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DEXAMETHASONE 20MG/5ML ORAL SOLUTION

Active substance(s): DEXAMETHASONE SODIUM PHOSPHATE

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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 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 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 or
pharmacist. This includes any side effects not listed in
this leaflet.
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

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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.
Dexamethasone
Oral
Solution
reduces
this
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
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. What you need to know before you take
Dexamethasone Oral Solution
Do not take Dexamethasone Oral Solution:
• if you are allergic (hypersensitive) to dexamethasone
or any of the other ingredients of Dexamethasone
Oral Solution 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
Warnings and precautions
Talk to your doctor or pharmacist 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.
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.
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.

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 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 Oral
Solution;
• 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.
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.
Taking other medicines and Dexamethasone Oral Solution
Tell your doctor or pharmacist if you are taking or have
recently taken any other medicines.
If you are taking any of the following medicines, you should
consult your doctor before taking dexamethasone:
• 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
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.
(continued overleaf)

Pregnancy, breast-feeding and fertility
Ask your doctor or pharmacist for advice if you are
pregnant, planning to get pregnant or breast-feeding.
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.
Driving and using machines
Dexamethasone Oral Solution has no influence on your
ability to drive or use machines.
Important information about some of the ingredients of
Dexamethasone Oral Solution
Your medicinal product contains liquid maltitol and
sorbitol. If you have been told by your doctor that you
have an intolerance to some sugars, contact your
doctor before taking this medicinal product.
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.

3. How to take Dexamethasone Oral Solution

Dexamethasone Oral Solution is only to be taken by
mouth. Your doctor will prescribe the most appropriate
dose to treat your condition.
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.
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
bottle.
• 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.

Figure 1.

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Package leaflet: Information for the user

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 from muscle weakness with this or
other steroids in the past
• 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 (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.

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

Figure 2.

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
▪ 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
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)
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
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 Oral Solution
0.5ml
0.375ml
0.25ml

ml

ml

0.125ml

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.
Children: 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
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 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 dose.
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 or pharmacist.

Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Do not refrigerate.
Store in the original package in order to protect from
light.
After first opening, use within 3 months.
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. 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
adaptor.
Marketing Authorisation Holder
Focus Pharmaceuticals Limited, Capital House, 1st
Floor, 85 King William Street, London EC4N 7BL, UK.
Tel: 00 44 (0)1283 495280
Fax: 00 44 (0)1283 495290
Email: medinfo@focuspharma.co.uk
Manufacturer
RAFARM S.A., Thesi Pousi-Xatzi, Agiou Louka, Paiania,
Attiki TK 19002, Greece

For information in large print, audio CD or
Braille please telephone
00 44 (0)1283 495 280 or email
medinfo@focuspharma.co.uk.
This leaflet was last revised in 06/2015

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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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