Dexamethasone Abdrug 8 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Dexametasona ABDrug 4 mg tablets

Dexametasona ABDrug 8 mg tablets

dexamethasone

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Dexametasona ABDrug is and what it is used for
2. What you need to know before taking Dexametasona ABDrug
3. How to take Dexametasona ABDrug
4. Possible side effects
5. How to store Dexametasona ABDrug
6. Contents of the pack and other information

1. What Dexamethasone ABDrug is and what it is used for

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

Dexamethasone ABDrug is indicated for the treatment of rheumatic and autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, juvenile idiopathic arthritis, polyarteritis nodosa), disorders of the respiratory tract (e.g., bronchial asthma, croup), skin conditions (e.g., erythroderma, pemphigus vulgaris), tuberculous meningitis only in conjunction with anti-infective treatment, blood disorders (e.g., idiopathic thrombocytopenic purpura in adults), cerebral edema, treatment of symptomatic multiple myeloma, acute lymphoblastic leukemia, Hodgkin's disease and non-Hodgkin's 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 postoperative vomiting, as part of antiemetic therapy.

2. What you need to know before taking Dexametasona ABDrug

Do not take Dexametasona ABDrug

• 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 receiving treatment for it).
• if you have a stomach or duodenal ulcer.
• if you are due to receive vaccination with live vaccines.

Warnings and precautions

Talk to your doctor or pharmacist before taking Dexametasona ABDrug:

• if you have ever had severe depression or manic depression (bipolar disorder). This includes having experienced depression before or while taking steroid medicines such as dexamethasone.
• if anyone in your immediate family has suffered from this condition.

Mental problems may occur while taking steroids such as Dexametasona ABDrug.

• These conditions can be serious.
• They usually begin within a few days or weeks after starting treatment.
• They are more likely to occur at high doses.
• Most of these problems resolve if the dose is reduced or treatment is stopped. However, if such problems occur, you may require treatment.

Consult your doctor if you (or someone taking this medicine) show any signs of mental health problems. This is especially important if you are depressed or may be thinking about suicide. In a few cases, mental health problems have occurred when doses were reduced or treatment stopped.

Talk to your doctor before taking this medicine:

• if you have kidney or liver problems (hepatic cirrhosis or severe renal failure),
• if you have or suspect you have a pheochromocytoma (a tumour of the adrenal glands),
• if you have high blood pressure, heart problems, or have recently had a heart attack (myocardial rupture has been reported),
• if you have diabetes or a family history of diabetes,
• if you have osteoporosis (weakening of the bones), particularly if you are a postmenopausal woman,
• if you have previously experienced muscle weakness with this or other steroids,
• if you have glaucoma (increased pressure in the eye) or a family history of glaucoma, or cataracts (clouding of the eye's lens causing reduced vision),
• if you have myasthenia gravis (a condition causing muscle weakness),
• if you have a gastrointestinal disorder or a peptic (stomach) ulcer,
• if you have psychiatric problems or have had psychiatric disorders that were worsened by this type of medicine,
• if you have epilepsy (a condition causing repeated seizures or fits),
• if you suffer from migraines,
• if you have an underactive thyroid gland,
• if you have a parasitic infection,
• if you have tuberculosis, sepsis, or a fungal infection in the eye,
• if you have cerebral malaria,
• if you have herpes (cold sores, genital herpes, or ocular herpes simplex due to possible corneal perforation),
• if you have asthma,
• if you are being treated for blood vessel blockage due to blood clots (thromboembolism),
• if you have corneal ulcers or corneal damage.

Treatment with corticosteroids may reduce your body’s ability to fight infections. This can sometimes lead to infections caused by germs that rarely cause infection under normal circumstances (called opportunistic infections). If you develop any 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, particularly if you are elderly. You should also inform your doctor if you have had tuberculosis or have been in areas where intestinal worm infections are common.

It is important that while taking this medicine you avoid contact with anyone who has 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 about any vaccinations you have received.

Contact your doctor if you experience symptoms of tumour lysis syndrome such as muscle cramps, muscle weakness, confusion, visual loss or changes, and difficulty breathing, especially if you have a malignant haematological condition.

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

Treatment with this medicine may trigger a pheochromocytoma crisis, which can be fatal. Pheochromocytoma is a rare tumour of the adrenal glands. A crisis may cause symptoms such as headache, sweating, palpitations, and hypertension. Contact your doctor immediately if you experience any of these symptoms.

Treatment with this medicine may cause central serous chorioretinopathy, an eye disorder causing blurred or distorted vision. This usually occurs in one of the two eyes.

Treatment with this medicine may cause tendon inflammation. In extremely rare cases, the tendon may rupture. This risk is increased when taking certain antibiotics or in patients with kidney problems. Contact your doctor if you experience pain, or swelling or stiffness in your joints or tendons.

Treatment with Dexametasona ABDrug may cause a condition called adrenal insufficiency. This may affect how your body responds to 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 an accident, are ill, experience any other physical stress, or require surgery (including dental procedures), or if you are to be vaccinated (particularly with live viral vaccines) while taking or after stopping Dexametasona ABDrug, you must inform the person treating you that you are taking or have taken steroids.

If you need suppression tests (tests measuring hormone levels in the body), skin allergy tests, or bacterial infection tests, you must inform the person performing the test that you are taking dexamethasone, as it may interfere with test results.

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

If you are elderly, some of the adverse effects of this medicine may be more severe, especially bone thinning (osteoporosis), high blood pressure, low potassium levels, diabetes, increased 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 important that their doctor regularly monitors their growth and development. Dexametasona ABDrug should not be routinely used in premature infants with respiratory problems.

Other medicines and Dexametasona ABDrug

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines:

• Anticoagulant medicines that thin the blood (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 problems

• Diuretics (tablets that increase water elimination)

• Intravenous amphotericin B

• Phenytoin, carbamazepine, primidone (medicines for epilepsy)

• Rifabutin, rifampicin, isoniazid (antibiotics used to treat tuberculosis)

• Antacids – particularly those containing magnesium trisilicate

• Barbiturates (medicines used to help sleep and relieve anxiety)

• Aminoglutethimide (an anticancer treatment)

• Carbenoxolone (used in the treatment of stomach ulcers)

• Ephedrine (a 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)

• Cholestyramine (for high cholesterol levels)

• Oestrogen hormones including oral contraceptives

• Tetracosactide used in adrenal function tests

• Sulpiride used to calm emotions

• Cyclosporine used to prevent transplant rejection

• Thalidomide used e.g., for multiple myeloma

• Praziquantel administered for certain worm infections

• Vaccination with live vaccines

• Chloroquine, hydroxychloroquine, and mefloquine (for malaria)

• Somatotropin

• Protirelin

Tell your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription. The risk of serious adverse effects may increase if you take dexamethasone together with these medicines:

• Some medicines may increase the effects of Dexametasona ABDrug, and your doctor may need to monitor you closely 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 for the treatment of diabetes
• Medicines used to treat heart problems
• Diuretics (tablets that increase water elimination)
• Intravenous amphotericin B
• 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
• Thalidomide 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 should read the leaflet of any other medicines you are taking together with Dexametasona ABDrug to understand relevant information before starting combined treatment. Special attention to pregnancy testing and contraception requirements is needed when using thalidomide, lenalidomide, or pomalidomide.

Dexametasona ABDrug with food, drinks, and alcohol

Dexamethasone should be taken with or after food to minimize gastrointestinal irritation. Drinks containing alcohol or caffeine should be avoided. Small, frequent meals are recommended, as well as the possibility of taking antacids if advised by your doctor.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Dexametasona ABDrug should only be prescribed during pregnancy, especially in the first trimester, if the benefits outweigh the risks to the mother and child.

If you become pregnant while using this medicine, do not stop taking Dexametasona ABDrug, but inform your doctor immediately.

Corticosteroids may pass into breast milk. Risk to newborns/infants cannot be excluded. A decision on whether to continue breastfeeding or discontinue dexamethasone therapy should be made, taking into account the benefit of breastfeeding for the child and the benefit of dexamethasone treatment for the mother.

Driving and using machines

Do not drive, operate tools or machinery, or perform any hazardous tasks if you experience adverse effects such as confusion, hallucinations, dizziness, fatigue, drowsiness, fainting, or blurred vision.

Dexametasona ABDrug contains lactose

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

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

Each 8 mg tablet contains 148 mg of lactose (74 mg glucose and 74 mg galactose).

This should be taken into account in patients with diabetes mellitus.

Sodium

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

3. How to take Dexametasona ABDrug

Consult your doctor or pharmacist if you have any doubts.

Dexametasona ABDrug is available as 4 mg, 8 mg, and 20 mg tablets. The 20 mg tablet can be divided into equal halves to provide additional 10 mg doses to facilitate swallowing.

Dexamethasone is usually taken at doses of 0.5 to 10 mg per day, depending on the condition being treated. In more severe conditions, 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 directed, the following dosage recommendations apply:

The dosage recommendations below are for guidance only. The initial and daily doses must always be determined based on the individual patient's response and the severity of the disease.

• Cerebral edema: 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.
• Acute 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 as a single dose.
• Acute skin diseases: Depending on the nature and extent of the disease, daily doses of 8–40 mg, in some cases up to 100 mg, followed by dose tapering according to clinical needs.
• Active phase of systemic rheumatic diseases: systemic lupus erythematosus 6–16 mg/day.
• Actively progressive severe rheumatoid arthritis: 12–16 mg/day for rapidly destructive forms; 6–12 mg/day for forms with extra-articular manifestations.
• Idiopathic thrombocytopenic purpura: 40 mg for 4 days in cycles.
• Tuberculous meningitis: Patients with grade II or III disease receive intravenous treatment for four weeks (0.4 mg per kilogram per day during week 1, 0.3 mg per kilogram per day during week 2, 0.2 mg per kilogram per day during week 3, and 0.1 mg per kilogram per day during week 4), followed by oral treatment for four weeks, starting with a total dose of 4 mg per day and reducing by 1 mg each week. Patients with grade I disease receive two weeks of intravenous treatment (0.3 mg per kilogram per day in week 1 and 0.2 mg per kilogram per day in week 2), followed by four weeks of oral treatment (0.1 mg per kilogram per day for 3 weeks, then a total of 3 mg per day, decreasing by 1 mg each week).
• Palliative treatment of neoplastic diseases: Initial dose and duration depend on cause and severity, 3–20 mg/day. Very high doses up to 96 mg may also be used for palliative treatment. For optimal dosing and to reduce the number of tablets, combinations of lower doses (4 and 8 mg) and the highest dose (20 mg) can be used.
• Prophylaxis and treatment of cytotoxic-induced emesis, emetogenic chemotherapy with antiemetic treatment: 8–20 mg of dexamethasone prior to chemotherapy, followed by 4–16 mg/day on days 2 and 3.
• Prevention and treatment of postoperative nausea and vomiting, as part of antiemetic therapy: single dose of 8 mg before surgery.
• Treatment of symptomatic multiple myeloma, acute lymphoblastic leukemia, Hodgkin’s disease, and non-Hodgkin lymphomas in combination with other medications: the usual dosage is 40 mg or 20 mg once daily.

For doses that cannot be achieved using the above recommendations, other medicinal products are available on the market.

The dose and frequency of administration vary according to the therapeutic protocol and associated treatment(s). Dexamethasone administration should follow the administration instructions for dexamethasone when specified in the summary of product characteristics of the associated treatments. If not, local or international treatment protocols and guidelines should be followed. Prescribing physicians must carefully evaluate the appropriate dexamethasone dose, taking into account the patient's condition and disease status.

Long-term treatment

For long-term treatment of various diseases, after initial therapy, dexamethasone glucocorticoid therapy should be switched to prednisone/prednisolone to reduce suppression of adrenal cortex function.

Use in children and adolescents

If a child is taking this medicine, it is important that the doctor regularly monitors their growth and development.

If you take more Dexametasona ABDrug than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Dexametasona ABDrug

If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for a missed dose.

If you stop taking Dexametasona ABDrug

If your treatment is to be discontinued, you must follow your doctor's recommendations. Your doctor may advise you to gradually reduce the amount of medicine you are taking until you stop completely. Various 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 the treatment was prescribed.

A "withdrawal syndrome" may also occur, including fever, muscle and joint pain, inflammation of the nasal lining (rhinitis), weight loss, skin itching, and eye inflammation (conjunctivitis). If you stop treatment too early and experience any of the symptoms mentioned, you should consult your doctor as soon as possible.

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

4. Possible adverse effects

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

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

• feeling depressed, including suicidal thoughts,
• feeling extremely euphoric (mania) or having mood swings,
• feeling anxious, having sleep problems, difficulty thinking or confusion, and memory loss,
• feeling, seeing, or hearing things that are not real; having strange or frightening thoughts, changes in behavior, or feeling isolated.

Consult your doctor immediately if you experience:

• severe abdominal pain, nausea, vomiting, diarrhoea, profound muscle weakness and fatigue, extremely low blood pressure, weight loss, and fever, as these may be signs of adrenal insufficiency,
• sudden abdominal pain, tenderness, nausea, vomiting, fever, and blood in the stool, which may be signs of intestinal perforation, especially if you have or have had a bowel disease.

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

Other possible adverse effects (frequency not known) may include:

• Increased susceptibility to infections, including viral and fungal infections, e.g., thrush; reactivation of tuberculosis or other infections, e.g., eye infections if previously experienced
• Reduction in the number of white blood cells or increase in the number of white blood cells, abnormal blood clotting,
• Allergic reaction to the medicine, including potentially life-threatening allergic reactions (which may present as rash and swelling of the throat and tongue, and in severe cases, difficulty breathing or dizziness)
• Problems with the body's hormonal regulation, swelling and weight gain, moon-shaped face (Cushingoid state), altered endocrine system response following stress and trauma, surgery, childbirth, or illness; your body may be unable to respond normally to serious stress such as accidents, surgery, childbirth, or illness; growth retardation in children and adolescents; irregular or absent menstrual cycles (periods); excessive growth of body hair (particularly in women)
• Weight gain, loss of protein and calcium imbalance, increased appetite, electrolyte imbalance, fluid retention, potassium loss which may lead to rhythm disorders, increased need for diabetes medication, previously undiagnosed diabetes becoming apparent, high levels of cholesterol and triglycerides in the blood (hypercholesterolemia and hypertriglyceridemia)
• Extreme mood changes, schizophrenia (mental disorder) which may worsen, depression, inability to sleep
• Unusually severe headache with visual disturbances due to treatment withdrawal, seizures, and worsening of epilepsy, dizziness
• Increased intraocular pressure, papilledema, thinning of ocular membranes, increased risk of viral, bacterial, and fungal eye infections, worsening of symptoms associated with corneal ulcers, worsening of existing eye infections, protrusion of the eyeballs, cataracts, blurred vision, visual disturbances, vision loss
• Congestive heart failure in susceptible individuals, cardiac muscle rupture following a recent heart attack, cardiac decompensation
• High blood pressure, blood clots: formation of blood clots that may block blood vessels, for example, in the legs or lungs (thromboembolic complications)
• Hiccups
• Nausea, vomiting, stomach discomfort and bloating, inflammation and ulcers in the oesophagus, peptic ulcers which may perforate and bleed, inflamed pancreas (which may present as pain in the back and abdomen), flatulence, oesophageal candidiasis
• Thinning of delicate skin, unusual skin markings, bruising, redness and inflammation of the skin, stretch marks, visible inflammation of capillaries, acne, increased sweating, skin rash, swelling, hair loss, unusual fat deposits, excessive hair growth, fluid retention in the body, capillary fragility leading to bleeding under the skin (increased capillary fragility), irritation of the skin 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 interruption of bone growth (premature epiphyseal closure)
• Changes in sperm count and motility, impotence
• Reduced response to vaccines and skin tests, slow wound healing, malaise
• A "withdrawal syndrome" may also occur, including fever, muscle and joint pain, inflammation of the nasal lining (rhinitis), weight loss, itchy painful skin nodules, and eye inflammation (conjunctivitis)

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dexamethasone ABDrug

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature conditions.

Store in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dexamethasone ABDrug

The active substance 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, pregelatinized corn starch, colloidal anhydrous silica (E551), magnesium stearate (E470b), and sodium stearyl fumarate. See section 2 “Dexamethasone ABDrug contains lactose”.

Appearance of the product and contents of the pack

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

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

PVC/PVDC90-Aluminum blisters in cardboard cartons.

Dexamethasone ABDrug 4 mg is available in packs containing 20, 30, 50, or 100 tablets.

Dexamethasone ABDrug 8 mg is available in packs containing 20, 30, 50, or 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Mabo-Farma S.A.

Calle Rejas 2, planta 1

28821 Coslada Madrid

Spain

Manufacturer

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

95-200 Pabianice

Poland

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

Date of the most recent review of this leaflet: February 2021

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/