Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dexamethasone TAD 4 mg tablets

Dexamethasone TAD 8 mg tablets

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, consult your doctor or pharmacist.
This medicine has been prescribed for you only, and you should not give it to others, 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

What Dexamethasone TAD is and what it is used for
What you need to know before taking Dexamethasone TAD
How to take Dexamethasone TAD
Possible side effects
How to store Dexamethasone TAD
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 indicated for the treatment of rheumatic and autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, juvenile idiopathic arthritis, polyarteritis nodosa), respiratory tract disorders (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.

Dexamethasone TAD 4 mg tablets

Dexamethasone TAD is used for the treatment of coronavirus disease 2019 (COVID-19) in adult and adolescent patients (aged at least 12 years with a body weight of at least 40 kg) who have difficulty breathing and require supplemental oxygen therapy.

2. What you need to know before taking Dexametasona TAD

Do not take Dexametasona TAD:

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

Warnings and precautions

If you are being treated for COVID-19, do not stop taking any other steroid medication unless your doctor tells you to.

Talk to your doctor, pharmacist, or nurse before starting Dexametasona TAD:

if you have ever had severe depression or manic depression (bipolar disorder), including depression before or while taking steroid medicines such as dexamethasone.
if a close family member has had this condition.

Mental health problems may occur while taking steroids such as Dexametasona TAD:

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 go away if the dose is reduced or treatment is stopped. However, if problems occur, you may need treatment.

Talk to 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 starting this medicine:

if you have kidney or liver problems (liver 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 eye pressure) or a family history of glaucoma, or cataracts (clouding of the eye's lens causing vision loss),
if you have myasthenia gravis (a disease causing muscle weakness),
if you have a gastrointestinal disorder or a stomach (peptic) ulcer,
if you have psychiatric problems or have had psychiatric disorders 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 fungal eye infection,
if you have cerebral malaria,
if you have herpes (mouth ulcers, genital herpes, or ocular herpes, 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 this medicine may trigger a pheochromocytoma crisis, which can be life-threatening. 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 corticosteroids may reduce your body’s ability to fight infections. This may sometimes lead to infections caused by germs that rarely cause illness 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 if you have visited regions where intestinal worm infections are common.

While taking this medicine, it is important to 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 must consult your doctor immediately. You should also inform your doctor if you have previously had infectious diseases such as measles or chickenpox, or if you have been vaccinated.

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, in case you have a malignant haematological condition.

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

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 if you have kidney problems. Contact your doctor if you experience pain, or swelling or stiffness in your joints or tendons.

Treatment with Dexametasona TAD may cause a condition called adrenal insufficiency. This may affect the medicine’s effectiveness during stress and trauma, surgery, childbirth, or illness, and your body may not respond normally to severe stress such as accidents, surgery, childbirth, or illness.

If you have an accident, are ill, have any other physical stress condition, or require surgery (including dental surgery), or are to be vaccinated (particularly with live viral vaccines) while taking or after stopping dexamethasone, 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, 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 may prescribe potassium supplements while you are taking this medicine.

If you are elderly, some of the adverse effects of this medicine may be more serious, 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

If a child is taking this medicine, it is important that their growth and development are monitored frequently by a doctor. Dexametasona TAD should not be routinely used in premature infants with respiratory problems.

Other medicines and Dexametasona TAD

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)
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 (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)
Estrogen hormones including oral contraceptives
Tetracosactide used in adrenal cortical function tests
Sulpiride used to calm emotions
Cyclosporine used to prevent transplant rejection
Thalidomide used e.g., for multiple myeloma
Praziquantel used 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 other medicines, including those obtained without a prescription. You may have an increased risk of serious adverse effects if you take dexamethasone with these medicines.

Some medicines may increase the effects of Dexametasona TAD, and your doctor may wish 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)
Amphotericin B injections
Acetazolamide (used for glaucoma and epilepsy)
Tetracosactide used in adrenal cortical 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 all medicines you take together with Dexametasona TAD for information about these medicines before starting treatment with Dexametasona TAD. Special attention to pregnancy testing and prevention needs is required when using thalidomide, lenalidomide, or pomalidomide.

Dexametasona TAD with food, drinks, and alcohol

Dexamethasone should be taken with or after food to minimize gastrointestinal tract irritation. Drinks containing alcohol or caffeine should be avoided. It is recommended to eat small, frequent meals and, if advised by your doctor, to consider taking antacids.

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 TAD should only be prescribed during pregnancy, especially in the first trimester, if the benefits outweigh the risks to the mother and unborn child. If you become pregnant while using this medicine, do not stop taking Dexametasona TAD 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 interrupt it, and whether to continue or interrupt dexamethasone treatment, should be made by weighing the benefit of breastfeeding to the child against 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 TAD 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.

3. How to take Dexamethasone TAD

Take Dexamethasone TAD only as directed by your doctor. Your doctor will determine how long you should take dexamethasone. If in doubt, consult your doctor or pharmacist again.

Dexamethasone TAD is available as 4 mg, 8 mg, 20 mg, and 40 mg tablets. The tablet may be divided into equal halves to provide additional doses of 2 mg and 10 mg, or to facilitate swallowing.

Dexamethasone is usually taken at doses of 0.5 to 10 mg daily, 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 possible should be used.

Unless otherwise directed, the following dosage recommendations apply:

The dosage recommendations below are for guidance only. 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) daily administered orally, divided into 3–4 individual doses.
Acute asthma: Adults: 16 mg/day for 2 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 disorders: Daily doses of 8–40 mg depending on the nature and extent of the disease, 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.
Active, progressively severe rheumatoid arthritis: 12–16 mg/day if associated with rapidly destructive forms; 6–12 mg/day if extra-articular manifestations are present.
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 body weight 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, reducing 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 mg and 8 mg) and higher doses (20 mg or 40 mg) may be used.
Prophylaxis and treatment of cytotoxic- or chemotherapy-induced emesis, as part of antiemetic therapy: 8–20 mg 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’s lymphomas in combination with other medications: the usual dosage is 40 mg or 20 mg once daily.

The dose and frequency of administration vary depending on the therapeutic protocol and associated treatment(s). Administration of dexamethasone should follow the instructions for dexamethasone administration 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, glucocorticoid treatment should be switched from dexamethasone to prednisone/prednisolone to reduce suppression of adrenal cortex function.

Dexamethasone 4 mg tablets

Treatment of Covid-19: In adult patients, a dose of 6 mg once daily is recommended for up to a maximum of 10 days.

Use in adolescents: Pediatric patients (adolescents at least 12 years of age and weighing 40 kg) should be given a dose of 6 mg once daily for up to a maximum of 10 days.

Use in children

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

If you take more Dexamethasone TAD than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Dexamethasone TAD

If you forget to take 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 missed doses.

If you stop taking Dexamethasone TAD

If your treatment is to be discontinued, you must follow your doctor's recommendations. Your doctor may advise you to gradually reduce the dose before stopping 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, 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 will experience them.

Contact your doctor immediately if you experience serious mental problems. These may affect 5 in every 100 people taking medicines such as dexamethasone. These problems include:

feeling depressed, including suicidal thoughts,
feeling extremely euphoric (mania) or having mood swings,
feeling anxious, having trouble sleeping, 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.

Contact your doctor immediately if you experience:

severe abdominal pain, nausea, vomiting, diarrhea, 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 stools, 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, contact your doctor immediately.

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

Increased risk of 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, 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 severe stress such as accidents, surgery, childbirth, or illness; growth retardation in children and adolescents; irregular or absent menstrual periods (periods); excessive growth of body hair (particularly in women),
Weight gain, loss of protein and calcium imbalance, increased appetite, electrolyte imbalance, fluid retention in the body, potassium loss which may cause rhythm disorders, increased need for diabetes medication, previously undiagnosed diabetes becoming apparent, elevated 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 vision 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, ocular proptosis, 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 esophagus, peptic ulcers which may perforate and bleed, inflamed pancreas (which may present as back and abdominal pain), flatulence, esophageal 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, reduced hair growth, unusual fat deposits, excessive hair growth, fluid retention in the body, capillary weakness leading to easy rupture observed as 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 effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may 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 TAD

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 is the last day of the month indicated.

This medicine does not require any special storage temperature.

Store in the original packaging to protect from light and moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point in your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dexamethasone TAD

The active substance is dexamethasone.

Dexamethasone TAD 4 mg tablets

Each tablet contains 4 mg of dexamethasone.

Dexamethasone TAD 8 mg tablets

Each tablet contains 8 mg of dexamethasone.
The other components (excipients) are lactose monohydrate, pregelatinized corn starch, colloidal anhydrous silica, and magnesium stearate (E470b). See section 2 “Dexamethasone TAD contains lactose”.

Appearance of the product and contents of the pack

4 mg tablets: white or almost white, round, bevelled-edged tablets, scored on one side (Thickness: 2.5–3.5 mm; Diameter: 5.7–6.3 mm). The tablet can be divided into equal doses.

8 mg tablets: white or almost white, oval tablets, scored on one side (Thickness: 3.5–5.5 mm; Length: 8.7–9.3 mm). The tablet can be divided into equal doses.

Dexamethasone TAD 4 mg is available in packs containing 10, 20, 28, 30, 50, 56, 60, 100, 10 x 1, 20 x 1, 28 x 1, 30 x 1, 50 x 1, 56 x 1, 60 x 1 and 100 x 1 tablets in blisters.

Dexamethasone TAD 8 mg is available in packs 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 certain pack 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

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

For further information about this medicinal product, please contact 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 medicinal product is authorized in the European Economic Area (EEA) Member States and in the United Kingdom (Northern Ireland) under the following names:

Hungary: Dexamethasone Krka 4 mg tabletta / Dexamethasone Krka 8 mg tabletta
Bulgaria: ?e?????????? ???? 4 mg ???????? / ?e?????????? ???? 8 mg ????????
Czech Republic: Dexamethasone Krka 4 mg / Dexamethasone Krka 8 mg
Estonia: Dexamethason Krka
Croatia: Dexamethason Krka 4 mg tablete / Dexamethason Krka 8 mg tablete
Latvia: Dexamethason Krka 4 mg tabletes / Dexamethason Krka 8 mg tabletes
Lithuania: Dexamethasone Krka 4 mg tabletes / Dexamethasone Krka 8 mg tabletes
Poland: Dexamethasone Krka
Romania: Dexametazona Krka 4 mg comprimate / Dexametazona Krka 8 mg comprimate
Slovenia: Dexamethason Krka 4 mg tablete / Dexamethason Krka 8 mg tablete
Slovakia: Dexametazon Krka 4 mg tablety / Dexametazon Krka 8 mg tablety
Germany: Dexamethason TAD 4 mg Tabletten / Dexamethason TAD 8 mg Tabletten
Spain: Dexametasona TAD 4 mg comprimidos / Dexametasona TAD 8 mg comprimidos
United Kingdom: Dexamethasone 4 mg tablets / Dexamethasone 8 mg tablets
Portugal: Dexametasona Krka 4 mg comprimidos / Dexametasona Krka 8 mg comprimidos

Date of the most recent revision of this leaflet: July 2021

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