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PREDNISOLONE 5MG TABLETS

Active substance(s): PREDNISOLONE

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Package leaflet: Information for the user
Prednesol 5mg Tablets
Prednisolone sodium phosphate
• 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.
Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Prednesol 5mg Tablets are and what they are used for
2. What you need to know before you take Prednesol 5mg Tablets
3. How to take Prednesol 5mg Tablets
4. Possible side effects
5. How to store Prednesol 5mg Tablets
6. Contents of the pack and other information
1. WHAT PREDNESOL 5MG TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Prednesol 5mg Tablets. This medicine contains the active
ingredient prednisolone which belongs to a group of medicines called corticosteroids or
“steroids”.
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. You must take this medicine regularly to
get maximum benefit from it.
Steroids work by reducing inflammation and lowering the body’s immune response.
Prednesol 5mg 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PREDNESOL 5MG TABLETS
Do not take Prednesol 5mg Tablets:
• if you are allergic to prednisolone or any of the other ingredients of this medicine (listed in
section 6). (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)
• if you have recently had a vaccination or have a vaccination planned
• if you 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.
Warnings and precautions
Talk to your doctor or pharmacist before taking Prednisolone 5mg Tablet if you have or
ever had:
• severe depression or manic-depressive illness (bipolar disorder). This includes having had
depression before while taking steroid medicines like Prednesol 5mg 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)
• scleroderma (also known as systemic sclerosis, an autoimmune disorder) because daily doses
of 15 mg or more may increase the risk of a serious complication called scleroderma renal
crisis. Signs of scleroderma renal crisis include increased blood pressure and decreased urine
production. The doctor may advise that you have your blood pressure and urine regularly
checked.
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.
Other medicines and Prednesol 5mg Tablets
Tell your doctor if you are taking, have recently taken or might take 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)
• 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)
• some medicines may increase the effects of Prednesol 5mg Tablets and your doctor may wish
to monitor you carefully if you are taking these medicines (including some medicines for HIV:
ritonavir, cobicistat).
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
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.
Prednesol 5mg Tablets contain sodium
This medicinal product contains sodium 27.24 mg per tablet. To be taken into consideration by
patients on a controlled sodium diet.
3. HOW TO TAKE PREDNESOL 5MG TABLETS
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
The recommended dose is:
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.
Use in children and adolescents:
To treat asthma attacks:
Children above 2 years - the doctor will decide the most appropriate dose to treat your child.
Children under 2 years - may be treated in the hospital.
Treatment for up to three days is usually enough, but may be longer.
Method of administration:
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.
If you take more Prednesol 5mg tablets than you should
If you take more Prednesol 5mg 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 Prednesol 5mg Tablets

If you forget to take Prednesol 5mg 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.
If you stop taking Prednesol 5mg Tablets
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 have any further questions on the use of this medicine, ask your doctor, pharmacist or
nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine 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
• scleroderma renal crisis in patients already suffering from scleroderma (an autoimmune
disorder). Signs of scleroderma renal crisis include increased blood pressure and decreased
urine production
• 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 consisting of raised, red, purple or brown skin lesion) has
also been reported to occur in patients receiving corticosteroids. Stopping treatment may
alleviate these symptoms.
Prednesol 5mg 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.
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 Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the
Google Play or Apple App Store. By reporting side effects you can help provide more
information on the safety of this medicine.

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 5MG TABLETS
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is printed on the carton and foil after EXP.
The expiry date refers to the last day of that month.
Store your tablets in a safe place below 25°C. Protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how
to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENT OF THE PACK AND OTHER INFORMATION
What Prednesol 5mg Tablets contain
The active substance is prednisolone (as sodium phosphate) 5 mg.
The other ingredients are: povidone, sodium acid citrate, sodium bicarbonate, sodium benzoate
(E211), erythrosine (E127) and saccharin sodium.
What Prednesol 5mg 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.
Not all pack sizes may be marketed.
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 December 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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