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Active substance(s): PREDNISOLONE

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PREDNISOLONE 1MG & 5 MG - 15-11-17.qxp_PREDNISOLONE 1MG & 5MG- 0033521117/04- 210 X 297mm 15/11/2017 15:49 Page 1

Patient information leaflet

Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
x Prednisolone is a steroid medicine, prescribed for many different
conditions, including serious illnesses
x You need to take it regularly to get the maximum benefit.
x 'RQ¶WVWRSWDNLQJWKLVPHGLFLQHwithout talking to your doctor - you may
need to reduce the dose gradually
x Prednisolone can cause side effects in some people (read section 3 below).
stomach problems can happen straight away. If you feel unwell in any way,
keep taking your tablets, but see your doctor straight away
x Some side effects only happen after weeks or months. These include
weakness of arms and legs, or developing a rounder face
x If you take prednisolone for more than 3 weeks, you will get a blue
µVWHURLGFDUG¶: always keep it with you and show it to any doctor or nurse
treating you
x 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.
x Keep this leaflet. You may need to read it again
x If you have any further questions, ask your doctor, pharmacist or nurse
x 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
x If you get any side effects, talk to your doctor or pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. See section 4
What is in this leaflet:
1. What Prednisolone is and what it is used for
2. What you need to know before you take Prednisolone
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 is and what it is used for

x 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
x Prednisolone is used for the treatment of severe hypersensitivity reactions,
bronchial asthma, rheumatoid arthritis, systemic lupus erythematosus
(inflammatory skin disorder), blood cancer, intestinal disorder, adrenal
insufficiency, heart disorder, inflammatory muscle disorder, inflammatory
kidney disorder and immuno-suppression in organ transplant. It also may be
used for other conditions as determined by your doctor. Consult your doctor
for more information

2. What you need to know before you take prednisolone
DO NOT TAKE these tablets if you:
x are allergic to Prednisolone or any of the ingredients of this tablet (listed in
section 6)
x have or ever had a peptic ulcer (ulcer in your stomach or duodenum)
x suffer or have suffered from any mental illness
x have tuberculosis
x have an infection (unless you are receiving anti-infective therapy)
x have a herpes infection of the eye
x are pregnant or breast feeding
Warnings and precautions
Talk to your doctor or pharmacist before taking these tablets:
x If you have or ever had severe depression or manic-depression (bipolar
disorder). This includes having had depression before while taking steroid
medicines like Prednisolone
x If any of your close family has had these illnesses
If either of these applies to you, talk to a doctor before taking
You should discuss with your doctor before taking this medicine if you:
x had septicaemia, epilepsy, depression, high blood pressure, a recent heart
attack, osteoporosis (disease of the bone leading to an increased risk of
fracture) or an underactive thyroid gland (leading to muscle cramps, fatigue,
paleness, weight gain)
x have or ever had diabetes or a family history of diabetes
x have glaucoma (raised pressure in your eye) or a family history of eye

x an eye disease affecting your sight due to fluid build-up at the back of the

x gone through, or are going through, the menopause
x ever had a blood clot inside a blood vessel, for example a DVT (deep vein

an active or a history of recurrent peptic ulcer, stomach bleeding or
have or have had liver, kidney or heart problems
have been recently vaccinated
myasthenia gravis (muscle weakness and fatigue)
any form of inflammatory bowel disease such as ulcerative colitis
have taken prednisolone tablets (or a similar medicine) before and had
muscular problems (steroid myopathy)if you have or have previously been
infected with a viral infection e.g. Chicken pox, shingles or other viral
infection, inform your doctor as soon as possible. If you are taking
prednisolone, or have taken it in the previous 3 months, you should not be
vaccinated within 10 days of exposure to chicken pox. If a diagnosis of
chicken pox is confirmed, the illness requires specialist care and treatment

If you take prednisolone for more than 3 weeks, you will get a steroid card
which has to be carried with you at all times.
Mental problems while taking Prednisolone
Mental health problems can happen while taking steroids like Prednisolone
(see also section 4).
x These illnesses can be serious
x Usually they start within a few days or weeks of starting the medicine.
x They are more likely to happen at high doses.
x 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.
Other medicines and Prednisolone
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines. In particular, tell your doctor if you are taking:
x medicines to treat high blood pressure or diuretics µZDWHUWDEOHWV¶
x medicines to treat epilepsy such as carbamazepine, phenobarbital, other
barbiturates, phenytoin, primidone, phenylbutazone
x medicines for diabetes including insulin
x digoxin and related cardiac glycoside drugs, used to treat heart failure and
rhythm disorders
x medicines to treat infections such as rifabutin, rifampicin, amphotericin,
ketoconazole, tetracycline, ritonavir
x medicines used to treat cancer such as etoposide
x mifepristone (used for abortion)
x ciclosporin (to prevent organ transplant rejection)
x anticoagulant drugs used to thin blood such as warfarin
x other non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin
x aminoglutethimide, acetazolamide, carbenoxolone or salicylates
x retinoids (for skin conditions), antacids (for indigestion)
x carbimazole (for hyperthyroidism)
x salbutamol, theophylline (for asthma)
x certain types of vaccines, you must not be given any live vaccines
x oestrogens, a type of female hormone
Prednisolone with food and drink
Avoid eating liquorice while taking prednisolone.
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.
Driving and Using Machines
If you do not have enough sleep you may be less alert and you should make
sure you are not affected before driving or operating machinery.
Prednisolone tablets contain lactose
If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicine, as it contains lactose.

3. How to take prednisolone tablets
Always take this medicine exactly as your doctor has told you. Check with
your doctor if you are not sure.

PREDNISOLONE 1MG & 5 MG - 15-11-17.qxp_PREDNISOLONE 1MG & 5MG- 0033521117/04- 210 X 297mm 15/11/2017 15:49 Page 2

Swallow the whole tablet with a glass of water.
Your doctor will decide the dose that is best for you. Always follow the
GRFWRU¶V instructions completely, and also follow the SKDUPDFLVW¶V instructions
on the label. If you do not understand or are in doubt about anything please ask
your doctor or pharmacist.
The dose can be taken in the morning or the total dose which can be taken for
two days can sometimes be taken as a single dose on alternate days.
Do not take more or less of your prescribed medicine. Do not use it more often
and do not use it for a longer period than instructed by your doctor.
The usual doses are:
Adults - The usual starting dose depends on the illness being treated and your
daily dose may be between 5 and 60 mg, then reduce to a maintenance dose of
5-20mg daily.
Children (aged 1 year or over)- 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.



epilepsy, 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, bone, joint or tendon pain,
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, increased levels of
cholesterol and altered levels of fat in the blood, weight gain. Growth in
infancy, childhood and adolescence may be reduced
Kidney - urinating at night, water and salt retention, loss of potassium in the
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, loss of eye sight, changes
Other ± vertigo (a feeling that you or your surroundings are moving),
buzzing in the ears, generally feeling tired or unwell

If you take more tablets than you should
If you or someone else has swallowed too many tablets, contact your nearest
hospital casualty department or doctor for immediate advice. Take the pack
and remaining tablets with you. Symptoms of overdose include drowsiness,
heartburn, indigestion, feeling and being sick.

Use in the elderly: The common side effect of Prednisolone may be associated
with more serious problems in old age, particularly osteoporosis (loss of bone
density), hypertension, (high blood pressure), low potassium level, diabetes,
susceptibility to infection and thinning of the skin. Close monitoring by
medical staff is required to avoid life-threatening reaction.

If you forget to take Prednisolone
If you forget to take a dose of this medicine and your dosing schedule is:
One dose every other day - take the missed dose as soon as possible if you
remember it the same morning, then continue with the regular dosing schedule.
If you remember later on in the day, then wait and take it the next morning,
then skip a day and start your regular dosing schedule again.
One dose a day - take the missed dose as soon as possible then continue with
the regular dosing schedule.
If you do not remember until the next day, skip the missed dose and do not
double the next dose. Then continue with the regular dosing schedule.

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: By reporting side effects you can help provide
more information on the safety of this medicine.

Withdrawal of Prednisolone
In the patients who have received more than 7.5mg or equivalent for more
than 3 weeks, withdrawal should not be abrupt. Assessment of your illness
may be needed during withdrawal .If your illness is unlikely to return on
withdrawal of the medicine, the dose of Prednisolone may be reduced rapidly.
Once a daily dose equivalent to 7.5mg of Prednisolone is reached, dose
reduction should be slower.
If you have any further questions on the use of this medicine, ask your doctor
or pharmacist.

4. Possible side effects
Like all medicines, your medicine can cause side effects, although not
everybody gets them.
Stop taking Prednisolone tablets and go to A&E taking the pack with you if
the following allergic reaction happens: puffy, swollen face, tongue or body,
which may cause shortness of breath, shock and collapse.
Serious effects: tell your doctor straight away if the following happens:
x inflammation of the pancreas (very severe abdominal pains)
x 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 in 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 dependent on or addicted to this product
Tell your doctor if the following occur
x 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 occur more easily. This is especially important
regarding chickenpox or measles
x 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, or have pain after eating), particularly in those with Irritable Bowel
Syndrome (IBS)
x Heart ± high blood pressure, congestive heart failure in those already at risk
x Nervous system ±unusual tiredness or weakness, headache, feeling dizzy,
confused, drowsy, nervousness, worsening of schizophrenia, worsening of

5. How to store prednisolone tablets
Keep this medicine out of the sight and reach of children.
x Do not use this medicine after the H[SLU\GDWHVWDWHGRQWKHODEHODIWHUµ(;3¶
The expiry date refers to the last day of that month
x Store in a cool dry place, below 25ºC
x Protect from bright light
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.

6. Contents of the pack and other information
What Prednisolone tablets contain
Prednisolone 1 mg Tablets:
The active ingredient is 1mg Prednisolone.
The other ingredients are lactose monohydrate, maize starch, colloidal
anhydrous silica, sodium starch glycollate, stearic acid and magnesium
Prednisolone 5mg Tablets:
The active ingredient is 5mg Prednisolone.
The other ingredients are lactose, maize starch and magnesium stearate.
See end of section 2 for further information on lactose.
What Prednisolone tablets look like and contents of the pack
x Prednisolone 1mg tablets are white, circular, biconvex, tablets or white,
circular, biconvex tablets embossed PV on the face and P/1 on the other.
x Prednisolone 5mg tablets are white, circular, flat, bevelled edged tablets
HPERVVHGµ39¶Rn one face and P/5 on the other
x Prednisolone 1 mg tablets are available in dispensing pack sizes of 28, 56,
84, 100, 250, 500 and 1000 tablets
x Prednisolone 5 mg tablets are available in pack sizes of 14, 28, 30, 56 tablets
(14, 28 & 56 tablets also in blister packs) and dispensing packs sizes of 500
and 1000 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Pharmvit Ltd, 177 Bilton Road, Perivale,
Greenford, Middlesex UB6 7HQ.
Telephone: 0208 997 5444
0208 997 5433
To request a copy of this leaflet in large print or audio format or for additional
copies, please contact the licence holder at the address (or telephone, fax)
PL 4556/0033 & PL 4556/0052
Reference: 0033521117/04
Date leaflet last revised:

November 2017


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