Patient Information Leaflet

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Dexamethasone Krka (Dexamethason HCS 8 mg), 8 mg, tablets
Dexamethasonum
Dexamethasone Krka and Dexamethason HCS 8 mg are different trade names for the same medicinal product.
Please read this leaflet carefully before using 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. This medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

What Dexamethasone Krka is and what it is used for
Important information 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 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, polyarteritis nodosa), respiratory diseases (e.g. bronchial asthma, croup), skin disorders (e.g. erythroderma, pemphigus vulgaris), tuberculous meningitis only in combination with anti-infective therapy, blood disorders (e.g. adult idiopathic thrombocytopenic purpura), 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.

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
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 means having experienced depression before or during treatment with corticosteroid medicines such as dexamethasone;
if any of your close family members have had these conditions.

Psychiatric problems may occur while taking corticosteroids 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 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 the medicine in the following cases:

kidney or liver disease (liver cirrhosis or chronic liver failure),
pheochromocytoma (adrenal gland tumour) 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 corticosteroid medicine,
glaucoma (increased pressure in the eye) or a family history of glaucoma or cataracts (clouding of the eye lens leading to impaired vision),
myasthenia gravis (a disease causing muscle weakness),
intestinal disease or stomach ulcer,
psychiatric problems or mental illness that has worsened due to use of this type of medicine,
epilepsy (a condition characterised by recurrent loss of consciousness or seizures),
migraine,
hypothyroidism,
parasitic infections,
tuberculosis, sepsis or fungal eye infection,
cerebral malaria,
herpes virus (of the mouth, genitals or eye, due to possible corneal perforation),
asthma,
ongoing treatment for blocked blood vessels due to blood clots (thromboembolic disease),
corneal ulceration and corneal injuries.

Taking this medicine may trigger a pheochromocytoma crisis, which can be
life-threatening. 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.
Corticosteroid treatment may weaken the body's ability to fight infection. This may
sometimes lead to infections caused by microorganisms that normally rarely cause infection (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 previous tuberculosis or travel to 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 possible exposure to any of
these diseases, consult your doctor immediately. You should also inform your doctor
about previous infectious diseases such as measles or chickenpox, and vaccinations against these
diseases.
Contact your doctor if the patient has any of the following conditions: symptoms
of tumour lysis syndrome, such as muscle cramps, muscle weakness, confusion, visual disturbances or
loss of vision, and rapid breathing, especially if the patient has a haematological malignancy.
If the patient experiences blurred vision or other visual disturbances, contact the
doctor.
Treatment with this medicine may cause chorioretinopathy, an eye disease causing decreased
visual acuity or visual disturbances. It 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 notice pain, stiffness or swelling in joints or tendons.
Taking Dexamethasone Krka may lead to a condition known as
adrenal insufficiency. This may affect the effectiveness of the medicine during stress or injury, surgery, childbirth or illness, and the body may not be able to respond naturally to serious stress caused by an accident, operation, childbirth
or illness.
If an accident, illness or other physically stressful event occurs during or after treatment with Dexamethasone Krka, when surgery (even dental) or vaccination (especially with live virus vaccines) is required, inform the treating doctor about steroid use.
When undergoing suppression tests (to detect hormone levels in blood),
allergy skin tests or bacterial infection tests, inform the person performing the test about dexamethasone use, 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 severe, 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 the 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 pills)
Intravenous amphotericin B
Phenytoin, carbamazepine, primidone (medicines used to treat epilepsy)
Rifabutin, rifampicin, isoniazid (antibiotic 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 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 support muscle movement in myasthenia (e.g. neostigmine)
Cholestyramine (a medicine used in case of elevated cholesterol levels)
Estrogen hormones, including oral contraceptives
Tetracosactide used in adrenal cortex function testing
Sultopride used as a tranquiliser
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 pills)
Intravenous amphotericin B
Acetazolamide (a medicine used to treat glaucoma and epilepsy)
Tetracosactide used in adrenal cortex function testing
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 support muscle movement in myasthenia (e.g. neostigmine)
Antibiotics, including erythromycin, fluoroquinolones

Before starting 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. When using thalidomide, lenalidomide or pomalidomide, pay particular attention to the need for pregnancy testing and pregnancy prevention.
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, possibly use gastric acid neutralising medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a
child, you should consult your doctor or pharmacist before using this medicine.
Dexamethasone Krka should be used during pregnancy, and especially 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 treatment, 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 dexamethasone treatment for the woman.
Driving and operating machinery
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 monohydrate
If you have previously been diagnosed with intolerance to certain sugars, you should
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 take dexamethasone. If in doubt, consult a
physician or pharmacist.
Dexamethasone Krka is available as 4 mg, 8 mg, 20 mg, and 40 mg tablets. The tablets may
be divided in half, providing additional strengths of 2 mg and 10 mg and making it easier for the
patient to swallow the tablet.
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 adverse 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 depending on 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 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 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 four consecutive 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 weekly; 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 weekly).
Palliative care in neoplastic diseases: initial dose and duration of treatment depending on cause and severity of 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 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 vomiting, in combination with other antiemetic drugs: 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 should be administered according to the dosing guidelines for dexamethasone described in the summary of product characteristics of the other drug being used, if provided. If not, national or international protocols and dosing 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 reduce the suppressive effect on the adrenal cortex.
Use in children and adolescents
When using this medicine in children, it is important that the physician carefully monitors children'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 physician 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.
Discontinuation of Dexamethasone Krka
If therapy must be discontinued, follow the physician’s instructions. These may include gradually reducing the dose until treatment is completely stopped. Symptoms after too rapid discontinuation include low blood pressure and, in some cases, recurrence of the original disease.
Withdrawal syndrome from corticosteroids 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 discontinued 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 adverse reactions

Like all medicines, this medicine can cause adverse reactions, 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 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, perceiving, or hearing things that are not there; 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, marked 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 there is an existing bowel disease.

This medicine may worsen existing heart conditions. If shortness of breath or ankle swelling occurs, you should immediately contact your doctor.
Other adverse reactions include (frequency unknown):

Increased susceptibility to infections, including viral and fungal infections, e.g. candidiasis, 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 severe, 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 in response to 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 absence of menstruation (amenorrhea); development of excessive hair growth (particularly in women).
Weight gain, negative protein-calcium balance, increased appetite, electrolyte imbalance, fluid retention in the body, potassium loss which may lead to cardiac arrhythmias, increased requirement for antidiabetic medications, manifestation of latent diabetes, elevated blood cholesterol and triglyceride levels (hypercholesterolemia and hypertriglyceridemia).
Severe mood swings, schizophrenia (mental disorder) may worsen, depression, insomnia.
Severe atypical headaches with visual disturbances related to discontinuation of the medicine, seizures and exacerbation of epilepsy, dizziness.
Increased intraocular pressure, eye swelling, thinning of the corneal epithelium, worsening of existing viral, fungal and bacterial eye infections, worsening of corneal ulcer symptoms, exacerbation 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, formation of thrombi which may block blood vessels, for example in the legs or lungs (thromboembolic complications).
Hiccups.
Nausea, vomiting, stomach discomfort and abdominal distension, 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 dilation, acne, excessive sweating, rash, swelling, hair loss, abnormal fat deposits, excessive body hair growth, fluid retention in the body, pigmentary disorders, 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), bone necrosis, tendon inflammation, tendon ruptures, muscle atrophy, myopathy, muscle weakness, early cessation of bone growth (premature closure of epiphyses).
Changes in sperm count and motility, impotence.
Impaired response to vaccination 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 adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions 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
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

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.
No special temperature storage conditions are required. Store in the original packaging to protect from light and moisture.
Medicines must 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. Each tablet contains 8 mg of dexamethasone.
Other ingredients of the medicine are: lactose monohydrate, pregelatinized corn starch, colloidal anhydrous silica, magnesium stearate. See section 2 "Dexamethasone Krka contains lactose monohydrate".

What Dexamethasone Krka looks like and contents of the pack
White or almost white, oval tablets with a break line on one side (thickness: 3.5–5.5 mm;
length: 8.7–9.3 mm). The tablet can be divided into equal doses.
Blister packs OPA/Aluminium/PVC/Aluminium in cardboard boxes.
Pack sizes: 10, 20, 30, 50, 60, 100 tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Austria, country of export:
HCS bvba
H. Kennisstraat 53
2650 Edegem, Belgium
Manufacturer:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Str. 5, 27472 Cuxhaven, Germany
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing authorisation number in Austria, country of export: 138041
Parallel import authorisation number: 21/22

Dexamethasone krka