Dexamethasone krka: detailed information

Package leaflet: Information for the user

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Dexamethasone Krka (Dexamethason HCS 40 mg)
40 mg, tablets
Dexamethasonum
Dexamethasone Krka and Dexamethason HCS 40 mg are different brand names of 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 further questions, please 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 the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

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 medicinal product has anti-inflammatory, analgesic, antiallergic and immunosuppressive properties.
Dexamethasone Krka is indicated in the treatment of rheumatic and autoimmune diseases (e.g. dermatomyositis), skin disorders (e.g. pemphigus vulgaris), blood disorders (e.g. idiopathic thrombocytopenic purpura in adults), symptomatic multiple myeloma, acute lymphoblastic leukaemia, Hodgkin's disease and non-Hodgkin's lymphoma in combination with other medicinal products, metastatic spinal cord compression (pressure on 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 using Dexamethasone Krka

Do not use Dexamethasone Krka:

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

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

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 members of your immediate family have had these conditions.

Psychiatric problems may occur during treatment with steroids such as Dexamethasone Krka.

These disorders may 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 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 using this medicine if you have:

kidney or liver disease (including 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 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 cataract (clouding of the eye lens leading to impaired vision),
myasthenia gravis (a disease causing muscle weakness),
bladder or stomach ulcer disease,
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 infection,
tuberculosis, sepsis or fungal eye infection,
cerebral malaria,
herpes virus infection (of the lips, genitals or eyes, due to possible corneal perforation),
asthma,
ongoing treatment 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 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 you develop any infection while being treated with this medicine, contact 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. You should also 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 previous infectious diseases such as measles or chickenpox, and vaccinations against these diseases.
Contact your doctor if you experience any of the following: tumour lysis syndrome symptoms such as muscle cramps, muscle weakness, confusion, visual disturbances or loss of vision, and shallow breathing, especially 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.
Treatment with this medicine may cause tendonitis. In extremely rare cases, tendon rupture may occur. This risk increases when combined with certain antibiotics or in patients with kidney problems. Contact your doctor if you notice pain, stiffness or swelling of joints or tendons.
Taking Dexamethasone Krka may lead to a condition known as adrenal insufficiency. This may affect the body's response during stress or injury, surgery, childbirth or illness, and the body may not be able to react naturally to serious physical stress caused by an accident, operation, childbirth or disease.
If you have an accident, illness or other physically stressful event during or after treatment with Dexamethasone Krka, or if you require a procedure (even dental) or vaccination (especially with live virus vaccines), inform the treating doctor that you are taking steroids.
If undergoing suppression tests (to detect 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.
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 you 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 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 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 (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)
Oestrogen hormones including oral contraceptives
Tetracosactide (used in tests to assess 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 (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)
Amphotericin B administered by injection
Acetazolamide (a medicine used to treat glaucoma and epilepsy)
Tetracosactide (used in tests to assess 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. neostygmine)
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
pregnancy testing and the need for contraception.
Dexamethasone Krka with food, drink and alcohol
Dexamethasone should be taken during or after meals to reduce gastrointestinal irritation. Avoid drinks 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, you should consult your doctor or pharmacist before using this medicine.
Dexamethasone Krka should be used during pregnancy, particularly in 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 monohydrate
If you have been previously diagnosed with intolerance to certain sugars, you should contact your doctor before taking this medicine.

3. How to use Dexamethasone Krka

This medicine should always be used as directed by the physician. If in doubt, consult your 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, which facilitates swallowing for the patient.
Please note that this is a high-dose medicinal product.
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 necessary. 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 doses are recommended:
The dosing recommendations below are provided 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: 40 mg for four days per cycle.
Idiopathic thrombocytopenic purpura: 40 mg for four consecutive days in cycles.
Metastatic spinal cord compression: initial dose and duration of treatment depend on the underlying cause and disease severity. 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, lower-strength tablets (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 the second and third days 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.

Dosage and frequency vary depending on the treatment regimen and concomitant medications. Dexamethasone administration should follow the dosing guidelines for dexamethasone specified in the product characteristics of any co-administered medicine, if provided. If not, national or international protocols and dosing guidelines should be followed. The prescribing physician must carefully assess the appropriate dose in each individual case, taking into account the patient’s condition and underlying disease.
Long-term treatment
In long-term treatment of certain conditions, after initial therapy, a switch from dexamethasone to prednisone or prednisolone should be considered to reduce the suppressive effect on the adrenal cortex.
Children and adolescents
When using this medicine in children, it is important that the physician closely monitors growth and development at regular intervals.
Use of a higher than recommended dose of Dexamethasone Krka
If an excessive amount of tablets has been taken, seek immediate medical advice from a doctor or go to the nearest hospital.
Missed dose of Dexamethasone Krka
If a dose is missed, it should be taken as soon as possible. If the next dose is due soon, only one dose should be taken. 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 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 ocular 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 side effects, although not everybody gets them.
You should inform your doctor immediately if serious psychiatric problems occur.
These may occur in about 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 there; unusual or frightening thoughts affecting behaviour or feelings of isolation.

You should inform your doctor immediately if any of 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 in patients with existing bowel disease.

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

Increased susceptibility to infections, including viral and fungal infections such as 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 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, fluid retention and weight gain, moon face (Cushingoid state), altered endogenous secretion due to 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 amenorrhea (absence of menstruation); development of excessive hair growth (particularly in women).
Weight gain, negative calcium and protein balance, increased appetite, electrolyte imbalance, fluid retention, 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 corneal epithelium, worsening of existing viral, fungal and bacterial eye infections, exophthalmos, cataracts, 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 perforate and bleed, pancreatitis (which may present as back and abdominal pain), intestinal gas, oesophageal candidiasis.
Thin, fragile skin, unusual skin lesions, 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, pigmentary changes, weakened capillaries visible as subcutaneous bleeding (increased capillary fragility), perioral dermatitis (inflammation of the skin around the mouth).
Reduced bone density with increased risk of fractures (osteoporosis), bone diseases, tendonitis, tendon rupture, 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 effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can also 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Dexamethasone Krka

Keep the medicine out of the 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 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 packaging and other information

What Dexamethasone Krka contains

The active substance is dexamethasone. Each tablet contains 40 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, 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.
OPA/Aluminium/PVC/Aluminium blister in a cardboard box.
Pack sizes: 10x1, 20x1, 30x1, 60x1 and 100x1 tablets.
For more detailed information, please contact the marketing authorisation holder or parallel importer.
Marketing authorisation holder in Austria, country of export:
HCS bvba
H. Kennisstraat 53
2650 Edegem
Belgium
Manufacturer:
TAD Pharma GmbH
Heinz-Lohmann-Str. 5
27472 Cuxhaven
Germany
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
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Austrian marketing authorisation number, country of export: 138043
Parallel import authorisation number: 351/22