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Active substance(s): PREDNISOLONE

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Patient Information Leaflet

Soluble Prednisolone Tablets 5 mg
(prednisolone sodium phosphate)
Your medicine is called Soluble Prednisolone Tablets 5 mg but
will be referred to as Soluble Prednisolone Tablets throughout this
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
- 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 Soluble Prednisolone Tablets are and what they are
used for
2. Before you take Soluble Prednisolone Tablets
3. How to take Soluble Prednisolone Tablets
4. Possible side effects
5. How to store Soluble Prednisolone Tablets
6. Further information
The name of your medicine is Soluble Prednisolone Tablets.
Soluble Prednisolone 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.
Soluble Prednisolone 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.
Do not take this medicine if you:
• are allergic to prednisolone or any of the other ingredients of
Soluble 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
• 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 Soluble 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
- 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
• 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
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);
• Ritonavir(used in HIV treatment);
• Oral contraceptives;
• Somatropin (used to treat growth problems);
• Medicines for diabetes such as insulin, glibenclamide or
• 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 transplants).
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
Carrying a Steroid card
Your doctor or pharmacist will have given you a
Steroid Treatment Card with your prescription or medicine.
must be shown to any of the following persons:
Doctor or Nurse

- before having any surgery or emergency
treatment or if any new treatment is


- before having any dental surgery.
- before buying any medicine.
- it is advisable to have regular eye tests.

Always take Soluble 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 10mg and 100mg 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
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.

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 schizophrenia;
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.

Talk to your doctor if you want to stop taking the tablets – your
doctor may want to reduce your dose gradually.

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.

If you take more tablets than you should
If you take more Soluble Prednisolone 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.

Soluble Prednisolone 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 you forget to take your medicine
If you forget to take Soluble Prednisolone 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
Like all medicines, Soluble Prednisolone Tablets can cause side
effects, although not everybody gets them.
Steroids including prednisolone can cause severe mental health
These are common in both adults and children. They can affect
about five in every 100 people taking medicines like
• 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 alone.
If you notice any of these problems talk to a doctor
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.
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 (gullet);
• thrush;
• inflammation of the pancreas causing abdominal pain
• muscle weakness;
• muscle pain;
• thinning of bones which makes fractures more likely
• damage to tendons;
• joint stiffness causing limited movement, pain and muscle

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, 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.
Do not store above 25°C. Store in the original package.
Do not take any tablets after the “use by” date shown on the pack.
Return any unused tablets to your pharmacist.
If your tablets show signs of deterioration or discolouration, you
should seek the advice of your pharmacist who will tell you what to
Medicines should not be disposed of via waste water or
household waste. Ask your pharmacist how to dispose of
medicines you no longer require or medicines that have expired.
These measures will help to protect the environment
What Soluble Prednisolone Tablets contain
Each tablet contains 5 mg of the active ingredient prednisolone
(as prednisolone sodium phosphate)
The other ingredients are: povidone, sodium acid citrate, sodium
bicarbonate, sodium benzoate (E211), erythrosine (E127) and
saccharin sodium.
What Soluble Prednisolone Tablets look like and the
contents of the pack
The tablets are small, pink, circular, flat, bevel-edged soluble
tablets engraved with ‘PRED 5' on one side and scored on the
reverse. The tablets are foil strip packed and supplied in cartons
of 30 and 100.
Manufactured by:
EirGen Pharma Limited, Westside Business Park, Old Kilmeaden
Road, Waterford, Ireland or:
Losan Pharma GmbH, Otto-Hahn-Strasse 13, D-79395
Neuenburg, Germany
PL 33948/0029
Procured from within the EU and repackaged by the Product
Licence Holder: Summer Healthcare Ltd., 4 Petre Road, Clayton
Business Park, Clayton-Le-Moors, Accrington BB5 5JB, UK.
Leaflet date: 21st March 2016

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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.