Dexamethasone Krka

Package Leaflet: Information for the User

Dexamethasone Krka, 4 mg, tablets

Dexamethasone Krka, 8 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, antiallergic, and immunosuppressive properties.
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, pemphigus vulgaris), tuberculous meningitis exclusively in combination with anti-infective therapy, blood diseases (e.g., idiopathic thrombocytopenic purpura in adults), cerebral 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 in combination with antiemetic drugs.
Dexamethasone Krka, 4 mg, tablets
The medicine is used to treat COVID-19 in adult patients and adolescents (12 years of age and older, weighing at least 40 kg) with breathing difficulties and requiring oxygen therapy.

2. Before you take Dexamethasone Krka

When not to take Dexamethasone Krka

Warnings and precautions

If you are being treated for COVID-19, do not stop taking any other steroid medicines unless your doctor tells you to.
Before starting to take Dexamethasone Krka, discuss this with your doctor, pharmacist, or nurse:

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 problems occur, they may need treatment.

You should talk to your doctor if you experience any of the following problems while taking this medicine: mental health problems, especially if you have depression or have had depression before, or if you have had mental health problems when taking steroid medicines like dexamethasone. It is particularly important if you are depressed or have had depression before, or if you have had mental health problems when taking steroid medicines like dexamethasone. If you experience any of the following problems, you should talk to your doctor: kidney or liver disease (liver cirrhosis or chronic liver failure), adrenal gland tumor (pheochromocytoma) or suspected adrenal gland tumor, high blood pressure, heart disease, or recent heart attack (there have been cases of heart rupture), diabetes or a history of diabetes in your 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 your family (clouding of the lens in the eye leading to vision loss), myasthenia gravis (a disease that causes muscle weakness), gastrointestinal disease or stomach ulcers, psychiatric problems or a history of psychiatric problems that have worsened when taking this type of medicine, epilepsy (a disease characterized by recurring losses of consciousness or seizures), migraine, hypothyroidism, parasitic infections, tuberculosis, sepsis, or fungal eye infections, cerebral malaria, herpes virus (oral or genital herpes, as well as eye herpes, due to the risk of corneal perforation), asthma, ongoing anticoagulant therapy (a disease that blocks blood vessels), corneal ulcers, and corneal injuries.

Taking this medicine can cause a tumor of the adrenal gland to rupture, which can be fatal. An adrenal gland tumor is a rare tumor of the adrenal gland. A rupture can manifest with the following symptoms: headache, sweating, palpitations, and high blood pressure. If you experience any of these symptoms, you should contact your doctor immediately.
Treatment with corticosteroids can weaken the body's ability to fight infection. This can sometimes lead to infections caused by microorganisms that do not normally cause infection (called opportunistic infections). 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 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 can worsen vision or cause vision disturbances. It 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 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. It 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 you have an accident, illness, or other special circumstances that put a physical strain on your body while taking Dexamethasone Krka, or if you need surgery (even dental surgery) or vaccination (especially with live virus vaccines), you should inform the treating doctor that you are taking steroids.
If you are undergoing suppression tests (detecting hormone levels in the blood), skin allergy tests, or tests for bacterial infections, you should inform the person performing the tests that you are taking dexamethasone, as it may affect the test results.
During treatment, 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 loss (osteoporosis), high blood pressure, low potassium levels, diabetes, 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 that the doctor closely monitors the child's growth and development at short intervals. Dexamethasone should not be used routinely in premature infants with respiratory distress syndrome.

Dexamethasone Krka and other medicines

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

• Anticoagulants (e.g., warfarin)
• Acetylsalicylic acid or similar (non-steroidal anti-inflammatory drugs), e.g., indomethacin
• Medicines used to treat diabetes
• Medicines used to treat high blood pressure
• Medicines used to treat heart disease
• Diuretics (diuretic medicines)
• Amphotericin B given by injection
• Phenytoin, carbamazepine, primidone (medicines used to treat epilepsy)
• Rifabutin, rifampicin, isoniazid (antibiotics 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 enhance muscle movement in myasthenia (e.g., neostigmine)
• Cholestyramine (a 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 used to treat parasitic infections
• Live vaccines
• Chloroquine, hydroxychloroquine, mefloquine (medicines used to treat malaria)
• Growth hormone
• Protirelin

Tell your doctor about all the medicines you are taking now or have taken recently, 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 disease
• Diuretics (diuretic medicines)
• Amphotericin B given by injection
• Acetazolamide (a medicine used to treat glaucoma and epilepsy)
• Tetracosactide used in the test to assess adrenal cortex 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, among other things, to treat multiple myeloma
• Live vaccines
• Medicines that enhance muscle movement in myasthenia (e.g., neostigmine)
• Antibiotics, including erythromycin, fluoroquinolones

Before taking Dexamethasone Krka, read the patient information leaflets for all the medicines you will be taking in combination with Dexamethasone Krka to get information about those medicines.

When using 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 be used during pregnancy, especially during the first trimester, only if the doctor believes that 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 inform your doctor immediately that you are pregnant.
Corticosteroids may pass into breast milk. There is a risk to newborns or infants.
The decision to continue or stop breastfeeding or to continue or stop treatment with dexamethasone should be made considering the benefits of breastfeeding to the baby and the benefits of dexamethasone treatment to the woman.

Driving and using machines

You should 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 that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Dexamethasone Krka

Always take Dexamethasone Krka exactly as your doctor has told you. Your doctor will decide how long you should take dexamethasone. If you are unsure, ask 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 two equal doses, 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 your 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.

• Cerebral edema:initial dose and duration of treatment depending on the cause and severity of the disease: 6-16 mg per day (up to 24 mg) orally, divided into 3-4 single doses.
• Acute asthma:adults: 16 mg per day for two days; children: 0.6 mg per kilogram of body weight for one to two days.
• Croup:children: 0.15-0.6 mg/kg 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 dose reduction according to clinical needs.
• Active phase of systemic rheumatic diseases:systemic lupus erythematosus 6-16 mg per day.
• – Active rheumatoid arthritis with a severe, progressive course:rapidly progressive destructive form of the disease 12-16 mg per day, with extra-articular symptoms 6-12 mg per day.
• Idiopathic thrombocytopenic purpura:40 mg for 4 days in cycles.
• Tuberculous meningitis:patients with stage II or III disease receive intravenous treatment for four weeks (0.4 mg per kilogram of body weight per day in the first week, 0.3 mg per kilogram of body weight per day in the second week, 0.2 mg per kilogram of body weight per day in the third week, and 0.1 mg per kilogram of body weight per day in the fourth week), 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 stage I disease receive intravenous treatment for two weeks (0.3 mg per kilogram of body weight per day in the first week and 0.2 mg per kilogram of body weight per day in the second week), 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 cause and severity of the disease: 3-20 mg per day. In palliative care, very high doses can also 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 emesis, in combination 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, in combination 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 according to the dosing recommendations for dexamethasone described in the summary of product characteristics of the other medicine taken, if provided. If not, national or international protocols and dosing guidelines should be followed. 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.
Dexamethasone Krka, 4 mg, tablets

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

Use in children and adolescents

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

Overdose

In case of overdose, contact your doctor or go to the nearest hospital immediately.

Missed dose

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

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 recurrence of the original disease.
There may also be 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 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 problems may occur in about 5 in 100 people taking medicines like dexamethasone. These problems include:

• feeling depressed, including thinking about suicide,
• feeling high (mania) or having mood swings,
• feeling anxious, sleep disturbances, problems with thinking, or feeling confused and losing memory,
• hearing, seeing, or feeling things that are not real; unusual or frightening thoughts that may affect behavior or make you feel isolated.

Tell your doctor immediately if you experience:

• severe stomach pain, nausea, vomiting, diarrhea, extreme muscle weakness, and fatigue, very low blood pressure, weight loss, and fever, as these may be signs of adrenal insufficiency,
• sudden stomach pain, tenderness, nausea, vomiting, fever, and blood in the stool, as these may be signs of a perforated intestine, especially if you have a pre-existing intestinal disease.

This medicine may 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 previously diagnosed.
• Decreased or increased white blood cell count, blood clotting disorders.
• Allergic reactions to the medicine, including severe, life-threatening allergic reactions (which can cause 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 the body's response to stress and trauma, surgical procedures, childbirth, or illness, and 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 cessation of menstruation, excessive hair growth (especially in women).
• Weight gain, negative protein and calcium balance, increased appetite, electrolyte imbalance, water retention, potassium loss, which 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, worsening of corneal ulcers, worsening of existing eye infections, exophthalmos, cataracts, vision disturbances, loss of vision, blurred vision.
• Congestive heart failure in susceptible patients, heart rupture after a recent heart attack, heart failure.
• High blood pressure, blood clots, formation of blood clots that can block blood vessels, e.g., in the legs or lungs (thromboembolic complications).
• Hiccups.
• Nausea, vomiting, stomach discomfort, and bloating, esophageal inflammation and ulcers, stomach ulcers that can perforate and bleed, pancreatitis (which can cause back and stomach 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, blood vessel fragility (increased risk of bruising and bleeding under the skin).
• Bone loss with increased risk of fractures (osteoporosis), bone death, 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, and general feeling of being unwell.
• There may also be a corticosteroid withdrawal syndrome, which includes 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 those not listed in this leaflet, you should tell your doctor or pharmacist. You can also report side effects 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
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 the medicine 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 that month.
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.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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, 4 mg, tablets Each tablet contains 4 mg of dexamethasone. Dexamethasone Krka, 8 mg, tablets Each tablet contains 8 mg of dexamethasone.
• The other ingredients 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

4 mg: White or almost white, round tablets with a score line on one side (thickness: 2.5-3.5 mm; diameter: 5.7-6.3 mm). The tablet can be divided into two equal doses.
8 mg: White or almost white, oval tablets with a score line on one side (thickness: 3.5-5.5 mm; length: 8.7-9.3 mm). The tablet can be divided into two equal doses.
4 mg tablets:
OPA/Aluminum/PVC/Aluminum blister pack in a cardboard box.
Pack sizes: 10, 20, 28, 30, 50, 56, 60, 100, 10x1, 20x1, 28x1, 30x1, 50x1, 56x1, 60x1, and 100x1 tablets.
8 mg tablets:
OPA/Aluminum/PVC/Aluminum blister pack 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 EU member states, please 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