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INFORMATION FOR PATIENTS
• 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 ‘ARE THERE ANY 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.
• Some side effects only happen after weeks or months.
These include weakness of arms and legs, or developing
a rounder face (read section ‘ARE THERE ANY SIDE-EFFECTS?’ 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
• 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.
It includes other important information on the safe and effective use of this
medicine that might be especially important for you. This leaflet was last updated on 15/02/2008.
You should keep
this leaflet throughout your course of treatment.
THE NAME OF YOUR MEDICINE IS PREDNISOLONE TABLETS
Prednisolone belongs to a group of medicines called steroids. Their full name is corticosteroids.
occur naturally in the body, and help to maintain health and well-being. Boosting your body with extra corticosteroids
(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 tablets contain the active ingredient prednisolone. The tablets come in two strengths, 1mg and 5 mg.
Other ingredients in your tablets are lactose, maize starch, stearic acid, purified talc and magnesium stearate.
Prednisolone tablets are white circular tablets with a breakline and marked CP on one side and PL1 or PL5 on the reverse.
Prednisolone tablets are available in strip packs of 28 tablets.
Marketing Authorisation Holder:
Wockhardt UK Limited, Ash Road North, Wrexham, LL13 9UF, UK.
CP Pharmaceuticals Limited, Ash Road North, Wrexham, LL13 9UF, UK.
HOW DOES YOUR MEDICINE WORK?
Prednisolone tablets belongs to a group of medicines called corticosteroids (steroids). These medicines work by damping down inflammation whatever
WHAT ARE PREDNISOLONE TABLETS FOR?
Prednisolone tablets are used to treat a wide variety of allergic reactions (e.g. asthma, eczema) and inflammatory conditions (e.g. arthritis). Your doctor
can tell you what you are being treated for.
BEFORE TAKING THIS MEDICINE
• You have ever had a reaction or been told that you are allergic to prednisolone or any of the other ingredients in the tablets. Check by reading the
• You have an infection (unless you are receiving anti-infective therapy).
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
• If any of your close family
has had these illnesses.
If either of these applies to you, talk to a doctor before taking prednisolone.
Before taking this medicine, you should let your doctor know if you are pregnant or breast-feeding or wish to become pregnant or start breast-feeding.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Taking another medicine while you are taking prednisolone can affect how it or the other medicine works. Make sure that your doctor knows what other
medicines you are taking. Do not take any other medicines while you are taking prednisolone unless you have told your doctor or pharmacist and asked
their advice. This includes medicines you may have bought yourself.
Examples of medicines that can cause problems if taken with prednisolone are:
• Some drugs used to treat epilepsy (carbamazepine, phenytoin, primidone and phenobarbital.)
• Some blood thinning agents (coumarin anticoagulants)
• Digoxin and related drugs called cardiac glycosides, used to treat heart failure
• Some diuretics (loop diuretics and thiazide diuretics)
• Some antibiotics (rifampicin, rifabutin)
• A steroid inhibitor, aminoglutethimide
• Some drugs for diabetes, including insulin
• Aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs), used to control pain and inflammation
• Female sex hormones in the oral contraceptive pill or HRT
• Mifepristone, used to terminate pregnancy
• Antiviral drugs such as ritonavir and indinavir
• Theophylline, used to treat diseases affecting the lungs such as asthma
• Isoniazid, used to treat tuberculosis
• Ketaconazole and amphotericin, used to treat fungal infections
• Ciclosporin, used to control inflammation
• Neuromuscular blockers, used to relax the muscles during a general anaesthetic
• Sympathomimetic drugs used to treat breathing difficulties such as salbutamol, bambuterol, salmeterol and terbutaline
• Prednisolone may also reduce the effectiveness of the contraceptive coil (also called an IUD or intra-uterine device) in preventing pregnancy.
If you have any doubts about whether you should take this medicine, then talk to your doctor.
ADVICE WHEN TAKING PREDNISOLONE TABLETS
Care should be taken if you have been told you have osteoporosis ie. weakening of the bones (especially if you have passed the menopause); high blood
pressure, or heart failure; past or present mental disorders (especially after previous steroid treatment); diabetes mellitus* (or diabetes in the family);
tuberculosis (or previous tuberculosis); glaucoma (or glaucoma in the family); severe liver or kidney problems; epilepsy; stomach ulcers, underactive
thyroid gland (hypothyroidism), suffered a recent heart attack or if previous steroid therapy has caused you to have severe muscle weakness. You should
consult your doctor if you have any doubts about whether you should take these tablets.
*If you have diabetes you will need to monitor your blood glucose more often than normal when you first start taking prednisolone or if you are already
taking prednisolone but your doctor then changes your dose.
Prednisolone 1mg & 5mg -
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Your doctor will wish to review you frequently during your treatment, particularly if you are a child or elderly.
If you have never had chickenpox, you should avoid close contact with people who have chicken pox or shingles (herpes zoster). If you do come into
contact with chickenpox or shingles while you are taking prednisolone tablets, or within three months of stopping these tablets, TELL YOUR DOCTOR
You should avoid contact with people with measles. If you do come into contact with measles while you are taking
prednisolone tablets, TELL YOUR DOCTOR IMMEDIATELY.
You must always inform your doctor, dentist, nurse or midwife or anyone else who is giving you treatment, that you
are receiving steroid treatment. Carry a "Steroid Treatment" card with you at all times.
TAKING THIS MEDICINE
For adults and the elderly the lowest effective dose will be used for the shortest time, to reduce the risk of
Initially the dose is 5mg to 60mg daily taken either in divided doses, as a single dose in the morning, after breakfast, or
as a double dose on alternate days. The dose can often be reduced after a few days to 2.5mg to 15mg daily, but higher
doses may still be needed for several weeks or months depending on how you respond to your treatment.
Prednisolone is only given to children on rare occasions and the lowest effective dose for the shortest time is given.
Your doctor will decide the dose that is best for you. Always follow your doctor's instructions completely. Also, follow
any instructions or warnings that appear on the label that the pharmacist has put on the pack. If you do not
understand, or are in any doubt, ask your doctor or pharmacist.
To obtain a tablet, press on the tablet from the blister (or bubble) side, pushing it through the foil. Do not remove the
tablet from the blister until you are ready to take it.
Unless told otherwise, take your tablets with a glass of water with or after food.
You should take your medicine for as long as your doctor tells you to. DO NOT STOP taking the tablets except on
medical advice. Always have a supply in reserve.
If your doctor decides to stop your treatment, this may be done gradually. Your doctor will decide how to lower the
dose, depending on how long you have been taking prednisolone tablets, how you respond, your normal dose and
what you are being treated for. If treatment is stopped too quickly this can lead to severe adrenal gland problems, low blood pressure and can be life
threatening. Occasionally, withdrawal symptoms may occur, including fever, muscular pain, weakness, joint pain, runny nose, conjunctivitis, painful
itchy skin lumps, loss of weight, mental changes, emotional changes, nausea, vomiting, low blood pressure, feeling faint, headache, raised pressure in
the brain, dizziness and reappearance of original disease symptoms.
Mental problems while taking prednisolone
Mental health problems can happen while taking steroids like prednisolone (see also section “ARE THERE ANY SIDE-EFFECTS?”).
• 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.
If you forget to take a dose, take another as soon as you remember. If your next dose is due within 6 hours, take a single dose now and do not take the
next dose. Never double the next dose to make up for the one missed.
In case of feverish illness, accident or
operation (emergency or otherwise), the steroid treatment MUST be continued. Your doctor may wish you to have
a larger dose or an injection at such times.
If you accidentally take too many tablets, you should contact your doctor, pharmacist or nearest hospital casualty department immediately. Take this
leaflet and any tablets you have left to show the doctor or pharmacist.
ARE THERE ANY SIDE-EFFECTS?
Like many medicines, prednisolone may cause side-effects, particularly if it has to be taken for a long time.
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.
• 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.
Prednisolone can irritate the stomach causing indigestion and even ulcers. You should tell your doctor at once if you get indigestion or stomach pains,
vomit blood or what looks like coffee grounds, or pass black or mahogany-coloured stools.
Prednisolone can slow growth in babies, children and adolescents.
Other possible side-effects of prednisolone include:
Increased appetite and weight gain, irregular periods or periods stopping completely in women, puffiness of the face or other parts of the body,
hairiness, weakening of bones, tendons and muscles, muscle wasting, high blood pressure, nervousness and restlessness, headaches, eye problems
including glaucoma, detached retina, cataracts, protruding eyeballs and sudden blindness, skin problems including severe rashes, bruises, increased
sweating, flushing, hiccups, feeling sick, allergic reactions, clotting disorders, aggravation of existing disorders (epilepsy, diabetes, tuberculosis and other
infections) and an increased tendency to pick up infections. There may be changes in blood levels of certain salts and lipids (fats).
If you experience any other side-effects or feel that the medicine is affecting you badly, tell your doctor or pharmacist.
It is important that you stay under the close supervision of your doctor. Even after you have stopped taking prednisolone you should tell any one who
treats you that you have been on steroid treatment.
SAFE KEEPING FOR THIS MEDICINE
Do not take this medicine if the expiry date on the label has passed or if the tablets show signs of “going off” such as discoloration.
Do not store these tablets above 25°C. Keep the tablets in the package or container in which they were given to you. Do not transfer the tablets to
Keep your tablets in a secure place out of the reach and sight of children.
Remember this medicine is for you only. Never give it to anyone else. It may harm them, even if their symptoms are the same as yours.
Unless your doctor tells you to, do not keep medicines that you no longer need. Give them back to your pharmacist.
Drug Interactions - Table of contents Dr. Gé za Lakner Preventable Drug-Related Morbidity (PDRM)Important principles for physicians to consider when prescribing any drugPostmarket ADE Reports by Top-10 Ranked Classes of Suspect Drugs (FDA, 1995)Barriers to Improved Monitoring and Reporting of ADEsFactors affecting serum drug concentrationCompetitive interaction for serum protein bind
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