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DEXAMETHASONE TABLETS 2MG

Active substance(s): DEXAMETHASONE

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Dexamethasone Tablets
2mg
(dexamethasone)
Your medicine is known by the above name, but will be referred to as
Dexamethasone throughout this leaflet.
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 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: 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 information)
• 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
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 system
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 Dexamethasone.
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 this
medicine.
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.
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 diabetes
• 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 Dexamethasone.
More important information about taking this kind of medicine
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



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 progestogen
• 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
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you are pregnant,
planning to become pregnant or are breast-feeding.
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
Dexamethasone
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 ‘prednisolone’
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'
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.
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, feeling 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
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. By reporting side
effects, you can help provide more information on the safety of this
medicine.
5. How to store Dexamethasone



Keep out of the sight and reach of children
Do not store above 25°C. Store in the original package. Protect from
light.
• Do not use after the expiry date which is stated on the pack
• If your medicine becomes discoloured or shows any signs of
deterioration, ask your pharmacist who will advise you what to do
• 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.
Each tablet contains 2mg dexamethasone.
• The other ingredients in Dexamethasone are potato starch,
propylene glycol, magnesium stearate and lactose monohydrate.
What Dexamethasone looks like and contents of the pack
• Dexamethasone are round, white tablets marked with XC/8 on one
side with Organon * on the other
• Dexamethasone are available in packs of 100 tablets.
Manufacturered by:
N.V.Organon, PO Box 20, 5340 BH Oss,The Netherlands.
OR
Organon SA. Usine Saint Charles, 60590 Eragny sur Epte, France.
Procured from within the EU and repackaged by the Product Licence
Holder: Summer Healthcare Ltd, 4 Petre Road, Clayton Business Park,
Accrington, Lancashire BB5 5JB
PL 33948/0033

Dexamethasone Tablets 2mg

Leaflet revision date: 12th June 2015

POM

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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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