DEXAMETHASONE 3.3 MG/ ML SOLUTION FOR INJECTION

Active substance: DEXAMETHASONE SODIUM PHOSPHATE

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hameln

Patient Information Leaflet
Dexamethasone 3.3 mg/ml Injection
Dexamethasone 6.6 mg/ml Injection
Dexamethasone 8.3 mg/ml Injection
Important information about this medicine

• Your doctor or nurse will give you the injection
• If this injection causes you any problems talk to your doctor, nurse or pharmacist
• Please tell your doctor or pharmacist, if you have any other medical conditions or have an allergy to
any of the ingredients of this medicine
• Please tell your doctor or pharmacist, if you are taking any other medicines
• Dexamethasone is a steroid medicine, prescribed for many different conditions, including serious
illnesses.
• You need to receive it regularly to get the maximum benefit.
• Don’t stop 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 below). 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 receiving 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 receive it for more than 3 weeks, 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 the leaflet. It includes other important information on the safe and effective use
of this medicine that might especially be important for you. This leaflet was last updated 01/2013.
Dexamethasone – benefit information
Dexamethasone belongs to a group of medicines called steroids. Their full name is corticosteroids.
These 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 reduces inflammation, which could
otherwise go on making your condition worse. You must take this medicine regularly to get maximum
benefit from it.
- Read all of this leaflet carefully before you start using this medicine. In some circumstances this
may not be possible and this leaflet will be kept in a safe place should you wish to read it.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, please ask your doctor or your pharmacist.
- This medicine has been prescribed for you personally and you should not pass it on to others. It may
harm them, even if their symptoms are the same as yours.
The name of your medicine is Dexamethasone 3.3 mg/ml Injection, Dexamethasone 6.6 mg/ml Injection
and Dexamethasone 8.3 mg/ml Injection, which will be referred to as Dexamethasone Injection
throughout this leaflet
Where to find information in this leaflet
1. What Dexamethasone Injection is and what it is used for
2. Before you are given Dexamethasone Injection
3. How to use Dexamethasone Injection
4. Possible side effects
5. Storing Dexamethasone Injection
6. Further information
cirrhosis (a serious scarring of the liver) and your
1. What Dexamethasone Injection is and what it
doctor may need to adjust the dose.
is used for
Dexamethasone belongs to a group of medicines
called steroids.
Dexamethasone is given by injection to patients
unable to take a tablet form of the medicine. When
given into a vein or muscle, dexamethasone
reduces inflammation and suppresses the
immune system and is used normally for patients
with:
• severe allergic reactions causing swelling of the
face and throat, low blood pressure and collapse
(angioneurotic oedema and anaphylaxis)
• shock caused by infection or severe
tuberculosis (also with anti-infective treatments
e.g. antibiotics)
• raised pressure in the skull caused by tumours
or infantile spasms

Sometimes, the injection is given into the
painful area itself e.g.inflammation of the joints
(rheumatoid arthritis and osteoarthritis)
2. Before you are given Dexamethasone Injection
You should NOT be given Dexamethasone
Injection if you:
• are sensitive or allergic to Dexamethasone or
any of the other ingredients in this injection.
• have a fungal infection that has spread to
involve the whole body.
• have any other widespread infection which is
not currently being treated.
• are to be vaccinated with live virus vaccines.
Please tell your doctor or nurse before being
given the injection if:
• you have ever had severe depression or
manic-depression (bipolar disorder). This
includes having had depression before while
taking steroid medicines like dexamethasone.
• any of your close family has had these
illnesses. If either of these applies to you, talk
to a doctor before receiving dexamethasone.
Mental health problems while taking
dexamethasone
Mental health problems can happen while taking
steroids like dexamethasone (see also section 4
Possible side effects)
• 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.
You should avoid any exposure to infectious
diseases. If you do not have a definite history of
chickenpox, you must avoid any contact with
chickenpox (herpes simplex), shingles (herpes
zoster) or measles. This precaution applies also if
your child is the patient treated with this medicine.
If you think you may have been exposed to these,
please seek advice from a doctor immediately as
the consequences can be serious (the steroids
can stop your body defending itself against
these diseases which can become severe and
widespread). If you develop these infections you
will need immediate treatment in hospital.
Corticosteroids may mask some signs of infection
and new infections may appear during their use.
Your doctors will try to use the smallest dose
necessary to help you. However there may be
times when an increase in dose will be needed.
Any reduction in dose will need to be made more
slowly than an increase. Your doctor will explain
this to you and will probably give you a “steroid
treatment card” to show to other doctors while
you need to take steroids (including by mouth).
Steroid treatment cards are also available from
your pharmacist.
Very occasionally your body might give you
“withdrawal effects” after taking steroids or
during dose reduction, including fever, tiredness
and aches and pains in muscles and joints.
You should tell your doctor if you develop such
symptoms even though there may be other
causes for these symptoms.
Corticosteroids can lead to raised blood
pressure, ankle swelling (by retention of salt)
and a loss of potassium in your water. Your doctor
will monitor your condition and treat these if they
arise. Steroids are also used cautiously, even if
necessary, if a patient taking them has a heart
attack.
Corticosteroids effects can be greater in patients
with hypothyroidism (when the thyroid gland
doesn’t make enough thyroid hormone) or

46696_20_13_Leaflet_Dexamethasone_3-3_6-6_8-3mgml_CM.indd 1

You should also tell the doctor if you:
• suffer from heart failure or have had a recent
heart attack
• suffer from high blood pressure
• suffer from kidney or liver problems
• suffer from diabetes or a relative has diabetes
• suffer from or have had a stomach or duodenal
ulcer
• suffer from osteoporosis (thinning and
weakness of the bone)
• have suffered from muscle weakness with this
or other steroids in the past
• suffer from myasthenia gravis (a disease
causing weak muscles)
• suffer from an eye infection with the herpes
virus
• suffer from glaucoma (increased pressure
within the eye) or a relative has glaucoma
• suffer from epilepsy
• suffer from schizophrenia
• have previously had tuberculosis
• have previously had amoebiasis (an infection
which is specific to tropical countries and causes
diarrhoea)
If high doses of this medicine are administered,
you may be advised to reduce salt intake and to
take extra potassium in the form of tablets.
Dexamethasone Injection contains 1.8 mmol (or
42 mg) sodium per maximum single dose of the
medicinal product (420 mg for a person with 70 kg
bodyweight).
To be taken into consideration by patients on a
controlled sodium diet.
In the case of local injection of Dexamethasone
Injection (e.g. injection into a joint), your doctor
will take special care to reduce the particular risk
of bacterial infection. This medicine should not be
injected directly into an infected site. Please tell
your doctor if you suffer from complications like
a marked increase in pain accompanied by local
swelling, further restriction of joint motion, fever
or malaise after a local injection of this medicine.
Your doctor will have to check if you suffer from
blood poisoning and take the appropriate action.
Injection into unstable joints should be avoided.
Please be advised not to over-use joints that
are still diseased, even if you do not suffer pain!
All patients taking steroid drugs for more than
a few days should carry “steroid treatment”
cards, which are available from your doctor
or pharmacist. These cards carry details of
your medicine and your doctor. If you have an
accident, fall ill, require any surgery (including
at the dentist’s) or are to have any vaccinations
(especially with so-called “live virus vaccines”)
during or after treatment with Dexamethasone
Injection you must tell the doctor treating you that
you are taking or have taken steroids.
Preterm neonates (premature babies)
Dexamethasone should not be used routinely in
preterm neonates with respiratory problems.
Children
If the patient is a child, the doctor will monitor
growth and development at intervals during
treatment because this medicine can cause
growth retardation. Treatment will be limited,
where possible, to a single dose on alternate
days.
Using other medicines:
Please tell your doctor or nurse if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription. This is
especially important with the following medicines
as they may interact with your Dexamethasone
Injection:
• aspirin or similar medicines
• phenytoin (used to treat epilepsy)

barbiturates (sedative drugs used to treat
sleeplessness and epilepsy)
• ephedrine (for nose decongestion)
• antibiotics called rifampicin and rifabutin (used
to treat tuberculosis)
• carbamazepine (used to treat epilepsy, pain and
manic depression)
• aminoglutethimide (an anticancer medicine)
• anticoagulant medicines which thin the blood
e.g. warfarin
• medicines for diabetes
• certain diuretics (water tablets)
• antiretroviral medicines e.g. ritonavir, darunavir,
indinavir, lopinavir, saquinavir and efavirenz
Because of the interactions with these drugs,
your doctor might have to adjust the dosage of
the medication given to you.

16/05/2013 09:57:17

If you are receiving certain anticoagulants at the
same time, your doctor will frequently check your
blood clotting, in order to reduce the chance of
bleeding.
Pregnancy or breast feeding:
Please tell your doctor or nurse before being
given this injection if you are pregnant or breast
feeding. The doctor will then decide if the injection
is suitable for you.
When dexamethasone is administered for
prolonged periods or repeatedly during pregnancy,
there may be an increased risk for growth
retardation in the unborn child.
If you are taking high doses of this medicine for
prolonged periods and you are breast-feeding,
your infant may take up dexamethasone through
the breast milk. Your doctor will monitor this.
Driving and using machines:
You should not drive or use machinery if you are
affected by the administration of Dexamethasone
Injection.
3. How to use Dexamethasone Injection
Your nurse or doctor will give you the injection.
Your doctor will decide the correct dosage for
you and how and when the injection will be given.
Since the injection will be given to you by a doctor
or nurse, it is unlikely that you will be given too
much or that you will miss a dose. If you think
you have been given too much or that you
have missed a dose, please contact your doctor
immediately.
Effects when treatment with Dexamethasone
Injection is stopped:
It can be dangerous to have your treatment with
Dexamethasone Injection stopped abruptly.
After prolonged therapy your body may have
gotten used to the administration of this medicine
and may have reduced the normal production of
hormones like the one contained in this medicine.
How your treatment is stopped will depend on the
disease you are being treated for and how much
Dexamethasone Injection you have been given.
It may be necessary to reduce the amount
of Dexamethasone Injection you are given
gradually until you stop having it altogether.
Your doctor has to make sure that the disease
you have been treated for is unlikely to relapse.
Dosage reduction must be adjusted if you are
subjected to unusual stress (e.g. another illness,
trauma or surgical procedures).
When the treatment is stopped too quickly,
withdrawal symptoms like fever, muscle pain,
joint pain and tiredness may occur. Too rapid a
reduction following prolonged treatment can lead
to insufficiency of hormone production in the
adrenal gland and low blood pressure (symptoms
of which can be tiredness, dizziness, headache,
palpitation). In extreme cases this may be fatal.
In a few cases, mental health problems have
occurred when doses are being lowered or
stopped – see section 4 below.
Therefore, if you suffer from any withdrawal
symptoms, please tell your doctor as soon as
possible!
4. Possible side effects
Like all medicines, Dexamethasone Injection can
cause side effects, although not everybody gets
them. Some side effects can happen straight
away while others may take weeks or months.
If you feel unwell in any way, keep receiving your
medicine, but see your doctor straight away
If you experience any of the following please
contact your doctor immediately as you may
need urgent medical attention!
• An allergic reaction which may include a
sudden itchy rash, swelling of the extremeties
(such as your hands and feet) and a swelling
of your mouth and throat (which may cause
difficulty in breathing
• If you experience sudden and (in cases of longterm therapy) unusual effects like a feeling you
are going to faint, bleeding, extreme weakness,
or a sudden pain in any of your organs,
The following unwanted side effects have been
reported for Dexamethasone Injection and are
listed below according to the organs that are
affected.
Psychiatric disorders (mental health problems)
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.
• 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 which 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.
Carers of patients receiving Dexamethasone
Injection should talk to a doctor immediately if
the patient shows any signs of mental health
problems. This is particularly important if the
patient appears to be depressed, or mentions
thoughts of suicide.
If you suffer from schizophrenia or epilepsy your
symptoms may worsen.
Infections and infestations
You may experience more frequent and severe
infections without noticing the symptoms as well
as opportunistic infections (caused by a usually
harmless microorganism in case of an impaired
immune system) or the recurrence of dormant
tuberculosis.
Abnormal growth of tissue
You may develop sterile abscesses (enclosed
collections of pus, likely to turn into hard solid
lumps as they scar).
Blood systems
There may be an abnormal increase in the
number of white blood cells.
Hormonal (endocrine disorders)
Menstrual irregularities, lack of menstruation,
abnormal hair growth, development of
Cushingoid state (symptoms of which include
central obesity with thin arms, thinning of the
skin with easy bruising, muscle wasting and
weakness, high blood pressure, uncontrolled
blood sugar, osteoporosis).
Children and adolescents may have suppressed
growth. Your response to stress caused by
trauma, surgery or illness may be reduced. You
may also experience decreased carbohydrate
tolerance, onset of latent diabetes mellitus,
increased need for insulin or other medicines if
you are diabetic.
Metabolism and nutrition disorders
You may notice that you gain weight or have an
increased appetite. Your body may also have
difficulty in handling nitrogen, calcium, sodium or
potassium appropriately.
Nervous system disorders
You may feel increased pressure in your head
with impaired vision, vertigo, headache or in
preterm infants cerebral palsy (malformation of
the brain) may occur.

Eye disorders
You may develop cataracts or feel increased
pressure in the eye or notice abnormal bulging
out of the eyeballs or thinning of the cornea or the
white, outer coat of the eyeball. Your vision may
become blurred due to congestion of the optic
disc or glaucoma with possible damage to the
optic nerves. Secondary eye infections due to
fungi or viruses can occur as can rare instances of
blindness associated with local therapy around
the face and head. Premature babies may suffer
retinopathy.
Disorders of the blood vessels or heart
High blood pressure, blood clots in the veins.
Susceptible patients may develop heart failure,
or the heart tissue may rupture following a
recent heart attack. In infants with a low birth
weight a heart muscle disease (hypertrophic
cardiomyopathy) may occur.
If you are treated for multiple myeloma with
dexamethasone in combination with lenalidomide
or thalidomide you will have an increased risk
of thromboembolic events including: Deep vein
thrombosis (a blood clot in the veins of your
leg) – a symptom of this is leg pain; Pulmonary
embolism (a blood clot in the arteries leading to
your lungs) – a symptom of this is chest pain or
shortness of breath.
Disorders of the stomach or the digestive system
You may suffer nausea, hiccups, heartburn or
reflux or infection or inflammation of the tube that
leads to your stomach. Peptic ulcer may occur
with possible bleeding or perforation of the
small and large bowel (particularly if you have
inflammatory bowel disease). Your pancreas may
become inflamed (pancreatitis) or your stomach
may swell.
Skin disorders
Your skin may become thin or fragile with red
or blood spots or bruising or it may become
lighter or darker (hypo- or hyperpigmentation).
Your face may become unusually red or you may
have acne, swelling around the eyes, mouth
and hands, hives, allergic dermatitis or stretch
marks. Wounds may take longer to heal, skin
tests may be affected and you may sweat more.
After injection into a vein you may feel a burning
or tingling sensation especially in the perineal
area (skin between anus and genital organs).
Muscle and bone disorders
You may suffer muscle weakness, loss of
muscle mass, osteoporosis (loss of bone
density) especially if you are postmenopausal,
vertebral compression fractures (collapsing of
a bone in the spine), aseptic necrosis of femoral
and humeral heads (severe knee and hip joint
problem, possibly requiring replacement joints),
fracture of long bones, tendon rupture, postinjection flare (following local injection e.g. into a
joint).
Reproductive system
The number and activity of spermatozoa may be
affected in men.
General disorders
You may have a general ill feeling.
Many of these side effects are serious therefore
please tell your doctor about your symptoms as
soon as possible.
Please note that it is very important that you do
not suddenly stop taking this medicine (even if
you are suffering from a side effect) unless your
doctor tells you to (see “Effects when treatment
with Dexamethasone Injection is stopped” in the
previous section of this leaflet).
If you think this injection is causing you any
problems, or you are at all worried, talk to your
doctor, nurse or pharmacist.
5. Storing Dexamethasone Injection
Store below 25°C. Do not freeze.
Keep the container in the outer carton, in order to
protect from light.
Keep the medicine out of the reach and sight of
children.
On the label you will find the letters “exp. date”
followed by some numbers. These numbers are
the date when the medicine is no longer fit for use.
Do not use this medicine after this date.
6. Further information
What Dexamethasone Injection contains:
This injection contains the active ingredient
dexamethasone sodium phosphate.
Dexamethasone 3.3 mg/ml Injection
Each ml of solution for injection contains 4 mg of
dexamethasone phosphate (as dexamethasone
sodium phosphate) equivalent to 3.3 mg of
dexamethasone.
Dexamethasone 6.6 mg/ml Injection
Each ml of solution for injection contains 8 mg of
dexamethasone phosphate (as dexamethasone
sodium phosphate) equivalent to 6.6 mg of
dexamethasone.
Dexamethasone 8.3 mg/ml Injection
Each ml of solution for injection contains 10 mg of
dexamethasone phosphate (as dexamethasone
sodium phosphate) equivalent to 8.3 mg of
dexamethasone.
This injection contains the following inactive
ingredients: propylene glycol, disodium edetate,
sodium hydroxide and water for injections.
What Dexamethasone Injection looks like and
contents of the pack:
Dexamethasone Injection is a clear, colourless
and sterile solution contained in clear glass
ampoules.
Dexamethasone 3.3 mg/ml Injection is available
in packs of 1, 5 and 10 ampoules, each ampoule
containing 1 ml or 2 ml solution.
Dexamethasone 6.6 mg/ml Injection is available
in packs of 1, 5 and 10 ampoules, each ampoule
containing 5 ml solution.
Dexamethasone 8.3 mg/ml Injection is available
in packs of 1 and 5 ampoules, each ampoule
containing 10 ml solution.
Not all pack sizes may be marketed.
The marketing authorisation numbers of these
medicine are
Dexamethasone 3.3 mg/ml Injection:
PL 01502/0079
Dexamethasone 6.6 mg/ml Injection:
PL 01502/0080
Dexamethasone 8.3 mg/ml Injection:
PL 01502/0081
Marketing authorisation holder:
hameln pharmaceuticals ltd
Nexus, Gloucester Business
Park
Gloucester, GL3 4AG
United Kingdom
Manufacturer:
hameln pharmaceuticals gmbh
Langes Feld 13
31789 Hameln
Germany
hameln rds a.s.
Horná 36
900 01 Modra
Slovak Republic
For any information about this medicine,
please contact the marketing authorisation
holder
This leaflet was last approved 14.05.2013

46696/20/13

46696_20_13_Leaflet_Dexamethasone_3-3_6-6_8-3mgml_CM.indd 2

16/05/2013 09:57:18

hameln

Patient Information Leaflet
Dexamethasone 3.3 mg/ml Injection
Dexamethasone 6.6 mg/ml Injection
Dexamethasone 8.3 mg/ml Injection
Important information about this medicine

• Your doctor or nurse will give you the injection
• If this injection causes you any problems talk to your doctor, nurse or pharmacist
• Please tell your doctor or pharmacist, if you have any other medical conditions or have an allergy to
any of the ingredients of this medicine
• Please tell your doctor or pharmacist, if you are taking any other medicines
• Dexamethasone is a steroid medicine, prescribed for many different conditions, including serious
illnesses.
• You need to receive it regularly to get the maximum benefit.
• Don’t stop 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 below). 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 receiving 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 receive it for more than 3 weeks, 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 the leaflet. It includes other important information on the safe and effective use
of this medicine that might especially be important for you. This leaflet was last updated on 01/2013.
Dexamethasone – benefit information
Dexamethasone belongs to a group of medicines called steroids. Their full name is corticosteroids.
These 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 reduces inflammation, which could otherwise go on
making your condition worse. You must take this medicine regularly to get maximum benefit from it.
- Read all of this leaflet carefully before you start using this medicine. In some circumstances this
may not be possible and this leaflet will be kept in a safe place should you wish to read it.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, please ask your doctor or your pharmacist.
- This medicine has been prescribed for you personally and you should not pass it on to others. It may
harm them, even if their symptoms are the same as yours.
The name of your medicine is Dexamethasone 3.3 mg/ml Injection, Dexamethasone 6.6 mg/ml Injection
and Dexamethasone 8.3 mg/ml Injection, which will be referred to as Dexamethasone Injection throughout
this leaflet
Where to find information in this leaflet
1. What Dexamethasone Injection is and what it is used for
2. Before you are given Dexamethasone Injection
3. How to use Dexamethasone Injection
4. Possible side effects
5. Storing Dexamethasone Injection
6. Further information
1. What Dexamethasone Injection is and what it
is used for
Dexamethasone belongs to a group of medicines
called steroids.
Dexamethasone is given by injection to patients
unable to take a tablet form of the medicine.
When given into a vein or muscle, dexamethasone
reduces inflammation and suppresses the immune
system and is used normally for patients with:
• severe allergic reactions causing swelling of the
face and throat, low blood pressure and collapse
(angioneurotic oedema and anaphylaxis)
• shock caused by infection or severe tuberculosis
(also with anti-infective treatments e.g.
antibiotics)
• raised pressure in the skull caused by tumours
or infantile spasms

Sometimes, the injection is given into the
painful area itself e.g.inflammation of the joints
(rheumatoid arthritis and osteoarthritis)
2. Before you are given Dexamethasone Injection
You should NOT be given Dexamethasone
Injection if you:
• are sensitive or allergic to Dexamethasone or
any of the other ingredients in this injection.
• have a fungal infection that has spread to involve
the whole body.
• have any other widespread infection which is
not currently being treated.
• are to be vaccinated with live virus vaccines.
Please tell your doctor or nurse before being
given the injection if:
• you have ever had severe depression or
manic-depression (bipolar disorder). This
includes having had depression before while
taking steroid medicines like dexamethasone.
• any of your close family has had these
illnesses. If either of these applies to you, talk to
a doctor before receiving dexamethasone.
Mental
health
problems
while
taking
dexamethasone
Mental health problems can happen while taking
steroids like dexamethasone (see also section 4
Possible side effects)
• 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.
You should avoid any exposure to infectious
diseases. If you do not have a definite history of
chickenpox, you must avoid any contact with
chickenpox (herpes simplex), shingles (herpes
zoster) or measles. This precaution applies also if
your child is the patient treated with this medicine.
If you think you may have been exposed to these,
please seek advice from a doctor immediately as
the consequences can be serious (the steroids
can stop your body defending itself against
these diseases which can become severe and
widespread). If you develop these infections you
will need immediate treatment in hospital.
Corticosteroids may mask some signs of infection
and new infections may appear during their use.
Your doctors will try to use the smallest dose
necessary to help you. However there may be
times when an increase in dose will be needed.
Any reduction in dose will need to be made more
slowly than an increase. Your doctor will explain
this to you and will probably give you a “steroid
treatment card” to show to other doctors while
you need to take steroids (including by mouth).
Steroid treatment cards are also available from
your pharmacist.
Very occasionally your body might give you
“withdrawal effects” after taking steroids or
during dose reduction, including fever, tiredness
and aches and pains in muscles and joints.
You should tell your doctor if you develop such
symptoms even though there may be other causes
for these symptoms.
Corticosteroids can lead to raised blood
pressure, ankle swelling (by retention of salt)
and a loss of potassium in your water. Your doctor
will monitor your condition and treat these if they
arise. Steroids are also used cautiously, even if
necessary, if a patient taking them has a heart
attack.

xxxxx_20_13_Leaflet_Dexamethasone_3-3_6-3_8-3mgml_HBM.indd 1

Corticosteroids effects can be greater in patients
with hypothyroidism (when the thyroid gland
doesn’t make enough thyroid hormone) or cirrhosis
(a serious scarring of the liver) and your doctor
may need to adjust the dose.
You should also tell the doctor if you:
• suffer from heart failure or have had a recent
heart attack
• suffer from high blood pressure
• suffer from kidney or liver problems
• suffer from diabetes or a relative has diabetes
• suffer from or have had a stomach or duodenal
ulcer
• suffer from osteoporosis (thinning and
weakness of the bone)
• have suffered from muscle weakness with this
or other steroids in the past
• suffer from myasthenia gravis (a disease
causing weak muscles)
• suffer from an eye infection with the herpes virus
• suffer from glaucoma (increased pressure within
the eye) or a relative has glaucoma
• suffer from epilepsy
• suffer from schizophrenia
• have previously had tuberculosis

have previously had amoebiasis (an infection
which is specific to tropical countries and causes
diarrhoea)
If high doses of this medicine are administered,
you may be advised to reduce salt intake and to
take extra potassium in the form of tablets.
Dexamethasone Injection contains 1.8 mmol (or
42 mg) sodium per maximum single dose of the
medicinal product (420 mg for a person with 70 kg
bodyweight).
To be taken into consideration by patients on a
controlled sodium diet.
In the case of local injection of Dexamethasone
Injection (e.g. injection into a joint), your doctor will
take special care to reduce the particular risk of
bacterial infection. This medicine should not be
injected directly into an infected site. Please tell
your doctor if you suffer from complications like
a marked increase in pain accompanied by local
swelling, further restriction of joint motion, fever
or malaise after a local injection of this medicine.
Your doctor will have to check if you suffer from
blood poisoning and take the appropriate action.
Injection into unstable joints should be avoided.
Please be advised not to over-use joints that are
still diseased, even if you do not suffer pain!
All patients taking steroid drugs for more than a
few days should carry “steroid treatment” cards,
which are available from your doctor or pharmacist.
These cards carry details of your medicine and
your doctor. If you have an accident, fall ill, require
any surgery (including at the dentist’s) or are to
have any vaccinations (especially with so-called
“live virus vaccines”) during or after treatment with
Dexamethasone Injection you must tell the doctor
treating you that you are taking or have taken
steroids.
Preterm neonates (premature babies)
Dexamethasone should not be used routinely in
preterm neonates with respiratory problems.
Children
If the patient is a child, the doctor will monitor
growth and development at intervals during
treatment because this medicine can cause
growth retardation. Treatment will be limited,
where possible, to a single dose on alternate days.
Using other medicines:
Please tell your doctor or nurse if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription. This is
especially important with the following medicines
as they may interact with your Dexamethasone
Injection:
• aspirin or similar medicines
• phenytoin (used to treat epilepsy)

barbiturates (sedative drugs used to treat
sleeplessness and epilepsy)
• ephedrine (for nose decongestion)
• antibiotics called rifampicin and rifabutin (used to
treat tuberculosis)
• carbamazepine (used to treat epilepsy, pain and
manic depression)
• aminoglutethimide (an anticancer medicine)

anticoagulant medicines which thin the blood
e.g. warfarin
• medicines for diabetes
• certain diuretics (water tablets)
• antiretroviral medicines e.g. ritonavir, darunavir,
indinavir, lopinavir, saquinavir and efavirenz
Because of the interactions with these drugs, your
doctor might have to adjust the dosage of the
medication given to you.

16/05/2013 09:59:10

If you are receiving certain anticoagulants at the
same time, your doctor will frequently check your
blood clotting, in order to reduce the chance of
bleeding.
Pregnancy or breast feeding:
Please tell your doctor or nurse before being
given this injection if you are pregnant or breast
feeding. The doctor will then decide if the injection
is suitable for you.
When dexamethasone is administered for
prolonged periods or repeatedly during pregnancy,
there may be an increased risk for growth
retardation in the unborn child.
If you are taking high doses of this medicine for
prolonged periods and you are breast-feeding,
your infant may take up dexamethasone through
the breast milk. Your doctor will monitor this.
Driving and using machines:
You should not drive or use machinery if you are
affected by the administration of Dexamethasone
Injection.
3. How to use Dexamethasone Injection
Your nurse or doctor will give you the injection.
Your doctor will decide the correct dosage for you
and how and when the injection will be given.
Since the injection will be given to you by a doctor
or nurse, it is unlikely that you will be given too
much or that you will miss a dose. If you think
you have been given too much or that you
have missed a dose, please contact your doctor
immediately.
Effects when treatment with Dexamethasone
Injection is stopped:
It can be dangerous to have your treatment with
Dexamethasone Injection stopped abruptly.
After prolonged therapy your body may have
gotten used to the administration of this medicine
and may have reduced the normal production of
hormones like the one contained in this medicine.
How your treatment is stopped will depend on the
disease you are being treated for and how much
Dexamethasone Injection you have been given.
It may be necessary to reduce the amount of
Dexamethasone Injection you are given gradually
until you stop having it altogether.
Your doctor has to make sure that the disease
you have been treated for is unlikely to relapse.
Dosage reduction must be adjusted if you are
subjected to unusual stress (e.g. another illness,
trauma or surgical procedures).
When the treatment is stopped too quickly,
withdrawal symptoms like fever, muscle pain,
joint pain and tiredness may occur. Too rapid a
reduction following prolonged treatment can lead
to insufficiency of hormone production in the
adrenal gland and low blood pressure (symptoms
of which can be tiredness, dizziness, headache,
palpitation). In extreme cases this may be fatal.
In a few cases, mental health problems have
occurred when doses are being lowered or
stopped – see section 4 below.
Therefore, if you suffer from any withdrawal
symptoms, please tell your doctor as soon as
possible!
4. Possible side effects
Like all medicines, Dexamethasone Injection can
cause side effects, although not everybody gets
them. Some side effects can happen straight away
while others may take weeks or months.
If you feel unwell in any way, keep receiving your
medicine, but see your doctor straight away
If you experience any of the following please
contact your doctor immediately as you may need
urgent medical attention!
• An allergic reaction which may include a sudden
itchy rash, swelling of the extremeties (such
as your hands and feet) and a swelling of your
mouth and throat (which may cause difficulty in
breathing
• If you experience sudden and (in cases of longterm therapy) unusual effects like a feeling you
are going to faint, bleeding, extreme weakness,
or a sudden pain in any of your organs,
The following unwanted side effects have been
reported for Dexamethasone Injection and are
listed below according to the organs that are
affected.
Psychiatric disorders (mental health problems)
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.
• 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 which 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.
Carers of patients receiving Dexamethasone
Injection should talk to a doctor immediately
if the patient shows any signs of mental health
problems. This is particularly important if the
patient appears to be depressed, or mentions
thoughts of suicide.

Nervous system disorders
You may feel increased pressure in your head with
impaired vision, vertigo, headache or in preterm
infants cerebral palsy (malformation of the brain)
may occur.
Eye disorders
You may develop cataracts or feel increased
pressure in the eye or notice abnormal bulging
out of the eyeballs or thinning of the cornea or the
white, outer coat of the eyeball. Your vision may
become blurred due to congestion of the optic
disc or glaucoma with possible damage to the
optic nerves. Secondary eye infections due to
fungi or viruses can occur as can rare instances
of blindness associated with local therapy around
the face and head. Premature babies may suffer
retinopathy.
Disorders of the blood vessels or heart
High blood pressure, blood clots in the veins.
Susceptible patients may develop heart failure,
or the heart tissue may rupture following a recent
heart attack. In infants with a low birth weight a heart
muscle disease (hypertrophic cardiomyopathy)
may occur.
If you are treated for multiple myeloma with
dexamethasone in combination with lenalidomide
or thalidomide you will have an increased risk
of thromboembolic events including: Deep vein
thrombosis (a blood clot in the veins of your leg) – a
symptom of this is leg pain; Pulmonary embolism
(a blood clot in the arteries leading to your lungs)
– a symptom of this is chest pain or shortness of
breath.
Disorders of the stomach or the digestive system
You may suffer nausea, hiccups, heartburn or
reflux or infection or inflammation of the tube that
leads to your stomach. Peptic ulcer may occur with
possible bleeding or perforation of the small and
large bowel (particularly if you have inflammatory
bowel disease). Your pancreas may become
inflamed (pancreatitis) or your stomach may swell.
Skin disorders
Your skin may become thin or fragile with red or
blood spots or bruising or it may become lighter
or darker (hypo- or hyperpigmentation). Your face
may become unusually red or you may have acne,
swelling around the eyes, mouth and hands, hives,
allergic dermatitis or stretch marks. Wounds may
take longer to heal, skin tests may be affected and
you may sweat more. After injection into a vein you
may feel a burning or tingling sensation especially
in the perineal area (skin between anus and genital
organs).
Muscle and bone disorders
You may suffer muscle weakness, loss of muscle
mass, osteoporosis (loss of bone density)
especially if you are postmenopausal, vertebral
compression fractures (collapsing of a bone
in the spine), aseptic necrosis of femoral and
humeral heads (severe knee and hip joint problem,
possibly requiring replacement joints), fracture of
long bones, tendon rupture, post-injection flare
(following local injection e.g. into a joint).
Reproductive system
The number and activity of spermatozoa may be
affected in men.
General disorders
You may have a general ill feeling.
Many of these side effects are serious therefore
please tell your doctor about your symptoms as
soon as possible.
Please note that it is very important that you do
not suddenly stop taking this medicine (even if
you are suffering from a side effect) unless your
doctor tells you to (see “Effects when treatment
with Dexamethasone Injection is stopped” in the
previous section of this leaflet).
If you think this injection is causing you any
problems, or you are at all worried, talk to your
doctor, nurse or pharmacist.
5. Storing Dexamethasone Injection
Store below 25°C. Do not freeze.
Keep the container in the outer carton, in order to
protect from light.
Keep the medicine out of the reach and sight of
children.
On the label you will find the letters “exp. date”
followed by some numbers. These numbers are the
date when the medicine is no longer fit for use. Do
not use this medicine after this date.
6. Further information
What Dexamethasone Injection contains:
This injection contains the active ingredient
dexamethasone sodium phosphate.
Dexamethasone 3.3 mg/ml Injection
Each ml of solution for injection contains 4 mg of
dexamethasone phosphate (as dexamethasone
sodium phosphate) equivalent to 3.3 mg of
dexamethasone.
Dexamethasone 6.6 mg/ml Injection
Each ml of solution for injection contains 8 mg of
dexamethasone phosphate (as dexamethasone
sodium phosphate) equivalent to 6.6 mg of
dexamethasone.
Dexamethasone 8.3 mg/ml Injection
Each ml of solution for injection contains 10 mg of
dexamethasone phosphate (as dexamethasone
sodium phosphate) equivalent to 8.3 mg of
dexamethasone.
This injection contains the following inactive
ingredients: propylene glycol, disodium edetate,
sodium hydroxide and water for injections.

If you suffer from schizophrenia or epilepsy your
symptoms may worsen.

What Dexamethasone Injection looks like and
contents of the pack:

Infections and infestations

Dexamethasone Injection is a clear, colourless and
sterile solution contained in clear glass ampoules.

You may experience more frequent and severe
infections without noticing the symptoms as well
as opportunistic infections (caused by a usually
harmless microorganism in case of an impaired
immune system) or the recurrence of dormant
tuberculosis.
Abnormal growth of tissue
You may develop sterile abscesses (enclosed
collections of pus, likely to turn into hard solid
lumps as they scar).
Blood systems
There may be an abnormal increase in the number
of white blood cells.
Hormonal (endocrine disorders)
Menstrual irregularities, lack of menstruation,
abnormal
hair
growth,
development
of
Cushingoid state (symptoms of which include
central obesity with thin arms, thinning of the skin
with easy bruising, muscle wasting and weakness,
high blood pressure, uncontrolled blood sugar,
osteoporosis).
Children and adolescents may have suppressed
growth. Your response to stress caused by
trauma, surgery or illness may be reduced. You
may also experience decreased carbohydrate
tolerance, onset of latent diabetes mellitus,
increased need for insulin or other medicines if
you are diabetic.
Metabolism and nutrition disorders
You may notice that you gain weight or have an
increased appetite. Your body may also have
difficulty in handling nitrogen, calcium, sodium or
potassium appropriately.

Dexamethasone 3.3 mg/ml Injection is available
in packs of 1, 5 and 10 ampoules, each ampoule
containing 1 ml or 2 ml solution.
Dexamethasone 6.6 mg/ml Injection is available
in packs of 1, 5 and 10 ampoules, each ampoule
containing 5 ml solution.
Dexamethasone 8.3 mg/ml Injection is available
in packs of 1 and 5 ampoules, each ampoule
containing 10 ml solution.
Not all pack sizes may be marketed.
The marketing authorisation numbers of these
medicine are
Dexamethasone 3.3 mg/ml Injection:
PL 01502/0079
Dexamethasone 6.6 mg/ml Injection:
PL 01502/0080
Dexamethasone 8.3 mg/ml Injection:
PL 01502/0081
Marketing authorisation holder:
hameln pharmaceuticals ltd
Nexus, Gloucester Business Park
Gloucester, GL3 4AG, United Kingdom
Manufacturer:
hameln pharmaceuticals gmbh
Langes Feld 13, 31789 Hameln, Germany
hameln rds a.s.
Horná 36, 900 01 Modra, Slovak Republic
For any information about this medicine, please
contact the marketing authorisation holder
This leaflet was last approved 14.05.2013
xxxxx/20/13

xxxxx_20_13_Leaflet_Dexamethasone_3-3_6-3_8-3mgml_HBM.indd 2

16/05/2013 09:59:10

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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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