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DEXAMETHASONE 0.5 MG TABLETS

Active substance(s): DEXAMETHASONE

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•F
 eeling anxious, having problems sleeping, difficulty
in thinking or being confused and losing your
memory.
•F
 eeling, seeing or hearing things which do not exist.
•H
 aving 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.
Other side effects can include:
•b
 rittle bones (osteoporosis), spontaneous fractures,
tendon rupture, muscle wasting
•d
 iabetes, reduced carbohydrate tolerance –
increased insulin need
•m
 ental disturbances such as excitability (euphoria),
delusions (paranoia), psychological dependence,
depression (risk of suicide in patients with a history
of mental disorder), being unable to sleep (insomnia),
Feeling, seeing or hearing things that do not exist.
Having strange and frightening thoughts, changing
how you act or having feelings of being alone, fits or
epilepsy may become worse, schizophrenia may
become worse
• s tomach ulcers which may perforate or bleed,
indigestion, having more of an appetite than usual,
diarrhoea, feeling or being sick, thrush (candidiasis)
• irregular or absent monthly periods, weight gain,
increased appetite
•m
 oon face, excess body hair (hirsutism), flushing,
increased bruising and skin discolouration, acne
• s tunted growth (infants, children, teenagers)
• increased liability to infection and severity of
infection
•d
 elayed wound healing, skin thinning, dilated
capillaries, heart muscle rupture subsequent to
recent heart attack, changes in fluid levels and the
levels of certain chemicals in your blood called
electrolytes, increased concentration of white blood
cells, allergic reactions (including anaphylaxis),
nausea, malaise, hiccups, increased sweating,
increased likelihood of blood clots
• increased pressure within brain
• increased severity of eye infections
• increased pressure in the eye (glaucoma)
• c hanges in vision including cataract
•h
 eadache, vertigo
• c ongestive heart failure
• r ash (urticaria) or red/purple spots (petechiae).
You are more likely to have side effects if you are on a
higher dose.
Your doctor will want to see you now and then to
lookout for these effects. If you notice any of these,
or if you get any other unusual feelings or symptoms,
keep taking Dexamethasone but contact your doctor
or pharmacist as soon as you can.

Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme
(Website: 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 Tablets
•K
 eep this medicine out of the sight and reach of
children.
•K
 eep the tablets in the original container in order to
protect from light.
•D
 o not use Dexamethasone tablets after the expiry
date which is stated on the carton, blister and bottle
after Exp:. The expiry date refers to the last day of
that month.
•M
 edicines should not be disposed via waste water
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.
6. Contents of the pack and other information
The name of your medicine is Dexamethasone 0.5 mg
or 2 mg Tablets. As well as containing 0.5 mg or 2 mg
of dexamethasone, each tablet contains lactose
monohydrate, microcrystalline cellulose, sodium
starch glycolate (type A), colloidal hydrated silica
and magnesium stearate (E470b).
Dexamethasone 0.5 mg Tablets are round, white
tablets marked DX 0.5 on one side.
Dexamethasone 2 mg Tablets are round, white tablets
marked DX 2 on one side.
The 0.5 mg tablets are supplied in blister packs
of 28, 50 and 100 tablets.
The 2 mg tablets are supplied in blister packs
of 50 and 100 tablets, and a plastic bottle of
500 tablets (Hospital dispensing pack).
Marketing Authorisation holder:
Auden Mckenzie (Pharma Division) Ltd., Mckenzie
House, Bury Street, Ruislip, Middlesex, HA4 7TL, UK.

This leaflet contains important information about Dexamethasone Tablets. Read this leaflet
carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed
in this leaflet. See section 4.
• 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 ‘Possible Side Effects’ section 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 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 ‘Possible Side Effects’ section below)
• If you take it for more than 3 weeks, you will get a blue ‘steroid card’: always keep it with you and show 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.
In this leaflet 1.
2.
3.
4.
5.
6.

What Dexamethasone Tablets are and what they are used for
What you need to know before you take Dexamethasone Tablets
How to take Dexamethasone Tablets
Possible side effects
How to store Dexamethasone Tablets
Contents of the pack and other information

1. W
 hat Dexamethasone Tablets are and what
they are used for
Dexamethasone Tablets belong 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.

Manufacturer:
TioFarma BV, Benjamin Franklinstraat 9,
Oud-Beijerland, The Netherlands.

Dexamethasone tablets reduce this inflammation,
which could otherwise go on making your condition
worse. You must take this medicine regularly to get
maximum benefit from it.

For information in large print, on tape, on
CD or in Braille, phone 01895 627 420.

Ask your doctor to explain why you have been given
Dexamethasone tablets if you are unsure.

Leaflet updated July 2015.

See also Section 2, What you need to know before
you take Dexamethasone Tablets, above.

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A1000097_2 V1 Dexamethasone 0-5&2mg PIL.indd 1

PATIENT INFORMATION LEAFLET
DEXAMETHASONE 0.5 mg and 2 mg TABLETS

2. What you need to know before you take
Dexamethasone Tablets
Do not take Dexamethasone Tablets if you:
•a
 re allergic (hypersensitive) to dexamethasone or any
of the other ingredients of Dexamethasone Tablets.
•h
 ave an infection.
•a
 re going to have any vaccinations – you must tell
your doctor or nurse that you have been prescribed
dexamethasone.

If you are not sure talk to your doctor or pharmacist
before taking Dexamethasone.
Take special care with Dexamethasone Tablets
Check with your doctor first 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.
•a
 ny of your close family has had these illnesses.
If either of these applies to you, talk to a doctor before
taking Dexamethasone.
Check with your doctor before taking your medicine if:
• y ou have recently had a heart attack
• y ou have a cancer of the blood
• y ou have tuberculosis (TB) or X-ray changes, or have
had it in the past
• y ou have a stomach ulcer or other digestive problem
• y ou have chickenpox, shingles, measles or any other
infection including an eye infection
• y ou had muscle weakness after taking steroids in
the past
• y ou have bowel problems such as ulcerative colitis
• y ou have epilepsy
• y ou suffer from migraines
• y ou have a history of allergy
• y ou have stunted growth.

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24/07/2015 11:51

Also, check with your doctor if any of the following
problems run in your family, or if you have any of them:
•d
 iabetes
•h
 eart problems
•h
 igh blood pressure
•a
 n eye condition called ‘glaucoma’
•k
 idney or liver problems
•a
 type of muscle weakening problem called
‘myasthenia gravis’
• t hinning of the bones (osteoporosis)
• low thyroid levels (hypothyroidism).
If you are not sure if any of the above run in your family,
or you have them, talk to your doctor or pharmacist
before taking the tablets.
Important
If you are taking or have recently (within the last
3 months) been taking Dexamethasone and you
become ill, suffer stress, get injured or are about to
have surgery, tell your doctor or other healthcare
professional.
If you have been on Dexamethasone for longer than
3 weeks and wish to stop taking it, do not stop
suddenly.
Taking Dexamethasone for a long time increases your
chance of getting infections and these might be worse
than normal. Also, dexamethasone treatment can hide
the usual symptoms of infection. Amoebic dysentery
and an infestation of a gut worm (strongyloidiasis) may
be activated or become worse, as may fungal and viral
infections of the eye.
It is particularly important to avoid contact with people
who have chicken pox, shingles or measles especially if
you have not already had these illnesses or are not sure
if you have had them. Go to your doctor immediately if
you come in contact with measles. Dexamethasone
increases the risk of a severe bout of chicken pox.
You should still take your Dexamethasone, but the
dose may need adjusting. If you are about to take
dexamethasone, or are already taking it, and you
get a rash or other symptoms of an infection,
tell your doctor immediately.
Mental Problems while taking Dexamethasone
Tablets
Mental problems can happen while taking steroids
like Dexamethasone (see also section 4 Possible
Side Effects).
• T hese illnesses can be serious.
•U
 sually they start within a few days or weeks of
starting the medicine.
• T hey are more likely to happen at high doses.
•M
 ost 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,

A1000097_2 V1 Dexamethasone 0-5&2mg PIL.indd 2

mental problems have happened when doses are
being lowered or stopped.
Pay attention when using Dexamethasone:
Dexamethasone should not be used routinely in
preterm neonates with respiratory problems.
Taking other medicines
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines including
those obtained without a prescription. This includes
herbal medicines. This is because Dexamethasone can
affect the way some medicines work. Also, some other
medicines can affect the way Dexamethasone works.
In particular do not take this medicine and tell your
doctor or pharmacist if you are taking any of the
following:
• s ome medicines for fungal infections such as
casofungin, amphotericin and ketoconazole
• c ough and cold medicines that contain a
decongestant called ephedrine
•a
 ntiviral drugs such as indinavir, lopinavir,
saquinavir, ritonavir
•a
 prepitant, a drug used to treat sickness and
feeling sick
•a
 spirin
•m
 edicines for fits (epilepsy) such as phenytoin,
phenobarbital, carbamazepine and primidone
•m
 edicines used for TB (tuberculosis) called rifabutin
or rifampicin
•m
 edicines used to thin the blood such as warfarin
•w
 ater tablets (diuretics)
•a
 medicine for cancer called aminoglutethimide
• s ome medicines for heart failure such as digoxin,
furosemide or bumetanide
•a
 medicine used for some infections called
erythromycin
•o
 ral contraceptive pills and hormone replacement
therapy (HRT)
•a
 type of growth hormone called somatropin
• s ome medicines for high blood pressure
• s ome medicines for heart disease such as
guanethidine, isosorbide mononitrate, isosorbide
dinitrate and theophylline
• c arbenoxolone, an ulcer-healing drug
•a
 nti-cancer drugs (cytotoxics)
•m
 ifepristone, a drug used to assist in the medical
termination of pregnancy
•m
 edicines sometimes used for asthma, low blood
pressure or in cough and cold remedies called
sympathomimetics
• c alcium supplements
•m
 edicines for pain and inflammation called NSAIDs
such as ibuprofen, diclofenac or naproxen
•a
 medicine for urea cycle disorder called sodium
phenylbutyrate (usually started by a specialist doctor
or consultant)
•m
 edicines for diabetes
•m
 edicines for heartburn, indigestion or stomach
ulcers, called antacids
•m
 edicines used to treat a condition called
myasthenia gravis.

If you are not sure if any of the above apply to you,
talk to your doctor or pharmacist before taking
Dexamethasone.

be reduced gradually. However, you should speak to
your doctor or pharmacist about the best way to safely
reduce your daily dose.

Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you
are pregnant, might become pregnant or are breast
feeding. Dexamethasone can reach your baby and may
slow its growth.

If you take more Dexamethasone Tablets than you
should
Taking too many tablets will cause much larger effects
and you may get any of the side effects described in
this leaflet. Tell your doctor who will treat your symptoms
and may slowly reduce your dexamethasone dose. Do
not stop taking your Dexamethasone Tablets suddenly.

Small amounts of dexamethasone may get into breast
milk; tell your doctor if you are breast feeding.
Driving and using machines
Steroids may cause a feeling of movement, even
while you are still and this can cause you to feel dizzy
(vertigo). Changes in your eyesight or muscle weakness
may also happen. If you are affected you should not
drive or operate machinery.
Important information about some of the ingredients
of Dexamethasone Tablets
Dexamethasone tablets contain lactose monohydrate:
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 Tablets
Remember always to carry a Steroid Treatment Card.
Make sure your doctor or pharmacist gives you this
and has filled out the details including the dose and
how long you will have treatment.
If you have surgery, an accident or become unwell while
taking this medicine, tell whoever is treating you that
you are taking Dexamethasone tablets.
Taking this medicine
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.
Swallow the tablets whole with some water.
Do not chew them.
Adults:
Your doctor will probably ask you to take a total DAILY
dose of between 2 mg and 10 mg. Up to 20 mg daily
may be given for treating swelling on the brain. Usually,
you will take your day’s dose of Dexamethasone Tablets
as a single dose in the morning.
Children:
•Y
 our child’s doctor will decide what dose should be
given to your child, depending on the condition that
is being treated and the size of your child.
•C
 hildren will be prescribed the lowest possible dose.
• T he doctor will keep an eye on their growth and
development.
Sometimes, you may need blood or urine tests to work
out how much you should take.
Do not stop taking Dexamethasone Tablets suddenly.
When you no longer need them, your daily dose should

If you forget to take Dexamethasone Tablets
• If you forget to take your dose, take it as soon as you
remember, then continue to take your medicine as
before.
If you are thinking about stopping or have recently
been told to stop Dexamethasone Tablets
Do not stop taking Dexamethasone Tablets just
because you feel better. If you stop too soon or too
suddenly you may get withdrawal symptoms which can
be severe. Refer to your Steroid Treatment Card and
always discuss your treatment with your doctor who will
tell you if treatment can be stopped and how to reduce
the dose gradually.
Sudden withdrawal (after 3 weeks or more of
treatment) can cause such a severe drop in blood
pressure it may kill you.
Less severe symptoms of withdrawal can include:
Fever, muscle pain, joint pain, runny nose (rhinitis),
sticky eyes (conjunctivitis), painful itchy skin lumps and
weight loss.
Your doctor or pharmacist will give you advice on how
to reduce the dose that you take if you need to do this.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Dexamethasone Tablets can cause
side effects, although not everybody gets them. People
taking steroids to replace similar naturally occurring
hormones, should be less likely to get side effects than,
people taking steroids for other illnesses. Your doctor
will want to see you now and then to look out for these
effects.
Serious effects: tell a doctor straight away
•A
 ny kind of skin rash or itching of the skin
•D
 ifficulty in breathing or collapse.
These are signs of an allergic reaction and you may
need to stop taking the medicine.
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.
•F
 eeling depressed, including thinking about suicide.
•F
 eeling high (mania) or moods that go up and down.
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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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