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DEXAMETHASONE 2MG/5ML ORAL SOLUTION

Active substance(s): DEXAMETHASONE SODIUM PHOSPHATE / DEXAMETHASONE SODIUM PHOSPHATE / DEXAMETHASONE SODIUM PHOSPHATE

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Package Leaflet: Information for the user

Dexamethasone 2mg/5ml Oral Solution
Dexamethasone

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 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 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, 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
• 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
diabetes
• 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

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 medicine.
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.

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.

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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

• 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
• 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 time.
Dexamethasone should not be routinely used in
preterm neonates with respiratory problems.
Contact your doctor if you experience blurred vision
or other visual disturbances.
You should tell your doctor if you have any of the
following:
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.

Dexamethasone Oral Solution contains
• 0.14 g sorbitol in each ml. When taken according
to the dosage recommendations each dose
supplies up to 3.15 g of sorbitol.
• 0.275 g maltitol in each ml. When taken according
to the dosage recommendations each dose
supplies up to 6.2 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.
Dexamethasone Oral Solution contains 0.09 g
propylene glycol in each ml. When taken according
to the dosage recommendations each dose supplies
up to 2 g of propylene glycol, it may cause
alcohol-like symptoms.
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 that you
have taken steroids
- 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.

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.

3. How to take Dexamethasone Oral Solution

Dexamethasone Oral Solution is only to be taken by
mouth.
Always take this medicines exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist, if you are not sure.
The recommended dose is:
Adults: initially 0.5 – 9mg daily, then a maintenance
dose of 1.5mg 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:
0.5 mg to 2mg per dose, given for a short period of
time.
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, pharmacist or nurse.

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 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

(continued overleaf)

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 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, 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:
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

Keep this medicine out of the sight and reach of
children.
Do not store above 25°C. Do not refrigerate.
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 use this medicine if you notice solid particles
inside the solution.
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 ml of solution contains 0.4 mg of
dexamethasone (as dexamethasone sodium
phosphate)
- the other ingredients are benzoic acid (E210),
propylene glycol (E1520), citric acid monohydrate
(E330), liquid maltitol (E965), liquid sorbitol
(non-crystallising) (E420), sodium citrate dihydrate
(E331), mint flavour, purified water.
What Dexamethasone Oral Solution looks like and
contents of the pack
Dexamethasone Oral Solution is a colourless to faint
yellow oral solution with mint flavour. It comes in an
amber glass bottle, holding 150 ml of solution, with
child resistant screw-cap.

4. Possible side-effects

Marketing Authorisation Holder
Focus Pharmaceuticals Limited, Capital House,
1st Floor, 85 King William Street, London EC4N 7BL, UK.

Tell a doctor straight away if you:
• experience serious mental health problems. They can
affect people taking medicines like dexamethasone.
These problems include:

This leaflet was last revised in April 2017.
LF-102355-01

Like all medicines, this medicine can cause
side-effects, although not everybody gets them.

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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 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
2mg/5ml Oral Solution, it will be called
Dexamethasone Oral Solution for ease here after.

 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.

Manufacturer
Vianex SA, Production Site (Plant A’)
12th klm National Road Athens-Lamia, 14451
Metamorfosi, Attiki, Greece

41100212/0

• 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 if you are taking or have
recently taken any other medicines, including
medicines obtained without a prescription.
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, cobicistat).

Expand Transcript

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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