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155 mm


Dexamethasone 20mg/5ml Oral Solution
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,
pharmacist or nurse.
- 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 take this medicine for more than three weeks,
you will get a blue ‘steroid card’: always keep it with
you and show it to any doctor, dentist, nurse, midwife
or anyone else who is giving you treatment.
- If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
The name of your medicine is Dexamethasone
Dexamethasone Oral Solution for ease here after.
What is in this leaflet
1. What Dexamethasone Oral Solution is and what it is
used for
2. What you need to know before you take
Dexamethasone Oral Solution
3. How to take Dexamethasone Oral Solution
4. Possible side-effects
5. How to store Dexamethasone Oral Solution
6. Contents of the pack and other information

1. What Dexamethasone Oral Solution is and
what it is used for

Dexamethasone Oral Solution contains 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.
inflammation, which could otherwise go on making
your condition worse. You must take this medicine
regularly to get maximum benefit from it.
Dexamethasone Oral Solution is used for one of the
• 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
 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. What you need to know before you take
Dexamethasone Oral Solution

Do not take Dexamethasone Oral Solution:
• if you are allergic to dexamethasone or any of the
other ingredients of this medicine (listed in section 6)
• 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
• if you have a stomach or duodenal ulcer
• if you have an infection with worms after travelling to
a tropical area.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking
Dexamethasone Oral Solution:
• 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
• if you have a bacterial or viral infection (such as
hepatitis, poliomyelitis)
• if you have kidney or liver problems
• if you have high blood pressure, heart disease or you
have recently had a heart attack
• if you have diabetes or there is a family history of
• if you have osteoporosis (thinning of the bones),
particularly if you are a female who has been through
the menopause
• if you have suffered from muscle weakness with this or
other steroids in the past
• if you have glaucoma (raised eye pressure) or there is
a family history of glaucoma
• if you have myasthenia gravis (a condition causing
weak muscles)
• if you have a bowel disorder (ulcerative colitis or
diverticulitis), have recently had an operation on your
bowel or a stomach (peptic or gastrointestinal) ulcer
• if you have psychiatric problems or you have had a
psychiatric illness which was made worse by this type
of medicine
• if you have epilepsy (condition where you have
repeated fits or convulsions)
• if you have migraines
• if you have an underactive thyroid gland
• if you have an infection with parasites (worms) or an
internal fungal infection

Driving and using machines
Dexamethasone Oral Solution has no influence on your
ability to drive or use machines.

• if you have tuberculosis (TB) or have recently had a
reaction to a vaccination for TB
• if you have septicaemia
• if you have a fungal infection in the eye, an injury to
your eye or an ulcer on the surface of your eye
(corneal ulceration)
• if you have cerebral malaria
• if you have herpes (cold sores or genital herpes)
• if you have asthma.
This may affect the dose you are given or your doctor
may want you to take other medicines at the same

Dexamethasone Oral Solution contains
• 0.098 g sorbitol in each ml. When taken according to
the dosage recommendations each dose supplies
up to 0.441 g of sorbitol.
• 0.275 g maltitol in each ml. When taken according to
the dosage recommendations each dose supplies
up to 1.2375 g of maltitol.
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicinal product.

Mental health problems while taking Dexamethasone
Oral Solution
Mental health problems can happen while taking
steroids like Dexamethasone Oral Solution.
• 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.

Carrying your steroid card
If you take this medicine for more than three weeks,
your doctor or pharmacist will give you a Steroid
Treatment Card with your prescription or medicine.
- keep this card with you always
- show it to any doctor, dentist, nurse, midwife or
anyone else who is giving you treatment
- even after your treatment is finished, tell any doctor,
dentist, nurse, midwife or anyone else who is giving
you treatment that you have taken steroids.

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.

3. How to take Dexamethasone Oral Solution

Dexamethasone Oral Solution is only to be taken by
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.

You should tell your doctor if you have any of the
Symptoms of tumour lysis syndrome such as muscle
cramping, muscle weakness, confusion, visual loss or
disturbances and shortness of breath, in case you suffer
from haematological malignancy.

Using the syringe
A 3ml graduated syringe and a syringe/bottle adaptor
is provided with your medicine. Use the syringe to
withdraw, from the bottle, the amount of
Dexamethasone Oral Solution that has been
prescribed for you by your doctor.
• insert the bottle adaptor firmly into the neck of the
• push the tip of the syringe into the hole in the top of
the adaptor and ensure that it is secure.
• hold the syringe in place and then turn the bottle
upside down (refer to Figure 1).
• still holding the syringe in place, pull the plunger
down to the correct mark on the syringe (refer to
Figure 1 and Figure 2).
• turn the bottle the right way up.
• remove the syringe, from the adaptor, by holding
onto the bottle and gently twisting the syringe.
• after use replace the bottle cap and wash the
syringe in warm water. Allow to dry.
• do not remove the adaptor from the bottle.

Contact your doctor if you experience blurred vision or
other visual disturbances.
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 Oral
Solution, 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
- 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 Oral
• 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
• 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
Dexamethasone 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.
Other medicines and Dexamethasone Oral Solution
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
If you are taking any of the following medicines, you
• anticoagulant medicines which thin the blood (e.g.
warfarin, coumarin)
• aspirin or similar (non-steroidal anti-inflammatory
drugs) e.g. indometacin
• medicines used to treat diabetes
• medicines used to treat high blood pressure
• diuretics (water tablets)
• amphotericin B injection
• phenytoin, carbamazepine, (epilepsy medication)
• rifabutin, rifampicin (antibiotics used to treat
• antacids or charcoal
• barbiturates (medication used to aid sleep and
relieve anxiety)
• aminoglutethimide (anti-cancer treatment)
• carbenoxolone (used in the treatment of stomach
• 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
• sultopride (used to calm emotions)
• ciclosporin (used to prevent rejection after
• thalidomide
• praziquantel (given for certain worm infections)
• isoniazid for tuberculosis.
Some medicines may increase the effects of
Dexamethasone oral solution and your doctor may
wish to monitor you carefully if you are taking these
medicines (including some medicines for HIV: ritonavir,
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this
Dexamethasone Oral Solution 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.
(continued overleaf)

Figure 1.

Each graduation on the syringe provided is equivalent
to 0.125ml of solution (refer to Figure 2).
Figure 2.

450 mm

Package leaflet: Information for the user

450 mm





155 mm

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:
Not known: frequency cannot be estimated from the
available data
• 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
• 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
• 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, visual disturbances, loss of
vision and blurred vision
• 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).
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:
By reporting side
effects you can help provide more information on the
safety of this medicine.

5. How to store Dexamethasone Oral Solution





The recommended dose is:
Adults: initially 0.125ml to 2.25ml daily, then a
maintenance dose of 0.375ml daily. The total dose can
be split into two or three smaller doses to be taken
throughout the day.
Use in children and adolescents: a single dose on
alternate days.
If Dexamethasone Oral Solution is being given to you as
part of some hospital tests, the range given will be:
0.125ml to 0.5ml per dose, given for a short period of
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 Oral Solution than
you should
If you take too much medicine contact a doctor or
hospital immediately.
If you forget to take Dexamethasone Oral Solution
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
If you stop taking Dexamethasone Oral Solution
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 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, pharmacist or nurse.

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
dexamethasone. These problems include:
 feeling depressed, including thinking about
 feeling high (mania) or moods that go up and
 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.
• have an allergic reaction to Dexamethasone Oral
Solution. Talk to your doctor immediately or go to

Keep this medicine out of the sight and reach of
Do not store above 25°C. Do not refrigerate.
Store in the original package in order to protect from
Do not use this medicine after the expiry date which is
stated on the bottle label and carton after EXP. The
expiry date refers to the last day of that month.
After first opening, use within 3 months.
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. Contents of the pack and other information

What Dexamethasone Oral Solution contains
- the active substance is dexamethasone. Each 5ml of
solution contains 20mg of dexamethasone (as
dexamethasone sodium phosphate)
- the other ingredients are: propylene glycol (E1520),
liquid maltitol (E965), liquid sorbitol (non-crystallising)
(E420), sodium citrate dihydrate (E331), EDTA
disodium, sucralose, sodium hydroxide (as a pH
adjuster), mint flavour, purified water.
What Dexamethasone Oral Solution looks like and
contents of the pack
Dexamethasone Oral Solution is a colourless to
yellowish oral solution with a mint odour. It comes in an
amber glass bottle, holding 30 or 50ml of solution, with a
child resistant screw-cap. The pack also contains a 3ml
plastic oral dosing syringe and a bottle/syringe
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Focus Pharmaceuticals Limited, Capital House, 1st
Floor, 85 King William Street, London EC4N 7BL, UK.
RAFARM S.A., Thesi Pousi-Xatzi, Agiou Louka, Paiania,
Attiki TK 19002, Greece
This leaflet was last revised in July 2017.

Commodity No.:
Pharma Code:
Core Spec Ref.:
Print Colours:

155 x 450 mm
302 C

Non-Print Colours:
Min. Font Size:

7 pt


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Further information

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