Pabi-dexamethason

Package Leaflet: Information for the Patient

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, you may need to read it again.
• 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 not listed in this leaflet, they should inform 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 (12 years of age 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 administered.
• Live vaccinations.

Warnings and precautions

Before starting Pabi-Dexamethason, discuss it with your doctor, pharmacist, or nurse.
The treatment should use 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 condition in this group of patients.
During the use of glucocorticosteroids, mental disorders may occur, from euphoria, insomnia, mood changes, and personality changes to severe depression and psychotic symptoms. The patient should inform the doctor 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 some 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 ineffectiveness of immunization.
The patient should inform the doctor about past infectious diseases, such as chickenpox, measles, and vaccinations received, as well as in the event of exposure to any of these 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 patient should inform the doctor before starting dexamethasone treatment):

• osteoporosis (particularly in postmenopausal women),
• hypertension or congestive heart failure,
• severe mental disorders (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,
• gastric ulcer,
• migraine,
• growth retardation,
• 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 patient should tell the doctor about all medicines being taken, including those obtained without a prescription. Some medicines may enhance the effect of Pabi-Dexamethason, and the doctor may want to carefully monitor the patient's condition when 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 patient should consult a doctor, even if the above warnings concern situations that have 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 patient should tell their doctor about all medicines being taken, including those obtained without a prescription, and those planned to be taken.
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 (requiring control of prothrombin time),
• medicines used to lower potassium levels,
• acetazolamide (a medicine used, among others, to treat glaucoma, epilepsy),
• ephedrine (a medicine used, among others, locally to constrict blood vessels in inflammatory conditions of the nasal mucosa).

The patient should not stop taking other steroid medicines without consulting their 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 taking 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 human milk and may disrupt growth, endogenous production of glucocorticosteroids, and cause other side effects. Mothers treated with glucocorticosteroids should not breastfeed.

Using Pabi-Dexamethason in Patients with Kidney or Liver Impairment

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

Using Pabi-Dexamethason in Elderly Patients

Pabi-Dexamethason should be used according to the doctor's recommendations. Side effects may be more severe in older people, particularly 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 according to 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 (12 years of age and older), 6 mg should be administered orally once a day for up to 10 days.

Taking a Higher Than Recommended Dose of Pabi-Dexamethason

In case of overdose, there is no specific antidote. Treatment is symptomatic and supportive.
In case of taking a higher dose 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.

Stopping Pabi-Dexamethason Treatment

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.
The patient should consult a doctor if they experience any of the following side effects.
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 retardation in infants, children, and adolescents, menstrual disorders, amenorrhea, Cushing's syndrome, hirsutism (excessive hair growth in women), decreased glucose tolerance, increased insulin requirements and antidiabetic drugs, premature epiphyseal closure.
• 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 (pseudotumor cerebri), 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.
• gastric upset, 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, aseptic necrosis of bone, tendon rupture, muscle weakness.
• leukocytosis (increased white blood cell count), hiccups, malaise.

Reporting Side Effects

If the patient experiences any side effects, including any not listed in the leaflet, they 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 to gather more information on the safety of the medicine.

5. How to Store Pabi-Dexamethason

The medicine should be stored 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 month.
Store in a temperature below 25°C, protected 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, with a score line on one side and "Dx" on the other.
Pabi-Dexamethason, 500 μg tablets
PVC/Aluminum blisters or orange glass bottles with a polyethylene (LDPE) cap, in a cardboard box.
20 tablets in a blister.
20 tablets in a bottle.
Pabi-Dexamethason, 1 mg tablets
PVC/Aluminum blisters or orange glass bottles with a polyethylene (LDPE) cap, in a cardboard box.
20 tablets in a blister.
20 tablets in a bottle.

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: