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DEXAMETHASONE 4 MG TABLETS

Active substance(s): DEXAMETHASONE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Dexamethasone 4 mg tablets
Dexamethasone

medicine has anti-inflammatory, analgesic and anti-allergic
effects, and suppresses the immune system.
Dexamethasone is recommended for the treatment of
rheumatic and autoimmune diseases (e.g. systemic lupus
erythematosus, rheumatoid artritis, juvenil idiopathic arthritis,
polyartheritis nodosa), diseases of respiratory tract (e.g.
bronchial asthma, croup), skin (e.g. erythroderma, pemphigus
vulgaris), tuberculous meningitis only in conjunction with
anti-infective therapy, diseases of blood (e.g. idiopathic
thrombocytopenic purpura in adults), cerebral oedema,
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, palliative
treatment of neoplastic diseases, prophylaxis and treatment
of nausea and vomiting caused by chemotherapy and
prevention and treatment of vomiting after operation, within
antiemetic treatment.

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
2. What you need to know before you take
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
Dexamethasone is a synthetic glucocorticoid. Glucocorticoids
are hormones produced by the cortex of adrenal glands. The

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

depression before or while taking steroid medicines like
dexamethasone.
• if any of your close family has had these illnesses.
Mental health problems can happen while taking steroids like
Dexamethasone.
• 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.
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),
• you have myasthenia gravis (a condition causing weak
muscles),

• you
• you

have a bowel disorder or a stomach (peptic) ulcer,
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.
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

malaria)

• Somatotropin
• Protirelin

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)
• 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)
• Antibiotics including fluoroquinolones
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.

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.
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
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

course form: running at fast destructive forms 12-16 mg/
day, with extra-articular manifestations 6-12 mg/day.
- Idiopathic thrombocytopenic purpura: 40 mg for 4
Always take this medicine exactly as your doctor has told
days in cycles.
you. Check with your doctor or pharmacist if you are not
- Tuberculous meningitis: Patients with grade II or III
sure.
disease received intravenous treatment for four weeks (0.4
Dexamethasone is in the form of tablets 4 mg, 8 mg, 20 mg
mg per kilogram per day for week 1, 0.3 mg per kilogram per
and 40 mg. The tablet can be divided into equal halves to
day for week 2, 0.2 mg per kilogram per day for week 3, and
provide additional 2 mg and 10 mg strengths or to help
0.1 mg per kilogram per day for week 4) and then oral
swallowing.
treatment for four weeks, starting at a total of 4 mg per day
Dexamethasone is given in usual doses of 0.5 to 10 mg daily, and decreasing by 1 mg each week. Patients with grade I
depending on the disease being treated. In more severe
disease received two weeks of intravenous therapy (0.3 mg
disease conditions doses above 10 mg per day may be
per kilogram per day for week 1 and 0.2 mg per kilogram per
required. The dose should be titrated to the individual patient day for week 2) and then four weeks of oral therapy (0.1 mg
response and disease severity. In order to minimize side
per kilogram per day for week 3, then a total of 3 mg per day,
effects, the lowest effective possible dose should be used.
decreasing by 1 mg each week).
- Palliative treatment of neoplastic diseases: Initial dose
Unless otherwise prescribed, the following dosage
and duration of treatment depending on the cause and
recommendations apply:
severity, 3-20 mg/day. Very high doses up to 96 mg may also
The below mentioned dosing recommendations are
be used for palliative treatment. For optimal dosing and
given for guidance only. The initial and daily doses
reduction of the number or tablets the combination of lower
should always be determined based on individual
dose strengths (4 and 8 mg) and higher dose strengths
patient response and disease severity.
(20 mg or 40 mg) can be used.
- Cerebral oedema: Initial dose and duration of treatment
- Prophylaxis and treatment of emesis induced by
depending on the cause and severity, 6-16 mg (up to
cytostatics, emetogenic chemotherapy within
24 mg)/day orally, divided into 3-4 individual doses.
antiemetic treatment: 8-20 mg dexamethasone prior to
- Acute asthma: Adults: 16 mg/day for two days. Children:
chemotherapy treatment, then 4-16 mg/day on day 2 and 3.
0.6 mg/kg body weight for one or two days.
- Prevention and treatment of postoperative vomiting,
- Croup: Children: 0.15mg/kg-0.6 mg/kg in a single dose.
within antiemetic treatment: single dose of 8 mg before
- Acute skin diseases: Depending on the nature and extent the surgery.
of the disease daily doses of 8-40 mg, in some cases up to
- Treatment of symptomatic multiple myeloma, acute
100 mg, which should be followed by down titration
lymphocytic leukemia, acute lymphoblastic leukemia,
according to clinical need.
Hodgkin’s disease and non-Hodgkin’s lymphoma in
- Active phase of rheumatic system disorders: Systemic combination with other medicinal products: the usual
lupus erythematosus 6-16 mg/day.
posology is 40 mg or 20 mg once per day.
- Active rheumatoid arthritis with severe progressive
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 of
dexamethasone to use, taking into account the condition 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.

weight loss, itchy skin and inflammation of the eye
(conjunctivitis). If you stop treatment too soon and some of
the mentioned symptoms occur, you must talk to your doctor
as soon as possible.
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.
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.

If you forget to take Dexamethasone
If you forget to take a dose, take it as soon as you remember
Tell a doctor straight away if you experience:
unless it is almost time for the next dose. Do not take a double
• severe abdominal pains, nausea, vomiting, diarrhoea,
dose to make up for a forgotten tablet.
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 are
• sudden abdominal pain, tenderness, nausea, vomiting,
taking gradually until you stop taking it altogether. The
fever and blood in stool as these may be signs of tearing of
symptoms that have been reported when treatment has been
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
This medicine may worsen your existing heart problem. If you
was given.
experience shortness of breath or ankle swelling, consult
A ‘withdrawal syndrome’ may also occur which includes fever,
your doctor straight away.
muscle and joint pain, inflammation of the nose lining (rhinitis),

Other side effects may be: (frequency not known):
• Greater chance of picking up infections, including viral and
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.

What Dexamethasone looks like and contents of the
pack
4 mg tablets: White or almost white, round tablets with
bevelled edges and scored on one side (Thickness: 2.5-3.5
mm; Diameter: 5.7-6.3 mm). The tablet can be divided into
equal doses.
Dexamethasone 4 mg tablets are available in boxes
containing 10, 20, 28, 30, 50, 56, 60, 100, 10 x 1, 20 x 1,
28 x 1, 30 x 1, 50 x 1, 56 x 1, 60 x 1 and 100 x 1 tablets, in
a box.
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

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 4 mg tablets
Each tablet contains 4 mg dexamethasone.
• The other ingredients are lactose monohydrate,
pregelatinised maize starch, colloidal anhydrous silicia, and
magnesium stearate (E572). See section 2 “Dexamethasone
contains lactose”.
P0490

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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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