Skip to Content

DEXAMETHASONE 2 MG TABLETS

Active substance(s): DEXAMETHASONE / DEXAMETHASONE / DEXAMETHASONE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

PACKAGE LEAFLET: INFORMATION FOR THE USER

Dexamethasone 2 mg Tablets
The name of your medicine is Dexamethasone 2 mg Tablets, but will be
referred to as Dexamethasone throughout this leaflet.
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
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
 Keep this leaflet. You may need to read it again
 If you have any further questions, ask your doctor or your pharmacist
 This medicine has been prescribed only 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
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
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.
Dexamethasone can be used to:
 Reduce inflammation
 Treat a number of different diseases of the immune system

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DEXAMETHASONE
Do not take Dexamethasone and tell your doctor if:
 You are allergic (hypersensitive) to dexamethasone or any other
ingredients in this medicine (listed in Section 6). The signs of an allergic
reaction include a rash, itching or shortness of breath
 You have an infection that affects the whole body
 You need to have a vaccination, particularly with ‘live virus’ vaccines
➔ Do not take this medicine if any of the above apply to you. Talk to your
doctor or pharmacist before taking Dexamethasone.
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 this
medicine.
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.

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 life-threatening 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
➔If you are not sure if any of the above apply to you, talk to your doctor or
pharmacist before using Dexamethasone.
More important information about taking this kind of medicine
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.
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 if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription. 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 non-steroidal 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
Talk to your doctor before taking this medicine if you are pregnant, planning
to become pregnant or are breast-feeding.
Driving and using machines
Dexamethasone is not likely to affect you being able to drive or use any
tools or machines.
Important information about some of the ingredients of
Dexamethasone
This medicine 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.

3. HOW TO TAKE DEXAMETHASONE
Take this medicine as your doctor or pharmacist has told you. Read the
label and ask the 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’
Usual dose for children
 The usual dose is 0.01 to 0.1 milligrams per kilogram of body weight
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
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 (two doses at the same time) to make up for
a forgotten dose
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.
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.
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 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
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
 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 out of the sight and reach of children
Do not store above 25°C.
Store in the original package in order to protect from light.
Do not use after the expiry date which is stated on the pack
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. CONTENTS OF THE PACK AND OTHER INFORMATION
What Dexamethasone contains
What Dexamethasone contains
• The active ingredient is Dexamethasone. Dexamethasone 2 mg Tablets
contain 2mg of Dexamethasone per tablet
• The other ingredients in Dexamethasone 2 mg Tablets are potato starch,
propylene glycol, magnesium stearate and lactose monohydrate.
What Dexamethasone looks like and contents of the pack
 Dexamethasone 2mg Tablets 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 Tablets.
Manufactured by Aspen Bad Oldesloe GmbH, 32-36 Industriestrasse,
23843 Bad Oldesloe, Germany and procured from within the EU and
repackaged in the UK by the Product Licence holder: CD Pharma Ltd, Unit
3, Manor Point, Manor Way, Borehamwood, Herts WD6 1EE.
Dexamethasone 2 mg Tablets
Date of preparation: 21 April 2017
st

POM

PL: 20492/0558

Blind or partially sighted? Is this
leaflet hard to see or read? Call 020
8236 3190 to obtain a leaflet in a
format suitable for you.

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.

Hide