PATIENT INFORMATION LEAFLET

797-6296
Mat.-Nr.0642370-01

Soluble Prednisolone Tablets 5 mg

What you should know about Soluble Prednisolone Tablets Before you take your lablets
Please read this carefully before startin~ to take your medicine Have you ever been told you are ollergic to prednisolone or ony 01 the
It provides a summary of the information available on your medicine. I! you other Ingredients?
have further questions or ore not sure obout anything, ask your doctor or
phamacist Have you ever had tuberculosis ITB), diabetes epilepsy, depression,
• Prednisolone is a steroid medicine, prescribedfor many different glaucoma (raised eye pre.ssure), hyp.erten ..s.ion (h.. igh ~Iood. pres.s.urel,

--
conditions including serious illnesses. oslteoporoSlS
u cers? (thinj1lng of the ~ones), myasthenio grav~. Qr stomach
You need to take it regularly to get the maximum benefit.
Don't stop taking this medicine without talking to your doctor you Are you taking any other medicines including medicines lor any olthe
may need to reduce the dose gradually. above (Onditia~? The effectiveness of certain treatments may be affected
Prednisolone can cause siae effects in some people (rood section b'y combinatioil
Check wilh yourof doctor
medicines.
first
If you have ever had severe depression or manic-depressive illness
side effects below). Some problems such as mood changes (feeling depressed, (bipolar disorder). This includes Iiaving had depression before while
or
in 'high')
any way,or slomach problems
keep taKing your can hopp'en
tablets, but stroight
see your oway.lfyoufeel
doctor unwell taking steroid medicines like prednisolone.
straight away; If any of your dose family has had these illnesses. I! either 01 these
• Some side effects only happen alter weeks or months. applies to you, talk to a doctor before taking prednisolone.
These include weakness of arms agd legs, or developing a

rounder
II face ihis
you take (read medicine
section side
foreffects
more forthan
morethree
information).
weeks, Tell your doctor il you are takin9 carbo maze pine, phenobai1bitane, phenl10in
you will get a blue 'steroid card': olways keep it with you or
are primidone
antibiotics),(usedephedrine
in epilepsx),
(found
rifampicin,
in certain
rilabutin
cough orand
erythromycin
cold remedies),
(which

and show It to any doctor or nurse treating you. warfarin, acenocoumarol

reduces natural (orthe
steroids in other anticoagulants){
body), aminoglutethimide
insulin gllDenciamide, meriormin(which
(or
Keep awayif you
shingles, fromhave
people
never who
had have
them. chicken-p.ox or you
They could affect
severely. I! you do come into contact with chicken-pox or other treatments
diuretics for diabetes),
(water tablets) ocetazolamide
sucli as (used for certain
bendraflumethiazide eye conditions),
and lurosemide (usea
shingles, see your dodor straight away.
to treat highused
medicines blood pressure,
to treat high heart
blood failure,
pressure,water retention
cardiac and swelling),
glycosides other
such as aigoxin
Now read the rest of this leaflet. It includes other important information (used to treat heart failure and irregular heart beat), non-steroidal
on the safe and effective use of lhis medicine that might be especially
important for you. This leaflel was last updated on 31701/08 anti-inflammatory drugs such as ibuprolenketoprolen and diclolenac,
long-term treatment with aspirin or other sa(icylate~ oestragens (found in
Prednisolone· benefit information. contraceptive pills, hormone replacement therapy (HKT), ond certmn cancer
treatments), amphotericin or ketoconazole (used for treating fungal infections)\
Prednisolone belongs to a group of medicines called steroids. Theirfull name somatropin Iiigh
(useddoses
to promote growth), medicines
theophyllinealso(used
bronchitiS), olthe lollowing used to
to treat
treat asthma
asthma ana
and
is corticosferoids. These wrticosteroids occur naturally in the body, and help to
other breathing problems: bambuterol, fenoterolj formoterol, salbutamol,
maintain health and well-being. Boosting your body with extra corticosteroid
salmeterol ana terbutaline; ritodrine lused or premature labour),
(such as prednisolone) is on ettective way to treat various illnesses involving
carbenoxolone (used to treat oesophageal u ceration), ritonavir (used to treat
inllammationgo on
otherwise in the body. your
making Prednisolone
candition reduces
worse. this
Youinflommotion{
must take tniswhich could
medidne viral inlections), ciclosporin (used to help the body accept bane marrow or
organ transplants), antichohnesterases (drugs used to treat the condition
regularly to get moximum benefit /rom it.
myasthenia gravis), methotrexate (used for rheumatoid arthritis, psoriasis and
• What your tablets contain certain types of cancer) and milespristone (used to terminate pregnancy).
Each smoll pink tablet contoins:
The active ingredient - prednisolone (os sodium phosphate) 5 mg Other Do you have liver or heort disease?
Are you on a low sodium diet?
ingredients - fovidone, sodium citrate, sodium Iiydrogen corbonate, sodium Are you going to have a gall bladder X-ray?
benzoate (E2 30
Packs contain 11,talilets
erythrosine
in loil (E127) and10 saccharin
strips of tablets. sodium.
Have
Have you just been
you hod immunised
a recent or isinlarction?
myocardial an immunisation planned?
Product Licence holder and manufacturer Do you have a virol infection such as meosles, chickenpox or shingles,
or ony other infection?
Product Licence
Sovereign House,holder: Waymade
Miles Gray Road, PLC, tradingEssex
Basildon as Sovereign
SS14 3FR.Medical, Have you been in contact or, durin9 treatment, come into contact with
Manufacturer: Losan Pharma GmbH, Otto-Hahn-StraBe 13 0-79395
anyone suffering from measles! chickenpox, or shingles, especially il you
Neuenburg.
have not previously' had these i Inesses yourself? I! you come into contact
with one ofwith
treatment these illnesses
Soluble within theTablets,
Prednisolone past three months
tell your or immediate~.
doctor during
• What your tablets do
Are you pregnant or planning to became pregnant? II steroids are taken
Soluble
one of a Prednisolone Tablets called
group 01 medidnes containcorticosteroids
prednisolone orsodium phosphateshould
"steroids"(tliey whichnot
is
for long periods
an increased riskofoftime or repeatedly
the baby growing during pregnancy,
more slowly there
while in the may be
mother's
be confused with "anabolic" steroids misused by some bodybuilders and athletes).
womb. However there are certain clinical situations where it would be
Soluble Prednisolone Tablets pre used to treat severe asthmo, rheumatoid arthritis,
acute ollergic reactions and severe skin conditions.
mare risky
Tablets tlianto the matheron and
carrying child them.
taking to stopYour
takingdoctor
Soluble
will Prednisolone
advise you.
Are you breast-feeding?
Many different diseases may be improved by the careful use of effective
medicines like this which mainly work by redUCing inflammation in the body. I! the answer to any of these questions is YES:

If you ore not sure why you are taking these tablets, ask your doctor. -II you Did
did you
NOTtell
youyour doctor
should at as
do so thesoon
last visit or an earlier
os possible visit1 starting
and BEFORE
the tablets.
Even so, your doctor moy still want you to take them.
 Mental health problems while taking Prednisolone • Whallo do if you lake 100 many tablels at once

Mental health problems can occur while taking steroids like Prednisolone It is very
more thanimportant
this couldtobestick to the dose
dangerous on the iflabel
especially manyoftablets
your medicine.
are token Taking
at one
(see also section Side Effects). time. In that case don't delay: ask your doctor what to do or contact your nearest
• These illnesses can be severe. hospital emergency deportment.
Usually they start within a few days or weeks of starting the medicine.
They are more likely to happen at high doses. • Side Effects
Most of these problems go away if the dose is lowered or the medicine A few people con be allergic to some medicines. If any ofthe following rore side
is stopped. However, if problems do occur they might need treatment. effects come on soon after taking your tablets tell your doctor immediately:
Sudden chest tightness or wheeziness
Talk to a doctor if you (or someone taking this medicine) show any signs of Chest pain
mental health prolilems. This is particularly important if you are depressed, or Heart pounding or beating irregularly

might be thinkmg
happened aboutaresuicide.
when doses being In a few coses,
lowered or the mentai
medicinehealth prolilems
stopped have
altogether. Swelling
Skin rash of- red
eye spots
lids, face or lips
or hives (skin lumps)

• (ar!ying a steroid card Severe effects: lell a doctor straight away

- If your doctor asks you to corry a STEROID CARO, be sure to keep it with Steroids including dexamethasone con couse severe mental health problems.
These ore common in both adults and children. They con affect about five in
you
Showalways.
it to any doctor, dentist, nurse or midwile or onyane else who is
every
• 100 people
Feehng taking medicines
depressed, like dexamethasone.
including thinking about suicide.
giving you treatment or vmcinotions.
Even
midwifeotteror your treotment
anyone else whohasis finished telltreatment
giving you any doctorhdentist, nursehod
t at you have or Feeling high (mania) or having moods that go up and down.
steroid treotment. Feeling anxious, haVing problems sleeping, having difficulty in thinking
or being confused and losing your memory.
A steroid In
Authority. card moy be
Sco~and, obtoined
steroid from
cords are your doctor,
available pharmocist
from your or Health
10(01 Stanish locol Health
Board. Feeling, seeing
frightening or hearing
thoughts, thingshow
changing which
you do
actnot exist. Having
or having feelingsstrange and
of being
alone.
II you notice any of these problems talk to a doclor slraighl away.
- • How to take your tablets
- Look at the label-It should say WHO should toke them, HOW MANY
and WHEN. If ~ does not or you are not sure, ask your doctor or pharmacist. Most
lowestpeQple taking
ettective dose these
for thetablets findpossible
shortest they cause
time.no problems iI taken at the
_ - The tablets con be swallowed whole but they are best taken as
a drink after allowing them to dissolve in a glass of water. II you have to toke these tablets for a lona. time your doctor will prescribe as
Take your Soluble Prednisolone Tablets as a single dose each morning, small a dose as possible. High doses token tor 0 long time or repeated in short
unless your doctor has advised you otherwise. courses can lead
severe muscle to side effects
weakness, such as skin
eye problems thinning
(cotaracts [stretch marks),
or glaucoma), bone bruising,
thinning

Dosage
vary depends
widely on the
between 10 condition
mg and 100being
mg treated
daily in and, lor an
divided adultl
doses, con
a ways or damage
mental (osteoporosis),
upsets. stomach
If you have had ulcers,
a recent heortirregular monthlyheart
attmk, further periods or, rarely,
complications
reducing to the smallest dose that works.
mayoccur.
If prescnbed
label says. for a CHILD, make sure the tablets are token as the In children hJ.gh doses taken for a malaise
long timeond
canhiccups.
stunt growth.
Other side etreets include nausea,
Treatment with steroids con make it easier for you to pick up infections and
certain infections such as chickenpox, can be made worse.
To treat acute asthma attacks, for children aged more than 5 years 0ldj30 to
40 mg mayTreatment
be given. be given; for
for up
chilaren
to threeaged
daysfrom 2 to 5 years
is usually old, 20
sufficient, but mg
the dai y may
length ot If you
tell feeldoctor.
your unwelr or have any unusual discomfort you do not understand -
the course should be tailored to the number of days necessary to recover.

For children aged less than 2 years old, 10 mg daily may be given, for up to • you If
II you taken
have do nol get tablets
all the belfer and you still feel unwell or
three days. II you have not taken all the tablets Iiut feel worse - Tell your doctor

If you are on long-term therapy make sure your supply oftablets does not run out.
• Looking aher your medicine
Keep Soluble Prednisolone Tablets at roam temperature, do not store above
• After slarting 10 toke your lablets 25°C.
As withStore in the original
all medicines, keep package.
Solulile Prednisolone Tablets safely away from
You mgy suddenly
Do NOT start to leer
stopbetter
takingafter
yourtaking
tabletstheunless
tabletsyou
for have
a fewbeen
days.told to do so children.
A child may be harmed by medicine prescribed far someone else.
byyou
It youranswer
doctor,YES
as ittocon
onemake you at
or more ill.the following guestions, then when your
doctor stops your steroid therapy your doctor may choose to do this gradually, KEEP OUT OF THE REACH AND SIGHT OF CHILDREN
by lowering your dose slowly over a period of time:

Have you been • What 10 do wilh any unused lablels

for longer than taking any steroids (this includes tablets or injections)
3 weeks?
If your doctor stops your treatment, return any unused tablets to a pharmacist
Have you
Have you taken
in the repeated coursesstopped
last 12 months of any long
steroids?
term therapy of any for safe
the disposal.
tablets Only
after the keep dote
expiry your on
tablets if your
the foil doctor tells you to. Do not toke
or carton.
steroids?
Do you have a hormonal imbolance which causes a condition known as Remember

adrenalcortical insufficiency? If you are unsure, ask your doctor.

This
to medicineelse.
someone is for YOU.
There Only
may lie areosons
doctor can
why prescribe it for that
it could harm you. person.
Never give it
Have
of you been
Soluble taking high
Prednisolone dailY doses
Tablets? • of steroids e.g. more than 40 mg
Have you usually been taking a steroid dose in the evening? • Further information
This leaflet does not contain all the information about your medicine.

If• you What to take

forget to do ifa dose,
you miss a dose
it is important to take another as soon as possible. II you have anywho
~uestions
or pharmacist has the orinformation
are not sureyou
about
need onythin9j
and wit ask youryou.
adVise doctor
Then go on as before.
You
publicmay be able to find out more about prescribed
libraries. medicines from books in

YOU MAYWANT TO READ THIS LEAFLET AGAIN. 00 NOT THROW IT AWAY

GN UNTIL YOU HAVE FINISHED YOUR MEDICINE

The information provided applies only to Solubie Prednisolone Tablets.

0642370-01 Date of preparation: January 2008