Dexamethasone Krka

Leaflet accompanying the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Dexamethasone Krka (Dexamethasone TAD)

4 mg, tablets
Dexamethasone
Dexamethasone Krka and Dexamethasone TAD are different trade names for the same medicine.

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 necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be passed on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. 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 is a synthetic glucocorticosteroid. Glucocorticosteroids are hormones produced by the adrenal cortex. This medicine has anti-inflammatory, analgesic, and anti-allergic properties, as well as immunosuppressive effects.
Dexamethasone Krka is indicated for the treatment of rheumatic and autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, juvenile idiopathic arthritis, giant cell arteritis), respiratory diseases (e.g., bronchial asthma, croup), skin diseases (e.g., erythroderma, common pemphigus), tuberculous meningitis exclusively in combination with anti-infective therapy, blood diseases (e.g., idiopathic thrombocytopenic purpura in adults), brain edema, symptomatic treatment of multiple myeloma, acute lymphoblastic leukemia, Hodgkin's disease, and non-Hodgkin's lymphoma in combination with other medicinal products, palliative treatment of cancer, prevention and treatment of nausea and vomiting caused by chemotherapy, as well as prevention and treatment of post-operative nausea and vomiting together with anti-emetic drugs.
Dexamethasone Krka, 4 mg, tablets
Dexamethasone Krka is used in the treatment of COVID-19 in adult patients and adolescents (aged 12 and older, weighing at least 40 kg) with breathing difficulties and requiring oxygen therapy.

2. Important information before taking Dexamethasone Krka

When not to take 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 it is already being treated);
• in case of stomach or duodenal ulcer disease;
• in case of an upcoming vaccination with a live vaccine.

Warnings and precautions

If the patient is being treated for COVID-19, they should not stop taking any other steroid medicines unless their doctor advises them to do so.
Before starting to take Dexamethasone Krka, the patient should discuss it with their doctor, pharmacist, or nurse:

• in case of a history of severe depression or manic-depressive illness (bipolar affective disorder); this means having had depression before or while taking steroid medicines like dexamethasone;
• in case of a family history of these illnesses.

Mental health problems can occur during treatment with steroids like Dexamethasone Krka.

• These disorders can be serious.
• They usually appear within a few days or weeks of starting to take the medicine.
• They occur more frequently after higher doses of the medicine.
• Most of these problems disappear after the dose is reduced or treatment is stopped. However, if such problems occur, they may require treatment.

The patient should consult their doctor if they experience any symptoms of mental health problems while taking this medicine. This is especially important if they have depression or thoughts of suicide. In a few cases, mental health problems have occurred after the dose was reduced or treatment was stopped.
The patient should consult their doctor before taking the medicine if they have:

• kidney or liver disease (liver cirrhosis or chronic liver failure),
• a chromaffin tumor (adrenal gland tumor) or suspected chromaffin tumor,
• high blood pressure, heart disease, or a recent heart attack (there have been cases of heart rupture),
• diabetes or a family history of diabetes,
• osteoporosis (bone density loss), especially in postmenopausal women,
• a history of muscle weakness caused by this or another steroid medicine,
• glaucoma (excessive pressure in the eyeball) or a family history of glaucoma or cataracts (lens clouding in the eye leading to vision impairment),
• myasthenia gravis(a disease causing muscle weakness),
• gastrointestinal disease or stomach ulcers,
• psychiatric problems or mental illness that has worsened due to the use of this type of medicine,
• epilepsy (a disease characterized by recurring losses of consciousness or seizures),
• migraine,
• hypothyroidism,
• parasitic infections,
• tuberculosis, sepsis, or fungal eye infections,
• cerebral malaria,
• herpes virus (oral or genital herpes, as well as eye herpes, due to the risk of corneal perforation),
• asthma,
• ongoing anticoagulant therapy due to blood vessel blockage (thromboembolic disease),
• corneal ulcers and corneal injuries.

Taking this medicine may cause a chromaffin tumor crisis, which can be fatal. A chromaffin tumor is a rare adrenal gland tumor. A crisis may manifest with the following symptoms: headaches, sweating, palpitations, and high blood pressure. If any of these symptoms occur, the patient should contact their doctor immediately.
Treatment with corticosteroids may weaken the body's ability to fight infection. This may sometimes lead to opportunistic infections caused by microorganisms that would not normally cause infection. If an infection occurs during treatment with this medicine, the patient should consult their doctor immediately. This is especially important in case of signs of pneumonia: cough, fever, shortness of breath, and chest pain. The patient may also experience a feeling of disorientation, especially in the elderly. The patient should also inform their doctor about any history of tuberculosis or living in areas where parasitic infections are common.
While taking this medicine, it is essential to avoid contact with people who have chickenpox, shingles, or measles. If the patient suspects potential contact with any of these diseases, they should consult their doctor immediately. The patient should also inform their doctor about any history of infectious diseases, such as measles or chickenpox, and any vaccinations against these diseases.
The patient should consult their doctor if they experience any of the following conditions: symptoms of tumor lysis syndrome, such as muscle cramps, muscle weakness, confusion, vision disturbances, or loss of vision, and shallow breathing, in case the patient has a hematological malignancy.
If the patient experiences blurred vision or other vision disturbances, they should consult their doctor.
Treatment with this medicine may cause choroidoretinopathy, an eye disease that impairs vision or causes vision disturbances. This usually affects one eye.
Treatment with this medicine may cause tendonitis. In extremely rare cases, tendon rupture may occur. This risk increases with the use of certain antibiotics and kidney problems. The patient should consult their doctor if they experience pain, stiffness, or swelling of the joints or tendons.
Taking Dexamethasone Krka may lead to a condition known as adrenal insufficiency. This may affect the effectiveness of the medicine in stressful situations or injury, surgery, childbirth, or illness, and the body may not be able to respond naturally to severe stress, such as accidents, surgery, childbirth, or illness.
If the patient experiences an accident, illness, or other special circumstances that put a physical strain on the body during or after treatment with Dexamethasone Krka, they should inform their doctor about taking steroids.
In case of suppression tests (detecting hormone levels in the blood), skin allergy tests, or bacterial infection tests, the patient should inform the person performing the tests about taking dexamethasone, as it may affect the test results.
During treatment, the doctor may also recommend reducing salt intake in the diet and potassium supplementation.
In elderly patients, some side effects of taking this medicine may be more severe, particularly bone density loss (osteoporosis), high blood pressure, low potassium levels, diabetes, increased susceptibility to infections, and skin thinning. The doctor will closely monitor the patient taking the medicine.

Children and adolescents

When using the medicine in children, it is essential for the doctor to closely monitor the child's growth and development at short intervals. Dexamethasone should not be used routinely in premature infants with respiratory failure.

Dexamethasone Krka and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they 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 (diuretic medicines)
• -- Amphotericin B injections
• -- Phenytoin, carbamazepine, primidone, (medicines used to treat epilepsy)
• -- Rifabutin, rifampicin, isoniazid (antibiotic used to treat tuberculosis)
• -- Antacids, especially those containing magnesium trisilicate
• -- Barbiturates (medicines used to facilitate sleep and reduce anxiety)
• -- Aminoglutethimide (medicine used to treat cancer)
• -- Carbenoxolone (medicine used to treat stomach ulcers)
• -- Ephedrine (medicine used to constrict blood vessels in inflammatory conditions of the nasal mucosa)
• -- Acetazolamide (medicine used to treat glaucoma and epilepsy)
• -- Hydrocortisone, cortisone, and other corticosteroids
• -- Ketoconazole, itraconazole (medicine used to treat fungal infections)
• -- Ritonavir (HIV)
• -- Antibiotics, including erythromycin, fluoroquinolones
• -- Medicines that support muscle movement in myasthenia (e.g., neostigmine)
• -- Cholestyramine (medicine used to treat high cholesterol)
• -- Estrogen hormones, including birth control pills
• -- Tetracosactide (used in the test to evaluate adrenal cortex function)
• -- Sulpiride used as a sedative
• -- Cyclosporine used to prevent transplant rejection
• -- Thalidomide used, among other things, to treat multiple myeloma
• -- Praziquantel (used to treat parasitic infections),
• -- Live vaccinations
• -- Chloroquine, hydroxychloroquine, mefloquine (medicines used to treat malaria)
• -- Growth hormone
• -- Protirelin

The patient should tell their doctor about all medicines they are currently taking or have recently taken, including those available without a prescription. The patient may be at increased risk of side effects when taking dexamethasone with

the following medicines:

• -- Some medicines may increase the effect of Dexamethasone Krka, and the doctor may want to monitor the patient if they 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 (diuretic medicines)
• -- Amphotericin B injections
• -- Acetazolamide (medicine used to treat glaucoma and epilepsy)
• -- Tetracosactide (used in the test to evaluate adrenal cortex function)
• -- Carbenoxolone (medicine used to treat stomach ulcers)
• -- Chloroquine, hydroxychloroquine, mefloquine (medicines used to treat malaria)
• -- Medicines used to treat high blood pressure
• -- Thalidomide used, among other things, to treat multiple myeloma
• -- Live vaccinations
• -- Medicines that support muscle movement in myasthenia (e.g., neostigmine)
• -- Antibiotics, including erythromycin, fluoroquinolones

Before starting to take Dexamethasone Krka, the patient should read the patient information leaflets of all medicines they will be taking in combination with Dexamethasone Krka to obtain information about these medicines. In case of thalidomide, lenalidomide, or pomalidomide, the patient should pay special attention to pregnancy testing and prevention.

Dexamethasone Krka with food, drink, and alcohol

Dexamethasone should be taken during or after a meal to reduce stomach upset. The patient should avoid drinks containing alcohol or caffeine. It is recommended to eat small, frequent meals and possibly use antacids, if advised by the doctor.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Dexamethasone Krka should be used during pregnancy, especially in the first trimester, only if the doctor believes the benefits to the mother outweigh the potential risks to the fetus.
If the patient becomes pregnant while taking Dexamethasone Krka, they should not stop taking it but immediately inform their doctor that they are pregnant.
Corticosteroids may pass into breast milk. The risk to newborns or infants cannot be excluded. The decision to continue or stop breastfeeding or continue or stop treatment with dexamethasone should be made, taking into account the benefits of breastfeeding for the child and the benefits of dexamethasone treatment for the woman.

Driving and using machines

The patient should not drive vehicles, operate machinery, or perform any hazardous tasks if they experience side effects such as disorientation, hallucinations, dizziness, fatigue, drowsiness, fainting, or blurred vision.

Dexamethasone Krka contains lactose monohydrate

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Dexamethasone Krka

Dexamethasone Krka should always be taken as directed by the doctor. The doctor will decide how long the patient should take dexamethasone. In case of doubts, the patient should consult their doctor or pharmacist.
Dexamethasone Krka is available in 4 mg, 8 mg, 20 mg, and 40 mg tablet forms. The tablets can be divided into halves, providing additional strengths of 2 mg and 10 mg and making it easier for the patient to swallow the tablet.
Dexamethasone is usually given in doses of 0.5 mg to 10 mg per day, depending on the disease being treated. In more severe disease states, doses above 10 mg per day may be required. The dose should be determined based on individual patient responses and disease severity. To minimize side effects, the smallest effective dose should be used.

If the doctor does not recommend otherwise, the following doses are recommended:

The following dosage recommendations are for informational purposes only.

Initial and daily doses should always be determined based on individual patient responses and disease severity.

• Brain edema:initial dose and duration of treatment depending on the causes and severity of the disease, 6-16 mg per day (up to a maximum of 24 mg) orally, divided into 3-4 single doses.
• Acute asthma:adults: 16 mg per day for two days; children: 0.6 mg per kilogram of body weight for one to two days.
• Croup:children: 0.15-0.6 mg/kg of body weight in a single dose.
• Acute skin diseases:depending on the type and extent of the disease, daily doses ranging 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 per day.
• Active rheumatoid arthritis with a severe, progressive course:rapidly progressive destructive form of the disease 12-16 mg per day, with extra-articular symptoms 6-12 mg per day.
• 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 per day in the first week, 0.3 mg per kilogram of body weight per day in the second week, 0.2 mg per kilogram of body weight per day in the third week, and 0.1 mg per kilogram of body weight per day in the fourth week), followed by oral treatment for four weeks, starting with a dose of 4 mg per day and reducing the dose by 1 mg every week; patients with stage I disease receive intravenous treatment for two weeks (0.3 mg per kilogram of body weight per day in the first week and 0.2 mg per kilogram of body weight per day in the second week), followed by oral treatment for four weeks (0.1 mg per kilogram of body weight per day in the third week of treatment, and 3 mg per day in the next week, reducing the dose by 1 mg every week).
• Palliative care in cancer:initial dose and duration of treatment depending on the causes and severity of the disease: 3-20 mg per day. 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, 4 mg and 8 mg tablets can be combined with 20 mg or 40 mg tablets.
• Prevention and treatment of chemotherapy-induced emetic reactions, together with other anti-emetic medicines:8-20 mg of dexamethasone before chemotherapy, followed by 4-16 mg per day on the second and third days of therapy.
• Prevention and treatment of post-operative nausea and vomiting, together with other anti-emetic medicines:a single dose of 8 mg before surgery.
• Treatment of symptomatic multiple myeloma, acute lymphoblastic leukemia, Hodgkin's disease, and non-Hodgkin's lymphoma, in combination with other medicines:the usual dose is 40 mg or 20 mg once a day. The dose and frequency of administration vary depending on the treatment regimen and other medicines taken. Administration of dexamethasone should be in accordance with the dosing instructions for dexamethasone described in the summary of product characteristics of the other medicine taken, if included. If not, the patient should follow national or international protocols and dosing guidelines. The prescribing doctor should carefully evaluate the appropriate dose in each case, considering the patient's condition and disease.

Long-term treatment
In case of long-term treatment of several diseases, after initial therapy, the glucocorticosteroid should be changed from dexamethasone to prednisone or prednisolone to limit the suppressive effect on the adrenal cortex.
Dexamethasone Krka, 4 mg, tablets

• Treatment of COVID-19:the recommended dose for adults is 6 mg once a day orally, for a maximum of 10 days. The recommended dose for adolescents is 6 mg once a day orally, for a maximum of 10 days, for adolescents (aged 12 and older, weighing at least 40 kg).

Use in children and adolescents

When using the medicine in children, it is essential for the doctor to closely monitor the child's growth and development at short intervals.

Taking a higher dose of Dexamethasone Krka than recommended

In case of taking too many tablets, the patient should immediately contact their doctor or go to the nearest hospital.

Missing a dose of Dexamethasone Krka

In case of missing a dose, the patient should take it as soon as possible. If it is almost time for the next dose, they should take only one dose. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Dexamethasone Krka

In case of needing to stop treatment, the patient should follow their doctor's recommendations.
These may include gradually reducing the dose of the medicine until it is completely stopped. Symptoms that occur after stopping treatment too quickly include low blood pressure, and in some cases, a relapse of the original disease.
The patient may also experience a corticosteroid withdrawal syndrome, including fever, muscle and joint pain, nasal congestion (rhinitis), weight loss, itching skin, and eye inflammation (conjunctivitis). If the patient stops taking the medicine too quickly and experiences any of these symptoms, they should contact their doctor as soon as possible.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Dexamethasone Krka can cause side effects, although not everybody gets them.
The patient should immediately inform their doctor about serious mental health problems.
These problems may occur in about 5 out of 100 people taking medicines like dexamethasone. These problems include:

• feeling depressed, including thoughts of suicide,
• feeling euphoric (mania) or mood swings,
• feeling anxious, insomnia, problems with rational thinking, or feeling disoriented and having memory lapses,
• perceiving, seeing, or hearing things that do not exist; unusual or frightening thoughts that affect behavior or feeling lonely.

The patient should immediately inform their doctor about:

• severe stomach pain, nausea, vomiting, diarrhea, significant muscle weakness, and fatigue, extremely low blood pressure, weight loss, and fever, as these may indicate adrenal insufficiency;
• sudden stomach pain, tenderness, nausea, vomiting, fever, and blood in the stool, as these may be symptoms of intestinal perforation, especially in the presence of existing intestinal disease.

This medicine may worsen existing heart disease. If the patient experiences shortness of breath or swelling of the ankles, they should immediately contact their doctor.
Other side effects include (frequency not known):

• -- Increased susceptibility to infections, including viral and fungal infections, e.g., thrush, recurrence of tuberculosis, or other infections, e.g., previously diagnosed eye infections.
• -- Decreased or increased white blood cell count, blood clotting disorders.
• -- Allergic reactions to the medicine, including serious, life-threatening allergic reactions (which may manifest as a rash, throat swelling, or tongue swelling, and in severe cases, difficulty breathing or dizziness).
• -- Hormonal regulation disorders, edema, and weight gain, moon face (Cushing's syndrome), changed effective hormone secretion in response to stress and trauma, surgical procedures, childbirth, or disease, the body may not be able to respond normally to severe stress, such as accidents, surgery, childbirth, or disease, growth retardation in children and adolescents, irregular menstrual cycle or cessation of menstruation, excessive hair growth (especially in women).
• -- Weight gain, negative protein and calcium balance, increased appetite, electrolyte imbalance, water retention, potassium loss, which may cause heart rhythm disturbances, increased need for anti-diabetic medicines, onset of latent diabetes symptoms, high cholesterol and triglyceride levels in the blood (hypercholesterolemia and hypertriglyceridemia).
• -- Severe mood swings, schizophrenia (a mental disorder) may worsen, depression, insomnia.
• -- Severe, unusual headaches with vision disturbances related to withdrawal of the medicine, seizures, and worsening of epilepsy, dizziness.
• -- Increased eye pressure, eye swelling, thinning of the cornea and conjunctiva, worsening of existing viral, fungal, and bacterial eye infections, worsening of corneal ulcers, worsening of existing eye infections, exophthalmos, cataracts, vision disturbances, loss of vision, blurred vision.
• -- Congestive heart failure in susceptible patients, heart rupture after a recent heart attack, heart failure.
• -- High blood pressure, blood clots, formation of blood clots that can block blood vessels, e.g., in the legs or lungs (thromboembolic complications).
• -- Hiccup.
• -- Nausea, vomiting, discomfort in the stomach, and abdominal bloating, esophageal inflammation and ulcers, stomach ulcers that can rupture and bleed, pancreatitis (which may manifest as back and abdominal pain), gas in the intestines, thrush of the esophagus.
• -- Thin, fragile skin, unusual skin spots, bruising, redness, and inflammation of the skin, stretch marks, visible swelling of blood vessels, acne, excessive sweating, rash, swelling, hair loss, abnormal fat deposits, excessive body hair, water retention, skin discoloration, skin irritation around the mouth (perioral dermatitis).
• -- Decreased bone density with an increased risk of fractures (osteoporosis), bone necrosis, tendonitis, tendon rupture, muscle wasting, myopathy, muscle weakness, premature closure of bone growth plates (premature epiphyseal closure).
• -- Changes in sperm count and motility, impotence.
• -- Impaired response to vaccination and skin tests, delayed wound healing, discomfort, malaise.
• -- The patient may also experience a corticosteroid withdrawal syndrome, including fever, muscle and joint pain, nasal congestion (rhinitis), weight loss, itching skin, and eye inflammation (conjunctivitis).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
Reporting side effects helps to gather more information on the safety of the medicine.

5. How to store Dexamethasone Krka

The medicine should be stored out of sight and reach of children.
The patient should not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
There are no special storage temperature recommendations. The medicine should be stored in its original packaging to protect it from light and moisture.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. 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 4 mg of dexamethasone.
• The other ingredients of the medicine are lactose monohydrate, cornstarch, colloidal silicon dioxide, magnesium stearate (E 470b). See section 2. "Dexamethasone Krka contains lactose monohydrate".

What Dexamethasone Krka looks like and contents of the packaging

White or almost white, round tablets with a score line on one side (thickness: 2.5-3.5 mm; diameter: 5.7-6.3 mm). The tablet can be divided into equal doses.
OPA/Al/PVC/Al blisters in a cardboard box.
Packaging: 20 tablets.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization 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

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Spanish export authorization number: 713555.5

Parallel import authorization number: 66/25

Date of leaflet approval: 17.02.2025

[Information about the trademark]