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Active substance: DEXAMETHASONE

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RA 3180 UK P3 (Ref. 2.0)


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.

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
your pharmacist
This medicine has been prescribed only 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 Dexamethasone is and what it is used for
2. Before you take Dexamethasone
3. How to take Dexamethasone
4. Possible side effects
5. How to store Dexamethasone
6. Further information
1. What Dexamethasone 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 can be used to:
• Reduce inflammation
• Treat a number of different diseases of the immune
2. Before you take Dexamethasone
Do not take Dexamethasone and tell your doctor if:
• You are allergic (hypersensitive) to dexamethasone or any
other ingredients in this medicine (listed in Section 6).
The signs of an allergic reaction include a rash, itching or
shortness of breath
• You have an infection that affects the whole body
• You need to have a vaccination, particularly with ‘live
virus’ vaccines
 Do not take this medicine if any of the above apply to
you, talk to your doctor or pharmacist before taking
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
• If any of your close family has had these illnesses
 If either of these applies to you, talk to a doctor
before taking this medicine.
Mental problems while taking Dexamethasone
Mental health problems can happen while taking steroids
like Dexamethasone (see also Section 4: Possible side
• 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.

Take special care with Dexamethasone
 Before you take Dexamethasone, tell your doctor if:
• You have a cancer of the blood because you may be at
risk of a very rare, potentially life-threatening condition
resulting from a sudden breakdown of tumour cells.
• You have kidney or liver problems
• You have high blood pressure or heart disease
• You have diabetes or there is a family history of
• You have thinning of the bones (osteoporosis),
particularly if you are a female who has been through
the menopause
• You have had muscle weakness with this or other
steroids in the past
• You have raised eye pressure (glaucoma) or there is a
family history of glaucoma
• You have a stomach (peptic) ulcer
• You have mental problems or you have had a mental
illness which was made worse by this type of medicine
such as ‘steroid psychosis’
• You have epilepsy
• You have migraines
• You have an underactive thyroid gland
• You have an infection with parasites
• You have tuberculosis (TB)
• You have stunted growth
 If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before using
More important information about taking this kind of
If you develop an infection while you are taking this
medicine, you should talk to your doctor.
Please tell any doctor, dentist or person who may be giving
you treatment that you are currently taking steroids or
have taken them in the past.
If you are living in the UK, you should always carry a blue
‘steroid card’ which gives clear guidance on the special care
to be taken when you are taking this medicine. Show this
to any doctor, dentist or person 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 in the past.
Do not use Dexamethasone for the treatment of Acute
Respiratory Distress Syndrome (ARDS; a serious lung
disease) if you have been diagnosed with this condition for
over 2 weeks.
Dexamethasone and viral infections
While you are taking this kind of medicine, you should
not come into contact with anyone who has chicken pox,
shingles or measles if you have not had these illnesses.
This is because you may need specialist treatment if
you get these diseases. If you think you may have had
exposure to any of these diseases, you should talk to your
doctor straight away. You should also tell your doctor if
you have ever had infectious diseases such as measles or
chicken pox and if you have had any vaccinations for these
conditions in the past.
 Please tell a doctor or anyone giving you treatment,
such as at a hospital, if:
• You have an accident
• You are ill
• You need any surgery. This includes any surgery you
may have at your dentist’s
• You need to have a vaccination, particularly with ‘live
virus’ vaccines
If any of the above apply to you, you should tell your
doctor or the person treating you even if you have stopped
taking this medicine.
If a child is taking this medicine, it is important that the
doctor monitors their growth and development regularly.
Dexamethasone should not be routinely given to premature
babies with respiratory problems.
Taking other medicines
Tell your doctor or pharmacist if you are taking or
have recently taken any other medicines. This includes
medicines you buy without a prescription, including
herbal medicines. Other medicines can affect the way
Dexamethasone works or Dexamethasone can affect the
way they work. In particular:
• Medicines to treat heart and blood problems, such
as warfarin, high blood pressure medicine and water
tablets (diuretics)
• Antibiotics such as rifampicin and rifabutin

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Important information about this medicine
• Dexamethasone is a steroid medicine, prescribed for
many different conditions including serious illnesses
• You need to take it regularly to get the maximum
• 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: Possible side effects). 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
medicine, 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
• If you take it for more than 3 weeks, in the UK, 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 chicken pox or
shingles, if you have never had them. They could affect
you severely. If you do come into contact with chicken
pox or shingles, see your doctor straight away

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Dexamethasone Tablets
BP 2mg


Medicines to treat epilepsy, such as phenytoin,
carbamazepine, phenobarbitone and primidone
Medicines to treat stomach problems, such as antacids
Carbenoxolone, sometimes used for ulcers
Medicines that control pain or lower inflammation,
such as aspirin, ibuprofen or similar non-steroidal
anti-inflammatories (NSAIDs)
Medicines used to treat diabetes
Medicines used to lower potassium levels
Medicines used to treat myasthenia
Ritonavir, indinavir or saquinavir used to treat HIV
Oral contraceptives containing oestrogen and
Anti-cancer treatments, such as aminoglutethimide
Methotrexate used for cancer or inflammatory problems
Ephedrine used to relieve symptoms of a blocked nose
Acetazolamide used for glaucoma

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Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you
are pregnant, planning to become pregnant or are
Driving and using machines
Dexamethasone is not likely to affect you being able to
drive or use any tools or machines.
Important information about some of the ingredients of
This medicine contains lactose. If you have been told by
your doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicinal product.
3. How to take Dexamethasone
Take this medicine as your doctor or pharmacist has told
you. Read the label and ask the doctor or pharmacist if you
are not sure.
Taking this medicine
• Your doctor will tell you how many tablets to take. This
will depend on your illness and how bad it is
• Take this medicine by mouth
• Swallow the tablets whole with a drink of water
• Do not crush or chew the tablets
Usual dose for adults
• The usual dose is 0.5mg to 10mg each day
• As you get better your doctor may then reduce your
dose or ask you to take another corticosteroid such as
Usual dose for children
• The usual dose is 0.01 to 0.1 milligrams per kilogram
of body weight
If you take more Dexamethasone than you should
 If you take more of this medicine than you should, talk
to a doctor or go to a hospital straight away. Take the
medicine pack with you so the doctor knows what you
have taken. The following effects may happen:
• Swelling of the throat
• Skin reaction
• Difficulty breathing
If you forget to take Dexamethasone
• If you forget a dose, take it as soon as you remember
it. However, if it is nearly time for the next dose, skip
the missed dose
• Do not take a double dose (two doses at the same
time) to make up for a forgotten dose
If you stop taking Dexamethasone
It can be dangerous to stop taking this medicine suddenly.
If you need to stop this treatment, follow your doctor’s
advice. He or she may tell you to lower the amount of
medicine you are taking gradually until you stop taking
it altogether. If you stop taking this medicine too quickly,
your condition may get worse.
You may also feel a ‘withdrawal symptom’. These may
include headache, problems with your vision (including pain
or swelling in the eye), feeling or being sick, fever, pain in
your muscles and joints, swelling in the inside of your nose,
weight loss, itchy skin and conjunctivitis.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Dexamethasone can cause side effects
although not everybody gets them.
Dexamethasone can also cause side effects when you stop
taking it.
• See Section 3, 'If you stop taking Dexamethasone'

If you have an allergic reaction to Dexamethasone see a
doctor straight away
An allergic reaction may include:
• Any kind of skin rash or itching of the skin
• Difficulty in breathing or collapse
If you get any of the following side effects see your doctor
as soon as possible:
• Stomach and gut problems: ulcers in the throat,
stomach ulcers, which may perforate or bleed,
indigestion, feeing sick (nausea) or being sick
(vomiting), a swollen stomach, having more of an
appetite than usual, hiccups, diarrhoea
• Inflamed pancreas: this may cause severe pain in the
back or tummy
• Problems with salts in your blood such as too much
sodium or low potassium or calcium. You may have
water retention
• Heart and blood problems: high blood pressure, blood
clots, problems with the muscles in your heart after a
recent heart attack
• Bone problems: thinning of the bones (osteoporosis)
with an increased risk of fractures, bone disease
• Recurring infections that get worse each time such as
thrush. Also chicken pox
• Skin problems: wounds that heal more slowly,
bruising, acne
• Eye problems: increased pressure in the eye including
glaucoma, eye disorders such as cataracts, eye infections
• Hormone problems: irregular or missing periods,
stunted growth in children and teenagers, swelling of
the face (called ‘Cushingoid’ or ‘moon’ face), it may
affect your diabetes and you may notice you start
needing higher doses of the medicine you take for
diabetes, your body may not be able to respond
normally to severe stress such as accidents, surgery
or illness, growth of extra body hair (particularly in
women), increased appetite or weight gain
• Nervous system problems: fits or epilepsy may
become worse, severe unusual headache with visual
problems, being unable to sleep, feeling depressed,
extreme mood swings, schizophrenia has become
worse, headache or problems with your vision
(including eye pain or swelling)
• General problems: may make you feel generally unwell
or tired
 If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, tell your
doctor or pharmacist.
5. How to store Dexamethasone

Keep out of the reach and sight of children
Do not store above 25°C. Do not store in the fridge
Do not use after the expiry date which is stated on
the pack
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose
of medicines no longer required. These measures will
help to protect the environment

6. Further information
What Dexamethasone contains
• The active ingredient is Dexamethasone.
Dexamethasone Tablets BP 2mg contain 2mg of
Dexamethasone per tablet
• The other ingredients in Dexamethasone Tablets BP 2mg
are potato starch, propylene glycol, magnesium stearate
and lactose.
What Dexamethasone looks like and contents of the pack
• Dexamethasone Tablets BP 2mg are round, flat and
white. They are marked with XC/8 on one side with
Organon * on the other
• Dexamethasone tablets are sold in containers of
100 and 50 tablets. They may also be available in
containers of 500 tablets.
The Marketing authorisation holder is:
Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest
Business Campus, Dublin 24, Ireland
The Manufacturer is:
N.V.Organon, PO Box 20, 5340 BH Oss,
The Netherlands.
This leaflet was last revised in February 2014.

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Serious side effects: tell a doctor straight away
Steroids including Dexamethasone can cause serious
mental health problems. These are common in both adults
and children. They can affect about 5 in every 100 people
taking medicines like Dexamethasone. These 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
 If you notice any of these problems, talk to a doctor
straight away.

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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.