DEXAMETHASONE TAD 40 mg TABLETS

Introduction

Package Leaflet: Information for the User

Dexamethasone TAD 20 mg tablets

Dexamethasone TAD 40 mg tablets

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

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

Dexamethasone TAD 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 treatment of multiple myeloma, acute lymphoblastic leukemia, Hodgkin's disease, and non-Hodgkin's lymphoma in combination with other medicines, metastatic spinal cord compression (pressure on the spinal cord nerves caused by a tumor), prophylaxis and treatment of nausea and vomiting caused by chemotherapy, as part of antiemetic treatment.

2. What you need to know before you take Dexamethasone TAD

Do not takeDexamethasone TADif:

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Dexamethasone TAD:

• if you have ever had severe depression or manic depression (bipolar disorder). This includes having had depression before or while taking steroid medicines like dexamethasone.
• if someone in your close family has had this disease.

Mental problems can occur while taking steroids like Dexamethasone TAD:

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

Talk to your doctor if you are taking (or someone taking this medicine) shows signs of mental problems.

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

Talk to your doctor before taking this medicine:

• if you have kidney or liver problems (liver cirrhosis or severe kidney failure),
• if you have or suspect you have pheochromocytoma (a tumor 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 had muscle weakness with this or other steroids in the past,
• if you have glaucoma (high eye pressure) or a family history of glaucoma, cataracts (clouding of the eye's lens 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 been worsened by this type of medicine,
• if you have epilepsy (a disease in which you have repeated seizures or attacks),
• if you have migraines,
• 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 ocular herpes simplex 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 this medicine can cause a pheochromocytoma crisis, which can be fatal. Pheochromocytoma is a rare tumor of the adrenal glands. Crises can have the following symptoms: headaches, sweating, palpitations, and high blood pressure. Contact your doctor immediately if you experience any of these signs.

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

It is essential that while taking this medicine, you avoid contact with anyone who has had chickenpox, shingles, or measles. 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 had any infectious diseases such as measles or chickenpox and if you have been vaccinated.

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

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

Treatment with this medicine 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 medicine 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 feel pain, swollen joints or tendons, or stiffness.

Treatment with Dexamethasone TAD can cause a disease called adrenocortical 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 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 situation, or require any surgery (even at the dentist) or are going to be vaccinated (particularly with live viral vaccines) while taking or have finished taking dexamethasone, you should inform the person treating you that you are taking or have taken steroids.

If you need to have suppression tests (tests for hormone levels in the body), skin allergy tests, or tests for bacterial infections, you should 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 a potassium supplement while you are 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 increased susceptibility to infections and skin thinning. Your doctor will monitor you more closely.

Children

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

Other medicines and Dexamethasone TAD

Tell your doctor or pharmacist if you are taking, have recently taken, or might 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 (pills that promote water elimination)
• Amphotericin B injection
• 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 (anticancer 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 myasthenia gravis patients (e.g., neostigmine)
• Colestyramine (for high cholesterol levels)
• Estrogen hormones including birth control pills
• Tetracosactide used in adrenocortical function tests
• Sultopride used to calm emotions
• Cyclosporine used to prevent transplant rejection
• Thalidomide used e.g., for multiple myeloma
• Praziquantel administered for certain worm infections
• Live vaccine vaccination
• Chloroquine, hydroxychloroquine, and mefloquine (for malaria)
• Somatotropin
• Protirelin

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

• Some medicines may increase the effects of Dexamethasone TAD, and your doctor may want 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 diabetes treatment
• Medicines used to treat heart problems
• Diuretics (pills that promote water elimination)
• Amphotericin B injections
• Acetazolamide (used for glaucoma and epilepsy)
• Tetracosactide used in adrenocortical 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
• Live vaccine vaccination
• Medicines that help muscle movement in myasthenia gravis patients (e.g., neostigmine)
• Antibiotics including fluoroquinolones.

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

Dexamethasone TAD with food, drinks, and alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Dexamethasone TAD should only be prescribed during pregnancy and particularly in the first trimester if the benefits outweigh the risks for the mother and the child. If you become pregnant during treatment with this medicine, do not stop taking Dexamethasone TAD, but inform your doctor immediately that you are pregnant. Corticosteroids can pass into breast milk. The risk to newborns/babies cannot be excluded. The decision to continue/discontinue breastfeeding or continue/discontinue treatment with dexamethasone should be made taking into account the benefit of breastfeeding for the child and the benefit of treatment with dexamethasone for the woman.

Driving and using machines

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

Dexamethasone TAD contains lactose

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

3. How to take Dexametasona TAD

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

Dexametasona TAD is available in tablet form in 4 mg, 8 mg, 20 mg, and 40 mg. The tablet can be divided into equal halves to take additional doses of 2 mg and 10 mg or to facilitate swallowing.

Dexametasona is usually taken at a dose 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 dosage recommendations apply:

The dosage recommendations mentioned below are for guidance only.

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 for 3 consecutive days, followed by a downward adjustment of the dose 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 duration of treatment depend on the cause and severity. Very high doses of up to 96 mg may be used for palliative treatment. For optimal dosing and reduction of the number of tablets, combinations of lower doses (4 mg and 8 mg) and higher doses (20 mg or 40 mg) can be used.
• Prophylaxis and treatment of chemotherapy-induced emesis, emetogenic chemotherapy within antiemetic treatment:8-20 mg (one 20 mg tablet or half of a 40 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 treatment(s). The administration of dexametasona should follow the instructions for the administration of dexametasona when 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 which dose of dexametasona should be used, taking into account the patient's situation and disease state.

Long-term treatment

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

Use in children

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 Dexametasona TAD 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and prospectus to the healthcare professional.

If you forget to take Dexametasona TAD

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 forgotten doses.

If you interrupt treatment with Dexametasona TAD

If your treatment is going to be interrupted, you should follow your doctor's recommendations. They may recommend that you gradually reduce the amount of medication you are taking until you stop taking it completely. Various 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 treatment was taken.

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

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

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people experience them.

Consult your doctor immediately if you experience severe mental problems. These can affect 5 out of 100 people who take medications like dexametasona. These problems include:

• feeling depressed, including suicidal thoughts,
• feeling very euphoric (mania) or mood swings,
• feeling anxious, having sleep problems, difficulty thinking, or being confused and losing memory,
• feeling, seeing, or hearing things that do not exist, having strange or frightening thoughts, changing your behavior, or feeling alone.

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 can be signs of adrenocortical insufficiency,
• sudden abdominal pain, sensitivity, nausea, vomiting, fever, and blood in the stool, which can be signs of intestinal perforation, particularly if you have or have had intestinal disease.

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

Other adverse effects may be (frequency not known):

• Increased risk of infections, including viral and fungal infections, e.g., thrush; recurrence of tuberculosis or other infections, e.g., eye infections, if you have already suffered from them
• Reduction in the number of white blood cells or increase in the number of white blood cells, abnormal coagulation,
• Allergic reaction to the medication, including potentially fatal allergic reactions (which can 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 normally to severe stress such as accidents, surgery, childbirth, or diseases, delayed growth in children and adolescents, irregular or absent menstrual cycles, excessive body hair growth (particularly in women)
• Weight gain, protein loss, and calcium imbalance, increased appetite, electrolyte imbalance, fluid retention, potassium loss, which can cause rhythm disorders, increased requirements for diabetes medication, unknown diabetes that becomes apparent, high levels of cholesterol and triglycerides in the blood (hypercholesterolemia and hypertriglyceridemia)
• Extreme mood changes, schizophrenia (mental disorder) that can worsen, depression, insomnia
• Severe and unusual headache with vision changes due to treatment withdrawal, seizures, and worsening of epilepsy, dizziness
• Increased eye pressure, papilledema, reduction of eye membranes, increased eye infections (viral, bacterial, and fungal), worsening of corneal ulcer symptoms, worsening of existing eye infections, protrusion of the eyeballs, cataracts, blurred vision, visual disturbances, loss of vision,
• Congestive heart failure in susceptible individuals, cardiac muscle rupture after a recent heart attack, cardiac decompensation
• High blood pressure, blood clots: formation of blood clots that can block blood vessels, e.g., in the legs or lungs (thromboembolic complications)
• Hiccups
• Nausea, vomiting, stomach discomfort, and abdominal swelling, esophageal inflammation and ulcers, peptic ulcers that can rupture and bleed, pancreatitis (which can appear as back and abdominal pain), flatulence, esophageal candidiasis
• Thinning of delicate skin, unusual skin marks, bruising, and skin inflammation, stretch marks, visible inflammation, capillaries, acne, increased sweating, skin rash, swelling, hair loss, unusual fat deposits, excessive hair growth, fluid retention in the body, weakness in the capillaries that facilitates breaking, observed as 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 interruption of bone growth (premature epiphyseal closure)
• Changes in sperm count and movement, impotence
• Reduced response to vaccines and skin tests, slow wound healing, discomfort
• A "withdrawal syndrome" may also occur, which includes fever, muscle and joint pain, inflammation of the nasal lining (rhinitis), weight loss, painful and itchy skin nodules, and eye inflammation (conjunctivitis)

Reporting of adverse effects:

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

5. Conservation of Dexametasona TAD

Keep this medication out of 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 and moisture.

Medications should not be thrown away through drains or trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Dexametasona TAD

• The active ingredient is dexametasona.

Dexametasona TAD 20 mg tablets

Each tablet contains 20 mg of dexametasona

Dexametasona TAD 40 mg tablets

Each tablet contains 40 mg of dexametasona.

• The other components (excipients) are lactose monohydrate, pregelatinized cornstarch, anhydrous colloidal silica, and magnesium stearate (E470b). See section 2 "Dexmetasona TAD contains lactose"

Appearance of the product and package contents

20 mg tablets: white or almost white, round tablets with beveled edges, scored, and marked with a 20 on one face (thickness: 4.0-6.0 mm; diameter: 10.7-11.3 mm). The tablet can be divided into equal doses.

40 mg tablets: white or almost white, oval tablets, scored on both faces (thickness: 6.0-8.0 mm; length: 18.7-19.3 mm). The tablet can be divided into equal doses.

Dexametasona TAD is available in packages containing 10, 20, 30, 50, 60, 100, 10 x 1, 20 x 1, 30 x 1, 50 x 1, 60 x 1, and 100 x 1 tablets in blisters.

Only some package sizes may be marketed.

Marketing authorization holder

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

or

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

This medication is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Hungary: Dexamethasone Krka 20 mg tablet / Dexamethasone Krka 40 mg tablet

Bulgaria: ???????????? 20 mg ???????? / ???????????? 40 mg ????????

Czech Republic: Dexamethasone Krka 20 mg / Dexamethasone Krka 40 mg

Estonia: Dexamethason Krka

Croatia: Dexamethason Krka 20 mg tablets / Dexamethason Krka 40 mg tablets

Latvia: Dexamethason Krka 20 mg tablets / Dexamethason Krka 40 mg tablets

Lithuania: Dexamethasone Krka 20 mg tablets / Dexamethasone Krka 40 mg tablets

Poland: Dexamethasone Krka

Romania: Dexametazona Krka 20 mg tablets / Dexametazona Krka 40 mg tablets

Slovenia: Dexamethason Krka 20 mg tablets / Dexamethason Krka 40 mg tablets

Slovakia: Dexametazon Krka 20 mg tablets / Dexametazon Krka 40 mg tablets

Germany: Dexamethason TAD 20 mg tablets / Dexamethason TAD 40 mg tablets

Spain: Dexametasona TAD 20 mg tablets / Dexametasona TAD 40 mg tablets

United Kingdom: Dexamethasone 20 mg tablets / Dexamethasone 40 mg tablets

Portugal: Dexametasona Krka 20 mg tablets / Dexametasona Krka 40 mg tablets

Date of the last revision of this prospectus:July 2021

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/