Dexamethasone Krka

Leaflet accompanying the packaging: information for the user

Dexamethasone Krka, 20 mg, tablets

Dexamethasone Krka, 40 mg, tablets

Dexamethasone

You should carefully read the contents of the leaflet before using 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.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your 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 using Dexamethasone Krka
• 3. How to use 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. The described medicine has anti-inflammatory, analgesic, and anti-allergic as well as 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), for the treatment of symptomatic multiple myeloma, acute lymphoblastic leukemia, Hodgkin's disease, and non-Hodgkin's lymphoma in combination with other medicinal products, for the treatment of metastatic spinal cord compression (nerve compression in the spinal cord caused by a tumor), for the prevention and treatment of nausea and vomiting caused by chemotherapy, together with antiemetic drugs.

2. Important information before using Dexamethasone Krka

Dexamethasone Krka should not be used

• in case of hypersensitivity to dexamethasone or any of the other ingredients of this medicine (listed in section 6);
• in case of a 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

Before using Dexamethasone Krka, you should consult a doctor or pharmacist:

• 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 any of these illnesses have occurred in close relatives.

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 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.

You should consult a 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 after the dose was reduced or treatment was stopped.
You should consult a doctor before using the 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 mass loss), especially in postmenopausal women,
• a history of muscle weakness caused by this or another steroid medicine,
• glaucoma (excessive growth of 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 causing muscle weakness),
• bladder or stomach disease,
• 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 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 due to blockage of blood vessels by clots (thromboembolic disease),
• corneal ulcers and corneal injuries.

Taking this medicine can cause a chromaffin tumor breakthrough, which can be fatal. A chromaffin tumor is a rare adrenal gland tumor. A breakthrough 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 rarely 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 a 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 you suspect potential contact with any of these diseases, you should consult your doctor immediately. You should also inform your doctor about any infectious diseases you have had, such as measles or chickenpox, and any 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, 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 impairs vision or causes vision disturbances. This usually affects one eye.
Therapy with this medicine can cause tendon inflammation. In extremely rare cases, tendon rupture can occur. This risk increases in case of treatment with 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 disease called 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 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.
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 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 using this medicine may be more severe, particularly bone density 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 the medicine.

Children and adolescents

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

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 disease
• Diuretic medicines (diuretics)
• 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 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

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 if you take 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 disease
• Diuretic medicines (diuretics)
• Amphotericin B given 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 starting treatment with 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, drinks, 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 ask your doctor or pharmacist for advice 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, you should not stop taking it, but immediately inform your doctor that you are pregnant.
Corticosteroids can 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

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to use Dexamethasone Krka

This medicine should always be used exactly as your doctor has told you. If you are not sure, you should ask your doctor or pharmacist.
Dexamethasone Krka comes 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 use of Dexamethasone Krka is recommended at the lowest effective dose.

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

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

The dosing recommendations listed below are for informational purposes only.

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

• Bullous pemphigoid: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 depending 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 syndrome, 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 recommendations for dexamethasone described in the summary of product characteristics of the other medicine being taken, if included. If not, you should 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 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 suppressive effect on the adrenal cortex.

Children and adolescents

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

Using a higher dose of Dexamethasone Krka than recommended

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

Missing a dose of Dexamethasone Krka

In case of missing a dose, you should take it as soon as possible. If it is almost time for the next dose, you should take only one dose. You 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, you should follow your doctor's recommendations. 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 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 using this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should immediately inform your doctor about serious mental health problems. They 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, trouble thinking, or feeling confused and disoriented,
• feeling, seeing, or hearing things that do not exist; unusual or frightening thoughts that affect behavior or feelings of loneliness.

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 they may indicate adrenal insufficiency;
• sudden abdominal pain, tenderness, nausea, vomiting, fever, and blood in the stool, as they may be symptoms of intestinal perforation, especially in 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 and fungal infections, e.g., thrush, recurrence of tuberculosis, or other infections, e.g., eye infections previously diagnosed.
• 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, swelling and weight gain, moon face (Cushing's syndrome), change in effective hormone secretion in response to stress and trauma, surgical procedures, childbirth, or illness, and the body may not be able to respond properly to severe stress, such as accidents, surgery, childbirth, or illness, growth retardation in children and adolescents, irregular menstrual cycle or cessation of menstruation (amenorrhea), excessive hair growth (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.
• 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, stomach discomfort, and abdominal bloating, esophageal inflammation, stomach ulcers, which can rupture and bleed, pancreatitis (which may manifest as back and abdominal pain), intestinal gas, thrush of the esophagus.
• Thin, fragile skin, unusual skin spots, bruising, redness, and skin inflammation, 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 increased risk of fractures (osteoporosis), bone disease, tendon inflammation, 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.
• It may also cause a corticosteroid withdrawal syndrome, which includes fever, muscle and joint pain, nasal congestion (rhinitis), weight loss, painful and itchy skin lesions, and eye inflammation (conjunctivitis).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. 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,
Phone: +48 22 49 21 301,
Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
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 after the term "EXP". The expiry date refers to the last day of the month stated.
The batch number is stated on the packaging after the term "Lot".
There are no special storage instructions for the medicinal product.
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. 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 of the medicine are lactose monohydrate, cornstarch, colloidal silicon dioxide, 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 about the names of the medicine in other European Economic Area countries, you should 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