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DEXAMETHASONE 20 MG TABLETS

Active substance(s): DEXAMETHASONE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Dexamethasone 20 mg tablets
Dexamethasone 40 mg tablets
Dexamethasone

Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their signs
of illness are the same as yours.
• If you 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 take Dexamethasone
3. How to take 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

depression before or while taking steroid medicines like
Dexamethasone.
• if any of your close family has had these illnesses.

Dexamethasone is a synthetic glucocorticoid. Glucocorticoids
are hormones produced by the cortex of adrenal glands. The Mental health problems can happen while taking steroids
like Dexamethasone.
medicine has anti-inflammatory, analgesic and anti-allergic
• These illnesses can be serious.
effects, and suppresses the immune system.
• Usually they start within a few days or weeks of starting
Dexamethasone is recommended for the treatment of
the medicine.
rheumatic and autoimmune diseases (e.g. myositis),
• They are more likely to happen at high doses.
skin (e.g. pemphigus vulgaris), diseases of blood (e.g.
• Most of these problems go away if the dose is lowered or
idiopathic thrombocytopenic purpura in adults), treatment of
the medicine is stopped. However, if problems do happen,
symptomatic multiple myeloma, acute lymphocytic leukemia,
they might need treatment.
acute lymphoblastic leukemia, Hodgkin’s disease and nonTalk to a doctor if you (or someone taking this medicine),
Hodgkin’s lymphoma in combination with other medicinal
show any signs of mental health problems. This is
products, palliative treatment of neoplastic diseases,
particularly important if you are depressed, or might be
prophylaxis and treatment of nausea and vomiting caused
thinking about suicide. In a few cases, mental health
by chemotherapy, within antiemetic treatment.
problems have happened when doses are being lowered or
stopped.

2. What you need to know before you take
Dexamethasone

Do not take Dexamethasone:
• 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 stomach or duodenal ulcer.
• if you are going to have a vaccination by live vaccines.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Dexamethasone:
• if you have ever had severe depression or manic
depression (bipolar disorder). This includes having had

Talk to your doctor before taking this medicine if:
• you have kidney or liver problems (liver cirrhosis or chronic
liver failure),
• you have a tumour of the adrenal gland
(pheochromocytoma),
• you have high blood pressure, heart disease or you have
recently had a heart attack (myocardial rupture has been
reported),
• you have diabetes or there is a family history of diabetes,
• you have osteoporosis (thinning of the bones), particularly
if you are a female who has been through the menopause,
• you have suffered from muscle weakness with this or
other steroids in the past,
• you have glaucoma (raised eye pressure) or there is a
family history of glaucoma, cataract (clouding of the lens

in the eye leading to a decrease in vision),
have myasthenia gravis (a condition causing weak
muscles),
• you have a bowel disorder or a stomach (peptic) ulcer,
• you have psychiatric problems or you have had a
psychiatric illness which was made worse by this type of
medicine,
• you have epilepsy (condition where you have repeated fits
or convulsions),
• you have migraine,
• you have an underactive thyroid gland,
• you have a parasitic infection,
• you have tuberculosis, septicaemia or a fungal infection in
the eye,
• you have cerebral malaria,
• you have herpes (cold sores or genital herpes and ocular
herpes simplex because of possible corneal perforation),
• you have asthma,
• you are treated for a blockage of blood vessels by blood
clots (thromboembolism),
• you have corneal ulcerations and corneal injuries.
• you

Treatment with corticosteroid may reduce your body’s ability
to fight infection. This can sometimes lead to infections
caused by germs that rarely cause infection under normal
circumstances (called opportunistic infections). If you get an
infection of any kind during treatment with this medicine,
contact your doctor immediately. This is particularly
important if you notice signs of pneumonia: cough, fever,
shortness of breath and chest pain. You may also feel
confused, particularly if you are elderly. You should also
tell your doctor if you have had tuberculosis or if you have
stayed in regions where roundworm infections are common.
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 of
any vaccinations.
Treatment with this medicine may cause central serous
chorioretinopathy, an eye disease that leads to blurred or
distorted vision. This happens usually in one of the eyes. If
you notice blurring or distorted vision that lasts for several
days, please contact your doctor.
Treatment with this medicine may cause tendon
inflammation. In extremely rare cases, a tendon may rupture.
This risk is increased by treatment with certain antibiotics
and by kidney problems. Contact your doctor if you notice
painful, stiff or swollen joints or tendons.
Treatment with Dexamethasone can cause a condition
called adrenocortical insufficiency. This can cause change in
effectiveness of the medicine following stress and trauma,
surgery, childbirth or illness and your body may not be
able to respond in the usual way to severe stress such as
accidents, surgery, childbirth or illness.
If you have an accident, are ill, have other specific physical
stress conditions, or require any surgery (even at the
dentists) or you require a vaccination (particularly with ‘live
virus’ vaccines) whilst taking or when you have finished
taking Dexamethasone, you should inform the person
treating you that you are taking or have taken steroids.
If you have suppression tests (test for the amount of
hormone in the body), skin test for allergy or test for
bacterial infection you should inform the person performing
the test that you are taking Dexamethasone as it may
interfere with the results.
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.
If you are elderly, some of the side effects of this medicine
may be more serious, especially thinning of the bones
(osteoporosis), high blood pressure, low potassium levels,
diabetes, susceptibility to infection and thinning of the skin.
Your doctor will monitor you more closely.
Children
If a child is taking this medicine, it is important that the
doctor monitors their growth and development at frequent
intervals.
Other medicines and Dexamethasone
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines:
• Anticoagulant medicines which thin the blood (e.g.
warfarin)
• Acetylsalicylic acid or similar (Non-Steroidal AntiInflammatory drugs) e.g. indometacin
• Medicines used to treat diabetes
• Medicines used to treat high blood pressure
• Medicines used to treat cardiac diseases
• Diuretics (water tablets)
• Amphotericin B injection
• Phenytoin, carbamazepine, primidone (epilepsy
medication)
• Rifabutin, rifampicin, isoniazid (antibiotics used to treat
tuberculosis)
• Antacids – particularly those containing magnesium
trisilicate
• 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, itraconazole (for fungal infections)
• Ritonavir (for HIV)
• Antibiotics including erythromycin, fluoroquinolones
• Medicines that help muscle movement in myasthenia

gravis (e.g. neostigmine)
• 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 used for e.g. multiple myeloma
• Praziquantel given for certain worm infections
• Vaccination with live vaccines
• Chloroquine, hydroxychloroquine and mefloquine (for

• Medicines used to treat high blood pressure
• Thalidomide used for e.g. multiple myeloma
• Vaccination with live vaccines
• Medicines that help muscle movement in myasthenia

gravis (e.g. neostigmine)
including fluoroquinolones

• Antibiotics

You must read the package leaflets of all
medicinal products to be taken in combination
with Dexamethasone for information related to
these medicines before starting treatment with
Dexamethasone. When thalidomide, lenalidomide or
pomalidomide is used, particular attention to pregnancy
testing and prevention requirements is needed.

• Somatotropin
• Protirelin

Dexamethasone with food, drink and alcohol
Dexamethasone should be taken with or after food to
minimise irritation to the gastrointestinal tract. Drinks
containing alcohol or caffeine should be avoided. Eating
small, frequent meals is recommended, and possibly taking
of antacids, if recommended by your doctor.

You may be at an increased risk of serious side
effects if you take dexamethasone together with
these medicines:
• Acetylsalicylic acid or similar (Non-Steroidal AntiInflammatory drugs) e.g. indometacin
• Medicines used to treat diabetes
• Medicines used to treat cardiac diseases
• Diuretics (water tablets)
• Amphotericin B injection
• Acetazolamide (used for glaucoma and epilepsy)
• Tetracosactide used in the test for adrenocortical function
• Carbenoxolone (used in the treatment of stomach ulcers)
• Chloroquine, hydroxychloroquine and mefloquine (for
malaria)

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 or
pharmacist for advice before taking this medicine.
Dexamethasone should be prescribed during pregnancy
and particularly in the first trimester only 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
Dexamethasone, but tell your doctor immediately that you
are pregnant.
Corticosteroids may pass into breast milk. A risk to the
newborns/infants cannot be excluded. A decision on whether
to continue/discontinue breast feeding or to continue/
discontinue therapy with Dexamethasone should be made

malaria)

taking into account the benefit of breast feeding to the child
and the benefit of Dexamethasone therapy to the woman.
Driving and using machines
Do not drive, use any tools or machines or carry out any
hazardous tasks if you experience side effects, such as
confusion, hallucinations, dizziness, tiredness, sleepiness,
fainting or blurred vision.
Dexamethasone contains lactose
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicine.

3. How to take Dexamethasone
Always take this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not
sure.
Dexamethasone is in the form of tablets 4 mg, 8 mg, 20
mg and 40 mg. The tablet can be divided into equal halves
to provide additional 2 mg and 10 mg strengths or to help
swallowing.
Please be aware that this is a high dosage medical
product.
Dexamethasone is recommended to be used at the
lowest effective dose, recommended by your doctor.
Dexamethasone is given in usual doses of 0.5 to 10 mg
daily, depending on the disease being treated. In more
severe disease conditions doses above 10 mg per day may
be required. The dose should be titrated to the individual
patient response and disease severity. In order to minimize
side effects, the lowest effective possible dose should be
used.

Unless otherwise prescribed, the following dosage
recommendations apply:
The below mentioned dosing recommendations are
given for guidance only. The initial and daily doses
should always be determined based on individual
patient response and disease severity.
Pemphigus: Initial dose of 300 mg for three days followed
by down titration according to clinical need.
• Myositis: 40 mg for 4 days in cycles.
• Idiopathic thrombocytopenic purpura: 40 mg for 4 days
in cycles.
• Palliative treatment of neoplastic diseases: Initial
dose and duration of treatment depending on the cause
and severity. Very high doses up to 96 mg may be used
for palliative treatment. For optimal dosing and reduction
of the number or tablets the combination of lower dose
strengths (4 and 8 mg) and higher dose strengths (20 mg
or 40 mg) can be used.
• Prophylaxis and treatment of emesis induced by
cytostatics, emetogenic chemotherapy within
antiemetic treatment: 8-20 mg (one 20 mg tablet or
one half of 40 mg tablet) prior to chemotherapy treatment,
then 4-16 mg/day on day 2 and 3.
• Treatment of symptomatic multiple myeloma, acute
lymphocytic leukemia, acute lymphoblastic leukemia,
Hodgkin’s disease and non-Hodgkin’s lymphoma in
combination with other medicinal products: the usual
posology is 40 mg or 20 mg once per day.
The dose and administration frequency varies with the
therapeutic protocol and the associated treatment(s).
Dexamethasone administration should follow instructions
for Dexamethasone administration when described in the
Summary of Product Characteristics of the associated
treatment(s). If this is not the case, local or international
treatment protocols and guidelines should be followed.


Prescribing physicians should carefully evaluate which dose If you have any further questions on the use of this
of Dexamethasone to use, taking into account the condition medicine, ask your doctor or pharmacist.
and disease status of the patient.
Long term treatment
For the long-term treatment of several conditions, after
initial therapy, glucocorticoid treatment should be switched
from Dexamethasone to prednisone/prednisolone to reduce
suppression on the function of the adrenal cortex.
Use in children
If a child is taking this medicine, it is important that the
doctor monitors their growth and development at frequent
intervals.
If you take more Dexamethasone than you should
If you take too much medicine contact a doctor or hospital
immediately.
If you forget to take Dexamethasone
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 tablet.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Tell a doctor straight away if you experience serious
mental health problems. They can affect about 5 in every
100 people taking medicines like Dexamethasone. These
problems include:
• feeling depressed, including thinking about suicide,
• feeling high (mania) or moods that go up and down,
• feeling anxious, having problems sleeping, difficulty in
thinking or being confused and losing your memory,
• feeling, seeing or hearing things that do not exist. Having
strange and frightening thoughts, changing how you act or
having feelings of being alone.

Tell a doctor straight away if you experience:
• severe abdominal pains, nausea, vomiting, diarrhoea,
profound muscle weakness and fatigue, extremely low
If you stop taking Dexamethasone
blood pressure, weight loss and fever as these may be
If your treatment is to be stopped follow your doctor’s advice.
signs of adrenocortical insufficiency;
He may tell you to reduce the amount of medicine you
• sudden abdominal pain, tenderness, nausea, vomiting,
are taking gradually until you stop taking it altogether. The
fever and blood in stool as these may be signs of tearing
symptoms that have been reported when treatment has been
of the bowel particularly if you have or have had a bowel
stopped too quickly have included low blood pressure and in
disease.
some cases, relapse of the disease for which the treatment
was given.
This medicine may worsen your existing heart problem.
A ‘withdrawal syndrome’ may also occur which includes
If you experience shortness of breath or ankle swelling,
fever, muscle and joint pain, inflammation of the nose lining
consult your doctor straight away.
(rhinitis), weight loss, itchy skin and inflammation of the eye
(conjunctivitis). If you stop treatment too soon and some of
Other side effects may be (frequency not known):
the mentioned symptoms occur, you must talk to your doctor • Greater chance of picking up infections, including viral and
as soon as possible.

fungal infections e.g. thrush; recurrence of tuberculosis
or some other infections, e.g. eye infections if you have
already had it
• Reduction in the number of white blood cells or increased
number of white blood cells, abnormal coagulation
• An allergic reaction to the medicine, including serious,
potentially life-threatening allergic reaction (which may
show as a rash and swelling of the throat or tongue and in
severe cases difficulty in breathing or dizziness)
• Impairment of the body’s regulation of hormones, swelling
and weight gain of the body, full-moon face (Cushingoid
state), change in effectiveness of endocrines following
stress and trauma, surgery, childbirth or illness, your body
may not be able to respond in the usual way to severe
stress such as accidents, surgery, childbirth or illness,
stunted growth in children and teenagers, irregular and
absence of menstrual cycles (periods) development of
excess body hair (particularly in women)
• Weight gain, loss of protein and calcium balance,
increased appetite, salt imbalances, water retention in the
body, potassium loss which can cause rhythm disorder,
increased requirement for diabetic medication, unknown
diabetes becomes evident, high levels of cholesterol
and triglycerides in the blood (hypercholesterolemia and
hypertriglyceridaemia)
• Extreme mood swings, schizophrenia (mental disorder)
may become worse, depression, inability to sleep
• Severe unusual headache with visual disturbances linked
with the withdrawal of treatment, fits and worsening of
epilepsy, dizziness
• Increased pressure in the eye, papilloedema, thinning
of the eye membranes, increased eye viral, fungal and
bacterial infections, worsening of symptoms associated
with corneal ulcers, worsening of existing eye infections,
protrusion of the eyeballs, cataracts

• Congestive

heart failure in susceptible people, cardiac
muscle rupture after a recent heart attack, cardiac
decompensation
• High blood pressure, blood clots: formation of blood clots
that may clog blood vessels for example in legs or lungs
(thromboembolic complications)
• Hiccups
• Nausea, vomiting, stomach discomfort and swollen
abdomen, inflammation and ulcers in the oesophagus,
peptic ulcers that may split and bleed, inflamed pancreas
(which may show as pain in the back and abdomen),
flatulence, oesophageal candidiasis
• Thinned delicate skin, unusual marks on the skin,
bruising, redness and inflammation of the skin, stretch
marks, visible swollen, capillaries, acne, increased
sweating, skin rash, swelling, thinning of the hair, unusual
fat deposits, excessive hair growth, water retaining in the
body, pigment disorders, weakened capillaries that rupture
easily, observed as bleeding under the skin (increased
capillary fragility), skin irritation around the mouth (perioral
dermatitis)
• Thinning of the bone with an increased risk of fractures
(osteoporosis), bone necrosis, tendinitis, ruptured tendons,
muscle wasting, myopathy, muscle weakness, early
stoppage of bone growth (premature epiphyseal closure)
• Changes to the number and movement of sperm,
impotence
• Impaired reaction to vaccination and skin tests, slow
wound healing, discomfort, malaise.
A ‘withdrawal syndrome’ may also occur which includes
fever, muscle and joint pain, inflammation of the nose
lining (rhinitis), weight loss, painful itchy skin nodules and
inflammation of the eye (conjunctivitis).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via Yellow
Card Scheme
Website: 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
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 packaging after EXP. The expiry date refers to
the last day of that month.
This medicine does not require any special temperature
storage conditions.
Store in the original package in order to protect from light
and moisture.
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 substance is Dexamethasone.
Dexamethasone 20 mg tablets
Each tablet contains 20 mg Dexamethasone.
Dexamethasone 40 mg tablets
Each tablet contains 40 mg Dexamethasone.

• The

other ingredients are lactose monohydrate,
pregelatinised maize starch, colloidal anhydrous
silicia, and magnesium stearate (E572). See section 2
“Dexamethasone contains lactose”.

What Dexamethasone looks like and contents of the
pack
20 mg tablets: White or almost white, round tablets with
bevelled edges, scored and engraved with 20 on one side
(Thickness: 4.0-6.0 mm; Diameter: 10.7-11.3 mm). The
tablet can be divided into equal doses.
40 mg tablets: White or almost white, oval tablets, scored
on both sides (Thickness: 6.0-8.0 mm; Diameter: 18.719.3 mm). The tablet can be divided into equal doses.
Dexamethasone is available in boxes containing 10, 20, 30,
50, 60, 100, 10 x 1, 20 x 1, 30 x 1, 50 x 1, 60 x 1 and 100
x 1 tablets in blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo
mesto, Slovenia
Distributed by:
Consilient Health (UK) Limited.
No.1 Church Road, Richmond upon Thames, Surrey. TW9
2QE
This leaflet was last revised in July 2016

P0494

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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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