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DEXAMETHASONE 500 MICROGRAM TABLETS

Active substance: DEXAMETHASONE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Dexamethasone® 500 microgram Tablets
Your medicine is known as the above but will be referred to as
Dexamethasone throughout the remainder of this leaflet.
Dexamethasone is a steroid medicine, prescribed for many
different conditions, including serious illnesses.
 You need to take it regularly to get the maximum benefit.
 Don’t stop taking this medicine without talking to your doctor you may need to reduce the dose gradually.
 Dexamethasone can cause side effects in some people (read
Section 4 below). Some problems such as mood changes (feeling
depressed, or ‘high’), or stomach problems can happen straight
away. If you feel unwell in any way, keep taking your tablets, but
see your doctor straight away.
 Some side effects only happen after weeks or months. These
include weakness of arms and legs, or developing a rounder face
(read Section 4 for more information).
 If you take it for more than 3 weeks, you will get a blue
‘steroid card’: always keep it with you and show it to any doctor
or nurse treating you.
 Keep away from people who have chickenpox or shingles, if
you have never had them. They could affect you severely. If you
do come into contact with chickenpox or shingles, see your
doctor straight away.
Now read the rest of this leaflet. It includes other important
information on the safe and effective use of this medicine that might
be especially important for you.
Please read all of this leaflet carefully before you start taking
this medicine.
 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. Do not pass it on to
others. It may harm them, even if their symptoms are the same as
yours.
 If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What this medicine is and what it is used for
2. Before you take Dexamethasone Tablets
3. How to take Dexamethasone Tablets
4. Possible side effects
5. How to store Dexamethasone Tablets
6. Further information
1. What this medicine is and what it is used for
Dexamethasone belongs to a group of medicines called steroids.
Their full name is corticosteroids. These 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 reduces this inflammation, which could otherwise go
on making your condition worse. You must take this medicine
regularly to get maximum benefit from it.
Some of the illnesses and conditions that dexamethasone is
used for include:
 swelling of the brain and increased pressure in the brain
caused by a tumour
 severe allergic reactions
 blood disorders such as leukaemia and haemolytic anaemia
(a reduction in red blood cells which can make the skin pale
yellow and cause weakness or breathlessness)
 sarcoidosis, an immune disease that can lead to excessive
levels of calcium and vitamin D in the body
 inflammation of the heart in association with heart attack or
heart surgery
 intestinal disorders, e.g. Crohn’s disease, ulcerative colitis
 respiratory disorders such as asthma
 tuberculosis (together with appropriate chemotherapy)
 certain inflammatory skin and muscular disorders
 inflammation of the eye
 rheumatoid arthritis
 kidney inflammation caused by SLE, a disease of the immune
system.
2. Before you take Dexamethasone Tablets
Do NOT take Dexamethasone Tablets if you
 are allergic to dexamethasone or to any of the other
ingredients (see Section 6)
 have an untreated infection affecting your whole body
 have a fungal infection affecting the whole of your body, e.g.
thrush
 are to have a ‘live virus’ vaccination.
If any of the above apply to you, speak to your doctor or pharmacist.
Check with your doctor first
 If you have ever had severe depression or manic
depression (bipolar disorder). This includes having had
depression before while taking steroid medicines like
dexamethasone.
 If any of your close family has had these illnesses.
If either of these applies to you, talk to a doctor before taking
dexamethasone.

Take special care with Dexamethasone Tablets
Before taking the tablets, tell your doctor if you have any of these
conditions as additional monitoring may be required:
 recently suffered from a heart attack
 tuberculosis
 kidney or liver problems, including cirrhosis
 an underactive thyroid
 high blood pressure
 diabetes, or a family history of diabetes; your doctor may need
to increase your dose of diabetic treatment
 heart problems
 thinning of the bones (osteoporosis)
 raised pressure in the eye(s) (glaucoma) or a family history of
glaucoma
 myasthenia gravis (which causes weakened muscles)
 intestinal or stomach problems
 had muscle weakness with steroids in the past
 an eye infection caused by herpes virus
 malaria affecting the brain
 epilepsy
 severe mental health problems or if you ever had severe
depression or manic depression (bipolar disorder) or if a
family member has or has ever had these problems. This
includes having had depression before while taking steroids.
Pay attention when using Dexamethasone
Dexamethasone should not be used routinely in preterm neonates
with respiratory problems.
Use in children
Long term use of steroids at high doses may cause slowing of growth
in children. Your doctor may check your child’s height at intervals
during treatment and reduce the dose if any effects are seen.
Mental problems while taking dexamethasone
Mental health problems can happen while taking steroids like
dexamethasone (see also Section 4 Possible side effects)
 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 problems. This is particularly important if you are
depressed, or might be thinking about suicide. In a few cases, mental
problems have happened when doses are being lowered or stopped.
Chickenpox, shingles, measles
These infections will become more serious during treatment with
steroids, and you will require urgent specialist care if you become
exposed to someone with these infections. DO NOT stop taking the
tablets.
If you have not had chickenpox, shingles or measles, you should
AVOID contact with anyone who has these illnesses.
If you think that you have been exposed to any of these infections,
seek immediate medical attention. Do this if you are taking these
tablets, or have taken them during the previous 3 months.
Surgery or other treatment by a doctor, dentist or nurse
If you have an accident, become ill, require any surgery (including at
the dentist's), or are to have any 'live virus’ vaccinations during or
after treatment with Dexamethasone Tablets, you MUST tell the
person treating you that you are taking or have taken steroids.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription and herbal preparations.
Some medicines may be affected by dexamethasone or they may
affect how well dexamethasone will work. Tell your doctor or
pharmacist if you are taking:
 aspirin or similar medicines
 phenytoin (to treat epilepsy)
 ephedrine (a nasal decongestant)
 barbiturates (to treat sleeplessness and epilepsy)
 ketoconazole (for fungal infections)
 rifampicin and rifabutin (antibiotics used to treat tuberculosis)
 erythromycin or similar antibiotics
 medicines used to treat HIV
 anticoagulants (to thin the blood), such as warfarin
 medicines for diabetes, including insulin; your doctor may
need to increase your dose of diabetic treatment
 diuretics (water tablets)
 carbamazepine (for epilepsy, pain, manic depression)
 aminoglutethimide (a cancer medicine)
 thalidomide (to treat leprosy)
 indometacin, as this may affect dexamethasone tests for
certain diseases.
Pregnancy and breast-feeding
Dexamethasone may pass to your unborn baby or into breast milk.
DO NOT take dexamethasone if you are pregnant, planning to
become pregnant or while breast-feeding unless advised to by your
doctor.
Steroids may affect sperm count and movement, in men.
Ask your doctor for advice before taking any medicine.
Driving and using machines
Dexamethasone is unlikely to affect your ability to operate machinery
or to drive.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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