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DEXAMETHASONE 500 MICROGRAM TABLETS

Active substance(s): DEXAMETHASONE / DEXAMETHASONE / DEXAMETHASONE

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Assessed against UK
PIL dated February 2017
Final draft mock up

PACKAGE LEAFLET: INFORMATION FOR THE USER
Dexamethasone® 500 microgram Tablets

Your medicine is known as the above but will be referred to as
Dexamethasone throughout the remainder of this leaflet.
 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.
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
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. 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 untreated infection affecting your whole body
 If you have a fungal infection affecting the whole of your body,
e.g. thrush
 If you 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 manicdepression (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.

Warnings and precautions
Talk to your doctor before taking Dexamethasone
Tablets.
You
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should tell your doctor if you have any of the following conditions:
 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.
 symptoms of tumour lysis syndrome such as muscle
cramping, muscle weakness, confusion, visual loss or
disturbance and shortness of breath, in case you suffer from
haematological malignancy.
Pay attention when using Dexamethasone Tablets
Dexamethasone should not be used routinely in preterm neonates
with respiratory problems.
Children and adolescents
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, you MUST tell the person
treating you that you are taking or have taken steroids.
Other medicines and Dexamethasone
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.
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
 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.
Some medicines may increase the effects of Dexamethasone and
your doctor may wish to monitor you carefully if you are taking these
medicines (including some medicines for HIV: ritonavir, cobicistat)
Pregnancy, breast-feeding and fertility
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.
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.

Jun 06, 2017

Driving and using machines
Dexamethasone is unlikely to affect your ability to operate machinery
or to drive.
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 or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will decide on the appropriate dose to suit your condition.
 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.
 The score line is only there to help you break the tablet if you
have difficulty swallowing it whole.
The recommended dose is:
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.
Use in children and adolescents:
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 Dexamethasone 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 Dexamethasone Tablets
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 forgotten dose.
If you stop taking Dexamethasone Tablets
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.

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
 visual disturbance, loss of 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.
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.
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
 KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
 Do not take after the expiry date which is stated on the blister,
carton/container/label. The expiry date refers to the last day of
that month.
 Do not store above 25ºC.
 Store in the original package to protect from light.
 Do not throw it away with your household waste or in water.
Return all the unwanted medicine to your pharmacist. This will
help to protect the environment
 If your tablets become discoloured, or show any signs of
deterioration, talk to your pharmacist. If your doctor tells you to
stop taking this medicine, return it to your pharmacist for safe
disposal. Only keep this medicine if your doctor tells you to.
6. Contents of the pack and other 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.

4. Possible side effects

What Dexamethasone look like and contents of the pack
Dexamethasone Tablets are round, white tablets with a break-line on
one side and marked ‘MSD’ on the other.
They are available in blister packs of 20, 30 and 60.

Like all medicines, this medicine 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.

Manufacturer
Manufactured by LABORATORIO MEDINFAR - PRODUTOS
FARMACEUTICOS, S.A. Rua Henrique de Paiva Couceiro, 29
Venda Nova, 2700-451 Portugal.

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.

Or

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.

FARMALABOR - PRODUTOS FARMACUETICOS, LDA. Zone
industrial de Condeixa-a-Nova 3150-194 Condeixa-a-Nova, Portugal.
Procured from within the EU and repackaged by the Product Licence
Holder: G-Pharma Ltd, Dakota Avenue, Salford M50 2PU.
POM
PL 16369/1623
Leaflet revision: 04/04/2017

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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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