CALCORT 6MG TABLETS

Active substance: 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.

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16-06-2014
IST CALCORT 6MG GB I02
1
11pt su 10,5pt

4-1/4

If any of the above applies to you, talk
to a doctor before taking Calcort.

-

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

167 x 304,8 DP

This leaflet was last revised in May 2014
© Sanofi 2008 - 2014

62C0006

This leaflet does not contain all the
information about your medicine. If you have
any questions or are not sure about anything,
ask your doctor or pharmacist.

Take special care and check with your
doctor before you take Calcort if:
SYou have ever had severe depression or
S
manic-depression (bipolar disorder).
This includes having had depression before
while taking steroid medicines like Calcort.
SAny of your close family has had these
S
illnesses.
SYou have or ever had mental problems
S
such as depression or psychoses.

0001110000

Manufacturer
Sanofi-aventis S.p.A
67019 Scoppito (L’Aquila), Italy

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.

Istruzione

Marketing Authorisation Holder
Sanofi, One Onslow Street, Guildford,
Surrey, GU1 4YS, UK
Tel: 0845 372 7101
email: uk-medicalinformation@sanofi.com

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)

PACK. ITEM:

Marketing Authorisation Holder and
Manufacturer

2. Before you take Calcort

Arkhé S.a.s.

What Calcort looks like and contents of the
pack
Calcort 6mg Tablets are round, white,
uncoated tablets, marked with a cross on one
face and a ‘6’ on the other face.

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

GB: GREAT BRITAIN

What Calcort contains
• Each tablet contains 6mg of the active
substance, deflazacort.
• The other ingredients are microcrystalline
cellulose, lactose, maize starch and
magnesium stearate.

Important things you need to know about
Calcort
• 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.
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

How Calcort works
• 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.

 Reflex Blue

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.

6. Further information

Is this leaflet hard to see or
read?
Phone 0845 372 7101 for help

The name of your medicine is Calcort 6mg
Tablets (called Calcort throughout this leaflet).
Calcort is a steroid medicine. Their full name
is glucocorticoids.

Verificare la corrispondenza delle pellicole
con l’artwork approvato - la nostra
responsabilità è limitata al rifacimento
delle eventuali pellicole errate.

Some of the side effects are more likely to
happen if you are elderly

• Keep out of the sight and reach of children.
• Do not take this medicine after the expiry
date, which stated on the carton after “EXP”.
The expiry date refers to the last day of that
month.
• Keep this medicine below 25°C. Keep it in
the pack in which it was given to you. Do
not transfer your medicine to another
container
• Ask your pharmacist how to dispose of
medicines no longer required. Do not
dispose of medicines by flushing down a
toilet or a sink or by throwing out with your
normal household rubbish. This will help to
protect the environment.

Deflazacort

Tel. 0862.404140
fax 0862.404140

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 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

5. How to store Calcort

Calcort 6mg Tablets

1. What Calcort is and what
it is used for

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Rare (affects 1 to 10 users in 10,000)
• Bleeding under the skin, redness
• General muscle weakness or tiredness

By reporting side effects you can help provide
more information on the safety of this
medicine.

PACKAGE LEAFLET: INFORMATION FOR THE USER

1 - Prima realizzazione

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

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 the
Yellow Card Scheme at: www.mhra.gov.uk/
yellowcard.

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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.

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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

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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.

16-06-2014
IST CALCORT 6MG GB I02

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

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.

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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

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

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.

Arkhé S.a.s.

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.

167 x 304,8 DP

Calcort and infections
Taking Calcort can mean that you get infections
more easily than usual, and these infections
can be more serious.

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.

62C0006

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

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

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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
0.25 mg and 1 mg of the medicine for each
kg of your child’s bodyweight, each day.
The usual dose for kidney problems (nephrotic
syndrome) is 1.5 mg 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 0.25 mg
and 1 mg of the medicine for each kg of
your child’s bodyweight, every other day.

Istruzione

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.

GB: GREAT BRITAIN

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

 Reflex Blue

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.

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.

PACK. ITEM:

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

Verificare la corrispondenza delle pellicole
con l’artwork approvato - la nostra
responsabilità è limitata al rifacimento
delle eventuali pellicole errate.

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)

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.

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

Tel. 0862.404140
fax 0862.404140

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.

3. How to take Calcort

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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 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.

• 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.

1 - Prima realizzazione

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.

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.

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