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PREDNISOLONE 5 MG TABLETS

Active substance: PREDNISOLONE

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Tell your doctor if the following occur:
Infections - lowered resistance to infections,
such as a cold, existing eye infections may
become worse or symptoms of a previous
infection such as tuberculosis (TB) may
happen more easily. This is especially
important regarding chickenpox or measles.
Endocrine - 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.
Stomach and intestines - increased
appetite, indigestion, a feeling of being full
or bloated, very sore throat and white areas
inside your mouth (oral thrush), feeling sick,
weight gain, stomach ulcers or perforation
(you may feel sick, have pain after eating),
particularly in those with Irritable Bowel
Syndrome (IBS).
Heart - high blood pressure, congestive
heart failure in those already at risk.
Nervous system - unusual tiredness or
weakness, nervousness, worsening of
schizophrenia, increased pressure in the skull
(causing painful eyes, changes in vision or a
bad headache, especially behind your eyes),
irritability, changes in behaviour.
Skin - reddish purple lines, thin skin, unusual
bruising, acne, wounds that will not heal.
Muscle or bones - muscle weakness or
wasting, pain in back, hips, ribs, arms,
shoulders or legs. Osteoporosis (may be
easier to fracture your bones or to tear your
tendons).
Hormones - filling or rounding out of the
face, periods become irregular or stop
altogether, unusual increase in hair growth
on body or face, changes in blood glucose
levels (diabetics may need a change of
dose in antidiabetic treatment) changes
in protein and calcium in the body, weight
gain. Growth in infancy, childhood and
adolescence may be reduced.
Kidney - urinating at night, water and salt
retention, loss of potassium in the urine.
Blood - blood clots, changes in the balance
of minerals in the blood (detected by a blood
test).
Eyes - cataracts, increased pressure in the eye
(glaucoma), thinning of the tissues of the eye,
pressure on the nerve of the eye, changes in
vision, seeing ‘floaters’, or eye pain.
Other - worsening of epilepsy, generally
feeling unwell.

Withdrawal symptoms - muscle or joint
pain, conjunctivitis, fever, weight loss, runny
nose and painful, itchy skin lumps.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. 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

Keep out of the reach and sight of children.
Store below 25oC in a dry place and protect
from light.
Do not use Prednisolone tablets after the
expiry date stated on the label, carton or
bottle. 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

• The active substance (the ingredient that
makes the tablets work) is prednisolone.
Each tablet contains either 1mg or 5mg of
the active ingredient.
• The tablet also contains lactose
monohydrate, maize starch, povidone,
purified talc, colloidal anhydrous silica,
magnesium stearate.

Contents of the pack
Prednisolone are white, circular, flat bevelled
edge tablets.
Pack sizes are 28.
Marketing Authorisation Holder and
Manufacturer
Actavis, Barnstaple, EX32 8NS, UK

page 4

• 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.

Index:
1 What Prednisolone tablets are and
what they are used for
2 Before you take Prednisolone
tablets
3 How to take Prednisolone tablets
4 Possible side effects
5 How to store Prednisolone tablets
6 Further information
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 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.

2 Before you take Prednisolone

tablets

Do not take Prednisolone tablets if you:

• are allergic (hypersensitive) to
prednisolone or any of the other
ingredients in Prednisolone tablets (see
section 6). An allergic reaction may include
a rash, itching, difficulty breathing or
swelling of the face, lips, throat or tongue.
• have cold sores that affect the eyes
• have an untreated infection.

Date of last revision:
August 2014.

Actavis, Barnstaple, EX32 8NS, UK

AAAH1190 50819356

296x210 Leaflet Reel Fed Bi Fold Profile (BST)

What Prednisolone tablets contain

Prednisolone tablets
1mg and 5mg

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page 1

Check with your doctor or pharmacist
before taking Prednisolone tablets if
you:
• have been in contact with anyone who has
chickenpox, shingles or measles. Contact
your doctor immediately for advice
• have or have a family history of diabetes or
glaucoma
• have oestoporosis, high blood pressure,
a recent heart attack, a stomach ulcer,
an underactive thyroid gland, epilepsy,
tuberculosis or septicaemia
• have taken prednisolone tablets (or a
similar medicine) before and had muscular
problems (steroid myopathy)
• have heart, kidney or liver problems/
disease
• suffer or have suffered from any mental
illness
• are being treated with vaccines
• have ever had severe depression or
manic-depression (bipolar disorder).
This includes having had depression
before while taking steroid medicines like
Prednisolone tablets or any of your close
family has had these illnesses
• Mental problems while taking
Prednisolone tablets:
Mental health problems can happen while
taking steroids like Prednisolone tablets
(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.

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296x210 Leaflet Reel Fed Bi Fold Profile (BST)

Taking other medicines
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained
without a prescription:
• medicines to treat high blood pressure or
diuretics (‘water tablets’)
• medicines to treat epilepsy such as
carbamazepine, phenobarbital, other
barbiturates, phenytoin, primidone,
phenylbutazone
• medicines for diabetes including insulin
• medicines to treat infections such as rifabutin,
rifampicin, amphotericin, ketoconazole,
tetracycline
•  edicines used to treat cancer such as
m
etoposide
•  ethothrexate (for arthritis, Crohn’s disease,
m
psoriasis)
• mifepristone (used for abortion)
• ciclosporin (to prevent organ transplant
rejection)
• anticoagulant drugs used to thin blood
• oral contraceptives (the ‘pill’)
• other non-steroidal anti-inflammatory drugs
(NSAIDs) or aspirin
• aminoglutethimide, acetazolomide,
carboxolone or salicylates
• retinoids (for skin conditions)
• antacids (for indigestion)
• carbimazole (for hyperthyroidism)
• theophylline (for asthma).

Driving and using machines
If you do not have enough sleep you may be less
alert and patients should make sure they are not
affected before driving or operating machinery.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before
taking this medicine.

Sugar intolerance
If you have been told by your doctor that you
have an intolerance to some sugars, contact
them before taking this medicine, as it contains
lactose.
If you see another doctor or go into hospital, let
them know what medicines you are taking.

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page 2

3 How to take Prednisolone tablets

If you stop taking Prednisolone
tablets

You will be supplied with a ‘Steroid Treatment
Card’ which includes important details of
your treatment. This card should be carried
at all times.
Always take Prednisolone tablets exactly as your
doctor has told you, especially if you are elderly.
If you are not sure, check with your doctor or
pharmacist.
Swallow the tablets whole, with a little water
as a single dose in the morning after breakfast
unless otherwise directed by the doctor.

If you stop taking the tablets suddenly
you may develop muscle or joint pain,
conjunctivitis, fever, weight loss, painful itchy
skin lumps or runny nose.
Talk to your doctor before you stop taking
the tablets and follow their advice.

4 Possible side effects

The usual doses are:
Adults - 20-40mg daily initially up to 80mg
daily, reducing to a maintenance dose of
5-20mg daily.
Children - Children do not take as many
tablets as adults. Your doctor will suggest the
correct number of tablets for them to take.
Once a dose is established, it may be
changed to use the lowest effective dose
depending on your response to the drug.
If you are diabetic, you may find that you
need to take more medication to balance
the effect of Prednisolone tablets. You should
discuss this with your doctor.
Your doctor should check your progress at
regular visits. Also, your progress may have
to be checked after you have stopped using
this medicine, since some of the effects may
continue.

If you forget to take Prednisolone
tablets
If you forget to take a dose, take one as soon
as you remember and then your next dose at
the usual time. Never take two doses at the
same time.

If you take more Prednisolone tablets
than you should
If you (or someone else) swallow a lot of
tablets at the same time, or you think a
child may have swallowed any contact your
nearest hospital casualty department or tell
your doctor immediately.

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Like all medicines, Prednisolone tablets can
cause side effects, particularly when you first
start taking it although not everybody gets
them. Please tell your doctor or pharmacist if
you notice any of the following effects or any
effects not listed.
Stop taking Prednisolone tablets and
contact your doctor straight away if
the following allergic reaction happens:
puffy, swollen face, tongue or body, which
may cause shortness of breath, shock and
collapse.
Tell your doctor straight away if the
following happens:
• inflammation of the pancreas (very severe
abdominal pains)
• Steroids including Prednisolone tablets
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. Having strange and frightening
thoughts, changing how you act or
having feelings of being alone
- feeling dependant or addicted to this
product.

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page 3

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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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