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SOLUBLE PREDNISOLONE TABLETS 5MG

Active substance(s): PREDNISOLONE / PREDNISOLONE / PREDNISOLONE

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Prednesol Tablets 5mg
Prednisolone sodium phosphate
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 5mg are and what they are used for
2. Before you take Prednesol Tablets 5mg
3. How to take Prednesol Tablets 5mg
4. Possible side effects
5. How to store Prednesol Tablets 5mg
6. Further information
1. WHAT PREDNESOL TABLETS 5MG ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Prednesol Tablets 5mg. Prednesol Tablets 5mg 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 5mg 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 5MG
Do not take this medicine if you:
• are allergic to prednisolone or any of the other ingredients of Prednesol Tablets 5mg (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 Tablets 5mg 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.
Contact your doctor if you experience blurred vision or other visual disturbances.
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.
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 TABLETS 5MG
Always take Prednesol Tablets 5mg 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 Prednesol Tablets 5mg 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 5mg, 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 5mg 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:
Not known (frequency cannot be estimated from the available data)
• 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;
• blurred vision;
• 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 5mg 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 PREDNESOL TABLETS 5MG
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

6. FURTHER INFORMATION
What Prednesol Tablets 5mg 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.
What Prednesol Tablets 5mg 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.
Marketing Authorisation Holder and Manufacturer responsible for release:
The Marketing Authorisation Holder:
Amdipharm UK Limited
Capital House,
85 King William Street,
London EC4N 7BL,
UK
The Manufacturer responsible for release:
Losan Pharma GmbH,
Otto-Hahn-Strasse 13 D-79395
Neuenburg,
Germany.
This leaflet was last revised in June 2017

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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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