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DEXAMETHASONE 2 MG/5 ML ORAL SOLUTION

Active substance(s): DEXAMETHASONE SODIUM PHOSPHATE / DEXAMETHASONE SODIUM PHOSPHATE / DEXAMETHASONE SODIUM PHOSPHATE

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Patient Information Leaflet

DEXAMETHASONE 2 mg/5 ml ORAL SOLUTION
(Dexamethasone Sodium Phosphate)
Important information about this medicine





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: Possible side effects). 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 section 4 for more information)
• If you take it for more than 3 weeks, in the UK, 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.
Read all of this leaflet carefully 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. 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 become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.







Tuberculosis, septicaemia or a fungal infection in the eye
Malaria that affects the brain (cerebral malaria)
Herpes, including cold sores or genital herpes
Asthma
You have stunted growth
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.
• Blurred vision or other visual disturbances

In this leaflet:
1. What is DEXAMETHASONE and what is it used for?
2. What you need to know before you take DEXAMETHASONE
3. How to take DEXAMETHASONE
4. Possible side effects
5. Storing DEXAMETHASONE
6. Further information
1. What is DEXAMETHASONE and what is it used for?
The name of this medicine is Dexamethasone 2 mg/5 ml Oral Solution. It contains
Dexamethasone sodium phosphate. Dexamethasone belongs to a group of
medicines called corticosteroids.
Corticosteroids are hormones that are found naturally in your body that help to
keep you healthy and well. Boosting your body with extra corticosteroid, such as
Dexamethasone, is an effective way to treat various illnesses involving inflammation
in the body. Dexamethasone lowers inflammation, which could otherwise go on
making your condition worse. You must take this medicine regularly to get maximum
benefit from it.
This medicine can be used for:
• Replacing natural corticosteroids when levels have been reduced
• Reducing swelling of the brain which is not caused by a head injury
• Treating swelling (inflammation) and certain allergies
• Treating cancer
• Controlling how well your adrenal glands work. These are glands that are next to
your kidneys
• Croup in babies and children. This affects the windpipe and the two airways that
branch off from it to the lungs. The top of the airway is slightly blocked causing the
barking cough, hoarse voice, a harsh sound (known as ‘stridor’) and breathing
difficulties.
You may be using this medicine for a different reason.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist
before taking Dexamethasone.
More important information about taking this kind of medicine
Taking this medicine can cause problems with your kidneys. This means that you
must stop taking this medicine gradually if you have been taking it for a long time.
Tell your doctor if you get ill, injured or have an operation while you are taking this
medicine. This is because they may need to increase your dose during this time.
If you develop an infection while you are taking this medicine, you should talk to your
doctor.
Please tell any doctor, dentist or person who may be giving you treatment that you
are currently taking steroids or have taken them in the past.
If you are living in the UK, you should always carry a ‘Steroid treatment’ card
which gives clear guidance on the special care to be taken when you are taking
this medicine. Show this to any doctor, dentist or person who may be giving you
treatment. Even after your treatment has finished you must tell anyone who is giving
you treatment that you have taken steroids in the past.
This medicine can cause children to grow more slowly. Because of this, they should
take the lowest possible dose for the shortest possible time. Children who use this
medicine for any length of time should be carefully monitored by the doctor.
The common side effects of Dexamethasone may be associated with more serious
consequences in old age especially thinning of the bones (osteoporosis), high blood
pressure, low potassium levels in the blood (hypokalaemia), diabetes, susceptibility
to infection and thinning of the skin. Extra supervision by your doctor is necessary.

Ask your doctor why this medicine has been prescribed for you.
2. What you need to know before you take DEXAMETHASONE
Do not take DEXAMETHASONE and consult your doctor if:
• You are allergic (hypersensitive) to Dexamethasone or any other ingredients in this
liquid (listed in Section 6). The signs of an allergic reaction include a rash, itching
or shortness of breath
• You have an infection (including fungal infections) that affects the whole body,
unless You are being treated for the infection
• You have an ulcer in your stomach (peptic ulcer) or digestive tract area (duodenal
ulcer)
• You have an infection with tropical worms
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.
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.
Warnings and precautions
Check with your doctor or pharmacist before taking your medicine if you have:
• Kidney or liver problems
• High blood pressure, heart disease or you have recently had a heart attack
• Diabetes or there is a family history of diabetes
• Thinning of the bones (osteoporosis), particularly if you are a female who has been
through the menopause
• Had muscle weakness with this or other steroids in the past
• Raised eye pressure (glaucoma) or there is a family history of glaucoma
• A condition causing muscle weakness (myasthenia gravis)
• A bowel problem or a stomach (peptic) ulcer
• Mental problems or you have had a mental illness which was made worse by this
type of medicine
• Epilepsy
• Migraines
• Had an allergy or unusual reaction to corticosteroids
• An underactive thyroid gland
• An infection with parasites

DEXAMETHASONE and viral infections
While you are taking this kind of medicine, you should not come into contact with
anyone who has chickenpox, shingles or measles. This is because you may need
specialist treatment if you get these diseases. If you think you may have had
exposure to any of these diseases, you should talk to your doctor immediately. You
should also tell your doctor if you have ever had infectious diseases such as measles
or chickenpox and if you have had any vaccinations for these conditions in the past.
Please tell a doctor or anyone giving you treatment, such as at a hospital, if:
• You have an accident
• You are ill
• You need any surgery. This includes any surgery you may have at your dentist’s
• You need to have a vaccination, particularly with ‘live virus’ vaccines such as MMR,
tuberculosis, yellow fever or oral typhoid.
If any of the above applies to you, you should tell your doctor or the person treating
you even if you have stopped taking this medicine.
If you have suppression tests or tests for infection, you should tell the person giving
you the test that you are taking this medicine as it may interfere with the results of the
test.
If a child is taking this medicine, it is important that the doctor monitors their growth
and development regularly. Dexamethasone should not be routinely given to
premature babies with respiratory problems.
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. Taking some
medicines together can be harmful.
In particular, tell your doctor or pharmacist if you are taking any of the following
medicines:
• Medicines to treat heart and blood problems, such as warfarin, high blood pressure
medicines, a cholesterol lowering medicine called colestyramine and water tablets
(diuretics)
• Medicines to treat infections, such as amphotericin B iv injection, rifabutin,
rifampicin, a medicine for fungal infections called ketoconazole, antibiotics
including erythromycin, a medicine for worm infections called praziquantel and a
medicine for tuberculosis called isoniazid
• Medicines to treat epilepsy, such as phenytoin, carbamazepine, primidone,
phenobarbital and acetazolamide, also used for glaucoma
• Medicines to treat stomach problems, such as antacids, charcoal and
carbenoxolone. You should leave at least two hours between taking these
medicines and Dexamethasone
• Medicines that calm emotions or for sleeping, such as barbiturates or sulpiride
• Medicines that control pain or lower inflammation, such as aspirin or similar nonsteroidal anti-inflammatory drugs (NSAIDs), such as indometacin, hydrocortisone,
cortisone and other corticosteroids. You should be carefully monitored if you are
taking NSAIDs at the same time as taking Dexamethasone because you are more
likely to get stomach or gut ulcers
• Medicines used to treat diabetes such as insulin, metformin or sulfonylureas such
as chlorpropamide

Dexamethasone 2 mg 5 ml Oral Solution PIL Teva UK
item no:

AAAJ7977

dimensions:

print proof no:

1

pharmacode:

origination date: 8.5.17
originated by:

218 x 350

min pt size:

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revised by:

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Tiofarma BV

2.
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8 pt

revision date:

supplier:

1. black
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approved for print/date

colours/plates:

approved:

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2.
3.

* Please note that only Actavis Global Artwork Studios are permitted to make changes to the above
artwork. No changes are permitted by any 3rd party other than added notes and mark ups for
required changes.

• Medicines that help muscle movement in myasthenia gravis, such as neostigmine
• 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)
• Oestrogen tablets including the contraceptive pill
• Ciclosporin used to stop the rejection of organs after transplants
• Anti-cancer treatments, such as aminoglutethimide and thalidomide, also used for
leprosy
• Ephedrine which helps to tighten blood vessels
• Tetracosactide
• Methotrexate
• Medicines to treat viral infections such as indinavir and aquinavir
• Live vaccines such as MMR, tuberculosis, yellow fever or oral typhoid
If you are unsure of the types of medicines you are taking, ask your doctor or
pharmacist.
Pregnancy and breast feeding
Talk to your doctor before taking this medicine if you are pregnant, planning to
become pregnant or are breast-feeding.
Driving and using machines
You may experience dizziness when taking this medicine (see section 4: possible
side effects). This may affect your ability to drive. If this happens, do not drive or use
tools or machinery.
Important information about some of the ingredients of DEXAMETHASONE
This medicine contains liquid maltitol (E965) and sorbitol (E420). If you have been
told by your doctor that you have an intolerance to some sugars, contact your doctor
before taking this medicinal product.
3. How to take DEXAMETHASONE
Always take this medicine exactly as your doctor or pharmacist has told you. You
should check with them if you are not sure.
Taking this medicine
• This medicine contains 2mg of dexamethasone in each 5ml
• Take this medicine by mouth. Some people may be given a dexamethasone
injection at the same time
• You may also find that your doctor will tell you to lower the amount of salt in your
diet
• You may also need to take potassium supplements whilst taking this medicine.
Your prescriber will advise you if this is necessary since patients should not
routinely be taking potassium without medical supervision
• If your daily dose is very small, ask your pharmacist for a device to help you
measure these amounts, such as an oral syringe.
The usual dose is:
Adults and older people:
• Take 0.5mg to 9mg each day as a single dose preferably in the morning
• If you are going to take the medicine for a long time your doctor will give you a
‘maintenance dose’ of 1.5mg each day
Children:
• A single dose on alternate days (every other day).
Croup in babies and children:
• Your doctor will work out the right dose in millilitres (mls) based on your child’s
weight. This is normally taken once, however sometimes your doctor will
recommend that a second dose is also taken after 12 hours. Make sure you follow
the doctor’s instructions.
If you are taking this medicine as part of hospital tests:
• Take 500 micrograms to 2 mg per dose
• You will have this medicine for a short period of time.

If you have an allergic reaction to Dexamethasone stop taking and seek
medical help immediately.
An allergic reaction may include:
• Any kind of skin rash, flaking skin, boils or sore lips and mouth
• Sudden wheezing, fluttering or tightness of the chest or collapse.
If you get any of the following side effects, stop taking Dexamethasone and
see your
doctor as soon as possible:
• Stomach and gut problems: inflamed food pipe (oesophagus), ulcers in the food
pipe or gut that may split and bleed, feeling sick (nausea) or being sick (vomiting),
stomach ache or a swollen stomach, having more of an appetite than usual,
hiccups, diarrhoea, tearing of the bowel, particularly if you have inflammatory
bowel disease
• Inflamed pancreas: this may cause severe pain in the back or tummy
• Problems with salts in your blood: such as too much sodium or low potassium
or calcium. You may have water retention
• Heart and blood problems: heart failure in people who are likely to have heart
problems, high blood pressure, blood clots (signs of this may include redness, pain
or numbness, throbbing, a burning feeling or swelling). There could also be a large
rise in the number of white cells in your body. Some types of blood tests will show
this affecting you
• Bone problems: thinning of the bones with more of a risk of fractures, also
hip, arm and leg bone problems, ruptured tendons, muscle wasting and muscle
weakness
• Recurring infections: that get worse each time. This may be a sign that your
immune system is low. Recurrence of TB (tuberculosis) if you have already had it
before. You may also get thrush
• Skin problems: wounds that heal more slowly, thinned, delicate skin unusual
purple spots on the skin or bruising, redness and inflammation of the skin, weaker
reaction to skin tests, stretch marks, acne, sweating more than usual, skin rash or
swollen small veins under the skin, thinning of hair
• Eye problems: cataracts, increased pressure in the eye including glaucoma
swelling inside the eye, blurred vision, thinning of the covering of the eyeball, eye
infections that you may already have can become worse, bulging of the eyeballs,
visual disturbances, loss of vision
• Hormone problems: growth of extra body hair (particularly in women), weight
gain, irregular or missing periods, changes in the levels of protein and calcium
in your body (which would be detected by a blood test), stunted growth in
children and teenagers and swelling and weight gain of the body and face (called
‘Cushingoid state’)
Dexamethasone may affect your diabetes and you may notice you start needing
higher doses of the medicine you take for diabetes. While taking dexamethasone
your body may not be able to respond normally to severe stress such as
accidents, surgery or illness
• Nervous system problems: fits or epilepsy may become worse, feeling dizzy,
headache, severe unusual headache with visual problems usually in children
(normally after treatment has been stopped), a feeling that you are addicted to the
medicine, being unable to sleep, feeling depressed, extreme mood swings
• Other side effects: may make you feel generally unwell. If you are a man, this
medicine can affect the amount of sperm and their movement.
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 (Website: www.mhra.gov.uk/yellowcard). By reporting
side effects you can help provide more information on the safety of this medicine.
5. Storing DEXAMETHASONE
Keep all medicines out of the reach and sight of children.
This medicinal product does not require any special storage conditions.
The label on the bottle shows an expiry date (month & year). Do not use this product
after this date. The expiry date refers to the last day of that month.

If you take more DEXAMETHASONE than you should:
Do not take more Dexamethasone than stated on the label of your medicine. If you
take too much medicine you should seek medical attention immediately, either by
calling your doctor, or going to the nearest casualty department. Always take the
labelled medicine container with you, even if there is no medicine left.
If you forget to take DEXAMETHASONE:
If you forget to take a dose, take it as soon as you remember unless it is almost time
for the next one then carry on as before. Never take two doses together.
If you stop taking DEXAMETHASONE:
• It can be dangerous to stop taking this medicine suddenly. If you need to stop this
treatment, follow your doctor’s advice. He or she may tell you to lower the amount
of medicine you are taking gradually until you stop taking it altogether.
• If you stop taking this medicine too quickly, you may have low blood pressure and,
in some cases, your illness could come back.
• You may also feel a ‘withdrawal symptom’. This may include fever, pain in your
muscles and joints, swelling in the inside of your nose, weight loss, itchy skin and
conjunctivitis.
Effects when treatment with DEXAMETHASONE is stopped:
After therapy with Dexamethasone for a longer period, the dose should be gradually
decreased in order to prevent a relapse of your disease and to allow your adrenal
gland to recover its normal function. The doctor will give you advice on how to do this.
If you have any further questions on the use of this product, ask your doctor or
pharmacist.
4. Possible side effects
Like all medicines, Dexamethasone can have side effects, although not everybody
gets them.
Serious side 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. These include:

Feeling depressed, including thinking about suicide

Feeling high (mania), very happy (euphoria) or moods that go
up and down

Feeling anxious or irritable, having problems sleeping, difficulty
in thinking or being confused and losing your memory

Feeling, seeing or hearing things that do not exist or believing
in things that are not real (delusions). Having strange and
frightening thoughts, changing how you act or having feelings of
being alone

Schizophrenia becoming worse.
If you notice any of these problems, talk to a doctor straight away.

Use within 3 months of opening.
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 5 ml of Dexamethasone Oral Solution contains 2 mg of the active substance
dexamethasone as dexamethasone sodium phosphate.
The medicine also contains benzoic acid (E210), propylene glycol (E1520), citric
acid monohydrate (E330), liquid maltitol (E965), garden mint flavour (containing
isopropanol and propylene glycol), liquid sorbitol (non-crystallising) (E420), sodium
citrate (E331) and purified water.
What DEXAMETHASONE looks like and contents of the pack:
Dexamethasone Oral Solution is a clear, colourless solution with an odour of mint.
Dexamethasone Oral Solution is available in a 150 ml pack.
Marketing authorisation holder:
Auden Mckenzie (Pharma Division) Ltd.
Mckenzie House
Bury Street
Ruislip
Middlesex
HA4 7TL
UK
Manufacturer:
Tiofarma B.V,
Benjamin Franklinstraat 7-9,
3261 LW Oud-Beijerland,
The Netherlands
This leaflet was last revised in May 2017.

VPAL4146
AAAJ7977

Dexamethasone 2 mg 5 ml Oral Solution PIL Teva UK
item no:

AAAJ7977

dimensions:

print proof no:

1

pharmacode:

origination date: 8.5.17
originated by:

218 x 350

min pt size:

5.
6.

Technical Approval

revised by:

date sent:

Tiofarma BV

2.
4.

8 pt

revision date:

supplier:

1. black
3.

db

approved for print/date

colours/plates:

approved:

8.5.17

Non Printing Colours
1.
2.
3.

* Please note that only Actavis Global Artwork Studios are permitted to make changes to the above
artwork. No changes are permitted by any 3rd party other than added notes and mark ups for
required changes.

Expand Transcript

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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