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PREDNISOLONE 1MG TABLETS

Active substance(s): PREDNISOLONE

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TEVA UK Ref:

231-30-24076-X LEA PREDNISOLONE A/S TAB TUK
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5

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

FURTHER INFORMATION

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: May 2015
PL 00289/0267, 00289/0276

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
Reporting of side effects
If you get any side effects, talk to your
doctor or pharmacist. 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
By reporting side effects you can help
provide more information on the safety of
this medicine.

REG0022947

Version 2.4

24076-X
320 x 323

Approved

15 May 2015

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PREDNISOLONE 1 mg AND
5 mg TABLETS
PACKAGE LEAFLET:
INFORMATION FOR THE USER

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, ask your
doctor or pharmacist.
• This medicine has been prescribed for
you. Do not pass it on to others. It may
harm them, even if their symptoms 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. See section 4
PREDNISOLONE LEAFLET - HEADLINES

• 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.

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 the maximum
benefit from it.
Prednisolone tablets are used in a wide
range of inflammatory and auto-immune
conditions including:
• allergies, including severe allergic
reactions
• inflammation affecting the: lungs,
including asthma, blood vessels and
heart, bowel or kidneys, muscles and
joints, including rheumatoid, arthritis, eye
and nervous system
• skin conditions
• some infections
• some cancers, including leukaemia,
lymphoma and myeloma
• to prevent organ rejection after a
transplant
Also:
• to make up the difference when the body’s
production of cortisone is too low to
maintain good health.
• to treat high calcium levels.

2

BEFORE YOU TAKE
PREDNISOLONE

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
Now read the rest of this leaflet. It includes
illnesses.
other important information on the safe and If either of these applies to you, talk to a
effective use of this medicine that might be doctor before taking Prednisolone.
especially important for you. This leaflet was
Talk to your doctor before you start to take
last updated in May 2015
this medicine if you:
IN THIS LEAFLET:
• have osteoporosis (weakened bones),
particularly if you are past the menopause
1. What Prednisolone is and what it is used
(the change of life), or have you suffered
for
from muscle weakness during previous
2. Before you take Prednisolone
treatment with corticosteroids
3. How to take Prednisolone
• have stomach ulcers
4. Possible side effects
• have heart, liver or kidney problems, or
5. How to store Prednisolone
have high blood pressure
6. Further information
• have ever suffered from tuberculosis
• suffer from diabetes, or if anyone in your
1 WHAT PREDNISOLONE IS AND
family suffer from diabetes
WHAT IT IS USED FOR
• have glaucoma (abnormally high pressure
in the eyes), or if any of your family suffer
Prednisolone – benefit information.
from glaucoma
Prednisolone belongs to a group of
• are epileptic
medicines called steroids. Their full name is • have ever had any psychiatric problems,
corticosteroids. These corticosteroids occur
or there is a family history of such
naturally in the body, and help to maintain
problems
health and well-being. Boosting your body
with extra corticosteroid (such as
Peel Here To Open

Page 1 of 3

Pharma code 101 (100110)
First bar is 105mm from top edge.

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).

4

Top of page cut-off to middle of registration mark = 44 mm

The following side effects have also been
reported. If you feel unwell with any of these
side effects, keep taking your tablets, but
see your doctor straight away:
• thromboembolism (blood clot)
• increased number of white blood cells
• indigestion/heartburn, stomach ulcers
with bleeding or perforation, bloating,
oesophageal (gullet) ulcers
• pancreatitis (nausea, vomiting, abdominal
pain and back pain)
• raised pressure in brain (which can cause
headaches, nausea and vomiting)
• weakness and wasting of the upper arm
and leg muscles, brittle bones, thinning or
wasting of the bones, bone fractures and
tendon rupture
• salt and water retention, high blood
pressure, a change in the mineral balance
in the blood
• heart problems which can cause shortness
of breath
• thinning of the skin and delayed healing,
bruising, stretch marks, patches of
reddening skin and acne
• increased sweating
• reduction in the balance between certain
hormones
• euphoria (feeling high)
• in infants, children and adolescents,
normal growth may be slowed or
stopped, which may be irreversible
• absence or irregular menstrual periods
• a rounder shaped face
• 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
• 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.

Version:

TEVA UK Ref:

231-30-24076-X LEA PREDNISOLONE A/S TAB TUK

PAGE 2: LEFT HAND INSIDE FACE AFTER FOLDING AND TACKING

• are receiving treatment for a condition
called myasthenia gravis (a rare muscle
weakness disorder)
• have ever had blood clots (for example
deep vein thrombosis (DVT), or,
thromboembolism
• are elderly and have low potassium levels
in your blood or are susceptible to
infections or thinning of the skin
• have had a recent immunisation or
vaccination
• have never had measles, chickenpox or
shingles
• have Cushing’s disease (a hormone
disorder which can cause symptoms
including gaining weight very quickly,
especially on the trunk and face, thinning
of the skin and sweating)
• suffer from hypothyroidism (an
underactive thyroid gland which can
cause tiredness or weight gain)
• have Duchenne’s muscular dystrophy.
If you are exposed to any of these whilst
taking Prednisolone, you must tell your
doctor immediately.
Important things to remember while you
are taking this medicine:
• You will be given a ‘steroid treatment’
card which has essential details about
your treatment. Carry this card with you
at all times whilst you are taking this
medicine.
• Because it is important for doctors,
dentists or other healthcare workers to
know you are on steroid treatment be sure
to keep your steroid card with you at all
times.
• Always show the card to any doctor, dentist,
pharmacist, nurse or anyone else who is
about to give you treatment. Even when
you have stopped the course of treatment,
tell them that you have been taking steroids.
• If you have not received a steroid card,
ask your doctor or pharmacist.
• If you need to have a vaccination whilst
you are taking this medicine, make sure
you tell the doctor or nurse you are taking
Prednisolone, as you should not receive
live vaccines, and other vaccines may be
less effective.
• DO NOT stop taking Prednisolone without
consulting your doctor first as stopping
this medicine suddenly may lead to
withdrawal effects (read section 3, If you
stop 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.

REG0022947

Version 2.4

Taking other medicines
Talk to your doctor if you are taking any of
the following:
• antivirals such as ritonavir which can be
used to treat HIV infection
• antifungals such as ketoconazole and
amphotericin which are used to treat
fungal infections
• diuretics (“water tablets”) including
acetazolamide
• indometacin (an anti-inflammatory used
for arthritis)
• anti-bacterials e.g. rifampicin, rifabutin,
erythromycin, rifamycin
• carbenoxolone (used to treat ulcers)
• hypoglycaemic agents e.g. glibenclamide
or insulin (used for diabetes)
• antihypertensives e.g. methyldopa
• carbamazepine, phenobarbital, phenytoin
or primidone (anti-convulsants)
• aminoglutethimide (used to treat
advanced breast cancer)
• anti-coagulants e.g. warfarin
• oestrogens, for example in the
contraceptive pill or HRT
• salbutamol, formoterol, bambuterol,
fenoterol, ritodrine, salmeterol and
terbutaline used to treat asthma
• salicylates such as aspirin
• ciclosporin which is used to treat
rheumatic disease, skin complaints or
after a transplant
• cardiac glycosides for example digoxin
which is used to help strengthen a weak
heart
• mifepristone, used to induce labour or
abortion
• cytotoxic drugs for example methotrexate
which is used to treat cancer
• somatotropin which is a growth hormone
• theophylline which is used for asthma and
chronic obstructive pulmonary disease
(COPD).
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
Important information about some of the
ingredients of Prednisolone
• Patients who are intolerant to lactose
should note that Prednisolone tablets
contain a small amount of lactose. If your
doctor has told you that you have an
intolerance to some sugars, contact your
doctor before taking this medicine.
Pregnancy and breast-feeding
• If you are pregnant, planning to become
pregnant or are breast-feeding, ask your
doctor for advice before taking any
medicine.
Driving and using machines
• Prednisolone is not expected to affect
your ability to drive or operate machinery.
If you feel dizzy or tired after taking
Prednisolone Tablets do not drive or
operate machinery until these effects have
worn off.

3

HOW TO TAKE PREDNISOLONE

Always take Prednisolone exactly as your
doctor has told you. You should check with
your doctor or pharmacist if you are not
sure.

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4

15 May 2015

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The tablets should be swallowed preferably
with a drink of water.
Different illnesses require different doses of
Prednisolone Tablets. Depending on your
illness your daily dose may be between 5
and 60 mg. Your doctor will decide when
and how to treat you with Prednisolone
Tablets
The usual dose is:
• Adults and the elderly
Initially, up to 20 mg daily in divided
doses. Your doctor may prescribe up to
60 mg in severe conditions.
Once your condition starts to get better,
your doctor may change your dosage to a
lower one. Your doctor may also reduce
your dosage before stopping treatment
completely. This may depend on your
illness, your dosage and how long you
have been taking this medicine. In all
cases you should be careful to follow any
changes.
The initial dose will normally be reduced
to the lowest effective maintenance dose
as soon as possible. The usual
maintenance dose is 2.5 to 15 mg daily.
In some cases, your doctor will tell you to
take the tablets every other morning.
• 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

If you take more Prednisolone than you
should
If you (or someone else) swallow a lot of the
tablets all together or if you think a child has
swallowed any of the tablets contact your
nearest hospital casualty department or
your doctor immediately.
Please take this leaflet, any remaining
tablets, and the container with you to the
hospital or doctor so that they know which
tablets were consumed.
If you forget to take Prednisolone
If you forget to take a tablet, take one as
soon as you remember, unless it is nearly
time to take the next one. DO NOT take a
double dose to make up for a forgotten
dose.
If you stop taking Prednisolone
DO NOT suddenly stop taking your
Prednisolone tablets as this may lead to
withdrawal syndrome which causes fever,
muscle and bone pain, runny nose and eyes,
painful itchy skin with nodules, and weight
loss which may result in low blood pressure
and death. Your doctor will tell you to reduce
your dose gradually to avoid these effects.
If you have any further questions on the use
of this product, ask your doctor or
pharmacist.

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.

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.

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
hospitalisation.
and thinning of the skin.
Whilst you are taking Prednisolone Tablets,
if any of the following occur tell your doctor
straight away:
• Infections: If you think you might have an
infection. You are more likely to develop
illnesses due to infection whilst you are
taking Prednisolone Tablets. Also any
existing infections may become worse.
This is especially so during periods of
stress. Certain infections can be serious if
not controlled.
• Chickenpox and Shingles: If you, anyone
in your family or regular contacts catch
chickenpox or shingles. This is because
you may become very ill if you get chicken
pox whilst taking Prednisolone Tablets and
for up to 3 months after you have stopped
taking Prednisolone Tablets. Do not stop
taking Prednisolone Tablets.
• Measles: If you, anyone in your family or
regular contacts catch measles. You
should avoid contact with people who
have measles.

Page 2 of 3

Serious effects: tell a doctor straight away
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.
• 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.
If you notice any of these problems keep
taking your tablets, but talk to a doctor
straight away.

THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

Teva Pharmaceuticals Europe B.V
1.3.2
mockup-pil-uk-pl-00289-0267-and-0276-prednisolone-1mg-and-5mg-tablets

APPROVALS
Signed by
Michael Silvester

REG0022947

Meaning of Signature
Regulatory Affairs Approval

Version 2.4

Approved

Server Date
18-May-2015 10:01:52 AM

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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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