Dexamethasone 4 mg tablets

• 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).

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

• if you are allergic to dexamethasone or any of the other ingredients of this medicine (listed in section 6).
• if you have an infection that affects the whole body (unless you are receiving treatment).
• if you have a stomach or duodenal ulcer.
• if you are going to have a vaccination by live vaccines.

• If you are treated for COVID-19, you should not stop taking any other steroid medications unless your doctor has instructed you to do so.

Talk to your doctor, pharmacist or nurse before taking dexamethasone:

• 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 any of your close family has had these illnesses.

Mental health problems can happen while taking steroids like dexamethasone.

• These illnesses can be serious.
• Usually they start within a few days or weeks of starting the medicine.
• They are more likely to happen at high doses.
• Most of these problems go away if the dose is lowered or the medicine is stopped. However, if problems do happen, they might need treatment.

Talk to a doctor if you (or someone taking this medicine), show any signs of mental health problems. This is particularly important if you are depressed, or might be thinking about suicide. In a few cases, mental health problems have happened when doses are being lowered or stopped.

Talk to your doctor before taking this medicine if:

• you have kidney or liver problems (liver cirrhosis or chronic liver failure),
• you have or are suspected of having pheochromocytoma (a tumour of the adrenal glands),
• you have high blood pressure, heart disease or you have recently had a heart attack (myocardial rupture has been reported),
• you have diabetes or there is a family history of diabetes,
• you have osteoporosis (thinning of the bones), particularly if you are a female who has been through the menopause,
• you have suffered from muscle weakness with this or other steroids in the past,
• you have glaucoma (raised eye pressure) or there is a family history of glaucoma, cataract (clouding of the lens in the eye leading to a decrease in vision),
• you have myasthenia gravis (a condition causing weak muscles),
• you have a bowel disorder or a stomach (peptic) ulcer,
• you have psychiatric problems or you have had a psychiatric illness which was made worse by this type of medicine,
• you have epilepsy (condition where you have repeated fits or convulsions),
• you have migraine,
• you have an underactive thyroid gland,
• you have a parasitic infection,
• you have tuberculosis, septicaemia or a fungal infection in the eye,
• you have cerebral malaria,
• you have herpes (cold sores or genital herpes and ocular herpes simplex because of possible corneal perforation),
• you have asthma,
• you are treated for a blockage of blood vessels by blood clots (thromboembolism),
• you have corneal ulcerations and corneal injuries.

Treatment with this medicine may cause pheochromocytoma crisis, which can be fatal. Pheochromocytoma is a rare tumour of the adrenal glands. Crisis can occur with the following symptoms: headaches, sweating, palpitations, and hypertension. Contact your doctor immediately if you experience any of these signs.

Treatment with corticosteroid may reduce your body’s ability to fight infection. This can sometimes lead to infections caused by germs that rarely cause infection under normal circumstances (called opportunistic infections). If you get an infection of any kind during treatment with this medicine, contact your doctor immediately. This is particularly important if you notice signs of pneumonia: cough, fever, shortness of breath and chest pain. You may also feel confused, particularly if you are elderly. You should also tell your doctor if you have had tuberculosis or if you have stayed in regions where roundworm infections are common.

It is important that whilst you are taking this medicine you avoid contact with anybody who has chickenpox, shingles or measles. If you think you may have had exposure 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 of any vaccinations.

You should tell your doctor if you have any symptoms of tumour lysis syndrome such as muscle cramping, muscle weakness, confusion, visual loss or disturbances and shortness of breath, in case you suffer from haematological malignancy.

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

Treatment with this medicine may cause central serous chorioretinopathy, an eye disease that leads to blurred or distorted vision. This happens usually in one of the eyes.

Treatment with this medicine may cause tendon inflammation. In extremely rare cases, a tendon may rupture. This risk is increased by treatment with certain antibiotics and by kidney problems. Contact your doctor if you notice painful, stiff or swollen joints or tendons.

Treatment with dexamethasone can cause a condition called adrenocortical insufficiency. This can cause change in effectiveness of the medicine following stress and trauma, surgery, childbirth or illness and your body may not be able to respond in the usual way to severe stress such as accidents, surgery, childbirth or illness.

If you have an accident, are ill, have other specific physical stress conditions, or require any surgery (even at the dentists) or you require a vaccination (particularly with ‘live virus’ vaccines) whilst taking or when you have finished taking dexamethasone, you should inform the person treating you that you are taking or have taken steroids.

If you have suppression tests (test for the amount of hormone in the body), skin test for allergy or test for bacterial infection you should inform the person performing the test that you are taking dexamethasone as it may interfere with the results.

You may also find that your doctor will reduce the amount of salt in your diet and give you a potassium supplement whilst you are taking this medicine.

If you are elderly, some of the side effects of this medicine may be more serious, especially thinning of the bones (osteoporosis), high blood pressure, low potassium levels, diabetes, susceptibility to infection and thinning of the skin.

Your doctor will monitor you more closely.

If a child is taking this medicine, it is important that the doctor monitors their growth and development at frequent intervals. Dexamethasone should not be used routinely in preterm neonates with respiratory problems.

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

• Anticoagulant medicines which 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 cardiac diseases
• Diuretics (water tablets)
• Amphotericin B injection
• Phenytoin, carbamazepine, primidone (epilepsy medication)
• Rifabutin, rifampicin, isoniazid (antibiotics used to treat tuberculosis)
• Antacids – particularly those containing magnesium trisilicate
• Barbiturates (medication used to aid sleep and relieve anxiety)
• Aminoglutethimide (anti-cancer treatment)
• Carbenoxolone (used in the treatment of stomach ulcers)
• Ephedrine (nasal decongestant)
• Acetazolamide (used for glaucoma and epilepsy)
• Hydrocortisone, cortisone and other corticosteroids
• Ketoconazole, itraconazole (for fungal infections)
• Ritonavir (for HIV)
• Antibiotics including erythromycin, fluoroquinolones
• Medicines that help muscle movement in myasthenia gravis (e.g. neostigmine)
• Colestyramine (for high cholesterol levels)
• Estrogen hormones including the contraceptive pill
• Tetracosactide used in the test for adrenocortical function
• Sultopride used to calm emotions
• Ciclosporin used to prevent rejection after transplants
• Thalidomide used for e.g. multiple myeloma
• Praziquantel given for certain worm infections
• Vaccination with live vaccines
• Chloroquine, hydroxychloroquine and mefloquine (for malaria)
• Somatotropin
• Protirelin

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. You may be at an increased risk of serious side effects if you take dexamethasone together with these medicines:

• Some medicines may increase the effects of dexamethasone and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat)
• Acetylsalicylic acid or similar (Non-Steroidal Anti-Inflammatory drugs) e.g. indometacin
• Medicines used to treat diabetes
• Medicines used to treat cardiac diseases
• Diuretics (water tablets)
• Amphotericin B injection
• Acetazolamide (used for glaucoma and epilepsy)
• Tetracosactide used in the test for adrenocortical function
• Carbenoxolone (used in the treatment of stomach ulcers)
• Chloroquine, hydroxychloroquine and mefloquine (for malaria)
• Medicines used to treat high blood pressure
• Thalidomide used for e.g. multiple myeloma
• Vaccination with live vaccines
• Medicines that help muscle movement in myasthenia gravis (e.g. neostigmine)
• Antibiotics including fluoroquinolones

You must read the package leaflets of all medicinal products to be taken in combination with dexamethasone for information related to these medicines before starting treatment with dexamethasone. When thalidomide, lenalidomide or pomalidomide is used, particular attention to pregnancy testing and prevention requirements is needed.

Dexamethasone should be taken with or after food to minimise irritation to the gastrointestinal tract. Drinks containing alcohol or caffeine should be avoided. Eating small, frequent meals is recommended, and possibly taking of antacids, if recommended by your doctor.

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

Dexamethasone should be prescribed during pregnancy and particularly in the first trimester only if the benefit outweighs the risks for the mother and child. If you become pregnant during the use of the product, do not stop using dexamethasone, but tell your doctor immediately that you are pregnant.

Corticosteroids may pass into breast milk. A risk to the newborns/infants cannot be excluded.

A decision on whether to continue/discontinue breast feeding or to continue/discontinue therapy with dexamethasone should be made taking into account the benefit of breast feeding to the child and the benefit of dexamethasone therapy to the woman.

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

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

The below mentioned dosing recommendations are given for guidance only.

The initial and daily doses should always be determined based on individual patient response and disease severity.

• Cerebral oedema: Initial dose and duration of treatment depending on the cause and severity, 6-16 mg (up to 24 mg) / day 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: 0.15mg/kg-0.6 mg/kg in 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, which should be followed by down titration according to clinical need.
• Active phase of rheumatic system disorders: Systemic lupus erythematosus 6-16 mg / day.
• Active rheumatoid arthritis with severe progressive course form: running at fast destructive forms 12-16 mg / day, with extra-articular manifestations 6-12 mg / day.
• Idiopathic thrombocytopenic purpura: 40 mg for 4 days in cycles.
• Tuberculous meningitis: Patients with grade II or III disease received intravenous treatment for four weeks (0.4 mg per kilogram per day for week 1, 0.3 mg per kilogram per day for week 2, 0.2 mg per kilogram per day for week 3, and 0.1 mg per kilogram per day for week 4) and then oral treatment for four weeks, starting at a total of 4 mg per day and decreasing by 1 mg each week. Patients with grade I disease received two weeks of intravenous therapy (0.3 mg per kilogram per day for week 1 and 0.2 mg per kilogram per day for week 2) and then four weeks of oral therapy (0.1 mg per kilogram per day for week 3, then a total of 3 mg per day, decreasing by 1 mg each week).
• Palliative treatment of neoplastic diseases: Initial dose and duration of treatment depending on the 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 reduction of the number of tablets the combination of lower dose strengths (4 and 8 mg) and higher dose strengths (20 mg or 40 mg) can be used.
• Prophylaxis and treatment of emesis induced by cytostatics, emetogenic chemotherapy within antiemetic treatment: 8-20 mg dexamethasone prior to chemotherapy treatment, then 4-16 mg/day on day 2 and 3.
• Prevention and treatment of postoperative vomiting, within antiemetic treatment: single dose of 8 mg before the surgery.
• Treatment of symptomatic multiple myeloma, acute lymphoblastic leukemia, Hodgkin‘s disease and non- Hodgkin‘s lymphoma in combination with other medicinal products: the usual posology is 40 mg or 20 mg once per day.
• Treatment of Covid-19: Adult patients are recommended to take 6 mg once a day for up to 10 days. Use in adolescents: Paediatric patients (adolescents of 12 years of age or older with body weight at least 40 kg) are recommended to take 6 mg once a day for up to 10 days.

The dose and administration frequency varies with the therapeutic protocol and the associated treatment(s).

Dexamethasone administration should follow instructions for dexamethasone administration when described in the Summary of Product Characteristics of the associated treatment(s). If this is not the case, local or international treatment protocols and guidelines should be followed.

Prescribing physicians should carefully evaluate which dose of dexamethasone to use, taking into account the condition and disease status of the patient.

Long term treatment

For the long-term treatment of several conditions, after initial therapy, glucocorticoid treatment should be switched from dexamethasone to prednisone/prednisolone to reduce suppression on the function of the adrenal cortex.

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

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

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 a forgotten tablet.

If your treatment is to be stopped follow your doctor’s advice. He may tell you to reduce the amount of medicine you are taking gradually until you stop taking it altogether. The symptoms that have been reported when treatment has been stopped too quickly have included low blood pressure and in some cases, relapse of the disease for which the treatment was given.

A ‘withdrawal syndrome’ may also occur which includes fever, muscle and joint pain, inflammation of the nose lining (rhinitis), weight loss, itchy skin and inflammation of the eye (conjunctivitis). If you stop treatment too soon and some of the mentioned symptoms occur, you must talk to your doctor as soon as possible.

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

For COVID-19 products/treatments report side effects directly via Yellow Card Scheme website: https://coronavirus-yellowcard. mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is dexamethasone.

Each tablet contains 4 mg of dexamethasone.

The other ingredients are: lactose monohydrate, sorbolac 400, sodium starch glycolate (Type A), magnesium stearate (E572), silica, colloidal anhydrous (E551).

Dexamethasone 4 mg tablets: White to off white, round, flat bevelled edge tablet approximately 8 mm in diameter, engraved with DX on one side and 4 on the other side.

Packed into Alu/PVC/PVDC blisters.

Pack sizes: 10, 20, 30, 50 or 100 tablets. Not all pack sizes may be marketed.