PREDNISOLONE TABLETS BP 5MG

Active substance: PREDNISOLONE

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Each tablet contains:
Prednisolone B.P. 5 mg.
Lactose is also present.

Prednisolone Tablets
B.P. 5 mg

DOSE: As directed by a
medical practitioner.
Please read the enclosed
Patient Information Leaflet.

PL 17509/0053

POM

KEEP ALL MEDICINES OUT
OF THE REACH AND
SIGHT OF CHILDREN.
B.N.:
D.O.M:
EXP.:

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PEEL HERE

Intrapharm Laboratories Ltd,
The Courtyard Barns,
Choke Lane,
Maidenhead,
Berkshire, SL6 6PT, UK.

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Store in a dry place below
25°C. Protect from light.

laboratories 50 tablets

Page 2

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• Prednisolone can cause side
PATIENT INFORMATION LEAFLET
PREDNISOLONE TABLETS B.P. 5 mg effects in some people (read
section 4 below). Some problems
• Prednisolone is a steroid
such as mood changes (feeling
medicine, prescribed for many
depressed, or 'high'), or stomach
different conditions, including serious
problems can happen straight away.
illnesses.
If you feel unwell in any way, keep
• You need to take it regularly to get
taking your tablets, but see your
the maximum benefit.
doctor straight away.
• Don’t stop taking this medicine
• Some side effects only happen
without talking to your doctor - you
after weeks or months. These
may need to reduce the dose
include weakness of arms and legs,
gradually.

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depends on the illness being
treated and your daily dose
may be between 5 and 60 mg.
Your doctor might tell you to
take it every other day. Your
doctor might reduce the dose
once your condition starts to
get better.
These tablets should be
swallowed whole with a glass
of water, preferably in the
morning after food.

Stopping taking
prednisolone: If you feel
better whilst taking these
tablets do not stop taking them.
Rather continue with the
course of treatment prescribed
by your doctor. For patients
receiving long-term treatment,
your doctor may wish to
monitor your progress closely
(especially if you are elderly).
If you have been on a

or developing a rounder face (read
section 4 for more information).
• If you take it for more than 3
weeks, you will get a blue
‘Steroid card': always keep it with
you and show it to a 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.
Read all of this leaflet carefully
before you start taking this
medicine because it contains
important information for you.
• Keep this leaflet. You may need to

Page 17

long-term course of treatment
your doctor may decide to cut
your dose gradually to avoid the
serious risks associated with
stopping suddenly.
Stopping treatment too
quickly or reducing dosage
too severely may be life
threatening in some patients.
Use in children and adolescents
Steroids can slow down normal

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growth. To lessen the effect the
doctor may prescribe a dose to
be taken every other day.
If any of the following happen
while you are taking
Prednisolone Tablets tell your
doctor straight away:
• If you or a close contact
catches chickenpox or
develops shingles. This is
because you may become
very ill if you get chickenpox

read it again.
• If you have any further questions,
ask your doctor or pharmacist.
• This medicine has been
prescribed for you only. Do not
pass it on to others. It may harm
them, even if their signs of
illness are the same as yours.
• If you get any side effects, talk
to your doctor or pharmacist.
This includes any possible side
effects not listed in this leaflet.

What is in this leaflet:
1. What Prednisolone Tablets are
and what they are used for
2. What you need to know before
you take Prednisolone Tablets
3. How to take Prednisolone
Tablets
4. Possible side effects
5. How to store Prednisolone
Tablets
6. Contents of the pack and other
information

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while taking prednisolone.
Avoid contact with people who
have chickenpox or shingles
while taking prednisolone and
for three months after you
have stopped taking it.
• If you or a close contact
catches measles. Avoid
contact with people who have
measles.
• If you think you might have an
infection. Infections can be

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worse when taking steroids
and need to be treated.
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.

The name of this medicine is
Prednisolone Tablets BP 5 mg
(referred to as Prednisolone
Tablets throughout this leaflet).
1. What Prednisolone Tablets
are and what they are used for
Prednisolone belongs to a group
of medicines called steroids.
Their full name is corticosteroids.
These corticosteroids occur
naturally in the body, and help to

maintain health and well-being.
Boosting your body with extra
corticosteroid (such as
prednisolone) is an effective way
to treat various illnesses involving
inflammation in the body.
Prednisolone reduces this
inflammation, which could
otherwise go on making your
condition worse. You must take
this medicine regularly to get
maximum benefit from it.

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• 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

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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.
If you take more Prednisolone
Tablets than you should:
If you take too many tablets, you
must seek medical help straight
away from your doctor or nearest
hospital casualty department.
Take any remaining tablets and

Prednisolone Tablets are used to
treat a wide range of
inflammatory and auto-immune
conditions including:
• inflammatory disorders
affecting the lungs (including
asthma), muscles and joints
(including Rheumatoid
Arthritis), bowels, kidneys,
blood vessels and heart, eyes,
nervous system
• allergies, including severe

allergic reactions
• skin conditions
• some cancers, blood disorders
and infections
• to help prevent the body
rejecting transplants.
They are also given when the
body is not making enough of its
own natural steroids and to treat
high calcium levels. They may
also be used to reduce a very
high body temperature. You must

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the container with you. It will help
your doctor.
If you forget to take
Prednisolone Tablets:
If you forget to take a dose at the
right time, take it as soon as you
remember. Do not take two
doses together. If it is almost
time for your next dose wait until
then, and then carry on as
before.
If you have any further questions

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on the use of this medicine, ask
your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine
can cause side effects, although
not everybody gets them.
Stop taking Prednisolone
Tablets and seek immediate
medical help if you develop any
of the following: sudden swelling
of the face, lips, tongue or body,

talk to a doctor if you do not feel
better or if you feel worse.
2. What you need to know
before you take Prednisolone
Tablets
Do not take Prednisolone
Tablets if you:
• are allergic (hypersensitive) to
prednisolone, other steroids, or
any other ingredients contained
in these tablets (see Section 6)

• have an infection which is not
being treated
• have a herpes infection of the
eye
• are suffering from galactose or
lactose intolerance or
glucose-galactose
malabsorption.
Check with your doctor first
• If you have ever had severe
depression or manic
depression (bipolar disorder).

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wheezing or difficulty breathing,
feeling faint, shock and collapse.
You may be having a severe
allergic reaction.
Serious effects: tell a doctor
straight away
• severe abdominal pain.
Steroids including prednisolone
can cause serious mental health
problems.
These are common in both adults
and children. They can affect

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about 5 in every 100 people
taking medicines like
Prednisolone Tablets.
• 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

This includes having had
depression before while taking
steroid medicines like
prednisolone
• If any of your close family has
had these illnesses.
If either of these applies to you,
talk to a doctor before taking
prednisolone.
Warnings and precautions
Talk to your doctor or
pharmacist before you take

Prednisolone Tablets if you
have:
• diabetes or a history of diabetes
in your family
• tuberculosis, or have ever been
treated for it
• glaucoma, or a history of
glaucoma in your family
• an eye disease affecting your
sight due to fluid build-up at the
back of the eye
• epilepsy, fits or seizures

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which do not exist. Having
strange and frightening thoughts,
changing how you act or having
feelings of being alone.
If you notice any of these
problems talk to a doctor
straight away.
Other side effects you may
experience:
• increased susceptibility to
infections, worsening of
existing infections including eye







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infections, flare-up of previous
infections e.g. tuberculosis
candida (thrush) infection,
causing a sore mouth and
throat
lesser reaction to skin tests e.g.
for tuberculosis
high blood pressure
heart problems that may cause
cough or shortness of breath
swelling or puffiness,
particularly around the ankles

• osteoporosis (bone thinning)
• gone through, or are going
through, the menopause
• high blood pressure, a heart
condition or have recently had
a heart attack
• liver or kidney problems
• a stomach ulcer, or have had
one in the past
• hypothyroidism (an underactive
thyroid gland)
• ever had a blood clot inside a

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blood vessel, for example a
DVT (deep vein thrombosis)
• Cushing’s disease
• ever had muscle weakness
caused by treatment with steroids
• a muscle weakness disorder
called Myasthenia Gravis for
which you are being treated
• Duchene’s muscular dystrophy
• a condition that is being treated
with medicines that suppress
your immune system e.g. for

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and feet
• heart muscle weakness
following a heart attack
• blood clots inside blood vessels,
higher risk of stroke
• putting on weight
• worsening of schizophrenia
• worsening of epilepsy, fits
• increase in blood glucose levels
• upset of diabetes control;
showing-up of diabetes
• inability to digest certain






carbohydrates (symptoms
include diarrhoea, bloating and
flatulence)
indigestion, pain when
swallowing, pain in the chest or
abdomen, feeling full or bloated,
diarrhoea
feeling sick or being sick
vertigo (a feeling that you or
your surroundings are moving)
loss of eye sight, blurred or
double vision, increased

cancer or after a transplant
Also talk to your doctor or
pharmacist before you take
Prednisolone Tablets if you need or
are planning to have a vaccination.
If any of the above applies to
you, or if you are not sure, talk to
your doctor or pharmacist before
you take Prednisolone Tablets.
Children and adolescents
Steroid treatment can slow down

the growth of children and
adolescents. Your doctor should
monitor this and may need to
adjust the dose for your child.
Other medicines and
Prednisolone Tablets
Tell your doctor or pharmacist if
you are taking, have recently
taken, or might take any other
medicines including any
preparations you may have
purchased yourself.

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pressure inside the eye
osteoporosis (bone thinning),
(glaucoma), bulging eyes,
weakening of the bones, bone
thinning of the eye tissues, eye fractures, damage to tendons
pain
• muscle disease, causing
buzzing in the ears
weakness or wasting, muscle
headache
pain
feeling dizzy, confused, dazed • slower than normal growth of
or drowsy
infants, children and adolescents
weakness in arms, legs or
• Cushing’s Syndrome,
down one side of the body
(symptoms include sudden
back pain
weight gain around the trunk and
bone, joint or tendon pain;
face, the face appears round)

The following medicines can
affect or can be affected by
prednisolone:
• medicines for diabetes,
including insulin
• medicines to treat epilepsy,
such as carbamazepine,
phenytoin, phenobarbital,
primidone
• anticoagulants, used to thin the
blood, e.g. warfarin
• antithyroid medicines, used to






reduce the amount of thyroid
hormones produced, e.g.
carbimazole, thiamazole
antacid medicines, used for
indigestion
aspirin
non-steroidal anti-inflammatory
drugs, used to treat pain and
swelling, e.g. indometacin,
ibuprofen
certain medicines used to treat
bacterial infections, including

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• extra hair growth
• thinning of the skin, slow
wound healing, bruising, stripes
on the skin, small blood
vessels appearing near the
surface of the skin, acne
• skin rash, hives, itching
• sweating more than usual
• irregular menstrual periods or
periods stopping completely
• feeling hungrier than usual,
increased appetite, weight gain

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• changes in the balance of
minerals in the body,
breakdown of body proteins
• increased levels of cholesterol
and altered levels of fats in the
blood
• increased number of white
blood cells
• feeling tired or generally unwell
• feeling dependent on, or
addicted to, this medicine
There is an increased risk of

rifampicin, rifabutin, erthromycin
• certain medicines used to treat
fungal infections, including
amphotericin, ketoconazole
• certain medicines used to treat
viral infections, including
ritonavir
• certain types of vaccines; tell
your doctor or nurse you are
taking prednisolone before you
are given any vaccinations. You
must not be given any live

vaccines.
• mifepristone, a drug used to
terminate pregnancy and
induce labour
• oral contraceptives (the ‘pill’)
• oestrogens, a type of female
hormone, e.g. in hormone
replacement therapy (HRT)
• medicines to treat high blood
pressure
• diuretics (“water tablets”)
• digoxin and related cardiac

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stomach bleeding and ulcers
when used with aspirin or other
non-steroidal anti-inflammatory
drugs (NSAIDs). Signs of
stomach bleeding can be black
tarry stools or vomiting.
In children and adolescents,
prolonged high doses can stunt
growth.
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
5. How to store Prednisolone
Tablets
• Do not use the tablets after the
expiry date which is stated on

Page 14

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glycoside drugs, used to treat
heart failure and rhythm
disorders
medicines used to relieve
asthma, e.g. salbutamol,
salmeterol, bambuterol,
terbutaline, formoteral,
fenoteral, ritodrine
theophylline
ciclosporin and other drugs that
suppress the immune system
drugs to treat cancer

• drugs which have
anticholinergic effects; these
include some medicines for
Parkinson’s disaese, asthma
or bronchitis, stomach cramps,
motion sickness, bladder
problems, allergies. Check
with your doctor or pharmacist.
• methotrexate
• acetazolamide
• carbenoxolone
• aminoglutethimide

Page 27

the label. The expiry date refers
to the last day of that month.
• Store in a dry place below 25°C
and protect from light.
• Keep this medicine out of the
sight and reach of children.
Do not throw away medicines via
wastewater or household waste.
Ask your pharmacist how to throw
away medicines you no longer
use. These measures will help
protect the environment.

6. Contents of the pack and
other information
What Prednisolone Tablets
contain
The active substance is
prednisolone. Each tablet
contains 5 mg prednisolone.
The other ingredients are lactose
(see section 2 ‘Prednisolone
Tablets contain lactose’), starch,
magnesium stearate, stearic acid
and sodium Iauryl sulphate.

• somatropin (growth hormone)
When you are first prescribed
prednisolone you should be given
a Steroid Treatment Card, which
you should carry with you at all
times to show any doctor, dentist,
nurse or anyone else who is
giving you medical treatment.
Prednisolone with food and
drink
Avoid eating liquorice while

Page 15

taking prednisolone.
Pregnancy and breast-feeding
If you are pregnant, think you
may be pregnant or are planning
to have a baby, ask your doctor
or pharmacist for advice before
taking this medicine.
If you are breast-feeding, tell
your doctor before you start
taking this medicine. Small
amounts of corticosteroid will
pass into your breast milk. Your

doctor will decide if you should
take this medicine.
Driving and using machines
If you feel dizzy or tired after
taking prednisolone do not
drive or operate machinery until
these effects have worn off.
Prednisolone Tablets contain
lactose. If you have been told
by your doctor that you have an
intolerance to some sugars,
contact your doctor before

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What Prednisolone Tablets look
like and contents of the pack
This pack contains small, white,
uncoated tablets with a breakline on
one side.
Prednisolone Tablets 5 mg are
available in packs containing 50, 100,
500 and 1000 tablets. Not all pack
sizes may be marketed.
Marketing Authorisation Holder
Intrapharm Laboratories Ltd,
The Courtyard Barns, Choke Lane,

Cookham Dean, Maidenhead,
Berkshire SL6 6PT, United Kingdom.
Manufacturer
Norbrook Laboratories Limited,
Newry, Co. Down, Northern Ireland.
This leaflet was last revised in July
2013
[Component code]

taking this medicinal product.
3. How to take Prednisolone
Tablets
Your doctor has decided the
dose which is best for you.
Always take this medicine
exactly as your doctor or
pharmacist has told you. Check
with your doctor or pharmacist
if you are not sure.
The usual starting dose

Page 1

Each tablet contains:
Prednisolone B.P. 5 mg.
Lactose is also present.

Prednisolone Tablets
B.P. 5 mg

DOSE: As directed by a
medical practitioner.
Please read the enclosed
Patient Information Leaflet.

PL 17509/0053
Intrapharm Laboratories Ltd,
The Courtyard Barns,
Choke Lane,
Maidenhead,
Berkshire, SL6 6PT, UK.
POM

KEEP ALL MEDICINES OUT
OF THE REACH AND
SIGHT OF CHILDREN.
Store in a dry place below
25°C. Protect from light.

laboratories 50 tablets

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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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