Package leaflet: Information for the user

PABI-DEXAMETHASONE, 4 mg, tablets
PABI-DEXAMETHASONE, 8 mg, tablets
Dexamethasonum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

What PABI-DEXAMETHASONE is and what it is used for
Important information before taking PABI-DEXAMETHASONE
How to take PABI-DEXAMETHASONE
Possible side effects
How to store PABI-DEXAMETHASONE
Contents of the pack and other information

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

PABI-DEXAMETHASONE is a synthetic glucocorticosteroid. Glucocorticosteroids are hormones produced by the adrenal cortex. This medicine has anti-inflammatory, analgesic, antiallergic, and immunosuppressive properties.
PABI-DEXAMETHASONE is indicated in the treatment of rheumatic and autoimmune diseases (e.g. systemic lupus erythematosus, rheumatoid arthritis, juvenile idiopathic arthritis, polyarteritis nodosa), respiratory diseases (e.g. bronchial asthma, croup), skin disorders (e.g. erythroderma, pemphigus vulgaris), tuberculous meningitis only in combination with anti-infective therapy, blood disorders (e.g. adult idiopathic thrombocytopenic purpura), cerebral oedema, symptomatic treatment of multiple myeloma, acute lymphoblastic leukaemia, Hodgkin's disease and non-Hodgkin's lymphoma in combination with other drugs, palliative treatment of malignant diseases, prevention and treatment of nausea and vomiting caused by chemotherapy, as well as prevention of postoperative vomiting in combination with antiemetic medicines.

2. Important information before using PABI-DEXAMETHASON

When not to use PABI-DEXAMETHASON

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

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

if you have ever had severe depression or bipolar disorder (manic-depressive illness); this refers to depression experienced before or during treatment with corticosteroids such as dexamethasone;
if any of your close family members have had these conditions.

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

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

You should consult your doctor if you experience any signs of psychiatric disorders while taking this medicine. This is particularly important in the case of depression or suicidal thoughts. In some cases, psychiatric disorders have occurred after reducing the dose or stopping treatment.

Consult your doctor before using this medicine if you have:

kidney or liver disease (liver cirrhosis or chronic liver failure),
pheochromocytoma (a tumour of the adrenal gland) or suspected pheochromocytoma,
high blood pressure, heart disease or recent heart attack (cases of cardiac rupture have occurred),
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 pressure in the eye) or a family history of glaucoma or cataracts (clouding of the eye lens leading to impaired vision),
myasthenia gravis (a disease causing muscle weakness),
intestinal disorders or stomach ulcer,
psychiatric problems or a mental illness that worsened with use of this type of medicine,
epilepsy (a condition characterised by recurrent seizures or convulsions),
migraine,
hypothyroidism,
parasitic infection,
tuberculosis, sepsis or fungal eye infection,
cerebral malaria,
herpes virus (of the mouth, genital organs or eye, due to possible corneal perforation),
asthma,
ongoing treatment for thromboembolic disease (blood vessel blockage by clots),
corneal ulceration or corneal injury.

Corticosteroid treatment may weaken the body's ability to fight infection. This may sometimes lead to infections caused by microorganisms that usually do not cause infection (called opportunistic infections). If any infection occurs during treatment with this medicine, consult your doctor immediately. This is particularly important in case of signs of pneumonia: cough, fever, shortness of breath and chest pain. Disorientation may also occur, especially in elderly patients. You should also inform your doctor about any history of tuberculosis or travel to areas where parasitic infections are common.

During treatment with this medicine, it is important to avoid contact with people who have chickenpox, shingles or measles. If you suspect possible exposure to any of these diseases, consult your doctor immediately. You should also inform your doctor about previous infectious diseases such as measles or chickenpox, and vaccinations against them.

Contact your doctor if the patient experiences 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 the patient has a haematological malignancy.

If the patient experiences blurred vision or other visual disturbances, contact a doctor.

Taking PABI-DEXAMETHASON may lead to a pheochromocytoma crisis, which can be fatal. Pheochromocytoma is a rare tumour of the adrenal gland. A crisis may manifest as: headache, sweating, palpitations and high blood pressure. If any of these symptoms occur, contact your doctor immediately.

Treatment with this medicine may cause chorioretinopathy, an eye disease causing decreased visual acuity or visual disturbances. It usually affects one eye.

Treatment with this medicine may cause tendon inflammation. In extremely rare cases, tendon rupture may occur. This risk increases when corticosteroids are used together with certain antibiotics or in patients with kidney problems. Contact your doctor if you notice pain, stiffness or swelling in joints or tendons.

Taking PABI-DEXAMETHASON may lead to a condition known as adrenal insufficiency. This may affect the body's response during stress or injury, surgery, childbirth or illness, and the body may not be able to react naturally to serious physical stress caused by an accident, operation, childbirth or disease. If an accident, illness or other physically stressful event occurs during or after treatment with PABI-DEXAMETHASON, when surgery (even dental) or vaccination (especially with live virus vaccines) is required, inform the treating physician that you are taking corticosteroids.

If suppression tests (to detect hormone levels in blood), skin allergy tests or bacterial infection tests are performed, 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 (osteoporosis), high blood pressure, low potassium levels, diabetes, increased susceptibility to infections and skin thinning. Your doctor will closely monitor the patient during treatment.

Children and adolescents
When using this medicine in children, it is important that the doctor carefully monitors children's growth and development at regular intervals. PABI-DEXAMETHASON should not be routinely used in premature infants with respiratory distress syndrome.

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 high blood pressure
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)
Medicines that neutralise gastric acid, particularly those containing magnesium trisilicate
Barbiturates (medicines used to aid sleep and reduce anxiety)
Aminoglutethimide (an anticancer medicine)
Carbenoxolone (a medicine used to treat stomach 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 case of elevated cholesterol)
Estrogen hormones including oral contraceptives
Tetracosactide (used in testing adrenal cortex function)
Sulpiride (used as a calming medicine)
Cyclosporine (used to prevent transplant rejection)
Thalidomide (used, among others, in the treatment of multiple myeloma)
Praziquantel (a medicine used to treat parasitic infections)
Live vaccines
Chloroquine, hydroxychloroquine, mefloquine (medicines used to treat malaria)
Growth hormone
Protirelin

Tell your doctor about all medicines currently taken or recently taken by the patient, including
over-the-counter medicines. The patient 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 testing adrenal cortex function)
Carbenoxolone (a medicine used to treat stomach ulcers)
Chloroquine, hydroxychloroquine, mefloquine (medicines used to treat malaria)
Medicines used to treat high blood pressure
Thalidomide (used, among others, in the treatment of multiple myeloma)
Live vaccines
Medicines that enhance muscle movement in myasthenia (e.g. neostigmine)
Antibiotics including erythromycin, fluoroquinolones

Before starting treatment with PABI-DEXAMETHASON, read the patient information leaflets of all medicines that will be taken concomitantly with PABI-DEXAMETHASON to obtain information about them. If thalidomide, lenalidomide or pomalidomide are used, special attention should be paid to pregnancy testing and the need for pregnancy prevention.

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 gastric acid neutralising medicines.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

PABI-DEXAMETHASON should be used during pregnancy, particularly in the first trimester, only if in the opinion of the doctor 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 continue or discontinue dexamethasone treatment 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, 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 monohydrate lactose
Each tablet of PABI-DEXAMETHASON 4 mg contains 74 mg of lactose (37 mg glucose and 37 mg galactose).
Each tablet of PABI-DEXAMETHASON 8 mg contains 148 mg of lactose (74 mg glucose and 74 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

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
PABI-DEXAMETHASON is available in tablet strengths of 4 mg, 8 mg, and 20 mg. The 20 mg tablets can be divided into halves to provide an additional dosage strength (10 mg) or to facilitate swallowing for the patient.
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 your doctor, the following doses 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.

Cerebral edema: Initial dose and duration of treatment depend on the cause and severity of the disease; oral dose from 6 mg to 16 mg (up to a maximum of 24 mg), 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: single dose of 0.15 mg/kg to 0.6 mg/kg body weight.
Acute skin disorders: Depending on the type and extent of the disease, daily doses range from 8 mg to 40 mg, and in some cases up to 100 mg, followed by dose reduction according to clinical needs.
Active phase of systemic rheumatic diseases: Systemic lupus erythematosus: 6 mg to 16 mg per day.
Active rheumatoid arthritis with severe, progressive course: Rapidly progressive destructive form: 12 mg to 16 mg per day; with extra-articular manifestations: 6 mg to 12 mg per day.
Idiopathic thrombocytopenic purpura: 40 mg for four 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), followed by oral treatment for four weeks, starting at 4 mg per day and reducing the dose by 1 mg weekly. 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), followed by oral treatment for four weeks (0.1 mg/kg body weight per day in the third week of treatment, then 3 mg per day in the following week, reducing the dose by 1 mg weekly).
Palliative care in neoplastic diseases: Initial dose and duration of treatment depend on the cause and severity of the disease: from 3 mg to 20 mg per day. In palliative care, very high doses may also be used, up to a maximum of 96 mg. For optimal dosing and to reduce the number of tablets, lower-strength tablets (4 mg and 8 mg) can be combined with higher-strength tablets (20 mg).
Prophylaxis and treatment of cytostatic-induced or emetogenic chemotherapy-related vomiting, in combination with other antiemetic medicines: 8–20 mg of dexamethasone before chemotherapy, followed by 4 mg to 6 mg per day on days 2 and 3 of therapy.
Prophylaxis and treatment of postoperative vomiting, in combination with other antiemetic medicines: 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 daily.

If appropriate dosing cannot be achieved using these strengths, consider using another medicine.
The dose and frequency of administration vary depending on the treatment regimen and other concomitant medications. Dexamethasone should be administered according to the dexamethasone dosing guidelines specified in the summary of product characteristics of any concomitantly administered medicine, if provided. If not, national or international dosing protocols and guidelines should be followed. The prescribing physician must 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 several diseases, after initial therapy, consider switching from dexamethasone to prednisone or prednisolone to reduce suppression of the adrenal cortex.

Children and adolescents
When treating children, it is important that the doctor closely monitors growth and development at regular intervals.

Taking more PABI-DEXAMETHASON than recommended
If too many tablets have been taken, contact a doctor immediately or go to the nearest hospital.

Missing a dose of PABI-DEXAMETHASON
If a dose is missed, 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 a missed dose.

Stopping PABI-DEXAMETHASON treatment
If treatment needs to be discontinued, follow your doctor’s instructions. These may include gradually reducing the dose until treatment is completely stopped. Symptoms that may occur after stopping treatment 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 your doctor immediately.

If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine can cause side effects, although not everyone will experience them.
You should immediately inform your doctor if serious psychiatric disturbances occur. These may
affect approximately 5 out of 100 people taking medicines such as dexamethasone. Such disturbances
include:

feelings of depression, including suicidal thoughts,
feelings of euphoria (mania) or mood swings,
feelings of anxiety, insomnia, difficulty thinking clearly, or feelings of confusion and memory loss,
experiencing, perceiving, or hearing non-existent things; unusual or frightening thoughts affecting behaviour or feelings of isolation.

You should immediately contact your doctor if the following occur:

severe abdominal pain, nausea, vomiting, diarrhoea, marked 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 in patients with existing bowel disease.

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

Increased susceptibility to infections, including viral and fungal infections (e.g. candidiasis), reactivation of tuberculosis, or other infections (e.g. previously diagnosed eye infections).
Decreased or increased white blood cell count, 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, fluid retention and weight gain, moon-shaped face (Cushingoid state), altered endogenous secretion in response to stress and trauma, surgical procedures, childbirth or illness; the body may be unable to respond adequately in situations of severe stress such as accidents, surgery, childbirth, or illness; growth suppression in children and adolescents, irregular menstrual cycle or amenorrhea (absence of menstruation), development of excessive hair growth (particularly in women).
Weight gain, negative protein-calcium balance, increased appetite, electrolyte imbalance, fluid retention, potassium loss which may lead to cardiac arrhythmias, increased requirement for antidiabetic medications, manifestation of latent diabetes, elevated blood cholesterol and triglyceride levels (hypercholesterolemia and hypertriglyceridemia).
Severe 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 swelling, thinning of the ocular epithelium, worsening of pre-existing viral, fungal, or bacterial eye infections, exophthalmos, cataracts, visual disturbances, vision loss, blurred vision.
Congestive heart failure in susceptible patients, cardiac rupture after recent myocardial infarction, heart failure.
Hypertension, blood clots, formation of thrombi 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 perforate and bleed, pancreatitis (which may present as back and abdominal pain), intestinal gas, oesophageal candidiasis.
Thin, fragile skin, unusual skin marks, bruising, redness and skin inflammation, striae, visible capillary dilation, acne, excessive sweating, rash, swelling, hair loss, abnormal fat deposits, excessive body hair growth, fluid retention, pigmentary changes, weakened capillaries visible as subcutaneous bleeding (increased capillary fragility), perioral dermatitis (inflammation of the skin around the mouth).
Reduced bone density with increased risk of fractures (osteoporosis), bone diseases, tendonitis, tendon rupture, muscle atrophy, myopathy, muscle weakness, premature cessation of bone growth (premature closure of epiphyses).
Changes in sperm count and motility, impotence.
Impaired response to vaccination and skin tests, slow wound healing, discomfort, malaise.
Withdrawal syndrome from corticosteroids may also occur, including fever, muscle and joint pain, rhinitis (nasal inflammation), weight loss, painful and itchy skin nodules, eye inflammation (conjunctivitis).

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, you should inform your doctor or pharmacist. Adverse effects can
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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide 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 following the abbreviation
EXP. The expiry date refers to the last day of the stated month.
No special storage temperature requirements for this 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 4 mg tablet contains 4 mg of dexamethasone.
Each PABI-DEXAMETHASONE 8 mg tablet contains 8 mg of dexamethasone.
The other ingredients are monohydrate lactose, corn starch, pregelatinized starch, 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
PABI-DEXAMETHASONE 4 mg tablets: white or almost white, round, flat-faced tablets, biconvex, with the number "4" embossed on one side.
PABI-DEXAMETHASONE 8 mg tablets: white or almost white, oval, flat-faced tablets, biconvex, with the number "8" embossed on one side.
Blister packs made of PVC/PVDC90/Aluminium in cardboard boxes.
PABI-DEXAMETHASONE 4 mg tablets are available in pack sizes containing 20, 30, 50 and 100 tablets.
PABI-DEXAMETHASONE 8 mg tablets are available in pack sizes containing 20, 30, 50 and 100 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

Pabi-dexamethasone