Patient leaflet - Prednisolone 5 mg tablets BP
1. What Prednisolone Tablets are and what they are used for
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. 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. What you need to know before you take Prednisolone Tablets
Do not take Prednisolone Tablets if you:
are allergic to prednisolone or any of the other
ingredients of Prednisolone Tablets (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).
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 from measles, chickenpox or shingles in the last three months.
Warnings and precautions
Talk to your doctor or pharmacist before taking Prednisolone Tablets, if you:
have or have ever had
severe depression or manic-depressive illness
(bipolar disorder). This includes having had depression before or whilst taking steroid medicines like Prednisolone Tablets or if anyone in your family has suffered from these illnesses.
- TB (tuberculosis)
diabetes
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 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 depends 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
Children above 2 years - the doctor decides 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.
The tablet can be divided into equal doses.
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 have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
If you take more Prednisolone Tablets than you should
If you take more 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.
If you forget to take Prednisolone Tablets
If you forget to take 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.
If you stop taking Prednisolone Tablets
Do not stop taking the tablets unless you have been instructed by your doctor, even if you feel better. If you stop taking the medicine unsupervised it can still 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 the 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 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
- slow heart rate
- 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 (sodium and potassium salts)
- 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 the 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.
Prednisolone 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 any of the side effects become
severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist immediately.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 search for MHRA Yellow Card in the Google Play or AppIe App store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Prednisolone Tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.
Do not store above 25ºC for tablets stored in polypropylene homopolymer containers with either low density polyethylene caps or LDPE/HDPE mixture caps. Medicinal product stored in blisters do not require any special storage conditions.
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. Contents of the pack and other information
What Prednisolone Tablets contain
Each tablet contains the active ingredient prednisolone 5 mg.
The other ingredients are Lactose, maize starch and magnesium stearate.
What Prednisolone Tablets look like and the contents of the pack
The tablets are white, round tablets scored on one side. Available in 28's, 30's, 500's and 1000's.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Relonchem Limited,
Cheshire House,
Gorsey Lane,
Widnes, WA8 0RP, UK.