Dexamethasone Krka

Package Leaflet: Information for the User

Dexamethasone Krka, 20 mg, tablets

Dexamethasone Krka, 40 mg, tablets

Dexamethasone

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

• 1. What is Dexamethasone Krka and what is it used for
• 2. Before you take Dexamethasone Krka
• 3. How to take Dexamethasone Krka
• 4. Possible side effects
• 5. How to store Dexamethasone Krka
• 6. Contents of the pack 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, anti-allergic, and immunosuppressive properties.
Dexamethasone Krka is indicated for the treatment of rheumatic and autoimmune diseases (e.g., muscle inflammation), skin diseases (e.g., common blistering disease), 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 medicinal products, 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. Before you take 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 problems can be serious.
• They usually occur within a few days or weeks of starting treatment.
• 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 treatment.

You should talk to your doctor if you get any of these mental health problems while taking this medicine. This is especially important if you are depressed or have thoughts of self-harm. In a few cases, mental health problems have occurred when the dose of this medicine was being lowered or stopped.
Talk to your doctor before taking this 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 loss), especially in postmenopausal women,
• a history of muscle weakness caused by this or other steroid medicines,
• 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 loss),
• myasthenia gravis(a disease that causes muscle weakness),
• stomach or duodenal ulcer disease,
• psychiatric or mental illness that has worsened with the use of this type of medicine,
• seizures (a disease characterized by repeated losses of consciousness or convulsions),
• migraine,
• hypothyroidism,
• parasitic infections,
• tuberculosis, sepsis, or fungal eye infection,
• cerebral malaria,
• herpes virus (oral or genital herpes and 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 can cause a chromaffin tumor crisis, which can be fatal. Chromaffin tumor is a rare adrenal gland tumor. Crisis can manifest with the following symptoms: headaches, sweating, palpitations, and high blood pressure. If you experience any of these symptoms, you should contact your doctor immediately.
Corticosteroid therapy can weaken the body's ability to fight infection. This can sometimes lead to opportunistic infections (infections caused by microorganisms that do not normally cause infection). If you develop any infection while taking this medicine, you should contact your doctor immediately. This is especially important if you have symptoms 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 if you have had tuberculosis or have been in areas where infections with worms are common.
While taking this medicine, it is essential to avoid contact with people who have chickenpox, shingles, or measles. If you suspect you have come into contact with any of these diseases, you should contact 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.
You should talk to your doctor if you experience any of the following conditions: 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, you should contact your doctor.
Treatment with this medicine can cause chorioretinopathy, an eye disease that can impair vision or cause vision disturbances. This usually affects one eye.
Treatment 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. You should contact 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. This can 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 you experience an accident, illness, or other special circumstances that put a physical strain on your body during or after treatment with Dexamethasone Krka, you should inform your treating doctor that you are taking steroids.
If you are having suppression tests (which detect hormone levels in the blood), skin allergy tests, or bacterial infection tests, you should 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 the amount of salt in your diet and supplementing with potassium.
In elderly patients, some side effects of this medicine may be more severe, particularly bone loss (osteoporosis), high blood pressure, low potassium levels, diabetes, susceptibility to infections, and skin thinning. Your doctor will closely monitor you while you are taking this medicine.

Children and adolescents

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

Dexamethasone Krka and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.

• Blood-thinning medicines (e.g., warfarin)
• Aspirin or similar medicines (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)
• Amphotericin B given 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 help you sleep or reduce anxiety)
• Aminoglutethimide (a medicine used to treat cancer)
• Carbenoxolone (a medicine used to treat stomach ulcers)
• Ephedrine (a medicine used to reduce nasal congestion)
• Acetazolamide (a medicine used to treat glaucoma and epilepsy)
• Hydrocortisone, cortisone, and other corticosteroids
• Ketoconazole, itraconazole (a medicine used to treat fungal infections)
• Ritonavir (HIV)
• Antibiotics, including erythromycin, fluoroquinolones
• Medicines that help muscle movement in myasthenia (e.g., neostigmine)
• Cholestyramine (a medicine used to treat high cholesterol)
• Estrogen hormones, including birth control pills
• Tetracosactide (used in a test to assess adrenal function)
• Sultopride used as a sedative
• Cyclosporin used to prevent transplant rejection
• Thalidomide used in the treatment of multiple myeloma
• Praziquantel (a medicine used to treat parasitic infections)
• Live vaccines
• Chloroquine, hydroxychloroquine, mefloquine (medicines used to treat malaria)
• Growth hormone
• Protirelin

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, including those obtained without a prescription. You may be at risk of increased side effects if you take Dexamethasone Krka 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 medicines (non-steroidal anti-inflammatory drugs), e.g., indomethacin
• Medicines used to treat diabetes
• Medicines used to treat heart disease
• Diuretics (water tablets)
• Amphotericin B given by injection
• Acetazolamide (a medicine used to treat glaucoma and epilepsy)
• Tetracosactide (used in a test to assess adrenal function)
• 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 in the treatment of multiple myeloma
• Live vaccines
• Medicines that help muscle movement in myasthenia (e.g., neostigmine)
• Antibiotics, including erythromycin, fluoroquinolones

Before taking Dexamethasone Krka, read the patient information leaflet for all medicines you will be taking with Dexamethasone Krka to get information about those medicines. If you are taking thalidomide, lenalidomide, or pomalidomide, pay special attention to pregnancy testing and prevention.

Dexamethasone Krka with food, drink, and alcohol

Dexamethasone should be taken during or after meals 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 baby, ask your doctor or pharmacist for advice before taking this medicine.
Dexamethasone Krka should only be used during pregnancy, especially during the first trimester, if the doctor believes the benefits to the mother outweigh the potential risks to the fetus.
If you become pregnant while taking Dexamethasone Krka, do not stop taking it, but tell your doctor immediately that you are pregnant.
Corticosteroids can pass into breast milk. There is a risk to newborns or infants.
The decision to continue or stop breastfeeding or continue or stop treatment with dexamethasone should be made taking into account the benefits of breastfeeding to the baby and the benefits of dexamethasone treatment to the woman.

Driving and using machines

Do not drive, 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

If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Dexamethasone Krka

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
Dexamethasone Krka comes in tablet form, 4 mg, 8 mg, 20 mg, and 40 mg. 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.

It is recommended to use the lowest effective dose of Dexamethasone Krka.

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 response and disease severity. To minimize side effects, the lowest effective dose should be used.

If your doctor does not prescribe 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.

• Bullous pemphigoid:initial dose 300 mg for three days, followed by dose reduction as clinically indicated.
• 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, 4 mg and 8 mg tablets can be combined with 20 mg or 40 mg tablets.
• Prevention and treatment of chemotherapy-induced emetic nausea and vomiting, together with other antiemetic medicines:8-20 mg (one 20 mg tablet or half a 40 mg tablet) before chemotherapy, and then 4-16 mg per day on the second and third days of therapy.
• 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 medicinal product being taken, if included. If not, follow national or international protocols and dosing guidelines. The prescribing doctor should carefully evaluate 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 minimize the suppressive effect on the adrenal cortex.

Children and adolescents

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

Overdose of Dexamethasone Krka

If you have taken too many tablets, contact 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 you need to stop treatment, 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 can also cause a corticosteroid withdrawal syndrome, which includes fever, muscle and joint pain, nasal inflammation (rhinitis), weight loss, itching skin, 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 questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Dexamethasone Krka can cause side effects, although not everybody gets them.
Tell your doctor immediately if you experience serious mental health problems. These can occur in about 5 in 100 people taking medicines like dexamethasone. These problems include:

• feeling depressed, including thinking about suicide,
• feeling high (mania) or mood swings,
• feeling anxious, insomnia, difficulty thinking, or feeling confused and losing memory,
• feeling, seeing, or hearing things that do not exist; unusual or frightening thoughts that affect behavior or make you feel isolated.

Tell your doctor immediately if you experience:

• 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 a perforated intestine, especially if you have existing intestinal disease.

This medicine can worsen existing heart disease. If you experience shortness of breath or swelling of the ankles, you should contact 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 can cause rash, throat swelling, or tongue swelling, and in severe cases, difficulty breathing or dizziness).
• Disorders of hormone regulation in the body, swelling, and weight gain, moon face (Cushing's syndrome), change in the body's ability to respond to stress and trauma, surgical procedures, childbirth, or illness, the body may not be able to respond normally to severe stress, such as accidents, surgery, childbirth, or illness, growth retardation in children and adolescents, irregular menstrual cycle or loss of menstrual cycle (amenorrhea), excessive hair growth (hirsutism), especially in women.
• 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, onset 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 cornea, worsening of existing viral, fungal, and bacterial eye infections, exophthalmos, cataracts, vision disturbances, loss of vision, blurred vision.
• 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).
• Hiccups.
• Nausea, vomiting, stomach discomfort, and abdominal bloating, esophageal inflammation, stomach ulcers, which can perforate and bleed, pancreatitis (which can cause 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 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 loss (osteoporosis), which can increase the risk of fractures, bone disease, 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 can also cause a corticosteroid withdrawal syndrome, which includes fever, muscle and joint pain, nasal inflammation (rhinitis), weight loss, painful and itchy skin lumps, eye inflammation (conjunctivitis).

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects 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
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide 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 after "EXP". The expiry date refers to the last day of the month stated.
The batch number is stated on the packaging after "Lot".
There are no special storage instructions for the medicinal product.
Store in the original packaging to protect from light and moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Dexamethasone Krka contains

• The active substance is dexamethasone. Dexamethasone Krka, 20 mg, tablets Each tablet contains 20 mg of dexamethasone. Dexamethasone Krka, 40 mg, tablets Each tablet contains 40 mg of dexamethasone.
• The other ingredients are lactose monohydrate, maize starch, colloidal anhydrous silica, magnesium stearate. See section 2 "Dexamethasone Krka contains lactose".

What Dexamethasone Krka looks like and contents of the pack

20 mg: White or almost white, round tablets with a score line and engraved with "20" on one side (thickness: 4.0-6.0 mm; diameter: 10.7-11.3 mm). The tablet can be divided into equal doses.
40 mg: White or almost white, oval tablets with a score line on both sides (thickness: 6.0-8.0 mm; length: 18.7-19.3 mm). The tablet can be divided into equal doses.
Blister pack OPA/Aluminum/PVC/Aluminum in a cardboard box.
Pack sizes: 10, 20, 30, 50, 60, 100, 10x1, 20x1, 30x1, 50x1, 60x1, and 100x1 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
To obtain more detailed information on the names of the medicine in other European Economic Area countries, contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500
Date of last revision of the leaflet:25.04.2022