DEXAMETHASONE 500 MICROGRAM TABLETS

Active substance: DEXAMETHASONE

View full screen / Print PDF » Download PDF ⇩

Transcript
Dexamethasone 500 microgram Tablets
Dexamethasone

F966

119/L/e/4

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. This leaflet was last updated in December 2012.
Please 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 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 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 this medicine is 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 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
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)
• carbamazepine (for epilepsy, pain, manic depression)
• aminoglutethimide (a cancer medicine)
• thalidomide (to treat leprosy)
• indometacin, 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
Continued over page

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.

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 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.

Prolonged use may lead to eye problems e.g. cataracts or
glaucoma.

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.

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 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.

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.
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.

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.
119/L/e/4

F966

5. How to store Dexamethasone Tablets





Keep out of the reach and the sight 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.
Store in a dry place, below 25ºC.
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.

6. Further information
What Dexamethasone Tablets contain
• The active ingredient is dexamethasone (500 micrograms)
• The other ingredients are:
calcium hydrogen phosphate, lactose, magnesium
stearate, maize starch, purified water.
(See end of Section 2 for further information on
lactose).
What Dexamethasone Tablets look like and contents of
the pack
Dexamethasone Tablets are round, white tablets with a
break-line on one side, marked ‘41’.
They are available in bottles of 28 or 100 tablets containing
an oxygen absorbing canister and blister packs of 28 or 30
tablets.
Not all pack types and sizes may be marketed.
Marketing Authorisation Holder
Chemidex Pharma Ltd, trading as Essential Generics,
7 Egham Business Village, Crabtree Road, Egham,
Surrey TW20 8RB.
Manufacturer
Dales Pharmaceuticals Ltd, Snaygill Industrial Estate,
Keighley Road, Skipton, Yorkshire BD23 2RW.
This leaflet was last revised in
December 2012

Expand view ⇕

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
(web2)