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CALCORT 6MG TABLETS

Active substance(s): DEFLAZACORT / DEFLAZACORT / DEFLAZACORT

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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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62C0007

89030315

167 x 315mm DP
3
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If any of the above applies to you, talk to
a doctor before taking Calcort.

20-12-2016
IST CALCORT 6MG GB I02

1000011011

This leaflet was last revised in December 2016
© Sanofi 2008 - 2016

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

Istruzioni

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:
SSYou have ever had severe depression or
manic-depression (bipolar disorder).
This includes having had depression before
while taking steroid medicines like Calcort.
SSAny of your close family has had these
illnesses.
SSYou have or ever had mental problems such as
depression or psychoses.

4, 1 / 4

Manufacturer
Sanofi S.p.A
S.S. 17 KM 22 - 67019 Scoppito (AQ), 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.

Sanofi S.p.A.

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)

Verificare la corrispondenza dell’artwork
approvato - la nostra responsabilità è
limitata al rifacimento dei file forniti.

Marketing Authorisation Holder and
Manufacturer

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

2. Before you take Calcort

Arkhé S.n.c.

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.

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.

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

Tel. 0862.404140
fax 0862.090006

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

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.

PACK. ITEM:

6. Further information

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.

GB: GREAT BRITAIN

• 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.

Is this leaflet hard to see or read? How Calcort works
• These corticosteroids occur naturally in the
Phone 0845 372 7101 for help

 Reflex Blue

5. How to store Calcort

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

3 - Modifica testo reg.

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

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

Deflazacort

2 - Modifica testo reg.

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

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.

Calcort 6mg Tablets

1. What Calcort is and what
it is used for

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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

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.

PACKAGE LEAFLET: INFORMATION FOR THE USER

1 - Prima realizzazione

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.

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

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20-12-2016
IST CALCORT 6MG GB I02

167 x 315mm DP
3
-

10,5 pt su 11 pt

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.

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.

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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.

Istruzioni

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.

PACK. ITEM:

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.

2, 3 / 4

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:
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.

GB: GREAT BRITAIN

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.

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

Sanofi S.p.A.

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

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.

 Reflex Blue

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 breastfeed

Like all medicines, Calcort can cause side effects,
although not everybody gets them.

Verificare la corrispondenza dell’artwork
approvato - la nostra responsabilità è
limitata al rifacimento dei file forniti.

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.

4. Possible side effects

Arkhé S.n.c.

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.

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

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 0862.090006

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

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.

3 - Modifica testo reg.

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

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.

3. How to take Calcort

• 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

2 - Modifica testo reg.

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).

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

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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 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.

• 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.

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 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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