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DEXAMETHASONE 8 MG TABLETS

Active substance(s): DEXAMETHASONE

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EAS1088b LEA DEXAMETHASONE 4mg & 8mg TABS TUK Dim’s Changed?:
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420 mm
210 mm
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DEXAMETHASONE 4 mg AND 8 mg TABLETS
PACKAGE LEAFLET
Information for the Patient

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 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.
• Dexamethasone is a steroid medicine, prescribed for many different
conditions, including serious illnesses
• You need to take it regularly to get the maximum benefit.
• Do not stop taking this medicine without talking to your doctor - you may
need to reduce the dose gradually.
• Dexamethasone can cause side effects in some people (read ‘Possible
Side Effects’ section 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 taking your medicine, but see your
doctor straight away.
• Some side effects only happen after weeks or months, these include
weakness of arms and legs, or developing a rounder face (read ‘Possible
Side Effects’ section below).
• If you take Dexamethasone 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 this leaflet. It includes other important information on
the safe and effective use of this medicine that might be especially important
for you.
What is in this leaflet:

1. What Dexamethasone Tablets are and what they are used for
2. What you need to know before you take Dexamethasone Tablets
3. How to take Dexamethasone Tablets
4. Possible side effects
5. How to store Dexamethasone Tablets
6. Contents of the pack and other information

1

What Dexamethasone Tablets are and what they are used for

Dexamethasone Tablets contain the active substance dexamethasone.
Dexamethasone belongs to a group of medicines called steroids.
Dexamethasone is a synthetic glucocorticoid. Glucocorticoids are hormones
produced by the cortex of adrenal glands. This 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 arthritis, juvenile idiopathic arthritis, polyarthritis nodosa),
• diseases of the respiratory tract (e.g. bronchial asthma, croup),
• diseases of the skin (e.g. erythroderma, pemphigus vulgaris),
• tuberculous meningitis, only in conjunction with anti-infective therapy,
• diseases of the blood (e.g. idiopathic thrombocytopenic purpura in adults),
• cerebral oedema,
• treatment of symptomatic multiple myeloma, 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,
• prevention and treatment of vomiting after an operation, within antiemetic
treatment.

2

What you need to know before you take Dexamethasone Tablets

Do not take Dexamethasone Tablets if you:
• are allergic to dexamethasone or any of the other ingredients of this
medicine (listed in section 6),
• have an infection that affects the whole body (unless you are receiving
treatment),
• have a stomach or duodenal ulcer,
• 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,
• any of your close family has had these illnesses,
• you have symptoms of tumour lysis syndrome such as, muscle cramping,
muscle weakness, confusion, visual loss or disturbances and shortness of
breath. In case you suffer from haematological malignancy.
Mental problems can happen while taking steroids like Dexamethasone
(read ‘Possible Side Effects’ section below)
• These illnesses can be serious.
• Usually they start within a few days or weeks of starting the medicine.
• They are more likely to happen at high doses.
• Most of these problems go away if the dose is lowered or the medicine is
stopped. However, if problems do happen they might need treatment.
Talk to a doctor if you (or someone taking this medicine) show any signs of
mental problems. This is particularly important if you are depressed, or might
be thinking about suicide. In a few cases, mental problems have happened
when doses are being lowered or stopped.
Talk to your doctor before taking this medicine if you:
• have kidney or liver problems (liver cirrhosis or chronic liver failure),
• have a tumour of the adrenal gland (pheochromocytoma),
• have high blood pressure, heart disease or you have recently had a heart
attack (myocardial rupture has been reported),
• have diabetes or there is a family history of diabetes,
• have osteoporosis (thinning of the bones), particularly if you are a female
who has been through the menopause,
• have suffered from muscle weakness with this or other steroids in the past,
• 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),
• 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,
• have epilepsy (condition where you have repeated fits or convulsions),
• have migraines,
• have an underactive thyroid gland,
• have a parasitic infection,
• have tuberculosis, septicaemia or a fungal infection in the eye,
• have cerebral malaria,
• have herpes (cold sores or genital herpes and ocular herpes simplex
because of possible corneal perforation),
• have asthma,

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25 October 2017
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• are treated for a blockage of blood vessels by blood clots
(thromboembolism),
• 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 never 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. Contact your doctor if you experience blurred vision or other
visual disturbances that lasts for several days. 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.
Elderly
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. Dexamethasone should not be
used routinely in preterm neonates with respiratory problems.
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 Anti-Inflammatory drugs) e.g.
indomethacin,
• 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),
• oestrogen 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.
Some medicines may increase the effects of Dexamethasone Tablets and
your doctor may wish to monitor you carefully if you are taking these
medicines (including some medicines for HIV: ritonavir, cobicistat).
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 Anti-Inflammatory drugs) e.g.
indomethacin,
• 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,
enalidomide or pomalidomide is used, particular attention to pregnancy
testing and prevention requirements is needed.
Pregnancy and breast-feeding
Pregnancy
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.

ZINC Ref:

EAS1088b LEA DEXAMETHASONE 4mg & 8mg TABS TUK Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
420 mm
210 mm
-

How to take Dexamethasone Tablets

Always take this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
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.
Dexamethasone should be taken with or after food. Swallow the tablets whole
with some water. Drinks containing alcohol or caffeine should be avoided.
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.
• Cerebral oedema: Initial dose and duration of treatment depending on the
cause and severity, 6-16 mg (up to 24 mg)/day orally, divided into 3-4
individual doses.
• Acute asthma: Adults: 16 mg/day for two days. Children: 0.6 mg/kg body
weight for one or two days.
• Croup: Children: 0.15mg/kg-0.6 mg/kg in a single dose.
• Acute skin diseases: Depending on the nature and extent of the disease
daily doses of 8-40 mg, in some cases up to 100 mg, which should be
followed by down titration according to clinical need.
• Active phase of rheumatic system disorders: Systemic lupus
erythematosus 6-16 mg/day.
• Active rheumatoid arthritis with severe progressive 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 days in cycles.
• Tuberculous meningitis: Patients with grade II or III disease received
intravenous treatment for four weeks (0.4 mg per kilogram per day for week
1, 0.3 mg per kilogram per day for week 2, 0.2 mg per kilogram per day for
week 3, and 0.1 mg per kilogram per day for week 4) and then oral
treatment for four weeks, starting at a total of 4 mg per day and decreasing
by 1 mg each week. Patients with grade I disease received two weeks of
intravenous therapy (0.3 mg per kilogram per day for week 1 and 0.2 mg per
kilogram per day for week 2) and then four weeks of oral therapy (0.1 mg
per kilogram per day for week 3, then a total of 3 mg per day, decreasing by
1 mg each week).
• Palliative treatment of neoplastic diseases: Initial dose and duration of
treatment depending on the cause and severity, 3-20 mg/day. Very high
doses up to 96 mg may also 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 dexamethasone prior
to chemotherapy treatment, then 4-16 mg/day on day 2 and 3.
• Prevention and treatment of postoperative vomiting, within antiemetic
treatment: single dose of 8 mg before the surgery.
• Treatment of symptomatic multiple myeloma, 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 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 Tablets than you should
If you take too much medicine contact a doctor or hospital immediately.
If you forget to take Dexamethasone Tablets
If you forget to take your 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.
If you stop taking Dexamethasone Tablets
If your treatment is to be stopped follow your doctor’s advice. They may tell
you to reduce the amount of medicine you are taking gradually until you stop
taking it altogether. The symptoms that have been reported when treatment
has been stopped too quickly have included low blood pressure and in some
cases, relapse of the disease for which the treatment was given.
A ‘withdrawal syndrome’ may also occur which includes fever, muscle and
joint pain, inflammation of the nose lining (rhinitis), weight loss, itchy skin and
inflammation of the eye (conjunctivitis). If 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.

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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.
Breast-feeding
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 Tablets 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.
Important Information
Remember always to carry a Steroid Treatment Card. Make sure your doctor
or pharmacist gives you this and has filled out the details including the dose
and how long you will have treatment.

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25 October 2017
PANTONE® GREEN C
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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 which 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:
• 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),
• severe abdominal pains, nausea, vomiting, diarrhoea, profound muscle
weakness and fatigue, extremely low blood pressure, weight loss and fever
as these may be signs of adrenocortical insufficiency,
• sudden abdominal pain, tenderness, nausea, vomiting, fever and blood in
stool as these may be signs of tearing of the bowel particularly if you have
or have had a bowel disease.
This medicine may worsen your existing heart problem. If you experience
shortness of breath or ankle swelling, consult your doctor straight away.
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,
• 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),
• blurred vision, visual disturbances, loss of vision.
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 the Yellow Card Scheme at Website: www.mhra.gov.uk/yellowcard
or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety
of this medicine.

5

How to store Dexamethasone Tablets

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 carton
and blister after Exp. The expiry date refers to the last day of that month.
Keep the tablets in the original container in order to protect from light.
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 Tablets contains:
• The active substance is dexamethasone.
• Each tablet contains either 4 mg or 8 mg Dexamethasone
• The other ingredients are lactose monohydrate, microcrystalline cellulose,
sodium starch glycolate (type A), colloidal hydrated silica and magnesium
stearate (E470b).
What Dexamethasone Tablets looks like and contents of the pack:
Dexamethasone 4 mg Tablets are round, white tablets marked DX 4 on one side.
Dexamethasone 8 mg Tablets are round, white tablets marked DX 8 on one side.
Dexamethasone Tablets are available in blister packs of 30, 50 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation holder:
TEVA UK Limited, Eastbourne, BN22 9AG, United Kingdom
Manufacturer:
TioFarma BV, Benjamin Franklinstraat, 5-10 3261 LW Oud-Beijerland,
The Netherlands.
This leaflet was last revised in October 2017
PL 00289/2198 and PL 00289/2199
EA1088b

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