Package leaflet: Information for the user

Dexamethasone Krka, 20 mg, tablets
Dexamethasone Krka, 40 mg, tablets
Dexamethasonum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please 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 other people, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, tell 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. polymyositis), skin diseases (e.g. pemphigus vulgaris), blood disorders (e.g. idiopathic thrombocytopenic purpura in adults), symptomatic treatment of multiple myeloma, acute lymphoblastic leukemia, Hodgkin's disease and non-Hodgkin's lymphoma in combination with other medicinal products, metastatic spinal cord compression (pressure on the spinal nerves caused by a tumour), and for the prevention and treatment of nausea and vomiting induced by chemotherapy, in combination with antiemetic medicines.

2. Important information before taking Dexamethasone Krka

Do not take Dexamethasone Krka

if you are allergic to dexamethasone or any of the other ingredients of this medicine (listed in section 6);
if you have a systemic infection (unless already being treated);
if you have a peptic ulcer of the stomach or duodenum;
if you are due to receive a live vaccine.

Warnings and precautions
Before taking Dexamethasone Krka, consult your doctor or pharmacist:

if you have ever had severe depression or bipolar disorder (manic-depressive illness); this means 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 disturbances may be serious.
They usually appear within a few days or weeks after starting the medicine.
They are more common with higher doses.
Most of these problems resolve when the dose is reduced or treatment is stopped. However, if such problems occur, they may require treatment.

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

kidney or liver disease (cirrhosis or chronic liver failure),
pheochromocytoma (adrenal gland tumour) or suspected pheochromocytoma,
hypertension, heart disease or recent myocardial infarction (cases of cardiac rupture have occurred),
diabetes or a family history of diabetes,
osteoporosis (loss of bone mass), especially in postmenopausal women,
a history of muscle weakness caused by this or another steroid medicine,
glaucoma (increased intraocular pressure) or a family history of glaucoma or cataracts (clouding of the eye lens leading to impaired vision),
myasthenia gravis (a disease causing muscle weakness),
bladder disease or gastric/duodenal ulcer,
psychiatric problems or a mental illness that has worsened due to treatment with 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 infection (of the mouth, genitals or eye, due to possible corneal perforation),
asthma,
ongoing therapy for blocked blood vessels due to blood 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 symptoms such as headache, sweating, palpitations and hypertension. 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 rarely cause infection under normal circumstances (called opportunistic infections). If you develop any infection during treatment with this medicine, consult your doctor immediately. This is particularly important in the 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.
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, contact your doctor immediately. You should also inform your doctor about past infectious diseases such as measles or chickenpox, and vaccinations against these diseases.
Contact your doctor if you experience any of the following: symptoms of tumour lysis syndrome, such as muscle cramps, muscle weakness, confusion, visual disturbances or loss of vision, and rapid breathing, if you have a haematological malignancy.
If you experience blurred vision or other visual disturbances, contact your doctor.
Treatment with this medicine may cause chorioretinopathy, an eye disease causing decreased visual acuity or visual disturbances. It usually affects one eye.
Therapy with this medicine may cause tendonitis. 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, surgical procedures, childbirth or illness, and the body may not be able to respond naturally to serious stress associated with accidents, surgery, childbirth or disease.
If an accident, illness or other physically stressful event occurs during or after treatment with Dexamethasone Krka, when a procedure (even dental) or vaccination (especially with live virus vaccines) is required, inform the treating doctor that you are taking steroids.
If undergoing suppression tests (detecting hormone levels in blood), skin allergy tests or bacterial infection tests, inform the person performing the tests that you are taking dexamethasone, as it may affect test results.
Your doctor may also recommend limiting salt intake and potassium supplementation during treatment.
In elderly patients, some side effects of this medicine may be more serious, particularly decreased bone density (osteoporosis), hypertension, hypokalaemia, diabetes, susceptibility to infections and skin thinning. Your doctor will closely monitor you during treatment.
Children and adolescents
When treating children, it is important that the doctor carefully monitors their growth and development at regular intervals. Dexamethasone should not be routinely used in premature infants with respiratory distress syndrome.
Dexamethasone Krka and 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 hypertension
Medicines used to treat heart disease
Diuretics (water tablets)
Intravenous amphotericin B
Phenytoin, carbamazepine, primidone (medicines used to treat epilepsy)
Rifabutin, rifampicin (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 gastric 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 tests assessing adrenal cortex function)
Sulpiride (used as a tranquiliser)
Cyclosporine (used to prevent transplant rejection)
Thalidomide (used, among others, in the treatment of plasma cell myeloma)
Praziquantel (a medicine 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 obtained 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 tests assessing adrenal cortex function)
Carbenoxolone (a medicine used to treat gastric ulcers)
Chloroquine, hydroxychloroquine, mefloquine (medicines used to treat malaria)
Medicines used to treat hypertension
Thalidomide (used, among others, in the treatment of plasma cell myeloma)
Live vaccines
Medicines that enhance muscle movement in myasthenia (e.g. neostigmine)
Antibiotics including erythromycin, fluoroquinolones

Before starting Dexamethasone Krka, read the patient leaflets of all medicines you will be taking
in combination with Dexamethasone Krka to obtain information about those medicines. If you
are taking thalidomide, lenalidomide or pomalidomide, pay special attention to the need for a
pregnancy test and the necessity of 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 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, consult your doctor or pharmacist before taking this medicine.
Dexamethasone Krka should be used during pregnancy, particularly in the first trimester, only if, in the doctor's opinion, 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 dexamethasone treatment for the woman.
Driving and operating machinery
Do not drive, operate machinery or perform any hazardous tasks if you experience adverse effects such as disorientation, hallucinations, dizziness, fatigue, somnolence, fainting or blurred vision.
Dexamethasone Krka contains lactose
If you have previously been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Dexamethasone Krka

This medicine should always be taken as directed by the physician. If in doubt, consult your doctor or pharmacist.
Dexamethasone Krka is available in tablet strengths of 4 mg, 8 mg, 20 mg, and 40 mg. Tablets may be divided into halves, providing additional strengths of 2 mg and 10 mg, and facilitating easier swallowing for the patient.
Please note that this is a medicinal product with a high dose.
It is recommended to use Dexamethasone Krka at the lowest effective dose.
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 adverse effects, the lowest effective dose should be used.
Unless otherwise directed by the physician, the following dosages are recommended:
The dosage recommendations listed below are for informational purposes only.
Initial and daily doses must always be determined based on individual patient response and disease severity.

Pemphigus: initial dose of 300 mg for three days, followed by dose reduction according to clinical needs.
Dermatomyositis and polymyositis: 40 mg for 4 days per cycle
Idiopathic thrombocytopenic purpura: 40 mg for 4 days per cycle.
Metastatic spinal cord compression: initial dose and duration of treatment depend on the cause and severity of the disease. In palliative care, very high doses may be used, up to a maximum of 96 mg. For optimal dosing and to reduce the number of tablets, tablets of lower strengths (4 mg and 8 mg) may be combined with higher strength tablets (20 mg or 40 mg).
Prophylaxis and treatment of nausea and vomiting induced by cytotoxic chemotherapy, emetogenic chemotherapy, in combination with other antiemetic medicines: 8–20 mg (one 20 mg tablet or half a 40 mg tablet) before chemotherapy, followed by 4–16 mg per day on days 2 and 3 of therapy.
Treatment of symptomatic multiple myeloma, acute lymphoblastic leukemia, Hodgkin’s disease, and non-Hodgkin’s lymphoma, in combination with other medicines: the usual dose is 40 mg or 20 mg once daily. The dose and frequency vary depending on the treatment regimen and concomitant medications. Dexamethasone administration should follow the dosing recommendations for dexamethasone described in the product characteristics of the other medicinal product 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
For long-term treatment of certain diseases, after initial therapy, the glucocorticoid should be switched from dexamethasone to prednisone or prednisolone to minimize suppression of the adrenal cortex.

Children and adolescents
When treating children, it is important that the physician carefully monitors growth and development at regular, short intervals.

Taking more than the recommended dose of Dexamethasone Krka
If an excessive number of tablets has been taken, contact a doctor immediately or go to the nearest hospital.

Missing a 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 reactions

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
You should inform your doctor immediately 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 unease, 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 there is an existing bowel disease.

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

Increased susceptibility to infections, including viral and fungal infections (e.g. candidiasis), reactivation of tuberculosis, or other infections such as 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 manifest 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 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); excessive hair growth (especially in women).
Weight gain, negative protein and 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 worsening of epilepsy, dizziness.
Increased intraocular pressure, eye swelling, thinning of the epithelium of the eye membranes, worsening of existing viral, fungal and bacterial 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 rupture and bleed, pancreatitis (which may present as back and abdominal pain), intestinal gas, oesophageal candidiasis.
Thin, delicate skin, unusual skin lesions, bruising, redness and skin inflammation, stretch marks, visible capillary network swelling, acne, excessive sweating, rash, swelling, hair loss, abnormal fat deposits, excessive body hair growth,

fluid retention in the body, pigmentary changes, weakening of capillaries
manifesting as subcutaneous bleeding (increased capillary fragility), skin irritation
around the mouth (perioral dermatitis).

Reduced bone density with increased risk of fractures (osteoporosis), bone diseases, tendon inflammation, tendon rupture, muscle atrophy, myopathy, muscle weakness, premature 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.
Withdrawal syndrome from corticosteroids 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 adverse reactions 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,
Faks: + 48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Dexamethasone Krka

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the abbreviation
"EXP". The expiry date refers to the last day of the stated month.
The batch number is indicated on the packaging after 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 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.
Dexamethasone Krka 20 mg tablets: Each tablet contains 20 mg of dexamethasone.
Dexamethasone Krka 40 mg tablets: Each tablet contains 40 mg of dexamethasone.
Other ingredients are monohydrate lactose, maize starch, pregelatinized starch, colloidal anhydrous silica, magnesium stearate. See section 2, “Dexamethasone Krka contains lactose”.

What Dexamethasone Krka looks like and contents of the pack
20 mg: White or almost white, round tablets with bevelled edges, with a division line and engraved marking "20" on one side (thickness: 4.0–6.0 mm; diameter: 10.7–11.3 mm). The tablet can be divided into equal doses.
40 mg: White or almost white, oval tablets with a division line on both sides (thickness: 6.0–8.0 mm; length: 18.7–19.3 mm). The tablet can be divided into equal doses.
Blister OPA/Aluminium/PVC/Aluminium 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 further 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 Warszawa
Tel. 22 57 37 500