Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Panafcortelone. It does not contain all the information that is known about Panafcortelone.
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 Panafcortelone 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 Panafcortelone is used for Panafcortelone 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. Panafcortelone also suppresses the body's defences which are responsible for the inflammation in "auto-immune" diseases, where the defence cells attack the body's own tissues. Panafcortelone 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. Panafcortelone 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. Panafcortelone 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. Your doctor, however, may prescribe Panafcortelone for another purpose. Ask your doctor if you have any questions about why Panafcortelone has been prescribed for you. Before you take Panafcortelone When you must not take it
Do not take Panafcortelone if you have ever had an allergic reaction to:
prednisolone or prednisone.
any of the tablet 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 Panafcortelone 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 Panafcortelone if the bottle shows signs of having been tampered with.
Do not take Panafcortelone 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 Panafcortelone.
You must tell your doctor if:
1. you are allergic to any other medicines or any foods, dyes or preservatives.
2. you have any medical conditions, including:
a current serious or uncontrolled infection
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
glaucoma (high pressure in the eye)
high blood pressure.
It may not be safe for you to take Panafcortelone if you have any of these medical conditions.
3. 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 Panafcortelone 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 Panafcortelone 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 Panafcortelone.
Your doctor or pharmacist can tell you what to do if you are taking any of these or other medicines.
4. you are pregnant or plan to become pregnant.
Do not take Panafcortelone 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 Panafcortelone as it is found in breastmilk.
If you have not told your doctor about any of these things, tell them before you take Panafcortelone.
Use in children
Take special care when giving Panafcortelone 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 Panafcortelone. 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 Panafcortelone, 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 Panafcortelone.
How to take Panafcortelone How much to take
Your doctor will tell you how much Panafcortelone to take. Take the amount your doctor tells you to.
The dose of Panafcortelone 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
Panafcortelone is best taken with or immediately after food.
When to take it
How often Panafcortelone 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 Panafcortelone:
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 Panafcortelone for only short periods of time, whilst others may require long term therapy.
What to expect
Individuals will vary greatly in their response to Panafcortelone. Your doctor will check your progress at regular intervals.
If you forget to take it
If you miss a dose of Panafcortelone whether you should take it or not will depend on how many times a day you take Panafcortelone.
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 (telephone 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital if you think that you or anyone else may have taken too much Panafcortelone. Do this even if there are no signs of discomfort or poisoning.
While you are taking Panafcortelone Things you must do
Take Panafcortelone 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 Panafcortelone has been reduced or treatment has been stopped.
Tell your doctor immediately if you become pregnant while taking Panafcortelone.
Tell all doctors, dentists and pharmacists who are treating you that you are taking Panafcortelone, especially if you are being started on any new medicines.
Tell your doctor, surgeon or dentist that you are taking Panafcortelone if you are about to undergo surgery or an operation.
The trauma of the operation or surgery may mean that your dose of Panafcortelone 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.
Panafcortelone 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 Panafcortelone. Ask your doctor, when and how you should stop taking Panafcortelone.
If you have been taking Panafcortelone 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 Panafcortelone 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 Panafcortelone suddenly unless advised by your doctor.
If you stop taking Panafcortelone 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 Panafcortelone, 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 Panafcortelone.
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 Panafcortelone, 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
Panafcortelone 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 Panafcortelone.
If you drink alcohol while taking Panafcortelone 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 Panafcortelone affects you. The signs and symptoms of infections such as fever or inflammation may be hidden by the anti-inflammatory action of Panafcortelone. 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 Panafcortelone.
Panafcortelone 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 Panafcortelone 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)
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 Panafcortelone is taken for short periods of time. Most of these side effects will improve or resolve with time. Long term use
When Panafcortelone 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)
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:
red or flushed face
extra hair growth
red or purple streaks
poor wound healing.
changes to the immune system:
an increased seriousness or frequency of infections.
changes in behaviour:
anxiety or nervousness
changes in eyes:
decreased or blurred vision
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following symptoms:
severe stomach or intestinal pain
sudden changes in your vision
symptoms such as severe dizziness, fainting, weakness, chest pain or irregular heart beat (severe cortisol deficiency)
These are all serious side effects of Panafcortelone 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 Panafcortelone 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 Panafcortelone. There is no evidence that Panafcortelone is addictive. After using Panafcortelone Storage
Keep Panafcortelone tablets in a cool dry place where the temperature stays below 30 °C.
Do not store Panafcortelone or any other medicine in the bathroom or near a sink or stove.
Heat and dampness can destroy some medicines. Keep Panafcortelone 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.
Dispose of the tablets where children cannot reach them.
Ask your pharmacist what to do with any Panafcortelone you may have left over if your doctor tells you to stop taking them, or you find that the tablets have passed the expiry date.
Product description What it looks like
Panafcortelone tablets are available in three strengths: 1mg, 5mg and 25mg.
The 1mg tablets are white, scored, round and flat. They are marked with "PL/1" on one side. The tablets are available in bottles of 100. The 5mg tablets are white, scored, round and flat. They are marked with "PL/5" on one side. The tablets are available in bottles of 30, 60. The 25mg tablets are white, scored, round and flat. They are marked with "PL/25" on one side. The tablets are available in bottles of 30. Ingredients
Panafcortelone 1mg - 1mg prednisolone per tablet.
Panafcortelone 5mg - 5mg prednisolone per tablet. Panafcortelone 25mg - 25mg prednisolone per tablet. Other ingredients
Panafcortelone tablets also contain:
Panafcortelone is supplied by:
Aspen Pharmacare Australia Pty Ltd
34-36 Chandos St
St Leonards NSW 2065
Australian Registration Numbers:
Panafcortelone 1mg - AUST R 27960
Panafcortelone 5mg - AUST R 27962
Panafcortelone 25mg - AUST R 27964
This leaflet was revised in May 2004