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Dexamethasone 4 mg. 20 tablets

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What Dexamethasone Krka is and what it is used for
Dexamethasone Krka is a synthetic glucocorticoid. Glucocorticoids are hormones released by the cortex of the adrenal glands. The drug has anti-inflammatory, analgesic and anti-allergic effects and suppresses the immune system.

Dexamethasone Krka is recommended for the treatment of rheumatic and autoimmune diseases (e.g. systemic lupus erythematosus, rheumatoid arthritis, juvenile idiopathic arthritis, polyarteritis nodosa), diseases of the respiratory tract (e.g. bronchial asthma, croup), skin (e.g. erythroderma. pemphigus vulgaris), tuberculous meningitis - only in combination with anti-infective therapy, blood diseases (for example, idiopathic thrombocytopenic purpura in adults), cerebral edema, symptomatic multiple myeloma, acute lymphoblastic leukemia, Hodgkin's disease and non-Hodgkin's lymphoma in combination with other drugs, palliative treatment of malignant diseases, prevention and treatment of nausea and vomiting caused by chemotherapy and prevention and treatment of vomiting after surgery, within the framework of antiemetic treatment.

Dexamethasone Krka 4 mg tablets
Dexamethasone Krka is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adult patients and adolescents (over 12 years of age and with a body weight of at least 40 kg) who have difficulty breathing and require oxygen therapy.

2. What you need to know 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 an infection that affects the whole body (unless you are undergoing treatment), if you have a stomach or duodenal ulcer, if you are about to be vaccinated with live vaccines.
Warnings and precautions
If you are a patient on therapy for COVID-19, you should not stop taking other medications that contain corticosteroids unless your doctor specifically tells you to.

Talk to your doctor, pharmacist or nurse before taking Dexamethasone Krka:
if you have ever had major depression or manic depression (bipolar disorder). This also includes a history of depression before or while taking steroid drugs such as dexamethasone.
if any of your close relatives have had these diseases.
Mental health problems can occur while taking steroids such as Dexamethasone Krka.

These violations can be serious.

They usually start within a few days or weeks of starting treatment. Their occurrence is more likely at high doses.

Most of these problems go away if the dose is reduced or the treatment is stopped. However, when such problems occur, treatment may be necessary.

Talk to your doctor if you (or someone taking this medicine) have any signs of mental health problems. This is especially important if you are depressed or have suicidal thoughts. In a few cases, psychiatric problems occurred when doses were reduced or discontinued.

Talk to your doctor before taking this medicine:
if you have kidney or liver problems (liver cirrhosis or chronic liver failure),
if you have or are suspected of having pheochromocytoma (a tumor of the adrenal glands), if you have high blood pressure, heart disease or have recently had a heart attack (there have been reports of heart muscle tearing), if you have diabetes or a family history of diabetes,
if you have osteoporosis (thinning of the bones), especially if you are a menopausal woman,
if you have experienced muscle weakness with this or other steroids in the past,
if you have glaucoma (increased intraocular pressure) or a family history of glaucoma, cataract (clouding of the lens in the eye, resulting in reduced vision),
if you have myasthenia gravis (a disease that causes muscle weakness),
if you have bowel disorders or a stomach (peptic) ulcer,
if you have mental problems or have had a mental illness that is made worse by this type of medicine,
if you have epilepsy (a condition where you have repeated seizures or convulsions), if you have migraines,
if you have reduced thyroid function, if you have a parasitic infection,
if you have tuberculosis, septicemia or a fungal infection of the eye, if you have cerebral malaria,
if you have herpes (herpes of the lips (labial) or genitals (genital) or of the eye (ocular herpes simplex) due to a possible corneal break),
if you have asthma,
if you are being treated for blockage of blood vessels by blood clots (thromboembolism),
if you have corneal ulcers or injuries.
In pheochromocytoma, treatment with this drug can cause a crisis that can be fatal. Pheochromocytoma is a rare tumor of the adrenal glands. The crisis can occur with the following symptoms: headache, sweating, palpitations and increased blood pressure (hypertension). Contact your doctor immediately if it stings
Children
If this medicine is taken by a child, it is important that the doctor monitors the child's growth and development at frequent intervals. Dexamethasone should not be used routinely in premature infants with respiratory problems.

Other medicines and Dexamethasone Krka
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines:
Anticoagulant medicines that thin the blood (eg warfarin)
Acetylsalicylic acid or other similar medicines (non-steroidal anti-inflammatory drugs), eg indomethacin
Medicines used to treat diabetes
Medicines used to treat high blood pressure
Medicines used to treat heart disease
Diuretics (water tablets)
Amphotericin B for injection
Phenytoin, carbamazepine, primidone (medicines for epilepsy)
Rifabutin, rifampicin, isoniazid (antibiotics used to treat tuberculosis)
Antacids - especially those containing magnesium trisilicate Barbiturates (medicines used to help sleep and reduce anxiety)
Aminoglutethimide (anticancer treatment) Carbenoxolone (used to treat stomach ulcers) Ephedrine (used to unblock the nose) Acetazolamide (used for glaucoma and epilepsy) Hydrocortisone, cortisone and other corticosteroids Ketoconazole, inraconazole (for fungal infections) Ritonavir (for HIV)
Antibiotics, including erythromycin, fluoroquinolones
Medicines that help muscle movements in myasthenia gravis (eg neostigmine)
Cholestyramine (for high cholesterol levels) Estrogen hormones, including birth control pills Tetracosactide, used in adrenal function tests Sultopride, used to calm emotions
Cyclosporine, used to prevent rejection after a transplant Thalidomide, used for example for multiple myeloma Praziquantel, prescribed for certain worm infections Vaccination with live vaccines
Chloroquine, hydroxychloroquine and mefloquine (for malaria)
Somatotropin
Protirelin
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. You may be at increased risk of serious side effects if you take dexamethasone together with these medicines.
Some medicines may increase the effect of Dexamethasone Krka and your doctor may want to monitor you closely if you are taking such medicines (including some HIV medicines: ritonavir, cobicistat).

Acetylsalicylic acid or other similar medicines (non-steroidal anti-inflammatory drugs), eg indomethacin
Medicines used to treat diabetes
Medicines used to treat heart disease
Diuretics (water tablets)
Amphotericin B for injection
Acetazolamide (used for glaucoma and epilepsy)
Tetracosactide used in the adrenal function test
Carbenoxolone (used to treat stomach ulcers)
Chloroquine, hydroxychloroquine and mefloquine (for malaria)
Medicines used to treat high blood pressure
Thalidomide, used for example in multiple myeloma
Vaccination with live vaccines
Medicines that help muscle movements in myasthenia gravis (eg neostigmine)
Antibiotics, including fluoroquinolones
You should read the leaflets of all medicinal products to be taken in combination with Dexamethasone Krka for information related to these medicines before starting treatment with Dexamethasone Krka. When thalidomide, lenalidomide, or pomalidomide is used, special attention should be paid to pregnancy testing and prevention requirements.

Dexamethasone Krka with food, drink and alcohol
Dexamethasone should be taken with or after a meal to minimize gastrointestinal irritation. Drinks containing alcohol or caffeine should be avoided. Eating small portions frequently and possibly taking antacids at your doctor's discretion is recommended.

Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine. Dexamethasone Krka should be prescribed during pregnancy and especially in the first trimester of pregnancy only if the benefit outweighs the risk to the mother and the child. If you become pregnant while taking the medicine, do not stop using Dexamethasone Krka, but immediately tell your doctor that you are pregnant.

Corticosteroids can pass into breast milk. A risk to newborns/infants cannot be excluded. A decision should be made whether to continue/discontinue breast-feeding or to continue/discontinue dexamethasone therapy, taking into account the benefit of breast-feeding for the child and the benefit of dexamethasone therapy for the woman.

Driving and using machines
Do not drive, use tools or machines, or perform any high-risk activities if side effects such as confusion, hallucinations occur
Cerebral edema:
Initial dose and duration of treatment, depending on the cause and severity - 6-16 mg (up to 24 mg) daily, orally, divided into 3-4 separate doses.

Acute asthma:
Adults: 16 mg daily, for two days.

Children: 0.6 mg/kg body weight, for one or two days,

Croup:
Children: 0.15 mg/kg - 0.6 mg/kg in a single dose.

Acute skin diseases:
Depending on the nature and degree of the disease - daily doses of 8-40 mg, in some cases up to 100 mg, which should be subsequently reduced according to clinical need.

Active phase of rheumatic systemic diseases:
systemic lupus erythematosus -6-16 mg daily.

Active rheumatoid arthritis with a severe progressive course:
rapidly occurring destructive forms - 12-16 mg daily; with extra-articular manifestations - 6-12 mg daily. Idnopathic thrombocytopenic purpura: 40 mg daily, for 4 days, in cycles.

Tuberculous meningitis:
Patients with stage II or III disease were treated intravenously for four weeks (0.4 mg per kilogram per day in Week 1, 0.3 mg per kilogram per day in Week 2, 0.2 mg per kilogram per day in Week 3 and 0.1 mg per kilogram per day in Week 4), and then orally, for four weeks, starting with a total dose of 4 mg per day, which is reduced by 1 mg every week. Patients with stage I disease were treated intravenously for two weeks (0.3 mg per kilogram per day in Week 1 and 0.2 mg per kilogram per day in Week 2) and then orally for four weeks (0.1 mg per kilogram per day in Week 3, then with a total dose of 3 mg per day, which is reduced by 1 mg every week).

Palliative treatment of malignant diseases:
Initial dose and duration of treatment, depending on the cause and severity - 3-20 mg daily. Very high doses up to 96 mg can also be used for palliative treatment. A combination of lower-dose (4 and 8 mg) and higher-dose (20 mg or 40 mg) concentrations can be used for optimal dosing and to reduce the number of tablets.

Prevention and treatment of vomiting caused by cytostatics, emetogenic chemotherapy, within antiemetic treatment:
8-20 mg dexamethasone before chemotherapy treatment, then 4-16 mg daily on Day 2 and Day 3.

Prevention and treatment of postoperative vomiting, within the framework of antiemetic treatment:
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 medicinal products:
the usual dose is 40 mg or 20 mg once daily.

The dose and frequency of administration vary, depending on the therapeutic protocol and concomitant treatment(s). Administration of dexamethasone should follow the directions for administration of dexamethasone when described in the SmPC of the concomitant treatment(s). Otherwise, local or international treatment protocols and guidelines should be followed. Prescribers should carefully consider which dose of dexamethasone to use, taking into account the condition and disease status of the patient.

Long-term treatment
In the long-term treatment of a number of conditions, after initial therapy, glucocorticoid treatment should be switched from dexamethasone to prednisone/prednisolone in order to reduce the suppression of adrenal cortex function.

Dexamethasone Krka 4 mg tablets
For treatment of Covid-19: Adult patients:
6 mg once daily for up to 10 days.

Use in adolescents:
Pediatric patients (adolescents over 12 years of age and weighing at least 40 kg) are recommended to take a dose of 6 mg once daily for up to 10 days.

Use in children
If this medicine is taken by a child, it is important that the doctor monitors the child's growth and development at frequent intervals.

If you have taken more than the required dose of Dexamethasone Krka
If you have taken more than the required dose of the medicine, contact a doctor or hospital immediately.

If you forget to take Dexamethasone Krka
If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for a missed tablet.

If you have stopped taking Dexamethasone Krka
If treatment must be discontinued, follow your doctor's advice. He may tell you to gradually reduce the amount of medicine you take until you stop taking it completely. Symptoms that have been reported when treatment is stopped too quickly have included low blood pressure and, in some cases, relapse of the disease for which the treatment was prescribed.

It is also possible to experience a "withdrawal syndrome", which includes fever, muscle and joint pain, inflammation of the lining of the nose (rhinitis), weight loss, itchy skin and inflammation of the eyes (conjunctivitis). If you stop treatment prematurely and if any of the symptoms mentioned appear, you should speak up
Weight gain, loss of balance between proteins and calcium, increased appetite, impaired salt balance, water retention in the body, loss of potassium that can cause irregular heart rhythm, increased need for diabetes medication, manifestation of hidden diabetes , high levels of cholesterol and triglycerides in the blood (hypercholesterolemia and hypertriglyceridemia).
Sudden changes in mood, worsening of schizophrenia (mental disorder), depression, insomnia.
Severe unusual headache with visual disturbances associated with discontinuation of treatment, seizures and worsening of epilepsy, dizziness.
Increased pressure in the eye, swelling of the eye, thinning of the eye membranes, increased viral, fungal and bacterial eye infections, worsening of symptoms related to corneal ulcers, worsening of existing eye infections, bulging eyeballs, cataracts, visual disturbances, loss of vision, blurred vision.
Congestive heart failure in predisposed individuals, tearing of the heart muscle after a recent heart attack, cardiac decompensation.
High blood pressure, blood clots; formation of blood clots that can block blood vessels, for example in the legs or lungs (thromboembolic complications). Hiccups.
Nausea, vomiting, stomach discomfort and bloating, inflammation and ulceration of the esophagus, peptic ulcers that can open and bleed, inflammation of the pancreas (which can manifest as back and abdominal pain), flatulence, esophageal candidiasis .
Thinned delicate skin, abnormal skin scarring, bruising, skin redness and inflammation, stretch marks, visibly dilated capillaries, acne, increased sweating, skin rashes, swelling, thinning hair, abnormal fat deposits, excessive hair growth, retention of water in the body, pigment disorders, weakened capillaries that can easily burst, manifested as bleeding under the skin (increased capillary fragility), irritation of the skin around the mouth (perioral dermatitis).
Thinning of bones with increased risk of fractures (osteoporosis), bone necrosis, tendinitis, torn tendons, loss of muscle mass, myopathy, muscle weakness, early cessation of bone growth (premature closure of the epiphysis). Changes in the number and movement of sperm, impotence. Impaired response to vaccinations and skin tests, slow wound healing, discomfort, malaise.
A "withdrawal syndrome" can also occur, which includes fever, muscle and joint pain, inflammation of the lining of the nose (rhinitis), weight loss, itchy and painful nodules on the skin, and inflammation of the eyes (conjunctivitis).
5. How to store Dexamethasone Krka
Keep out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP/EXP. The expiry date corresponds to the last day of the month stated.

This medicine does not require special temperature storage conditions. Store in the original package to protect from light and moisture.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional 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, pregelatinized maize starch, colloidal anhydrous silica and magnesium stearate (E470b). See point 2 "Dexamethasone Krka contains lactose".
What Dexamethasone Krkai looks like and what the package contains
4 mg tablets: white or almost white, round tablets with bevelled edges and 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 tablets: white or off-white oval tablets, scored on one side (thickness: 3.5-5.5 mm; length: 8.7-9.3 mm). The tablet can be divided into two equal doses.

Dexamethasone Krka 4 mg tablets are available in boxes containing 10, 20, 28, 30, 50, 56, 60, 100, 10 x 1, 20 x 1, 28 x 1, 30 x 1, 50 x 1, 56 x 1 , 60 x 1 and 100 x 1 tablets in blisters. Dexamethasone Krka 8 mg tablets are available in boxes containing 10, 20, 30, 50, 60, 100, 10 x 1, 20 x 1, 30 x 1, 50 x 1, 60 x 1 and 100 x 1 tablets in blisters. Not all types of packaging can be put on sale.

 

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