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DEFLAZACORT 6MG TABLETS

Active substance(s): DEFLAZACORT / DEFLAZACORT / DEFLAZACORT

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Other side effects:
Please tell your doctor or pharmacist if any of the
following side effects gets serious or lasts longer than a
few days.

Uncommon (affects 1 to 10 users in 1,000)

• Stomach or bowel problems such as feeling full or
bloated, indigestion, heartburn or stomach pain
• Increase in appetite and weight gain including
around your face. Or, you may lose weight or feel
weak.
• Hair, including body or facial hair, grows more than
normal
• Increased thirst and needing to pass water more
often than usual. These could be signs of diabetes.
If you are already diabetic, your doctor may
prescribe more of your diabetes medicine to balance
the effects of deflazacort. You should discuss this
with your doctor
• Raised blood pressure and increased water
retention
• Tiredness, confusion, muscle weakness or muscle
cramps. This may be due to low levels of potassium
in your body
• Mood changes, difficulty in sleeping
• If you have had tuberculosis (TB) in the past it may
return
• Skin problems such as acne, appearance of stretch
marks
• You may get infections more easily than usual

Rare (affects 1 to 10 users in 10,000)



Bleeding under the skin, redness
General muscle weakness or tiredness

Not known (frequency cannot be estimated from
the available data)
• Bones and tendons may break or tear more easily
than usual. Also tendons may get inflamed and
become painful.
• Irregular periods in women or they may stop
altogether
• Becoming dependent on deflazacort (also called
psychological dependence)
• If you have schizophrenia your symptoms may get
worse
• Fungal infection such as thrush
• Eye disease that causes detachment of the retina
and bulging eyes
• Eye problems such as glaucoma and cataracts can
happen if you take this medicine for a long time
• Eye infections (viral) may spread or return if you
have had them in the past
• Increase in the risk of clots forming in your blood
• Blood problems such as leukocytosis
• Wounds and cuts do not heal as quickly as usual
• Noticeable blood vessels, thinning of the skin
• Sudden or severe muscle weakness or tiredness
following an operation
Some of the side effects are more likely to happen if
you are elderly

Children and teenagers taking this medicine may
grow less than normal. (Not known: frequency cannot
be estimated from the available data)
If you think this is happening to a child, tell your doctor.

Reporting of side effects

Package Leaflet: Information For The User

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.

Calcort 6mg Tablets

1. What Calcort is and what it is used
for

(deflazacort)

Calcort is a steroid medicine. Their full name is

The name of your medicine is Calcort 6mg Tablets but
will be referred to as Calcort throughout this leaflet.

glucocorticoids.
How Calcort works

5. How to store Calcort

Calcort is round, white, uncoated tablet marked with a
cross on one face and a ‘6’ on the other face.
Calcort comes in boxes of 20 tablets.

• Calcort is a steroid medicine. This can be
prescribed for many different conditions, including
serious illnesses.
• You need to take it regularly to get the maximum
benefit.
• Do not stop taking this medicine without talking to
your doctor - you may need to lower the dose
gradually.
• Calcort can cause side effects in some people
(read section 4 for more information). These include
problems such as mood changes (feeling
depressed, or ‘high’), or stomach problems, which
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 be
given 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,
measles 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.

Manufactured by: Faes Farma S.A., Maximo Aguirre
14, 48940 Leioa, Vizcaya, Spain.

Read all of this leaflet carefully before you start
taking this medicine

• Keep out of the sight and reach of children.
• Do not store above 25°C. Store in the original
package.
• Do not take the tablets after the expiry date which is
stated on the carton and blisters label after ‘Exp’.
The expiry date refers to the last day of that month.
• If the tablets become discoloured or show any signs
of deterioration, seek the advice of your pharmacist
• Remember if your doctor tells you to stop taking this
medicine, return any unused medicine to your
pharmacist for safe disposal. Only keep this
medicine if your doctor tells you to.
• 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 Calcort contains
The active ingredient in Calcort is deflazacort.
Each tablet contains 6mg deflazacort.
The other ingredients are lactose, maize starch,
microcrystalline cellulose and magnesium stearate.

What Calcort looks like and contents of the
pack

Procured from within the EU and repackaged
by the Product Licence holder: B&S Healthcare,
Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU,
UK.
Calcort® 6mg Tablets; PL 18799/1063
POM
Leaflet date: 21.06.2017

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 0208 515 3763 to obtain the
leaflet in a format suitable for you.

®

Important things you need to know about
Calcort

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your
doctor or pharmacist.
• This medicine has been prescribed for you. Do not
give it 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.
• Your doctor may have given you this medicine
before from another company. It may have looked
slightly different. However, either brand will have the
same effect.

In this leaflet:
1. What Calcort is and what it is used for
2. Before you take Calcort
3. How to take Calcort
4. Possible side effects
5. How to store Calcort
6. Further information

• These corticosteroids occur naturally in the body,
and help to maintain health and wellbeing.
• Boosting your body with extra corticosteroid (such
as Calcort) is an effective way to treat various
illnesses involving inflammation in the body.
• Calcort works by reducing this inflammation, which
could otherwise go on making your condition worse.
• Calcort also works by stopping reactions known as
autoimmune reactions. These reactions happen
when your body’s immune system attacks the body
itself and causes damage.
• You must take this medicine regularly to get
maximum benefit from it.

Calcort can be used to:

• Treat inflammation including asthma, arthritis and
allergies
• Treat problems with your skin, kidney, heart,
digestive system, eyes or blood
• Treat problems where your body has growths
(tumours)
• Suppress the immune system in transplant
operations

2. Before you take Calcort
Do not take this medicine and tell your
doctor if:

× You are allergic (hypersensitive) to deflazacort or
any of the other ingredients in these tablets (see
Section 6: Further information)
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of your
lips, face, throat or tongue
× You have an infection that affects your whole body
(systemic infection), which is not already being
treated
× You are having or have recently had any
vaccinations with live viruses (see ‘vaccinations’
below)
Do not take this medicine if any of the above apply to
you. If you are not sure, talk to your doctor or
pharmacist before taking Calcort.

Take special care and check with your
doctor before you take Calcort if:
S You have ever had severe depression or
manic-depression (bipolar disorder).
This includes having had depression before while
taking steroid medicines like Calcort.
S Any of your close family has had these illnesses.
S You have or ever had mental problems such as
depression or psychoses.
If any of the above applies to you, talk to a doctor
before taking Calcort.

Mental problems while taking Calcort
Mental health problems can happen while taking
steroids like Calcort (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.

Check with your doctor before taking this
medicine if:







You have epilepsy (fits)
You or anyone in your family has diabetes
You have high blood pressure
You have kidney, liver or heart problems
You have brittle or weak bones called osteoporosis
You have an eye disease that causes detachment
of your retina and bulging eyes
• You or anyone in your family has an eye problem
called glaucoma
• You have an underactive thyroid gland
• You have problems with your digestive system,
including your food pipe (oesophagitis), gut
(ulcerative colitis, diverticulitis) or stomach (peptic
ulcer)
• You have ever had a bad reaction such as muscle
weakness to any steroid
• You have or ever had an infection caused by a virus
or fungus. This includes infections such as athlete’s
foot, thrush and cold sores (that may also affect the
eye)
• You have or ever had ‘tuberculosis’ (TB)
• You have any problems with your blood vessels
such as a blood clot
Calcort may cause inflammation of tendons and easy
tearing especially when given together with antibiotics
such as ciprofloxacin.
Irregular periods in women and blood problems such as
leukocytosis (increase in white blood cells count) may
also occur.
If any of the above apply to you, your doctor may want
to see you more often during your treatment.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines.
This includes medicines you obtain without a
prescription, including herbal medicines. This is
because Calcort and other medicines can affect the
way some other medicines work.
Some medicines may increase the effects of Calcort
and your doctor may wish to monitor you carefully if you
are taking these medicines (including some medicines
for HIV: ritonavir, cobicistat).
In particular, check with your doctor if you are taking
any of the following medicines. Your doctor may want to
change the dose of Calcort, or the other medicine.
• Painkillers such as aspirin
• Aminoglutethimide – used for some types of cancer
• Ketoconazole – used to treat infections
• Water tablets (diuretics) such as spironolactone,
triamterene or amiloride

• Medicines for thinning your blood (such as warfarin)
• Medicines for diabetes
• Medicines for epilepsy such as phenobarbitone,
primidone, phenytoin, carbamazepine,
acetazolamide
• Medicines which contain oestrogens including oral
contraceptives
• Medicines for tuberculosis (TB) such as rifampicin or
rifabutin
• Medicines for high blood pressure
• Medicines for indigestion and heartburn (antacids). If
you are taking an antacid leave at least 2 hours
between taking it and Calcort
• Medicines for asthma such as salbutamol and
theophylline.

Vaccinations
If you have just had any injections or vaccinations, tell
your doctor before you take Calcort. If you are going to
have any injections or vaccinations, tell your doctor or
nurse you are taking Calcort. This includes those
needed for a foreign holiday. Some vaccines should not
be given to patients taking Calcort. This is because
Calcort can affect the way some vaccines work.

Operations
If you are going to have an operation, tell your doctor or
nurse you are taking Calcort. Muscle relaxants are
sometimes used during an operation or in intensive
care unit. Calcort and muscle relaxants can affect one
another.

Pregnancy and breast-feeding
Talk to your doctor before taking Calcort if:
• You are pregnant, plan to get pregnant, or think you
may be pregnant
• You are breast-feeding, or planning to breast-feed

Calcort and infections
Taking Calcort can mean that you get infections more
easily than usual, and these infections can be more
serious.
Chickenpox, measles or shingles
If you get chickenpox, measles or shingles while taking
Calcort, you can become seriously ill
• Keep away from people who have chickenpox,
measles or shingles, if you have never had them.
They could affect you severely. If you do come into
contact with chickenpox, measles or shingles, see
your doctor straight away. Your doctor may want to
give you a vaccination to help you from getting these
infections.
• If you do catch Chickenpox, measles or shingles, tell
your doctor straight away. Your doctor will advise
you on how to take Calcort. You may be told to
increase the number of tablets that you use.

Blue steroid card

• If you take this medicine for more than three
weeks, you will be given a blue ‘steroid card’ by your
doctor or pharmacist
• It contains information about your medicine,
including dose instructions. This is important if you
fall ill or are in an accident
• You should carry the card with you at all times

Important information about some ingredients
in Calcort
This medicine contains lactose. If you have been told
that you cannot digest or tolerate some sugars, talk to
your doctor before taking this medicine

3. How to take Calcort
Always take Calcort exactly as your doctor has told you.
The dose will depend on the illness being treated and
any other medicines you are taking. You should check
with your doctor or pharmacist if you are not sure.

Taking this medicine

• Take this medicine by mouth
• Swallow your tablets whole with a glass of water
• It is important to take your medicine at the right
times

Adults

• The usual dose for most conditions, including
rheumatoid arthritis is half to three tablets each day
• The dose for severe asthma may be up to 8 or 12
tablets each day. This dose may be gradually
reduced once the asthma attack has been
controlled.
• For some problems up to 20 tablets may be needed
each day for several days

Children

• Calcort may be given every day or every other day
• The doctor will work out the dose based on your
child’s age and weight
• Your child will be given the lowest possible dose.
• The usual dose for chronic arthritis is between
0.25mg and 1mg of the medicine for each kg of your
child’s bodyweight, each day.
The usual dose for kidney problems (nephrotic
syndrome) is 1.5mg of the medicine for each kg of
your child’s bodyweight, each day. Depending on
how well the medicine works for your child, this dose
may then be slowly lowered.
• The usual dose for asthma is between 0.25mg and
1mg of the medicine for each kg of your child’s
bodyweight, every other day.

Elderly
Your doctor may need to check you more carefully for
side effects

If you take more Calcort than you should
Tell your doctor or go to the nearest hospital casualty
department straight away. Remember to take with you
any tablet that are left and the pack.
This is so the doctor knows what you have taken.

If you forget to take Calcort
If you forget to take a dose take it as soon as you
remember, unless it is time for your next dose. Do not
take a double dose to make up for a forgotten dose.

Stopping treatment

• You need to take Calcort regularly to get the
maximum benefit
• Do not stop taking this medicine without talking to
your doctor - you may need to lower the dose
gradually
• Stopping the treatment suddenly can sometimes
cause problems such as a high temperature, a runny
nose, sore, red, sticky eyes, aching muscles and
joints, itchy skin and weight loss. Also, sickness

(vomiting), headaches and drowsiness – this is more
likely to happen in children
You may also notice the following symptoms if you stop
treatment with Calcort. If this happens, tell a doctor
straight away as these could be signs of a serious
illness:
• Sudden, severe pain in the back, stomach and legs
• Being sick (vomiting) and diarrhoea
• Feeling faint or dizzy, this could be a sign of low
blood pressure

4. Possible side effects
Like all medicines, Calcort can cause side effects,
although not everybody gets them.
Stop taking your medicine and see a doctor or go to
a hospital straight away if:
Uncommon (affects 1 to 10 users in 1,000)
• You get swelling of the hands, feet, ankles, face, lips
or throat which may cause difficulty in swallowing or
breathing. You could also notice an itchy, lumpy
rash (hives) or nettle rash (urticaria). This may mean
you are having an allergic reaction to Calcort.
• You pass black tarry stools or notice fresh or clotted
blood in your stools (faeces). You may also notice
dark bits that look like coffee grounds in your vomit.
These could be signs of a stomach ulcer.

Not known (frequency cannot be estimated from the
available data)
• You get severe stomach pain which may reach
through to your back. This could be a sign of
pancreatitis
Serious effects: Tell a doctor straight away if you
notice any of the following side effects:
Steroids including Calcort 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 Calcort.
Serious effects: Tell a doctor straight away if you
notice any of the following side effects.
Uncommon (affects 1 to 10 users in 1,000)
• Feeling depressed, including thinking about suicide.
Not known (frequency cannot be estimated from the
available data)
• 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.

Other serious side effects include:
Not known (frequency cannot be estimated from the
available data)
• A very sore throat. You may also have difficulty in
swallowing and the inside of your mouth may have
white areas on the surface
• Headache, which is usually worse in the morning, on
coughing or straining, and feeling sick (nausea).
Also, fits, fainting, eyesight problems, painful eyes or
confusion can occur. If you notice any of these
problems talk to a doctor straight away.

Other side effects:
Please tell your doctor or pharmacist if any of the
following side effects gets serious or lasts longer than a
few days.

Uncommon (affects 1 to 10 users in 1,000)

• Stomach or bowel problems such as feeling full or
bloated, indigestion, heartburn or stomach pain
• Increase in appetite and weight gain including
around your face. Or, you may lose weight or feel
weak.
• Hair, including body or facial hair, grows more than
normal
• Increased thirst and needing to pass water more
often than usual. These could be signs of diabetes.
If you are already diabetic, your doctor may
prescribe more of your diabetes medicine to balance
the effects of deflazacort. You should discuss this
with your doctor
• Raised blood pressure and increased water
retention
• Tiredness, confusion, muscle weakness or muscle
cramps. This may be due to low levels of potassium
in your body
• Mood changes, difficulty in sleeping
• If you have had tuberculosis (TB) in the past it may
return
• Skin problems such as acne, appearance of stretch
marks
• You may get infections more easily than usual

Rare (affects 1 to 10 users in 10,000)



Bleeding under the skin, redness
General muscle weakness or tiredness

Not known (frequency cannot be estimated from
the available data)
• Bones and tendons may break or tear more easily
than usual. Also tendons may get inflamed and
become painful.
• Irregular periods in women or they may stop
altogether
• Becoming dependent on deflazacort (also called
psychological dependence)
• If you have schizophrenia your symptoms may get
worse
• Fungal infection such as thrush
• Eye disease that causes detachment of the retina
and bulging eyes
• Eye problems such as glaucoma and cataracts can
happen if you take this medicine for a long time
• Eye infections (viral) may spread or return if you
have had them in the past
• Increase in the risk of clots forming in your blood
• Blood problems such as leukocytosis
• Wounds and cuts do not heal as quickly as usual
• Noticeable blood vessels, thinning of the skin
• Sudden or severe muscle weakness or tiredness
following an operation
Some of the side effects are more likely to happen if
you are elderly

Children and teenagers taking this medicine may
grow less than normal. (Not known: frequency cannot
be estimated from the available data)
If you think this is happening to a child, tell your doctor.

Reporting of side effects

Package Leaflet: Information For The User

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.

Deflazacort 6mg Tablets

5. How to store Deflazacort
• Keep out of the sight and reach of children.
• Do not store above 25°C. Store in the original
package.
• Do not take the tablets after the expiry date which is
stated on the carton and blisters label after ‘Exp’.
The expiry date refers to the last day of that month.
• If the tablets become discoloured or show any signs
of deterioration, seek the advice of your pharmacist
• Remember if your doctor tells you to stop taking this
medicine, return any unused medicine to your
pharmacist for safe disposal. Only keep this
medicine if your doctor tells you to.
• 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 Deflazacort contains
The active ingredient in Deflazacort is deflazacort.
Each tablet contains 6mg deflazacort.
The other ingredients are lactose, maize starch,
microcrystalline cellulose and magnesium stearate.

What Deflazacort looks like and contents of the
pack
Deflazacort is round, white, uncoated tablet marked
with a cross on one face and a ‘6’ on the other face.
Deflazacort comes in boxes of 20 tablets.

Manufactured by: Faes Farma S.A., Maximo Aguirre
14, 48940 Leioa, Vizcaya, Spain.

Procured from within the EU and repackaged
by the Product Licence holder: B&S Healthcare,
Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU,
UK.
Deflazacort 6mg Tablets; PL 18799/1063
POM
Leaflet date: 21.06.2017

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 0208 515 3763 to obtain the
leaflet in a format suitable for you.

1. What Deflazacort is and what it is
used for

The name of your medicine is Deflazacort 6mg Tablets
but will be referred to as Deflazacort throughout this
leaflet.

Deflazacort is a steroid medicine. Their full name is

Important things you need to know about
Deflazacort

• These corticosteroids occur naturally in the body,
and help to maintain health and wellbeing.
• Boosting your body with extra corticosteroid (such
as Deflazacort) is an effective way to treat various
illnesses involving inflammation in the body.
• Deflazacort works by reducing this inflammation,
which could otherwise go on making your condition
worse.
• Deflazacort also works by stopping reactions known
as autoimmune reactions. These reactions happen
when your body’s immune system attacks the body
itself and causes damage.
• You must take this medicine regularly to get
maximum benefit from it.

• Deflazacort is a steroid medicine. This can be
prescribed for many different conditions, including
serious illnesses.
• You need to take it regularly to get the maximum
benefit.
• Do not stop taking this medicine without talking to
your doctor - you may need to lower the dose
gradually.
• Deflazacort can cause side effects in some
people (read section 4 for more information). These
include problems such as mood changes (feeling
depressed, or ‘high’), or stomach problems, which
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 be
given 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,
measles 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
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your
doctor or pharmacist.
• This medicine has been prescribed for you. Do not
give it 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.
• Your doctor may have given you this medicine
before from another company. It may have looked
slightly different. However, either brand will have the
same effect.

In this leaflet:
1. What Deflazacort is and what it is used for
2. Before you take Deflazacort
3. How to take Deflazacort
4. Possible side effects
5. How to store Deflazacort
6. Further information

glucocorticoids.
How Deflazacort works

Deflazacort can be used to:

• Treat inflammation including asthma, arthritis and
allergies
• Treat problems with your skin, kidney, heart,
digestive system, eyes or blood
• Treat problems where your body has growths
(tumours)
• Suppress the immune system in transplant
operations

2. Before you take Deflazacort
Do not take this medicine and tell your
doctor if:

× You are allergic (hypersensitive) to deflazacort or
any of the other ingredients in these tablets (see
Section 6: Further information)
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of your
lips, face, throat or tongue
× You have an infection that affects your whole body
(systemic infection), which is not already being
treated
× You are having or have recently had any
vaccinations with live viruses (see ‘vaccinations’
below)
Do not take this medicine if any of the above apply to
you. If you are not sure, talk to your doctor or
pharmacist before taking Deflazacort.

Take special care and check with your
doctor before you take Deflazacort if:
S You have ever had severe depression or
manic-depression (bipolar disorder).
This includes having had depression before while
taking steroid medicines like Deflazacort.
S Any of your close family has had these illnesses.
S You have or ever had mental problems such as
depression or psychoses.
If any of the above applies to you, talk to a doctor
before taking Deflazacort.

Mental problems while taking Deflazacort
Mental health problems can happen while taking
steroids like Deflazacort (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.

Check with your doctor before taking this
medicine if:







You have epilepsy (fits)
You or anyone in your family has diabetes
You have high blood pressure
You have kidney, liver or heart problems
You have brittle or weak bones called osteoporosis
You have an eye disease that causes detachment
of your retina and bulging eyes
• You or anyone in your family has an eye problem
called glaucoma
• You have an underactive thyroid gland
• You have problems with your digestive system,
including your food pipe (oesophagitis), gut
(ulcerative colitis, diverticulitis) or stomach (peptic
ulcer)
• You have ever had a bad reaction such as muscle
weakness to any steroid
• You have or ever had an infection caused by a virus
or fungus. This includes infections such as athlete’s
foot, thrush and cold sores (that may also affect the
eye)
• You have or ever had ‘tuberculosis’ (TB)
• You have any problems with your blood vessels
such as a blood clot
Deflazacort may cause inflammation of tendons and
easy tearing especially when given together with
antibiotics such as ciprofloxacin.
Irregular periods in women and blood problems such as
leukocytosis (increase in white blood cells count) may
also occur.
If any of the above apply to you, your doctor may want
to see you more often during your treatment.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines.
This includes medicines you obtain without a
prescription, including herbal medicines. This is
because Deflazacort and other medicines can affect the
way some other medicines work.
Some medicines may increase the effects of
Deflazacort and your doctor may wish to monitor you
carefully if you are taking these medicines (including
some medicines for HIV: ritonavir, cobicistat).
In particular, check with your doctor if you are taking
any of the following medicines. Your doctor may want to
change the dose of Deflazacort, or the other medicine.
• Painkillers such as aspirin
• Aminoglutethimide – used for some types of cancer
• Ketoconazole – used to treat infections
• Water tablets (diuretics) such as spironolactone,
triamterene or amiloride

• Medicines for thinning your blood (such as warfarin)
• Medicines for diabetes
• Medicines for epilepsy such as phenobarbitone,
primidone, phenytoin, carbamazepine,
acetazolamide
• Medicines which contain oestrogens including oral
contraceptives
• Medicines for tuberculosis (TB) such as rifampicin or
rifabutin
• Medicines for high blood pressure
• Medicines for indigestion and heartburn (antacids). If
you are taking an antacid leave at least 2 hours
between taking it and Deflazacort
• Medicines for asthma such as salbutamol and
theophylline.

Vaccinations
If you have just had any injections or vaccinations, tell
your doctor before you take Deflazacort. If you are
going to have any injections or vaccinations, tell your
doctor or nurse you are taking Deflazacort. This
includes those needed for a foreign holiday. Some
vaccines should not be given to patients taking
Deflazacort. This is because Deflazacort can affect the
way some vaccines work.

Operations
If you are going to have an operation, tell your doctor or
nurse you are taking Deflazacort. Muscle relaxants are
sometimes used during an operation or in intensive
care unit. Deflazacort and muscle relaxants can affect
one another.

Pregnancy and breast-feeding
Talk to your doctor before taking Deflazacort if:
• You are pregnant, plan to get pregnant, or think you
may be pregnant
• You are breast-feeding, or planning to breast-feed

Deflazacort and infections
Taking Deflazacort can mean that you get infections
more easily than usual, and these infections can be
more serious.
Chickenpox, measles or shingles
If you get chickenpox, measles or shingles while taking
Deflazacort, you can become seriously ill
• Keep away from people who have chickenpox,
measles or shingles, if you have never had them.
They could affect you severely. If you do come into
contact with chickenpox, measles or shingles, see
your doctor straight away. Your doctor may want to
give you a vaccination to help you from getting these
infections.
• If you do catch Chickenpox, measles or shingles, tell
your doctor straight away. Your doctor will advise
you on how to take Deflazacort. You may be told to
increase the number of tablets that you use.

Blue steroid card

• If you take this medicine for more than three
weeks, you will be given a blue ‘steroid card’ by your
doctor or pharmacist
• It contains information about your medicine,
including dose instructions. This is important if you
fall ill or are in an accident
• You should carry the card with you at all times

Important information about some ingredients
in Deflazacort
This medicine contains lactose. If you have been told
that you cannot digest or tolerate some sugars, talk to
your doctor before taking this medicine

3. How to take Deflazacort
Always take Deflazacort exactly as your doctor has told
you. The dose will depend on the illness being treated
and any other medicines you are taking. You should
check with your doctor or pharmacist if you are not
sure.

Taking this medicine

• Take this medicine by mouth
• Swallow your tablets whole with a glass of water
• It is important to take your medicine at the right
times

Adults

• The usual dose for most conditions, including
rheumatoid arthritis is half to three tablets each day
• The dose for severe asthma may be up to 8 or 12
tablets each day. This dose may be gradually
reduced once the asthma attack has been
controlled.
• For some problems up to 20 tablets may be needed
each day for several days

Children

• Deflazacort may be given every day or every other
day
• The doctor will work out the dose based on your
child’s age and weight
• Your child will be given the lowest possible dose.
• The usual dose for chronic arthritis is between
0.25mg and 1mg of the medicine for each kg of your
child’s bodyweight, each day.
The usual dose for kidney problems (nephrotic
syndrome) is 1.5mg of the medicine for each kg of
your child’s bodyweight, each day. Depending on
how well the medicine works for your child, this dose
may then be slowly lowered.
• The usual dose for asthma is between 0.25mg and
1mg of the medicine for each kg of your child’s
bodyweight, every other day.

Elderly
Your doctor may need to check you more carefully for
side effects

If you take more Deflazacort than you should
Tell your doctor or go to the nearest hospital casualty
department straight away. Remember to take with you
any tablet that are left and the pack.
This is so the doctor knows what you have taken.

If you forget to take Deflazacort
If you forget to take a dose take it as soon as you
remember, unless it is time for your next dose. Do not
take a double dose to make up for a forgotten dose.

Stopping treatment

• You need to take Deflazacort regularly to get the
maximum benefit
• Do not stop taking this medicine without talking to
your doctor - you may need to lower the dose
gradually
• Stopping the treatment suddenly can sometimes
cause problems such as a high temperature, a runny
nose, sore, red, sticky eyes, aching muscles and

joints, itchy skin and weight loss. Also, sickness
(vomiting), headaches and drowsiness – this is more
likely to happen in children
You may also notice the following symptoms if you stop
treatment with Deflazacort. If this happens, tell a doctor
straight away as these could be signs of a serious
illness:
• Sudden, severe pain in the back, stomach and legs
• Being sick (vomiting) and diarrhoea
• Feeling faint or dizzy, this could be a sign of low
blood pressure

4. Possible side effects
Like all medicines, Deflazacort can cause side effects,
although not everybody gets them.
Stop taking your medicine and see a doctor or go to
a hospital straight away if:
Uncommon (affects 1 to 10 users in 1,000)
• You get swelling of the hands, feet, ankles, face, lips
or throat which may cause difficulty in swallowing or
breathing. You could also notice an itchy, lumpy
rash (hives) or nettle rash (urticaria). This may mean
you are having an allergic reaction to Deflazacort.
• You pass black tarry stools or notice fresh or clotted
blood in your stools (faeces). You may also notice
dark bits that look like coffee grounds in your vomit.
These could be signs of a stomach ulcer.

Not known (frequency cannot be estimated from the
available data)
• You get severe stomach pain which may reach
through to your back. This could be a sign of
pancreatitis
Serious effects: Tell a doctor straight away if you
notice any of the following side effects:
Steroids including Deflazacort 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 Deflazacort.
Serious effects: Tell a doctor straight away if you
notice any of the following side effects.
Uncommon (affects 1 to 10 users in 1,000)
• Feeling depressed, including thinking about suicide.
Not known (frequency cannot be estimated from the
available data)
• 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.

Other serious side effects include:
Not known (frequency cannot be estimated from the
available data)
• A very sore throat. You may also have difficulty in
swallowing and the inside of your mouth may have
white areas on the surface
• Headache, which is usually worse in the morning, on
coughing or straining, and feeling sick (nausea).
Also, fits, fainting, eyesight problems, painful eyes or
confusion can occur. If you notice any of these
problems talk to a doctor straight away.

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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