oral use.
The tablets should be taken during or after a meal. Swallow the tablets whole with sufficient fluid. The daily dose should be administered as a single morning dose. In patients requiring high-dose treatment due to their condition, multiple doses throughout the day may be necessary to achieve maximum effect.
Duration of treatment
The duration of treatment depends on the disease and its course. The doctor will determine the treatment regimen, which the patient must strictly follow. After achieving a satisfactory treatment response, the dose will be reduced to a maintenance dose or treatment will be discontinued. In general, the dose should be gradually tapered.
In cases of hypothyroidism or liver cirrhosis, lower doses may be sufficient or dose reduction may be required.
Use of a higher than recommended dose of Dexamethasone Krka
Generally, Dexamethasone Krka is well tolerated without complications, even after short-term use at high doses. No special measures are required. In case of severe or unusual adverse reactions, consult a doctor.
Missed dose of Dexamethasone Krka
A missed dose may be taken within the same day; on the following day, resume the dose as prescribed by the doctor.
Do not take a double dose to make up for a missed dose.
If several doses are missed, the disease may sometimes worsen. In such a case, consult a doctor, who will assess and possibly adjust the treatment.
Stopping Dexamethasone Krka
Follow the doctor's instructions exactly. Do not stop taking Dexamethasone Krka on your own. Long-term use of Dexamethasone Krka may lead to suppression of the body's own glucocorticoid production.
Situations of significant 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 or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Possible adverse reactions
Hormone replacement therapy:
There is a low risk of adverse reactions occurring when the recommended doses are used in
hormone replacement therapy. With long-term use, especially at high doses, adverse reactions have commonly been reported with varying severity, but their frequency 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 intestinal tuberculosis.
Blood and lymphatic system disorders:
Changes in blood morphology (increased white blood cell count or increased count of all blood cells, decreased count 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), decreased or increased blood pressure, circulatory collapse, myocardial infarction, weakening of the immune system.
Endocrine disorders:
Development of Cushing's syndrome (typical symptoms: large, round face – "moon face", central obesity and facial flushing).
Metabolism and nutrition disorders:
Increased body weight, increased blood glucose concentration, diabetes, increased blood lipid levels (cholesterol and triglycerides), increased sodium levels with 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 thoughts.
Nervous system disorders:
Increased intracranial pressure, emergence of symptoms of latent epilepsy, increased tendency to seizures in epilepsy.
Eye disorders:
Increased intraocular pressure (glaucoma), lens clouding (cataract), worsening of corneal ulceration, exacerbation of viral, fungal and bacterial eye infections, worsening of bacterial corneal infection, ptosis (drooping eyelid), pupil dilation, conjunctival edema, scleral 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, bleeding from the stomach or intestines, pancreatitis, indigestion, hiccups.
Skin and subcutaneous tissue disorders:
Striae, skin thinning ("parchment skin"), dilated blood vessels, tendency to bruising, petechial or superficial skin hemorrhages, acne, inflammatory skin conditions of the face, particularly around the mouth, nose and eyes, skin pigmentation changes.
Musculoskeletal and connective tissue disorders:
Muscle disorders, muscle weakness, muscle atrophy, bone loss (osteoporosis) which occurs depending on dose and may also occur during short-term use, other forms of bone degeneration (bone necrosis), tendon disorders, tendonitis, tendon rupture, growth suppression in children.
Warning:
Too rapid reduction of the dose after long-term treatment may cause withdrawal symptoms such as muscle and joint pain (withdrawal syndrome).
Reproductive system and breast disorders:
Disorders of sex hormone secretion (resulting in absence of menstrual bleeding, male-pattern body hair growth in women – hirsutism, impotence).
General disorders and administration site conditions:
Delayed wound healing.
If any of the listed adverse reactions occur, or any other adverse reaction during treatment with Dexamethasone Krka, consult a doctor or pharmacist.
Never discontinue treatment without consulting a doctor.
In case of gastrointestinal symptoms, back, shoulder or hip joint pain, psychiatric disturbances, noticeable fluctuations in blood glucose levels (in diabetic patients), or other disturbances, contact a doctor immediately.
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 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Dexamethasone Krka

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

The active substance is dexamethasone. Each tablet contains 0.5 mg of dexamethasone.
The other ingredients are monohydrate lactose, maize starch gelatinised, 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 bevelled edges, diameter: 4.8 – 5.2 mm, thickness: 1.4 – 2.2 mm.
Blister pack made of OPA/Aluminium/PVC/Aluminium, 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 Authorisation 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 further information on product names in other countries of the European Economic Area, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Tel. 22 57 37 500