Dexamethasone Krka

Leaflet accompanying the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Dexamethasone Krka (Dexamethasone HCS 8 mg), 8 mg, tablets

Dexamethasone
Dexamethasone Krka and Dexamethasone HCS 8 mg 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 you need to.
• 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 given 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 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 is a synthetic glucocorticosteroid. Glucocorticosteroids are hormones produced by the adrenal cortex. This medicine has anti-inflammatory, analgesic, and antiallergic 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 postoperative nausea and vomiting together with antiemetic drugs.

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 gastric or duodenal ulcer disease;
• in case of an upcoming vaccination with a live vaccine.

Warnings and precautions

Before starting to take Dexamethasone Krka, you should discuss it with your doctor, pharmacist, or nurse:

• if you have ever had a serious depression or manic-depressive illness (bipolar affective disorder); this means having had depression before or while taking steroid medicines like dexamethasone;
• if any of your close family members have had these illnesses.

Mental health problems can occur while taking steroids like Dexamethasone Krka.

• These problems can be serious.
• They usually occur within a few days or weeks of starting the medicine.
• They are more likely to occur with higher doses of the medicine.
• Most of these problems go away when the dose is lowered or the treatment is stopped. However, if these problems occur, they may need to be treated.

You should consult your doctor if you experience any symptoms of mental health problems while taking this medicine. This is especially important if you have depression or thoughts of suicide. In a few cases, mental health problems have occurred when the dose was lowered or the treatment was stopped.
You should consult your doctor before taking this medicine if you 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 history of diabetes in the family,
• osteoporosis (bone loss), especially in postmenopausal women,
• a history of muscle weakness caused by this or another steroid medicine,
• glaucoma (increased pressure in the eye) or a history of glaucoma or cataracts in the family (clouding of the lens in the eye leading to vision impairment),
• myasthenia gravis(a disease causing muscle weakness),
• gastrointestinal disease or stomach ulcers,
• psychiatric problems or a history of psychiatric illness that has worsened with 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 infection,
• cerebral malaria,
• herpes virus (oral or genital herpes, as well as eye herpes, due to the possible perforation of the cornea),
• asthma,
• ongoing anticoagulant therapy due to blocked blood vessels (thromboembolic disease),
• corneal ulcers and corneal injuries.

Taking this medicine can cause a chromaffin tumor crisis, which can be fatal. A chromaffin tumor is a rare adrenal gland tumor. The crisis may manifest with the following symptoms: headaches, sweating, palpitations, and high blood pressure. If any of these symptoms occur, you should contact your doctor immediately.
Corticosteroid therapy can weaken the body's ability to fight infection. This can sometimes lead to the occurrence of infections caused by microorganisms that normally do not cause infection (called opportunistic infections). If an infection occurs during treatment with this medicine, you should consult your doctor immediately. This is especially important in case of signs of pneumonia: cough, fever, shortness of breath, and chest pain. You may also experience a feeling of disorientation, especially in the elderly. You should also inform your doctor about any previous 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 you suspect potential contact with any of these diseases, you should consult your doctor immediately. You should also inform your doctor about any previous infectious diseases, such as measles or chickenpox, and about vaccinations against these diseases.
You should consult your doctor if you 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 blood cancer.
If you experience blurred vision or other vision disturbances, you should contact your doctor.
Treatment with this medicine can cause chorioretinopathy, an eye disease that impairs vision or causes vision disturbances. This usually affects one eye.
Treatment with this medicine can cause tendonitis. In extremely rare cases, it can lead to tendon rupture. This risk increases with the use of certain antibiotics and kidney problems. You should consult your doctor if you experience pain, stiffness, or swelling of the joints or tendons.
Taking Dexamethasone Krka can lead to a condition called adrenal insufficiency. This can affect the effectiveness of the medicine in stressful situations or trauma, 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 an accident, illness, or other special circumstances that put a physical strain on the body occur during or after treatment with Dexamethasone Krka, you should inform the treating doctor about taking steroids.
In case of suppression tests (detecting hormone levels in the blood), skin allergy tests, or bacterial infection tests, you should inform the person performing the tests about taking dexamethasone, as it may affect the test results.
During therapy, your doctor may also recommend reducing the amount of salt in your diet and potassium supplementation.
In elderly patients, some side effects of 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 growth and development of children at short intervals. Dexamethasone should not be used routinely in premature infants with respiratory failure.

Dexamethasone Krka and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

• Anticoagulant medicines (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 diseases
• Diuretic medicines (diuretics)
• Amphotericin B administered by injection
• 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 in cancer treatment)
• 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 in case of high cholesterol levels)
• Estrogen hormones, including birth control pills
• Tetracosactide used in the test to assess adrenal cortex function
• Sultopride used as a sedative
• Cyclosporine used to prevent transplant rejection
• Thalidomide used, among other things, in the treatment of multiple myeloma
• Praziquantel used in the treatment of parasitic infections
• "Live" vaccinations
• Chloroquine, hydroxychloroquine, mefloquine (medicines used to treat malaria)
• Growth hormone
• Protirelin

You should tell your doctor about all medicines you are currently taking or have recently taken, including those available without a prescription. You 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 your doctor may want 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 diseases
• Diuretic medicines (diuretics)
• Amphotericin B administered by injection
• Acetazolamide (medicine used to treat glaucoma and epilepsy)
• Tetracosactide used in the test to assess 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, in the treatment of multiple myeloma
• "Live" vaccinations
• Medicines that support muscle movement in myasthenia (e.g., neostigmine)
• Antibiotics, including erythromycin, fluoroquinolones

Before starting to take Dexamethasone Krka, you should read the patient information leaflets of all medicines you will be taking in combination with Dexamethasone Krka to obtain information about these medicines. When using thalidomide, lenalidomide, or pomalidomide, you should pay special attention to performing a pregnancy test and preventing pregnancy.

Dexamethasone Krka with food, drink, and alcohol

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

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.
Dexamethasone Krka should be used during pregnancy, especially in the first trimester, only if the doctor believes that the benefit to the mother outweighs the potential risk to the fetus.
If you become pregnant while taking Dexamethasone Krka, you should not stop taking it, but immediately inform your doctor that you 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

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

Dexamethasone Krka contains lactose monohydrate

If you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking this medicine.

3. How to take Dexamethasone Krka

Dexamethasone Krka should always be taken as directed by your doctor. Your doctor will decide how long you should take dexamethasone. If you have any doubts, you should consult your doctor or pharmacist.
Dexamethasone Krka comes in the form of 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 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 the severity of the disease. 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 the severity of the disease.

• 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.

For brain edema, the initial dose and duration of treatment depend 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 per kilogram of body weight in a single dose.
• Acute skin diseases:depending on the type and extent of the disease, daily doses of 8-40 mg, and in some cases up to 100 mg, followed by a reduction in dose 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 disease stage II or III 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), and then 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 disease stage I 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), and then 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 syndrome, together with other antiemetic medicines:8-20 mg of dexamethasone before chemotherapy, and then 4-16 mg per day on the second and third days of therapy.
• Prevention and treatment of postoperative nausea and vomiting, together with other antiemetic 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 being taken, if included. If not, the national or international protocols and dosing guidelines should be followed. The prescribing doctor should carefully assess the appropriate dose in each case, taking into account the patient's condition and disease.

Long-term treatment
In the case of long-term treatment of several diseases, after initial therapy, it is recommended to switch from dexamethasone to prednisone or prednisolone to limit the inhibitory effect on the adrenal cortex.

Use in children and adolescents

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

Overdose of Dexamethasone Krka

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

Missed dose of Dexamethasone Krka

If you miss a dose, you should take it as soon as possible. If it is almost time for your next dose, you should take only one dose. You should not take a double dose to make up for a missed dose.

Stopping treatment with Dexamethasone Krka

If you need to stop treatment, you should follow your doctor's instructions. They 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.
It may also cause a corticosteroid withdrawal syndrome, which includes fever, muscle and joint pain, nasal congestion (rhinitis), weight loss, itching, and eye inflammation (conjunctivitis). If you stop taking the medicine too quickly and experience any of these symptoms, you should contact your doctor as soon as possible.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Dexamethasone Krka can cause side effects, although not everybody gets them.
You should immediately inform your 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.

You should immediately inform your doctor about:

• severe abdominal pain, nausea, vomiting, diarrhea, significant 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 a perforated intestine, especially in the presence of existing intestinal disease.

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

• Increased susceptibility to infections, including viral, fungal, and bacterial 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).
• Disorders of hormonal regulation in the body, edema, and weight gain, moon face (Cushing's syndrome), change in the effective secretion of the adrenal cortex in response to stress and trauma, surgical procedures, childbirth, or illness, the body may not be able to respond properly to stressful situations, such as accidents, surgery, childbirth, or illness, growth retardation in children and adolescents, irregular menstrual cycle

or cessation of menstrual cycle (amenorrhea), excessive hair growth (especially in women).

• Weight gain, negative protein balance, increased appetite, electrolyte imbalance, water retention, potassium loss, which can cause heart rhythm disturbances, increased need for antidiabetic medicines, manifestation of latent diabetes, 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 corneal epithelium, 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, for example, in the legs or lungs (thromboembolic complications).
• Hiccup.
• Nausea, vomiting, discomfort in the stomach, and abdominal bloating, esophageal inflammation, stomach ulcers, which can perforate and bleed, pancreatitis (which can manifest as back and abdominal pain), gas in the intestines, thrush of the esophagus.
• Thin, fragile skin, unusual skin markings, bruising, redness, and inflammation of the skin, stretch marks, visible swelling of small blood vessels, acne, excessive sweating, rash, swelling, hair loss, abnormal fat deposits, excessive hair growth on the body, water retention, skin discoloration, skin irritation around the mouth (perioral dermatitis).
• Bone density loss 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.
• It may also cause a corticosteroid withdrawal syndrome, which includes fever, muscle and joint pain, nasal congestion (rhinitis), weight loss, itching, and eye inflammation (conjunctivitis).

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dexamethasone Krka

The medicine should be stored out of sight and reach of children.
You should not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
There are no special storage instructions. Store in the original packaging to protect from light and moisture.
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 8 mg of dexamethasone.
• The other ingredients of the medicine are: lactose monohydrate, maize starch, colloidal silicon dioxide, magnesium stearate. See section 2 "Dexamethasone Krka contains lactose monohydrate".

What Dexamethasone Krka looks like and contents of the packaging

White or almost white, oval tablets with a dividing line on one side (thickness: 3.5-5.5 mm; length: 8.7-9.3 mm). The tablet can be divided into equal doses.
OPA/Aluminum/PVC/Aluminum blisters in a cardboard box.
Packaging: 10, 20, 30, 50, 60, 100 tablets.
For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Austria, the country of export:

HCS bvba

• H. Kennisstraat 53 2650 Edegem, Belgium

Manufacturer:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Str. 5, 27472 Cuxhaven, Germany

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Austrian marketing authorization number, country of export:138041

Parallel import authorization number: 21/22 Date of approval of the leaflet: 05.01.2022