PREDNISOLONE TABLETS 5MG

Active substance: PREDNISOLONE

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Driving and using machinery
This medicine should not affect your ability to drive or use machines.

Patient Information Leaflet
726-7453-APIL

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.

Soluble Prednisolone Tablets 5 mg
Prednisolone sodium phosphate

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
1. WHAT SOLUBLE PREDNISOLONE TABLETS ARE AND
WHAT THEY ARE USED FOR
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.
2. BEFORE YOU TAKE SOLUBLE PREDNISOLONE TABLETS
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 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 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 (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.

3. HOW TO TAKE SOLUBLE PREDNISOLONE TABLETS
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.

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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.

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.

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.

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.

Taking other medicines
Please tell your doctor if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.

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 dose.

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.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Soluble Prednisolone Tablets can cause side
effects, although not everybody gets them.

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.
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 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.
5. HOW TO STORE SOLUBLE PREDNISOLONE TABLETS
Store your tablets in a safe place below 25°C.
Do not take any tablets after the “use by” date shown on the pack.
Return any unused tablets to your pharmacist.
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN

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.

6. FURTHER INFORMATION
What Soluble Prednisolone Tablets contain
Each tablet contains the active ingredient prednisolone (as sodium
phosphate) 5 mg.
The other ingredients are: povidone, sodium citrate, sodium hydrogen
carbonate, sodium benzoate (E211), erythrosine (E127) and saccharin
sodium.

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.

Marketing Authorisation Holder and
Manufacturer responsible for release:
The Marketing Authorisation Holder:
Waymade PLC, trading as Sovereign Medical.
Sovereign House,
Miles Gray Road,
Basildon,
Essex SS14 3FR

What Soluble Prednisolone Tablets look like and the contents
of the pack
The tablets are small, pink soluble tablets engraved with
‘Pred 5 Sov’ on one side and scored on the reverse. The tablets
are foil strip packed and supplied in cartons of 30 or 100 tablets.

The Manufacturer responsible for release:
Losan Pharma GmbH,
Otto-Hahn-Strasse 13 D-79395
Neuenburg,
Germany.
06 42 370 - 03

Date of preparation of leaflet: May 2010

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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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