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DEXAMETHASONE 500 MICROGRAM TABLETS

Active substance: DEXAMETHASONE

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Patient Information Leaflet

Dexamethasone 500 microgram tablets
• Dexamethasone is a steroid medicine, prescribed for many different
conditions, including serious illnesses.
• You need to take it regularly to get the maximum benefit.
• Don’t stop taking this medicine without talking to your doctor - you
may need to reduce the dose gradually.
• Dexamethasone can cause side effects in some people (read
Section 4 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 tablets, but see your
doctor straight away.
• Some side effects only happen after weeks or months. These
include weakness of arms and legs, or developing a rounder face
(read Section 4 for more information).
• If you take it for more than 3 weeks, 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 chickenpox or shingles, if you
have never had them. They could affect you severely. If you do come
into contact with chickenpox 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.
Please read all of this leaflet carefully before you start taking this
medicine.
• 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. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
• The name of your medicine is Dexamethasone 500 microgram tablets,
but will be referred to as Dexamethasone or Dexamethasone tablets
throughout the remainder of this leaflet.
In this leaflet:
1) What this medicine is and what it is used for
2) Before you take Dexamethasone tablets
3) How to take Dexamethasone tablets
4) Possible side effects
5) How to store Dexamethasone tablets
6) Further information
1) WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR
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 this inflammation, which could otherwise go on
making your condition worse. You must take this medicine regularly to
get maximum benefit from it.
Some of the illnesses and conditions that dexamethasone is used for
include:
• swelling of the brain and increased pressure in the brain caused by a
tumour
• severe allergic reactions
• blood disorders such as leukaemia and haemolytic anaemia (a
reduction in red blood cells which can make the skin pale yellow and
cause weakness or breathlessness)
• sarcoidosis, an immune disease that can lead to excessive levels of
calcium and vitamin D in the body
• inflammation of the heart in association with heart attack or heart
surgery
• intestinal disorders, e.g. Crohn’s disease, ulcerative colitis
• respiratory disorders such as asthma
• tuberculosis (together with appropriate chemotherapy)
• certain inflammatory skin and muscular disorders
• inflammation of the eye
• rheumatoid arthritis
• kidney inflammation caused by SLE, a disease of the immune system.
2) BEFORE YOU TAKE DEXAMETHASONE TABLETS
Do NOT take Dexamethasone tablets if you
• are allergic to dexamethasone or to any of the other ingredients (see
Section 6)
• have an untreated infection affecting your whole body
• have a fungal infection affecting the whole of your body, e.g. thrush
• are to have a ‘live virus’ vaccination.
If any of the above apply to you, speak to your doctor or pharmacist.
Check with your doctor first
• If you have ever had severe depression or manic depression
(bipolar disorder). This includes having had depression before while
taking steroid medicines like dexamethasone.
• If any of your close family has had these illnesses.
If either of these applies to you, talk to a doctor before taking
dexamethasone.
Take special care with Dexamethasone tablets
Before taking the tablets, tell your doctor if you have any of these
conditions as additional monitoring may be required:
• recently suffered from a heart attack
• tuberculosis
• kidney or liver problems, including cirrhosis
• an underactive thyroid
• high blood pressure

• diabetes, or a family history of diabetes; your doctor may need to
increase your dose of diabetic treatment
• heart problems
• thinning of the bones (osteoporosis)
• raised pressure in the eye(s) (glaucoma) or a family history of
glaucoma
• myasthenia gravis (which causes weakened muscles)
• intestinal or stomach problems
• had muscle weakness with steroids in the past
• an eye infection caused by herpes virus
• malaria affecting the brain
• epilepsy
• severe mental health problems or if you ever had severe depression
or manic depression (bipolar disorder) or if a family member has or has
ever had these problems. This includes having had depression before
while taking steroids.
Pay attention when using Dexamethasone
Dexamethasone should not be used routinely in preterm neonates with
respiratory problems.
Use in children
Long term use of steroids at high doses may cause slowing of growth in
children. Your doctor may check your child’s height at intervals during
treatment and reduce the dose if any effects are seen.
Mental 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 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.
Chickenpox, shingles, measles
These infections will become more serious during treatment with
steroids, and you will require urgent specialist care if you become
exposed to someone with these infections. DO NOT stop taking the
tablets.
If you have not had chickenpox, shingles or measles, you should AVOID
contact with anyone who has these illnesses.
If you think that you have been exposed to any of these infections, seek
immediate medical attention. Do this if you are taking these tablets, or
have taken them during the previous 3 months.
Surgery or other treatment by a doctor, dentist or nurse
If you have an accident, become ill, require any surgery (including at the
dentist’s), or are to have any ‘live virus’ vaccinations during or after
treatment with Dexamethasone tablets, you MUST tell the person
treating you that you are taking or have taken steroids.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription and herbal preparations.
Some medicines may be affected by dexamethasone or they may affect
how well dexamethasone will work. Tell your doctor or pharmacist if you
are taking:
• aspirin or similar medicines
• phenytoin (to treat epilepsy)
• ephedrine (a nasal decongestant)
• barbiturates (to treat sleeplessness and epilepsy)
• ketoconazole (for fungal infections)
• rifampicin and rifabutin (antibiotics used to treat tuberculosis)
• erythromycin or similar antibiotics
• medicines used to treat HIV
• anticoagulants (to thin the blood), such as warfarin
• medicines for diabetes, including insulin; your doctor may need to
increase your dose of diabetic treatment
• diuretics (water tablets)
• carbamazepine (for epilepsy, pain, manic depression)
• aminoglutethimide (a cancer medicine)
• thalidomide (to treat leprosy)
• indometacin, as this may affect dexamethasone tests for certain
diseases.
Pregnancy and breast-feeding
Dexamethasone may pass to your unborn baby or into breast milk.
DO NOT take dexamethasone if you are pregnant, planning to become
pregnant or while breast-feeding unless advised to by your doctor.
Steroids may affect sperm count and movement, in men.
Ask your doctor for advice before taking any medicine.
Driving and using machines
Dexamethasone is unlikely to affect your ability to operate machinery or
to drive.
Important information about some of the ingredients of
Dexamethasone tablets
• lactose
If you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicine.

Taking dexamethasone long term
You may be given a blue ‘steroid treatment card’: always keep it with you
and show it to any doctor, pharmacist or nurse treating you.

Tell your doctor if you get any of the following symptoms:
• headache
• acne
• a feeling of dizziness or spinning
• increased sweating
• nausea
• changes in vision
• malaise (feeling ill)
• slow wound healing
• hiccoughs
• thinned, delicate skin
• fits
• difficulty swallowing, sore throat, a feeling of chest pain (which may be
signs of a fungal infection in the oesophagus (gullet))
• stomach pain and discomfort, swollen abdomen
• increased appetite
• raised blood pressure
• salt imbalances, fluid retention
• swelling and weight gain of the body and face
• high blood sugar, with symptoms such as excessive thirst
• increased requirement for diabetic medication
• muscle weakness and wasting
• thinning of bone with an increased risk of fractures
• pain behind the ribs radiating towards the back, often worse when lying
down, nausea, vomiting, fever. This may be due to inflammation of
your pancreas
• bruising and unusual skin markings or rash
• raised pressure in the eye(s) (glaucoma), cataracts
• irregular periods or absence of periods in women
• increase in body and facial hair growth
• slow growth or development in children and adolescents
• increased frequency or severity of infections.

See your doctor if you develop any new infections while taking these
tablets.

Blood or skin tests: tell the doctor or nurse if you are having blood tests
for bacterial infection, or skin tests, as the results may be affected.

Prolonged use may lead to eye problems e.g. cataracts or glaucoma.

If any of the side effects get troublesome, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.

3) HOW TO TAKE DEXAMETHASONE TABLETS
Always take Dexamethasone tablets exactly as your doctor has told you
and always read the label. Your doctor will decide on the appropriate
dose to suit your condition. Ask your doctor or pharmacist if you are not
sure.
• Swallow the tablets with plenty of water, with or immediately after a
meal to prevent upset stomach.
• Take the tablets regularly as advised by your doctor to obtain the
maximum benefit.
Doses
Adults and the elderly: the usual starting dose is 1 to 18 tablets per
day.
Your doctor will tell you the correct dose and when to take it depending
on your condition, and may give you the lowest dose to reduce side
effects and to control your condition.
Your doctor may change the dose during treatment.
Elderly patients will be monitored more frequently.
Children: usually a single dose on alternate days will be given. The
doctor will also monitor growth and development at intervals during
treatment.
During treatment: because of possible side effects, your doctor may
monitor you at intervals during your treatment.

Withdrawal symptoms, such as fever, muscle weakness or pain, aching
joints or malaise (feeling ill), may occur after stopping long term
treatment with dexamethasone.
If you take more than you should
1. Tell your doctor, pharmacist or nearest hospital casualty department
immediately.
2. Take the tablet pack/container and any remaining tablets with you so
that people can see what you have taken.
3. Do this even if you feel well.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
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 TABLETS

If you forget to take
If you forget to take a dose, take it as soon as you remember, but if it is
almost time for your next dose, skip the missed dose and continue as
usual.
Do not take a double dose to make up for a missed dose.
If you stop taking
Stopping this medicine suddenly can be dangerous, and may cause:
• low blood pressure
• a relapse of the disease for which treatment was given.
Keep taking the tablets until your doctor tells you how and when to stop.
Do not let yourself run out of medicine, especially over the weekends or
on holidays.
The bottle contains a canister containing oxygen absorbing materials.
Keep the canister in the bottle. Do not swallow it.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.
4) POSSIBLE SIDE EFFECTS
Like all medicines, Dexamethasone tablets can cause side effects,
although not everybody gets them. Do not be alarmed by this list of
possible side effects. You may not experience any of them.
Some side effects only happen after weeks or months.
Seek medical help immediately if you have any of the following allergic
reactions:
• difficulty breathing or swallowing, swelling of the face, lips, tongue or
throat
• severe itching of the skin, with a red rash or raised lumps.
Also seek immediate medical attention if you have come in contact
with anyone suffering from chickenpox, shingles or measles.
Serious effects: tell a doctor straight away
Steroids including dexamethasone can cause serious mental health
problems.
These are common in both adults and children. They can affect about 5
in every 100 people taking medicines like dexamethasone.
• 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.

• Keep out of the sight and reach of children.
• Do not use Dexamethasone tablets after the expiry date which is
stated on the blister/carton. The expiry date refers to the last day of
that month.
• Store in a dry place below 25°
C.
• Store in original container to protect from light.
• If your tablets become discoloured or show any sign of deterioration,
return them to your pharmacist.
• Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6) FURTHER INFORMATION
What Dexamethasone contains
Each tablet contains 500 micrograms of the active ingredient
dexamethasone.
The other ingredients are:
Calcium hydrogen phosphate, lactose, magnesium stearate, maize
starch, purified water.
What Dexamethasone looks like and contents of the pack
Dexamethasone 500 microgram tablets are white, round tablets marked
with “MSD” on one side and with a break-line on the other.
Dexamethasone 500 microgram tablets come in blister packs of 30
tablets.
Manufacturer
LABORATÓRIO MEDINFAR - PRODUTOS FARMACÊUTICOS, S.A.
Rua Henrique de Paiva Couceiro, 29
Venda Nova, 2700-451 Amadora
Portugal
FARMALABOR - PRODUTOS FARMACÊUTICOS, LDA
Zona Industrial de Condeixa-a-Nova
3150-194 Condeixa-a-Nova
Portugal
Procured from within the EU by the Product Licence holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.
Repackaged by XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
POM

PL 33532/0537
th

Leaflet date: 18 January 2015
Leaflet code: XXXXXXXXXX

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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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