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PREDNISOLONE 1MG TABLETS

Active substance: PREDNISOLONE

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PREDNISOLONE 1 mg AND
5 mg TABLETS

Withdrawal Symptoms: anorexia, nausea,
vomiting, lethargy, headache, fever, joint
pain, peeling of skin, muscle pain,
inflammation of nose, conjunctivitis, painful
itchy skin nodules, loss of weight and/or
hypotension.

PREDNISOLONE LEAFLET – HEADLINES

HOW TO STORE PREDNISOLONE

Keep out of the reach and sight of children.
Do not store above 25°C. Store in the
original package. Do not transfer them to
another container.
Do not use Prednisolone after the expiry
date that is stated on the outer packaging.
The expiry date refers to the last day of that
month.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6

BEFORE YOU TAKE PREDNISOLONE

• 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 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 any doctor or
nurse treating you.
• Keep away from people who have
chicken-pox or shingles, if you have never
had them. They could affect you severely.
If you do come into contact with chicken
pox 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. This leaflet was
last updated in July 2010

If any of the side effects get serious, or if you
notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

5

2

FURTHER INFORMATION

What Prednisolone tablets contain:
• The active ingredient is prednisolone
1 mg or 5 mg.
• The other ingredients are lactose
monohydrate, dextrin, maize starch and
stearic acid (E570).
What Prednisolone tablets looks like and
contents of the pack:
• Prednisolone 1 mg are white biconvex
tablets, marked ‘APS’ on one side and
‘1/2401’ on the reverse; or marked ‘APS
2401’ on one side and plain on the reverse.
• Prednisolone 5 mg are white biconvex
tablets, marked ‘APS’ on one side and
‘5/2402’ on the reverse; or marked ‘APS’
breakline ‘2402’ on one side and plain on
the reverse.
• The 1 mg tablets are available in packs of
28, 56, 60, 84, 90, 100, and 500.
• The 5 mg tablets are available in packs of
28, 30, 500, 1000 and 10 x 50
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation holder and
company responsible for manufacture:
TEVA UK Limited, Eastbourne, BN22 9AG.
This leaflet was last revised: July 2010
PL 00289/0267, 00289/0276

24076-V
320 x 323

DO NOT take Prednisolone and talk to your
doctor if you:
• are allergic (hypersensitive) to
prednisolone or any of the other
ingredients of this medicine
• have an infection unless it is being treated
with a specific antibiotic
• are suffering from herpes infection of the
eye.
Take special care with Prednisolone
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.
Talk to your doctor before you start to take
this medicine if you:
• have osteoporosis (weakened bones),
particularly if you are past the menopause
(the change of life), or have you suffered
from muscle weakness during previous
treatment with corticosteroids
• have stomach ulcers
• have heart, liver or kidney problems, or
have high blood pressure
• have ever suffered from tuberculosis
• suffer from diabetes, or if anyone in your
family suffer from diabetes
• have glaucoma (abnormally high pressure
IN THIS LEAFLET:
in the eyes), or if any of your family suffer
1. What Prednisolone is and what it is used
from glaucoma
for
• are epileptic
2. Before you take Prednisolone
• have ever had any psychiatric problems, or
3. How to take Prednisolone
there is a family history of such problems
4. Possible side effects
• are receiving treatment for a condition
5. How to store Prednisolone
called myasthenia gravis (a rare muscle
6. Further information
weakness disorder)
• have ever had blood clots (for example
1 WHAT PREDNISOLONE IS AND WHAT deep vein thrombosis (DVT), or,
IT IS USED FOR
thromboembolism
• are elderly and have low potassium levels
Prednisolone – benefit information.
in your blood or are susceptible to
infections or thinning of the skin
Prednisolone belongs to a group of
• have had a recent immunisation or
medicines called steroids. Their full name is
vaccination
corticosteroids. These corticosteroids occur • have never had measles, chickenpox or
naturally in the body, and help to maintain
shingles
health and well-being. Boosting your body
• have Cushing’s disease (a hormone
with extra corticosteroid (such as
disorder which can cause symptoms
Prednisolone) is an effective way to treat
including gaining weight very quickly,
various illnesses involving inflammation in
especially on the trunk and face, thinning
the body. Prednisolone reduces this
of the skin and sweating)
inflammation, which could otherwise go on • suffer from hypothyroidism (an
making your condition worse. You must take
underactive thyroid gland which can
this medicine regularly to get the maximum
cause tiredness or weight gain)
benefit from it.
• have Duchenne’s muscular dystrophy.
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Pharma code 101

Prednisolone tablets are used in a wide
range of inflammatory and auto-immune
conditions including:
• allergies, including severe allergic reactions
PACKAGE LEAFLET: INFORMATION
• inflammation affecting the: lungs,
FOR THE USER
including asthma, blood vessels and
heart, bowel or kidneys, muscles and
Read all of this leaflet carefully before you
joints, including rheumatoid, arthritis, eye
start taking this medicine.
and nervous system
• Keep this leaflet. You may need to read it
• skin conditions
again.
• If you have any further questions, ask your • some infections
• some cancers, including leukaemia,
doctor or pharmacist.
lymphoma and myeloma
• This medicine has been prescribed for
• to prevent organ rejection after a transplant
you. Do not pass it on to others. It may
harm them, even if their symptoms are
Also:
the same as yours.
• to make up the difference when the body’s
• If any of the side effects get serious, or if
production of cortisone is too low to
you notice any side effects not listed in
maintain good health.
this leaflet, please tell your doctor or
• to treat high calcium levels.
pharmacist.

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• abnormal feeling of well being, feeling of
dependency on treatment
• depression, difficulty sleeping
• dizziness
• worsening of schizophrenia
• pressure on the nerve to the eye
(sometimes in children after stopping
treatment)
• abnormally high pressure in the eye
(glaucoma), swelling of the optic disc
• whitening or clouding of the lens
(cataracts), thinning of the eye tissue
(sclera and cornea)
• worsening of viral and fungal eye infections
• worsening of epilepsy
• fatigue and general feeling of being unwell.

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• salicylates such as aspirin
• ciclosporin which is used to treat
rheumatic disease, skin complaints or
after a transplant
• cardiac glycosides for example digoxin
Important things to remember while you
which is used to help strengthen a weak
are taking this medicine:
heart
• You will be given a ‘steroid treatment’ card
• mifepristone, used to induce labour or
which has essential details about your
abortion
treatment. Carry this card with you at all
• cytotoxic drugs for example methotrexate
times whilst you are taking this medicine.
which is used to treat cancer
• Because it is important for doctors,
• somatotropin which is a growth hormone
dentists or other healthcare workers to
know you are on steroid treatment be sure • theophylline which is used for asthma and
chronic obstructive pulmonary disease
to keep your steroid card with you at all
(COPD).
times.
• Always show the card to any doctor,
dentist, pharmacist, nurse or anyone else Please tell your doctor or pharmacist if you are
who is about to give you treatment. Even taking or have recently taken any other
medicines, including medicines obtained
when you have stopped the course of
without a prescription.
treatment, tell them that you have been
taking steroids.
Important information about some of the
• If you have not received a steroid card,
ingredients of Prednisolone
ask your doctor or pharmacist.
• Patients who are intolerant to lactose
• If you need to have a vaccination whilst
should note that Prednisolone tablets
you are taking this medicine, make sure
contain a small amount of lactose. If your
you tell the doctor or nurse you are taking
doctor has told you that you have an
Prednisolone, as you should not receive
intolerance to some sugars, contact your
live vaccines, and other vaccines may be
doctor before taking this medicine.
less effective.
• DO NOT stop taking Prednisolone without
Pregnancy and breast-feeding
consulting your doctor first as stopping
• If you are pregnant, planning to become
this medicine suddenly may lead to
pregnant or are breast-feeding, ask your
withdrawal effects (read section 3, If you
doctor for advice before taking any
stop taking Prednisolone).
medicine.
Mental problems while taking Prednisolone
Driving and using machines
Mental health problems can happen while
• Prednisolone is not expected to affect
taking steroids like Prednisolone (see also
your ability to drive or operate machinery.
section 4, Possible Side Effects).
If you feel dizzy or tired after taking
• These illnesses can be serious.
Prednisolone Tablets do not drive or
• Usually they start within a few days or
operate machinery until these effects have
weeks of starting the medicine.
worn off.
• They are more likely to happen at high
doses.
• Most of these problems go away if the
3 HOW TO TAKE PREDNISOLONE
dose is lowered or the medicine is
stopped. However, if problems do happen Always take Prednisolone exactly as your
doctor has told you. You should check with
they might need treatment.
your doctor or pharmacist if you are not
Talk to a doctor if you (or someone taking
sure.
this medicine), show any signs of mental
problems. This is particularly important if
The tablets should be swallowed preferably
you are depressed, or might be thinking
with a drink of water.
about suicide. In a few cases, mental
problems have happened when doses are
Different illnesses require different doses of
being lowered or stopped.
Prednisolone Tablets. Depending on your
illness your daily dose may be between 5
Taking other medicines
and 60 mg. Your doctor will decide when and
Talk to your doctor if you are taking any of
how to treat you with Prednisolone Tablets
the following:
• antivirals such as ritonavir which can be
The usual dose is:
used to treat HIV infection
• Adults and the elderly
• antifungals such as ketoconazole and
Initially, up to 20 mg daily in divided
amphotericin which are used to treat
doses. Your doctor may prescribe up to
fungal infections
60 mg in severe conditions.
• diuretics (“water tablets”) including
Once your condition starts to get better,
acetazolamide
your doctor may change your dosage to a
• indometacin (an anti-inflammatory used
lower one. Your doctor may also reduce
for arthritis)
your dosage before stopping treatment
• anti-bacterials e.g. rifampicin, rifabutin,
completely.
erythromycin, rifamycin
This may depend on your illness, your
• carbenoxolone (used to treat ulcers)
dosage and how long you have been
• hypoglycaemic agents e.g. glibenclamide
taking this medicine. In all cases you
or insulin (used for diabetes)
should be careful to follow any changes.
• antihypertensives e.g. methyldopa
• carbamazepine, phenobarbital, phenytoin
The initial dose will normally be reduced to
or primidone (anti-convulsants)
the lowest effective maintenance dose as
• aminoglutethimide (used to treat
soon as possible. The usual maintenance
advanced breast cancer)
dose is 2.5 to 15 mg daily.
• anti-coagulants e.g. warfarin
In some cases, your doctor will tell you to
• oestrogens, for example in the
take the tablets every other morning.
contraceptive pill or HRT
• salbutamol, formoterol, bambuterol,
fenoterol, ritodrine, salmeterol and
terbutaline used to treat asthma
If you are exposed to any of these whilst
taking Prednisolone, you must tell your
doctor immediately.

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• Children
Prednisolone is only used to treat children
if considered essential by their doctor.
The dose will be a proportion of the adult
dose according to the age of the child.
• Children over 12 years
Three quarters of the adult dose
• Children over 7 years
One half of the adult dose
• Children over 1 year
One quarter of the adult dose
The use of steroids can slow down normal
growth of children and adolescents. In order
to lessen this effect the tablets are often
taken in a single dose every other day.

4

POSSIBLE SIDE EFFECTS

Like all medicines, Prednisolone can cause
side effects, although not everybody gets
them. Some of these side effects such as
mood changes (feeling depressed, or 'high'),
or stomach problems can happen straight
away, while others may only happen after
weeks or months such as weakness of arms
and legs, or developing a rounder face.

Stop taking the tablets and tell your doctor
immediately or go to the casualty
department at your nearest hospital if the
following happens:
• an allergic reaction (swelling of the lips,
Treatment of the elderly:
face or neck leading to severe difficulty in
When steroids are taken by elderly patients
breathing; skin rash or hives).
some of the unwanted side effects can be
This is a very serious but rare side effect.
more serious especially brittle bone disease, You may need urgent medical attention or
diabetes, high blood pressure, infections and hospitalisation.
thinning of the skin.
Serious effects: tell a doctor straight away
Whilst you are taking Prednisolone Tablets, Steroids including prednisolone can cause
if any of the following occur tell your doctor serious mental health problems.
straight away:
These are common in both adults and
• Infections: If you think you might have an children. They can affect about 5 in every
infection. You are more likely to develop
100 people taking medicines like
illnesses due to infection whilst you are
prednisolone.
taking Prednisolone Tablets. Also any
• Feeling depressed, including thinking
existing infections may become worse.
about suicide.
This is especially so during periods of
• Feeling high (mania) or moods that go up
stress. Certain infections can be serious if
and down.
not controlled.
• Feeling anxious, having problems
• Chickenpox and Shingles: If you, anyone
sleeping, difficulty in thinking or being
in your family or regular contacts catch
confused and losing your memory.
chickenpox or shingles. This is because
• Feeling, seeing or hearing things which do
you may become very ill if you get chicken
not exist. Having strange and frightening
pox whilst taking Prednisolone Tablets and
thoughts, changing how you act or having
for up to 3 months after you have stopped
feelings of being alone.
taking Prednisolone Tablets. Do not stop
If you notice any of these problems keep
taking Prednisolone Tablets.
taking your tablets, but talk to a doctor
• Measles: If you, anyone in your family or
straight away.
regular contacts catch measles. You
should avoid contact with people who
The following side effects have also been
have measles.
reported. If you feel unwell with any of these
side effects, keep taking your tablets, but
If you take more Prednisolone than you
see your doctor straight away:
should
• thromboembolism (blood clot)
If you (or someone else) swallow a lot of the
• increased number of white blood cells
tablets all together or if you think a child has
• indigestion/heartburn, stomach ulcers
swallowed any of the tablets contact your
with bleeding or perforation, bloating,
nearest hospital casualty department or your
oesophageal (gullet) ulcers
doctor immediately.
• pancreatitis (nausea, vomiting, abdominal
Please take this leaflet, any remaining
pain and back pain)
tablets, and the container with you to the
• raised pressure in brain (which can cause
hospital or doctor so that they know which
headaches, nausea and vomiting)
tablets were consumed.
• weakness and wasting of the upper arm
and leg muscles, brittle bones, thinning or
If you forget to take Prednisolone
wasting of the bones, bone fractures and
If you forget to take a tablet, take one as
tendon rupture
soon as you remember, unless it is nearly
• salt and water retention, high blood
time to take the next one. DO NOT take a
pressure, a change in the mineral balance
double dose to make up for a forgotten
in the blood
dose.
• heart problems which can cause shortness
of breath
If you stop taking Prednisolone
• thinning of the skin and delayed healing,
DO NOT suddenly stop taking your
bruising, stretch marks, patches of
Prednisolone tablets as this may lead to
reddening skin and acne
withdrawal syndrome which causes fever,
• increased sweating
muscle and bone pain, runny nose and eyes, • reduction in the balance between certain
painful itchy skin with nodules, and weight
hormones
loss which may result in low blood pressure • euphoria (feeling high)
and death. Your doctor will tell you to reduce • in infants, children and adolescents,
your dose gradually to avoid these effects.
normal growth may be slowed or
stopped, which may be irreversible
If you have any further questions on the use • absence or irregular menstrual periods
of this product, ask your doctor or
• a rounder shaped face
pharmacist.
• excessive hair growth
• increased appetite, weight gain
• carbohydrate imbalance requiring
anti-diabetic therapy
• reduction of nitrogen and calcium in the
blood
• recurrence of tuberculosis, thrush infections

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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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