Package Insert: Information for the User

Dexamethasone ABDrug 20 mg Tablets

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Dexametasona ABDrug is a synthetic glucocorticoid. Glucocorticoids are hormones produced by the cortex of the adrenal glands. This medication has anti-inflammatory, analgesic, and antiallergic effects, and suppresses the immune system.

Dexametasona ABDrug is recommended for the treatment of rheumatic and autoimmune diseases (e.g., myositis), skin diseases (e.g., pemphigus vulgaris), blood diseases (e.g., idiopathic thrombocytopenic purpura in adults), symptomatic multiple myeloma, acute lymphoblastic leukemia, Hodgkin's disease, and non-Hodgkin lymphoma along with other medications, metastatic spinal cord compression (pressure on the spinal cord nerves caused by a tumor)prophylaxis and treatment of nausea and vomiting caused by chemotherapy, within the antiemetic treatment.

Do not takeDexamethasone ABDrug:

• if you are allergic to dexamethasone or any of the other ingredients of this medicine (listed in section 6).
• if you have a whole-body infection (unless you are receiving treatment).
• if you have a stomach or duodenal ulcer.
• if you are to be vaccinated with live vaccines

Warnings and precautions

Consult your doctor or pharmacist before starting to take Dexamethasone ABDrug :

• if you have ever had a severe depression or manic depression (bipolar disorder). This includes having had depression before or while taking steroid medicines like dexamethasone.
• if a close relative of yours has suffered from this disease.

Mental problems may occur while taking steroids like Dexamethasone ABDrug :

• These illnesses can be serious.
• They usually start a few days or weeks after starting treatment.
• It is more likely to occur at high doses.
• Most of these problems disappear if the dose is reduced or the treatment is stopped. However, if the problems occur, you may need treatment.

Consult your doctor if you are taking (or someone taking this medicine), show any signs of mental problems.

This is especially important if you are depressed, or you might be thinking of suicide. In a few cases, mental problems have occurred when the dose was reduced or stopped.

Consult your doctor before starting to take this medicine:

• if you have kidney or liver problems (cirrhosis or severe renal failure),
• if you have or suspect you have phaeochromocytoma (a tumour of the adrenal glands),
• if you have high blood pressure, heart problems or if you have recently had a heart attack (myocardial rupture),
• if you have diabetes or a family history of diabetes,
• if you have osteoporosis (bone weakening), particularly if you are a woman who has passed the menopause,
• if you have muscle weakness with this or other steroids in the past,
• if you have glaucoma (high eye pressure) or a family history of glaucoma, cataracts (opacity of the lens of the eye that causes a decrease in vision),
• if you have myasthenia gravis (a disease that causes muscle weakness),
• if you have an intestinal problem or stomach ulcer (peptic),
• if you have mental health problems or have had psychiatric disorders that have been made worse by this type of medicine,
• if you have epilepsy (a disease in which you have seizures or repeated attacks),
• if you suffer from migraine,
• if you have a low-activity thyroid gland,
• if you have a parasitic infection,
• if you have tuberculosis, septicemia or fungal infection in the eye,
• if you suffer from cerebral malaria,
• if you have herpes (mouth ulcers or genital herpes and simple ocular herpes due to possible corneal perforation),
• if you have asthma,
• if you are being treated for blockage of blood vessels by blood clots (thromboembolism),
• if you suffer from corneal ulcers and corneal damage.

The treatment with corticosteroids may reduce your body's ability to cope with infections. This can lead to infections caused by germs, which rarely cause infection in normal circumstances (called opportunistic infections). If you have any type of infection during treatment with this medicine, contact your doctor immediately. This is especially important if you notice signs of pneumonia: cough, fever, difficulty breathing and chest pain. You may also feel confused, especially if you are an elderly patient. You should also inform your doctor if you have had tuberculosis or if you have been in regions where intestinal worm infections are common.

It is essential that while taking this medicine, you avoid contact with someone who has had chickenpox, shingles or measles. If you think you may have been exposed to any of these diseases, you must consult your doctor immediately. You should also inform your doctor if you have ever had infectious diseases such as measles or chickenpox and if you have been vaccinated.

Contact your doctor if you experience symptoms of tumour lysis syndrome such as muscle cramps, muscle weakness, confusion, loss or alteration of vision and difficulty breathing, in the case that you suffer from a malignant haematological process.

Contact your doctor if you experience blurred vision or other visual disturbances.

The treatment with this medicine may cause a phaeochromocytoma crisis, which can be fatal. Phaeochromocytoma is a rare tumour of the adrenal glands. The crises may have the following symptoms: headaches, sweating, palpitations and hypertension. Contact your doctor immediately if you experience any of these signs.

The treatment with this medicine may cause central serous chorioretinopathy, an eye disorder that causes blurred or distorted vision. This usually occurs in one of the two eyes. The treatment with this medicine may cause tendon inflammation. In extremely rare cases, the tendon can rupture. This risk is increased with certain antibiotics and kidney problems. Contact your doctor if you experience pain, swollen or stiff joints or tendons.

The treatment with Dexamethasone ABDrug may cause a condition called adrenal insufficiency. This can cause a change in the effectiveness of the medicine after stress and trauma, surgery, childbirth, or illness, and your body may not be able to respond in the usual way to severe stress, such as accidents, surgery, childbirth, or illness.

If you have had an accident, are ill, have any other specific physical stress, or require any surgery (even at the dentist) or are to be vaccinated (particularly with live vaccines) while taking or having finished taking dexamethasone, you must inform the person treating you that you are taking or have taken steroids.

If you need to have suppression tests (tests for the amount of hormone in the body), skin prick tests or tests for bacterial infections, you must inform the person doing the test that you are taking dexamethasone, as it may interfere with the results.

Your doctor may reduce the amount of salt in your diet and give you some potassium supplements while taking this medicine.

If you are an elderly patient, some of the side effects of this medicine may be more severe, especially bone thinning (osteoporosis), high blood pressure, low potassium levels, diabetes and susceptibility to infections and skin thinning. Your doctor will monitor you more closely.

Children and adolescents

If a child is taking this medicine, it is essential that your doctor monitors their growth and development at frequent intervals.Dexamethasone ABDrug should not be used routinely in premature babies with respiratory problems.

Other medicines and Dexamethasone ABDrug

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine:

• Anticoagulant medicines that thin the blood (e.g. warfarin)
• Acid acetylsalicylic 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 problems
• Diuretics (tablets that help the body get rid of water)
• Amphotericin B injection
• Phenobarbital, carbamazepine, primidone (medicines for epilepsy)
• Rifabutin, rifampicin, isoniazid (antibiotics used to treat tuberculosis)
• Antacids – particularly those containing magnesium trisilicate
• Barbiturates (medicines used to help you sleep and relieve anxiety)
• Aminoglutethimide (cancer treatment)
• Carbenoxolone (used in the treatment of stomach ulcers)
• Ephedrine (nasal decongestant)
• Acetazolamide (used for glaucoma and epilepsy)
• Hydrocortisone, cortisone and other corticosteroids
• Ketoconazole, itraconazole (for fungal infections)
• Ritonavir (for HIV)
• Antibiotics including erythromycin, fluoroquinolones
• Medicines that help muscle movement in patients with myasthenia gravis (e.g., neostigmine)
• Colestiramine (for high cholesterol)
• Estrogen hormones including the contraceptive pill
• Tetracosactide used in adrenal function tests
• Sultopride used to calm emotions
• Ciclosporin used to prevent rejection after transplants
• Talidomide used e.g., for multiple myeloma
• Praziquantel administered for certain intestinal worm infections
• Vaccination with live vaccines
• Chloroquine, hydroxychloroquine and mefloquine (for malaria)
• Somatotropin
• Protirelin

Inform your doctor if you are taking or have taken recently other medicines, even those bought without a prescription. You may have an increased risk of severe side effects if you take dexamethasone with these medicines

• Some medicines may increase the effects of Dexamethasone ABDrug and your doctor may want to monitor you closely if you are taking these medicines (including some HIV medicines: ritonavir, cobicistat).
• Acid acetylsalicylic or similar (non-steroidal anti-inflammatory drugs) e.g., indomethacin
• Medicines used to treat diabetes
• Medicines used to treat heart problems
• Diuretics (tablets that help the body get rid of water)
• Amphotericin B injections
• Acetazolamide (used for glaucoma and epilepsy)
• Tetracosactide used in adrenal function tests
• Carbenoxolone (used in the treatment of stomach ulcers)
• Chloroquine, hydroxychloroquine and mefloquine (for malaria)
• Medicines used to treat high blood pressure
• Talidomide used e.g., for multiple myeloma
• Vaccination with live vaccines
• Medicines that help muscle movement in myasthenia gravis (e.g., neostigmine)
• Antibiotics including fluoroquinolones.

You must read the leaflet of all the medicines you take with Dexamethasone ABDrug, regarding the information of these medicines before starting the treatment with Dexamethasone ABDrug. When using talidomide, lenalidomide or pomalidomide, special attention needs to be paid to pregnancy tests and prevention needs.

Dexamethasone ABDrug with food, drinks and alcohol,beveragesandalcohol

Dexamethasone should be taken with or after food to minimize gastrointestinal irritation. You should avoid drinks that contain alcohol or caffeine. You should take small, frequent meals, and the possibility of taking antacids, if recommended by your doctor.

Pregnancy andbreastfeeding

If you are pregnant or breastfeeding, or think you might be pregnant, consult your doctor or pharmacist before using this medicine.

Dexamethasone ABDrug should only be prescribed during pregnancy and particularly in the first trimester, if the benefits outweigh the risks for the mother and the baby. If you become pregnant while taking the medicine, do not stop taking Dexamethasone ABDrug, but inform your doctor immediately that you are pregnant.

Corticosteroids can pass into breast milk. The risk in newborns/babies cannot be ruled out. The decision to continue or stop breastfeeding or to continue or stop dexamethasone treatment should be made taking into account the benefit of breastfeeding for the baby and the benefit of dexamethasone treatment for the woman.

Driving and operating machines

Do not drive, use tools or machines, or perform any hazardous task if you experience side effects such as confusion, hallucinations, dizziness, fatigue, sleepiness, fainting, or blurred vision.

Dexamethasone ABDrug contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine..

Each 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 mellitus.

Sodium

This medicine contains less than 23 mg of sodium (1mmol) per tablet; this is, essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Dexamethasone is presented in the form of tablets of 4 mg, 8 mg, and 20 mg. The tablet can be divided into two equal halves to take additional doses of 10 mg or to facilitate swallowing.

Dexamethasone ABDrug is usually taken at doses of 0.5 to 10 mg per day, depending on the disease being treated.

In more severe diseases, doses above 10 mg per day may be required. The dose should be adjusted according to the individual patient's response and the severity of the disease. To minimize adverse effects, the lowest effective dose should be used.

Unless otherwise indicated, the following dose recommendations apply:

The dose recommendations mentioned below are only orientative. The initial and daily doses should always be determined based on the individual patient's response and the severity of the disease.

• Pemphigus:initial dose of 300 mg followed by a descending dose adjustment based on clinical need.
• Myositis:40 mg for 4 days in cycles.
• Idiopathic thrombocytopenic purpura:40 mg for 4 days in cycles.
• Metastatic spinal cord compression:The initial dose and treatment duration depend on the cause and severity. Very high doses of up to 96 mg may be used for palliative treatment. To optimize dosing and reduce the number of tablets, combinations of lower doses (4 mg and 8 mg) and higher doses (20 mg) may be used.
• Prophylaxis and treatment of chemotherapy-induced emesis, emetogenic chemotherapy within antiemetic treatment:8-20 mg (one 20 mg tablet) before chemotherapy, followed by 4-16 mg/day on days 2 and 3.
• Treatment of symptomatic multiple myeloma, acute lymphoblastic leukemia, Hodgkin's disease, and non-Hodgkin's lymphoma in combination with other medications:The usual dosage is 40 mg or 20 mg once a day.

The dose and frequency of administration vary with the therapeutic protocol and associated treatments. Dexamethasone administration should follow the instructions for dexamethasone administration as described in the technical data sheet of the associated treatments. If this is not the case, local or international treatment protocols and guidelines should be followed. Prescribing physicians should carefully evaluate what dose of dexamethasone should be used, taking into account the patient's disease situation and state.

Long-term treatment

For long-term treatment of various diseases, after initial therapy, the treatment with glucocorticoids should be changed from dexamethasone to prednisone/prednisolone to reduce adrenal cortex function suppression.

Use in children and adolescents

If a child is taking this medication, it is essential that the doctor monitor their growth and development at frequent intervals.

If you take more Dexamethasone ABDrug than you should

If you take too much medication, contact your doctor or hospital immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the leaflet to the healthcare professional.

If you forget to take Dexamethasone ABDrug

If you forget to take a dose, take it as soon as you remember, unless it is almost time for the next dose.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Dexametasona ABDrug

If your treatment is to be interrupted, follow your doctor's recommendations. He may recommend that you gradually reduce the amount of medication you are taking gradually until you stop taking it completely. Different symptoms have been reported when treatment is interrupted too quickly, such as low blood pressure and, in some cases, relapse of the disease for which you took the treatment. You may also experience a "withdrawal syndrome" that includes fever, muscle and joint pain, inflammation of the nasal mucosa (rhinitis), weight loss, skin itching, and eye inflammation (conjunctivitis). If you interrupt treatment too soon and any of the mentioned symptoms appear, you should speak with your doctor as soon as possible.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Consult your doctor immediately if you experience severe mental problems. These may affect 5 out of 100 people who take medicines like dexamethasone. These problems include:

• feeling depressed, including suicidal thoughts,
• feeling extremely euphoric (manic) or experiencing mood swings,
• feeling anxious, having trouble sleeping, difficulty thinking or being confused, and memory loss,
• feeling, seeing, or hearing things that do not exist. Having strange or terrifying thoughts, changing your behavior, or feeling lonely.

Consult your doctor immediately if you experience:

• severe abdominal pain, nausea, vomiting, diarrhea, deep muscle weakness, and fatigue, extremely low blood pressure, weight loss, and fever, as these may be signs of adrenal insufficiency,
• sudden abdominal pain, sensitivity, nausea, vomiting, fever, and blood in the stool, which may be signs of a perforated intestine, particularly if you have or have had an intestinal disease.

This medicine may worsen existing heart problems. If you experience shortness of breath or swelling of the ankles, consult your doctor immediately.

Other side effects may be (unknown frequency):

• Increased risk of infections, including viral and fungal infections, e.g., cold sores; recurrence of tuberculosis or other infections, e.g., eye infections if you have already had them
• Reduction in the number of white blood cells or increase in the number of white blood cells, abnormal coagulation,
• Medication allergy, including potentially fatal allergic reactions (which may appear as a rash and swelling of the throat and tongue, and in severe cases, difficulty breathing or dizziness)
• Hormonal regulation problems in the body, swelling, and weight gain, moon face (Cushing's syndrome), change in the effectiveness of the endocrine system after stress and trauma, surgery, childbirth, or disease, your body may not be able to respond in the usual way to severe stress, such as accidents, surgery, childbirth, or diseases, delayed growth in children and adolescents, irregular or absent menstrual cycles, excessive hair growth on the body (particularly in women)
• Weight gain, protein loss, and calcium imbalance, increased appetite, electrolyte imbalance, fluid retention in the body, potassium loss that can cause arrhythmias, increased medication requirements for diabetes, unknown diabetes that becomes apparent, high levels of cholesterol and triglycerides in the blood (hypercholesterolemia and hypertriglyceridemia)
• Extreme mood swings, schizophrenia (mental disorder) that may worsen, depression, inability to sleep
• Severe and unusual headache with vision changes due to withdrawal from treatment, seizures, and worsening of epilepsy, dizziness.
• Increased eye pressure, papilledema, reduction of ocular membranes, increased ocular infections, viral, bacterial, and fungal, worsening of corneal ulcer symptoms, worsening of existing eye infections, protrusion of eyeballs, cataracts, blurred vision, visual disturbances, vision loss,
• Heart failure in susceptible individuals, heart muscle rupture after a recent heart attack, cardiac decompensation
• High blood pressure, blood clots: formation of blood clots that may block blood vessels, e.g., in legs or lungs (thromboembolic complications)
• Hiccups
• Nausea, vomiting, stomach discomfort, and swollen abdomen, inflammation, and ulcers in the esophagus, peptic ulcers that may rupture and bleed, inflamed pancreas (which may appear as back and abdominal pain), flatulence, esophageal candidiasis
• Delicate skin thinning, unusual skin marks, bruises, redness, and inflammation of the skin, stretch marks, visible inflammation, capillaries, acne, increased sweating, skin rash, swelling, hair loss, unusual fatty deposits, excessive hair growth, fluid retention in the body, capillary weakness that facilitates rupture observed as bleeding under the skin (increased capillary fragility), skin irritation around the mouth (perioral dermatitis)
• Weakening of bones with an increased risk of fractures (osteoporosis), bone necrosis, tendinitis, tendon rupture, muscle loss, myopathy, muscle weakness, premature closure of bone growth (premature epiphyseal closure)
• Changes in sperm count and movement, impotence
• Reduced reaction to vaccines and skin tests, slow wound healing, discomfort
• A "withdrawal syndrome" may also occur, including fever, muscle and joint pain, inflammation of the nasal mucosa (rhinitis), weight loss, painful skin nodules with itching, and eye inflammation (conjunctivitis)

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature.

Store in the original packaging to protect it from light.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition ofDexamethasone ABDrug

The active ingredient is dexamethasone.

Each tablet contains 20 mg of dexamethasone.

The other components are lactose, cornstarch, anhydrous colloidal silica (E551) and magnesium stearate (E470b) and sodium stearate fumarate. See section 2 “Dexamethasone ABDrug contains lactose”.

Appearance of the productand contents of the package

White to off-white colored, round, scored on one face, and with a diameter of 12 mm tablets.

The tablet can be divided into equal doses.

PVC/PVDC 90-Aluminum blisters in cardboard boxes.

Dexamethasone ABDrug is available in packages containing 20 and 30 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Mabo-Farma S.A.

Calle Rejas 2, 1st floor

28821 Coslada Madrid

Spain

Responsible for manufacturing

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

95-200 Pabianice

Poland

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:February 2021

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es//