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PREDNISOLONE 1MG TABLETS BP

Active substance(s): PREDNISOLONE

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PREDNISOLONE

PIL :0033520215-02

210 X 310MM

3/9/15

3:00 PM

Page 1

Patient information leaflet

PREDNISOLONE TABLETS 1MG & 5MG

Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
• 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 3
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
• If you take prednisolone 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.
• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor, pharmacist or nurse
• 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 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

• 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
• 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:
• are allergic to Prednisolone or any of the ingredients of this tablet (listed
in section 6)
• have or ever had a peptic ulcer (ulcer in your stomach or duodenum)
• suffer or have suffered from any mental illness
• have tuberculosis
• have an infection (unless you are receiving anti-infective therapy)
• are pregnant or breast feeding
Warnings and precautions
Talk to your doctor or pharmacist before taking these tablets:
• 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
• If any of your close family has had these illnesses
If either of these applies to you, talk to a doctor before taking
Prednisolone

You should discuss with your doctor before taking this medicine if you:
• 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)
• have or ever had diabetes or a family history of diabetes
• have glaucoma (raised pressure in your eye) or a family history of eye
problems
• an active or a history of recurrent peptic ulcer, stomach bleeding or
perforation
• 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).
• 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.
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:
• 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
• medicines used to treat cancer such as etoposide
• methotrexate (for arthritis, Crohn’s disease, 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, acetazolamide, carbenoxolone or salicylates
• retinoids (for skin conditions)
• antacids (for indigestion)
• carbimazole (for hyperthyroidism)
• theophylline (for asthma)
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.
Swallow the whole tablet with a glass of water.
Dosage:
Your doctor will decide the dose that is best for you. Always follow the
doctor’s instructions completely, and also follow the pharmacist’s

PREDNISOLONE

PIL :0033520215-02

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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 - 20-40mg daily initially up to 80mg daily, 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.
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.
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.

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:
• inflammation of the pancreas (very severe abdominal pains)
• 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
• 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
• 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)
• 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










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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

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 lifethreatening reaction.


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 this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the label after
‘EXP’. The expiry date refers to the last day of that month
• Store in a cool dry place, below 25ºC
• 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
stearate.
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

• Prednisolone 1mg tablets are white, circular, biconvex, tablets or

white, circular, biconvex tablets embossed PV on the face and P/1 on
the other.
• Prednisolone 5mg tablets are white, circular, flat, bevelled edged
tablets embossed ‘PV’ on one face and P/5 on the other
• Prednisolone 1 mg tablets are available in dispensing pack sizes of 100,
250, 500 and 1000 tablets
• Prednisolone 5 mg tablets are available in pack sizes of 14, 28, 30, 56
tablets 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
Fax:
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) above.
PL 4556/0033 & PL 4556/0052
Reference: 0033520215/02

Date leaflet last revised: February 2015

POM

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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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