Dexamethasone krka: detailed information

Package leaflet: Information for the user

Dexamethasone Krka, 4 mg, tablets
Dexamethasone Krka, 8 mg, tablets
Dexamethasonum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

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 personally. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What Dexamethasone Krka is and what it is used for
What you need to know before taking Dexamethasone Krka
How to take Dexamethasone Krka
Possible side effects
How to store Dexamethasone Krka
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 medicinal product 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, but only in combination with anti-infective therapy, haematological 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 malignant diseases, prevention and treatment of nausea and vomiting caused 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 COVID-19 infection, do not stop taking any other steroid medicines unless advised by a doctor.
Before starting to take Dexamethasone Krka, discuss this with your doctor, pharmacist or nurse:

if you have ever had severe depression or bipolar disorder (manic-depressive illness); this means having experienced depression before or during treatment with steroid medicines such as dexamethasone;
if any of your close family members have had these conditions.

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

kidney or liver disease (liver cirrhosis or chronic liver failure),
pheochromocytoma (a tumour of the adrenal gland) or suspected pheochromocytoma,
high blood pressure, heart disease or recent heart attack (cases of heart rupture have occurred),
diabetes or a history of diabetes in the family,
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 lens of the eye leading to vision loss),
myasthenia gravis (a disease causing muscle weakness),
bowel disease or stomach ulcer,
psychiatric problems or a mental illness that has worsened due to taking this type of medicine,
epilepsy (a condition characterised by recurrent loss of consciousness or seizures),
migraine,
hypothyroidism,
parasitic infection,
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 tumour of the adrenal gland. A crisis may manifest 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 infection. This may sometimes lead to infections caused by microorganisms that rarely cause infection 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 about any previous tuberculosis or travel to areas where parasitic infections are common.
While taking this medicine, it is important to avoid contact with people who have chickenpox, shingles or measles. If you suspect possible exposure to any of these diseases, consult your doctor immediately. You should also inform your doctor about any previous infectious diseases such as measles or chickenpox, and about vaccinations against these diseases.
Contact your doctor if the patient experiences any of the following: tumour lysis syndrome symptoms such as muscle cramps, muscle weakness, confusion, vision disturbances or loss of vision, and rapid breathing, if the patient has a haematological malignancy.
If the patient experiences blurred vision or other vision disturbances, contact a doctor.
Treatment with this medicine may cause chorioretinopathy, an eye disease causing decreased visual acuity or vision 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 called adrenal insufficiency. This may affect the effectiveness of treatment during stress or injury, surgery, childbirth or illness, and the body may not be able to respond naturally to serious stress associated with an accident, surgery, childbirth or illness.
If an accident, illness or other physically stressful situation occurs during or after treatment with Dexamethasone Krka, when surgery is required (even dental procedures) or vaccination (especially with live virus vaccines), inform the treating doctor about steroid use.
When undergoing suppression tests (to detect hormone levels in blood), skin allergy tests or tests to detect bacterial infection, inform the person performing the tests 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 children'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, 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 (water tablets)
Intravenous amphotericin B
Phenytoin, carbamazepine, primidone (medicines used to treat epilepsy)
Rifabutin, rifampicin, isoniazid (antibiotics used to treat tuberculosis)
Medicines that neutralise 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 mucous membranes)
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 the test assessing 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 medicines available without a prescription. 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)
Intravenous amphotericin B
Acetazolamide (a medicine used to treat glaucoma and epilepsy)
Tetracosactide used in the test assessing 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 erytromycin, fluoroquinolones

Before starting to take Dexamethasone Krka, read the patient information leaflets of all medicines you will be taking in combination with Dexamethasone Krka to obtain information about these medicines. If taking thalidomide, lenalidomide or pomalidomide, pay special attention to the need for a pregnancy test and pregnancy prevention.
Dexamethasone Krka with food, drink and alcohol
Dexamethasone should be taken during or after a meal to reduce gastrointestinal irritation. Avoid drinks containing alcohol or caffeine. It is recommended to eat small, frequent meals and, if advised by your doctor, possibly use medicines that neutralise gastric acid.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
Dexamethasone Krka should be used during pregnancy, and particularly during the first trimester, only if, in the opinion of the doctor, the benefit to the mother outweighs the potential risk to the foetus.
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. 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 treatment with dexamethasone for the woman.
Driving and using machines
Do not drive, operate machinery or perform any dangerous tasks if you experience adverse effects such as disorientation, hallucinations, dizziness, fatigue, drowsiness, fainting or blurred vision.
Dexamethasone Krka contains lactose
If you have previously been diagnosed with an intolerance to certain sugars, you should contact 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 take dexamethasone. If in doubt, consult a doctor or pharmacist.
Dexamethasone Krka is available as 4 mg, 8 mg, 20 mg and 40 mg tablets. Tablets may be divided
into halves, 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 disease severity.
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 oedema: 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 individual doses.
Acute asthma: adults: 16 mg per day for two days; children: 0.6 mg per kilogram body weight for one to two days.
Croup: children: 0.15–0.6 mg per kilogram body weight as a single dose.
Acute skin diseases: depending on the type and extent of the disease, daily doses ranging from 8–40 mg, and in some cases up to 100 mg; thereafter, the dose should be tapered according to clinical need.
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 body weight per day in the first week, 0.3 mg per kilogram body weight per day in the second week, 0.2 mg per kilogram body weight per day in the third week, and 0.1 mg per kilogram 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 weekly; patients with stage I disease receive intravenous treatment for two weeks (0.3 mg per kilogram body weight per day in the first week and 0.2 mg per kilogram body weight per day in the second week), followed by oral treatment for four weeks (0.1 mg per kilogram 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 weekly).
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 vomiting induced by cytostatic agents, emetogenic chemotherapy, **in combination with other antiemetic drugs: 8–20 mg of dexamethasone before chemotherapy, followed by 4–16 mg per day on days 2 and 3 of therapy.
Prophylaxis and treatment of postoperative nausea and vomiting, **in combination with other antiemetic drugs: a single dose of 8 mg before surgery.
Treatment of symptomatic multiple myeloma, acute lymphoblastic leukaemia, 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 recommendations for dexamethasone described in the product characteristics of the other medication being used, if provided. If not, national or international dosing guidelines and protocols 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 reduce the suppressive effect on 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.
Use of a higher than recommended dose of Dexamethasone Krka
If too many tablets are taken, contact a doctor immediately or go to the nearest hospital.
Missed dose of 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. These may include gradually reducing the dose until treatment is completely stopped. Symptoms following too rapid discontinuation may 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 the medicine is stopped too quickly and any of these symptoms occur, contact a doctor immediately.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone 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 uneasiness, insomnia, difficulty thinking clearly, or feelings of confusion and memory loss,
experiencing, perceiving or hearing things that are not real; unusual or frightening thoughts affecting behaviour or feelings of isolation.

You should immediately inform your doctor if the following occur:

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 if you have an existing bowel disease.

This medicine may worsen pre-existing heart conditions. If you experience shortness of breath or swollen ankles, contact your doctor immediately.

Other adverse effects (frequency unknown) include:

Increased susceptibility to infections, including viral and fungal infections (e.g. aspergillosis), reactivation of tuberculosis or other infections, e.g. previously diagnosed eye infections.
Decreased or increased white blood cell count, 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 the body's hormonal regulation, fluid retention 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 adequately in situations of severe stress such as accidents, surgery, childbirth or illness; growth suppression in children and adolescents; irregular menstrual cycle or amenorrhea (absence of menstruation); development of excessive hair growth (especially in women).
Weight gain, negative calcium and protein balance, increased appetite, electrolyte imbalances, fluid retention, potassium loss which may lead to cardiac arrhythmias, increased requirement for antidiabetic medications, manifestation of latent diabetes mellitus, elevated blood cholesterol and triglyceride levels (hypercholesterolemia and hypertriglyceridemia).
Marked mood swings, exacerbation of schizophrenia (a psychiatric disorder), depression, insomnia.
Severe atypical headaches with visual disturbances related to drug withdrawal, seizures and worsening of epilepsy, dizziness.
Increased intraocular pressure, eye swelling, thinning of the ocular epithelium, worsening of pre-existing viral, fungal or bacterial eye infections, exacerbation of corneal ulcer symptoms, worsening of existing eye infections, exophthalmos (protruding eyes), cataracts, visual disturbances, vision loss, 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 perforate and bleed, pancreatitis (which may present as back and abdominal pain), intestinal gas, oesophageal candidiasis.
Thin, fragile skin, unusual skin markings, bruising, redness and skin inflammation, striae, visible capillary dilation, acne, excessive sweating, rash, swelling, hair loss, abnormal fat deposits, excessive body hair growth, fluid retention, pigmentary changes, weakened capillaries leading to 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 growth plates).
Changes in sperm quantity and motility, impotence.
Impaired response to vaccination and skin tests, delayed 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 adverse effects
If any adverse effects occur, including any not listed in this leaflet, you should inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse 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 following the abbreviation
"EXP". The expiry date refers to the last day of the stated month.
The batch number is indicated on the packaging following the abbreviation "Lot".
There are no special storage temperature requirements for this 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. Such measures will help
protect the environment.

6. Contents of the package 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.
Other ingredients: monohydrate lactose, pregelatinized corn starch, colloidal anhydrous silica, 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 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.
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 equal doses.

4 mg tablets:
OPA/Aluminium/PVC/Aluminium blister, 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/Aluminium/PVC/Aluminium blister, 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 Authorisation 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

For more detailed information on the product names in other European Economic Area countries, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw, Poland
Tel. 22 57 37 500