Dexamethasone Krka

Package Leaflet: Information for the User

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

Dexamethasone Krka (Dexamethasone HCS 20 mg)

20 mg, tablets

Dexamethasone
Dexamethasone Krka and Dexamethasone HCS 20 mg are different trade names for the same medicine.

Before taking the medicine, carefully read the contents of the leaflet, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any further doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• 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. Package contents 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., muscle inflammation), skin diseases (e.g., common pemphigus), blood diseases (e.g., idiopathic thrombocytopenic purpura in adults), symptomatic treatment of multiple myeloma, acute lymphoblastic leukemia, Hodgkin's disease, and non-Hodgkin's lymphoma in combination with other medicines, metastatic spinal cord compression (nerve compression in the spinal cord caused by a tumor), prevention and treatment of nausea and vomiting caused by chemotherapy, together with antiemetic drugs.

2. Important information before taking Dexamethasone Krka

Do not take Dexamethasone Krka:

• if you are allergic to dexamethasone or any of the other ingredients of this medicine (listed in section 6);
• if you have a systemic infection (unless it is already being treated);
• if you have stomach or duodenal ulcer disease;
• if you are about to receive a live vaccine.

Warnings and precautions

Before taking Dexamethasone Krka, consult your doctor or pharmacist:

• if you have ever had severe 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 during treatment with steroids like Dexamethasone Krka.

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

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 reduced or treatment was stopped.
Consult your doctor before taking the medicine if you have:

• kidney or liver disease (liver cirrhosis or chronic liver failure),
• chromaffin tumor (adrenal gland tumor) or suspected chromaffin tumor,
• high blood pressure, heart disease, or recent heart attack (there have been cases of heart rupture),
• diabetes or a history of diabetes in the family,
• osteoporosis (bone mass loss), especially in postmenopausal women,
• a history of muscle weakness caused by this or another steroid medicine,
• glaucoma (increased pressure in the eyeball) or a history of glaucoma or cataracts in the family (lens clouding in the eye leading to vision impairment),
• myasthenia gravis(a disease that causes muscle weakness),
• bladder or stomach disease,
• psychiatric problems or mental 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 therapy for blocked blood vessels by blood clots (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, consult your doctor immediately.
Corticosteroid therapy can weaken the body's ability to fight infection. This can sometimes lead to opportunistic infections caused by microorganisms that normally do not cause infection. If an infection occurs during treatment with this medicine, consult your doctor immediately. This is especially important in case of signs of pneumonia: cough, fever, shortness of breath, and chest pain. There may also be a feeling of disorientation, especially in the elderly. You should also inform your doctor if you have had tuberculosis or have been 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, consult your doctor immediately. You should also inform your doctor if you have had infectious diseases, such as measles or chickenpox, and if you have been vaccinated against these diseases.
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, if you have a blood cancer.
If you experience blurred vision or other vision disturbances, consult your doctor.
Treatment with this medicine can cause chorioretinopathy, an eye disease that impairs vision or causes vision disturbances. This usually affects one eye.
Therapy with this medicine can cause tendonitis. In extremely rare cases, tendon rupture can occur. This risk increases with the use of certain antibiotics and kidney problems. Consult your doctor if you experience pain, stiffness, or swelling of the joints or tendons.
Taking Dexamethasone Krka can lead to a condition known as adrenal insufficiency. It 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 an accident, illness, or other special circumstances that physically stress the body occur during or after treatment with Dexamethasone Krka, and surgery is required (even dental surgery) or vaccination (especially with live virus vaccines), inform the treating doctor that you are taking steroids.
When performing suppression tests (detecting hormone levels in the blood), skin allergy tests, or bacterial infection tests, inform the person performing the tests that you are taking dexamethasone, as it may affect the test results.
During therapy, your doctor may also recommend reducing salt intake 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

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

• Anticoagulants (e.g., warfarin)
• Aspirin 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
• Diuretics (diuretic medicines)
• Amphotericin B administered by injection
• Phenytoin, carbamazepine, primidone (medicines used to treat epilepsy)
• Rifabutin, rifampicin (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 reduce nasal congestion)
• 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 assess adrenal cortex function)
• Sultopride used as a sedative
• Cyclosporine used to prevent transplant rejection
• Thalidomide used, among other things, to treat multiple myeloma
• Praziquantel (medicine used to treat parasitic infections)
• Live vaccinations
• Chloroquine, hydroxychloroquine, mefloquine (medicines used to treat malaria)
• Growth hormone
• Protirelin

Tell your doctor about all the 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)
• Aspirin or similar (non-steroidal anti-inflammatory drugs), e.g., indomethacin
• Medicines used to treat diabetes
• Medicines used to treat heart diseases
• Diuretics (diuretic medicines)
• 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, to treat multiple myeloma
• Live vaccinations
• Medicines that support muscle movement in myasthenia (e.g., neostigmine)
• Antibiotics, including erythromycin, fluoroquinolones

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

Dexamethasone Krka with food, drink, and alcohol

Dexamethasone should be taken during or after a meal to reduce stomach upset. 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, consult your doctor or pharmacist before taking this medicine.
Dexamethasone Krka should be used during pregnancy, especially during 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, do not stop taking it, but inform your doctor immediately that you are pregnant.
Corticosteroids may pass into breast milk. The risk to newborns or infants cannot be ruled out. The decision to continue or stop breastfeeding or continue or stop treatment with dexamethasone should be made considering the benefits of breastfeeding to the child and the benefits of dexamethasone treatment to the woman.

Driving and using machines

Do 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 intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take Dexamethasone Krka

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
Dexamethasone Krka is available in 4 mg, 8 mg, 20 mg, and 40 mg tablets. The tablets can be divided into halves, which provides additional strengths of 2 mg and 10 mg and allows the patient to swallow the tablet more easily.

Note that this is a high-dose medicinal product.

The recommended dose of Dexamethasone Krka should be used.

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 necessary. The dose should be determined based on individual patient response and disease severity. To minimize side effects, the lowest 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 response and disease severity.

• -Pemphigus:initial dose of 300 mg for three days, followed by dose reduction according to clinical needs.
• -Muscle inflammation:40 mg for 4 days in a cycle.
• Idiopathic thrombocytopenic purpura:40 mg for 4 days in cycles.
• Metastatic spinal cord compression:initial dose and duration of treatment depend on the cause and severity of the disease. In palliative care, very high doses may be used, up to 96 mg. For optimal dosing and to reduce the number of tablets, tablets of lower strength (4 mg and 8 mg) can be combined with tablets of higher strength (20 mg or 40 mg).

For the prevention and treatment of chemotherapy-induced nausea and vomiting, in combination with other antiemetic medicines: 8-20 mg (one 20 mg tablet or half of a 40 mg tablet) before chemotherapy, and then 4-16 mg per day on the second and third days of therapy.

• -Symptomatic treatment of 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 being taken. Dexamethasone administration should be carried out according to the dosage recommendations for dexamethasone described in the summary of product characteristics of the other medicine being taken, if included. If not, follow national or international protocols and dosage guidelines. The prescribing doctor should carefully evaluate the appropriate dose in each case, considering 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.

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

If you have taken too many tablets, consult your doctor or go to the nearest hospital immediately.

Missed dose of Dexamethasone Krka

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

Stopping treatment with Dexamethasone Krka

If treatment needs to be stopped, 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, recurrence of the original disease.
There may also be a corticosteroid withdrawal syndrome, including fever, muscle and joint pain, nasal congestion (rhinitis), weight loss, itching skin, and eye inflammation (conjunctivitis). If you stop taking the medicine too quickly and experience any of these symptoms, consult your doctor immediately.
If you have any further questions about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Dexamethasone Krka can cause side effects, although not everybody gets them.
Consult your doctor immediately if you experience serious mental health problems. These 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 memory loss,
• perceiving, seeing, or hearing things that do not exist; unusual or frightening thoughts that affect behavior or feeling lonely.

Consult your doctor immediately if you experience:

• 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 intestinal perforation, especially if you have existing intestinal disease.

This medicine may worsen existing heart disease. If you experience shortness of breath or swelling of the ankles, consult your doctor immediately.
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., 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, swelling, and weight gain, moon face (Cushing's syndrome), changes 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 severe stress, such as accidents, surgery, childbirth, or illness.
• Weight gain, negative protein and calcium balance, increased appetite, electrolyte imbalance, water retention, potassium loss, which can cause heart rhythm disturbances, increased need for antidiabetic medicines, occurrence 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, non-standard headaches with vision disturbances related to withdrawal of the medicine, seizures, and worsening of epilepsy, dizziness.
• Increased eye pressure, eye swelling, thinning of the eye's surface, worsening of existing viral, fungal, and bacterial 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, inflammation, and ulcers in the esophagus, stomach ulcers that can rupture and bleed, pancreatitis (which may manifest as back and abdominal pain), intestinal gas, esophageal candidiasis.
• 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).
• Bone density loss (osteoporosis), bone disease, tendonitis, tendon rupture, muscle wasting, myopathy, muscle weakness, premature closure of bone growth plates.
• Changes in sperm count and motility, impotence.
• Impaired response to vaccination and skin tests, slow wound healing, discomfort, malaise.
• There may also be 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 you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. 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
Reporting side effects will help gather more information on the safety of this 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. The expiry date refers to the last day of the month.
There are no special storage temperature requirements.
Store in the original packaging to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Dexamethasone Krka contains

• The active substance of the medicine is dexamethasone. Each tablet contains 20 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 package

White or almost white, round tablets with a score line and the inscription "20" on one side (thickness: 4.0-6.0 mm; diameter: 10.7-11.3 mm). The tablet can be divided into equal doses.
Blister pack OPA/Al/PVC/Al in a cardboard box.
Packaging: 20 tablets.
For more detailed information, consult 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:

TAD Pharma GmbH
Heinz-Lohmann-Str. 5
27472 Cuxhaven
Germany
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
Austrian export license number: 138042

Parallel import license number: 234/22 Date of approval of the leaflet: 01.06.2022

[Information about the trademark]