Package leaflet: Information for the user

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

Keep this leaflet so that you can read it again if necessary.
If you have any 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 someone else, 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

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 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 (nerve compression of the spinal cord caused by a tumour), and for the prevention and treatment of nausea and vomiting induced by chemotherapy, in combination with antiemetic medicines.

2. 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 affective disorder (manic-depressive illness); this includes experiencing depression before or during treatment with corticosteroids such as dexamethasone;
if any of your close family members have had these conditions.

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

These disorders can be serious.
They usually appear within a few days or weeks after starting the medicine.
They occur more frequently 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 medical treatment.

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

kidney or liver disease (including cirrhosis or chronic liver failure),
pheochromocytoma (a tumour of the adrenal gland) 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,
previous muscle weakness caused by this or another corticosteroid,
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),
bladder problems or gastric ulcer,
psychiatric disorders or mental illness that has worsened due to treatment with this type of medicine,
epilepsy (a condition characterised by recurrent seizures or loss of consciousness),
migraine,
hypothyroidism,
parasitic infections,
tuberculosis, sepsis or fungal eye infection,
cerebral malaria,
herpes virus infection (of the lips, genital organs or eyes, due to possible corneal perforation),
asthma,
ongoing treatment for blood vessel blockage due to clots (thromboembolic disease),
corneal ulceration or corneal injury.

Treatment with this medicine may trigger a pheochromocytoma crisis, which can be life-threatening. Pheochromocytoma is a rare tumour of the adrenal gland. A crisis may present 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 infections. This may sometimes lead to infections caused by microorganisms that normally rarely cause disease (called opportunistic infections). If you develop any infection during treatment with this medicine, contact your doctor immediately. This is particularly important if you have 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 worm infections are common.
While taking this medicine, avoid contact with people who have chickenpox, shingles or measles. If you suspect possible exposure to any of these diseases, contact your doctor immediately. Inform your doctor about past infectious diseases such as measles or chickenpox, and about vaccinations received for these diseases.
Contact your doctor if the patient experiences 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 the patient has a haematological malignancy.
If the patient develops blurred vision or other visual disturbances, contact a doctor.
Treatment with this medicine may cause chorioretinopathy, an eye disease causing decreased visual acuity or visual disturbances. It usually affects one eye.
Treatment with this medicine may cause tendonitis. In very 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 experience pain, stiffness or swelling in joints or tendons.
Taking Dexamethasone Krka may lead to a condition called 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 accidents, surgery, childbirth or disease.
If an accident, illness or other physically stressful event occurs during or after treatment with Dexamethasone Krka, when surgery (even dental procedures) or vaccination (especially with live virus vaccines) is required, inform the treating physician that you are taking steroids.
If undergoing suppression tests (to detect hormone levels in blood), skin allergy tests or bacterial infection screening, inform the person performing the test that you are taking dexamethasone, as it may affect test results.
During treatment, your doctor may also recommend limiting salt intake and potassium supplementation.
In elderly patients, some side effects of this medicine may be more severe, particularly decreased bone density (osteoporosis), hypertension, 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 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 (NSAIDs), 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)
Antacids, 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 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 medicine)
Antibiotics including erythromycin, fluoroquinolones
Medicines that enhance muscle movement in myasthenia (e.g. neostygmine)
Cholestyramine (a medicine used for high cholesterol)
Oestrogen hormones, including oral contraceptives
Tetracosactide (used in adrenal cortex function testing)
Sulpiride (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 (NSAIDs), 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 adrenal cortex function testing)
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 multiple myeloma)
Live vaccines
Medicines that enhance muscle movement in myasthenia (e.g. neostygmina)
Antibiotics including erythromycin, fluoroquinolones

Before starting Dexamethasone Krka, read the patient information leaflets of all other medicines
you are taking in combination with Dexamethasone Krka to obtain information about them. If
taking thalidomide, lenalidomide or pomalidomide, special attention must be paid to pregnancy
testing and the need for effective contraception.
Dexamethasone Krka with food, drink and alcohol
Dexamethasone should be taken during or after meals to reduce gastrointestinal irritation. Avoid beverages containing alcohol or caffeine. It is recommended to eat small, frequent meals and, if advised by your doctor, to use antacids.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant or are planning to become pregnant, 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 treatment but inform your doctor immediately.
Corticosteroids may pass into breast milk. Risk to newborns or infants cannot be excluded. The decision whether to continue or discontinue breastfeeding or to continue or discontinue dexamethasone treatment should be made by weighing the benefits of breastfeeding for the child against the benefits of dexamethasone treatment for the mother.
Driving and using machines
Do not drive, operate machinery or perform any hazardous 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, consult your doctor before taking this medicine.

3. How to use Dexamethasone Krka

This medicine should always be used as directed by the physician. In case of doubt, consult your
doctor or pharmacist.
Dexamethasone Krka is available in tablet form in strengths of 4 mg, 8 mg, 20 mg, and 40 mg. Tablets
can be divided into halves, providing additional strengths of 2 mg and 10 mg, and making it easier for
the patient to swallow the tablet.
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 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.

Pemphigus: initial dose of 300 mg for three days, followed by dose reduction according to clinical needs.
Polymyositis: 40 mg for four days per cycle.
Idiopathic thrombocytopenic purpura: 40 mg for four consecutive 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, lower-strength tablets (4 mg and 8 mg) can be combined with higher-strength tablets
(20 mg or 40 mg).

Prevention and treatment of nausea and vomiting caused 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.

The dose and frequency of administration vary depending on the treatment regimen and other
medicines being used. Dexamethasone should be administered according to the dosing guidelines
for dexamethasone specified in the product characteristics of any other concomitantly used medicine,
if such information is provided. If not, national or international protocols and dosing guidelines
should be followed. The prescribing physician should carefully assess the appropriate dose in each
individual case, taking into account the patient's condition and disease.
Long-term treatment
In long-term treatment of certain diseases, after initial therapy, glucocorticoid therapy should be
switched from dexamethasone to prednisone or prednisolone 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 the growth
and development of children at regular intervals.
Use of a higher than recommended dose of Dexamethasone Krka
If an excessive amount 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 the missed dose.
Stopping Dexamethasone Krka treatment
If treatment needs to be discontinued, follow the doctor'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.
Steroid 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 as soon as possible.
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 adverse reactions, although not everyone will experience them.
You should immediately inform your doctor if serious psychiatric problems occur.
These may affect 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 unease, insomnia, difficulty thinking clearly, or feelings of confusion and memory loss,
experiencing, seeing or hearing things that are not real; unusual or frightening thoughts affecting behaviour or feelings of isolation.

You should immediately contact your doctor if you experience:

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

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

Increased susceptibility to infections, including viral and fungal infections such as 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 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 face (Cushingoid state), altered endogenous secretion following stress and trauma, surgical procedures, childbirth or illness; the body may be unable to respond appropriately in situations of severe stress such as accidents, surgery, childbirth or illness; growth suppression in children and adolescents; irregular menstrual cycle or amenorrhea (absence of menstruation); development of 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 drug discontinuation, 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 (protruding eyes), 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, delicate skin, unusual skin spots, bruising, redness and skin inflammation, stretch marks, visible capillary swelling, acne, excessive sweating, rash, swelling, hair loss, abnormal fat deposits, excessive body hair growth, fluid retention in the body, pigmentary disturbances, weakened capillaries visible as subcutaneous bleeding (increased capillary fragility), irritation of the skin around the mouth (perioral dermatitis).
Decreased bone density with increased risk of fractures (osteoporosis), bone disorders, tendonitis, tendon rupture, muscle atrophy, myopathy, muscle weakness, impaired bone growth (premature closure of epiphyseal plates).
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, inform your doctor, pharmacist or nurse. Adverse reactions 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
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Dexamethasone Krka

Keep the 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 in use. 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 20 mg of dexamethasone.
The other ingredients are monohydrate lactose, pregelatinized corn starch, colloidal anhydrous silica, magnesium stearate (E 470b). See section 2. "Dexamethasone Krka contains monohydrate lactose".

What Dexamethasone Krka looks like and contents of the pack
White or almost white, round tablets with bevelled edges, a score 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.
OPA/Al/PVC/Al blisters in a cardboard box.
Pack sizes: 20 x 1 tablet.
For more detailed information, please contact the responsible party or the parallel importer.
Responsible party in Spain, country of export:
TAD Pharma GmbH
Heinz-Lohmann-Straße 5
27472 Cuxhaven, Germany
Manufacturer:
Krka, d.d., Novo mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Spanish (country of export) marketing authorization number: 713561.6
Parallel import authorization number: 65/25

Dexamethasone krka