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DEXAMETHASONE 3.8 MG/ML SOLUTION FOR INJECTION

Active substance(s): DEXAMETHASONE SODIUM PHOSPHATE

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Package leaflet: Information for the patient

Dexamethasone
3.8 mg/ml
solution for injection

Dexamethasone
3.8 mg/ml
solution for injection
Dexamethasone

Dexamethasone

Important information about this medicine
• 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 section 4: Possible side effects). 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 section 4 for
more information)
• If you take it for more than 3 weeks, in the UK, you
will get a blue ‘steroid card’: always keep it with you
and show it to 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.
Read all of this leaflet carefully before you start
using 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.
- 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.
What is in this leaflet
1. What Dexamethasone is and what it is used for
2. What you need to know before you use
Dexamethasone
3. How you use Dexamethasone
4. Possible side effects
5. How to store Dexamethasone
6. Contents of the pack and other information
1. What Dexamethasone is and what it is used for
The name of your medicine is Dexamethasone. This
belongs to a group of medicines called corticosteroids.
Corticosteroids are hormones that are found naturally
in your body that help to keep you healthy and
well. Boosting your body with extra corticosteroid,
such as Dexamethasone, is an effective way to treat
various illnesses involving inflammation in the body.
Dexamethasone lowers inflammation, which could
otherwise go on making your condition worse. You
must take this medicine regularly to get maximum
benefit from it.
Dexamethasone can be used to:
• Reduce inflammation
• Treat a number of different diseases of the
immune system
2. What you need to know before you use
Dexamethasone
Do not use Dexamethasone:
- if you are allergic to dexamethasone or any of the
other ingredients of this medicine (listed in section 6).
The signs of an allergic reaction include a rash, itching
or shortness of breath
- if you have an infection that affects the whole body
- if you have an infection of a joint
- if you have unstable joints. This is a condition where
joints, such as the knee, can suddenly give way.
➣ Do not have this medicine if any of the above
 apply to you.
Warnings and precautions
Talk to your doctor or pharmacist before using
Dexamethasone:
• If you have ever had severe depression or manic
depression (bipolar disorder).
This includes having had depression before while
taking steroid medicines like Dexamethasone
• If any of your close family has had these illnesses
If either of these applies to you, talk to a doctor before
having this medicine.
Mental problems while having Dexamethasone
Mental health problems can happen while having
steroids like Dexamethasone (see also section 4).

• 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 problems. This is
particularly important if you are depressed, or might be
thinking about suicide. In a few cases, mental problems
have happened when doses are being lowered
or stopped.
Take special care with Dexamethasone
➣ Before you have Dexamethasone, tell your doctor if:
• You have had allergic reactions with a corticosteroid
treatment. Severe allergic reactions (including shock)
have been seen with injected corticosteroids.
• You have a cancer of the blood because you may
be at risk of a very rare, potentially life-threatening
condition resulting from a sudden breakdown of
tumour cells.
• You have 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
• You have kidney or liver problems
• You have high blood pressure or heart disease
• You have diabetes or there is a family history
of diabetes
• You have thinning of the bones (osteoporosis),
particularly if you are a female who has been through
the menopause
• You have had muscle weakness with this or other
steroids in the past
• You have raised eye pressure (glaucoma) or there is
a family history of glaucoma
• You have a stomach (peptic) ulcer
• You have mental problems or you have had a mental
illness which was made worse by this type of
medicine such as ‘steroid psychosis’
• You have epilepsy
• You have migraines
• You have an infection with parasites
• You have tuberculosis (TB)
• You have stunted growth
• You have ‘Cushing’s syndrome’
• You have had a head injury
• You have had a stroke
• Contact your doctor if you experience blurred vision
or other visual disturbances.
If you are not sure if any of the above apply to you,
talk to your doctor or pharmacist before having
Dexamethasone.
If you develop an infection while you are having this
medicine, you should talk to your doctor. Please tell
any doctor, dentist or person who may be giving you
treatment that you are currently taking steroids or have
taken them in the past.
If you are living in the UK, you should always carry
a blue ‘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.
Do not use Dexamethasone for the treatment of Acute
Respiratory Distress Syndrome (ARDS; a serious lung
disease) if you have been diagnosed with this condition
for over 2 weeks.
Dexamethasone and viral infections
While you are having this kind of medicine, you should
not come into contact with anyone who has chicken
pox, shingles or measles if you have not had these
illnesses. This is because you may need specialist
treatment if you get these diseases. If you think you
may have had exposure to any of these diseases, you
should talk to your doctor straight away. You should
also tell your doctor if you have ever had infectious
diseases such as measles or chicken pox and if you have
had any vaccinations for these conditions in the past.
➣ Please tell a doctor or anyone giving you treatment,
such as at a hospital, if:
• You have an accident
• You are ill
• You need any surgery. This includes any surgery you
may have at your dentist’s
• You need to have a vaccination
If any of the above apply to you, you should tell your
doctor or the person treating you even if you
have stopped having this medicine.

The following information is intended for healthcare
professionals only:
This is an extract from the Summary of Product
Characteristics (SmPC) to assist in the administration of
Dexamethasone 3.8 mg/ml solution for injection.
The prescriber should be familiar with the full SmPC in
order to determine the appropriateness of the use of
the product in a particular patient. The full SmPC can
be found on the electronic Medicines Compendium
(eMC) website: http://www.‌‌medicines.org.‌‌uk/emc/.
The Patient Information Leaflet provided (see the other
half of this leaflet) should be given to the patient.
Dexamethasone 3.8 mg/ml solution for injection
contains dexamethasone base in the form of the salt,
dexamethasone sodium phosphate.
Each vial contains 1 ml of solution. Each 1 ml of
solution contains 3.8 mg dexamethasone base (as
sodium phosphate). This is equivalent to 5.0 mg
dexamethasone sodium phosphate.
PREPARATION AND OTHER HANDLING
INSTRUCTIONS
Dexamethasone solution for injection may be diluted
with the following solutions for injection or infusion:
• Sodium Chloride 0.9% infusion, Glucose
5% Infusion, Compound Sodium Lactate Infusion,
Hartmann’s Solution for Injection, Ringer-Lactate
Solution for Injection, Ringer’s Solution for Injection,
Sorbitol 5% Injection, Invert Sugar 10% Injection and
Rheomacrodex
Using the above infusion fluids, Dexamethasone solution
for injection can also be injected into the infusion line
without causing precipitation of the ingredients.
For single use only.
Discard any unused solution after use.
Any unused product or waste material should be
disposed of in accordance with local requirements.
The product should only be used when the solution is
clear and particle free.
DOSAGE AND ADMINISTRATION
Posology
Note: All dose recommendations stated in this section
are expressed as mg dexamethasone base.
In general, glucocorticoid dosage depends on
the severity of the condition and response of the
patient. Under certain circumstances (e.g. in stress),
extra dosage adjustments may be necessary. If no
favourable response is noted within a couple of days,
glucocorticoid therapy should be discontinued.
Adults and Elderly
Once the disease is under control the dosage should be
reduced or tapered off to the lowest suitable level under
continuous monitoring and observation of the patient.
For acute life-threatening situations (e.g. anaphylaxis,
acute severe asthma) substantially higher dosages may
be needed. Cerebral oedema (adults): initial dose 8 16 mg IV followed by 5 mg IV or IM every 6 hours, until
a satisfactory result has been obtained. In brain surgery
these dosages may be necessary until several days
after the operation. Thereafter, the dosage has to be
tapered off gradually. Increase of intracranial pressure
associated with brain tumours can be counteracted by
continuous treatment.
For local treatment, the following dosages can be
recommended:
•  intra-articulary: 
1.6-3 mg large joints

0.6-0.8 mg small joints
•  intrabursally: 
1.6-3 mg;
•  in tendon sheaths: 0.3-0.8mg
The frequency of these injections may vary from every
3 - 5 days to every 2 - 3 weeks. For rectal drip in cases
of ulcerative colitis: 4 mg diluted in 120 ml saline.
Paediatric population
Dosage requirements are variable and may have to
be changed according to individual needs. Usually
0.2 mg/kg to 0.4 mg/kg of body weight daily.
Please refer to Table 1 for assistance when calculating
any required dosage.
Table 1. Concentration vs. Volume
Desired concentration
Required volume of
(mg dexamethasone base)
product*(ml)
3.8
1.00
4
1.05
8
2.10
12
3.15
16
4.20
* Dexamethasone 3.8 mg/ml solution for injection

Method of administration
Dexamethasone solution for injection may be
administered intravenously (IV), subcutaneously
(SC), intramuscularly (IM), by local injection or as
a rectal drip.
For administration by IV infusion: see section on
‘Preparation and Other Handling Instructions’.
With IV administration high plasma levels can be
obtained rapidly.
Rapid IV injection of massive doses of glucocorticoids
may sometimes cause cardiovascular collapse; the
injection should therefore be given slowly over a period
of several minutes.
Intra-articular injections should be given under strictly
aseptic conditions.
WARNINGS
Severe allergic reactions. Rare instances of
anaphylactoid/anaphylactic reactions with a possibility
of shock have occurred in patients receiving parenteral
corticosteroid therapy. Appropriate precautionary
measures should be taken with patients who have a
history of allergic reactions to corticosteroids.
Tumor lysis syndrome. In post-marketing experience
tumour lysis syndrome (TLS) has been reported in
patients with haematological malignancies following
the use of dexamethasone alone or in combination
with other chemotherapeutic agents. Patients at high
risk of TLS such as patients with high proliferative rate,
high tumour burden, and high sensitivity to cytotoxic
agents, should be monitored closely and appropriate
precaution taken.
Potentially severe psychiatric adverse reactions may
occur with systemic steroids. Symptoms typically
emerge within a few days or weeks of starting
the treatment. Risks may be higher with high
doses/systemic exposure, although dose levels do
not allow prediction of the onset, type, severity or
duration of reactions. Most reactions recover after
either dose reduction or withdrawal, although specific
treatment may be necessary. Please seek advice if
worrying psychological symptoms develop, especially
if depressed mood or suicidal ideation is suspected.
Please also be alert to possible psychiatric disturbances
that may occur either during or immediately after dose
tapering/withdrawal of systemic steroids, although such
reactions have been reported infrequently.
Take particular care when considering the use of
systemic corticosteroids in patients with existing
or previous history of severe affective disorders in
themselves or in their first degree relatives (including
depressive or manic-depressive illness and previous
steroid psychosis).
Undesirable effects may be minimised by using the
lowest effective dose for the minimum period, and by
administering the daily requirement as a single morning
dose or whenever possible as a single morning dose on
alternative days. Frequent patient review is required to
appropriately titrate the dose against disease activity.
After parenteral administration of glucocorticoids
serious anaphylactoid reactions have occasionally
occurred, particularly in patients with a history of
allergy. If such an anaphylactoid reaction occurs, treat
the patient with adrenaline and positive pressure
ventilation.
Corticosteroids should not be used for the management
of head injury or stroke because it is unlikely to be of
any benefit and may even be harmful.
When treating Acute Respiratory Distress Syndrome
(ARDS), therapy with corticosteroids should start within
the first 2 weeks of onset of ARDS.
Preterm neonates
Available evidence suggests long-term
neurodevelopment adverse events after early treatment
(<96 hours) of premature infants with chronic lung
disease at starting doses of 0.25 mg/kg twice daily.
Dexamethasone withdrawal
Adrenal cortical atrophy develops during prolonged
therapy and may persist for years after stopping
treatment. Withdrawal of corticosteroids after
prolonged therapy must therefore always be gradual to
avoid acute adrenal insufficiency, being tapered off over
weeks or months according to the dose and duration of
treatment.
In patients who have received more than physiological
doses of systemic corticosteroids (approx. 1 mg
dexamethasone) for greater than 3 weeks, withdrawal
should not be abrupt. How dose reduction should be

carried out depends largely on whether the disease is
likely to relapse as the dose of systemic corticosteroids
is reduced. Clinical assessment of disease activity may
be needed during withdrawal. If the disease is unlikely
to relapse on withdrawal of systemic corticosteroids
but there is uncertainty about HPA suppression, the
dose of systemic corticosteroid may be reduced rapidly
to physiological doses. Once a daily dose of 1 mg
dexamethasone is reached, dose reduction should be
slower to allow the HPA-axis to recover.
Abrupt withdrawal of systemic corticosteroid treatment,
which has continued up to 3 weeks is appropriate if
it is considered that the disease is unlikely to relapse.
Abrupt withdrawal of doses of up to 6 mg daily of
dexamethasone for 3 weeks is unlikely to lead to
clinically relevant HPA-axis suppression in the majority
of patients. In the following patient groups, gradual
withdrawal of systemic corticosteroid therapy should be
considered even after courses lasting 3 weeks or less:
• Patients who have had repeated courses of systemic
corticosteroids, particularly if taken for greater
than 3 weeks.
• When a short course has been prescribed within
one year of cessation of long-term therapy (months
or years).
• Patients who may have reasons for
adrenocortical insufficiency other than exogenous
corticosteroid therapy.
• Patients receiving doses of systemic corticosteroid
greater than 6 mg daily of dexamethasone.
• Patients repeatedly taking doses in the evening.
During prolonged therapy any intercurrent illness,
trauma or surgical procedure will require a temporary
increase in dosage; if corticosteroids have been stopped
following prolonged therapy they may need to be
temporarily re-introduced.
Patients should carry ‘steroid treatment’ cards which
give clear guidance on the precautions to be taken to
minimise risk and which provide details of prescriber,
drug, dosage and the duration of treatment.
Anti-inflammatory/Immunosuppressive effects
and Infection
Suppression of the inflammatory response and immune
function increases the susceptibility to infections and
their severity. The clinical presentation may often be
atypical, and serious infections such as septicaemia
and tuberculosis may be masked and may reach an
advanced stage before being recognised.
Appropriate antimicrobial therapy should accompany
glucocorticoid therapy when necessary e.g. in
tuberculosis and viral and fungal infections of the eye.
Chickenpox is of particular concern since
this normally minor illness may be fatal in
immunosuppressed patients.
Patients (or parents of children) without a definite
history of chickenpox should be advised to avoid
close personal contact with chickenpox or herpes
zoster and if exposed they should seek urgent
medical attention. Passive immunisation with varicella
zoster immunoglobulin (VZIG) is needed by exposed
non-immune patients who are receiving systemic
corticosteroids or who have used them within the
previous 3 months; this should be given within 10 days
of exposure to chickenpox. If a diagnosis of chickenpox
is confirmed, the illness warrants specialist care and
urgent treatment. Corticosteroids should not be
stopped and the dose may need to be increased.
Measles
Patients should be advised to take particular care to
avoid exposure to measles and to seek immediate
medical advice if exposure occurs; prophylaxis with
intramuscular normal immunoglobin may be needed.
Live vaccines should not be given to individuals with
impaired immune responsiveness. The antibody
response to other vaccines may be diminished.
Visual disturbance
Visual disturbance may be reported with systemic
and topical corticosteroid use. If a patient presents
with symptoms such as blurred vision or other visual
disturbances, the patient should be considered for
referral to an ophthalmologist for evaluation of possible
causes which may include cataract, glaucoma or rare
diseases such as central serous chorioretinopathy
(CSCR) which have been reported after use of systemic
and topical corticosteroids.
Special precautions
Particular care is required when considering the
use of systemic corticosteroids in patients with the
following conditions and frequent patient monitoring is
necessary:
a. Osteoporosis (post-menopausal females are
particularly at risk)
b. Hypertension or congestive heart failure
c. Existing or previous history of severe affective
disorders (especially previous steroid psychosis)
d. Diabetes mellitus (or a family history of diabetes)
e. History of tuberculosis, since glucocorticoids may
induce reactivation
f. Glaucoma (or a family history of glaucoma)
g. Previous corticosteroid-induced myopathy
h. Liver failure
i. Renal insufficiency
j. Epilepsy
k. Gastro-intestinal ulceration
l. Migraine
m. Certain parasitic infestations in particular
amoebiasis
n. Incomplete statural growth since glucocorticoids
on prolonged administration may accelerate
epiphyseal closure
o. Patients with Cushing’s syndrome

In the treatment of conditions such as tendinitis or
tenosynovitis care should be taken to inject into the
space between the tendon sheath and the tendon as
cases of ruptured tendon have been reported.
Paediatric population
Corticosteroids cause dose-related growth retardation
in infancy, childhood and adolescence, which may be
irreversible.
Dexamethasone has been used ‘off label’ to treat
and prevent chronic lung disease in preterm infants.
An association between the use of dexamethasone in
preterm infants and the development of cerebral palsy
has been suggested. In view of this possible safety
concern, an assessment of the risk:benefit should be
made on an individual patient basis.
Use in the Elderly
The common adverse effects of systemic corticosteroids
may be associated with more serious consequences in
old age. Close clinical supervision is required to avoid
life-threatening reactions.
Please see SmPC section 4.5 for interaction with other
medicinal products and other forms of interaction.
This medicinal product contains less than 1 mmol
sodium (23 mg) per dose, i.e. essentially ‘sodium- free’.
OVERDOSE
It is difficult to define an excessive dose of
a corticosteroid as the therapeutic dose will vary
according to the indication and patient requirements.
Massive IV corticosteroid doses given as a pulse in
emergencies are relatively free from hazardous effects.
Exaggeration of corticosteroid related adverse effects
may occur. Treatment should be asymptomatic and
supportive as necessary.
STORAGE
As packaged for sale
Store in a refrigerator (2°C - 8°C). Do not freeze. Store in the
original package.
Following dilution with infusion fluids (see
‘PREPARATION AND OTHER HANDLING
INSTRUCTIONS’):
Chemical and physical in-use stability of dilutions has
been demonstrated for at least 24 hours, at 25°C (room
temperature)
From a microbiological point of view, the product should be
used immediately.
If not used immediately, in-use storage times and conditions
prior to use are the responsibility of the user and would
normally not be longer than 24 hours at 2 to 8°C, unless
dilution has taken place in controlled and validated aseptic
conditions.
MARKETING AUTHORISATION HOLDER
Aspen Pharma Trading Limited, 3016 Lake Drive,
Citywest Business Campus, Dublin 24, Ireland
This leaflet was last revised in January 2018

Children
If a child is having this medicine, it is important that the
doctor monitors their growth and development regularly.
Dexamethasone should not be routinely given to
premature babies with respiratory problems.
Other medicines and Dexamethasone
Please tell your doctor if you are taking, have recently
taken or might take any other medicines, including
medicines obtained without a prescription. Other
medicines can affect the way Dexamethasone works
or Dexamethasone can affect the way they work.
In particular:
• Medicines to treat heart and blood problems, such
as warfarin, high blood pressure medicine, and water
tablets (diuretics)
• Antibiotics such as rifampicin and rifabutin
• Medicines that are broken down in the body by an
enzyme in the liver (CYP 3A4) such as HIV protease
inhibitors (e.g indinavir) or certain antibiotics (e.g.
erythromycin)
• Some medicines may increase the effects of
Dexamethasone and your doctor may wish to
monitor you carefully if you are taking these
medicines (including some medicines for HIV:
ritonavir, cobicistat)
• Medicines to treat epilepsy, such as phenytoin,
carbamazepine, phenobarbitone and primidone
• Medicines that control pain or lower inflammation,
such as aspirin or phenylbutazone
• Medicines used to treat diabetes
• Medicines used to lower potassium levels
• Medicines used to treat myasthenia
• Anti-cancer treatments, such as aminoglutethimide
• Ephedrine used to relieve symptoms of
a blocked nose
• Acetazolamide used for glaucoma
• Carbenoxolone sometimes used for ulcers
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor for advice before taking this medicine.
Driving and using machines
Dexamethasone is not likely to affect you being able to
drive or use any tools or machines.
Dexamethasone contains less than 1 mmol sodium
(23 mg) per dose, i.e. essentially ‘sodium- free’.
3. How you have Dexamethasone
Dexamethasone is normally given by a doctor. It will be
given as an injection into a muscle or under your skin.
It can also be given as an injection into a vein. The dose
depends on your illness and how bad it is. The dose in
adults is normally from 0.5 to 24mg daily, and in children
0.2 to 0.4mg/kg daily. Your doctor will decide the dose.
If you use more Dexamethasone than you should
If you think you have been given too much
Dexamethasone, tell your doctor straight away. The
following effects may happen:
• Swelling of the throat
• Skin reaction
• Difficulty breathing
If you stop using Dexamethasone
It can be dangerous to stop having this medicine
suddenly. If you need to stop this treatment, follow
your doctor’s advice. He or she may tell you to lower
the amount of medicine you are having gradually until
you stop having it altogether. If you stop having this
medicine too quickly, your condition may get worse.
You may also feel a ‘withdrawal symptom’. These may
include headache, problems with your vision (including
pain or swelling in the eye), feeling or being sick, fever,
pain in your muscles and joints, swelling in the inside of
your nose, weight loss, itchy skin and conjunctivitis.
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.
Dexamethasone can also cause side effects when you
stop using it.
• See section 3, ‘If you stop having Dexamethasone’
Serious side effects: tell a doctor straight away
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.
These 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
If you notice any of these problems, talk to a doctor
straight away.
If you have an allergic reaction to Dexamethasone see
a doctor straight away
An allergic reaction may include:
• Any kind of skin rash or itching of the skin
• Difficulty in breathing or collapse
• Swelling of the face, lips, tongue and/or throat with
difficulty in swallowing or breathing (angioedema).
If you get any of the following side effects see your
doctor as soon as possible:
• Stomach and gut problems: stomach ulcers which
may perforate or bleed, indigestion, having more
of an appetite than usual, diarrhoea, feeling or
being sick

• I  nflamed pancreas: this may cause severe pain in the
back or tummy
• Problems with salts in your blood such as too much
sodium or low potassium or calcium. You may have
water retention
• Heart and blood problems: high blood pressure,
blood clots
• Bone problems: thinning of the bones (osteoporosis)
with an increased risk of fractures, bone disease,
damaged tendons, damage to the joint where the
injection was given
• Recurring infections that get worse each time such as
chicken pox and thrush
• Skin problems: wounds that heal more slowly,
bruising, acne, sweating more than usual. Burning,
redness and swelling where the injection was given.
This does not last long
• Eye problems: increased pressure in the eye
including glaucoma, eye disorders such as cataracts,
eye infections, visual disturbances, loss of vision,
blurred vision
• Hormone problems: irregular or missing periods,
stunted growth in children and teenagers, swelling
of the face (called a ‘Cushingoid’ or ‘moon’ face).
It may affect your diabetes and you may notice you
start needing higher doses of the medicine you take
for diabetes. Your body may not be able to respond
normally to severe stress such as accidents, surgery
or illness, growth of extra body hair (particularly in
women), increased appetite or weight gain
• Nervous system problems: fits or epilepsy may
become worse, severe unusual headache with visual
problems, being unable to sleep, feeling depressed,
extreme mood swings, schizophrenia may become
worse, headache or problems with your vision
(including eye pain or swelling)
Reporting of side effects
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, tell your doctor
or pharmacist. You can also report side effects directly
via the national reporting system Yellow Card Scheme.
Website: www.mhra.gov.uk/yellowcard or search for
MHRA Yellow Card in the Google Play or Apple App
Store. By reporting side effects you can help provide
more information on the safety of this medicine.
5. How to store Dexamethasone
Keep this medicine out of the sight and reach
of children
Do not use this medicine after the expiry date which is
stated on the label and carton after “EXP”. The expiry
date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C). Do not freeze. Store
in the original package
After first opening, the product should be used
immediately to avoid microbial contamination.
When diluted with infusion fluids, chemical and physical
in-use stability of dilutions has been demonstrated for
at least 24 hours, at 25°C (room temperature). If not
used immediately, in-use storage conditions prior to use
are the responsibility of the user and would normally
not be longer than 24 hours at 2 to 8°C, unless dilution
has taken place in controlled and validated aseptic
conditions.
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 contains
- The active ingredient is dexamethasone
(as sodium phosphate). Each 1 ml contains
3.8 mg dexamethasone (as sodium phosphate)
which is equivalent to 5.0 mg dexamethasone
sodium phosphate
- The other ingredients are glycerol, disodium edetate,
water for injections and sodium hydroxide or
phosphoric acid
What Dexamethasone looks like and contents
of the pack
Dexamethasone is a clear, colourless liquid. It comes in
vials containing 1 ml of solution. Vials are available in
packs of 1 or 10. Not all pack sizes may be marketed.
The Marketing Authorisation Holder and
Manufacturer
Aspen Pharma Trading Limited, 3016 Lake Drive,
Citywest Business Campus, Dublin 24, Ireland
The Manufacturers:
Famar L’Aigle, Usine de Saint-Rémy; Rue de l’Isle,
28380 Saint Remy Sur Avre, France.
For any information about this medicine, please
contact the local representative of the Marketing
Authorisation Holder:
United Kingdom
24 Hour Helpline +441748 823 391 (free phone UK
only 0800 0087 392)
This leaflet was last revised in
January 2018

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