PREDNISOLONE TABLETS BP 1MG

Active substance: PREDNISOLONE MICRONISED

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Each tablet contains:
Prednisolone B.P. 1 mg.
Lactose is also present.

Prednisolone Tablets
B.P. 1 mg

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

PL 17509/0052

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. 1 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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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 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

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.

Page 17

doctor may wish to monitor your
progress closely (especially if you
are elderly). If you have been on
a 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.

Page 4

Use in children and adolescents
Steroids can slow down normal
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

• Keep this leaflet. You may need
to 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

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because you may become
very ill if you get chickenpox
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.

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• If you think you might have an
infection. Infections can be
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

6. Contents of the pack and
other information
The name of this medicine is
Prednisolone Tablets BP 1 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

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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),

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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.
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

this medicine regularly to get
maximum benefit from it.
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

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hospital casualty department.
Take any remaining tablets and
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

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before. If you have any further
questions 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

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also be used to reduce a very
any other ingredients
high body temperature. You must contained in these tablets (see
talk to a doctor if you do not feel
Section 6)
better or if you feel worse.
• have an infection which is not
being treated
2. What you need to know
before you take Prednisolone • have a herpes infection of the
eye
Tablets
• are suffering from galactose or
Do not take Prednisolone
lactose intolerance or
Tablets if you:
glucose-galactose
• are allergic (hypersensitive) to
malabsorption.
prednisolone, other steroids, or

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of the following: sudden swelling
of the face, lips, tongue or body,
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
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

Check with your doctor first
• If you have ever had severe
depression or manic depression
(bipolar disorder). 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

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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.
If you notice any of these
problems talk to a doctor
straight away.
Other side effects you may
experience:
• increased susceptibility to






Page 9

infections, worsening of
existing infections including eye
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

sight due to fluid build-up at the
back of the eye
• epilepsy, fits or seizures
• 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
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

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• swelling or puffiness,
particularly around the ankles
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;

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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)

• Duchene’s muscular dystrophy
• a condition that is being treated
with medicines that suppress
your immune system e.g. for
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

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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

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• loss of eye sight, blurred or
double vision, increased
pressure inside the eye
(glaucoma), bulging eyes,
thinning of the eye tissues, eye
pain
• buzzing in the ears
• headache
• feeling dizzy, confused, dazed
or drowsy
• weakness in arms, legs or
down one side of the body

• back pain
• bone, joint or tendon pain;
osteoporosis (bone thinning),
weakening of the bones, bone
fractures, damage to tendons
• muscle disease, causing
weakness or wasting, muscle
pain
• slower than normal growth of
infants, children and
adolescents
• Cushing’s Syndrome,

you are taking, have recently
taken, or might take any other
medicines including any
preparations you may have
purchased yourself.
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

Page 25








(symptoms include sudden
weight gain around the trunk and
face, the face appears round)
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

Page 12

periods stopping completely
• feeling hungrier than usual,
increased appetite, weight gain
• 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

drugs, used to treat pain and
swelling, e.g. indometacin,
ibuprofen
• certain medicines used to treat
bacterial infections, including
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

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• feeling dependent on, or
addicted to, this medicine
There is an increased risk of
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

Page 14

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hormone, e.g. in hormone
replacement therapy (HRT)
• medicines to treat high blood
pressure
• diuretics (“water tablets”)
• digoxin and related cardiac
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 disease, asthma
or bronchitis, stomach cramps,
motion sickness, bladder

Page 27

5. How to store Prednisolone
Tablets
• Do not use the tablets after the
expiry date which is stated on
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

problems, allergies. Check
with your doctor or pharmacist.
• methotrexate
• acetazolamide
• carbenoxolone
• aminoglutethimide
• 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,

Page 15

dentist, nurse or anyone else
who is giving you medical
treatment.
Prednisolone with food and drink
Avoid eating liquorice while
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

Page 28

contains 1 mg prednisolone.
The other ingredients are lactose (see
section 2 ‘Prednisolone Tablets
contain lactose’), starch, magnesium
stearate and sodium Iauryl sulphate.
What Prednisolone Tablets look
like and contents of the pack
This pack contains small, white,
uncoated tablets. Prednisolone
Tablets 1 mg are available in packs
containing 50, 100 and 500 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]

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
taking this medicinal product.
3. How to take Prednisolone
Tablets
Your doctor has decided the
dose which is best for you.

Page 1

Each tablet contains:
Prednisolone B.P. 1 mg.
Lactose is also present.

Prednisolone Tablets
B.P. 1 mg

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

PL 17509/0052
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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