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PREDNISOLONE 1MG TABLETS

Active substance(s): PREDNISOLONE

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

TEVA UK Ref:

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323 mm
320 mm
160 mm
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22 June 2016

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PREDNISOLONE 1 mg AND
5 mg TABLETS

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.

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

5

How to store Prednisolone tablets

24076-Y

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.

Approved

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
Now read the rest of this leaflet. It includes
while taking steroid medicines like
other important information on the safe and
Prednisolone
effective use of this medicine that might be
• if any of your close family has had these
especially important for you.
illnesses.
What is in this leaflet
• if you have osteoporosis (weakened
1. What Prednisolone tablets are and what
bones), particularly if you are past the
they are used for
menopause (the change of life), or have
2. What you need to know before you take
you suffered from muscle weakness
Prednisolone tablets
during previous treatment with
3. How to take Prednisolone tablets
corticosteroids
4. Possible side effects
• if you have stomach ulcers
5. How to store Prednisolone tablets
• if you have heart, liver or kidney
6. Contents of the pack and other information
problems, or have high blood pressure
• if you have ever suffered from tuberculosis
1 What Prednisolone tablets are and • if you suffer from diabetes, or if anyone in
what they are used for
your family suffer from diabetes
• if you have glaucoma (abnormally high
Prednisolone – benefit information.
pressure in the eyes), or if any of your
Prednisolone tablets contain the active
family suffer from glaucoma
substance prednisolone. Prednisolone
• if you are epileptic
belongs to a group of medicines called
• if you have ever had any psychiatric
steroids. Their full name is corticosteroids.
problems, or there is a family history of
These corticosteroids occur naturally in the
such problems
body, and help to maintain health and
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Version 3.8

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

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

Withdrawal Symptoms: anorexia, nausea,
vomiting, lethargy, headache, fever, joint

Package leaflet:
Information for the user

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 this
medicine regularly to get the maximum
benefit from it.

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

pain, peeling of skin, muscle pain,
inflammation of nose, conjunctivitis, painful
itchy skin nodules, loss of weight and/or
hypotension

Keep this medicine out of the sight and
reach of children.
Do not store above 25°C. Store in the
original package. Do not transfer them to
another container.
Do not use this medicine after the expiry
Other side effects
date which is stated on the carton and
The following side effects have also been
blister after EXP. The expiry date refers to
reported. If you feel unwell with any of these the last day of that month.
side effects tell you doctor:
Do not throw away any medicines via
Not known: frequency cannot be estimated wastewater or household waste. Ask your
pharmacist how to throw away medicines
from the available data
you no longer use. These measures will help
• indigestion/heartburn, stomach ulcers
protect the environment.
with bleeding or perforation, bloating,
diarrhoea, oesophageal (gullet) ulcers
of the pack and other
6 Contents
• raised pressure in brain (which can cause
information
headaches, nausea and vomiting)
• weakness and wasting of the upper arm
What Prednisolone tablets contain:
and leg muscles, brittle bones, thinning or • The active ingredient is prednisolone 1 mg
wasting of the bones, bone fractures and
or 5 mg.
tendon rupture
• The other ingredients are lactose
• salt and water retention, high blood
monohydrate, dextrin, maize starch and
pressure, a change in the mineral balance
stearic acid (E570).
in the blood
• increased sweating
What Prednisolone tablets looks like and
• reduction in the balance between certain
contents of the pack:
hormones
• Prednisolone 1 mg are white biconvex
• in infants, children and adolescents,
tablets, marked ‘APS’ on one side and
normal growth may be slowed or
‘1/2401’ on the reverse; or marked ‘APS
stopped, which may be irreversible
2401’ on one side and plain on the reverse.
• absence or irregular menstrual periods
• Prednisolone 5 mg are white biconvex
• a rounder shaped face
tablets, marked ‘APS’ on one side and
• excessive hair growth
‘5/2402’ on the reverse; or marked ‘APS’
• increased appetite, weight gain
breakline ‘2402’ on one side and plain on
• carbohydrate imbalance requiring
the reverse.
anti-diabetic therapy
• The 1 mg tablets are available in packs of
• reduction of nitrogen and calcium in the
28, 56, 60, 84, 90, 100, and 500.
blood
• recurrence of tuberculosis, thrush infections • The 5 mg tablets are available in packs of
28, 30, 500, 1000 and 10 x 50
• dizziness
Not all pack sizes may be marketed.
• vision loss
• pressure on the nerve to the eye
Marketing Authorisation Holder and
(sometimes in children after stopping
Manufacturer
treatment)
Marketing Authorisation holder and
• abnormally high pressure in the eye
company responsible for manufacture:
(glaucoma), swelling of the optic disc
TEVA UK Limited, Eastbourne, BN22 9AG.
• whitening or clouding of the lens
This leaflet was last revised in June 2016
(cataracts), thinning of the eye tissue
PL 00289/0267, 00289/0276
(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.

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• 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.

Version:

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

TEVA UK Ref:

Dim’s Changed?:
Length:
Width:
Folded to:
Foil Width:

No
323 mm
320 mm
160 mm
N/A

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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• if you are receiving treatment for a
condition called myasthenia gravis (a rare
muscle weakness disorder)
• 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

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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
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines
• 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)
• 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.

Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
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.

Version 3.8

Approved

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.
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 recommended 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 recommended
maintenance dose is 2.5 to 15 mg daily.
In some cases, your doctor will tell you to
take the tablets every other morning.
• Use in children
Prednisolone tablets are 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

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.
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
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 tablets
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 tablets
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, this medicine can cause
side effects, although not everybody gets
them.

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

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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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