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PREDNISOLONE 1MG TABLETS

Active substance(s): PREDNISOLONE / PREDNISOLONE / PREDNISOLONE

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ZINC Ref:

EAS1075a LEA PREDNISOLONE 1MG AND 5MG TAB TUK
Dim’s Changed?:
Length:
Width:
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No
323mm
320 mm
160 mm
N/A

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.

5

How to store Prednisolone tablets

Do not store above 25°C. Store in the
Other side effects
original package. Do not transfer them to
another container.
The following side effects have also been
reported. If you feel unwell with any of these Do not use this medicine after the expiry
date which is stated on the carton and
side effects tell you doctor:
blister after EXP. The expiry date refers to
Not known: frequency cannot be estimated the last day of that month.
from the available data
Do not throw away any medicines via
• indigestion/heartburn, stomach ulcers
wastewater or household waste. Ask your
with bleeding or perforation, bloating,
pharmacist how to throw away medicines
diarrhoea, oesophageal (gullet) ulcers
you no longer use. These measures will help
• raised pressure in brain (which can cause protect the environment.
headaches, nausea and vomiting)
• weakness and wasting of the upper arm
6 Contents of the pack and other
and leg muscles, brittle bones, thinning or
information
wasting of the bones, bone fractures and
What Prednisolone tablets contain:
tendon rupture
• The active ingredient is prednisolone 1 mg
• salt and water retention, high blood
or 5 mg.
pressure, a change in the mineral balance
• The other ingredients are lactose
in the blood
monohydrate, dextrin, maize starch and
• increased sweating
stearic acid (E570).
• reduction in the balance between certain
hormones
• 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
• dizziness
• vision loss
• 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
• increased cholesterol or fat levels in blood.
• 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.
• Blurred vision

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 in August 2017
PL 00289/0267, 00289/0276

EAS1075a
24076-AB
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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 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.
• 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. See section 4
PREDNISOLONE TABLETS LEAFLET - HEADLINES

• Prednisolone tablets are 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 tablets can cause side
effects in some people (see 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 (see 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.

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 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

What you need to know before
you take Prednisolone tablets

Do not take Prednisolone tablets:
• if you are allergic to prednisolone or any
of the other ingredients of this medicine
(listed in section 6)
• if you have an infection unless it is being
treated with a specific antibiotic
• if you are suffering from herpes infection
of the eye.
• if you are suffering from galactose or
lactose intolerance or glucose-galactose
malabsorption.

Warnings and precautions
Talk to your doctor or pharmacist before
taking Prednisolone tablets
• 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 you have osteoporosis (weakened
bones), particularly if you are past the
What is in this leaflet
menopause (the change of life), or have
1. What Prednisolone tablets are and what
you suffered from muscle weakness
they are used for
during previous treatment with
2. What you need to know before you take
corticosteroids
Prednisolone tablets
• if you have stomach ulcers
3. How to take Prednisolone tablets
• if you have heart, liver or kidney
4. Possible side effects
problems, or have high blood pressure
5. How to store Prednisolone tablets
• if you have ever suffered from tuberculosis
6. Contents of the pack and other information • if you suffer from diabetes, or if anyone in
your family suffer from diabetes
1 What Prednisolone tablets are and • if you have glaucoma (abnormally high
what they are used for
pressure in the eyes), or if any of your
family suffer from glaucoma
Prednisolone – benefit information.
• if you are epileptic

if you have ever had any psychiatric
Prednisolone tablets contain the active
problems, or there is a family history of
substance prednisolone. Prednisolone
such problems
belongs to a group of medicines called
• if you are receiving treatment for a
steroids. Their full name is corticosteroids.
condition called myasthenia gravis (a rare
These corticosteroids occur naturally in the
muscle weakness disorder)
body, and help to maintain health and
well-being. Boosting your body with extra
Peel Here To Open

Pharma code 641 (010000010)
First bar is 105mm from top edge.

Keep this medicine out of the sight and
reach of children.

17 August 2017

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

• feeling anxious, irritablility, having
problems sleeping, difficulty in thinking
or being confused and losing your
memory
• feeling, seeing or hearing things which
do not exist. Abnormal feeling of
wellbeing, feeling of dependency on
treatment. Having strange and
frightening thoughts, changing how
you act or having feelings of being alone
• heart problems which can cause shortness
of breath
• increased number of white blood cells
• thromboembolism (blood clot)
• pancreatitis (nausea, vomiting, abdominal
pain and back pain)
• thinning of the skin and delayed healing,
bruising, stretch marks, itching, patches of
reddening skin and acne.
If you notice any of these problems keep
taking your tablets, but talk to a doctor
straight away.

4

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Version:

Colours Used:

ZINC Ref:

EAS1075a LEA PREDNISOLONE 1MG AND 5MG TAB TUK
Dim’s Changed?:
Length:
Width:
Folded to
Foil Width:

No
323mm
320 mm
160 mm
N/A

PAGE 2: LEFT HAND INSIDE FACE AFTER FOLDING AND TACKING

• if you have ever had blood clots (for
example deep vein thrombosis (DVT), or,
thromboembolism
• if you are elderly and have low potassium
levels in your blood or are susceptible to
infections or thinning of the skin
• if you have had a recent immunisation or
vaccination
• if you have never had measles,
chickenpox or shingles
• if you 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)
• if you suffer from hypothyroidism (an
underactive thyroid gland which can
cause tiredness or weight gain)
• if you have Duchenne’s muscular dystrophy
• if you have inflammatory bowel disease
such as Crohn’s disease
• if you have an eye disease caused by fluid
build-up at the back of the eye that causes
visual impairment.
• if you are undergoing immunosuppression
therapy for example in the treatment of
cancer
• if you have systemic sclerosis
Contact your doctor if you experience
blurred vision or other visual disturbances.
If any of these applies to you while taking
Prednisolone tablets, 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 tablets, as you should not
receive live vaccines, and other vaccines
may be less effective.
• DO NOT stop taking Prednisolone tablets
without consulting your doctor first as
stopping this medicine suddenly may lead
to withdrawal effects (see section 3).
Mental problems while taking Prednisolone
tablets
Mental health problems can happen while
taking steroids like Prednisolone (see
section 4).
• 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.

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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.

Driving and using machines
Prednisolone tablets are 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.

Other medicines and Prednisolone tablets
Please tell your doctor if you are taking or
have recently taken any other medicines,
including medicines obtained without a
prescription.
• Some medicines may increase the effects of
Prednisolone tablets and your doctor may
wish to monitor you carefully if you are
taking these medicines (including some
medicines for HIV: ritonavir, cobicistat).
• 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)
• antithyroids such as carbimazole
• isoniazid which is used to treat tuberculosis
• antacids such as magnesium trisilicate or
aluminium hydroxide, used to treat the
symptoms of heartburn and indigestion
• antimuscarinics/ anticholinergics such as
atropine sulfate
• immunosuppressants which dampen down
the activity of the body’s immune system
• vaccinations: You must tell your doctor or
nurse that you are taking a steroid before
you are given any vaccinations. Steroids
affect your immune response and you
must not be given any live vaccines
• liquorice can delay the clearance of
prednisolone.

Prednisolone tablets contain lactose
Prednisolone tablets contain 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 or breast-feeding, think
you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist
for advice before taking this medicine.

3

How to take Prednisolone tablets

Always take this medicine exactly as your
doctor has told you. Check with your doctor
or pharmacist if you are not sure.

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.

If you take more Prednisolone tablets than
you should
If you (or someone else) swallow a lot of the
tablets all together or if you think a child has
Different illnesses require different doses of swallowed any of the tablets contact your
nearest hospital casualty department or
Prednisolone Tablets. Depending on your
illness your daily dose may be between 5 and your doctor immediately.
Please take this leaflet, any remaining
60 mg. Your doctor will decide when and
tablets, and the container with you to the
how to treat you with Prednisolone Tablets
hospital or doctor so that they know which
The recommended dose is:
tablets were consumed.
• Adults and the elderly
Initially, up to 20 mg daily in divided doses. If you forget to take Prednisolone tablets
Your doctor may prescribe up to 60 mg in If you forget to take a tablet, take one as
soon as you remember, unless it is nearly
severe conditions.
time to take the next one. DO NOT take a
Once your condition starts to get better,
your doctor may change your dosage to a double dose to make up for a forgotten
dose.
lower one. Your doctor may also reduce
your dosage before stopping treatment
If you stop taking Prednisolone tablets
completely. This may depend on your
illness, your dosage and how long you have DO NOT suddenly stop taking your
been taking this medicine. In all cases you Prednisolone tablets as this may lead to
withdrawal syndrome which causes fever,
should be careful to follow any changes.
muscle and bone pain, runny nose and eyes,
painful itchy skin with nodules, and weight
The initial dose will normally be reduced
to the lowest effective maintenance dose loss which may result in low blood pressure
and death. Your doctor will tell you to reduce
as soon as possible. The recommended
your dose gradually to avoid these effects.
maintenance dose is 2.5 to 15 mg daily.
In some cases, your doctor will tell you to
If you have any further questions on the use
take the tablets every other morning.
of this product, ask your doctor or pharmacist.
• Use in children
Prednisolone tablets are only used to treat 4 Possible side effects
children if considered essential by their
Like all medicines, this medicine can cause
doctor.
The dose will be a proportion of the adult side effects, although not everybody gets
them.
dose according to the age of the child.
The tablets should be swallowed preferably
with a drink of water.

• 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

Serious side effects:
Stop taking Prednisolone 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,
face or neck leading to severe difficulty in
The use of steroids can slow down normal
breathing; skin rash or hives).
growth of children and adolescents. In order
This is a very serious but rare side effect.
to lessen this effect the tablets are often
You
may need urgent medical attention or
taken in a single dose every other day.
hospitalisation.
• Use in the elderly:
When steroids are taken by elderly patients Tell your doctor straight away if you
experience any of the following:
some of the unwanted side effects can be
more serious especially brittle bone disease, • Steroids including prednisolone can cause
serious mental health problems. These are
diabetes, high blood pressure, infections
common in both adults and children. They
and thinning of the skin.
can affect about 5 in every 100 people
Whilst you are taking Prednisolone Tablets,
taking medicines like prednisolone tablets.
if any of the following occur tell your doctor
These include:
straight away:
• feeling depressed, including thinking
• Infections: If you think you might have an
about suicide
infection. You are more likely to develop
• feeling high (mania) or moods that go
illnesses due to infection whilst you are
up and down

Expand Transcript

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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