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Prednesol® 5mg Tablets
(prednisolone sodium phosphate)
Your medicine is known by the above name, but will be referred to as
Prednesol Tablets throughout this:
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this
medicine. It provides a summary of the information available on
your medicine. If you have any questions or are not sure about
anything ask your doctor or pharmacist.
− 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 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 for more information).
− If you take this medicine for more than three 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 may be especially
important for you.
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 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.
In this leaflet:
1) What Prednesol Tablets are and what they are used for
2) Before you take Prednesol Tablets
3) How to take Prednesol Tablets
4) Possible side effects
5) How to store Prednesol Tablets
6) Further information

1) What Prednesol Tablets are and what they are used for
The name of your medicine is Prednesol Tablets. Prednesol Tablets contain
the active ingredient prednisolone which belongs to a group of medicines
called corticosteroids or “steroids”. Steroids work by reducing inflammation
and lowering the body’s immune response.
Prednesol Tablets are used to treat a variety of inflammatory diseases
including severe asthma, rheumatoid arthritis, allergic reactions, bowel
diseases, severe skin conditions, kidney disorders and some blood disorders.

2) Before you take Prednesol Tablets
Do not take this medicine if you:
− are allergic to prednisolone or any of the other ingredients of
Prednisolone Tablets (allergic reactions include mild symptoms such as
itching and/or rash. More severe symptoms include swelling of the face,
lips, tongue and/or throat with difficulty in swallowing or breathing);
− have recently had a vaccination or have a vaccination planned;
− have a viral infection such as measles, chickenpox or shingles, or any
other infection. Tell your doctor immediately if you have come into
contact with anyone suffering with measles, chickenpox or shingles in the
last three months.
Take special care if you:
• have or have ever had:
− severe depression or manic-depressive illness (bipolar disorder).
This includes having had depression before while taking steroid
medicines like Prednisolone Tablets or if anyone in your family has
suffered from these illnesses;
− TB (tuberculosis);
− diabetes;
− epilepsy;
− depression or other mental illness;
− an eye disease caused by a rise of pressure within the eye
− osteoporosis (thinning of the bones);
− muscle problems when steroids have been taken before;
− stomach ulcers;
− high blood pressure, heart failure or recently suffered a heart attack;
− any liver or kidney problems;
− an under-active thyroid (hypothyroidism).
If any of the above applies to you, or you are not sure please tell your
doctor or pharmacist before you use this medicine.

Mental health problems while taking Prednisolone
Mental health problems can occur while taking steroids like prednisolone (see
also section 4 Possible Side Effects).
• These illnesses can be severe.
• 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 occur they might need treatment.
Talk to a doctor if you (or someone taking this medicine) show any signs of
mental health problems. This is particularly important if you are depressed or
might be thinking about suicide. In a few cases, mental health problems have
happened when doses are being lowered or the medicine stopped altogether.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
• Some medicines may increase the effects of Prednesol Tablets and your
doctor may wish to monitor you carefully if you are taking these
medicines (including some medicines for HIV: ritonavir, cobicistat)
This is especially important if you are taking:
Medicines for epilepsy such as carbamazepine, phenobarbitone, phenytoin
or primidone;
• Antibiotics such as rifampicin, erythromycin;
• Mifepristone (used to terminate pregnancy);
• Oral contraceptives;
• Somatropin (used to treat growth problems);
• Medicines for diabetes such as insulin, glibenclamide or metformin;
• Medicines to treat high blood pressure, such as diuretics (water tablets)
like bendroflumethiazide and furosemide;
• Warfarin or other medicines used to thin the blood;
• Aspirin or similar medicines;
• Theophylline (used to treat asthma);
• Medicines to treat fungal infections such as amphotericin,
• Acetazolamide (used to treat glaucoma);
• Carbenoxolone (used to treat stomach ulcers);
• Methotrexate (used for rheumatoid arthritis, psoriasis and certain types
of cancer);
• Any medicine which belong to a group of medicines called
• Medicines used to treat myasthenia gravis;
• Medicines used to make x-rays clearer;
• Ciclosporin (used to stop the body rejecting bone marrow or organ
Pregnancy and breast-feeding
Tell your doctor before being given this medicine if you are or think you may
be pregnant, or if you are breast-feeding.
Driving and using machinery
This medicine should not affect your ability to drive or use machines.
Carrying a Steroid card
Your doctor or pharmacist will have given you a Steroid Treatment Card
with your prescription or medicine.
shown to any of the following persons:
Doctor or Nurse
− before having any surgery or emergency treatment
or if any new treatment is prescribed.
− before having any dental surgery.
− before buying any medicine.
− it is advisable to have regular eye tests.

3) How to take Prednesol Tablets
Always take Prednisolone Tablets exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
The tablets can be swallowed whole, but they are best taken as a drink after
dissolving them in a glass of water. Take your tablets as a single dose each
morning, unless your doctor has told you otherwise.
The dose will depend on the condition you are being treated for and can vary
between 10 mg and 100 mg daily. Your doctor will always reduce the dose to
the smallest dose that works for you.
To treat asthma attacks:
Children aged 5 years and above – 30 mg to 40 mg
Children aged 2 to 5 years old - 20 mg daily
Children under 2 years old – up to 10 mg daily for up to three days
Treatment for up to three days is usually enough, but may be longer.
Do not stop taking the tablets unless you have been told to do so by your
doctor, even if you feel better, as it can make you ill.
It can cause withdrawal symptoms such as fever, sickness, pain in the
muscles and joints, runny nose, sore, red and sticky eyes (conjunctivitis),
itchy skin and weight loss.
Talk to your doctor if you want to stop taking the tablets - your doctor may
want to reduce your dose gradually.

If you take more tablets than you should
If you take more Prednesol Tablets than you should, contact your doctor or
nearest hospital emergency department immediately. Remember to take this
leaflet and/or the package with you to show the doctor what you have taken.
If you forget to take your medicine
If you forget to take Prednesol Tablets, take the next dose as soon as you
remember unless it is almost time for your next dose. Do not take a double
dose to make up for a forgotten dose.

4) Possible side effects
Like all medicines, Prednesol Tablets can cause side effects, although not
everybody gets them.

5) How to store Prednesol Tablets
• Do not take after the expiry date printed on the carton, and blister label
after EXP. The expiry date refers to the last day of that month.
• Do not store above 25°C. Store in the original package. Protect from light.
• If the tablets become discoloured or show any other signs of deterioration,
you should seek the advice of your pharmacist who will tell you what to do.
• 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 to protect the environment.

6) Further information
What Prednesol Tablets contain
Each tablet contains 5mg prednisolone (as prednisolone sodium phosphate).

Steroids including prednisolone can cause severe mental health problems.
These are common in both adults and children. They can affect about five in
every 100 people taking medicines like Prednisolone.
• Feeling depressed, including thinking about suicide.
• Feeling high (mania) or having moods that go up and down.
• Feeling anxious, having problems sleeping, having 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
If you notice any of these problems talk to a doctor immediately.

What Prednesol Tablets looks like and content of the pack
The tablets are pink, round tablets engraved with ‘PRED 5’ on one side and a
scoreline on the other.

If you notice;
• itching or skin rashes;
• swelling of the face, lips or throat;
• difficulty in breathing or wheeziness.
Stop taking the tablets and tell your doctor immediately. These may be
signs of an allergic reaction.

Who makes and repackages your medicine
Your medicine is manufactured by Losan Pharma GmbH, Otto-Hahn-Strasse
13, D79395 Neuenburg, Germany. Procured from within the EU and
repackaged by Product Licence Holder: Primecrown Ltd, 4/5 Northolt Trading
Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.

The other ingredients are: povidone, sodium acid citrate, sodium bicarbonate,
sodium benzoate (E211), erythrosine (E127), and saccharin sodium.

Each blister pack contains 20 or 30 tablets.
PL 10383/2113

Prednesol 5mg Tablets


Leaflet date: 27.04.2017
The side effects which can occur if steroids are given in high doses for a long
time are:
• generally feeling unwell;
• feeling sick (nausea);
• hiccups;
• indigestion or stomach discomfort;
• stomach ulcer (which can rupture and bleed) or ulcer in the oesophagus
• thrush;
• inflammation of the pancreas causing abdominal pain (pancreatitis);
• muscle weakness;
• muscle pain;
• thinning of bones which makes fractures more likely (osteoporosis);
• damage to tendons;
• joint stiffness causing limited movement, pain and muscle spasms;
• fluid retention causing swelling;
• feeling dehydrated;
• high blood pressure;
• slow healing of wounds, thinning of the skin, bruising, acne, marks which
look like stretch marks;
• small red, purple or blue spots found along the surface of the skin
(caused by blood vessels under the skin);
• low adrenal gland function;
• slowed growth in infants, children and teenagers;
• irregular or stopped menstrual periods;
• swollen, round face (Cushingoid facies);
• excess hair growth;
• increased appetite and weight gain;
• intolerance to carbohydrates;
• mood changes, dependence, depression, difficulty sleeping, worsening of
• severe headaches with blurred vision or temporary visual problems in
children (usually after stopping treatment);
• worsening of epilepsy;
• raised pressure in the eyes (glaucoma), cataracts, thinning and
inflammation of the cornea (part of the eye), worsening of viral or fungal
eye diseases and visual impairment;
• heart attack (sudden severe chest pains);
• changes in body chemistry;
• an increase in the number of white blood cells;
• formation of blood clots;
• Long term use of high dose steroids, may lead to a weakening of the
immune system, which can increase the risk of malignancy.
Kaposi's sarcoma (a type of cancer) has also been reported to occur in
patients receiving corticosteroids. However, once the treatment has been
stopped, this may go away.
Prednesol Tablets can make it easier for you to pick up infections which may
very rarely be fatal. Infections such as chicken-pox and measles can be
made worse or TB (tuberculosis) may recur.
If any of the side effects becomes severe, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist immediately.
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:
By reporting side effects you can help provide more information on the safety
of this medicine.

Prednesol is a registered trade mark of Amdipharm Mercury International
Limited, Jersey.

Blind or partially sighted?
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Call 020 8839 3000 to obtain the
leaflet in a format suitable for you.

Expand Transcript

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.