Skip to Content

PREDNISOLONE 5MG SOLUBLE TABLETS

Active substance(s): PREDNISOLONE / PREDNISOLONE SODIUM PHOSPHATE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

Prednisolone 5mg Soluble Tablets
(prednisolone sodium phosphate)
This product is available in the above name, but will be referred to as
Prednisolone throughout this 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 Prednisolone is and what it is used for
2. Before you take Prednisolone
3. How to take Prednisolone
4. Possible side effects
5. How to store Prednisolone
6. Further information
1. WHAT PREDNISOLONE IS AND WHAT IT IS USED FOR
Prednisolone contains 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.
Prednisolone is 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 PREDNISOLONE
Do not take this medicine if you:
 are allergic to prednisolone or any of the other ingredients of
Prednisolone (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 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
(glaucoma);
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.
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
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,
ketoconazole;
 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
sympathomimetics;
 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 machines.
Carrying a Steroid card
Your doctor or pharmacist will have given you a Steroid Treatment
Card with your prescription or medicine.
YOU SHOULD ALWAYS CARRY THIS CARD WITH YOU as it 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 prescribed.
Dentist
- before having any dental surgery.
Pharmacist
- before buying any medicine.
Optician
- it is advisable to have regular eye tests.
3. HOW TO TAKE PREDNISOLONE
Always take Prednisolone 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.

Adults:
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.
Children:
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 Prednisolone 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 Prednisolone, 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, Prednisolone can cause side effects, although not
everybody gets them.
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 alone.
If you notice any of these problems talk to a doctor immediately.
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
(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 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.

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.
Prednisolone 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.
Reporting of side effects
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. You can
also report side effects directly via The Yellow Card Scheme at
www.mhra.gov.uk/yellowcard or Tel: Freephone 0808 100 3352. By
reporting side effects you can help provide more information on the
safety of this medicine.
5. HOW TO STORE PREDNISOLONE
Keep out of the sight and reach of children
Do not store above 25°C. Store in the original package.
Protect from light.
Do not use Soluble Prednisolone after the expiry date which is stated
on the carton as {EXP MM/YYYY}. The expiry date refers to the last
day of that month.
If your tablets become discoloured or show any other signs of
deterioration, consult 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 Prednisolone contains
The active ingredient is prednisolone sodium phosphate.
Each tablet contains 5mg prednisolone (as sodium phosphate).
The other ingredients are povidone, sodium acid citrate, sodium
bicarbonate, sodium benzoate (E211), erythrosine (E127) and
saccharin sodium.
What Prednisolone looks like and contents of the pack
Prednisolone are small, pink, round tablets engraved ‘PRED 5’ on one
side and a scoreline on the other.
The scoreline allows the tablets to be divided into equal parts.
Prednisolone comes in blister packs of 20 tablets.
Manufacturer: EirGen Pharma Limited, Westside Business
Park, Old Kilmeaden Road, Waterford, Ireland.
Procured from within the EU by the Product Licence Holder: Millsdale
Pharmaceuticals, John Street, Warrington, Cheshire, WA2 7UB. UK.
POM

PL No. 08811/ 0046
th

This leaflet was prepared 24 April 2015.

Expand view ⇕

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.

Hide