<!DOCTYPE DOCUMENT SYSTEM "icon.dtd" []>

<DOCUMENT author="perl program" datec=020199 title="leaflet" book="ABPI" edition="1996-97" section="company">
<PB n=1>
<CB n=1>
<FIGURE></FIGURE>
<CB n=2>
<FIGURE></FIGURE>
<CB n=1>
<FIGURE></FIGURE>
<CB n=2>
<FIGURE></FIGURE>
<DIV type=0>

<HEAD weight="bold" >
WHAT IS IN DEXAMETHASONE TABLETS BP
</HEAD>

<DIV type=1>

<HEAD weight="bold" >
500 micrograms or 2mg?
</HEAD>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
Active Substance
</HEAD>


<BLOCK>
Dexamethasone tablets BP 500mcg contain 500mcg of Dexamethasone per tablet.
</BLOCK>


<BLOCK>
Dexamethasone tablets BP 2mg contain 2mg of Dexamethasone per tablet.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
Other Substances
</HEAD>


<BLOCK>
Dexamethasone tablets 500mcg also contain glycerol, potato starch, magnesium stearate, talc and lactose.
</BLOCK>


<BLOCK>
Dexamethasone tablets 2mg also contain potato starch, propylene glycol, magnesium stearate and lactose.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
Appearance
</HEAD>

<DIV type=2>

<HEAD ltag="bullet" >
 on the other  
</HEAD>




<BLOCK>

<EMPH weight="bold">
500 microgram
</EMPH>
500  <CB n=2> <FIGURE></FIGURE> <CB n=1> <FIGURE></FIGURE> <PB n=3> <CB n=2> 2 mg2  <CB n=1> <FIGURE></FIGURE> <CB n=2> <FIGURE></FIGURE>
</BLOCK>


<LIST type="bulleted">

<ITEM>

<BLOCK>
 on the other.
</BLOCK>

</ITEM>

</LIST>



<BLOCK>
Dexamethasone tablets are sold in containers of 100 and 50 tablets They may also be available in containers of 500 tablets
</BLOCK>


<BLOCK>

<EMPH weight="bold">
Therapeutic Group
</EMPH>
 Dexamethasone belongs to a group of medicines called corticosteroids. Corticosteroids work by reducing inflammation in the body and can be used to treat many different diseases
</BLOCK>


</DIV>

</DIV>
<DIV type=1>

<HEAD weight="bold" >
Product licence holder
</HEAD>

<DIV type=2>

<HEAD>
Organon Laboratories Limited Cambridge Science Park MiIton Road Cambridge CB4 4FL
</HEAD>


</DIV>

</DIV>
<DIV type=1>

<HEAD weight="bold" >
Manufactured by:
</HEAD>

<DIV type=2>

<HEAD>
Organon Laboratories Ltd Newhouse Industrial Estate Newhouse Motherwell Scotland ML1 5SH
</HEAD>


</DIV>

</DIV>
<DIV type=1>

<HEAD weight="bold" >
WHAT IS
</HEAD>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
DEXAMETHASONE USED FOR?
</HEAD>


<BLOCK>
Dexamethasone can be used to reduce inflammation or to treat a number of different diseases of the immune system.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
WHEN SHOULD DEXAMETHASONE
</HEAD>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
NOT BE TAKEN?
</HEAD>


<BLOCK>
Dexamethasone may not be suitable for you if you suffer from certain allergies or other medical conditions. Before you take Dexamethasone, make sure you tell your doctor if you suffer or have ever suffered from any of the following:
</BLOCK>


<LIST type="bulleted">

<ITEM>

<BLOCK>
hypersensitivity to any ingredient in this medicine
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
an infection that affects the whole body
</BLOCK>

</ITEM>

</LIST>



</DIV>
<DIV type=1>

<HEAD weight="bold" >
What precautions should
</HEAD>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
be taken?
</HEAD>


<BLOCK>
While taking Dexamethasone you may need to be examined by your doctor more frequently.
</BLOCK>


<BLOCK>
You should always carry a ‘Steroid treatment’ card which gives clear guidance on the special care to be taken when you are using this medicine. Show this to any doctor, dentist or nurse who may be giving you treatment. Even after your treatment has finished you must tell anyone who is giving you treatment that you have taken steroids.
</BLOCK>


<BLOCK>
You must tell your doctor if you have or have ever had any of the following:
</BLOCK>


<LIST type="bulleted">

<ITEM>

<BLOCK>
Osteoporosis (thinning of the bones) Hypertension (very high blood pressure)
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Heart disease
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Diabetes
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
TB (tuberculosis)
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Glaucoma (raised eye pressure) or a family history of glaucoma
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Serious affective disorders especially steroid psychosis - psychiatric illness made worse by steroids
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Muscle disease caused by corticosteroids
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Liver disease
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Kidney disease
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Epilepsy
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Stomach ulcers
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Migraine
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Certain parasitic infections
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Stunted growth
</BLOCK>

</ITEM>

</LIST>



<BLOCK>
It is important that you avoid close contact with anybody who is suffering from chicken pox or shingles if you have not previously suffered from these illnesses. If you develop chicken pox while taking Dexamethasone tell your doctor immediately.
</BLOCK>


<BLOCK>
If you are in an accident or need an operation tell your doctor that you are taking Dexamethasone tablets.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
Are you going on holiday?
</HEAD>


<BLOCK>
If you think you may need a vaccination, tell your doctor you are taking Dexamethasone tablets <PB n=4> <CB n=1>
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
WHAT OTHER MEDICINES ARE YOU
</HEAD>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
TAKING?
</HEAD>


<BLOCK>
Other medicines may effect how Dexamethasone works or Dexamethasone may effect how they work. Tell your doctor if you are using (or intend to use) any other medicines.
</BLOCK>


<BLOCK>
Other drugs that reduce the effect of Dexamethasone are:
</BLOCK>


<LIST type="bulleted">

<ITEM>

<BLOCK>
Antibiotics such as rifampicin, rifabutin.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Drugs for epilepsy e g carbamazepine, phenytoin, phenobarbitone, primidone.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Drugs used in the treatment of breast cancer e.g. aminoglutethimide.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Antacids, especially those containing magnesium trisilicate.
</BLOCK>

</ITEM>

</LIST>



<BLOCK>
Some medicines may not work as well when Dexamethasone is taken at the same time The effectiveness of
</BLOCK>


<LIST type="ordered">

<ITEM>

<BLOCK>
drugs used to treat diabetes (hypoglycaemic agents)
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
drugs used to treat high blood pressure (antihypertensives)
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
diuretics (water pills)
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
drugs which regulate heart beat (cardiac glycosides) are reduced when Dexamethasone is taken.
</BLOCK>

</ITEM>

</LIST>



<BLOCK>
Dexamethasone affects acetazolamide, loop diuretics, thiazide diuretics and carbenoxolone: these drugs are used to lower potassium levels.
</BLOCK>


<BLOCK>
The effects of drugs which prevent blood clotting; (coumarin anticoagulants e.g. warfarin) may be increased by Dexamethasone and frequent tests may be required.
</BLOCK>


<BLOCK>
Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and aspirin may cause stomach ulcers if you are taking Dexamethasone as well. Please ask your doctor for advice.
</BLOCK>


<BLOCK>

<EMPH weight="bold">
Pregnancy
</EMPH>
 Dexamethasone may be harmful during pregnancy. If you are pregnant. think that you may be pregnant or if you are breastfeeding then you must tell your doctor Your doctor will decide if Dexamethasone can be given to you Ability to drive or operate machinery As far as s known, Dexamethasone has no effect on alertness or concentration <CB n=2> Other Ingredients
</BLOCK>


<BLOCK>
Dexamethasone contains lactose, if you are allergic to this or any other ingredient, tell your doctor before you take Dexamethasone.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
How should Dexamethasone
</HEAD>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
be taken?
</HEAD>


<BLOCK>
It is important to take this medication only as directed by your doctor or pharmacist.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
How much:
</HEAD>


<BLOCK>
The dose is chosen by your doctor and usually depends on how serious your condition is. Always follow your doctor s instructions and read the pharmacy label. If you are unsure ask your doctor or pharmacist.
</BLOCK>


<BLOCK>
Usually a dose of O.5-1.0mg per day is given. Once your condition has improved the dosage will be reduced or another corticosteroid such as 'Prednisolone' may be given.
</BLOCK>


<BLOCK>
(For more serious conditions such as acute asthma, a higher dose may be necessary.) The tablets should be swallowed whole, without chewing, with some water
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
Children:
</HEAD>


<BLOCK>
The dosage is chosen by the doctor to suit the needs of the patient.
</BLOCK>


<BLOCK>
A dose of 0.01-0.1 milligrams per kilogram of body weight is usual.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
What to do if someone accidentally takes too much
</HEAD>


<BLOCK>
Too high a dose of Dexamethasone may cause:
</BLOCK>


<LIST type="bulleted">

<ITEM>

<BLOCK>
swelling of the throat (glottis oedema)
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
skin allergy (uticaria)
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
difficulty in breathing (bronchospasm) If anyone accidentally takes too many tablets. tell your doctor immediately
</BLOCK>

</ITEM>

</LIST>



<BLOCK>

<EMPH weight="bold">
When will I stop taking Dexamethasone
</EMPH>
 Do not stop taking Dexamethasone just because your complaints seem to have disappeared. If you stop too early or too suddenly your condition may worsen, you may get withdrawal symptoms Always discuss your treatment with your doctor who will tell you how to reduce the dose gradually If treatment can be stopped <CB n=1>
</BLOCK>


<BLOCK>
Symptoms of withdrawal include fever. pain in muscle and joint, inflammation of nose lining (rhinitis), weight loss, itchy skin, eye inflammation (pink eye conjunctivitis)
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
What to do if you miss a dose:
</HEAD>


<BLOCK>
Don't panic. take the next dose as soon as you remember then continue to take your medicine as before.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
What undesirable effects may Dexamethasone
</HEAD>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
cause?
</HEAD>


<BLOCK>
The occurrence of side effects can be minimised by taking the lowest possible dose for the shortest possible time. If you have any of these side effects or any others tell your doctor. He will review your case and do what is best for you.
</BLOCK>


<LIST type="bulleted">

<ITEM>

<BLOCK>
lowered resistance or response to stress
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
stunted growth in infants, children and teenagers
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
irregularities in the menstrual cycle (periods) or complete absence of periods
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Cushingoid face (e.g. &quot;moon face")
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
hirsutism (excess hair especially in women)
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
weight gain
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
vomiting
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
reduced carbohydrate tolerance which needs more anti-diabetic therapy
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
increased appetite
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
swollen stomach
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
loss of protein and calcium balance
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
increased chance of picking up infections or mild infections get worse e.g. chicken pox
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
osteoporosis (thinning of bones)
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
bone disease
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
sodium and water retention and/or potassium loss due to high carbon dioxide levels (hypokalaemic alkalosis)
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
high blood pressure
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
extreme mood swings
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
depression
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
inability to sleep (insomnia)
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
(schizophrenia may get worse (schizophrenia aggravation)
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
epilepsy gets worse (more fits)
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
severe unusual headache and visual disturbance
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
increased eye pressure (glaucoma)
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
eye disorders and eye infection
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
indigestion
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
stomach ulcers
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
pain in abdomen and back (pancreatitis)
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
skin disorders such as bruising, acne, slow healing of wounds
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
hypersensitivity reactions (allergic reactions) e g rash, itch and difficulty in breathing
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
blood clots [thrombosis)
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Candidiasis [thrush)
</BLOCK>

</ITEM>

</LIST>



</DIV>
<DIV type=1>

<HEAD weight="bold" >
How should you store Dexamethasone?
</HEAD>


<BLOCK>
Dexamethasone should be kept in a fridge or below 25°C in the dark As with all medicines Dexamethasone should be kept in a safe place out of reach of children There is a &quot;use by&quot; date on the pack. This medicine should not be used after this date This information was last updated in August 1995
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
General Things To Remember About Medicines
</HEAD>


<LIST type="ordered">

<ITEM>

<BLOCK>
This medicine has been prescribed for your current medical problems Do not use it for other medical problems.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Do not allow other people to use your medicines and do not use medicines meant for other people.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Tell any doctor treating you what medicines you are taking.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Return unused medicines to the pharmacy for disposal.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Make sure that other people you may live with or who look after you read this information.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Keep the tablets out of the reach of children.
</BLOCK>

</ITEM>

</LIST>


</DIV>

</DIV>

</DOCUMENT>
