Prednesol 5mg Tablets

• 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.

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

• 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, chicken pox or shingles, or any other infection. Tell your doctor immediately if you have come into contact with anyone suffering with measles, chicken pox or shingles in the last three months.

Talk to your doctor or pharmacist before taking Prednesol 5mg Tablets 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 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.

The use of steroids can slow down normal growth of children and adolescents which may be irreversible.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

This is especially important if you are taking:

• medicines for epilepsy such as carbamazepine, phenobarbitone, phenytoin or primidone
• antibiotics such as rifampicin, rifabutin, 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 Non Steroidal Anti-Inflammatory Drugs (e.g. ibuprofen)
• medicines to treat fungal infections such as amphotericin, ketoconazole
• acetazolamide (used to treat glaucoma)
• carbenoxolone (used to treat stomach ulcers)
• aminoglutethimide, methotrexate (used for rheumatoid arthritis, psoriasis and certain types of cancer)
• any medicine which belong to a group of medicines called sympathomimetics (e.g. ephedrine (a nasal decongestant))
• 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)
• medicines used to treat asthma (e.g. theophylline, bambuterol, fenoterol, formoterol, ritodrine, salbutamol, salmeterol and terbutaline).
• 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).

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.

This medicine should not affect your ability to drive or use machines.

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.

This medicine contains 37.1 mg sodium (main component of cooking/table salt) in each tablet. This is equivalent to 1.85% of the recommended maximum daily dietary intake of sodium for an adult.

This medicine contains 7.5 mg benzoate salt in each tablet. Benzoate salt may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).

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, 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, 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.

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.

• 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
• loss of protein and calcium balance
• dizziness
• 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
• sensation of spinning (vertigo)
• heart attack (sudden severe chest pains)
• slow heart rate
• 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 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.

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.

• The active substance is prednisolone (as sodium phosphate ester) 5 mg.
• The other ingredients are: povidone, sodium acid citrate, sodium bicarbonate, sodium benzoate, erythrosine (E127) and saccharin sodium.

Pink, biplanar tablets with bevelled edge. Score line on one face and ‘PRED 5 SOV’ engraved on the other around the periphery. The tablets are foil strip packed and supplied in cartons of 30 or 100 tablets.

Not all pack sizes may be marketed.