4 mg tablets
dexamethasone
1. What Dexamethasone Krka is and what it is used for
Dexamethasone Krka belongs to a group of medicines called glucocorticoids. This medicine reduces inflammation, pain, and symptoms of allergic reactions and suppresses the immune system.
Dexamethasone Krka is used to treat rheumatic and autoimmune diseases (eg systemic lupus erythematosus ( inflammatory rheumatic disease), rheumatoid arthritis, rheumatoid arthritis, polyarteritis nodosa ( inflammation of the body’s small blood vessels)), respiratory diseases (eg asthma, croup), skin (eg erythroderma( redness of large parts of the skin surface), pemphigus Vulgaris ( autoimmune skin disease)), infectious diseases ( meningeal tuberculosis ), blood diseases (eg idiopathic thrombocytopenic purpura (an autoimmune blood disease) in adults), swelling of the brain (cerebral edema), treatment of cancer (eg multiple myeloma, acute lymphocytic leukemia, Hodgkin’s disease and Non-Hodgkin’s lymphoma in combination with other drugs), symptomatic treatment of cancer, prevention and treatment of nausea and vomiting triggered by chemotherapy as well as prevention and treatment of vomiting after surgery.
Dexamethasone contained in Dexamethasone Krka may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Dexamethasone Krka
Do not use 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 (if you do not receive the treatment).
- if you have stomach ulcers or ulcers on the duodenum one.
- if you are going to be vaccinated with a live vaccine.
Warnings and cautions
Talk to your doctor or pharmacist before taking Dexamethasone Krka:
- if you have ever had severe depression or manic depression ( bipolar disorder ). This includes having had depression before or while taking steroid medicines such as dexamethasone.
- if someone in your immediate family has had these diseases.
Take special care and talk to your doctor about:
- you have kidney or liver problems (cirrhosis of the liver or chronic liver failure),
- you have a tumor in the adrenal glands ( pheochromocytoma ),
- you have high blood pressure, heart disease or have recently had a heart attack (heart muscle strains have been reported),
- you have diabetes or if there is diabetes in the family,
- you have osteoporosis (osteoporosis), especially if you are a woman who has gone through menopause,
- you have ever suffered from muscle weakness during previous treatment with this or any other steroid,
- you have an eye disease, such as glaucoma (increased pressure in the eye) or if there is glaucoma in the family, cataracts (cloudiness of the lens of the eye that leads to impaired vision), have corneal ulcers, and damage to the cornea, contact your doctor if you experience blurred vision or other visual disturbances,
- you have myasthenia gravis (a disease that causes muscle weakness),
- you have any intestinal disease or stomach ulcer,
- you have mental health problems or have had a mental illness that was exacerbated by this type of medicine,
- you have epilepsy (a condition in which you have repeated seizures or seizures),
- you have migraines,
- you have an underactive thyroid gland,
- you have an infection or suffer from an infection of some kind somewhere in your body during treatment with this medicine, you should also tell your doctor if you have had tuberculosis,
- you should also avoid contact with anyone who has chickenpox, shingles, or measles,
- you should also inform your doctor if you have ever had infectious diseases such as measles or chickenpox and any vaccinations,
- you have asthma,
- you are being treated for blood vessel blockage due to blood clots ( thromboembolism ),
- you get painful, stiff, or swollen joints or tendons,
- you have a fever, feel stressed, have an accident, give birth, or have to undergo surgery (even at the dentist) as these conditions may require a dose change,
- you should take an inhibition test (test to measure the amount of hormone in the body), skin test for allergy, or a test for bacterial infection, as this medicine may affect the test results,
- you are older, because some of the side effects are of this drug may be more severe, especially brittle bones ( osteoporosis ), high blood pressure, low potassium levels, diabetes, susceptibility to infection, and thinning of the skin.
Children and young people
If a child is taking this medicine, the doctor must check its growth and development at regular intervals. Dexamethasone should not be used routinely in premature babies with breathing difficulties.
Other medicines and Dexamethasone Krka
Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Tell your doctor or pharmacist if you are taking:
- Anticoagulants that are blood thinners (eg warfarin )
- Acetylsalicylic acid or similar (non-steroidal anti-inflammatory drugs) e.g. indomethacin
- Drugs used to treat diabetes
- Drugs used to treat high blood pressure
- Drugs used to treat heart disease
- Diuretics (diuretic tablets)
- Amphotericin B injection
- Phenytoin , carbamazepine, primidone (antiepileptic drugs)
- Rifabutin, rifampicin, isoniazid ( antibiotics used to treat tuberculosis )
- Antacids (especially antacids) – especially those containing magnesium trisilicate
- Barbiturates (medicines used to help you fall asleep and relieve anxiety)
- Aminoglutethimide (treatment for cancer)
- Carbenoxolone (used to treat stomach ulcers )
- Ephedrine (decongestant)
- Acetazolamide (used to treat glaucoma and epilepsy )
- Hydrocortisone, cortisone, and other corticosteroids s
- Ketoconazole , itraconazole (against fungal infections)
- Ritonavir (for HIV )
- Antibiotics including erythromycin, fluoroquinolones are
- Drugs that facilitate muscle movement in myasthenia gravis (eg neostigmine)
- Cholestyramine (for high cholesterol levels)
- Estrogen hormones including birth control pills
- Tetracosactide used in adrenal cortex function testing
- Sultopride used to calm emotions
- Ciclosporin used to prevent rejection after transplants
- Thalidomide used e.g. multiple myeloma
- Praziquantel gave for certain machine infections
- Vaccination with live vaccines
- Chloroquine, hydroxychloroquine and mefloquine (against malaria )
- Somatotropin
- Protirelin
- Some medicines may increase the effect of Dexamethasone Krka and your doctor may want to monitor you closely if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat)
You may be at increased risk of serious side effects if you take dexamethasone with these medicines:
- Acetylsalicylic acid or similar drugs (non-steroidal anti-inflammatory drugs) e.g. indomethacin
- Drugs used to treat diabetes
- Drugs used to treat heart disease
- Diuretics (diuretic tablets)
- Amphotericin B injection
- Acetazolamide (used to treat glaucoma and epilepsy )
- Tetracosactide used in adrenal cortex function testing
- Carbenoxolone (used to treat stomach ulcers )
- Chloroquine, hydroxychloroquine and mefloquine (against malaria )
- Drugs used to treat high blood pressure
- Thalidomide used against e.g. multiple myeloma
- Vaccination with live vaccines
- Drugs that facilitate muscle movement in myasthenia gravis (eg neostigmine)
- Antibiotics including fluoroquinolones are
You must read the package leaflets of all medicines taken in combination with Dexamethasone Krka for information on these medicines before starting treatment with Dexamethasone Krka. When using thalidomide, lenalidomide, or pomalidomide, special attention must be paid to pregnancy tests and to prevent pregnancy.
Dexamethasone Krka with food, drink, and alcohol
Dexamethasone should be taken with or without food to minimize gastrointestinal irritation.
Beverages that contain alcohol or caffeine should be avoided. It is recommended to eat small, regular meals and possibly to take antacids if recommended by your doctor.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Dexamethasone should only be prescribed during pregnancy, especially during the first trimester (first 3 months of pregnancy), if the benefits outweigh the risks to the mother and child. If you become pregnant while taking this medicine, do not stop using Dexamethasone Krka, but tell your doctor immediately that you are pregnant. Corticosteroids can pass into breast milk. A risk to the newborn / infant cannot be ruled out. Decisions to discontinue breast-feeding or to discontinue/refrain from treatment with dexamethasone should be taken after taking into account the benefit of breast-feeding to the child and the benefit of treatment to the woman.
Driving and using machines
Do not drive, use tools or machines, and do not perform dangerous tasks if you experience side effects such as confusion, hallucinations, dizziness, fatigue, drowsiness, fainting, or blurred vision.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Dexamethasone Krka contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to use Dexamethasone Krka
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Dexamethasone Krka is available in 4 mg tablets. The tablet can be divided into equal halves to give strength of 2 mg or to facilitate swallowing.
Dose one is determined by your doctor.
Dexamethasone is usually given in doses of 0.5 to 10 mg daily, depending on the disease being treated. For more serious illnesses, a dose of more than 10 mg per day may be required. The dose should be adjusted according to the individual treatment response and the severity of the disease. To minimize side effects, the lowest effective dose should be used.
Use for children and adolescents
If a child is taking this medicine, the doctor must check its growth and development at regular intervals.
If you use more Dexamethasone Krka then you should
If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
If you forget to use Dexamethasone Krka
If you forget to take a dose, take it as soon as you remember unless it is time to take the next dose. Do not take a double dose to make up for a forgotten tablet.
If you stop using Dexamethasone Krka
If your treatment is to be stopped, follow your doctor’s instructions. Your doctor may advise you to gradually reduce the amount of medicine you are taking until you stop taking it altogether. The symptoms that have been reported when treatment has been stopped too quickly have included low blood pressure, and sometimes recurrence of the disease for which the drug was used.
A “withdrawal syndrome” can also occur which includes fever, muscle and joint pain, inflammation of the nasal mucosa ( rhinitis ), weight loss, itchy skin, and inflammation of the eye ( conjunctivitis ). If you stop treatment too early and any of the above symptoms occur, contact your doctor immediately.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a doctor immediately if:
- you feel depressed, including suicidal thoughts,
- you feel high (mania) or have a mood that goes up and down,
- you feel anxious, have trouble sleeping, have difficulty thinking or are confused and lose your memory,
- you feel, see or hear things that do not exist. Have strange and frightening thoughts, you change your behavior or have feelings of loneliness,
- you experience severe abdominal pain, nausea, vomiting, diarrhea, pronounced muscle weakness and fatigue, extremely low blood pressure, weight loss, and fever as these may be signs of adrenal insufficiency.
- you experience sudden abdominal pain, tenderness, nausea, vomiting, fever, and blood in the stool as this may be a sign of stretch marks in the bowel, especially if you have or have had a bowel disease,
- you are experiencing shortness of breath or swelling in your ankles, as this may be a sign of worsening of your existing heart disease.
Other side effects may be (occurs in an unknown number of users):
- Increased risk of infection, including viral and fungal infections, e.g. cod; recurrence of tuberculosis or other infection, e.g. eye infection you if you have already had it
- Decreased white blood cell count or increased white blood cell count, abnormal coagulation
- An allergic reaction to the medicine, including severe, possibly life-threatening allergic reactions (which may manifest as rash and swelling in the throat or tongue and severe cases of difficulty breathing or dizziness)
- Deterioration of the body’s ability to regulate hormone production, swelling of the body and weight gain, moon face (Cushing-like condition), altered effectiveness of hormones after stress and trauma, surgery, childbirth or illness, the inability of the body to respond normally to severe stress such as accidents, surgery, childbirth or illness, stunted growth in children and adolescents, irregular or missed periods, increased body hair growth (especially in women)
- Weight gain, disturbed protein and calcium balance, increased appetite, salt imbalance, fluid retention in the body, potassium loss that can cause heart rhythm disorders, increased need for antidiabetic drugs, hidden diabetes can be noticeable, high levels of cholesterol and triglycerides in the blood ( hypercholesterolemia and hypertriglyceridemia ),
- Extreme mood swings, schizophrenia (mental illness) can get worse, depression, sleep problems
- Severe abnormal headache with vision problems related to discontinuation of treatment, seizures or worsening epilepsy, dizziness
- Increased pressure in the eye, papilloedema, thinning of eye membranes, increased incidence of viral, fungal, and bacterial infections in the eye, worsening of symptoms associated with corneal ulcers, worsening of existing eye infections, bulging of the eyeball, cataracts, blurred vision
- Heart failure in people at risk of heart problems, heart muscle ruptures after a recent heart attack, heart failure
- High blood pressure, blood clots: formation of blood clots that can clog the blood vessels in, for example, bones or lungs (thromboembolic complications)
- Hiccup
- Nausea, vomiting, stomach discomfort and swollen stomach, inflammation, and ulcers in the esophagus, gastric ulcers that may rupture and bleed, inflamed pancreas (which may manifest itself in pain in the back and abdomen), flatulence, a fungal infection in the esophagus ( esophageal candidiasis )
- Thin and brittle skin, abnormal spots on the skin, bruising, redness and inflammation of the skin, stretch marks in the skin, visibly swollen capillaries(small blood vessels), acne, increased sweating, rash, swelling, thin hair, unusual fat accumulation, excessive hair growth, fluid accumulation in the body, pigment disorders, weakened capillaries that are easily deficient and seen as bleeding under the skin (fragile capillaries ), skin irritation around the mouth (perioral dermatitis )
- Osteoporosis with increased risk of fracture ( osteoporosis ), bone necrosis (dead bone tissue), tendonitis (tendinitis), tendon rupture, muscle wasting, myopathy(muscle disease), muscle weakness, early cessation of bone growth ( premature closure of the epiphyses)
- Changed number of sperm and changed movement pattern of sperm, impotence
- Weakened reaction to vaccination and skin tests, slow wound healing, discomfort, malaise
- A “withdrawal syndrome” can also occur which includes fever, muscle and joint pain, inflammation of the nasal mucosa ( rhinitis ), weight loss, painful and itchy lumps of skin, and inflammation of the eye ( conjunctivitis ).
5. How to store Dexamethasone Krka
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
No special temperature instructions.
Store in the original package. Sensitive to light. Moisture sensitive.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is dexamethasone. Each tablet contains 4 mg of dexamethasone.
- The other ingredients are lactose monohydrate, pregelatinized maize starch, colloidal anhydrous silica, and magnesium stearate (E470b). See section 2 “Dexamethasone Krka contains lactose”.
What the medicine looks like and the contents of the pack
White or almost white, round tablets with beveled edges and a breakline on one side (Thickness: 2.5–3.5 mm; Diameter: 5.7–6.3 mm). The tablet can be divided into two equal doses.
Dexamethasone Krka 4 mg tablets are available in cartons containing 10, 20, 30, 100, 10 x 1, 20 x 1, 30 x 1 and 100 x 1 tablets in blisters.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia