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PREDNISOLONE 2.5 MG GASTRO-RESISTANT TABLETS

Active substance(s): PREDNISOLONE

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Package leaflet: Information for the user
Prednisolone 2.5mg and 5mg Gastro-resistant Tablets
Read all of this leaflet carefully before you start taking 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 symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4
PREDNISOLONE LEAFLET - HEADLINES










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 Possible 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 4 Possible 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 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. 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 in March 2016.
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
4. Possible side effects
5. How to store Prednisolone
6. Contents of the pack and other information
1. What Prednisolone is and what it is used for

Prednisolone – benefit information.
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 wellbeing. 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 tablets are used in a wide range of inflammatory and auto-immune conditions
including:
• Allergies, including anaphylaxis (severe allergic reaction)
• in the treatment of inflammation, affecting the:
• lungs including; bronchial asthma
• blood vessels, and heart
• bowel or kidneys
• muscles and joints, including rheumatoid arthritis
• eye and 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
If you are unsure why you have been prescribed prednisolone – then consult your doctor.
2. What you need to know before you take Prednisolone
Do not take Prednisolone and talk to your doctor:
• if you are allergic (hypersensitive) to prednisolone or any of the other ingredients of this
medicine
• if you have an infection unless it is being treated with a specific antibiotic.
• if you are suffering from herpes infection of the eye
Warnings and precautions
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
• If any of your close family has had these illnesses.
If either of these applies to you, talk to a doctor before taking Prednisolone.
Talk to your doctor before you start to take this medicine if you:
• have an infection or have had tuberculosis
• have diabetes or glaucoma (increased pressure in the eye),or if there is a family history of these
















have or have ever had depression, suffer from a mental disorder or if there is a family history of
these
have epilepsy
have osteoporosis (thinning of the bones) particularly if you are past the menopause (the change of
life), or suffer from a muscle disease resulting from previous corticosteroid therapy
suffer from peptic ulcers (stomach or duodenal ulcers) or severe dyspepsia (indigestion)
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)
have hypertension (high blood pressure), heart failure or have recently suffered a heart attack
have an underactive thyroid gland which can cause tiredness or weight gain
have liver or kidney disease (if in doubt ask your doctor)
have had a recent immunisation or vaccination
have ever suffered from a bacterial infection/infestation affecting the gastro-intestinal tract or
bowel
have never had measles, chickenpox or shingles. If you are exposed to any of these whilst taking
Prednisolone, you must tell your doctor immediately
have Cushing’s disease (a hormone disorder which can cause tiredness or weight gain)
have Duchenne’s muscular dystrophy.

Important things to remember while you are taking this medicine:
If you are taking a steroid for a long time your doctor may have asked you to carry a Steroid Card.
• Because it is important for doctors, dentists or other healthcare workers to know you are on steroid
treatment be sure to keep your steroid card with you at all times.
• Always show the card to any doctor, dentist, pharmacist, nurse or anyone else who is about to
give you treatment. Even when you have stopped the course of treatment, tell them that you have
been taking steroids.
A steroid card may be obtained from your doctor or pharmacist.
• If you need to have a vaccination whilst you are taking this medicine, make sure you tell the
doctor or nurse you are taking Prednisolone, as you should not receive live vaccines, and other
vaccines may be less effective.
• DO NOT stop taking Prednisolone without consulting your doctor first as stopping this medicine
suddenly may lead to withdrawal effects (read section 3, If you stop taking Prednisolone).
Mental problems while taking Prednisolone
Mental health problems can happen while taking steroids like Prednisolone (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 like 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
Talk to your doctor if you are taking any of the following:
• drugs for epilepsy e.g. carbamazepine, phenobarbital, phenytoin, primidone
• antibiotics, antifungals, anti-bacterials or anti-virals e.g. rifampicin, rifabutin, ritonavir,
amphotericin, erythromycin, ketoconazole or itraconazole


























medicines or insulins for diabetes
medicines for high blood pressure, heart problems (e.g. digoxin) or diuretics (to increase urine
output)
anticoagulants to thin the blood e.g. warfarin or acenocoumarol
antiarthritis drugs
salicylates or non-steroidal anti-inflammatory drugs (NSAIDs) for pain relief e.g. aspirin and
ibuprofen, indometacin
acetazolamide (for glaucoma),
carbenoxolone (for stomach ulcers)
mifepristone (used in pregnancy termination)
oestrogens and progestogens (present in oral contraceptives or HRT)
methotrexate and aminoglutethimide (used in cancer treatment)
ephedrine (used in nasal decongestants or for breathing problems)
ciclosporin (used following organ transplant to prevent rejection)
muscle relaxants (e.g. pancuronium and vecuronium)
growth hormone somatropin
medicines used for myasthenia gravis e.g. neostigmine
medicines for asthma/breathing problems e.g. salbutamol, formoterol, fenoterol, terbutaline,
bambuterol, salmeterol, ritodrine, theophylline.
antithyroids such as carbimazole
isoniazid which is used to treat tuberculosis
antacids such as magnesium trisilicate or aluminium hydroxide, used to treat the symptoms of
heartburn and indigestion
antimuscarinics/ anticholinergics such as atropine sulfate
immunosuppressants which dampen down the activity of the body’s immune system
live vaccines
anaesthetics
liquorice can delay the clearance of prednisolone

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Please tell your doctor if you are to have an X-ray as prednisolone may reduce effects of
anticholinesterase in cholecystographic X-ray
Prednisolone contains lactose
• Patients who are intolerant to lactose should note that Prednisolone tablets contain a small
amount of lactose. If your doctor has told you that you have an intolerance to some sugars,
contact your doctor before taking this medicine.
Pregnancy and breast-feeding
• If you are pregnant, planning to become pregnant or are breast-feeding, ask your doctor for
advice before taking any medicine.
Driving and using machines
• Prednisolone is not expected to affect your ability to drive or operate machinery.
3. How to take Prednisolone

Always take this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
The tablets should be swallowed preferably with a drink of water.
Swallow them whole without biting or breaking the tablets (these are designed to pass through the
stomach unchanged and dissolve in the small intestine).
Different illnesses require different doses of prednisolone tablets. Depending on your illness your
daily dose may be between 5 and 60 mg. 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.

The usual dose is:
• Adults
Short term dose is 20 to 30 mg each day reducing by 2.5 or 5 mg every 2 to 5 days.
Rheumatoid arthritis: 10 to 15 mg each day.
Once your condition starts to get better, your doctor may change your dosage to 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.


Children
Prednisolone is only used to treat children if considered essential by their doctor.
The dose is reduced to between a quarter and three quarters of the adult dose, depending upon
clinical factors. The doctor will decide on the appropriate dose for your child.
• Children over 12 years
Three quarters of the adult dose
• Children over 7 years
One half of the adult dose
• Children over 1 year
One quarter of the adult dose
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.



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.

Whilst 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 catch chickenpox or
shingles. This is because you may become very ill if you get chicken pox whilst taking

prednisolone tablets. You should avoid contact with people who have chicken pox 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 catch measles. You should avoid
contact with people who have measles.
If you take more Prednisolone than you should
If you (or someone else) swallow a lot of the tablets all together, or if you think a child has
swallowed any of the tablets, contact your nearest hospital casualty department or your doctor
immediately.
Please take this leaflet, any remaining tablets, and the container with you to the hospital or doctor so
that they know which tablets were consumed.
If you forget to take Prednisolone
• If you forget to take a dose, take another as soon as possible and continue as before. DO NOT
take a double dose to make up for a forgotten dose.
If you stop taking Prednisolone
• DO NOT suddenly stop taking your Prednisolone tablets unless advised by your doctor, as you
could become ill and suffer withdrawal symptoms such as fever, muscle and bone pain, runny
nose and eyes, painful itchy skin with nodules and weight loss which may result in low blood
pressure and death. Your doctor will reduce your treatment gradually as appropriate to avoid
these effects.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of
these side effects such as mood changes (feeling depressed, or ‘high’), or stomach problems can
happen straight away, while others may only happen after weeks or months such as weakness of
arms and legs, or developing a rounder face.
Your doctor will have prescribed the lowest suitable dose for you. Most patients taking a short
course will have no problems.
Stop taking the tablets and tell your doctor immediately or go to the casualty department at your
nearest hospital if the following happens:
• an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing;
skin rash or hives)
This is a very serious but rare side effect. You may need urgent medical attention or
hospitalisation.
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 keep taking your tablets but, talk to a doctor straight away.
The following side effects have also been reported. If you feel unwell with any of these side effects,
keep taking your tablets, but see your doctor straight away
Other side effects you may experience:
• osteoporosis (bone thinning – especially in post menopausal women) or other bone, muscle or
tendon damage or muscle weakness
• peptic ulcer (stomach or duodenal ulcer)
• indigestion, swollen abdomen, diarrhoea, inflammation of the pancreas, yeast infection and
inflammation and ulceration of the oesophagus
• aggravation of epilepsy or schizophrenia
• raised blood pressure or blood disorders
• eye problems such as a loss of vision due to abnormally high pressure in the eye, clouding of the
lens of the eye, bulging eyes, thinning of the tissues of the eye or infections
• raised pressure in brain (which can cause headaches, nausea and vomiting)
• dizziness
• euphoria (feeling high)
• feeling of dependency on treatment
• irregular or absence of monthly periods, hairiness, facial swelling (moon face or cushingoid
syndrome), skin bruising or peeling, redness of the face, slower healing of wounds, stretch
marks, small spider veins
• itching, rash, hives, acne
• increased sweating
• sodium and water retention, potassium loss, increased alkaline in the blood, change in the levels
of some hormones
• passing more urine during the night
• weight gain, increased appetite, intolerance of carbohydrate in the diet, changes in protein and
calcium balance
• blood clotting problems, nausea, tiredness and feeling unwell
• increased number of white blood cells
• heart problems which can cause shortness of breath
• in those who have recently suffered a heart attack, worsening of their condition may occur
• in children, long-term treatment with high doses may result in reduced growth rate which may
be irreversible
• increased susceptibility and severity of infections, recurrence of dormant tuberculosis
• increased cholesterol or fat levels in blood
• increased blood sugar levels
Withdrawal Symptoms: anorexia, nausea, vomiting, lethargy, headache, fever, joint pain, peeling of
skin, muscle pain, inflammation of nose, conjunctivitis, painful itchy skin nodules, loss of weight
and/or hypotension
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original package. Protect from moisture. Do not transfer them to
another container.
Do not use Prednisolone after the expiry date that is stated on the outer packaging. The expiry date
refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. These measures will help protect the environment.
6.

Contents of the pack and other information

What Prednisolone Gastro-resistant Tablets contain:
• The active ingredient is prednisolone 2.5 mg or 5 mg.
• The other ingredients are lactose, maize starch, magnesium stearate.
• Tablet coating ingredients: polyvinyl acetate phthalate, stearic acid. Brown tablets (2.5 mg);
yellow iron oxide, iron oxide red, black iron oxide, talc, polyvinyl alcohol, polyethylene glycol.
Red tablets (5.0 mg); FD & C red aluminium lake, polyvinyl alcohol, polyethylene glycol,
titanium dioxide (E171), talc, quinoline yellow aluminium lake.
• Printing ingredients: Brown tablets (2.5 mg); shellac, titanium dioxide (E171), propylene glycol
(E1520). Red tablets (5.0 mg); shellac, iron oxide black (E172) and propylene glycol (E1520).
What Prednisolone Gastro-resistant Tablets look like and contents of the pack:
• Prednisolone 2.5 mg gastro-resistant are brown tablets marked ‘2P1’ on one side and plain on
the other side.
• Prednisolone 5 mg gastro-resistant are red tablets coded ‘2P2’ on one side and plain on the other
side.



The 2.5 mg tablets are available in packs of 28, 30, 50, 100 and 500.
The 5 mg tablets are available in packs of 28, 30, 50, 56, 100 and 500.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder and company responsible for manufacture: TEVA UK Ltd,
Eastbourne, BN22 9AG.
This leaflet was last revised in March 2016
PL 00289/0775-6

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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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