Pabi-dexamethason

Leaflet attached to the packaging: patient information

Pabi-Dexamethason, 500 micrograms (μg), tablets

Pabi-Dexamethason, 1 mg, tablets

Dexamethasone

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. 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 side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Pabi-Dexamethason and what is it used for
• 2. Important information before taking Pabi-Dexamethason
• 3. How to take Pabi-Dexamethason
• 4. Possible side effects
• 5. How to store Pabi-Dexamethason
• 6. Contents of the pack and other information

1. What is Pabi-Dexamethason and what is it used for

Dexamethasone - the active substance of Pabi-Dexamethason - is a synthetic adrenal cortex hormone from the group of glucocorticosteroids for oral use with long-lasting and very strong anti-inflammatory, anti-allergic, antipyretic, and immunosuppressive effects.
Indications for use:
Diseases that respond to glucocorticosteroid treatment. As an auxiliary in controlling brain edema.
Pabi-Dexamethason is used in the treatment of COVID-19 in adult patients and adolescents (aged 12 and older with a body weight of at least 40 kg), requiring oxygen therapy.

2. Important information before taking Pabi-Dexamethason

When not to take Pabi-Dexamethason

Pabi-Dexamethason should not be used in the following cases:

• If the patient is allergic to dexamethasone or any of the other ingredients of this medicine (listed in section 6).
• In systemic infections, unless anti-infective therapy is being used.
• Live vaccinations.

Warnings and precautions

Before starting Pabi-Dexamethason, discuss it with your doctor, pharmacist, or nurse.
Treatment should be carried out with the smallest effective dose of dexamethasone. If possible, the dose should be reduced gradually.
General precautions for the use of steroid drugs in certain diseases, masking infections, concomitantly used drugs, etc. should be observed in accordance with current recommendations.
Pabi-Dexamethason should not be administered in COVID-19 disease in patients who do not require oxygen or mechanical ventilation, due to the lack of therapeutic benefits and the risk of worsening the patient's condition in this group.
During the use of glucocorticosteroids, mental disorders may occur, from euphoria, insomnia, mood changes, and personality changes to severe depression and psychotic symptoms. The doctor should be informed about any previous emotional instability, psychotic tendencies, or past diseases, such as depression or manic-depressive syndrome. Symptoms accompanying these conditions may worsen under the influence of glucocorticosteroids.
Glucocorticosteroids may mask certain symptoms of inflammation, and during their use, new infections may occur. During the use of glucocorticosteroids, reduced resistance and difficulties in localizing infections may occur.
Patients treated with immunosuppressive doses of glucocorticosteroids should not be vaccinated with live viral vaccines (e.g., smallpox, measles) due to the risk of neurological disorders and ineffective immunization.
The doctor should be informed about past infectious diseases, such as chickenpox, measles, and vaccinations received, as well as in the event of exposure to any of the mentioned diseases.
During the use of dexamethasone, exposure to viral diseases (chickenpox, measles) should be avoided, especially if the patient has not had these diseases in the past.
Glucocorticosteroids may activate latent amoebiasis.
Particular caution should be exercised when using glucocorticosteroids in the following diseases (the doctor should be informed about them before starting dexamethasone):

• osteoporosis (particularly in postmenopausal women),
• hypertension or congestive heart failure,
• severe mental illnesses (especially post-traumatic) currently or in the past,
• diabetes (or a family history of diabetes),
• tuberculosis in the past,
• glaucoma (or a family history of glaucoma),
• steroid-induced muscle weakness in the past,
• liver failure,
• kidney failure,
• hypothyroidism,
• epilepsy,
• stomach ulcers,
• migraines,
• growth inhibition,
• certain parasitic infections. Particular caution should be exercised when using glucocorticosteroids after a recent myocardial infarction. After administration of glucocorticosteroids, severe anaphylactoid reactions may occur, such as laryngeal edema, urticaria, bronchospasm, especially in patients with a history of allergies. The doctor should be informed about all medicines being taken by the patient currently or recently, including those available without a prescription. Some medicines may enhance the effect of Pabi-Dexamethason, and the doctor may want to carefully monitor the condition of the patient taking such medicines (including certain HIV medicines: ritonavir, cobicistat).

If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.
Taking Pabi-Dexamethason may cause a pheochromocytoma crisis, which can be fatal. Pheochromocytoma is a rare adrenal gland tumor. The crisis may manifest with the following symptoms: headaches, sweating, palpitations, and hypertension. If any of these symptoms occur, the patient should immediately contact their doctor.
The doctor should be consulted, even if the above warnings concern situations that occurred in the past.

Children and adolescents

Caution should be exercised when using dexamethasone in children.
Dexamethasone should not be routinely used in premature infants with respiratory problems.
Children's growth and development should be carefully monitored during long-term use of glucocorticosteroids.

Pabi-Dexamethason and other medicines

The doctor should be informed about all medicines being taken by the patient currently or recently, as well as any medicines the patient plans to take.
Pabi-Dexamethason should be used with caution with the following medicines:

• phenytoin, carbamazepine, primidone, phenobarbital (medicines used to treat epilepsy),
• rifampicin, rifabutin (antibiotics),
• antacids, especially those containing magnesium silicate (medicines used to treat stomach disorders),
• aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, (medicines used to treat pain and inflammation),
• medicines used to treat diabetes, including insulin,
• antihypertensive and diuretic medicines,
• ritonavir, indinavir, or saquinavir (antiviral medicines used to treat HIV),
• methotrexate (a medicine used to treat cancer and inflammatory conditions),
• oral contraceptives containing estrogen and progestogen,
• anticoagulant medicines derived from coumarin (prothrombin time control required),
• medicines used to lower potassium levels,
• acetazolamide (a medicine used, among other things, to treat glaucoma, epilepsy),
• ephedrine (a medicine used, among other things, locally to constrict blood vessels in inflammatory conditions of the nasal mucosa).

Other steroid medicines should not be discontinued unless advised by a doctor.

Pabi-Dexamethason with food and drink

The medicine should be taken with meals.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.
The medicine may only be used if, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the fetus. Children of mothers treated with high doses of glucocorticosteroids during pregnancy should be monitored due to the risk of adrenal insufficiency.
Glucocorticosteroids pass into breast milk and may disrupt growth, endogenous production of glucocorticosteroids, and cause other adverse effects. Mothers treated with glucocorticosteroids should not breastfeed.

Using Pabi-Dexamethason in patients with kidney and/or liver disorders

The medicine should be used with caution in patients with liver and/or kidney disorders.

Using Pabi-Dexamethason in elderly patients

Pabi-Dexamethason should be used in accordance with the doctor's recommendations. Adverse reactions may have a more severe course in older people, particularly regarding osteoporosis, hypertension, hypokalemia (low potassium levels in the blood), diabetes, susceptibility to infections, and skin thinning.

Driving and operating machinery

There is no data on the effect of dexamethasone on the ability to drive and operate machinery.

Pabi-Dexamethason contains lactose

Pabi-Dexamethason contains lactose. If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Pabi-Dexamethason

This medicine should always be used in accordance with the doctor's recommendations. The doctor will decide how long to take dexamethasone. In case of doubts, consult a doctor.
Doses are determined individually, depending on the type of disease and the patient's response to treatment.
Adults: usually 0.5 mg to 10 mg per day, depending on the type of disease.
If the medicine is discontinued after administration for more than a few days, it should be discontinued gradually.

Use in children

Children: 0.01 mg to 0.1 mg per kilogram of body weight.

In the treatment of COVID-19

In adult patients in the treatment of COVID-19, a dose of 6 mg per day should be used, orally, for up to 10 days.
In adolescents (aged 12 and older), 6 mg should be administered orally once a day for up to 10 days.

Taking a higher dose of Pabi-Dexamethason than recommended

In the event of an overdose, there is no specific antidote. Treatment is symptomatic and supportive.
In the event of taking a higher dose of the medicine than recommended, the patient should immediately consult a doctor or pharmacist.

Missing a dose of Pabi-Dexamethason

A double dose should not be taken to make up for a missed dose.

Discontinuing Pabi-Dexamethason

If the medicine is discontinued after use for more than a few days, it should be discontinued gradually.
Long-term use of glucocorticosteroids and sudden discontinuation of these medicines may lead to withdrawal symptoms: fever, muscle pain, joint pain, and malaise.
In case of any further doubts related to the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Pabi-Dexamethason can cause side effects, although not everybody gets them.
Consult a doctor if any of the following side effects occur.
Frequency not known (frequency cannot be estimated from the available data)

• increased susceptibility and severity of infections with suppressed clinical symptoms, resistant infections, recurrence of inactive tuberculosis, reduced response to vaccines and skin tests, hypersensitivity reactions, including anaphylaxis, allergic dermatitis, urticaria, angioedema.
• disorders of hormone secretion by the hypothalamus, pituitary gland, and adrenal glands, growth inhibition in infants, children, and adolescents, menstrual disorders, amenorrhea, Cushing's syndrome, hirsutism (excessive male-type hair growth in women), decreased glucose tolerance, increased insulin requirements and antidiabetic drugs, premature bone aging.
• weight gain, negative nitrogen and calcium balance, increased appetite, sodium and water retention, potassium loss, hypokalemic alkalosis.
• affective disorders (irritability, euphoria, depression, and mood changes, suicidal thoughts), psychiatric reactions (mania, hallucinations, delusions, worsening of schizophrenia), behavioral disorders, nervousness, anxiety, sleep disorders, cognitive function disorders (disorientation, memory lapses).
• seizures, worsening of epilepsy, increased intracranial pressure, and papilledema (pseudo brain tumor), dizziness, headaches, psychological dependence.
• posterior subcapsular cataract, increased intraocular pressure, glaucoma, congestive heart failure, exophthalmos, thinning of the cornea and sclera, exacerbation of viral and fungal eye diseases, blurred vision.
• thrombosis with embolism, rupture of the heart muscle after a recent myocardial infarction, hypertension.
• indigestion, peptic ulcer with possible perforation and bleeding, acute pancreatitis, fungal infection, esophageal ulceration, bloating, vomiting, nausea.
• impaired wound healing, bruising, skin thinning, ecchymoses, and petechiae, flushing, striae, acne, increased sweating.
• osteoporosis, vertebral and long bone fractures, bone necrosis, tendon rupture, muscle weakness.
• leukocytosis (increased white blood cell count), hiccups, malaise.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Pabi-Dexamethason

The medicine should be stored in a place invisible and inaccessible to children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Store in a temperature below 25°C, protect from light.

6. Contents of the pack and other information

What Pabi-Dexamethason contains

• The active substance of the medicine is dexamethasone. One tablet contains 500 μg or 1 mg of dexamethasone.
• The other excipients are: lactose monohydrate, potato starch, gelatin, magnesium stearate.

What Pabi-Dexamethason looks like and contents of the pack

White or slightly yellowish tablets, round, flat on both sides, scored on both sides; one side marked "Dx", the other side with a dividing line.
Pabi-Dexamethason, 500 μg tablets
PVC/Aluminum blisters or orange glass vials with a polyethylene (LDPE) cap, in a cardboard box.
20 tablets in a blister pack.
20 tablets in a vial.
Pabi-Dexamethason, 1 mg tablets
PVC/Aluminum blisters or orange glass vials with a polyethylene (LDPE) cap, in a cardboard box.
20 tablets in a blister pack.
20 tablets in a vial.

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Date of last revision of the leaflet: