Package Insert: Patient Information

Dexamethasone ABDrug 4 mg Tablets

Dexamethasone ABDrug 8 mg Tablets

dexamethasone

Read this entire package insert carefully before starting to take this medication because 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 for you only and should not be given 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 ABDrugis a synthetic glucocorticoid. Glucocorticoids are hormones produced by the cortex of the adrenal glands. This medication has anti-inflammatory, analgesic, antiallergic effects and suppresses the immune system.

Dexametasona ABDrugis recommended for the treatment of rheumatic and autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, juvenile idiopathic arthritis, polyarteritis nodosa), respiratory tract disorders (e.g., bronchial asthma, croup), skin disorders (e.g., erythrodermia, pemphigus vulgaris), tuberculous meningitis only in combination with anti-infective treatment, blood disorders (e.g.,idiopathic thrombocytopenic purpurain adults), cerebral edema, symptomatic multiple myeloma, acute lymphoblastic leukemia, Hodgkin's disease, and non-Hodgkin lymphoma in combination with other medications, palliative treatment of neoplastic diseases, prophylaxis and treatment of nausea and vomiting caused by chemotherapy, and prevention and treatment of vomiting after surgery, as part of antiemetic treatment.

Do not takeDexametasona ABDrug

• if you are allergic to dexamethasone or any of the other ingredients of this medication (listed in section 6).
• if you have an infection that affects your whole body (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 takeDexametasona ABDrug:

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

Mental problems may occur while taking steroids likeDexametasona ABDrug.

• These conditions can be serious.
• They usually start a few days or weeks after starting treatment.
• It is more likely to occur with 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 (or someone taking this medication), show any signs of mental problems. This is especially important if you are depressed, or may be thinking of suicide. In a few cases, mental problems have occurred when the doses were reduced or stopped.

Consult your doctor before taking this medication:

• if you have kidney or liver problems (cirrhosis or severe renal failure),
• if you have or suspect you have phaeochromocytoma (a tumor of the adrenal glands),
• if you have high blood pressure, heart problems or 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 gone through 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 vision loss),
• if you have myasthenia gravis (a disease that causes muscle weakness),
• if you have an intestinal problem or stomach ulcer (peptic),
• if you have psychiatric problems or have had psychiatric disorders that have worsened with this type of medication,
• if you have epilepsy (a disease in which you have seizures or repeated attacks),
• if you suffer from migraine,
• if you have an underactive thyroid gland,
• if you have a parasitic infection,
• if you have tuberculosis, septicemia or fungal eye infection,
• if you have 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 blood vessel obstruction by blood clots (thromboembolism),
• if you have corneal ulcers and corneal damage

Treatment with corticosteroids can reduce your body's ability to fight infections. This can lead to infections caused by germs that rarely cause infection in normal circumstances (called opportunistic infections). If you have any type of infection during treatment with this medication, 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 to avoid contact with someone who has chickenpox, shingles or measles while taking this medication. If you think you may have been exposed to any of these diseases, you should consult your doctor immediately. You should also inform your doctor if you have ever had infectious diseases such as measles or chickenpox and about any vaccinations.

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

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

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

Treatment with this medication can cause central serous chorioretinopathy, an eye disorder that causes blurred or distorted vision. This usually occurs in one of the two eyes.

Treatment with this medication can 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.

Treatment withDexametasona ABDrugcan cause a condition called adrenal insufficiency. This can cause a change in the effectiveness of the medication after stress and trauma, surgery, childbirth, or illness, and your body may not be able to respond normally 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 viral vaccines) while taking or having finished takingDexametasona ABDrug, 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 your body), skin allergy tests or tests for bacterial infections, you must inform the person performing 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 medication.

If you are an elderly patient, some of the side effects of this medication 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 medication, it is essential that your doctor monitor their growth and development at frequent intervals.Dexametasona ABDrugshould not be used routinely in premature babies with respiratory problems.

Other medications andDexametasona ABDrug

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

• Anticoagulant medications that thin the blood (e.g. warfarin)
• Acetylsalicylic acid or similar (non-steroidal anti-inflammatory drugs) e.g. indomethacin
• Medications used to treat diabetes
• Medications used to treat high blood pressure
• Medications used to treat heart problems
• Diuretics (tablets that promote water elimination)
• Anfotericin B injectionB
• Phenobarbital, carbamazepine, primidone (medications for epilepsy)
• Rifabutin, rifampicin, isoniazid (antibiotics used to treat tuberculosis)
• Antacids – particularly those containing magnesium trisilicate
• Barbiturates (medications used to help sleep and alleviate 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
• Medications that help muscle movement in patients with myasthenia gravis (e.g. neostigmine)
• Colestiramine (for high cholesterol levels)
• Estrogen hormones including oral contraceptives
• 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 medications, even those purchased without a prescription. You may increase the risk of severe side effects if you take dexamethasone with these medications:

• Some medications may increase the effects ofDexametasona ABDrugand your doctor may want to monitor you closely if you are taking these medications (including some HIV medications: ritonavir, cobicistat).
• Acetylsalicylic acid or similar (non-steroidal anti-inflammatory drugs) e.g. indomethacin
• Medications used to treat diabetes
• Medications used to treat heart problems
• Diuretics (tablets that promote water elimination)
• Anfotericin 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)
• Medications used to treat high blood pressure
• Talidomide used e.g. for multiple myeloma
• Vaccination with live vaccines
• Medications that help muscle movement in myasthenia gravis (e.g. neostigmine)
• Antibiotics including fluoroquinolones.

You should read the leaflet of all medications you take withDexametasona ABDrugin relation to the information corresponding to these medications before starting treatment withDexametasona ABDrug. When using talidomide, lenalidomide or pomalidomide, special attention should be paid to pregnancy tests and prevention needs.

Dexametasona ABDrugwith food, drinks and alcohol

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

Pregnancy and breastfeeding

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

Dexametasona ABDrugshould 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 medication, do not stop takingDexametasona 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 continue or stop dexamethasone treatment should be made considering the benefit of breastfeeding for the baby and the benefit of dexamethasone treatment for the woman.

Driving and operating machinery

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

Dexametasona ABDrugcontains lactose

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

Each 4 mg tablet contains 74 mg of lactose (37 mg of glucose and 37 mg of galactose).

Each 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 mellitus.

Sodium

This medication contains less than 23 mg of sodium (1mmol) per tablet; it is essentially "sodium-free".

Consult your doctor or pharmacist if you are unsure.

Dexametasona ABDrug is available in tablet form of4 mg, 8 mg and 20 mg.The 20 mg tablet can be divided into two equal halves and provide additional doses of 10 mgto facilitate swallowing.

Dexametasona 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 advisory. The initial and daily doses should always be determined based on the individual patient's response and the severity of the disease.

• Cerebral edema:The initial dose and duration of treatment depend on the cause and severity, 6-16 mg (up to 24 mg) / day administered orally, divided into 3-4 individual doses.
• Asthma:Adults: 16 mg/day for two days. Children: 0.6 mg/kg body weight for one or two days.
• Croup:Children: 0.15 mg/kg-0.6 mg/kg in a single dose.
• Acute skin diseases:Depending on the nature and severity of the disease, daily doses of 8-40 mg, in some cases up to 100 mg, followed by a titration to the lowest clinical needs.
• Active phase of systemic rheumatic diseases:Lupus erythematosus systemic 6-16 mg/day.
• Severe progressive rheumatoid arthritis:Acting with rapid destructive forms 12-16 mg/day, with extra-articular manifestations 6-12 mg/day.
• Idiopathic thrombocytopenic purpura:40 mg for four days in cycles.
• Tuberculous meningitis:Patients with grade II or III disease receive intravenous treatment for four weeks (0.4 mg/kg/day during week 1, 0.3 mg/kg/day during week 2, 0.2 mg/kg/day during week 3, and 0.1 mg/kg/day during week 4) and then oral treatment for four weeks, starting with a total doseof 4 mg/day and decreasing 1 mg each week. Patients with grade I disease are treated for two weeks with intravenous treatment (0.3 mg/kg/day during week 1 and 0.2 mg/kg/day during week 2) and then four weeks of oral treatment (0.1 mg/kg/day for three weeks, then a total of 3 mg/day, decreasing 1 mg each week).
• Palliative treatment of neoplastic diseases:The initial dose and duration of treatment depend on the cause and severity, 3-20 mg/day. High doses of up to 96 mg may also be used for palliative treatment. To optimize dosing and reduce the number of tablets, combinations of lower doses (4 and 8 mg) and the highest dose (20 mg) may be used.
• Prevention and treatment of chemotherapy-induced emesis, chemotherapy-induced emesis with antiemetic treatment:8-20 mg of dexametasona before chemotherapy,then 4-16 mg/day on days 2 and 3.
• Prevention and treatment of postoperative vomiting, within antiemetic treatment:Single dose of 8 mg before surgery.
• Treatment of 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.

For doses that cannot be achieved using the recommendations below, other medications are available on the market.

The dose and frequency of administration vary according to the therapeutic protocol and associated treatment(s). Dexametasona administration should follow the instructions for dexametasona 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 dexametasona should be used, taking into account the patient's situation and disease status.

Long-term treatment

For long-term treatment of various diseases, after initial therapy, treatment with glucocorticoids should be changed from dexametasona to prednisona/prednisolona to reduce adrenal cortex function suppression.

Use in children and adolescents

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

If you take moreDexametasona 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 or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to takeDexametasona 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 make up for the missed dose.

If you interrupt treatmentDexametasona 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 until you stop taking it completely. Different symptoms have been reported when treatment is stopped 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, itching skin, and eye inflammation (conjunctivitis). If you stop treatment too soon and any of the mentioned symptoms appear, consult your doctor as soon as possible.

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

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

Consult your doctor immediately if you experience severe mental problems. These can 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 stool, which may be signs of intestinal perforation, especially 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, for example, cold sores; recurrence of tuberculosis or other infections, for example, 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 skin rash and swelling of the throat and tongue, and in severe cases, difficulty breathing or dizziness)
• Hormonal regulation problems, 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 (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, eyeball protrusion, 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, for example, 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 observed bleeding under the skin (increased capillary fragility), skin irritation around the mouth (perioral dermatitis)
• Bone weakening 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
• Withdrawal syndrome may also occur, including fever, muscle pain, 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 thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofDexametasona ABDrug

The active ingredient is dexamethasone.

Each 4 mg tablet contains 4 mg of dexamethasone.

Each 8 mg tablet contains 8 mg of dexamethasone.

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

Appearance of the productand contents of the package

4 mg: White or almost white, round, flat tablets with the number “4” engraved on one of the faces.

8 mg: White or almost white, oval-shaped, flat tablets with the number “8” engraved on one of the faces.

PVC/PVDC 90-Aluminum blisters in cardboard boxes.

Dexametasona ABDrug 4 mg is available in packages containing 20, 30, 50, 100 tablets.

Dexametasona ABDrug 8 mg is available in packages containing 20, 30, 50, 100 tablets.

Only some package sizes may be marketed.

Holder of the marketing authorizationlicense

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:

Date of the last review of this leaflet:February 2021

The 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/