Pabi-dexamethason

Leaflet accompanying the packaging: information for the user

PABI-DEXAMETHASON, 4 mg, tablets

PABI-DEXAMETHASON, 8 mg, tablets

Dexamethasone

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person. 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 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., systemic lupus erythematosus, rheumatoid arthritis, juvenile idiopathic arthritis, giant cell arteritis), respiratory diseases (e.g., bronchial asthma, croup), skin diseases (e.g., erythroderma, common pemphigus), tuberculous meningitis exclusively in combination with anti-infective therapy, blood diseases (e.g., idiopathic thrombocytopenic purpura in adults), cerebral edema, symptomatic treatment of multiple myeloma, acute lymphoblastic leukemia, Hodgkin's disease, and non-Hodgkin's lymphoma in combination with other drugs, palliative treatment of cancer, prevention and treatment of nausea and vomiting caused by chemotherapy, as well as prevention of vomiting after surgery together with antiemetic drugs.

2. Important information before taking PABI-DEXAMETHASON

When not to take PABI-DEXAMETHASON

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

Warnings and precautions

Before taking PABI-DEXAMETHASON, you should 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 medicines like dexamethasone;
• In case any of your close relatives have had these illnesses.

Psychiatric disorders can occur during treatment with steroids like PABI-DEXAMETHASON.

• These disorders can be severe.
• They usually appear within a few days or weeks of starting treatment.
• They occur more frequently when high doses of the medicine are used.
• Most of these disorders disappear after the dose is reduced or treatment is stopped. However, if such disorders occur, they may require treatment.

You should consult a doctor if you experience any signs of psychiatric disorders while taking this medicine. This is especially important if you have depression or thoughts of suicide. In a few cases, psychiatric disorders have occurred after the dose was reduced or treatment was stopped.

You should consult a doctor before taking the medicine if you have:

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

Treatment with corticosteroids can weaken the body's ability to fight infection. This can sometimes lead to the occurrence of infections caused by microorganisms that normally do not cause infection (called opportunistic infections). If an infection occurs during treatment with this medicine, you should immediately consult a doctor. This is especially important in case of symptoms of pneumonia: cough, fever, shortness of breath, and chest pain. You may also experience a feeling of disorientation, especially in the elderly. You should also inform your doctor about a history of tuberculosis or living in areas where infections with worms are common.

While taking this medicine, it is essential to avoid contact with people who have chickenpox, shingles, or measles. If you suspect potential contact with any of these diseases, you should immediately consult a doctor. You should also inform your doctor about any history of infectious diseases, such as measles or chickenpox, and any vaccinations against these diseases.

You should consult a doctor if you experience 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 you have a blood cancer.

If you experience blurred vision or other vision disturbances, you should contact a doctor.

Taking this medicine can cause a breakdown of a chromaffin tumor, which can be fatal. A chromaffin tumor is a rare adrenal gland tumor. A breakdown may manifest with the following symptoms: headaches, sweating, palpitations, and hypertension. If you experience any of these symptoms, you should immediately contact a doctor.

Treatment with this medicine can cause choroidoretinopathy, an eye disease that impairs vision or causes vision disturbances. This usually affects one eye.

Treatment with this medicine can cause tendonitis. In extremely rare cases, it can lead to tendon rupture. This risk increases with the use of certain antibiotics and kidney problems. You should consult a doctor if you experience pain, stiffness, or swelling of the joints or tendons.

Taking PABI-DEXAMETHASON can lead to a condition known as adrenal insufficiency. It may affect the effectiveness of the medicine in situations of stress 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, you should inform the treating doctor about taking steroids.

In the case of suppression tests (detecting hormone levels in the blood), skin allergy tests, or tests for bacterial infection, you should inform the person performing the tests about taking dexamethasone, as it may affect the test results.

During therapy, your doctor may also recommend reducing salt intake in your diet and potassium supplementation.

In the case of elderly patients, some side effects of taking 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 closely monitor their growth and development at short intervals. PABI-DEXAMETHASON should not be used routinely in premature infants with respiratory failure.

PABI-DEXAMETHASON and other medicines

You should 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 (a medicine used in cancer treatment)
• Carbenoxolone (a medicine used to treat stomach ulcers)
• Ephedrine (a medicine used to constrict blood vessels in inflammatory conditions of the nasal mucosa)
• Acetazolamide (a medicine used to treat glaucoma and epilepsy)
• Hydrocortisone, cortisone, and other corticosteroids
• Ketoconazole, itraconazole (a medicine used to treat fungal infections)
• Ritonavir (HIV)
• Antibiotics, including erythromycin, fluoroquinolones
• Medicines that support muscle movement in myasthenia (e.g., neostigmine)
• Cholestyramine (a 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 other things, in the treatment of multiple myeloma
• Praziquantel (a medicine used to treat parasitic infections),
• Live vaccinations
• Chloroquine, hydroxychloroquine, mefloquine (medicines used to treat malaria)
• Growth hormone
• Protirelin.

You should 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 your 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 (a medicine used to treat glaucoma and epilepsy)
• Tetracosactide (used in the test 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 hypertension
• Thalidomide used, among other things, in the treatment of multiple myeloma
• Live vaccinations
• Medicines that support muscle movement in myasthenia (e.g., neostigmine)
• Antibiotics, including erythromycin, fluoroquinolones

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

PABI-DEXAMETHASON with food, drink, and alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your 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, you should not stop taking it, but immediately inform your doctor about the pregnancy. Corticosteroids may pass into breast milk, and it is not possible to exclude the risk to newborns or infants. The decision to continue or stop breastfeeding or 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 machinery, 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 4 mg tablet contains 74 mg of lactose (37 mg of glucose and 37 mg of galactose). Each PABI-DEXAMETHASON 8 mg tablet contains 148 mg of lactose (74 mg of glucose and 74 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

In case of doubts about taking the medicine, you should consult a doctor or pharmacist. PABI-DEXAMETHASON is available in the form of 4 mg, 8 mg, and 20 mg tablets. The 20 mg tablets can be divided into halves to obtain an additional product strength (10 mg) or to facilitate swallowing the tablet. 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 disease severity. 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 disease severity.

• Cerebral edema: initial dose and duration of treatment depending on the causes and severity of the disease, from 6 mg to 16 mg (up to 24 mg) orally, divided into 3-4 single doses.
• Acute asthma symptoms: adults: 16 mg per day for two days; children: 0.6 mg/kg body weight for one to two days.
• Croup: children: from 0.15 mg/kg to 0.6 mg/kg body weight in a single dose.
• Acute skin diseases: depending on the type and extent of the disease, daily doses in the range of 8 mg to 40 mg, and in some cases up to 100 mg, followed by a reduction in dose according to clinical needs.
• Active phase of systemic rheumatic diseases: systemic lupus erythematosus from 6 mg to 16 mg per day.
• Active rheumatoid arthritis with a severe, progressive course: rapidly progressive destructive form of the disease from 12 mg to 16 mg per day, with extra-articular symptoms from 6 mg to 12 mg per day.
• Idiopathic thrombocytopenic purpura: 40 mg for 4 days in cycles.
• Tuberculous meningitis: patients with stage II or III disease receive intravenous treatment for four weeks (0.4 mg/kg body weight per day in the first week, 0.3 mg/kg body weight per day in the second week, 0.2 mg/kg body weight per day in the third week, and 0.1 mg/kg body weight per day in the fourth week), and then oral treatment for four weeks, starting with a dose of 4 mg per day and reducing the dose by 1 mg every week. Patients with stage I disease receive intravenous treatment for two weeks (0.3 mg/kg body weight per day in the first week and 0.2 mg/kg body weight per day in the second week), and then oral treatment for four weeks (0.1 mg/kg body weight per day in the third week of treatment, and in the next week 3 mg per day, reducing the dose by 1 mg every week).
• Palliative care in cancer: initial dose and duration of treatment depending on the causes and severity of the disease: from 3 mg to 20 mg per day. In palliative care, very high doses can also be used, up to 96 mg. For optimal dosing and to reduce the number of tablets, 4 mg and 8 mg tablets can be combined with higher strengths (20 mg).
• Prevention and treatment of chemotherapy-induced nausea and vomiting, and emetogenic chemotherapy, together with other antiemetic medicines: 8-20 mg of dexamethasone before chemotherapy, and then 4-6 mg per day on the second and third days of therapy.
• Prevention and treatment of postoperative nausea and vomiting, together with other antiemetic medicines: a single dose of 8 mg before surgery.
• 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 a day.

If you cannot achieve proper dosing using these strengths, you should consider using a different medicine. The dose and frequency of administration vary depending on the treatment regimen and other medicines being taken. Administration of dexamethasone should be done in accordance with the dosing guidelines for dexamethasone described in the product characteristics of the other medicine being taken, if they are included. If not, you should follow national or international protocols and dosing guidelines. The doctor prescribing the medicine should carefully evaluate 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 closely monitor their growth and development at short intervals.

Overdose of PABI-DEXAMETHASON

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

Missed dose of PABI-DEXAMETHASON

In case of missing a dose, you should take it as soon as possible. If it is almost time for the next dose, you should 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 treatment, you should follow the doctor's recommendations. They may include gradually reducing the dose of the medicine until it is completely stopped. Symptoms that occur after stopping treatment too quickly include low blood pressure, and in some cases, a relapse of the original disease. You may also experience corticosteroid withdrawal syndrome, which includes fever, muscle and joint pain, rhinitis (runny nose), weight loss, itchy skin, and conjunctivitis (eye inflammation). If you experience any of these symptoms after stopping the medicine too quickly, you should contact your doctor as soon as possible.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. You should 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 thoughts of suicide,
• feeling euphoric (mania) or mood swings,
• feeling anxious, insomnia, trouble thinking, or feeling confused and disoriented,
• feeling, seeing, or hearing things that do not exist; unusual or frightening thoughts that affect behavior or feeling lonely.

You should 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 perforation, 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, you should immediately contact your doctor.

Other side effects include (frequency not known):

• increased susceptibility to infections, including viral, fungal, and bacterial 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 swelling, or tongue swelling, and in severe cases, difficulty breathing or dizziness).
• hormonal regulation disorders, edema, and weight gain, moon face (Cushing's syndrome), changes in the body's response to stress and trauma, surgical procedures, childbirth, or illness, and the body may not be able to respond normally to significant stress, such as accidents, surgery, childbirth, or illness, growth retardation in children and adolescents, irregular menstrual cycle or amenorrhea (absence of menstruation), excessive hair growth (especially in women).
• weight gain, negative protein balance, increased appetite, electrolyte imbalance, water retention, potassium loss, which can cause heart rhythm disturbances, increased need for antidiabetic medicines, onset of latent diabetes, high cholesterol and triglyceride levels in the blood (hypercholesterolemia and hypertriglyceridemia).
• severe mood swings, schizophrenia (a mental disorder) may worsen, depression, insomnia.
• severe, unusual headaches with vision disturbances related to withdrawal of the medicine, seizures, and worsening of epilepsy, dizziness.
• increased eye pressure, eye swelling, thinning of the cornea, worsening of existing viral, fungal, or bacterial eye infections, exophthalmos (bulging eyes), cataracts, vision disturbances, loss of vision, blurred vision.
• congestive heart failure in susceptible patients, heart rupture after a recent myocardial infarction, heart failure.
• hypertension, blood clots, formation of blood clots that can block blood vessels, for example, in the legs or lungs (thromboembolic complications).
• hiccups.
• nausea, vomiting, discomfort in the stomach, and abdominal bloating, esophageal inflammation and ulcers, stomach ulcers, which can perforate and bleed, pancreatitis (which can manifest as back and abdominal pain), gas in the intestines, oral thrush.
• 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, abnormal fat deposits, excessive hair growth on the body, water retention, skin discoloration, skin irritation around the mouth (perioral dermatitis).
• decreased bone density with an increased risk of fractures (osteoporosis), bone diseases, tendonitis, tendon rupture, muscle wasting, 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, delayed wound healing, discomfort, malaise.
• it may also cause corticosteroid withdrawal syndrome, which includes fever, muscle and joint pain, rhinitis (runny nose), weight loss, itchy skin, and conjunctivitis (eye inflammation).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can 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. By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store PABI-DEXAMETHASON

Store in a place out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging after the term "EXP". The expiry date refers to the last day of the month stated. There are no special recommendations for the storage temperature of the medicinal product. Store in the original packaging to protect from light. Medicines should not be disposed of via wastewater or household waste. You should 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 4 mg tablet contains 4 mg of dexamethasone. Each PABI-DEXAMETHASON 8 mg tablet contains 8 mg of dexamethasone. The other ingredients of the medicine are lactose monohydrate, cornstarch, colloidal silicon dioxide, magnesium stearate, and sodium stearyl fumarate. See section 2. PABI-DEXAMETHASON contains lactose monohydrate.

What PABI-DEXAMETHASON looks like and contents of the packaging

PABI-DEXAMETHASON, 4 mg, tablets: white or almost white, round, flat tablets with the number "4" embossed on one side. PABI-DEXAMETHASON, 8 mg, tablets: white or almost white, oval, flat tablets with the number "8" embossed on one side. PVC/PVDC90/Aluminum blisters in a cardboard box. PABI-DEXAMETHASON, 4 mg, tablets are available in packages containing 20, 30, 50, and 100 tablets. PABI-DEXAMETHASON, 8 mg, tablets are available in packages containing 20, 30, 50, and 100 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: 03.2023