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DEXAMETHASONE TABLETS BP 2MG

Active substance(s): DEXAMETHASONE

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ASPEN Artwork Panel

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AW Version:
2

Package leaflet: Important information for the patient

Dexamethasone 2mg Tablets

New Item Code:
17-2185

Dexamethasone

Replacement:
12000000109872

• 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

Market:
United Kingdom

Number of Colours:
1
BLACK

Manufacturing Site:
ABO

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.

Drawing Ref. Number:
BE68_148X594

Originated by:
David Leiva
Originated at:
APTL

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

Originated on:
25 Oct 2017
Amended on:
20 Nov 2017

1. What Dexamethasone is and what it is used for
The name of your medicine is Dexamethasone. This 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.

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 while taking steroid medicines like Dexamethasone
• If any of your close family has had these illnesses
Mental problems while taking Dexamethasone
Mental health problems can happen while taking steroids like Dexamethasone (see also section 4).
• 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.
Take special care with Dexamethasone
Before you take Dexamethasone, tell your doctor if:
• You have a cancer of the blood because you may be at risk of a very rare, potentially lifethreatening condition resulting from a sudden breakdown of tumour cells.
• 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
• You have kidney or liver problems
• You have high blood pressure or heart disease
• You have diabetes or there is a family history of diabetes
• You have thinning of the bones (osteoporosis), particularly if you are a female who has been
through the menopause
• You have had muscle weakness with this or other steroids in the past
• You have raised eye pressure (glaucoma) or there is a family history of glaucoma
• You have a stomach (peptic) ulcer
• You have mental problems or you have had a mental illness which was made worse by this type of
medicine such as ‘steroid psychosis’
• You have epilepsy
• You have migraines
• You have an underactive thyroid gland
• You have an infection with parasites
• You have tuberculosis (TB)
• You have stunted growth
• Contact your doctor if you experience blurred vision or other visual disturbances.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using
Dexamethasone.

PHARMA CODE N° xxxx

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 blue ‘steroid 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.
Do not use Dexamethasone for the treatment of Acute Respiratory Distress Syndrome (ARDS;
a serious lung disease) if you have been diagnosed with this condition for over 2 weeks.
Dexamethasone and viral infections
While you are taking this kind of medicine, you should not come into contact with anyone who
has chicken pox, shingles or measles if you have not had these illnesses. 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 straight away. You should also tell your doctor
if you have ever had infectious diseases such as measles or chicken pox 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
If any of the above apply to you, you should tell your doctor or the person treating you even if you
have stopped taking this medicine.
Children
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.
Other medicines and Dexamethasone
Tell your doctor if you are taking, have recently taken or might take any other medicines. Other
medicines can affect the way Dexamethasone works or Dexamethasone can affect the way they
work. In particular:
• Medicines to treat heart and blood problems, such as warfarin, high blood pressure medicine and
water tablets (diuretics)
• Antibiotics such as rifampicin and rifabutin
• Medicines to treat epilepsy, such as phenytoin, carbamazepine, phenobarbitone and primidone
• Medicines to treat stomach problems, such as antacids
• Carbenoxolone, sometimes used for ulcers
• Medicines that control pain or lower inflammation, such as aspirin, ibuprofen or similar nonsteroidal anti-inflammatories (NSAIDs)
• Medicines used to treat diabetes
• Medicines used to lower potassium levels
• Medicines used to treat myasthenia
• Indinavir or saquinavir used to treat HIV
• 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)
• Oral contraceptives containing oestrogen and progestogen
• Anti-cancer treatments, such as aminoglutethimide
• Methotrexate used for cancer or inflammatory problems
• Ephedrine used to relieve symptoms of a blocked nose
• Acetazolamide used for glaucoma
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor for advice before taking this medicine.
Driving and using machines
Dexamethasone is not likely to affect you being able to drive or use any tools or machines.
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 medicinal product.

PHARMA CODE N° xxxx

Dexamethasone can be used to:
• Reduce inflammation
• Treat a number of different diseases of the immune system

ASPEN Artwork Panel • May 2013 • Version 5

Drawing Version:
05

What is in this leaflet

Do not take Dexamethasone:
- If you are allergic to dexamethasone or any of the other ingredients of this medicine (listed in
section 6). The signs of an allergic reaction include a rash, itching or shortness of breath
- If you have an infection that affects the whole body
- If you need to have a vaccination, particularly with ‘live virus’ vaccines
Do not take this medicine if any of the above apply to you.

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Product Name:
Dexamethasone

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.

2. What you need to know before you take Dexamethasone

Page:
1 of 2

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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.
Taking this medicine
• Your doctor will tell you how many tablets to take. This will depend on your illness and
how bad it is
• Take this medicine by mouth
• Swallow the tablets whole with a drink of water
• Do not crush or chew the tablets
Usual dose for adults
• The usual dose is 0.5mg to 10mg each day
• As you get better your doctor may then reduce your dose or ask you to take another
corticosteroid such as ‘prednisolone’

AW Version:
2

Page:
2 of 2

New Item Code:
17-2185
Replacement:
12000000109872
Market:
United Kingdom

If you forget to take Dexamethasone
• If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next
dose, skip the missed dose
• Do not take a double dose to make up for a forgotten dose

Number of Colours:
1
BLACK

Manufacturing Site:
ABO

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, your condition may get worse.

Drawing Ref. Number:
BE68_148X594

You may also feel a ‘withdrawal symptom’. These may include headache, problems with your vision
(including pain or swelling in the eye), feeling or being sick, fever, pain in your muscles and joints,
swelling in the inside of your nose, weight loss, itchy skin and conjunctivitis.

Originated by:
David Leiva

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Originated at:
APTL

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Dexamethasone can also cause side effects when you stop taking it.
• See Section 3: If you stop taking Dexamethasone
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) 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 that 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.
If you have an allergic reaction to Dexamethasone see a doctor straight away
An allergic reaction may include:
• Any kind of skin rash or itching of the skin
• Difficulty in breathing or collapse
• Swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing
(angioedema)
If you get any of the following side effects see your doctor as soon as possible:
• Stomach and gut problems: ulcers in the throat, stomach ulcers, which may perforate or bleed,
indigestion, feeling sick (nausea) or being sick (vomiting), a swollen stomach, having more of an
appetite than usual, hiccups, diarrhoea
• 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: high blood pressure, blood clots, problems with the muscles in your
heart after a recent heart attack
• Bone problems: thinning of the bones (osteoporosis) with an increased risk of fractures,
bone disease
• Recurring infections that get worse each time such as thrush and chicken pox
• Skin problems: wounds that heal more slowly, bruising, acne
• Eye problems: increased pressure in the eye including glaucoma, eye disorders such as cataracts,
eye infections, visual disturbances, loss of vision, blurred vision
• Hormone problems: irregular or missing periods, stunted growth in children and teenagers,
swelling of the face (called ‘Cushingoid’ or ‘moon’ face). It may affect your diabetes and you may
notice you start needing higher doses of the medicine you take for diabetes. Your body may not
be able to respond normally to severe stress such as accidents, surgery or illness, growth of extra
body hair (particularly in women), increased appetite or weight gain
• Nervous system problems: fits or epilepsy may become worse, severe unusual headache with
visual problems, being unable to sleep, feeling depressed, extreme mood swings, schizophrenia
may become worse, headache or problems with your vision (including eye pain or swelling)
• General problems: may make you feel generally unwell or tired
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:
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. How to store Dexamethasone
Keep this medicine out of the sight and reach of children
Do not store above 25°C. Do not store in the fridge
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers
to the last day of that month.
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 contains
- The active substance is dexamethasone.
Dexamethasone Tablets BP 2mg contain 2mg of dexamethasone per tablet
- The other ingredients in Dexamethasone Tablets BP 2mg are potato starch, propylene glycol,
magnesium stearate and lactose.
PHARMA CODE N° xxxx

What Dexamethasone looks like and contents of the pack
- Dexamethasone Tablets BP 2mg are round, flat and white. They are marked with XC/8 on one side
and plain on the other side
- Dexamethasone tablets are sold in containers of 100 and 50 tablets. They may also be available
in containers of 500 tablets.
Marketing Authorisation Holder and Manufacturer
Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
The Manufacturer is:
Aspen Bad Oldesloe GmbH, 32-36 Industriestrasse, 23843 Bad Oldesloe, Germany
For any information about this product, please contact the local representative of the Marketing
Authorisation Holder:
United Kingdom
24 Hour Helpline +441748 823 391 (free phone UK only 0800 0087 392)
This leaflet was last revised in November 2017

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Drawing Version:
05

Originated on:
25 Oct 2017
Amended on:
20 Nov 2017

ASPEN Artwork Panel • May 2013 • Version 5

If you take more Dexamethasone than you should
If you take more of this medicine than you should, talk to a doctor or go to a hospital straight away.
Take the medicine pack with you so the doctor knows what you have taken. The following effects
may happen:
• Swelling of the throat
• Skin reaction
• Difficulty breathing

160 mm Measuring Bar

Product Name:
Dexamethasone

Usual dose for children
• The usual dose is 0.01 to 0.1 milligrams per kilogram of body weight

+ 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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