Pabi-dexamethason

Leaflet accompanying the packaging: information for the user

PABI-DEXAMETHASON, 20 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 further doubts, consult a doctor or pharmacist.
• 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 or pharmacist. 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 packaging and other information

1. What is PABI-DEXAMETHASON and what is it used for

PABI-DEXAMETHASON is a synthetic glucocorticosteroid. Glucocorticosteroids are hormones produced by the adrenal cortex. The described drug has anti-inflammatory, analgesic, and anti-allergic properties, as well as immunosuppressive effects.
PABI-DEXAMETHASON is indicated for the treatment of rheumatic and autoimmune diseases (e.g., muscle inflammation), skin diseases (e.g., common pemphigus), blood diseases (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 drugs, metastatic spinal cord compression (nerve compression in the spinal cord caused by a tumor), prevention and treatment of nausea and vomiting caused by chemotherapy, together with antiemetic drugs.

2. Important information before taking PABI-DEXAMETHASON

PABI-DEXAMETHASON should not be taken:

• In case of hypersensitivity to dexamethasone or any other component of this medicine (listed in section 6);
• In case of systemic infection (unless it is already being treated);
• In case of stomach or duodenal ulcer disease;
• In case of an upcoming vaccination with a live vaccine.

Warnings and precautions

Before taking PABI-DEXAMETHASON, consult a doctor or pharmacist:

• In case of a history of severe depression or manic-depressive illness (bipolar affective disorder); this means having had depression before or while taking steroid medications like dexamethasone;
• In case any of these illnesses have occurred in close family members.

Psychiatric disorders may occur during the use of steroids, such as PABI-DEXAMETHASON.

• These disorders can be severe.
• They usually appear within a few days or weeks of starting the medication.
• They occur more frequently when using high doses of the medicine.
• Most of these disorders disappear after reducing the dose or stopping the therapy. However, if such disorders occur, they may require treatment.

Consult a doctor if any signs of psychiatric disorders occur while taking this medicine. This is especially important in case of depression or suicidal thoughts. In a few cases, psychiatric disorders have occurred after reducing the dose or stopping the medication.
Consult a doctor before taking the medicine in case of:

• Kidney or liver disease (liver cirrhosis or chronic liver failure),
• Adrenal gland tumor (pheochromocytoma)
• Hypertension, heart disease, or recent heart attack (there have been cases of heart rupture),
• Diabetes or a history of diabetes in the family,
• Osteoporosis (bone mass loss), especially in postmenopausal women,
• A history of muscle weakness caused by this or another steroid medication,
• Glaucoma (excessive growth of pressure in the eyeball) or a history of glaucoma or cataracts in the family (lens clouding in the eye leading to vision impairment),
• Myasthenia gravis (a disease causing muscle weakness),
• Gastrointestinal diseases or stomach ulcers,
• Psychiatric problems or mental illness that has worsened due to the use of this type of medication,
• Epilepsy (a disease characterized by recurring losses of consciousness or seizures),
• Migraine,
• Hypothyroidism,
• Parasitic infections,
• Tuberculosis, sepsis, or fungal eye infection,
• Cerebral malaria,
• Herpes virus (oral or genital and eye, due to possible corneal perforation),
• Asthma,
• Ongoing therapy for blocked blood vessels due to blood clots (thromboembolic disease),
• Corneal ulcers and corneal injuries.

Treatment with corticosteroids may weaken the body's ability to fight infection. This can sometimes lead to the occurrence of infections caused by microorganisms that normally rarely cause infection (called opportunistic infections). If an infection occurs during treatment with this medicine, consult a doctor immediately. This is especially important in case of signs of pneumonia: cough, fever, shortness of breath, and chest pain. There may also be a feeling of disorientation, especially in the elderly. It is also necessary to inform the doctor about a history of tuberculosis or living in areas where infections with worms are common.
During the use of this medicine, it is essential to avoid contact with people suffering from chickenpox, shingles, or measles. If there is a suspicion of potential contact with any of these diseases, consult a doctor immediately. It is also necessary to inform the doctor about a history of infectious diseases, such as measles or chickenpox, and vaccinations against these diseases.
Consult a doctor if the patient experiences any of the following symptoms: symptoms of tumor lysis syndrome, such as muscle cramps, muscle weakness, confusion, vision disturbances, or loss of vision, and shortness of breath, in case the patient has a blood cancer.
If the patient experiences blurred vision or other vision disturbances, they should contact a doctor.
Treatment with this medicine may cause chorioretinopathy, an eye disease that impairs vision or causes vision 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 using certain antibiotics and kidney problems. Consult a doctor in case of pain, stiffness, or swelling of the joints or tendons.
Taking PABI-DEXAMETHASON may lead to a condition known as adrenal insufficiency. It may affect the effectiveness of the medicine in stressful situations or injury, surgery, childbirth, or illness, and the body may not be able to respond naturally to significant stress, such as accidents, surgery, childbirth, or illness.
If an accident, illness, or other special circumstances that put a physical strain on the body occur during or after treatment with PABI-DEXAMETHASON, and a procedure (even dental) or vaccination (especially with live virus vaccines) is necessary, inform the treating doctor about the use of steroids.
In the case of suppression tests (detecting hormone levels in the blood), skin allergy tests, or bacterial infection tests, inform the person performing the tests about the use of dexamethasone, as it may affect the test results.
During therapy, the doctor may also recommend reducing salt intake in the diet and potassium supplementation.
In the case of elderly patients, some side effects of using this medicine may be severe, particularly a decrease in bone density (osteoporosis), hypertension, low potassium levels, diabetes, susceptibility to infections, and skin thinning. The doctor will closely monitor the patient taking the medicine.

Children and adolescents

When using the medicine in children, it is essential for the doctor to carefully monitor the growth and development of children at short intervals. PABI-DEXAMETHASON should not be used routinely in premature infants with respiratory failure.

PABI-DEXAMETHASON 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 diseases
• Diuretics
• Amphotericin B administered by injection
• Phenytoin, carbamazepine, primidone, (medicines used to treat epilepsy)
• Rifabutin, rifampicin, isoniazid (antibiotic used to treat tuberculosis)
• Antacids, especially those containing magnesium trisilicate
• Barbiturates (medicines used to facilitate sleep and reduce anxiety)
• Aminoglutethimide (medicine used in cancer treatment)
• Carbenoxolone (medicine used to treat stomach ulcers)
• Ephedrine (medicine used to reduce swelling of nasal mucous membranes)
• Acetazolamide (medicine used to treat glaucoma and epilepsy)
• Hydrocortisone, cortisone, and other corticosteroids
• Ketoconazole, itraconazole (medicine used to treat fungal infections)
• Ritonavir (HIV)
• Antibiotics, including erythromycin, fluoroquinolones
• Medicines that support muscle movement in myasthenia (e.g., neostigmine)
• Cholestyramine (medicine used in case of high cholesterol levels)
• Estrogen hormones, including birth control pills
• Tetracosactide (used in the test to assess adrenal cortex function)
• Sultopride used as a sedative
• Cyclosporine used to prevent transplant rejection
• Thalidomide used, among others, in the treatment of multiple myeloma
• Praziquantel (medicine used to treat parasitic infections),
• Live vaccinations
• 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 those available without a prescription. You may be at increased risk of side effects when taking dexamethasone with

the following medicines:

• Some medicines may increase the effect of PABI-DEXAMETHASON, and the doctor may want 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 diseases
• Diuretics
• Amphotericin B administered by injection
• Acetazolamide (medicine used to treat glaucoma and epilepsy)
• Tetracosactide (used in the test to assess adrenal cortex function)
• Carbenoxolone (medicine used to treat stomach 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 vaccinations
• Medicines that support muscle movement in myasthenia (e.g., neostigmine)
• Antibiotics, including erythromycin, fluoroquinolones

Before starting to take PABI-DEXAMETHASON, read the patient information leaflets of all medicines that you will be taking in combination with PABI-DEXAMETHASON to obtain information about these medicines. When using thalidomide, lenalidomide, or pomalidomide, pay special attention to performing a pregnancy test and the need to prevent pregnancy.

PABI-DEXAMETHASON with food, drinks, and alcohol

Dexamethasone should be taken during or after a meal to reduce irritation of the digestive tract. Avoid drinks containing alcohol or caffeine. It is recommended to eat small, frequent meals and possibly use antacids, if advised by a doctor.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult a doctor or pharmacist before taking this medicine.
PABI-DEXAMETHASON should be used during pregnancy, especially in the first trimester, only if the doctor believes that the benefit to the mother outweighs the potential risk to the fetus.
If you become pregnant while taking PABI-DEXAMETHASON, do not stop taking it, but inform your doctor about the pregnancy immediately.
Corticosteroids may pass into breast milk. The risk to newborns or infants cannot be excluded. The decision to continue or stop breastfeeding or to continue or stop 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 using machines

Do not drive vehicles, operate equipment, or machines, or perform any hazardous tasks if you experience side effects such as disorientation, hallucinations, dizziness, fatigue, drowsiness, fainting, or blurred vision.
PABI-DEXAMETHASON contains lactose monohydrate
Each PABI-DEXAMETHASON 20 mg tablet contains 370 mg of lactose (185 mg of glucose and 185 mg of galactose).
This should be taken into account in patients with diabetes.
The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

3. How to take PABI-DEXAMETHASON

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
PABI-DEXAMETHASON comes in 4 mg, 8 mg, and 20 mg tablets. The 20 mg tablets can be divided into two halves to obtain an additional product strength (10 mg) or to facilitate swallowing for the patient.

Remember that this is a high-dose medicinal product.

It is recommended to use the medicine in the smallest effective dose.

Dexamethasone is usually administered in doses of 0.5 mg to 10 mg per day, depending on the disease being treated. In more severe disease states, doses above 10 mg per day may be necessary. The dose should be determined based on individual patient responses and the severity of the disease. To minimize side effects, the smallest effective dose should be used.

If the doctor does not recommend otherwise, the following doses are recommended:

The dosing recommendations below are for informational purposes only.

Initial and daily doses should always be determined based on individual patient responses and the severity of the disease.

• Pemphigus:initial dose of 300 mg for three days, followed by a reduction in dose according to clinical needs.
• Muscle inflammation:40 mg for 4 days in a cycle
• Idiopathic thrombocytopenic purpura:40 mg for 4 days in cycles.
• Metastatic spinal cord compression:initial dose and duration of treatment depending on the causes and severity of the disease. In palliative care, very high doses may be used, up to 96 mg.

For optimal dosing and to reduce the number of tablets, it is possible to combine tablets of lower strength (4 mg and 8 mg) with tablets of higher strength (20 mg).

Prevention and treatment of vomiting caused by cytostatics, emetogenic chemotherapy

together with other antiemetic medicines:from 8 mg to 20 mg (one 20 mg tablet) before chemotherapy, and then from 4 mg to 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:

usually, the dose used is 40 mg or 20 mg once a day.
The dose and frequency of administration vary depending on the treatment regimen and other medicines being taken. The administration of dexamethasone should be carried out in accordance with the dosing instructions for dexamethasone described in the summary of product characteristics of the other medicine being taken, if they are included. If not, follow national or international protocols and dosing guidelines. The doctor prescribing the medicine should carefully assess the appropriate dose in each case, taking into account the patient's condition and their disease.
Long-term treatment
In the case of long-term treatment of several diseases, after initial therapy, it is recommended to switch from dexamethasone to prednisone or prednisolone to limit the inhibitory effect on the adrenal cortex.

Children and adolescents

When using the medicine in children, it is essential for the doctor to carefully monitor the growth and development of children at short intervals.

Overdose of PABI-DEXAMETHASON

In case of taking too many tablets, contact a doctor or go to the nearest hospital immediately.

Missed dose of PABI-DEXAMETHASON

In case of a missed dose, 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 treatment with PABI-DEXAMETHASON

In case of needing to stop the therapy, follow the doctor's recommendations. They may include gradually reducing the dose of the medicine until it is completely stopped. Symptoms that may occur after too rapid cessation of therapy include decreased blood pressure, and in some cases, recurrence of the original disease.
It may also cause a corticosteroid withdrawal syndrome, including fever, muscle and joint pain, nasal inflammation (rhinitis), weight loss, itching, and eye inflammation (conjunctivitis). If any of these symptoms occur after too rapid cessation of the medicine, contact a doctor as soon as possible.
If you have any further questions about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Immediately inform your doctor about serious psychiatric disorders. They may occur in about 5 out of 100 people taking medicines like dexamethasone. These disorders include:

• feeling depressed, including suicidal thoughts,
• feeling euphoric (mania) or mood swings,
• feeling uncertain, insomnia, trouble thinking, or feeling lost and memory loss,
• perceiving, seeing, or hearing things that do not exist; unusual or frightening thoughts that affect behavior or feeling lonely.

Immediately inform your doctor about:

• severe abdominal pain, nausea, vomiting, diarrhea, significant muscle weakness, and fatigue, extremely low blood pressure, weight loss, and fever, as they may indicate adrenal insufficiency;
• sudden abdominal pain, tenderness, nausea, vomiting, fever, and blood in the stool, as they may be symptoms of intestinal rupture, especially in the case of existing intestinal disease.

This medicine may worsen existing heart diseases. If you experience shortness of breath or swelling of the ankles, contact a doctor immediately.
Other side effects include (frequency not known):

• Increased susceptibility to infections, including viral and fungal infections, e.g., thrush, recurrence of tuberculosis, or other infections, e.g., previously diagnosed eye infections.
• Decreased or increased white blood cell count, blood clotting disorders.
• Allergic reactions to the medicine, including severe, life-threatening allergic reactions (which may manifest as a rash, throat or tongue swelling, and in severe cases, difficulty breathing or dizziness).
• Disorders of hormonal regulation in the body, swelling, and weight gain, moon face (Cushing's syndrome), change in effective hormone secretion in response to stress and trauma, surgical procedures, childbirth, or illness, the body may not be able to respond properly to stressful situations, such as accidents, surgery, childbirth, or illness, growth inhibition in children and adolescents, irregular menstrual cycle or loss of menstrual cycle (amenorrhea), excessive hair growth (hirsutism), especially in women.
• Weight gain, negative protein and calcium balance, increased appetite, electrolyte imbalance, water retention, potassium loss, which can cause heart rhythm disturbances, increased need for antidiabetic medicines, occurrence of latent diabetes symptoms, high cholesterol and triglyceride levels in the blood (hypercholesterolemia and hypertriglyceridemia).
• Severe mood swings, schizophrenia (a mental disorder) may worsen, depression, insomnia.
• Severe, non-standard headaches with vision disturbances related to withdrawal of the medicine, seizures, and worsening of epilepsy, dizziness.
• Increased eye pressure, eye swelling, thinning of the eye's surface layers, worsening of existing viral, fungal, and bacterial eye infections, exophthalmos, cataracts, vision disturbances, loss of vision, blurred vision.
• Congestive heart failure in susceptible patients, heart rupture after a recent heart attack, heart failure.
• Hypertension, blood clots, formation of blood clots that can block blood vessels, for example, in the legs or lungs (thromboembolic complications).
• Hiccup.
• Nausea, vomiting, discomfort in the stomach, and abdominal bloating, inflammation, and ulcers in the esophagus, stomach ulcers, which can rupture and bleed, pancreatitis (which may manifest as back and abdominal pain), intestinal gas, thrush of the esophagus.
• Thin, fragile skin, unusual skin spots, bruising, redness, and inflammation of the skin, stretch marks, visible swelling of blood vessels, acne, excessive sweating, rash, swelling, hair loss, unnatural fat deposits, excessive hair growth on the body, water retention, skin discoloration, weakening of blood vessels visible as subcutaneous bleeding (increased brittleness of blood vessels), irritation of the skin around the mouth (perioral dermatitis).

Decreased bone density with a higher risk of fractures (osteoporosis), bone diseases, tendonitis, tendon rupture, muscle atrophy, myopathy, muscle weakness, premature closure of bone growth plates (premature epiphyseal closure).

• Changes in sperm count and motility, impotence.
• Impaired response to vaccination and skin tests, slow wound healing, discomfort, malaise.
• It may also cause a corticosteroid withdrawal syndrome, including fever, muscle and joint pain, nasal inflammation (rhinitis), weight loss, itching, and eye inflammation (conjunctivitis).

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or pharmacist. Side effects can also be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 40 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

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month.
There are no special storage instructions for the medicinal product.
Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What PABI-DEXAMETHASON contains

The active substance of the medicine is dexamethasone.
Each PABI-DEXAMETHASON 20 mg tablet contains 20 mg of dexamethasone.
The other ingredients of the medicine are lactose monohydrate, maize starch, colloidal anhydrous silica, magnesium stearate, and sodium stearyl fumarate.
See section 2. "PABI-DEXAMETHASON contains lactose monohydrate".

What PABI-DEXAMETHASON looks like and contents of the pack

White or almost white, round, flat tablets with a dividing line on one side. The tablet can be divided into two equal doses.
Blisters of PVC/PVDC90/Aluminum in a cardboard box.
PABI-DEXAMETHASON, 20 mg, tablets are available in packs of 20 and 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

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

Manufacturer

Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice

Date of last revision of the leaflet: