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DEXAMETHASONE 4 MG SOLUBLE TABLETS

Active substance(s): DEXAMETHASONE SODIUM PHOSPHATE

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Package leaflet: Information for the user

Dexamethasone 2 mg, 4 mg and 8 mg soluble tablets
Dexamethasone

Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
• 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 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
side effects not listed in this leaflet.
What is in this leaflet:
1. What Dexamethasone soluble tablets is
and what it is used for
2. What you need to know before you take
Dexamethasone soluble tablets
3. How to take Dexamethasone soluble
tablets
4. Possible side-effects
5. How to store Dexamethasone soluble
tablets
6. Contents of the pack and other
information
1. W
 hat Dexamethasone soluble
tablets are and what they are used
for
Dexamethasone soluble tablets contain
the active substance dexamethasone.
Dexamethasone belongs to a group of
medicines called steroids (the full name is
‘corticosteroids’). 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 soluble tablets reduce
this inflammation, which could otherwise
go on making your condition worse. You
must take this medicine regularly to get the
maximum benefit from it.
Dexamethasone soluble tablets are used
for one of the following:
• where your natural corticosteroid levels
have been reduced and you need to
replace them
• where swelling of the brain has occurred
• if you are having tests for diseases
which may decrease your natural
corticosteroid level, such as Cushing’s
syndrome (a hormonal disorder)
• to reduce inflammation and suppress the
immune system in:
– allergy (hypersensitivity)
– polymyalgia rheumatica (chronic
inflammation of the larger arteries),
polyarteritis nodosa (chronic
inflammation of small and medium
arteries)
– blood disorders including haemolytic
anaemia (disorder which breaks
down red blood cells), leukaemia
(cancer of the blood), myeloma (bone
marrow tumour)
– Crohn’s disease, ulcerative colitis
(inflammation of the bowel),
hepatitis
– polymyositis (inflammation of
muscles)
– increased pressure in the head not
linked to tumours, worsening of
multiple sclerosis
– inflammation of the eye
– inflammation of the kidney
– breathing problems including
chronic bronchial asthma and
chronic obstructive pulmonary
disease (COPD) which may show as
shortness of breath during exercise,
difficulty breathing in and out deeply
and persistent cough. (Disorders
where there is inflammation of the
lung).
– rheumatoid arthritis (painful joint
disease), rheumatism, inflammation
of a wide area of the body
– chronic and severe diseases of the
skin (including Stevens-Johnson
syndrome and a rare condition
known as mycosis fungoides)
– leukaemia of the lymphatic system,
Hodgkin’s and Non-Hodgkin’s
lymphoma, breast cancer that has
spread around the body, Kahler’s
disease (cancer of blood cells) and
high calcium levels caused by this
disease
– after organ transplants and to prevent
nausea and vomiting following
chemotherapy
2. W
 hat you need to know before you
take Dexamethasone soluble tablets
Do not take Dexamethasone soluble
tablets:
• if you are allergic (hypersensitive)
to dexamethasone or any of the other
ingredients of Dexamethasone soluble
tablets or you have ever had an unusual
reaction to these substances
• if you have an infection that affects the
whole body (unless you are receiving
treatment)
• if you have a fungal infection that
affects the whole body
• if you have a stomach or duodenal ulcer
• if you have an infection with worms
after travelling to a tropical area
Warning and precautions
Talk to your doctor or pharmacist before
taking Dexamethasone soluble tablets:
• 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.
• if any of your close family has had these
illnesses.
• if the treatment is for a premature
baby. Dexamethasone should not be
routinely used in preterm neonates with
respiratory problems.
Mental health problems while taking
Dexamethasone soluble tablets
Mental health problems can happen while
taking steroids like Dexamethasone.
• 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 health problems. This is particularly
important if you are depressed, or might
be thinking about suicide. In a few cases,
mental health problems have happened
when doses are being lowered or stopped.
Talk to your doctor before taking this
medicine if:
• you have a bacterial or viral infection
(such as hepatitis, poliomyelitis)
• you have kidney or liver problems
• you have high blood pressure, heart
disease or you have recently had a heart
attack
• you have diabetes or there is a family
history of diabetes
• you have osteoporosis (thinning of the
bones), particularly if you are a female
who has been through the menopause
• you have suffered in the past from
muscle weakness with this or other
steroids
• you have glaucoma (raised eye
pressure) or there is a family history of
glaucoma
• you have myasthenia gravis (a condition
causing weak muscles)
• you have a bowel disorder (ulcerative
colitis or diverticulitis), have recently
had an operation on your bowel or a
stomach ulcer (peptic or gastrointestinal
ulcer)
• you have psychiatric problems or you
have had a psychiatric illness which was
made worse by this type of medicine
• you have epilepsy (condition where you
have repeated fits or convulsions)
• you have migraines
• you have an underactive thyroid gland
• you have an infection with parasites
(worms) or an internal fungal infection
• you have tuberculosis (TB) or have
recently had a reaction to a vaccination
for TB
• you have septicaemia
• you have a fungal infection in the eye,
an injury to your eye or an ulcer on the
surface of your eye (corneal ulceration)
• you have cerebral malaria
• you have herpes (cold sores or genital
herpes)
• you have asthma
This may affect the dose you are given or
your doctor may want you to take other
medicines at the same time.
More Important Information about
taking this medicine
• Taking this medicine may increase your
risk of getting an infection. It may also
mask the symptoms of an existing or
developing infection and make it harder
to find out what is wrong. If you develop
an infection whilst on this medicine you
should talk to your doctor.
• If you have an accident, are ill, require
surgery (even at the dentists) or you
require a vaccination (particularly with
‘live virus’ vaccines) whilst taking
or when you have finished taking
Dexamethasone soluble tablets, you
should inform the person treating
you that you are taking or have taken
steroids.
• If you have an allergy test, a
suppression test (test for hormone
levels) or a test for an infection, you
should inform the person performing the
test that you are taking dexamethasone
as it may interfere with the results.
• If you need a vaccination tell your
doctor as it may not be effective or you
may have a greater chance of getting an
infection from a ‘live’ vaccine.
• If you have a doping test when taking
this medicine you may get a positive
result.
• Your doctor may want to perform
regular check ups on you while you are
taking Dexamethasone soluble tablets:
– They may be more frequent if you
have other health problems (such as
diabetes or kidney problems) or if you
are elderly as any side effects may be
more serious for you.
– If a child is taking this medicine, it
is important that their growth and
development is checked at frequent
intervals as dexamethasone can cause
children to grow more slowly.
– If you are taking this medicine
for a long time, regular (every 3
months) checks of your vision are
recommended.
– If you are taking high doses your
doctor may monitor the levels of
potassium in your blood. You may
also find that your doctor will reduce
the amount of salt in your diet and
give you a potassium supplement
whilst you are taking this medicine.
• If you take this medicine for more
than 3 weeks, you should always
carry a ‘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.
Dexamethasone soluble tablets and Viral
Infections
– It is important that whilst you are
taking this medicine you avoid contact
with anybody who has chickenpox,
shingles or measles. If you think you
may have had exposure to any of these
diseases, you should consult your doctor
immediately.
– You should also inform your doctor if
you have ever had infectious diseases
such as measles or chickenpox and if
you have had any vaccinations for these
diseases in the past.
Taking other medicines and
Dexamethasone soluble tablets
If you are taking any of the following
medicines, you should consult your doctor
before taking Dexamethasone soluble
tablets:
• 
anticoagulant medicines which thin the
blood (e.g. warfarin, coumarin)
• 
aspirin or similar (non-steroidal antiinflammatory drugs) e.g. indomethacin
• medicines used to treat diabetes
• medicines used to treat high blood
pressure
• diuretics (water tablets)
• amphotericin B injection
continued overleaf

• p henytoin, carbamazepine, (epilepsy
medication)
• rifabutin, rifampicin (antibiotics used to
treat tuberculosis)
• antacids or charcoal
• barbiturates (medication used to aid
sleep and relieve anxiety)
• aminoglutethimide (anti-cancer
treatment)
• carbenoxolone (used in the treatment of
stomach ulcers)
• ephedrine (nasal decongestant)
• acetazolamide (used for glaucoma and
epilepsy)
• 
hydrocortisone, cortisone and other
corticosteroids
• ketoconazole (for fungal infections)
• ritonavir (for HIV)
• antibiotics including erythromycin
• colestyramine (for high cholesterol
levels)
• estrogen hormones including the
contraceptive pill
• tetracosactide (used in the test for
adrenocortical function)
• sultopride (used to calm emotions)
• 
ciclosporin (used to prevent rejection
after transplants)
• thalidomide
• praziquantel (given for certain worm
infections)
• isoniazid for tuberculosis
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
Pregnancy, breast-feeding and fertility
Ask your doctor or pharmacist for advice if
you are pregnant, planning to get pregnant
or breast-feeding.
Dexamethasone soluble tablets should
only be prescribed during pregnancy,
particularly in the first trimester, if the
benefit outweighs the risks for the mother
and child. If you become pregnant during
the use of the product, do not stop using it,
but tell your doctor immediately that you
are pregnant.
Dexamethasone is excreted in breast
milk. There are no known risks to infants.
Nevertheless, breast-feeding should be
discontinued when using higher doses or
long-term treatment.
Driving and using machines
Dexamethasone soluble tablets have no
influence on your ability to drive or use
machines.
Important information about some
of the ingredients of Dexamethasone
soluble tablets
Dexamethasone soluble tablets 2 mg
contains 14.96 mg of sodium per tablet.
Dexamethasone soluble tablets 4 mg
contains 29.95 mg of sodium per tablet.
Dexamethasone soluble tablets 8 mg
contains 60.5 mg of sodium per tablet.
This should be taken into consideration by
patients on a controlled sodium diet.
3. H
 ow to take Dexamethasone soluble
tablets
Dexamethasone soluble tablets are only
to be taken by mouth. Your doctor will
prescribe the most appropriate dose to treat
your condition.
The tablets should be taken as a drink
after dissolving them in a glass of water.
Take your tablets as a single dose each
morning, unless your doctor has told you
otherwise.
Always take this medicine exactly as your
doctor has told you. These instructions will
have been added to the dispensing label by
your pharmacist. You should check with
your doctor or pharmacist if you are not
sure.
The recommended dose is:
Adults:
The usual dose of dexamethasone is 0.5 mg
to 10 mg each day. If your doctor wishes
you to take less than 2 mg per day, you will
be prescribed a different dexamethasone
product.
Children: a single dose on alternate days.
If Dexamethasone soluble tablets are being
given to you as part of some hospital tests,
the dose given will be 2 mg, for a short
period of time.
Important: If you are unsure how much
medicine to take, please contact your
doctor or pharmacist for advice.
Do not exceed or take less than the stated
dose.
Do not take it more or less often than
prescribed.
If you take more Dexamethasone soluble
tablets than you should
If you take too much medicine contact a
doctor or hospital immediately.
If you forget to take Dexamethasone
soluble tablets
If you forget to take a dose, take it as soon
as you remember unless it is almost time
for the next dose.
Do not take a double dose to make up for a
forgotten dose.
If you stop taking Dexamethasone
soluble tablets
It can be dangerous to stop taking this
medicine abruptly. The symptoms that have
been reported when treatment has been
stopped too quickly include low blood
pressure and sometimes, relapse of the
disease for which the medicine was given.
A ‘withdrawal syndrome’ may also occur
which includes fever, muscle and joint pain,
inflammation of the nose lining (rhinitis),
weight loss, itchy skin and inflammation of
the eye (conjunctivitis). If your treatment is
to be stopped follow your doctor’s advice.
He/she may tell you to reduce the amount
of medicine you are taking gradually until
you stop taking it altogether.
If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause
side-effects, although not everybody gets
them.
Tell a doctor straight away if you
experience serious mental health
problems. They can affect people taking
medicines like dexamethasone. These
problems 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

• f eeling, seeing or hearing things that
do not exist. Having strange and
frightening thoughts, changing how you
act or having feelings of being alone.
Talk to your doctor immediately or go to
hospital straight away if you experience
any of the following side effects:
• red and lumpy skin rash
• difficulty in breathing
• swelling of the face, mouth, lips or
eyelids
Other side effects may include:
• 
mental health problems: a feeling
of dependence, a severe headache
with visual disturbances (linked to
withdrawal of treatment), worsening of
schizophrenia (where you may sense,
see or hear things that do not exist,
become withdrawn or have mistaken
beliefs or suspicions)
• 
stomach and bowel problems:
nausea, vomiting, hiccups, increased
appetite, stomach discomfort, swollen
abdomen, inflammation and ulcers in
the oesophagus, heartburn, stomach
ulcers that may bleed, inflamed pancreas
(causing pain in the back and abdomen),
tearing of the bowel particularly if
you have inflammatory bowel disease,
unusual fat deposits
• 
metabolism and problems with salt
levels: weight gain, salt imbalances,
water retention in the body, potassium
loss due to low carbon dioxide levels
(hypokalaemic alkalosis), loss of protein
and calcium balance, increased need
for diabetic medication, increased
cholesterol levels
• 
heart and blood problems: blood clots,
congestive heart failure in susceptible
people, heart muscle rupture (especially
if you have recently had a heart attack),
high blood pressure, raised or lowered
levels of red and white blood cells,
inflammation and thickening of the
veins or arteries
• 
muscle, bone and skin problems:
thinning of the bones with an increased
risk of fractures, bone disease, ruptured
tendons, muscle wasting, weakness.
excess body hair (particularly in
women), slow wound healing, thinned
delicate skin, unusual marks on the skin,
bruising, redness and inflammation of
the skin, stretch marks, visible swollen
capillaries, acne, increased sweating,
impaired reaction to skin tests, skin rash,
thinning of the hair
• 
immune system problems: thrush,
greater chance of picking up infections,
recurrence of tuberculosis if you have
already had it, blood disorders due to
infection
• 
eye problems: cataracts, increased
pressure in the eye, swelling of the
eye, thinning of the eye membranes,
worsening of existing eye infections,
protrusion of the eyeballs
• 
reproductive system problems:
irregular or lack of menstruation
(periods), impotence
• 
hormonal problems: impairment of
the body’s regulation of hormones,
slow growth in children and teenagers,
swelling and weight gain of the body
and face (Cushingoid state)
• 
nervous system problems: fits and
worsening of epilepsy, dizziness,
headache
• 
other general effect: a change in the
effectiveness of the medicine following
stress and trauma, surgery or illness,
withdrawal effects (fever, muscle and
joint pain, inflammation of the eye or
nose, itchy skin and weight loss)
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 at www.mhra.gov.
uk/yellowcard. By reporting side effects
you can help provide more information on
the safety of this medicine.
5. H
 ow to store Dexamethasone
soluble tablets
Keep this medicine out of the sight and
reach of children.
This medicinal product does not require
any special temperature storage conditions.
Store in the original package.
Do not use this medicine after the expiry
date printed on the bottle label and carton
after EXP. The expiry date means the last
day of that month.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will
help protect the environment.
6. C
 ontents of the pack and other
information
What Dexamethasone soluble tablets
contain
The active substance is dexamethasone.
Each 2 mg tablet contains 2 mg of
dexamethasone (as dexamethasone sodium
phosphate).
Each 4 mg tablet contains 4 mg of
dexamethasone (as dexamethasone sodium
phosphate).
Each 8 mg tablet contains 8 mg of
dexamethasone (as dexamethasone sodium
phosphate).
The other ingredients are: sodium
bicarbonate, disodium citrate 1.5 hydrate,
povidone K 30, sodium saccharin, sodium
benzoate, yellow sunset (E110).
What Dexamethasone soluble tablets
look like and contents of the pack
Dexamethasone 2 mg soluble tablets are
salmon, oblong tablets
Dexamethasone 4 mg soluble tablets are
salmon, biconvex, round tablets
Dexamethasone 8 mg soluble tablets are
salmon, biconvex, engraved ‘8’, round
tablets
Dexamethasone soluble tablets are
available in blisters containing 10, 30, 50 or
100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Glenmark Pharmaceuticals Europe Limited
Laxmi House, 2B Draycott Avenue
Kenton, Middlesex
HA3 0BU
United Kingdom
Manufacturer
RAFARM S.A.
Thesi Pousi-Xatzi, Agiou Louka, Paiania,
Attiki, TK 19002, Greece
This leaflet was last revised in 02/2016

PRODUCT:

Amends:

Dexamethasone 2 mg, 4 mg and
8 mg soluble tablets ALL UK

Cutter Guide
Black

Times New Roman ALL 9 pts
body copy (min)

18.2.16

Internal proof approval
Signed (digitally)

GC

GM0150

Artwork Signoff(digitally):

2.5.14
Leaflet (PIL)
135 x 550 mm

Approval:

8

Y

Indesign CS 5

External proof approval
Signed (digitally)

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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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