General Information
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Redipred. It does not contain all the information that is known about Redipred.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking Redipred against the benefits they expect it will have for you.
If you have any concerns about taking this medicine ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What Redipred is used for
Redipred is used in the treatment of many different conditions. Some of these conditions include: severe allergies, severe or chronic asthma, skin problems, arthritis, inflammatory diseases of the bowel, cancer and "auto-immune" diseases.
Redipred is used to prevent or reduce the symptoms of inflammation (such as swelling, redness, pain, tenderness or itching) in any part of the body. These symptoms can occur in response to injury or can be caused by many different conditions.
Redipred works by entering inflammatory cells and blocking the inflammatory reaction. It is only able to prevent or reduce symptoms of your condition, it does not cure it.
Redipred belongs to a group of medicines called corticosteroids. It is a synthetic version of a naturally occurring body hormone called cortisol. This hormone is made by the adrenal glands which lie just above your kidneys.
Your doctor, however, may prescribe Redipred for another purpose. Ask your doctor if you have any questions about why Redipred has been prescribed for you.
Before you take Redipred
When you must not take it
Do not take Redipred if you have ever had an allergic reaction to:
prednisolone or prednisone.
any of the ingredients listed at the end of this leaflet.
If you have an allergic reaction you may get a skin rash, have difficulty in breathing, get symptoms of hayfever or feel faint.
Do not take Redipred after the expiry date (EXP) printed on the bottle. It may have no effect at all, or an entirely unexpected effect if you take it after the expiry date.
Do not take Redipred if the bottle shows signs of having been tampered with.
Do not take Redipred if you have a current serious or uncontrolled infection, including fungal infections.
Do not take Redipred to treat any other complaints unless your doctor has instructed you to do so.
Before you start to take it
Your doctor must know about all the following before you start to take Redipred.
You must tell your doctor if:
you are allergic to any other medicines or any foods, dyes or preservatives.
you have any medical conditions, including:
a current serious or uncontrolled infection, including fungal infections
recent surgery or serious injury
diabetes mellitus (sugar diabetes)
osteoporosis (softening of the bone)
a stomach ulcer or other stomach or intestinal problems
liver, kidney or heart disease
tuberculosis
epilepsy
muscle weakness
glaucoma (high pressure in the eye)
thyroid disease
high blood pressure.
It may not be safe for you to take Redipred if you have any of these medical conditions.
you are taking any other medicines, including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop.
Some of the medicines in common use that may interfere with Redipred include:
antacids (in large amounts)
medicines for diabetes
some medicines for heart disease
medicines for removal of fluid (diuretics)
some medicines for epilepsy
some types of antibiotics
potassium or salt supplements
immunisations or vaccines.
These medicines may be affected by Redipred or may affect how well it works. You may need to take different amounts of your medicine or you may need to take different medicines. Your doctor or pharmacist has a more complete list of medicines to avoid while taking Redipred. Your doctor or pharmacist can tell you what to do if you are taking any of these or other medicines.
you are pregnant or plan to become pregnant.
Do not take Redipred if you are pregnant unless you and your doctor have discussed the risks and benefits involved.
It is recommended that you do not breastfeed while taking Redipred as it is found in breastmilk.
If you have not told your doctor about any of these things, tell them before you take Redipred.
Use in children:
Take special care when giving Redipred to children. It should only be given under your doctor's supervision.
If possible, children should not be exposed to common childhood illnesses such as chickenpox or measles while they are taking Redipred. They may suffer from more serious attacks of these illnesses if such exposure occurs.
Children should not be vaccinated with "live" vaccines against common childhood illnesses while they are taking Redipred, as this may result in severe attacks of these illnesses.
Potentially serious side effects can occur in children and growing teenagers who are taking corticosteroids. Some of these include obesity, slowed growth, osteoporosis (softening of the bone), and changes to the adrenal glands.
Use in elderly:
Elderly patients may be more sensitive to the effects or side effects of Redipred.
How to take Redipred
How much to take
Your doctor will tell you how much Redipred to take. Take the amount your doctor tells you to.
The dose of Redipred prescribed by your doctor will depend on the condition being treated and your response to the treatment. Your initial dose will be maintained or adjusted until a satisfactory response is noted.
How to take it
Redipred is best taken with or immediately after food.
When to take it
How often Redipred can be taken may vary depending on what condition is being treated. It can be taken once daily, several times a day or on alternate days (every other day).
If you are taking Redipred
once a day, it is best taken at the same time each day as instructed by your doctor.
several times a day, it is best if you can have the doses evenly spaced throughout the day.
on alternate days, it is best to take it in the morning (after breakfast).
Do not miss any doses and do not stop taking the medicine even if you do feel better as this may make your symptoms worse.
How long to take it
This will depend on your condition and on your response to treatment. Some people will need Redipred for only short periods of time, whilst others may require long term therapy.
What to expect:
Individuals will vary greatly in their response to Redipred. Your doctor will check your progress at regular intervals.
If you forget to take it
If you miss a dose of Redipred whether you should take it or not will depend on how many times a day you take Redipred.
If you take one dose a day.
If you miss a dose and remember in less than 12 hours, take it straight away, then continue as normal the next day. Otherwise, skip that day's dose but be sure to take the next day's dose when it is due.
If you take several doses a day.
If you miss a dose and it is more than 2 hours before your next dose is due, take it straight away, then continue as you normally would.
If it is less than 2 hours to your next dose, skip the dose you have missed but be sure to take the next dose when you are meant to.
If you take a dose on alternate days.
If you miss a dose and remember it the same morning, take it straight away, then continue as you normally would. If you do not remember the missed dose until later, wait and take it the following morning. Then skip a day before continuing your regular dosage schedule.
Do not try to make up for missed doses by taking more than one dose at a time.
If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.
If you take too much (Overdose)
Immediately telephone your doctor or Poisons Information Centre for advice, or go to casualty at your nearest hospital if you think that you or anyone else may have taken too much Redipred. Do this even if there are no signs of discomfort or poisoning. Keep telephone numbers for these places handy.
While you are taking Redipred
Things you must do
Take Redipred exactly as your doctor has prescribed.
If you do not follow your doctor's instructions, you may not get improvement in the symptoms of your condition. Try not to miss any doses and take the medicine even if you feel well.
Tell your doctor if your condition returns or becomes worse after your dose of Redipred has been reduced or treatment has been stopped.
Tell your doctor immediately if you become pregnant while taking Redipred.
Tell all doctors, dentists and pharmacists who are treating you that you are taking Redipred, especially if you are being started on any new medicines.
Tell your doctor, surgeon or dentist that you are taking Redipred if you are about to undergo surgery or an operation. The trauma of the operation or surgery may mean that your dose of Redipred may need to be increased to cover the stressful period.
Tell your doctor straight away if you are a diabetic, and you notice a change in the results of your blood or urine sugar tests. Redipred may affect your blood sugar levels as it can affect the body's ability to handle glucose. For diabetics, this means that your diabetes may become more severe. For others, diabetes may develop for the first time while taking corticosteroids such as Redipred.
Ask your doctor, when and how you should stop taking Redipred. If you have been taking Redipred for a long time, your doctor may gradually reduce the amount you are taking over a period of several days, weeks or months before stopping completely.
If you have been taking Redipred for a short period of time, this may not apply.
Things you must not do
Do not give this medicine to anyone else even if their symptoms seem similar to yours.
Do not stop taking Redipred suddenly unless advised by your doctor. If you stop taking Redipred suddenly, the symptoms of your condition may return, or you may develop symptoms of cortisol deficiency such as fainting, weakness, restlessness, nausea, vomiting, headache, dizziness, muscle weakness or joint pain.
If you want to stop taking Redipred, your doctor will tell you how to do it gradually.
Do not have any immunisations (particularly with "live" vaccines such as measles, oral polio or yellow fever) without your doctor's approval while you are being treated with Redipred.
Things to be careful of
Avoid close contact with anyone who has a contagious disease such as measles or chickenpox. Exposure to such diseases while you are taking Redipred, particularly if large doses are being taken, can put you at greater risk of developing these diseases if you have not had them before. Tell your doctor straight away if you think you have been exposed to chickenpox or measles.
Things to be aware of
Redipred is not known to cause drowsiness and does not appear to affect the ability to drive or operate machinery.
Check with your doctor or pharmacist before drinking alcohol while you are taking Redipred. If you drink alcohol while taking Redipred you may find that stomach problems occur.
As with any new medicine, you should take care when driving, operating machinery or drinking alcohol until you know how Redipred affects you.
The signs and symptoms of infections such as fever or inflammation may be hidden by the anti-inflammatory action of Redipred. You should see your doctor for medical advice for any but the most minor infections.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Redipred.
Redipred helps most people who take it, but it may have unwanted side effects in some people. All medicines have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Short term use:
When Redipred is taken for short periods of time it is unlikely to cause any problems.
Tell your doctor if you notice any of the following side effects and they worry you.
nausea (feeling sick)
vomiting
anorexia (which may result in weight loss)
increased appetite (which may result in weight gain)
stomach bloating or irritation
diarrhoea or constipation.
These common side effects may occur when Redipred is taken for short periods of time. Most of these side effects will improve or resolve with time.
Long term use:
When Redipred is taken for long periods of time and in high doses the risk of side effects is greater.
Tell your doctor if you notice any of the following and they worry you:
general changes to the body:
bloating and rounding of the face (moon face)
headache
dizziness
weight gain
redistribution of body fat
water retention leading to swollen
legs and feet, high blood pressure or an irregular heart beat.
cramps or weakness in the muscles of the arms and legs.
slowed growth in children
irregular menstrual periods.
changes to the skin:
acne
red or flushed face
extra hair growth
red or purple streaks
easy bruising
skin thinning
increased sweating
poor wound healing.
changes to the immune system:
an increased seriousness or frequency of infections.
changes in behaviour:
mood changes
anxiety or nervousness
restlessness
trouble sleeping.
changes in eyes:
decreased or blurred vision
cataracts.
Tell your doctor immediately or go to casualty at your nearest hospital if you notice any of the following symptoms:
severe stomach or intestinal pain
epileptic fits
sudden changes in your vision
symptoms such as severe dizziness, fainting, weakness, chest pain or irregular heart beat
psychiatric disturbances.
These are all serious side effects of Redipred which may occur with high doses and long term use. You may need urgent medical attention or hospitalisation.
Some side effects can only be detected by your doctor. So, when Redipred is taken for long periods of time it is important to visit your doctor regularly for check-ups. Such side effects can include:
osteoporosis or other changes in bone which can result in an increased chance of fractures due to brittleness or softening of the bone.
changes in other hormone levels in your body
changes in the body's ability to handle glucose (steroid diabetes)
effects on the parathyroid and thyroid glands (glands which control body calcium and body metabolism).
increased amounts of cholesterol in the blood
changes to your white blood cells
changes to your nervous system which may affect the way your nerves work
changed sperm count
increased blood pressure
increased pressure in the skull.
Tell your doctor if you notice anything else that is making you feel unwell.
Some people may get other side effects while using Redipred.
There is no evidence that Redipred is addictive.
After using Redipred
Storage
Keep Redipred oral liquid in a cool dry place where the temperature stays below 30°C. Protect from light.
Do not store Redipred or any other medicine in the bathroom or near a sink or stove. Heat and dampness can destroy some medicines.
Keep Redipred where young children cannot reach it. A locked cupboard at least one-and-a-half metres above ground is a good place to store medicines.
Do not leave it in the car on hot days.
Disposal
Dispose of the liquid where children can not reach them.
Ask your pharmacist what to do with any Redipred you may have left over, if your doctor tells you to stop taking it, or you find that the liquid has passed the expiry date.
Product description
What it looks like
Redipred is a raspberry flavoured, clear, colourless to slightly yellow solution. Redipred is available in 30mL bottles.
Ingredients
Active ingredient Redipred Oral Liquid contains 6.72mg/mL prednisolone sodium phosphate (equivalent to 5mg prednisolone)
Other Ingredients
Redipred Oral Liquid also contain:
sorbitol solution
disodium edetate
sodium phosphate-dibasic anhydrous
sodium phosphate - monbasic
methyl hydroxybenzoate
propyl hydroxybenzoate
raspberry flavour
water - purified
Manufacturer
Redipred is supplied in Australia by:
Rhône-Poulenc Rorer Australia Pty Ltd
7 Maitland Place
Norwest Business Park
Baulkham Hills NSW 2153
AUSTRALIA
This leaflet was prepared in November 1996
Australian Registration Number: AUST R 62506
Published by MIMS/myDr February 1999