Prednisolone 5 mg soluble 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 Prednisolone soluble tablets are and what they are used for
2. What you need to know before you take Prednisolone soluble tablets
3. How to take Prednisolone soluble tablets
4. Possible side effects
5. How to store Prednisolone soluble 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 Prednisolone soluble 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 Prednisolone soluble 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 Prednisolone soluble 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 lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine contains 14.47 mg sodium (main component of cooking/table salt) in each tablet. This is equivalent to 0.72% of the recommended maximum daily dietary intake of sodium for an adult. Talk to your doctor or pharmacist if you need 27 or more tablets daily for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet.

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 necessary, your doctor may also give you the recommended dose of Prednisolone soluble tablets dissolved in the required amount of water (a minimum volume of 10ml per tablet is required for complete dissolution) through a nasogastric or a gastric feeding tube. Afterwards, the tube should be flushed with 10 ml of water for children and adults. For neonates, a smaller flush volume of 2 ml may be used.

If you take more Prednisolone soluble 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 soluble 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.

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: monosodium citrate, lactose, sodium hydrogen carbonate, hypromellose, saccharin sodium, magnesium stearate.

White, round tablets packed in OPA-ALU-PVC blisters. The tablets are presented in packs of 30 tablets.

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