What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 12762/0618.


Dexamethasone 4 mg tablets

Package leaflet: Information for the patient

Dexamethasone 4 mg tablets

dexamethasone

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, pharmacist or nurse.
  • 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

1. WHAT DEXAMETHASONE TABLET IS AND WHAT IT IS USED FOR

The name of your medicine is Dexamethasone. This belongs to a group of medicines called corticosteroids.

Corticosteroids are hormones that are found naturally in your body that help to keep you healthy and well. Boosting your body with extra corticosteroid, such as Dexamethasone, is an effective way to treat various illnesses involving inflammation in the body.

Dexamethasone lowers inflammation, which could otherwise go on making your condition worse. You must take this medicine regularly to get maximum benefit from it.

Dexamethasone is recommended for the treatment of rheumatic and autoimmune diseases (e.g. systemic lupus erythematosus, rheumatoid artritis, juvenil idiopathic arthritis, polyartheritis nodosa), diseases of respiratory tract (e.g. bronchial asthma, croup), skin (e.g. erythroderma, pemphigus vulgaris), tuberculous meningitis only in conjunction with anti-infective therapy, diseases of blood (e.g. idiopathic thrombocytopenic purpura in adults), cerebral oedema, treatment of symptomatic multiple myeloma, acute lymphoblastic leukemia, Hodgkin’s disease and non-Hodgkin’s lymphoma in combination with other medicinal products, palliative treatment of neoplastic diseases, prophylaxis and treatment of nausea and vomiting caused by chemotherapy and prevention and treatment of vomiting after operation, within antiemetic treatment.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DEXAMETHASONE TABLET

Do not take Dexamethasone Tablet:

  • 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.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Dexamethasone Tablet:

  • 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 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
  • you have kidney or liver problems (liver cirrhosis or chronic liver failure),
  • you have a tumour of the adrenal gland (pheochromocytoma),
  • 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 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.

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. If you notice blurring or distorted vision that lasts for several days, please contact your doctor.

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.

Children

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

Other medicines and Dexamethasone Tablet

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.

You may be at an increased risk of serious side effects if you take dexamethasone together with these medicines:

  • Acetylsalicylic acid or similar (Non-Steroidal Anti- Inflammatory drugs) e.g. indomethacin
  • 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 Tablet with food, drink and alcohol

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.

Pregnancy and breast-feeding

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 new-borns/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

Driving and using machines

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.

Dexamethasone Tablet contains lactose

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

3. HOW TO TAKE DEXAMETHASONE TABLET

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Dexamethasone is in the form of tablets 1 mg and 4 mg. The tablet can be divided into equal halves. Dexamethasone is given in usual doses of 0.5 to 10 mg daily, depending on the disease being treated. In more severe disease conditions doses above 10 mg per day may be required.

The dose should be titrated to the individual patient response and disease severity. In order to minimize side effects, the lowest effective possible dose should be used.

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.

Use in children

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

The usual dose is 0.01 to 0.1 milligrams per kilogram of body weight.

If you take more Dexamethasone Tablet than you should

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

If you forget to take Dexamethasone Tablet

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 you stop taking Dexamethasone 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 have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell a doctor straight away if you experience serious mental health problems. They can affect about 5 in every 100 people taking medicines like dexamethasone. These problems include:

  • feeling depressed, including thinking about suicide,
  • feeling high (mania) or moods that go up and down,
  • feeling anxious, having problems sleeping, difficulty in thinking or being confused and losing your memory,
  • feeling, seeing or hearing things that do not exist. Having strange and frightening thoughts, changing how you act or having feelings of being alone.

Tell a doctor straight away if you experience:

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

This medicine may worsen your existing heart problem. If you experience shortness of breath or ankle swelling, consult your doctor straight away.

Other side effects may be: (frequency not known):

  • Greater chance of picking up infections, including viral and fungal infections e.g. thrush; recurrence of tuberculosis or some other infections, e.g. eye infections if you have already had it
  • Reduction in the number of white blood cells or increased number of white blood cells, abnormal coagulation
  • An allergic reaction to the medicine, including serious, potentially life-threatening allergic reaction (which may show as a rash and swelling of the throat or tongue and in severe cases difficulty in breathing or dizziness)
  • Impairment of the body’s regulation of hormones, swelling and weight gain of the body, full-moon face (Cushingoid state), change in effectiveness of endocrines following stress and trauma, surgery, childbirth or illness, your body may not be able to respond in the usual way to severe stress such as accidents, surgery, childbirth or illness, stunted growth in children and teenagers, irregular and absence of menstrual cycles (periods) development of excess body hair (particularly in women)
  • Weight gain, loss of protein and calcium balance, increased appetite, salt imbalances, water retention in the body, potassium loss which can cause rhythm disorder, increased requirement for diabetic medication, unknown diabetes becomes evident, high levels of cholesterol and triglycerides in the blood (hypercholesterolemia and hypertriglyceridaemia)
  • Extreme mood swings, schizophrenia (mental disorder) may become worse, depression, inability to sleep
  • Severe unusual headache with visual disturbances linked with the withdrawal of treatment, fits and worsening of epilepsy, dizziness
  • Increased pressure in the eye, papilloedema, thinning of the eye membranes, increased eye viral, fungal and bacterial infections, worsening of symptoms associated with corneal ulcers, worsening of existing eye infections, protrusion of the eyeballs, cataracts, visual disturbances, loss of vision
  • Congestive heart failure in susceptible people, cardiac muscle rupture after a recent heart attack, cardiac decompensation
  • High blood pressure, blood clots: formation of blood clots that may clog blood vessels for example in legs or lungs (thromboembolic complications)
  • Hiccups
  • Nausea, vomiting, stomach discomfort and swollen abdomen, inflammation and ulcers in the oesophagus, peptic ulcers that may split and bleed, inflamed pancreas (which may show as pain in the back and abdomen), flatulence, oesophageal candidiasis
  • Thinned delicate skin, unusual marks on the skin, bruising, redness and inflammation of the skin, stretch marks, visible swollen, capillaries, acne, increased sweating, skin rash, swelling, thinning of the hair, unusual fat deposits, excessive hair growth, water retaining in the body, pigment disorders, weakened capillaries that rupture easily, observed as bleeding under the skin (increased capillary fragility), skin irritation around the mouth (perioral dermatitis)
  • Thinning of the bone with an increased risk of fractures (osteoporosis), bone necrosis, tendinitis, ruptured tendons, muscle wasting, myopathy, muscle weakness, early stoppage of bone growth (premature epiphyseal closure)
  • Changes to the number and movement of sperm, impotence
  • Impaired reaction to vaccination and skin tests, slow wound healing, discomfort, malaise.
  • A ‘withdrawal syndrome’ may also occur which includes fever, muscle and joint pain, inflammation of the nose lining (rhinitis), weight loss, painful itchy skin nodules and inflammation of the eye (conjunctivitis).

Reporting of side effects

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

5. HOW TO STORE DEXAMETHASONE TABLET

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

This medicine needs to be stored below 25°C and in the original pack to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Dexamethasone Tablet contains

  • The active substance is dexamethasone.
  • The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmelose sodium and magnesium stearate (E572). See section 2 “Dexamethasone Tablet contains lactose”.

What Dexamethasone Tablet looks like and contents of the pack

Round, biplane, white uncoated tablets with bevel and single scoreline.

Dexamethasone 4 mg with embossing ‘D | 4’.

The tablet can be divided into equal doses.

Dexamethasone 4 mg tablets are available in boxes containing 10 x 1, 20 x 1, 30 x 1, 40 x 1, 50 x 1, 60 x 1 and 100 x 1 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Mercury Pharmaceuticals Limited
Capital House
85 King William Street
London
EC4N 7BL
United Kingdom

Manufacturer

Formula Pharmazeutische und chemische
Entwicklungs GmbH
Goerzallee 305b
D-14167 Berlin
Germany

This leaflet was last revised in 03/2019.

LF-115792-01