Package leaflet: Information for the user

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Dexamethasone Krka (Dexamethasone TAD)
8 mg, tablets
Dexamethasonum
Dexamethasone Krka and Dexamethasone TAD are different brand names for the same medicine.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of 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 is a synthetic glucocorticosteroid. Glucocorticosteroids are hormones produced by the adrenal cortex. This medicine has anti-inflammatory, analgesic, antiallergic, and immunosuppressive properties.
Dexamethasone Krka is indicated in the treatment of rheumatic and autoimmune diseases (e.g. systemic lupus erythematosus, rheumatoid arthritis, juvenile idiopathic arthritis, polyarteritis nodosa), respiratory diseases (e.g. bronchial asthma, croup), skin disorders (e.g. erythroderma, pemphigus vulgaris), tuberculous meningitis only in combination with anti-infective therapy, blood disorders (e.g. idiopathic thrombocytopenic purpura in adults), cerebral oedema, symptomatic treatment of multiple myeloma, acute lymphoblastic leukaemia, Hodgkin's disease and non-Hodgkin's lymphoma in combination with other medicinal products, palliative treatment of malignant diseases, and for the prevention and treatment of nausea and vomiting caused by chemotherapy, as well as for the prevention and treatment of postoperative vomiting in combination with antiemetic medicines.

2. Important information before using Dexamethasone Krka

When not to use Dexamethasone Krka

if the patient is allergic to dexamethasone or any of the other ingredients of this medicine (listed in section 6);
in case of systemic infection (unless already being treated);
in case of peptic ulcer of the stomach or duodenum;
shortly before receiving a live vaccine.

Warnings and precautions
If the patient is being treated for a COVID-19 infection, do not stop taking any other steroid medications unless otherwise instructed by a doctor.
Before starting treatment with Dexamethasone Krka, discuss the following with your doctor, pharmacist, or nurse:

if you have ever experienced severe depression or bipolar disorder (manic-depressive illness); this includes having had depression before or during treatment with corticosteroid medicines such as dexamethasone;
if any member of your immediate family has had these conditions.

Psychiatric problems may occur during treatment with corticosteroids such as Dexamethasone Krka.

These disorders can be serious.
They usually appear within a few days or weeks after starting the medicine.
They are more common with higher doses.
Most of these problems resolve when the dose is reduced or treatment is stopped. However, if such problems occur, they may require medical treatment.

Consult your doctor if you experience any symptoms of psychiatric problems while taking this medicine. This is particularly important in cases of depression or suicidal thoughts. In some cases, psychiatric problems have occurred after reducing the dose or stopping treatment.
Consult your doctor before using Dexamethasone Krka if you have:

kidney or liver disease (liver cirrhosis or chronic liver failure),
pheochromocytoma (adrenal gland tumor) or suspected pheochromocytoma,
high blood pressure, heart disease, or recent heart attack (cases of cardiac rupture have been reported),
diabetes or a family history of diabetes,
osteoporosis (loss of bone mass), especially in postmenopausal women,
previous muscle weakness caused by this or another corticosteroid medicine,
glaucoma (increased pressure in the eye) or a family history of glaucoma or cataracts (clouding of the eye lens leading to impaired vision),
myasthenia gravis (a disease causing muscle weakness),
intestinal disease or stomach ulcer,
psychiatric disorders or mental illness that worsened during treatment with corticosteroids,
epilepsy (a condition characterized by recurrent seizures or convulsions),
migraine,
hypothyroidism,
parasitic infections,
tuberculosis, sepsis, or fungal eye infection,
cerebral malaria,
herpes virus (of the mouth, genitals, or eye, due to possible corneal perforation),
asthma,
ongoing treatment for blood vessel blockage by clots (thromboembolic disease),
corneal ulceration or corneal injury.

Treatment with this medicine may trigger a pheochromocytoma crisis, which can be fatal. Pheochromocytoma is a rare tumor of the adrenal glands. A crisis may present with symptoms such as headache, sweating, palpitations, and high blood pressure. If any of these symptoms occur, contact your doctor immediately.
Corticosteroid treatment may weaken the body's ability to fight infections. This may sometimes lead to infections caused by microorganisms that rarely cause disease under normal circumstances (called opportunistic infections). If any infection occurs during treatment with this medicine, contact your doctor immediately. This is particularly important in cases of signs of pneumonia: cough, fever, shortness of breath, and chest pain. Disorientation may also occur, especially in elderly patients. Inform your doctor about any previous tuberculosis or travel to areas where parasitic infections are common.
While taking this medicine, avoid contact with people who have chickenpox, shingles, or measles. If you suspect possible exposure to any of these diseases, contact your doctor immediately. Inform your doctor about any previous infectious diseases such as measles or chickenpox, and about vaccinations against these diseases.
Contact your doctor if the patient experiences any of the following: symptoms of tumor lysis syndrome, such as muscle cramps, muscle weakness, confusion, vision disturbances, or loss of vision, especially if the patient has a hematological malignancy.
If the patient experiences blurred vision or other visual disturbances, contact a doctor.
Treatment with this medicine may cause chorioretinopathy, an eye disease causing decreased visual acuity or visual disturbances. This usually affects one eye.
Treatment with this medicine may cause tendon inflammation. In very rare cases, tendon rupture may occur. This risk increases when combined with certain antibiotics or kidney problems. Contact your doctor if you experience pain, stiffness, or swelling in joints or tendons.
Taking Dexamethasone Krka may lead to a condition called adrenal insufficiency. This may affect the medicine's effectiveness during stress, injury, surgery, childbirth, or illness, and the body may not be able to respond naturally to serious physical stress caused by accidents, operations, childbirth, or disease. If an accident, illness, or other physically stressful event occurs during or after treatment with Dexamethasone Krka, or if surgery (even dental) or vaccination (especially with live virus vaccines) is required, inform the treating physician about steroid use.
If undergoing suppression tests (to detect hormone levels in blood), allergy skin tests, or bacterial infection screening, inform the person conducting the tests that you are taking dexamethasone, as it may affect test results.
During treatment, your doctor may also recommend limiting salt intake and potassium supplementation.
In elderly patients, some side effects of this medicine may be more serious, particularly decreased bone density (osteoporosis), high blood pressure, low potassium levels, diabetes, increased susceptibility to infections, and skin thinning. Your doctor will closely monitor the patient during treatment.
Children and adolescents
When treating children, it is important that the doctor carefully monitors growth and development at regular intervals. Dexamethasone should not be routinely used in premature infants with respiratory distress syndrome.
Dexamethasone Krka with other medicines
Tell your doctor about all medicines you are currently taking or have recently taken, including medicines you plan to take.

-- Anticoagulants (e.g., warfarin)
-- Acetylsalicylic acid or similar (non-steroidal anti-inflammatory drugs), e.g., indomethacin
-- Medicines used to treat diabetes
-- Medicines used to treat high blood pressure
-- Medicines used to treat heart disease
-- Diuretics (water tablets)
-- Intravenous amphotericin B
-- Phenytoin, carbamazepine, primidone (medicines used to treat epilepsy)
-- Rifabutin, rifampicin, isoniazid (antibiotics used to treat tuberculosis)
-- Antacids, particularly those containing magnesium trisilicate
-- Barbiturates (medicines used to aid sleep and reduce anxiety)
-- Aminoglutethimide (an anticancer medicine)
-- Carbenoxolone (a medicine used to treat stomach ulcers)
-- Ephedrine (a medicine used to constrict blood vessels in inflammatory conditions of nasal mucosa)
-- Acetazolamide (a medicine used to treat glaucoma and epilepsy)
-- Hydrocortisone, cortisone, and other corticosteroids
-- Ketoconazole, itraconazole (medicines used to treat fungal infections)
-- Ritonavir (HIV)
-- Antibiotics including erythromycin, fluoroquinolones
-- Medicines that enhance muscle movement in myasthenia (e.g., neostigmine)
-- Cholestyramine (a medicine used in cases of elevated cholesterol)
-- Estrogen hormones, including oral contraceptives
-- Tetracosactide (used in adrenal cortex function testing)
-- Sultopride (used as a calming medicine)
-- Cyclosporine (used to prevent transplant rejection)
-- Thalidomide (used, among others, in the treatment of multiple myeloma)
-- Praziquantel (used to treat parasitic infections)
-- Live vaccines
-- Chloroquine, hydroxychloroquine, mefloquine (medicines used to treat malaria)
-- Growth hormone
-- Protirelin

Tell your doctor about all medicines you are currently taking or have recently taken, including over-the-counter medicines. You may be at increased risk of adverse effects when taking dexamethasone with the following medicines:

-- Some medicines may increase the effect of Dexamethasone Krka, and your doctor may need to monitor you if you are taking these medicines (including some HIV medicines: ritonavir, cobicistat)
-- Acetylsalicylic acid or similar (non-steroidal anti-inflammatory drugs), e.g., indomethacin
-- Medicines used to treat diabetes
-- Medicines used to treat heart disease
-- Diuretics (water tablets)
-- Intravenous amphotericin B
-- Acetazolamide (a medicine used to treat glaucoma and epilepsy)
-- Tetracosactide (used in adrenal cortex function testing)
-- Carbenoxolone (a medicine used to treat stomach ulcers)
-- Chloroquine, hydroxychloroquine, mefloquine (medicines used to treat malaria)
-- Medicines used to treat high blood pressure
-- Thalidomide (used, among others, in the treatment of multiple myeloma)
-- Live vaccines
-- Medicines that enhance muscle movement in myasthenia (e.g., neostigmine)
-- Antibiotics including erythromycin, fluoroquinolones

Before starting Dexamethasone Krka, read the patient information leaflets of all other medicines you are taking in combination with Dexamethasone Krka to obtain information about these medicines. If you are taking thalidomide, lenalidomide, or pomalidomide, pay special attention to the need for pregnancy testing and contraception.
Dexamethasone Krka with food, drink, and alcohol
Dexamethasone should be taken during or after meals to reduce gastrointestinal irritation. Avoid drinks containing alcohol or caffeine. It is recommended to eat small, frequent meals and, if advised by your doctor, to use antacids.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Dexamethasone Krka should be used during pregnancy, particularly in the first trimester, only if, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the fetus.
If you become pregnant while taking Dexamethasone Krka, do not stop treatment but inform your doctor immediately.
Corticosteroids may pass into breast milk. Risk to newborns or infants cannot be excluded. The decision whether to continue or discontinue breastfeeding or to continue or discontinue treatment with dexamethasone should be made, taking into account the benefits of breastfeeding for the child and the benefits of dexamethasone treatment for the mother.
Driving and operating machinery
Do not drive, operate machinery, or perform any hazardous tasks if you experience adverse effects such as disorientation, hallucinations, dizziness, fatigue, drowsiness, fainting, or blurred vision.
Dexamethasone Krka contains lactose monohydrate
If you have previously been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Dexamethasone Krka

Dexamethasone Krka should always be taken exactly as prescribed by the doctor. The doctor will decide how long the patient should take dexamethasone. If in doubt, consult the doctor or pharmacist.

Dexamethasone Krka is available as 4 mg, 8 mg, 20 mg, and 40 mg tablets. The tablets can be divided into halves, providing additional strengths of 2 mg and 10 mg, and making them easier to swallow.

Dexamethasone is usually administered in doses ranging from 0.5 mg to 10 mg daily, depending on the disease being treated. In more severe conditions, doses exceeding 10 mg daily may be necessary. The dose should be adjusted according to individual patient response and disease severity. To minimize side effects, the lowest effective dose should be used.

Unless otherwise directed by the doctor, the following doses are recommended:
The dosing recommendations listed below are for informational purposes only.
Initial and daily doses must always be determined based on individual patient response and disease severity.

Cerebral edema: initial dose and duration of treatment depend on the cause and severity of the disease; 6–16 mg daily (up to a maximum of 24 mg), orally, divided into 3–4 single doses.
Acute asthma: adults: 16 mg daily for two days; children: 0.6 mg per kilogram of body weight for one to two days.
Croup: children: 0.15–0.6 mg per kilogram of body weight as a single dose.
Acute skin diseases: depending on the type and extent of the disease, daily doses range from 8–40 mg, and in some cases up to 100 mg, followed by dose reduction according to clinical needs.
Active phase of systemic rheumatic diseases: systemic lupus erythematosus: 6–16 mg daily.
Active, severe, progressive rheumatoid arthritis: rapidly progressive destructive form: 12–16 mg daily; with extra-articular manifestations: 6–12 mg daily.
Idiopathic thrombocytopenic purpura: 40 mg for 4 days in cycles.
Tuberculous meningitis: patients with stage II or III disease receive intravenous treatment for four weeks (0.4 mg per kilogram of body weight daily in the first week, 0.3 mg per kilogram daily in the second week, 0.2 mg per kilogram daily in the third week, and 0.1 mg per kilogram daily in the fourth week), followed by oral treatment for four weeks, starting at 4 mg daily and reducing the dose by 1 mg weekly; patients with stage I disease receive intravenous treatment for two weeks (0.3 mg per kilogram daily in the first week and 0.2 mg per kilogram daily in the second week), followed by oral treatment for four weeks (0.1 mg per kilogram daily in the third week of treatment, then 3 mg daily in the following week, reducing the dose by 1 mg weekly).
Palliative care in neoplastic diseases: initial dose and duration of treatment depend on the cause and severity of the disease: 3–20 mg daily. In palliative care, very high doses may also be used, up to a maximum of 96 mg. For optimal dosing and to reduce the number of tablets, lower-strength tablets (4 mg and 8 mg) can be combined with higher-strength tablets (20 mg or 40 mg).
Prophylaxis and treatment of cytotoxic, emetogenic chemotherapy-induced vomiting, in combination with other antiemetics: 8–20 mg of dexamethasone before chemotherapy, followed by 4–16 mg daily on the second and third days of therapy.
Prophylaxis and treatment of postoperative vomiting, in combination with other antiemetics: a single 8 mg dose before surgery.
Treatment of symptomatic multiple myeloma, acute lymphoblastic leukemia, Hodgkin's disease, and non-Hodgkin's lymphoma, in combination with other drugs: the usual dose is 40 mg or 20 mg once daily. The dose and frequency vary depending on the treatment regimen and other medications used. Dexamethasone should be administered according to the dosing guidelines described in the product characteristics of the other medication being used, if provided. If not, national or international protocols and dosing guidelines should be followed. The prescribing physician should carefully evaluate the appropriate dose in each case, considering the patient's condition and disease.

Long-term treatment
In long-term treatment of several diseases, after initial therapy, the glucocorticoid should be switched from dexamethasone to prednisone or prednisolone to minimize suppression of the adrenal cortex.

Use in children and adolescents
When treating children, it is important that the doctor carefully monitors growth and development at regular intervals.

Taking more Dexamethasone Krka than recommended
If too many tablets have been taken, contact a doctor immediately or go to the nearest hospital.

Missing a dose of Dexamethasone Krka
If a dose is missed, take it as soon as possible. If it is almost time for the next dose, take only one dose. Do not take a double dose to make up for a missed dose.

Stopping Dexamethasone Krka
If treatment needs to be discontinued, follow the doctor's instructions. This may include gradually reducing the dose until treatment is completely stopped. Symptoms that may occur after stopping treatment too quickly include low blood pressure and, in some cases, recurrence of the original disease.

A corticosteroid withdrawal syndrome may also occur, including fever, muscle and joint pain, nasal mucosal inflammation (rhinitis), weight loss, skin itching, and eye inflammation (conjunctivitis). If the medication is stopped too quickly and any of these symptoms occur, contact a doctor immediately.

If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
You should immediately inform your doctor if serious psychiatric problems occur.
These may affect approximately 5 out of 100 people taking corticosteroid medicines such as dexamethasone. These problems include:

feelings of depression, including suicidal thoughts,
feelings of euphoria (mania) or mood swings,
feelings of uneasiness, insomnia, difficulty thinking clearly, or feelings of confusion and memory loss,
experiencing, perceiving or hearing things that are not real; unusual or frightening thoughts affecting behaviour or feelings of isolation.

You should immediately inform your doctor if the following occur:

severe abdominal pain, nausea, vomiting, diarrhoea, marked muscle weakness and fatigue, extremely low blood pressure, weight loss and fever, as these may indicate adrenal insufficiency;
sudden abdominal pain, tenderness, nausea, vomiting, fever and blood in the stool, as these may be symptoms of intestinal perforation, especially if you have an existing bowel disease.

This medicine may worsen existing heart conditions. If you experience shortness of breath or ankle swelling, contact your doctor immediately.
Other adverse effects (frequency not known) include:

-- Increased susceptibility to infections, including viral and fungal infections such as candidiasis, reactivation of tuberculosis or other infections, e.g. previously diagnosed eye infections.
-- Decreased or increased number of white blood cells, coagulation disorders.
-- Allergic reactions to the medicine, including severe, life-threatening allergic reactions (which may present as rash, swelling of the throat or tongue, and in severe cases, difficulty breathing or dizziness).
-- Disorders of hormonal regulation in the body, oedema and weight gain, moon face (Cushingoid state), altered internal secretion as a result of stress and trauma, surgical procedures, childbirth or illness; the body may be unable to respond adequately in situations of severe stress such as accidents, surgery, childbirth or illness; growth suppression in children and adolescents, irregular menstrual cycle or amenorrhoea (absence of menstruation), development of excessive hair growth (especially in women).
-- Weight gain, negative protein and calcium balance, increased appetite, electrolyte imbalance, fluid retention in the body, potassium loss which may lead to cardiac arrhythmias, increased requirement for antidiabetic medications, manifestation of latent diabetes, elevated blood cholesterol and triglyceride levels (hypercholesterolaemia and hypertriglyceridaemia).
-- Extreme mood swings, schizophrenia (mental disorder) may worsen, depression, insomnia.
-- Severe atypical headaches with visual disturbances related to discontinuation of the medicine, seizures and worsening of epilepsy, dizziness.
-- Increased intraocular pressure, eye oedema, thinning of the corneal epithelium, worsening of existing viral, fungal and bacterial eye infections, exacerbation of corneal ulcer symptoms, worsening of existing eye infections, exophthalmos (protruding eyes), cataract, visual disturbances, loss of vision, blurred vision.
-- Congestive heart failure in susceptible patients, cardiac rupture after recent myocardial infarction, heart failure.
-- Hypertension, blood clots, thrombus formation which may block blood vessels, for example in the legs or lungs (thromboembolic complications).
-- Hiccups.
-- Nausea, vomiting, gastric discomfort and abdominal distension, inflammation and ulcers in the oesophagus, stomach ulcers which may rupture and bleed, pancreatitis (which may present as back and abdominal pain), intestinal gas, oesophageal candidiasis.
-- Thin, fragile skin, unusual skin markings, bruising, redness and skin inflammation, stretch marks, visible capillary dilation, acne, excessive sweating, rash, swelling, hair loss, abnormal fat deposits, excessive body hair growth, fluid retention in the body, pigmentary changes, weakened capillaries visible as subcutaneous bleeding (increased fragility of vessels), perioral dermatitis (skin inflammation around the mouth).
-- Reduced bone density with increased risk of fractures (osteoporosis), avascular necrosis of bone, tendonitis, tendon rupture, muscle atrophy, myopathy, muscle weakness, impaired muscle strength, premature cessation of bone growth (premature closure of epiphyseal plates).
-- Changes in sperm quantity and motility, impotence.
-- Impaired response to vaccination and skin tests, slow wound healing, discomfort, malaise.
-- Withdrawal syndrome from corticosteroids may also occur, including fever, muscle and joint pain, rhinitis (nasal inflammation), weight loss, painful and itchy skin nodules, eye inflammation (conjunctivitis).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, you should inform your doctor, pharmacist or nurse. 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
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Dexamethasone Krka

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
No special temperature storage instructions are required. Store in the original packaging to protect from light and moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Dexamethasone Krka contains

The active substance is dexamethasone. Each tablet contains 8 mg of dexamethasone.
The other ingredients are monohydrate lactose, pregelatinized corn starch, colloidal anhydrous silica, magnesium stearate (E 470b). See section 2. "Dexamethasone Krka contains monohydrate lactose".

What Dexamethasone Krka looks like and contents of the pack
White or almost white, oval tablets with a score line on one side (thickness: 3.5–5.5 mm;
length: 8.7–9.3 mm). The tablet can be divided into equal doses.
Blister packs OPA/Al/PVC/Al in a cardboard box.
Pack sizes: 20 tablets.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Spain, the country of export:
TAD Pharma GmbH
Heinz-Lohmann-Straße 5
27472 Cuxhaven, Germany
Manufacturer:
Krka, d.d. Novo mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland
Spanish marketing authorisation number, country of export: 713556.2
Parallel import authorisation number: 64/25

Dexamethasone krka