PREDNISOLONE TABLETS BP 5MG

Active substance: PREDNISOLONE

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

BRAILLE TRANSLATION:

PL 17509/0053

Prednisolone Tablets
B.P. 5 mg

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

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

B.N.:
D.O.M:
EXP.:

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

P R E D N I S O L O N E

POM

KEEP ALL MEDICINES OUT
OF THE REACH AND
SIGHT OF CHILDREN.

laboratories 50 tablets

5
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PATIENT INFORMATION
LEAFLET
PREDNISOLONE TABLETS
B.P. 5 mg
• Prednisolone is a steroid
medicine, 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

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your doctor - you may need
to reduce the dose gradually.
• Prednisolone can cause
side effects in some people
(read section 4 below). Some
problems such as mood
changes (feeling depressed,
or 'high'), or stomach
problems 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
get a blue ‘Steroid card':
always keep it with you
and show it to a doctor or
nurse treating you.

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Peel
Here

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.

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

laboratories 50 tablets

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 read it again.
• If you have any further
questions, ask your doctor
or pharmacist.

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

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 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

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• 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.

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POM

KEEP ALL MEDICINES OUT
OF THE REACH AND
SIGHT OF CHILDREN.

• 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

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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

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

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

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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.
Use in children and adolescents
Steroids can slow down normal growth.

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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 while
taking prednisolone. Avoid contact
with people who have chickenpox or

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.
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.

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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 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.

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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 talk to a doctor if
you do not feel better or if
you feel worse.

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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 important if you

M G

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

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

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• 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). 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

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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 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 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.

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• an eye disease affecting
your 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

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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 losing
your memory.
• Feeling, seeing or hearing
things which do not exist.

• 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

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• 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 cancer or
after a transplant
• Phaeochromocytoma
• attacks causing dramatic increases in
blood pressure, heart rate and/or
headaches

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

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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 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 and feet
• heart muscle weakness following a
heart attack
• blood clots inside blood vessels,
higher risk of stroke
• putting on weight
• worsening of schizophrenia

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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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• 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
pressure inside the eye
(glaucoma), bulging eyes,
thinning of the eye tissues,
eye pain
• buzzing in the ears

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

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of thyroid hormones
including rifampicin,
produced, e.g.
rifabutin, erythromycin
carbimazole, thiamazole
• certain medicines used to
• antacid medicines, used
treat fungal infections,
for indigestion
including amphotericin,
• aspirin
ketoconazole
• non-steroidal
• certain medicines used to
anti-inflammatory drugs,
treat viral infections,
used to treat pain and
including ritonavir
swelling, e.g. indometacin, • certain types of vaccines;
ibuprofen
tell your doctor or nurse
• certain medicines used to you are taking prednisolone
treat bacterial infections,
before you are given any

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• 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, (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

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 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 problems, allergies,

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• irregular menstrual periods or 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
• feeling dependent on, or addicted to,
this medicine

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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.

medicines used to relax muscles
during surgery. 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, dentist, nurse or

anyone else who is giving you
medical treatment.
If you are going to have surgery tell
your doctor or dentist that you are
taking Prednisolone Tablets.
Prednisolone Tablets may reduce the
effect of some medicines used to relax
muscles during surgery, e.g.
pancuronium, vecuronium.
Prednisolone with food and drink
Avoid eating liquorice while taking
prednisolone.

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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 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.

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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.

continued overleaf

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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,

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 taking this medicinal product.

stearic acid and sodium
Iauryl sulphate.
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.

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Marketing Authorisation
This leaflet was last revised in
Holder
November 2013
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.

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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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