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PREDNISOLONE 2.5 MG GASTRO-RESISTANT TABLETS

Active substance: PREDNISOLONE

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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.

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.

• Feeling depressed, including thinking
about suicide

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.

• Feeling high (mania) or moods that go up
and down

5

HOW TO STORE PREDNISOLONE

Keep out of the reach and sight of children.
• Feeling, seeing or hearing things which do Do not store above 25°C. Store in the
original package. Protect from moisture. Do
not exist. Having strange and
not transfer them to another container.
frightening thoughts, changing how you
Do not use Prednisolone after the expiry
act or having feelings of being alone.
date that is stated on the outer packaging.
If you notice any of these problems keep
The expiry date refers to the last day of that
taking your tablets but, talk to a doctor
month.
straight away.
Medicines should not be disposed of via
The following side effects have also been
wastewater or household waste. Ask your
reported. If you feel unwell with any of these pharmacist how to dispose of medicines no
side effects, keep taking your tablets, but
longer required. These measures will help to
see your doctor straight away:
protect the environment.
• osteoporosis (bone thinning – especially
in post menopausal women) or other
bone, muscle or tendon damage or
muscle weakness
• peptic ulcer (stomach or duodenal ulcer)
• indigestion, swollen abdomen,
inflammation of the pancreas, yeast
infection and inflammation and ulceration
of the oesophagus
• aggravation of epilepsy or schizophrenia
• raised blood pressure or blood disorders
• eye problems such as a loss of vision due
to abnormally high pressure in the eye,
clouding of the lens of the eye, thinning of
the tissues of the eye or infections
• raised pressure in brain (which can cause
headaches, nausea and vomiting)
• dizziness
• euphoria (feeling high)
• feeling of dependency on treatment
• irregular or absence of monthly periods,
hairiness, facial swelling (moon face or
cushingoid syndrome), skin bruising or
peeling, redness of the face, acne, slower
healing of wounds, stretch marks, small
spider veins
• itching, rash, hives, acne
• increased sweating
• sodium and water retention, potassium
loss, increased alkaline in the blood,
change in the levels of some hormones
• passing more urine during the night
• weight gain, increased appetite,
intolerance of carbohydrate in the diet,
changes in protein and calcium balance
• allergic reactions, blood clotting
problems, nausea and tiredness
• increased number of white blood cells
• heart problems which can cause shortness
of breath
• in those who have recently suffered a
heart attack, worsening of their condition
may occur
• in children, long-term treatment with high
doses may result in reduced growth rate
which may be irreversible
• increased susceptibility and severity of
infections, recurrence of dormant
tuberculosis.

6

FURTHER INFORMATION

What Prednisolone Gastro-resistant Tablets
contain:
• The active ingredient is prednisolone
2.5 mg or 5 mg
• The other ingredients are lactose, maize
starch, magnesium stearate
• Tablet coating ingredients: polyvinyl
acetate phthalate, stearic acid. Brown
tablets (2.5 mg); yellow iron oxide, iron
oxide red, black iron oxide, talc, polyvinyl
alcohol, polyethylene glycol. Red tablets
(5.0 mg);
FD & C red aluminium lake, polyvinyl
alcohol, polyethylene glycol, titanium
dioxide (E171), talc, quinoline yellow
aluminium lake.
• Printing ingredients: Brown tablets (2.5
mg); shellac, titanium dioxide (E171),
propylene glycol (E1520). Red tablets (5.0
mg); shellac, iron oxide black (E172) and
propylene glycol (E1520).
What Prednisolone Gastro-resistant Tablets
look like and contents of the pack:
• Prednisolone 2.5 mg gastro-resistant are
brown tablets marked ‘2P1’ on one side
and plain on the other side.
• Prednisolone 5 mg gastro-resistant are red
tablets coded ‘2P2’ on one side and plain
on the other side.
• The 2.5 mg tablets are available in packs
of 28, 30, 50, 100 and 500.
• The 5 mg tablets are available in packs of
28, 30, 50, 56, 100 and 500.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation holder and
company responsible for manufacture: TEVA
UK Ltd, Eastbourne, BN22 9AG.
This leaflet was last revised: March 2011
PL 00289/0775-6

PREDNISOLONE
2.5 mg AND 5 MG
GASTRO-RESISTANT TABLETS

1

WHAT PREDNISOLONE IS AND WHAT
IT IS USED FOR

Prednisolone – benefit information.
Prednisolone belongs to a group of
PACKAGE LEAFLET: INFORMATION
medicines called steroids. Their full name is
FOR THE USER
corticosteroids. These corticosteroids occur
naturally in the body, and help to maintain
Read all of this leaflet carefully before you
health and well-being. Boosting your body
start taking this medicine.
with extra corticosteroid (such as
Prednisolone) is an effective way to treat
• Keep this leaflet. You may need to read it
various illnesses involving inflammation in the
again.
body. Prednisolone reduces this inflammation,
• If you have any further questions, ask your which could otherwise go on making your
doctor or pharmacist.
condition worse. You must take this medicine
regularly to get maximum benefit from it.
• This medicine has been prescribed for
Prednisolone tablets are used in a wide
you. Do not pass it on to others. It may
range of inflammatory and auto-immune
harm them, even if their symptoms are
conditions including:
the same as yours.
• 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.
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 Possible Side
Effects 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.

• Allergies, including anaphylaxis (severe
allergic reaction)
• in the treatment of inflammation, affecting
the:
• lungs including; bronchial 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 boost steroid levels when the body is
not making enough natural steroid on its
own

• to treat high calcium levels.
• Some side effects only happen after
If you are unsure why you have been
weeks or months. These include weakness prescribed prednisolone – then consult your
of arms and legs, or developing a rounder doctor.
face (read section 4 Possible Side Effects
for more information).
BEFORE YOU TAKE PREDNISOLONE
• 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.

2

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

• Keep away from people who have
chicken-pox or shingles, if you have never
had them. They could affect you severely. • have an infection unless it is being treated
with a specific antibiotic
If you do come into contact with chicken
pox or shingles, see your doctor straight
• are suffering from herpes infection of the
away.
eye.
Now read the rest of this leaflet. It includes Take special care with Prednisolone
other important information on the safe and Check with your doctor first:
effective use of this medicine that might be • If you have ever had severe depression or
especially important for you. This leaflet was
manic-depression (bipolar disorder). This
last updated in March 2011.
includes having had depression before
while taking steroid medicines like
Prednisolone
IN THIS LEAFLET:
1. What Prednisolone is and what it is used
for
2. Before you take 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.

3. How to take Prednisolone
4. Possible side effects
5. How to store Prednisolone
6. Further information

47506-B
320 x 323

Peel Here To Open

Pharma code 123

• Feeling anxious, having problems
sleeping, difficulty in thinking or being
confused and losing your memory

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Talk to your doctor before you start to take
this medicine if you:
• have an infection or have had tuberculosis
• have diabetes or glaucoma (increased
pressure in the eye), or if there is a family
history of these
• have or have ever had depression, suffer
from a mental disorder or if there is a
family history of these
• have epilepsy
• have osteoporosis (thinning of the bones)
particularly if you are past the menopause
(the change of life), or suffer from a
muscle disease resulting from previous
corticosteroid therapy
• suffer from peptic ulcers (stomach or
duodenal ulcers) or severe dyspepsia
(indigestion)
• 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)
• have hypertension (high blood pressure),
heart failure or have recently suffered a
heart attack
• have an underactive thyroid gland which
can cause tiredness or weight gain
• have liver or kidney disease (if in doubt
ask your doctor)
• have had a recent immunisation or
vaccination
• have ever suffered from a bacterial
infection/infestation affecting the
gastro-intestinal tract or bowel
• have never had measles, chickenpox or
shingles. If you are exposed to any of
these whilst taking Prednisolone, you
must tell your doctor immediately
• have Cushing’s disease (a hormone
disorder which can cause tiredness or
weight gain)
• have Duchenne’s muscular dystrophy.
Important things to remember while you
are taking this medicine:
If you are taking a steroid for a long time your
doctor may have asked you to carry a Steroid
Card.
• 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
• A steroid card may be obtained from 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.
Taking other medicines
Talk to your doctor if you are taking any of
the following:
• drugs for epilepsy e.g. carbamazepine,
phenobarbital, phenytoin, primidone
• antibiotics, antifungals, anti-bacterials or
anti-virals e.g. rifampicin, rifabutin,
ritonavir, amphotericin, erythromycin,
ketoconazole or itraconazole
• medicines or insulins for diabetes
• medicines for high blood pressure, heart
problems (e.g. digoxin) or diuretics (to
increase urine output)
• anticoagulants to thin the blood e.g.
warfarin or acenocoumarol
• antiarthritis drugs
• salicylates or non-steroidal
anti-inflammatory drugs (NSAIDs) for pain
relief e.g. aspirin and ibuprofen,
indometacin
• acetazolamide (for glaucoma)
• carbenoxolone (for stomach ulcers)
• mifepristone (used in pregnancy
termination)
• oestrogens and progestogens (present in
oral contraceptives or HRT)
• methotrexate and aminoglutethimide
(used in cancer treatment)
• ephedrine (used in nasal decongestants or
for breathing problems)
• ciclosporin (used following organ
transplant to prevent rejection)
• muscle relaxants (e.g. pancuronium and
vecuronium)
• growth hormone somatropin
• medicines used for myasthenia gravis e.g.
neostigmine
• medicines for asthma/breathing problems
e.g. salbutamol, formoterol, fenoterol,
terbutaline, bambuterol, salmeterol,
ritodrine, theophylline
• live vaccines
• anaesthetics.
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
Please tell your doctor if you are to have an
X-ray as prednisolone may reduce effects of
anticholinesterase in cholecystographic
X-ray.
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.

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• 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. You
should avoid contact with people who
Driving and using machines
have chicken pox or shingles whilst taking
• Prednisolone is not expected to affect
prednisolone tablets and for up to 3
your ability to drive or operate machinery.
months after you have stopped taking
prednisolone tablets. Do not stop taking
3 HOW TO TAKE PREDNISOLONE
prednisolone tablets.
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.

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

• Measles: If you, anyone in your family or
regular contacts catch measles. You
should avoid contact with people who
have measles.

The tablets should be swallowed preferably
with a drink of water.

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.

Swallow them whole without biting or
breaking the tablets (these are designed to
pass through the stomach unchanged and
dissolve in the small intestine).
Different illnesses require different doses of
prednisolone tablets. Depending on your
illness your daily dose may be between 5
and 60 mg. In some cases you may be
instructed to take it every other day. Your
doctor will decide when and how to treat
you with prednisolone tablets.
The usual dose is:

If you forget to take Prednisolone
• If you forget to take a dose, take another
as soon as possible and continue as
before.
DO NOT take a double dose to make up
for a forgotten dose.

• Adults
Short term dose is 20 to 30 mg each day
reducing by 2.5 or 5 mg every 2 to 5 days. If you stop taking Prednisolone
Rheumatoid arthritis: 10 to 15 mg each day. • DO NOT suddenly stop taking your
Prednisolone tablets unless advised by
Once your condition starts to get better,
your doctor, as you could become ill and
your doctor may change your dosage to a
suffer withdrawal symptoms such as
lower one. Your doctor may also reduce
fever, muscle and bone pain, runny nose
your dosage before stopping treatment
and eyes, painful itchy skin with nodules
completely. This may depend on your
and weight loss which may result in low
illness, your dosage and how long you have
blood pressure and death. Your doctor will
been taking this medicine. In all cases you
reduce your treatment gradually as
should be careful to follow any changes.
appropriate to avoid these effects.
• Children
If you have any further questions on the use
Prednisolone is only used to treat children
of this product, ask your doctor or pharmacist.
if considered essential by their doctor.
The dose is reduced to between a quarter
4 POSSIBLE SIDE EFFECTS
and three quarters of the adult dose,
depending upon clinical factors. The
Like all medicines, Prednisolone can cause
doctor will decide on the appropriate dose
side effects, although not everybody gets
for your child.
them. Some of these side effects such as
• Children over 12 years
mood changes (feeling depressed, or ‘high’),
Three quarters of the adult dose
or stomach problems can happen straight
away, while others may only happen after
• Children over 7 years
weeks or months such as weakness of arms
One half of the adult dose
and legs, or developing a rounder face.
• Children over 1 year
Your doctor will have prescribed the lowest
One quarter of the adult dose
suitable dose for you. Most patients taking a
short course will have no problems.
The use of steroids can slow down normal
growth of children and adolescents. In order Stop taking the tablets and tell your doctor
to lessen this effect the tablets are often
immediately or go to the casualty
taken in a single dose every other day.
department at your nearest hospital if the
following happens:
• Elderly
When steroids are taken by elderly
• an allergic reaction (swelling of the lips,
patients some of the unwanted side
face or neck leading to severe difficulty in
effects can be more serious especially
breathing; skin rash or hives)
brittle bone disease, diabetes, high blood
This is a very serious but rare side effect.
pressure, infections and thinning of the
You may need urgent medical attention or
skin.
hospitalisation.
Whilst 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.

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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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