PABI-DEXAMETHASONE

Package leaflet: Information for the user

PABI-DEXAMETHASON, 20 mg, tablets
Dexamethasonum
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• 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. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

PABI-DEXAMETHASON is a synthetic glucocorticosteroid. Glucocorticosteroids are hormones produced by the adrenal cortex. This medicine has anti-inflammatory, analgesic, antiallergic and immunosuppressive properties.
PABI-DEXAMETHASON 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 treatment of multiple myeloma, acute lymphoblastic leukemia, Hodgkin's disease and non-Hodgkin's lymphoma in combination with other drugs, metastatic spinal cord compression (pressure on spinal nerves caused by a tumour), and for the prevention and treatment of nausea and vomiting induced by chemotherapy, in combination with antiemetic medicines.

2. Important information before taking PABI-DEXAMETHASON
Do not take PABI-DEXAMETHASON:

• if you are allergic to dexamethasone or to any of the other ingredients of this medicine (listed in section 6);
• if you have a systemic infection (unless you are already receiving treatment);
• if you have peptic ulcer of the stomach or duodenum;
• if you are due to receive a live vaccine.

Warnings and precautions
Before taking PABI-DEXAMETHASON, consult your doctor or pharmacist:

• if you have ever had severe depression or bipolar affective disorder (manic-depressive illness); this includes depression occurring before or during treatment with corticosteroids such as dexamethasone;
• if any members of your immediate family have had these conditions.

Psychiatric disturbances may occur during treatment with corticosteroids such as PABI-DEXAMETHASON.

• These disturbances may be severe.
• They usually appear within a few days or weeks after starting treatment.
• They are more common when high doses are used.
• Most of these disturbances resolve after dose reduction or discontinuation of therapy. However, if such disturbances occur, they may require treatment.

Consult your doctor if you experience any signs of psychiatric disturbances while taking this medicine. This is particularly important in cases of depression or suicidal thoughts. In some cases, psychiatric disturbances have occurred after dose reduction or discontinuation of the medicine.
Consult your doctor before taking this medicine if you have:

• kidney or liver disease (liver cirrhosis or chronic liver failure),
• adrenal tumour (pheochromocytoma),
• hypertension, heart disease or recent myocardial infarction (cases of cardiac rupture have been reported),
• 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 intraocular pressure) or a family history of glaucoma or cataract (clouding of the eye lens leading to impaired vision),
• myasthenia gravis (a disease causing muscle weakness),
• intestinal disorders or gastric ulcer,
• psychiatric problems or a 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 mouth, genitals or eye, due to possible corneal perforation),
• asthma,
• ongoing treatment for thromboembolic disease (blocked blood vessels due to clots),
• corneal ulceration or corneal injury.

Corticosteroid treatment may impair the body's ability to fight infections. This may sometimes lead to infections caused by microorganisms that rarely cause disease under normal circumstances (called opportunistic infections). If any infection occurs during treatment with this medicine, consult your doctor immediately. This is particularly important if you experience 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 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, consult your doctor immediately. Inform your doctor about previous infectious diseases such as measles or chickenpox, and about vaccinations against these diseases.
Contact your doctor if you experience any of the following symptoms: tumour lysis syndrome symptoms such as muscle cramps, muscle weakness, confusion, visual disturbances or loss of vision, and shortness of breath, especially if you have a haematological malignancy.
If you experience blurred vision or other visual disturbances, contact your doctor.
Treatment with this medicine may cause chorioretinopathy, an eye disease causing reduced 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 PABI-DEXAMETHASON may lead to a condition known as adrenal insufficiency. This may affect the effectiveness of the medicine during stress or injury, surgery, childbirth or illness, and the body may not be able to respond naturally to serious stress caused by an accident, operation, childbirth or illness.
If an accident, illness or other physically stressful event occurs during or after treatment with PABI-DEXAMETHASON, when surgery (even dental procedures) or vaccination (especially with live virus vaccines) is required, inform the treating doctor that you are taking corticosteroids.
If undergoing suppression tests (to detect hormone levels in blood), skin allergy tests or bacterial infection tests, inform the person conducting the tests 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 severe, particularly decreased bone density (osteopor0sis), hypertension, hypokalaemia, diabetes, increased susceptibility to infections and skin thinning. Your doctor will closely monitor you during treatment.

Children and adolescents
When treating children, it is important that the doctor carefully monitors their growth and development at regular intervals. PABI-DEXAMETHASON should not be routinely used in premature infants with respiratory insufficiency.

PABI-DEXAMETHASON with other medicines
Tell your doctor about all medicines you are currently taking or have recently taken, including
those 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 disease
• Diuretics
• Intravenous amphotericin B
• Phenytoin, carbamazepine, primidone (medicines used to treat epilepsy)
• Rifabutin, rifampicin, isoniazid (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)
• Antibiotics including erythromycin, fluoroquinolones
• Medicines that enhance muscle movement in myasthenia (e.g. neostigmine)
• Cholestyramine (a medicine used in cases of elevated cholesterol)
• Oestrogen hormones, including oral contraceptives
• Tetracosactide (used in tests to assess adrenal cortex function)
• Sulpiride (used as a calming medicine)
• Cyclosporine (used to prevent transplant rejection)
• Thalidomide (used, among others, in the treatment of plasma cell myeloma)
• Praziquantel (a medicine used to treat parasitic infections)
• Live vaccines
• Chloroquine, hydrochloroquine, 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 available 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 PABI-DEXAMETHASON, 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), e.g. indomethacin
• Medicines used to treat diabetes
• Medicines used to treat heart disease
• Diuretics
• Intravenous amphotericin B
• Acetazolamide (a medicine used to treat glaucoma and epilepsy)
• Tetracosactide (used in tests to assess adrenal cortex function)
• Carbenoxolone (a medicine used to treat gastric ulcers)
• Chloroquine, hydrochloroquine, mefloquine (medicines used to treat malaria)
• Medicines used to treat hypertension
• Thalidomide (used, among others, in the treatment of plasma cell myeloma)
• Live vaccines
• Medicines that enhance muscle movement in myasthenia (e.g. neostigmine)
• Antibiotics including erythromycin, fluoroquinolones

Before starting PABI-DEXAMETHASON, read the patient leaflets of all medicines you will be taking in combination with PABI-DEXAMETHASON to obtain information about these medicines. If you are taking thalidomide, lenalidomide or pomalidomide, pay special attention to the need for pregnancy testing and prevention of pregnancy.

PABI-DEXAMETHASON 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 taking this medicine.
PABI-DEXAMETHASON should only be used during pregnancy, particularly in the first trimester, if in the doctor's opinion the benefit to the mother outweighs the potential risk to the foetus.
If you become pregnant while taking PABI-DEXAMETHASON, do not stop taking it, 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 treatment with dexamethasone should be made taking into account the benefits of breastfeeding for the child and the benefits of dexamethasone treatment for the mother.

Driving and operating machinery
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.

PABI-DEXAMETHASON contains lactose monohydrate
Each 20 mg tablet of PABI-DEXAMETHASON contains 370 mg of lactose (185 mg glucose and 185 mg galactose).
This should be taken into account in patients with diabetes.
The medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. the medicine is considered "sodium-free".

3. How to use PABI-DEXAMETHASON

This medicine should always be used as directed by the physician. If you have any doubts about
how to use the medicine, consult your doctor or pharmacist.
PABI-DEXAMETHASON is available as 4 mg, 8 mg, and 20 mg tablets. The 20 mg tablets may be
split in half to provide an additional dosage strength (10 mg) or to facilitate swallowing for the patient.
Please note that this is a medicinal product containing a high dose.
It is recommended to use the product [proprietary name] 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
adverse effects, the lowest effective dose should be used.
Unless otherwise directed by the physician, the following dosages 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 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 depend on the cause and severity of the disease. Very high doses, up to 96 mg, may be used in palliative care.

For optimal dosing and to reduce the number of tablets, lower-strength tablets (4 mg and 8 mg) may be
combined with higher-strength tablets (20 mg).

• Prevention and treatment of cytostatic- or chemotherapy-induced emesis, in combination with other antiemetic medicines: 8 mg to 20 mg (one 20 mg tablet) before chemotherapy, followed by 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: 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
concomitant medications. Dexamethasone administration should follow the dosing guidelines for
dexamethasone described in the summary of product characteristics of the other medicinal product
being used, if provided. If not, national or international protocols and dosing guidelines should be followed.
The prescribing physician should carefully evaluate 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, it is advisable to switch 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 carefully monitor the child's growth
and development at regular, short intervals.
Use of a higher than recommended dose of PABI-DEXAMETHASON
If too many tablets are taken, contact a doctor immediately or go to the nearest hospital.
Missed dose of PABI-DEXAMETHASON
If a dose is missed, it should be taken as soon as possible. If it is almost time for the next dose, only one
dose should be taken. Do not take a double dose to make up for a missed dose.
Stopping PABI-DEXAMETHASON treatment
If treatment needs to be discontinued, follow the physician's instructions. These may include gradually
reducing the dose until treatment is completely stopped. Symptoms that may occur after stopping therapy
too quickly include low blood pressure and, in some cases, recurrence of the original disease.
A corticosteroid 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 immediately.
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 experiences them.
You should immediately inform your doctor if serious psychiatric disorders occur. These may
occur in approximately 5 out of 100 people taking medicines such as dexamethasone. Such disorders
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, perceiving or hearing things that are not there; unusual or frightening thoughts affecting behaviour or feelings of isolation.

You should immediately contact your doctor if any of the following occur:

• 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 intestinal disease is already present.

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

• Increased susceptibility to infections, including viral and fungal infections such as aspergillosis, 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 severe, 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 hormonal regulation, oedema and weight gain, moon-shaped face (Cushingoid state), altered endogenous secretion following stress and trauma, surgical procedures, childbirth or illness; the body may be unable to respond properly in situations of severe stress such as accidents, surgery, childbirth or illness; growth suppression in children and adolescents; irregular menstrual cycle or amenorrhoea (absence of menstruation); development of excessive hair growth (especially in women).

• Weight gain, negative calcium and protein 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 (hypercholesterolaemia and hypertriglyceridaemia).

• Extreme mood swings, schizophrenia (mental disorder) may worsen, depression, insomnia.

• Severe atypical headaches with visual disturbances related to discontinuation of the medicine, seizures and worsening of epilepsy, dizziness.

• Increased intraocular pressure, eye oedema, thinning of the corneal epithelium, worsening of existing viral, fungal and bacterial eye infections, exophthalmos, cataract, visual disturbances, vision loss, 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, gastric discomfort and abdominal distension, inflammation and ulcers in the oesophagus, gastric ulcers which may rupture and bleed, pancreatitis (which may present as back and abdominal pain), intestinal gas, oesophageal candidiasis.

• Thin, delicate skin, atypical skin lesions, bruising, redness and skin inflammation, striae, visible capillary oedema, acne, excessive sweating, rash, swelling, hair loss, abnormal fat deposits, excessive body hair growth, fluid retention in the body, pigmentary disorders, weakened capillaries visible as subcutaneous bleeding (increased capillary fragility), perioral dermatitis (inflammation of the skin around the mouth).

• Decreased bone density with increased risk of fractures (osteoporosis), bone diseases, 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.

• Corticosteroid withdrawal syndrome 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 not listed in this leaflet, you should inform your doctor or pharmacist. 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 40 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Pabi-Dexamethason

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container after the abbreviation
EXP. The expiry date refers to the last day of the stated month.
There are no special requirements regarding the storage temperature of the medicinal product.
Store in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the pack and other information

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

What PABI-DEXAMETHASONE looks like and contents of the pack
White or almost white, round, biconvex tablets with a division line on one side. The tablet can be divided into two equal doses.
PVC/PVDC90/Aluminium blisters in a cardboard box.
PABI-DEXAMETHASONE 20 mg tablets are available in packs containing 20 and 30 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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