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PREDNESOL 5MG SOLUBLE TABLETS

Active substance(s): PREDNISOLONE SODIUM PHOSPHATE / PREDNISOLONE SODIUM PHOSPHATE / PREDNISOLONE SODIUM PHOSPHATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Prednesol® 5mg Soluble Tablets




(prednisolone sodium phosphate)

Your medicine is available using the name Prednesol 5mg
Soluble Tablets but will be referred to as Prednesol Soluble
Tablets 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 chickenpox or
shingles, if you have never had them. They could affect
you severely. If you do come into contact with
chickenpox 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 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.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Prednesol Soluble Tablets are and what they are
used for
Before you take Prednesol Soluble Tablets
How to take Prednesol Soluble Tablets
Possible side effects
How to store Prednesol Soluble Tablets
Further information

1. What Prednesol Soluble Tablets are and
what they are used for
Prednesol Soluble 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 Soluble 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 Soluble Tablets
Do not take this medicine if you:


are allergic to prednisolone or any of the other
ingredients of Prednesol Soluble 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 Prednesol Soluble 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 (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 Prednesol
Soluble Tablets

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 5mg 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, 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.
Page 1 of 2

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 Prednesol Soluble Tablets
Always take Prednesol Soluble 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.

Adults:

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.

Children:

To treat asthma attacks:
Children aged 5 years and above – 30mg to 40mg
Children aged 2 to 5 years old - 20mg daily
Children under 2 years old – up to 10mg 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 Soluble 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 Soluble 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 Soluble Tablets 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
Prednesol Soluble Tablets.

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.
Prednesol Soluble Tablets can make it easier for you to pick
up infections which may very rarely be fatal. Infections such
as chickenpox and measles can be made worse or TB
(tuberculosis) may recur.

If your medicine becomes discoloured or show signs of
deterioration, you should seek the advice of your pharmacist.
Medicines should not be disposed via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. The measures will help to
protect the environment.

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

Also contains: povidone, sodium acid citrate, sodium
bicarbonate, sodium benzoate (E211), erythrosine (E127) and
sodium saccharin.

What Prednesol Soluble Tablets look like and the
contents of the pack
Prednesol Soluble Tablets are small, pink, soluble tablets
engraved 'Pred 5' on one side and scored on the reverse.

Prednesol Soluble Tablets are available in packs of 20 tablets.

Manufacturer

Manufactured by:
Eirgen Pharma Limited, Unit 64/65, West Side Business Park,
Old Kilmeadan Road, Waterford, Ireland.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd.,
7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0606

POM

Leaflet revision and issue date: 19.04.17
Prednesol® is a registered trademark of Amdipharm Mercury
International Ltd.

Blind or partially sighted?
Is this leaflet hard to see or
read?
Call +44 (0) 1302 365000
(Regulatory)
Please be ready to give the
following information:
Product name: Prednesol
5mg Soluble Tablets
Reference No: 21828/0606

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: 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 Prednesol Soluble Tablets
Keep out of the sight and reach of children.
Do not store above 25°C.
Store in the original package in order to protect from light.
Do not use after the expiry date printed on the carton label
and blister strip. The expiry date refers to the last day of that
month.
If your doctor decides to stop your treatment, take any
leftover medicine back to the pharmacy.

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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.

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