Prednisolone 10 mg/ml Oral solution

• 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 or your child 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 or your child 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.

• 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 it for more than 3 weeks, you will get a blue ‘Steroid card’: always keep it with you and show it to a doctor or nurse treating you.
• Keep away from people who have chickenpox or shingles, if you have never had them. They could affect you severely. If you do come into contact with chickenpox or shingles, see your doctor straight away.

1. What Prednisolone Oral Solution is and what it is used for
2. What you need to know before you use Prednisolone Oral Solution
3. How to use Prednisolone Oral Solution
4. Possible side effects
5. How to store Prednisolone Oral Solution
6. Contents of the pack and other information

• to treat breathing difficulties associated with asthma;
• to treat severe allergic reactions;
• to treat illnesses which cause inflammation of the skin, small and medium sized arteries, muscles and joints (including rheumatoid arthritis);
• to treat problems with your immune system, where the immune system attacks the cells in your body;
• to treat certain kidney problems;
• to treat certain illnesses resulting in inflammation of the bowels e.g. Bowel diseases such as ulcerative colitis or Crohn’s disease;
• to treat inflammation of the heart;
• to treat problems with your blood including haemolytic anaemia (a disorder which breaks down red blood cells) and leukaemia;
• to prevent rejection following an organ transplant.

• if you are allergic to prednisolone or any of the other ingredients of this medicine (listed in section 6). Signs of a severe allergic reaction may include a red and lumpy skin rash, itching, difficulty breathing, swelling of face, mouth, lips , tongue, throat or eyelids, unexplained high temperature (fever) and feeling faint. If the swelling affects your throat and makes breathing and swallowing difficult, go to hospital straight away;
• if you have an infection which affects your entire body (unless you are receiving treatment for the infection);
• if you have recently had any “live” vaccinations 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, pharmacist or nurse before taking Prednisolone Oral Solution:

• if you have or ever had severe depression or manic depressive illness (bipolar disorder). This includes having had depression before or while taking steroid medicines like Prednisolone Oral Solution;
• if any of your close family has had these illnesses;
• if you have Scleroderma (also known as systemic sclerosis, an autoimmune disorder) because daily doses of 15mg 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.

Mental health problems can happen while taking steroids like Prednisolone Oral Solution.

• These illnesses can be serious.
• 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 happen, 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 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 if you have previously had chickenpox, shingles or measles or if you have been vaccinated against these infections.
• It is important that whilst you are taking this medicine, you avoid contact with anybody who has chickenpox, shingles or measles especially if you have not already had them. If you think you may have come into contact with a person who has chickenpox, shingles or measles, you should contact your doctor immediately.
• If you catch chickenpox, shingles or measles, tell your doctor immediately. Your doctor will advise you on how to take prednisolone. Your doctor may want to change your dose of Prednisolone Oral Solution.

• if you have, or have ever had, tuberculosis (TB) or blood poisoning (septicaemia);
• if you have liver or kidney problems;
• if you have high blood pressure (or a family history of high blood pressure), heart disease or you have recently had a heart attack;
• if you have or have a family history of the following:
  • diabetes
  • osteoporosis (thinning of the bones)
  • glaucoma (raised eye pressure)
  • epilepsy (fits);
• if you have ever previously suffered from muscle weakness when using prednisolone or any other steroids, in the past;
• if you have, or have had, a stomach ulcer;
• if you have an underactive thyroid gland (hypothyroidism).

If you have any of the above conditions, your doctor may monitor you carefully whilst you are taking this medicine.

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

• Some medicines may increase the effects of Prednisolone Oral Solution and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
• Rifampicin and rifabutin (antibiotics used to treat tuberculosis): taking these medicines with prednisolone may stop prednisolone from working properly.
• Carbamazepine, phenytoin, primidone and phenobarbitone (for epilepsy): taking these medicines with prednisolone may stop prednisolone from working properly.
• Ephedrine (a nasal decongestant): taking ephedrine with prednisolone may stop prednisolone from working properly.
• Aminoglutethimide (anti-cancer treatment): taking this medicine with prednisolone may stop prednisolone from working properly.
• Mifepristone (used for termination of pregnancy): taking mifepristone with prednisolone may stop prednisolone from working properly for several days.
• Erythromycin (an antibiotic, used to treat infections): if taken with prednisolone, your doctor may need to change your dose of prednisolone or you may experience more side effects.
• Ketoconazole (used to treat fungal infections): if taken with prednisolone, your doctor may need to change your dose of prednisolone or you may experience more side effects.
• Ciclosporin (used to prevent rejection after transplants): if taken with prednisolone, your doctor may need to change your dose of prednisolone or you may experience more side effects.
• Oestrogen hormones including the contraceptive pill: if taken with prednisolone, you may experience more side effects and your doctor may need to change your dose of prednisolone.
• Medicines for diabetics such as insulin, glibenclamide or metformin: if taken with prednisolone, then these medicines may not work properly.
• Medicines used to treat high blood pressure (e.g. hydralazine): if taken with prednisolone, then these types of medicines may not work properly.
• Diuretics also known as water tablets (e.g. bendrofluazide): if taken with prednisolone, then these types of medicine may not work properly.
• Somatotropin (a growth hormone): if taken with prednisolone, your medicine may no longer work properly.
• Medicines used to treat myasthenia gravis (muscle weakness), such as neostigmine: if taken with prednisolone, these medicines may not work as well.
• Medicines used to make x-rays clearer: if taken with prednisolone, these medicines may not work as well.
• Anticoagulant medicines which thin the blood (e.g. warfarin and coumarin): if taken with prednisolone, you may be at an increased risk of bleeding, therefore your doctor is likely to monitor you more closely.
• Aspirin and Non-Steroidal Anti-Inflammatory Drugs (e.g. ibuprofen): if taken with prednisolone you may be more likely to develop ulcers or bleeding from the stomach.
• Salicylates (e.g. Aspirin): if taken with prednisolone you may experience an increase in side effects of the salicylate once you stop taking prednisolone.
• Methotrexate (anti-cancer treatment): if taken with prednisolone you may experience more severe side effects.

In addition, please tell your doctor or pharmacist if you are taking any of the following medicines, as taking these medicines with Prednisolone Oral Solution may cause you to have a lower level of potassium in your blood than normal (hypokalaemia):

• Acetazolamide (used for glaucoma and epilepsy);
• Diuretics also known as water tablets e.g. furosemide and bendroflumethiazide (used to treat high blood pressure);
• Carbenoxolone (used in the treatment of stomach ulcers);
• Medicines used to treat asthma (e.g. theophylline, bambuterol, fenoterol, formoterol, ritodrine, salbutamol, salmeterol and terbutaline);
• Amphotericin (used to treat fungal infections).

Vaccinations

If you have recently had or are planning to have any vaccinations, tell your doctor before taking Prednisolone Oral Solution.

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.

• Sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate. May cause allergic reactions (possibly delayed).
• Sodium. This medicinal product contains 2.5mg of sodium per 1ml oral solution (10mg prednisolone) and 25mg of sodium per 10ml of oral solution (100mg prednisolone) daily. To be taken into consideration by patients on a controlled sodium diet.

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

Your doctor or pharmacist will give you a Steroid Treatment Card with your prescription or medicine.

Keep this card with you always 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.
• Even after your treatment has finished, tell any doctor, dentist, nurse, midwife or anyone else who is giving you treatment that you have taken steroids.

A 5ml graduated syringe is provided with your medicine. Use the syringe to withdraw, from the bottle, the amount of Prednisolone Oral Solution that has been prescribed for you by your doctor.

• Insert the syringe in the bottle and hold it in place.
• Still holding the syringe in place, pull the plunger up until you withdraw the prescribed amount of oral solution. (refer to Figure 1 and Figure 2).
• Remove the syringe from the bottle.
• After use, close the bottle with its cap and wash the syringe with hot water. Let the syringe dry.

Each graduation of the syringe above the 0.5ml graduation is equivalent to 0.25ml of solution.

The lowest dose that can be administered with this syringe is 0.25ml. If you need to take 0.25ml of solution, insert the syringe in the bottle and, holding it in place, pull the plunger up to the 0.75ml graduation. Then, place the syringe above a spoon and push the plunger until the graduation of 0.5 ml. The solution in the spoon corresponds to 0.25ml.

The recommended dose is:

Adults

• The usual starting dose is 1ml to 10ml per day.
• Your doctor may reduce the dose, after a few days or weeks, depending on how well your condition is responding to the treatment.

For Rheumatoid Arthritis

• The usual starting dose is between 0.75ml and 1ml per day.

Use in children and adolescents

• Your doctor will decide the most appropriate dose to treat your child.
• If Prednisolone Oral Solution has been prescribed for your child, for the treatment of acute asthma attacks the following dosing regime may be given for up to three days:
  • For children over 5 years of age, 3 to 4ml may be prescribed;
  • For children aged 2-5 years of age, 2ml may be prescribed;
  • For children aged under 2 years, 1ml may be prescribed if your child is being treated in a hospital.

Important: If you are unsure how much medicine to take, please contact your doctor or pharmacist for advice.

Method of administration: For oral use only.

If you take more oral solution than your doctor has told you to, contact a doctor or your nearest hospital casualty department immediately and take this medicine with you to show the doctor what you have taken.

• If you forget to take a dose, take it as soon as you remember unless it is almost time for the next dose.
• Do not take a double dose to make up for a forgotten dose.

Speak to your doctor before you stop taking Prednisolone Oral Solution.

• Do not stop taking this medicine suddenly. Your doctor will tell you how to reduce your dose slowly over a number of weeks or months to help lower the chance of you getting withdrawal symptoms.
• Stopping Prednisolone Oral Solution (particularly if stopped suddenly) can lead to withdrawal symptoms. The most common are:
  • high temperature
  • muscle and joint pain
  • runny nose
  • weight loss
  • itchy skin
  • red, sore and sticky eyes (conjunctivitis)
  • headache
  • being sick
  • blurred vision
  • low blood pressure.
• If you get severe withdrawal symptoms tell your doctor straight away. He/she may ask you to start taking your medicine again and then to start coming off it again more slowly.

• Severe allergic reaction which may include itching or a red and lumpy skin rash, difficulty breathing, or wheeziness, swelling of face, mouth, lips or eyelids, unexplained high temperature (fever) and feeling faint.

• Serious mental health problems. Steroids, including prednisolone, can cause serious mental health problems. These are common in both adults and children. They can affect about five in every 100 people using medicines like prednisolone. The symptoms include:
  • feeling depressed, including thinking about suicide;
  • feeling high (mania) or moods that can go up (euphoric mood) and down;
  • feeling anxious, having problems sleeping, 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 have feelings of being alone.
• If you have epilepsy and you have more fits than normal.

The following side effects may occur if prednisolone is given for a long period of time:

Not known (frequency cannot be estimated from the available data).

• generally feeling unwell
• feeling or being sick (nausea)
• hiccups
• indigestion or stomach discomfort
• stomach ulcers (which can rupture and bleed) ulcers in the oesophagus (gullet)
• diarrhoea
• thrush
• inflammation of the pancreas causing abdominal pain (pancreatitis)
• muscle weakness
• muscle pain
• thinning of the bones with an increased risk of fractures (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 periods or your periods may stop altogether
• excess hair growth
• increased appetite and weight gain
• increased sweating
• 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
• increased pressure in the eye (glaucoma), swelling in the eye, cataracts, thinning and inflammation of the eye membranes, worsening of viral or fungal eye diseases
• vertigo (sensation of spinning)
• heart attack (sudden severe chest pains)
• tearing of the heart muscle tissues, particularly if you have recently had a heart attack
• slow heart rate
• changes in body chemistry (salt imbalances: sodium and potassium salts)
• raised level of white blood cells
• formation of blood clots
• blocked blood vessel (embolism)
• blurred vision
• detachment of the retina causing visual impairment
• protrusion of the eyeballs
• 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.

Prednisolone Oral Solution 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.

Children and teenagers taking this medicine may grow more slowly than normal. If you, as the patient or carer, are worried about the effects of taking this medicine, go back and discuss it with your doctor.

If you are elderly, your doctor will monitor you closely whilst you are taking this medicine as you may be more likely to experience 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 at: 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. Each 1ml of oral solution contains 10mg prednisolone (as prednisolone sodium phosphate).

The other ingredients are: glycerol, xylitol, sucralose, sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, orange flavour, vanilla cream flavour, sodium methyl parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate (E217), disodium edetate, sodium hydroxide and/or hydrochloric acid (as pH adjusters) and purified water.

Prednisolone 10mg/ml Oral Solution is a clear, colourless to yellowish oral solution with a characteristic odour of orange. It is available in an amber glass bottle containing 30ml of medicine. The pack also contains a 5ml plastic oral dosing syringe.