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DEXAMETHASONE 500 MICROGRAM TABLETS

Active substance(s): DEXAMETHASONE

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Dexamethasone 500 microgram Tablets
Dexamethasone - Headlines
 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.
Your medicine is known by the above name, but will be referred to as
Dexamethasone Tablets throughout this leaflet.
Patient Information Leaflet
Please read all of this leaflet carefully before you start taking the
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 only. 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. This
includes any possible side effects not listed in this leaflet.
In this leaflet:
1) What this medicine 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 your 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)
• carbamezapine (for epilepsy, pain, manic depression)
• aminoglutehimide (a cancer medicine)
• thalidomide (to treat leprosy)
• indomethacin, 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.

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.
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.
See your doctor if you develop any new infections while taking these
tablets.
Prolonged use may lead to eye problems e.g. cataracts or glaucoma.
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.
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.
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.

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 of 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.
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.
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.
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
• Keep out of the sight and reach of children.
• Do not take after the expiry date printed on the carton or blister label.
The expiry date refers to the last day of that month.
• Do not store above 25°C.
• If you tablets become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.
• 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 Tablets contain:
The active ingredient is dexamethasone. Each tablet contains 500
micrograms dexamethasone.
The other ingredients are: lactose monohydrate, maize starch, magnesium
stearate.
See end of Section 2 for further information on lactose.
What Dexamethasone Tablets looks like and contents of the pack
Dexamethasone are round, white, biconvex tablets, 6mm in diameter, with
no markings on either side.
Dexamethasone Tablets are available in packs of 30 tablets.
PL 10383/2162

Dexamethasone 500 micrograms Tablets

POM

Who makes and repackages your medicine
Your medicine is manufactured by Balkanpharma-Razgrad AD, 68 Aprilsko
Vastanie Blvd., 7200 Razgrad, Bulgaria. Procured from within the EU and
repackaged by Product Licence Holder: Primecrown Ltd, 4/5 Northolt
Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 05.09.2016

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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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