Dexamethasone krka

Package leaflet: Information for the user

Warning! Keep the leaflet. The information on the immediate packaging is in a foreign language.
Dexamethasone Krka (Dexamethasone TAD)
4 mg, tablets
Dexamethasonum
Dexamethasone Krka and Dexamethasone TAD are different brand names of the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any adverse effects not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

1. What Dexamethasone Krka is and what it is used for
2. Important information before taking 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 Dexamethasone Krka is and what it is 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 in the treatment of rheumatic and autoimmune diseases (e.g. systemic lupus erythematosus, rheumatoid arthritis, juvenile idiopathic arthritis, polyarteritis nodosa), respiratory diseases (e.g. bronchial asthma, croup), skin diseases (e.g. erythroderma, pemphigus vulgaris), tuberculous meningitis exclusively in combination with anti-infective therapy, blood disorders (e.g. idiopathic thrombocytopenic purpura in adults), cerebral oedema, symptomatic treatment of multiple myeloma, acute lymphoblastic leukaemia, Hodgkin's disease and non-Hodgkin's lymphoma in combination with other medicinal products, palliative treatment of neoplastic diseases, prevention and treatment of nausea and vomiting induced by chemotherapy, as well as prevention and treatment of postoperative vomiting in combination with antiemetic medicines.
Dexamethasone Krka 4 mg tablets
Dexamethasone Krka is used in the treatment of COVID-19 in adult and adolescent patients (aged 12 years and older, weighing at least 40 kg) who have difficulty breathing and require oxygen therapy.

2. Important information before using Dexamethasone Krka

When not to use Dexamethasone Krka

• if the patient is allergic to dexamethasone or any of the other ingredients of this medicine (listed in section 6);
• in case of systemic infection (unless already being treated);
• in case of peptic ulcer of the stomach or duodenum;
• shortly before receiving a live vaccine.

Warnings and precautions
If the patient is being treated for a COVID-19 infection, do not stop taking any other steroid medications unless advised otherwise by a doctor.
Before starting treatment with Dexamethasone Krka, discuss this with your doctor, pharmacist, or nurse:

• if you have ever had severe depression or bipolar disorder (manic-depressive illness); this includes experiencing depression before or during treatment with steroid medicines such as dexamethasone;
• if any member of your immediate family has had these conditions.

Psychiatric problems may occur while taking steroids such as Dexamethasone Krka.

• These disorders can be serious.
• They usually appear within a few days or weeks after starting the medicine.
• They are more common with higher doses of the medicine.
• Most of these problems disappear when the dose is reduced or treatment is stopped. However, if such problems occur, they may require treatment.

Consult your doctor if you experience any symptoms of psychiatric problems while taking this medicine. This is particularly important in cases of depression or suicidal thoughts. In some cases, psychiatric problems have occurred after reducing the dose or stopping treatment.
Consult your doctor before using this medicine if you have:

• kidney or liver disease (liver cirrhosis or chronic liver failure),
• pheochromocytoma (adrenal gland tumor) or suspected pheochromocytoma,
• high blood pressure, heart disease or recent heart attack (cases of cardiac rupture have occurred),
• diabetes or a family history of diabetes,
• osteoporosis (loss of bone mass), especially in postmenopausal women,
• previous muscle weakness caused by this or another steroid medicine,
• glaucoma (increased pressure in the eye) or a family history of glaucoma or cataracts (clouding of the eye lens leading to vision loss),
• myasthenia gravis (a disease causing muscle weakness),
• intestinal disease or stomach ulcer,
• psychiatric disorders or mental illness that has worsened due to use of such medicines,
• epilepsy (a condition characterized by recurrent loss of consciousness or seizures),
• migraine,
• hypothyroidism,
• parasitic infections,
• tuberculosis, sepsis or fungal eye infection,
• cerebral malaria,
• herpes virus (of the mouth, genital organs or eye, due to possible corneal perforation),
• asthma,
• ongoing treatment for blood vessel blockage by clots (thromboembolic disease),
• corneal ulceration or corneal injury.

Taking this medicine may trigger a pheochromocytoma crisis, which can be fatal. Pheochromocytoma is a rare tumor of the adrenal gland. A crisis may present with the following symptoms: headache, sweating, palpitations, and high blood pressure. If any of these symptoms occur, contact your doctor immediately.
Treatment with corticosteroids may weaken the body's ability to fight infections. This may sometimes lead to infections caused by microorganisms that rarely cause disease under normal circumstances (called opportunistic infections). If any infection occurs during treatment with this medicine, consult your doctor immediately. This is particularly important in case of signs of pneumonia: cough, fever, shortness of breath, and chest pain. Disorientation may also occur, especially in elderly patients. Inform your doctor if you have had tuberculosis or have been in areas where parasitic infections are common.
During treatment with this medicine, it is important to avoid contact with people who have chickenpox, shingles, or measles. If you suspect potential exposure to any of these diseases, contact your doctor immediately. You should also inform your doctor about past infectious diseases such as measles or chickenpox, and vaccinations against them.
Contact your doctor if the patient experiences any of the following: symptoms of tumor lysis syndrome, such as muscle cramps, muscle weakness, confusion, visual disturbances or loss of vision, and rapid breathing, especially if the patient has a hematological malignancy.
If the patient develops blurred vision or other visual disturbances, contact a doctor.
Treatment with this medicine may cause chorioretinopathy, an eye disease causing decreased visual acuity or visual disturbances. This usually affects one eye.
Treatment with this medicine may cause tendon inflammation. In extremely rare cases, tendon rupture may occur. This risk increases when combined with certain antibiotics or kidney problems. Contact your doctor if you experience pain, stiffness, or swelling in joints or tendons.
Taking Dexamethasone Krka may lead to a condition known as adrenal insufficiency. This may affect the medicine's effectiveness during stress, injury, surgery, childbirth, or illness, and the body may not be able to respond naturally to serious physical stress caused by an accident, surgery, childbirth, or illness.
If an accident, illness, or other physically stressful event occurs during or after treatment with Dexamethasone Krka, or if surgery (even dental procedures) or vaccination (especially with live virus vaccines) is required, inform the treating physician that you are taking steroids.
If undergoing suppression tests (to detect hormone levels in blood), skin allergy tests, or bacterial infection screening, inform the person performing the test that you are taking dexamethasone, as it may affect test results.
During treatment, your doctor may also recommend limiting salt intake and potassium supplementation.
In elderly patients, some side effects of this medicine may be more serious, particularly decreased bone density (osteoporosis), high blood pressure, low potassium levels, diabetes, increased susceptibility to infections, and skin thinning. Your doctor will closely monitor the patient during treatment.

Children and adolescents
When using this medicine in children, it is important that the doctor carefully monitors the child's growth and development at regular intervals. Dexamethasone should not be routinely used in premature infants with respiratory distress syndrome.

Dexamethasone Krka with other medicines
Tell your doctor about all medicines you are currently taking or have recently taken, including 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 (water tablets)
• -- Amphotericin B administered by injection
• -- Phenytoin, carbamazepine, primidone (medicines used to treat epilepsy)
• -- Rifabutin, rifampicin, isoniazid (antibiotic used to treat tuberculosis)
• -- Medicines that neutralize gastric acid, particularly those containing magnesium trisilicate
• -- Barbiturates (medicines used to aid sleep and reduce anxiety)
• -- Aminoglutethimide (an anticancer medicine)
• -- Carbenoxolone (a medicine used to treat stomach ulcers)
• -- Ephedrine (a medicine used to constrict blood vessels in inflammatory conditions of nasal mucosa)
• -- Acetazolamide (a medicine used to treat glaucoma and epilepsy)
• -- Hydrocortisone, cortisone and other corticosteroids
• -- Ketoconazole, itraconazole (medicines 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 in cases of elevated cholesterol)
• -- Estrogen hormones including oral contraceptives
• -- Tetracosactide (used in testing adrenal cortex function)
• -- Sulpiride, used as a calming medicine
• -- Cyclosporine, used to prevent transplant rejection
• -- Thalidomide, used among others in the treatment of 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 medicines you are currently taking or have recently taken, including over-the-counter medicines. You may be at increased risk of adverse effects when taking dexamethasone with the following medicines:

• -- Some medicines may increase the effect of Dexamethasone Krka, and your doctor may wish 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 (water tablets)
• -- Amphotericin B administered by injection
• -- Acetazolamide (a medicine used to treat glaucoma and epilepsy)
• -- Tetracosactide (used in testing 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 others in the treatment of multiple myeloma
• -- Live vaccines
• -- Medicines that enhance muscle movement in myasthenia (e.g. neostigmine)
• -- Antibiotics including erythromycin, fluoroquinolones

Before starting treatment with Dexamethasone Krka, read the patient leaflets of all medicines you will be taking in combination with Dexamethasone Krka to obtain information about these medicines. If you are taking thalidomide, lenalidomide, or pomalidomide, pay special attention to performing a pregnancy test and the need for contraception.

Dexamethasone Krka with food, drink, and alcohol
Dexamethasone should be taken during or after a meal to reduce gastrointestinal irritation. Avoid beverages containing alcohol or caffeine. It is recommended to eat small, frequent meals and, if advised by your doctor, to use antacids.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Dexamethasone Krka should be used during pregnancy, especially in the first trimester, only if, in the opinion of the doctor, the benefit to the mother outweighs the potential risk to the fetus.
If you become pregnant while taking Dexamethasone Krka, do not stop taking it, but inform your doctor immediately.
Corticosteroids may pass into breast milk. Risk to newborns or infants cannot be excluded. The decision whether to continue or discontinue breastfeeding or to continue or discontinue 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 operating machinery
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 monohydrate lactose
If you have previously been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to use Dexamethasone Krka

Dexamethasone Krka should always be used as directed by the physician. The physician will decide
how long the patient should continue treatment with dexamethasone. If in doubt, consult a
physician or pharmacist.
Dexamethasone Krka is available in 4 mg, 8 mg, 20 mg, and 40 mg tablets. The tablets can be
split in half, providing additional strengths of 2 mg and 10 mg, and making it easier for the patient
to swallow.
Dexamethasone is usually administered in doses ranging from 0.5 mg to 10 mg per day, depending
on the disease being treated. In more severe conditions, doses exceeding 10 mg per day may be
required. The dose should be adjusted according to individual patient response and severity of
the disease. To minimize side effects, the lowest effective dose should be used.
Unless otherwise directed by the physician, the following doses are recommended:
The dosing recommendations listed below are for informational purposes only.
Initial and daily doses must always be determined based on individual patient response
and disease severity.

• Cerebral edema: initial dose and duration of treatment depend on the cause and severity of the disease; 6–16 mg per day (up to a maximum of 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 per kilogram of body weight as a single dose.
• Acute skin diseases: depending on the type and extent of the disease, daily doses range from 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 severe, progressive course: rapidly progressive destructive form: 12–16 mg per day; with extra-articular manifestations: 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), followed by oral treatment for four weeks, starting at 4 mg per day and reducing the dose by 1 mg each 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), followed by oral treatment for four weeks (0.1 mg per kilogram of body weight per day in the third week of treatment, then 3 mg per day in the following week, reducing the dose by 1 mg each week).
• Palliative care in neoplastic diseases: initial dose and duration of treatment depend on the cause and severity of the disease: 3–20 mg per day. In palliative care, very high doses may also be used, up to a maximum of 96 mg. For optimal dosing and to reduce the number of tablets, lower-strength tablets (4 mg and 8 mg) may be combined with higher-strength tablets (20 mg or 40 mg).
• Prophylaxis and treatment of cytostatic-induced, emetogenic chemotherapy-induced vomiting, in combination with other antiemetics: 8–20 mg of dexamethasone before chemotherapy, followed by 4–16 mg per day on the second and third days of therapy.
• Prophylaxis and treatment of postoperative vomiting, in combination with other antiemetics: 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 drugs: the usual dose is 40 mg or 20 mg once daily. The dose and frequency vary depending on the treatment regimen and other medications used. Dexamethasone administration should follow the dosing guidelines for dexamethasone described in the product characteristics of the other drug being used, if provided. If not, national or international dosing protocols and guidelines should be followed. The prescribing physician should carefully evaluate the appropriate dose in each case, taking into account the patient's condition and disease.

Long-term treatment
In long-term treatment of several diseases, after initial therapy, the glucocorticoid should be switched
from dexamethasone to prednisone or prednisolone to minimize suppression of the adrenal cortex.
Dexamethasone Krka 4 mg tablets

• Treatment of COVID-19: in adult patients, the recommended dose is 6 mg once daily orally for up to 10 days. Use in adolescents: in adolescents (aged 12 years and older, weighing at least 40 kg), oral administration of 6 mg once daily for up to 10 days is recommended.

Use in children and adolescents
When using this medicine in children, it is important that the physician carefully monitors the child's
growth and development at regular intervals.

Taking more Dexamethasone Krka than recommended
If too many tablets are taken, contact a physician immediately or go to the nearest hospital.

If you forget to take Dexamethasone Krka
If a dose is missed, take it as soon as possible. If it is almost time for the next dose, take only one dose. Do not take a double dose to make up for a missed dose.

Stopping Dexamethasone Krka
If treatment needs to be discontinued, follow the physician's instructions. This may include gradually reducing the dose until treatment is completely stopped. Symptoms that may occur after stopping treatment too quickly include low blood pressure and, in some cases, recurrence of the original disease.
A corticosteroid withdrawal syndrome may also occur, including fever, muscle and joint pain, nasal mucosal inflammation (rhinitis), weight loss, skin itching, and eye inflammation (conjunctivitis). If treatment is stopped too quickly and any of these symptoms occur, contact a physician as soon as possible.

If you have any further questions about the use of this medicine, consult your physician or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
You should immediately inform your doctor if serious psychiatric problems occur.
These may affect approximately 5 out of 100 people taking corticosteroid medicines such as dexamethasone. These problems include:

• feelings of depression, including suicidal thoughts,
• feelings of euphoria (mania) or mood swings,
• feelings of anxiety, insomnia, difficulty thinking clearly, or feelings of confusion and memory loss,
• experiencing, seeing or hearing things that are not there; unusual or frightening thoughts affecting behaviour or feelings of isolation.

You should immediately contact your doctor if you experience:

• severe abdominal pain, nausea, vomiting, diarrhoea, significant muscle weakness and fatigue, extremely low blood pressure, weight loss and fever, as these may indicate adrenal insufficiency;
• sudden abdominal pain, tenderness, nausea, vomiting, fever and blood in the stool, as these may be symptoms of intestinal perforation, especially in patients with existing bowel disease.

This medicine may worsen pre-existing heart conditions. If you experience shortness of breath or ankle swelling, contact your doctor immediately.
Other side effects (frequency unknown) include:

• -- Increased susceptibility to infections, including viral and fungal infections such as aspergillosis, reactivation of tuberculosis, or other infections, e.g. previously diagnosed eye infections.
• -- Decreased or increased number of white blood cells, coagulation disorders.
• -- Allergic reactions to the medicine, including serious, life-threatening allergic reactions (which may present as rash, swelling of the throat or tongue, and in severe cases, difficulty breathing or dizziness).
• -- Disorders of hormonal regulation, oedema and weight gain, moon-shaped face (Cushingoid state), altered endogenous secretion following stress and trauma, surgical procedures, childbirth or illness; the body may be unable to respond appropriately in situations of severe stress such as accidents, surgery, childbirth or illness; growth suppression in children and adolescents; irregular menstrual cycle or amenorrhoea (absence of menstruation); development of excessive hair growth (particularly in women).
• -- Weight gain, negative calcium and protein balance, increased appetite, disturbances in electrolyte balance, fluid retention in the body, potassium loss which may lead to cardiac arrhythmias, increased requirement for antidiabetic medicines, manifestation of latent diabetes, elevated blood cholesterol and triglyceride levels (hypercholesterolaemia and hypertriglyceridaemia).
• -- Extreme mood swings, schizophrenia (mental disorder) may worsen, depression, insomnia.
• -- Severe, atypical headaches with visual disturbances related to discontinuation of the medicine, seizures and worsening of epilepsy, dizziness.
• -- Increased intraocular pressure, eye oedema, thinning of the epithelial layer of the eye, worsening of existing viral, fungal or bacterial eye infections, exacerbation of corneal ulcer symptoms, worsening of existing eye infections, exophthalmos, cataract, visual disturbances, loss of vision, blurred vision.
• -- Congestive heart failure in susceptible patients, cardiac rupture after recent myocardial infarction, heart failure.
• -- Hypertension, blood clots, thrombus formation which may block blood vessels, for example in the legs or lungs (thromboembolic complications).
• -- Hiccups.
• -- Nausea, vomiting, stomach discomfort and abdominal bloating, inflammation and ulcers in the oesophagus, gastric ulcers which may rupture and bleed, pancreatitis (which may present as back and abdominal pain), intestinal gas, oesophageal candidiasis.
• -- Thin, fragile skin, unusual skin marks, bruising, redness and skin inflammation, stretch marks, visible capillary network, acne, excessive sweating, rash, swelling, hair loss, abnormal fat deposits, excessive body hair growth, fluid retention in the body, pigmentary changes, weakened capillaries visible as subcutaneous bleeding (increased capillary fragility), perioral dermatitis (skin inflammation around the mouth).
• -- Decreased bone density with increased risk of fractures (osteoporosis), avascular necrosis of bone, tendonitis, tendon rupture, muscle atrophy, myopathy, muscle weakness, premature cessation of bone growth (premature closure of epiphyseal plates).
• -- Changes in sperm count and motility, impotence.
• -- Impaired response to vaccinations and skin tests, slow wound healing, discomfort, malaise.
• -- Corticosteroid withdrawal syndrome may also occur, including fever, muscle and joint pain, nasal mucosal inflammation (rhinitis), weight loss, painful and itchy skin nodules, eye inflammation (conjunctivitis).

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Side effects can also be reported directly to the Department for Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Dexamethasone Krka

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
There are no special storage temperature requirements. Store in the original packaging to protect from light and moisture.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the pack and other information

What Dexamethasone Krka contains

• The active substance is dexamethasone. Each tablet contains 4 mg of dexamethasone.
• The other ingredients are monohydrate lactose, pregelatinized starch, corn, colloidal anhydrous silica, magnesium stearate (E 470b). See section 2. "Dexamethasone Krka contains monohydrate lactose".

What Dexamethasone Krka looks like and contents of the pack
White or almost white, round tablets with bevelled edges, 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 equal doses.
OPA/Al/PVC/Al blisters in a cardboard box.
Pack sizes: 20 tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Spain, the country of export:
TAD Pharma GmbH
Heinz-Lohmann-Straße 5
27472 Cuxhaven, Germany
Manufacturer:
Krka, d.d. Novo mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland
Marketing authorisation number in Spain, the country of export: 713555.5
Parallel import authorisation number: 66/25