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PREDNISOLONE 2.5MG TABLETS

Active substance(s): PREDNISOLONE / PREDNISOLONE / PREDNISOLONE

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bruising
stretch marks
patches of skin reddening
itching
rash
hives
acne
extra hair growth
slow healing of wounds
increased sweating
hiding or altering reactions to skin
tests such as for tuberculosis
reduction of growth in babies,
children and adolescents
absence or irregularity of
menstrual periods
face becomes very round
weight gain
increased blood sugar
carbohydrate imbalance in
diabetes
euphoria (feeling high)
feeling of dependency on
treatment
depression
general unwell feeling
vision problems
worsening of schizophrenia
worsening of epilepsy
risk of stroke is increased in
Horton disease
blurred vision
increased pressure in the eyeball
(glaucoma)
whitening or clouding of the lens
(cataracts)
pressure on the nerve to the eye,
thinning of the tissues of the eye
(sclera and cornea)
bulging eyes
worsening of viral or fungal
infections of the eye
risk of contracting infection is
increased
existing infections can worsen
signs of infection can be masked
previous infections, such as
tuberculosis (TB) may be reactivated (flare up)
muscle wasting of the upper arms
and legs
muscle pain
brittle bone disease or wasting of
the bones
bone fractures
tendon rupture
indigestion
stomach ulcers with bleeding or
perforation
bloating
ulcers in the gullet (oesophagus)
which may cause discomfort on
swallowing

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50933677 BBBA0803

• candidiasis (thrush)
• abdominal (stomach) pain
• increased appetite which may
result in weight gain
• diarrhoea
• water and salt retention
• high blood pressure
(hypertension)
• a change in the levels of some
hormones, mineral balance or
protein in blood tests
• increased cholesterol or fat levels
in blood.
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 Website:
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 this medicine out of the sight
and reach of children.
Do not use this medicine after the
expiry date which is stated on the
carton or the foil blister strip. The
expiry date refers to the last day of
that month.

Do not throw away any medicines
via wastewater or household waste.
Ask your pharmacist how to throw
away medicines you no longer use.
These measures will help protect
the environment.

Manufacturer
Actavis, Barnstaple, EX32 8NS, UK

6.Contents of the pack and other
information

If you would like a
leaflet with larger text,
please contact
01271 385257.

• The active substance is
prednisolone. Each tablet
contains either 2.5mg, 5mg,
10mg, 20mg, 25mg or 30mg of
the active ingredient.

JDE No.:

50933677

Date Sent:
11/05/17
Technologist: R.Wrey

• 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 chickenpox or shingles,
if you have never had them.
They could affect you severely. If
you do come into contact with
chickenpox or shingles, see your
doctor straight away.

This leaflet was last revised in
May 2017

Read all of this leaflet carefully
before you start using 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.

• The tablet also contains lactose
monohydrate, pregelatinised
starch, sodium starch glycolate
(type A), Iron oxide yellow (E172),
Iron oxide red (E172), Glycerol
dibehenate, magnesium stearate.
Continued top of next column

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This includes any possible side
effects not listed in this leaflet. See
section 4.
What is in this leaflet
1. What Prednisolone Tablets are
and what they are used for
2. What you need to know before
you take Prednisolone Tablets
3. How to take Prednisolone Tablets
4. Possible side effects
5. How to store Prednisolone Tablets
6. Contents of the pack and other
information
1.What Prednisolone Tablets are
and what they are used for
Prednisolone Tablets belong 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 corticosteroids
(such as Prednisolone Tablets) is
an effective way to treat various
illnesses involving inflammation
in the body. Prednisolone Tablets
reduces this inflammation, which
could otherwise go on making your
condition worse. You must take this
medicine regularly to get 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 or 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.
2.What you need to know before
you take Prednisolone Tablets
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 Tablets.
• If any of your close family has had
these illnesses.
If either of these applies to you,
talk to a doctor before taking
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).
An allergic reaction may include a
rash, itching, difficulty breathing
or swelling of the face, lips, throat
or tongue
• if you have cold sores that effect
the eyes
• if you have an untreated
infection
• 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:
• suffer from or have ever been
treated for tuberculosis (TB)
• have high blood pressure
• have a heart condition
• have liver or kidney problems
• suffer from diabetes or diabetes
runs in your family
• have osteoporosis (thinning of the
bone), particularly if you are past
the menopause (the change of
life)
• are going through, or are past the
menopause

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page 4

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page 1

Prednisolone 2.5mg, 5mg, 10mg, 20mg, 25mg & 30mg Tablets PIL - UK
approved for print/date

Dimensions: 296x210 (Reel Fed)
Component: Leaflet for Blisters
Pharmacode: 7807

Prednisolone 2.5mg, 5mg, 10mg,
20mg, 25mg and 30mg Tablets

They are available in packs of 28
tablets. The 25mg tablet is also
available in packs of 56 tablets.
Marketing Authorisation Holder
Actavis, Barnstaple, EX32 8NS, UK

What Prednisolone Tablets contain

Package leaflet: Information for the user

2.5mg tablet
Yellow, 7mm, round, flat, tablet, with
a score line on one side, imprinted
with “A610” on one side and “2.5” on
the other.
5mg tablet
White, 7mm, round, flat, tablet, with
a score line on one side, imprinted
with “A620” on one side and “5” on
the other.
10mg tablet
Red, 7mm, round, flat, tablet, with
a score line on one side, imprinted
with “A630” on one side and “10” on
the other.
20mg tablet
Red, 9mm, round, flat, tablet, with
a score line on one side, imprinted
with “A640” on one side and “20” on
the other.
25mg tablet
White, 9mm, round, flat, tablet, with
a score line on one side, imprinted
with “A650” on one side and “25” on
the other.
30mg tablet
Yellow, 9mm, round, flat, tablet, with
a score line on one side, imprinted
with “A670” on one side and “30” on
the other.

Keep the blister packs in the outer
carton in order to protect from light.

296x210 Leaflet Reel Fed Bi Fold Profile (BST)

Prednisolone
All strengths x all sizes (UK)

What Prednisolone Tablets look
like and contents of the pack

Proof Round

2

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0803

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

S.Anson
19.05.17
25.05.17
S.Anson

Date sent:
n/a
Date received: n/a

Dimensions:
296 x 210
Min Body Text Size: 8.5pt
Supplier:
Actavis UK

Colours

Non Printing Colours

1. Black

1. Profile

2.

2.

3.

3.

4.
5.
6.

Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

• suffer from epilepsy (fits)
• suffer from stomach ulcers
• have taken Prednisolone Tablets
(or other steroids) before and
had muscular problems (steroid
myopathy)
• 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 planning to have a vaccination
• 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
• have inflammatory bowel disease
such as Crohn’s disease
• have an eye disease caused by
fluid build-up at the back of the
eye that causes visual impairment
• are undergoing
immunosuppression therapy
for example in the treatment of
cancer.
Contact your doctor if you
experience blurred vision or other
visual disturbances.
Children and adolescents
The use of steroids can slow down
normal growth of children and
adolescents. Your doctor may need
to stop treatment or adjust the dose
for your child accordingly.
If any of the above applies to you,
or if you are not sure, speak to your
doctor or pharmacist before you
take Prednisolone Tablets.
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
• antibiotics such as erythromycin
and rifamycin which are used to
treat bacterial infections
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• antiepileptic drugs such as
carbamazepine, phenobarbital,
phenytoin and primidone which
are used to treat epilepsy
• oestrogens, for example in the
contraceptive pill or HRT
• thiazide diuretics (“water tablets”)
for example bendroflumethiazide
used for water retention or high
blood pressure
• medicines to treat high blood
pressure
• anticoagulats for example
warfarin which is used to thin the
blood
• carbenoxolone which is used for
ulcers
• salbutamol, formoterol,
bambuterol, fenoteral, ritodrine,
salmeterol and terbutaline used to
treat asthma
• antimuscarinics/ anticholinergics
• immunosuppressants which
dampen down the activity of the
body’s immune system
• antacids such as magnesium
trisilicate or aluminium hydroxide,
used to treat the symptoms of
heartburn and indigestion
• drugs for diabetes including
insulin
• 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
• non-steroidal anti-inflammatory
drugs (NSAIDs) for example
aspirin, ibuprofen and
indometacin used for pain relief or
to treat rheumatic disease
• mifepristone, used to induce
labour or abortion
• cytotoxic drugs for example
methotrexate which is used to
treat cancer
• 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
• somatropin which is a growth
hormone
• acetazolamide which is used in
the treatment of glaucoma and
epilepsy
• loop diuretics for example
furosemide which is used to treat
heart failure
• theophylline which is used for
asthma and chronic obstructive

JDE No.:

50933677

Date Sent:
11/05/17
Technologist: R.Wrey

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.

Avoid eating liquorice whilst taking
Prednisolone Tablets.
Pregnancy, breast-feeding and
fertility
Pregnancy
If you are pregnant or breastfeeding, think you may be pregnant
or are planning to have a baby, ask
your doctor or pharmacist for advice
before taking this medicine.

Treatment of the elderly
When steroids are taken by elderly
patients some of the unwanted
side effects can be more serious
especially brittle bone disease,
diabetes, high blood pressure,
infections and thinning of the skin.

Breast-feeding
If you are breast-feeding you must
tell your doctor before you start the
treatment. Your doctor will want
to examine your baby during your
time of treatment. Small amounts of
steroids are present in breast milk.

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 catches chickenpox
or shingles. This is because you
may become very ill if you get
chickenpox whilst taking
Prednisolone Tablets. You should
avoid contact with people who
have chickenpox or shingles
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 catches
measles. You should avoid
contact with people who have
measles.

Fertility
Prednisolone Tablets may reduce
fertility in men.
Driving and using machines
If you feel dizzy or tired after taking
Prednisolone Tablets do not drive
or operate machinery until these
effects have worn off.
Prednisolone Tablets contain
lactose
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.
3.How to take 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 this medicine exactly
as your doctor or pharmacist has
told you. Check with your doctor or
pharmacist if you are not sure.

Your doctor will give you a steroid
treatment card. You must carry it
with you at all times. You should
show your steroid treatment card to
anyone who is giving you treatment
such as a doctor, nurse or dentist.

Different illnesses require different
doses of Prednisolone Tablets.
Depending on your illness your
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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.
Use in children and adolescents
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.
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. Show any
leftover medicines or the empty
packet to the doctor.
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 a double dose to make
up for a forgotten dose.
If you stop taking Prednisolone
Tablets
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. In some severe cases
a drop in blood pressure and death
may occur.
Talk to your doctor before you stop
taking the tablets and follow their
advice.

If you have any further questions
on the use of this medicine, ask
your doctor or pharmacist.
4.Possible side effects
Like all medicines, this medicine can
cause side effects, particularly when
you first start taking it although not
everybody gets them.
Stop taking Prednisolone Tablets
and contact your doctor straight
away if the following allergic
reaction (have been reported)
happens;
Puffy, swollen face, tongue or body,
which may cause shortness of
breath, shock and collapse.
Serious effects: Tell your doctor
straight away
• Inflammation of the pancreas
(very severe abdominal pains).
• Painful skin ulcers.
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
talk to a doctor straight away.
Other side effects you may
experience:
• tiredness
• increased number of white blood
cells
• blood clotting
• nausea and vomiting
• heart problems which can cause
shortness of breath
• convulsions
• dizziness
• vertigo
• headache
• raised pressure in the brain (which
can cause headaches, nausea and
vomiting)
• sleeplessness
• thinning of the skin

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page 2

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page 3

Prednisolone 2.5mg, 5mg, 10mg, 20mg, 25mg & 30mg Tablets PIL - UK
approved for print/date

Dimensions: 296x210 (Reel Fed)
Component: Leaflet for Blisters
Pharmacode: 7807

daily dose may be between 5 and
60mg. 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.

Prednisolone Tablets with food,
drink and alcohol
Prednisolone Tablets should be
swallowed with water and taken
following a meal to reduce stomach
irritation.

Continued top of next column

296x210 Leaflet Reel Fed Bi Fold Profile (BST)

Prednisolone
All strengths x all sizes (UK)

pulmonary disease (COPD)
• antithyroids such as carbimazole
• isoniazid which is used to treat
tuberculosis.

Proof Round

2

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0803

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

S.Anson
19.05.17
25.05.17
S.Anson

Date sent:
n/a
Date received: n/a

Dimensions:
296 x 210
Min Body Text Size: 8.5pt
Supplier:
Actavis UK

Colours

Non Printing Colours

1. Black

1. Profile

2.

2.

3.

3.

4.
5.
6.

Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

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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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