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Package leaflet: Information for the user

Dexamethasone 20mg/5ml Oral Solution

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 take this medicine for more than three weeks, you will get a blue ‘steroid card’: always keep it with you and show it to any doctor, dentist, nurse, midwife or anyone else who is giving you treatment.

If you get any side effects talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

What is in this leaflet:

1.    What Dexamethasone Oral Solution is and what it is used for

2.    What you need to know before you take Dexamethasone Oral Solution

3.    Howto take Dexamethasone Oral Solution

4.    Possible side-effects

5.    How to store Dexamethasone Oral Solution

6.    Contents of the pack and other information

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1. What Dexamethasone Oral Solution is and what it is used for

Dexamethasone Oral Solution contains the active substance dexamethasone. Dexamethasone belongs to a group of medicines called steroids (the full name is corticosteroids). Corticosteroids occur naturally in the body, and help to maintain health and well-being. Boosting your body with extra corticosteroid (such as dexamethasone) is an effective way to treat various illnesses involving inflammation in the body. Dexamethasone Oral Solution reduces this inflammation, which could otherwise go on making your condition worse. You must take this medicine regularly to get maximum benefit from it.

Dexamethasone Oral Solution is used for one of the following:

where your natural corticosteroid levels have been reduced and you need to replace them where swelling of the brain has occurred if you are having tests for diseases which may decrease your natural corticosteroid level, such as Cushing’s syndrome (a hormonal disorder) to reduce inflammation and suppress the immune system in:

■    allergy (hypersensitivity)

■    polymyalgia rheumatica (chronic inflammation of the larger arteries), polyarteritis nodosa (chronic inflammation of small and medium arteries)

■    blood disorders including haemolytic anaemia (disorder which breaks down red blood cells), leukaemia (cancer of the blood), myeloma (bone marrow tumour)

■    Crohn’s disease, ulcerative colitis (inflammation of the bowel), hepatitis

■    polymyositis (inflammation of muscles)

■    increased pressure in the head not linked to tumours, worsening of multiple sclerosis

■    inflammation of the eye

■    inflammation of the kidney

■    breathing problems including chronic bronchial asthma and chronic obstructive pulmonary disease (COPD) which may show as shortness of breath during exercise, difficulty breathing in and out deeply and persistent cough. Disorders where there is inflammation of the lung.

■    rheumatoid arthritis (painful joint disease), rheumatism, inflammation of a wide area of the body

■    chronic and severe diseases of the skin (including Stevens-Johnson syndrome and a rare condition known as mycosis fungoides)

■    leukaemia of the lymphatic system, Hodgkin’s and Non-Hodgkin’s lymphoma, breast cancer that has spread around the body, Kahler’s disease (cancer of blood cells) and high calcium levels caused by this disease

■    after organ transplants and to prevent nausea and vomiting following chemotherapy

2. What you need to know before you take Dexamethasone Oral Solution

Do not take Dexamethasone Oral Solution:

if you are allergic (hypersensitive) to dexamethasone or any of the other ingredients of Dexamethasone Oral Solution or you have ever had an unusual reaction to these substances

if you have an infection that affects the whole body

(unless you are receiving treatment)

if you have a fungal infection that affects the whole body

if you have a stomach or duodenal ulcer

if you have an infection with worms after travelling to

a tropical area

Warnings and precautions

Talk to your doctor or pharmacist before taking Dexamethasone Oral Solution:

•    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.

if the treatment is for a premature baby. Dexamethasone should not be routinely used in preterm neonates with respiratory problems.

Mental health problems while taking Dexamethasone Oral Solution

Mental health problems can happen while taking steroids like Dexamethasone Oral Solution.

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 nealth problems have happened when doses are oeing lowered or stopped.

Talk to your doctor before taking this medicine if:

•    you have a bacterial or viral infection (such as hepatitis, poliomyelitis)

•    you have kidney or liver problems

•    you have high blood pressure, heart disease or you have recently had a heart attack

•    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

•    you have myasthenia gravis (a condition causing weak muscles)

•    you have a bowel disorder (ulcerative colitis or diverticulitis), have recently had an operation on your bowel or a stomach (peptic or gastrointestinal) 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 migraines

•    you have an underactive thyroid gland

•    you have an infection with parasites (worms) or an internal fungal infection

•    you have tuberculosis (TB) or have recently had a reaction to a vaccination forTB

•    you have septicaemia

•    you have a fungal infection in the eye, an injury to your eye or an ulcer on the surface of your eye (corneal ulceration)

•    you have cerebral malaria

•    you have herpes (cold sores or genital herpes)

•    you have asthma This may affect the dose you are given or your doctor may want you to take other medicines at the same time.

More Important Information about taking this medicine

-    Taking this medicine may increase your risk of getting an infection. It may also mask the symptoms of an existing or developing infection and make it harder to find out what is wrong. If you develop an infection whilst on this medicine you should talk to your doctor

-    If you have an accident, are ill, require surgery (even at the dentists) or you require a vaccination (particularly with ‘live virus’ vaccines) whilst taking or when you have finished taking Dexamethasone Oral Solution, you should inform the person treating you that you are taking or have taken steroids.

-    If you have an allergy test, a suppression test (test for hormone levels) or a test for an infection, you should inform the person performing the test that you are taking dexamethasone as it may interfere with the results.

-    If you need a vaccination tell your doctor as it may not be effective or you may have a greater chance of getting an infection from a ‘live’ vaccine.

-    If you have a doping test when taking this medicine you may get a positive result.

-    Your doctor may want to perform regular check ups on you while you are taking Dexamethasone Oral Solution;

•    They may be more frequent if you have other health problems (such as diabetes or kidney problems) or if you are elderly as any side effects may be more serious for you.

•    If a child is taking this medicine, it is important that their growth and development is checked at frequent intervals as dexamethasone can cause children to grow more slowly.

•    If you are taking this medicine for a long time, regular (every 3 months) checks of your vision are recommended.

•    If you are taking high doses your doctor may monitor the levels of potassium in your blood. 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.

Dexamethasone and Viral Infections

-    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 chickenpox and if you have had any vaccinations for these diseases in the past.

Taking other medicines and Dexamethasone Oral Solution

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

If you are taking any of the following medicines, you should consult your doctor before taking dexamethasone:

•    anticoagulant medicines which thin the blood (e.g warfarin, coumarin)

•    aspirin or similar (non-steroidal anti-inflammatory drugs) e.g. indometacin

•    medicines used to treat diabetes

•    medicines used to treat high blood pressure

•    diuretics (water tablets)

•    amphotericin B injection

•    phenytoin, carbamazepine, (epilepsy medication)

•    rifabutin, rifampicin (antibiotics used to treat tuberculosis)

•    antacids or charcoal

•    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 (for fungal infections)

•    ritonavir (for HIV)

•    antibiotics including erythromycin

•    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

•    praziquantel (given for certain worm infections)

•    isoniazid for tuberculosis Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

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