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PREDNISOLONE 25MG TABLETS

Active substance: PREDNISOLONE

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R766620

Sanofi
UK

Prednisolone
R766620
25 mg
cprs

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The name of your medicine is Prednisolone 25mg Tablets
(called Prednisolone throughout this leaflet). Prednisolone
is a steroid medicine. Their full name is glucocorticoids.
How Prednisolone works
• These corticosteroids occur naturally in the body, and
help to maintain health and well-being.
• Boosting your body with extra corticosteroid (such as
prednisolone) is an effective way to treat various
illnesses involving inflammation in the body.

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Do not take this medicine and tell your doctor if:
• You are allergic (hypersensitive) to prednisolone, or
any of the ingredients in these tablets (see Section 6:
Further information)
Signs of an allergic reaction include: 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
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 prednisolone.
Take special care and check with your doctor
before you take prednisolone if:
• You have ever had severe depression or
manic-depression (bipolar disorder). This includes
having had depression before while taking steroid
medicines like prednisolone.
• Any of your close family has had these illnesses.

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2. BEFORE YOU TAKE PREDNISOLONE

• Prednisolone works by reducing this inflammation,
which could otherwise go on making your condition
worse.
• Prednisolone 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.
Prednisolone can be used to treat:
• Illnesses (sometimes called collagen disease) which
cause inflammation of the skin, muscles or joints.
These include rheumatic fever and systemic lupus
erythematosus (SLE)
• Blood problems such as anaemia and leukaemia
• Skin and kidney problems
• Stomach problems such as ulcerative colitis

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1. WHAT PREDNISOLONE IS AND WHAT
IT IS USED FOR

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 Prednisolone is and what it is used for
2. Before you take Prednisolone
3. How to take Prednisolone
4. Possible side effects
5. How to store Prednisolone
6. Further information

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Patient Information Leaflet
Important things you need to know about
Prednisolone
• Prednisolone 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.
• Don’t stop taking this medicine without talking to
your doctor - you may need to lower the dose
gradually.
• Prednisolone 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 that 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 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

PREDNISOLONE 25MG TABLETS

COMPIÈGNE

NA
A6 - 05.10.2011
1-606062
606062-1d
150 x 210 mm
8 pts
Code sécurité
766620

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Numéro de Pages
1 / 4

Prednisolone and infections
Taking Prednisolone can mean that you get infections
more easily than usual, and these infections can be more
serious
Chicken pox or shingles
If you get chickenpox or shingles while taking
prednisolone, you can become seriously ill.
• 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.
• If you do come into contact with someone with these
infections, you must see your doctor or pharmacist
straightaway. Your doctor may want to give you a
vaccination to help stop you from getting these
infections.
• If you do catch chicken pox or shingles, tell your
doctor straightaway. Your doctor will advise you on
how to take prednisolone. You may be told to increase
the number of tablets that you take.
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 were to fall
ill or be involved in an accident
• You should carry the card with you at all times
Important information about some of the
ingredients in Prednisolone
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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Sanofi
UK

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Prednisolone
R766620
25 mg
cprs
1

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N° version Country Ex.
N° plan Dimensionnel
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Taking other medicines
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines. This includes
medicines obtained without a prescription, including
herbal medicines. This is because prednisolone and other
medicines can affect the way each other work.
In particular, check with your doctor if you are taking any
of the following medicines. Your doctor may want to
change the dose of prednisolone, or the other medicine.
• Painkillers such as aspirin
• Aminoglutethimide - used for some types of cancer
• Medicines for thinning your blood (such as warfarin)
• Medicines for diabetes
• Medicines for epilepsy
• Medicines for tuberculosis (TB)
• Medicines which contain oestrogens including oral
contraceptives
Vaccinations
If you have just had any injections or vaccinations, tell
your doctor before you take prednisolone. If you are going
to have any injections or vaccinations, tell your doctor or
nurse you are taking prednisolone. This includes those
needed for a foreign holiday. Some vaccines should not
be given to patients taking prednisolone. This is because
prednisolone can affect the way some vaccines work.
Operations
If you are going to have an operation, tell your doctor or
nurse you are taking prednisolone. Muscle relaxants are
sometimes used during an operation or in an intensive
care unit. These and prednisolone can affect one another.
Pregnancy and breast-feeding
Talk to your doctor before taking prednisolone if:
• You are pregnant, plan to get pregnant, or think you
may be pregnant
• You are breast-feeding, or planning to breast-feed

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• 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 prednisolone.
Mental problems while taking prednisolone
Mental health problems can happen while taking steroids
like prednisolone (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 or anyone in your family has an eye problem
called ‘glaucoma’
• You have or ever had a stomach 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
• You have or ever had ‘tuberculosis’ (TB)
If any of the above apply to you, your doctor may want to
see you more often during your treatment.

COMPIÈGNE

NA
A6 - 05.10.2011
1-606062
606062-1d
150 x 210 mm
8 pts
Code sécurité
766620

Numéro de Pages
2 / 4

Couleur
Nbre/Réf.

Prednisolone
R766620
25 mg
cprs
1

N° version Logo/Name
N° version Country Ex.
N° plan Dimensionnel
N° plan positionnement
Dimensions
Taille mini caractères

-3-

Sanofi
UK

Notice double

Like all medicines, Prednisolone 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:
• 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
Prednisolone 25mg Tablets
• 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
• You get severe stomach pain which may reach through
to your back. This could be a sign of pancreatitis

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4. POSSIBLE SIDE EFFECTS

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• 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:
If any of these side effects gets serious or lasts longer
than a few days, or if you notice any side effects not
listed in the leaflet, please tell your doctor or pharmacist.
• Stomach or bowel problems such as feeling full or
bloated, indigestion, heartburn or stomach pain
• Increase in appetite and weight gain including
developing a rounder face. Or, you may lose weight or
feel weak.
• Bones and tendons may break or tear more easily than
usual (called ‘osteoporosis’)
• Irregular periods in women or they may stop altogether
• Hair, including body or facial hair, grows more than normal

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Other serious side effects include:

Serious effects: Tell a doctor straight away if you
notice any of the following side effects:
Steroids including prednisolone 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 prednisolone. These side effects
include:
• Feeling depressed, including thinking about suicide
• Feeling high (mania) or moods that go up and down
• Feeling anxious, having problems sleeping, difficulty in
thinking or being confused and losing your memory
• Feeling, seeing or hearing things which do not exist.
Having strange and frightening thoughts, changing
how you act or having feelings of being alone

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Always take prednisolone 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
• Swallow your tablets whole with a glass of water
• It is important to take your medicine at the right times
Usual doses
• The usual starting dose is 3 tablets, taken together
each morning
• Your doctor may decide that you need more tablets
than this each day
• Your doctor may tell you to take the medicine every
other morning
• Your doctor may change your dose if you have been
taking prednisolone for a long time, if you become ill
or need to have an operation
Always follow your doctor's advice about how and when
to take your medicine and always read the label on the
pack. If you are not sure, ask your doctor or pharmacist.
If you take more Prednisolone than you should
Tell your doctor or go to the nearest hospital casualty
department straight away. Remember to take with you
any tablets that are left and the pack. This is so the
doctor knows what you have taken.
If you forget to take Prednisolone
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 Prednisolone regularly to get the
maximum benefit.
• Don’t 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 prednisolone. If this happens, tell a doctor
straightaway 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

Version N°

3. HOW TO TAKE PREDNISOLONE

COMPIÈGNE

NA
A6 - 05.10.2011
1-606062
606062-1d
150 x 210 mm
8 pts
Code sécurité
766620

Black U
Numéro de Pages
3 / 4

Sanofi
UK

Notice double

Nom du produit
Référence article
Dosage
Quantité
Couleur
Nbre/Réf.

Prednisolone
R766620
25 mg
cprs
1

N° version Logo/Name
N° version Country Ex.
N° plan Dimensionnel
N° plan positionnement
Dimensions
Taille mini caractères
NA
A6 - 05.10.2011
1-606062
606062-1d
150 x 210 mm
8 pts

Black U

R766620

Laboratoires
Pays

Type Article

-4-

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• Keep out of the reach and sight of children.
• Do not take this medicine after the expiry date, which
you will find on the pack.
• Keep this medicine below 25°C, in a dry place and
protect it from light. 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.

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What Prednisolone 25mg Tablets contain:
Each tablet contains 25mg of the active ingredient,
prednisolone.
Other ingredients are: lactose, potato starch,
pregelatinised maize starch, magnesium stearate and
purified talc.
What Prednisolone 25mg Tablets look like and
contents of the pack:
Prednisolone 25mg tablets are white, round, bevel edged
tablets with a break line on one side and plain on the
other.
This medicine comes in blister packs of 56 tablets.
The Marketing Authorisation Holder is: Zentiva, One
Onslow Street, Guildford, Surrey, GU1 4YS, UK.
The Manufacturer is: Sanofi Zentiva Industrie
56, route de Choisy au Bac, 60205 Compiègne cedex,
France
This leaflet was revised July 2012.

6. FURTHER INFORMATION

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5. HOW TO STORE PREDNISOLONE

Children and teenagers taking this medicine may grow
less than normal. If you think this is happening to a child,
tell your doctor.
If any of the side effects get serious or lasts longer than a
few days, or if you notice any side effects not listed in the
leaflet, please tell your doctor or pharmacist.

Version N°

• 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 effect of
prednisolone. You should discuss this with your doctor
• Raised blood pressure and increased water retention
• Tiredness, confusion, and muscle weakness and
muscle cramps. This may be due to low levels of
potassium in your body
• Mood changes, difficulty in sleeping
• Becoming dependent on prednisolone (also called
psychological dependence)
• If you have epilepsy you may notice you get fits
(seizures) more often than usual or they are more
severe. If this happens, tell your doctor as he/she may
want to change the dose of your epilepsy medicine
while you are taking prednisolone
• If you have schizophrenia your symptoms may get
worse
• If you have had tuberculosis (TB) in the past it may
return
• Eye problems such as glaucoma and cataracts can
happen if you take this medicine for a long time
• Eye infections (fungal or 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
• Skin problems such as acne, flushing, redness,
thinning of the skin and appearance of stretch marks
• General muscle weakness or tiredness
• You may get infections more easily than usual
• Sudden or severe muscle weakness or tiredness
following an operation or time spent as a patient in an
Intensive Care Unit (see Section 2 above on
‘Vaccinations or operations’)
Some of the above effects are more likely to happen if
you are elderly



COMPIÈGNE

Code sécurité
766620

Numéro de Pages
4 / 4

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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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