Consumer Medicine Information
What is this leaflet
This leaflet answers some common questions about PREDSOL SUPPOSITORIES and/or PREDSOL RETENTION ENEMA.
It does not contain all of the available information.
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 using PREDSOL 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 is PREDSOL
The name of your medicine is PREDSOL.
The active ingredient is called PREDNISOLONE (as sodium phosphate).
PREDSOL is a type of glucocorticoid and belongs to the group of medicines called corticosteroids.
PREDSOL SUPPOSITORIES and PREDSOL RETENTION ENEMA are for use in the rectum only. They should not be taken by mouth.
What is PREDSOL used for
PREDSOL is used for
haemorrhagic and granular proctitis (a type of inflammation in the rectum).
post radiation proctitis (inflammation in the rectum following radiation therapy).
rectal complications of Crohn's disease (inflammation of the intestine).
Your doctor, however, may have prescribed PREDSOL for another purpose, for example, haemorrhoids.
Ask your doctor if you have any questions about why PREDSOL has been prescribed for you.
If you have any concerns, you should discuss this with your doctor or in his/her absence with your pharmacist.
This medicine is available only on a doctor's prescription.
Before you take PREDSOL
When you must not use it
Do not use PREDSOL if you are allergic to:
Prednisolone or any of the ingredients listed at the end of this leaflet.
Do not use PREDSOL if you have tuberculous or fungal infections (such as tinea, thrush or ringworm) of the skin, acute herpes simplex (such as cold sores, shingles or chicken pox), vaccinia (cowpox), varicella (a rare form of chicken pox) or any viral infection.
Do not use PREDSOL if the area around the rectum is traumatised or showing signs of sepsis.
Do not use PREDSOL if you are currently on oral or intravenous corticosteroid therapy or have markedly impaired circulation. (check with your doctor).
PREDSOL, like all medicines, should not be used during pregnancy unless your doctor specifically tells you to.
Do not use PREDSOL after the expiry date printed on the pack.
If you use it after the expiry date has passed, it may have no effect at all, or worse, there may be an entirely unexpected effect.
Do not purchase or use PREDSOL if the packaging is torn or shows signs of tampering.
Before you start to take it
You must tell your doctor if you are:
1.allergic to any other medicines or any foods, dyes or preservatives.
2.you are pregnant or plan to become pregnant.
3.you are breast feeding or plan to breast feed.
If you have not told your doctor about any of the above, tell him/her before you use PREDSOL.
Taking other medicines
Tell your doctor if you are taking any other medicines, including medicines, creams, ointments or lotions that you buy without a prescription from a pharmacy, supermarket or health food shop.
Do not use in children unless specifically directed to by your doctor.
Some medicines may interfere with PREDSOL.
antacids, antidiabetic agents (oral or insulin), digitalis glycosides, diuretics, barbiturates, phenytoin, rifampicin, potassium supplements, ritrodine, foods or medications containing sodium, somatren, somatropin, vaccines, live viruses.
Troleandomycin, ketoconazole may require the dose of PREDSOL to be reduced.
Chronic, high dose Aspirin may have its effects reduced so it should be closely monitored.
The effects of anticoagulants may be variable, so close monitoring is required.
The above medicines may either reduce the effectiveness of PREDSOL, reduce its own effectiveness and/or react with PREDSOL resulting in untoward or sometimes dangerous side effects.
Your doctor or pharmacist has more information on medicines to be careful with or avoid while using PREDSOL.
How and When to use PREDSOL
How to use it
Insert into the rectum gently as directed.
It may be warmed before use by placing the bag in a vessel of hot water for a few minutes.
The patient should lie down on the left side with the knees drawn up. Remove the stopper from the bag, lubricate the nozzle with petroleum jelly and gently insert about half the length of the nozzle into the rectum. The bag should then be slowly rolled up like a tube of toothpaste until it is emptied, taking a minute or two to do so.
The nozzle should then be removed, with the bag still rolled up, and the whole unit discarded. The patient should then roll over to lie face down for three to five minutes but may sleep in any comfortable position.
When to use it
Insert one at bedtime and the other after morning defecation. When response is good, treatment may continue for some months or until investigation shows improvement.
One enema is used nightly on retiring for two to four weeks. Treatment may be continued if the response is good but should not be persisted with if response is inadequate.
It is important with either suppositories or the retention enema to use them exactly as directed. If you use less than you should, it may not work as well and your medical condition may not improve. Using it more frequently than you should may not improve your condition any faster and may cause or increase side effects.
If you forget to use PREDSOL at a required time.
Use it as soon as you remember and then return to your normal dosing time. If your next dose is almost due, leave using PREDSOL until that time.
Do not try to make up for missed doses by using more than one dose at a time. This may increase the chance of getting an unwanted side effect.
If you have trouble remembering when to use PREDSOL, ask your pharmacist for some hints.
If you accidentally swallow it:
Immediately phone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, or go to casualty at your nearest hospital, if you think you or anyone else may have swallowed PREDSOL. Do this even if there are no signs of discomfort or poisoning. Also report any other medicine or alcohol which has been taken. You may need urgent medical attention.
Keep telephone numbers for these places handy.
While you are using PREDSOL
Things you must do
Tell your doctor if you feel PREDSOL is not helping your condition.
Tell all doctors, pharmacists and dentists who treat you that you use PREDSOL.
Tell your doctor if, for any reason, you have not used your PREDSOL as prescribed. Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.
Tell your doctor immediately if you become pregnant while using PREDSOL.
Always discuss with your doctor any problems or difficulties during or after using PREDSOL.
Things you must not do
Do not give PREDSOL to anyone else even though their symptoms seem similar to yours.
Do not use PREDSOL for other conditions unless your doctor tells you. PREDSOL has been prescribed for you for a specific condition. If you use it for another condition, it may not work or may make the condition worse.
Do not give PREDSOL to small children.
Things to be careful of
Do not use PREDSOL for a long time. If you use for longer than recommended or use more than the prescribed dose, the chances of systemic absorption of the drug through the rectum and the chance of side effects increases. Ask your doctor or pharmacist if you are concerned about the length of time you have used PREDSOL.
PREDSOL SUPPOSITORIES and/or RETENTION ENEMA are only to be used in the rectum. They are NOT to be swallowed.
Tell your doctor or pharmacist as soon as possible if you do not feel well while using PREDSOL.
PREDSOL helps most people with medical conditions listed in the beginning of this leaflet, 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 of pharmacist any questions you may have.
Common side effects:
The most common side effects of PREDSOL are:
There is a possibility of systemic absorption of prednisolone, especially if PREDSOL is used for a long time. This may result in hypothalamic-pituitary-adrenal (HPA) axis suppression, especially in children.
HPA are three organs that regulate and maintain hormone levels in the body. Your doctor will decide, if there is a need for a test to monitor the hormone levels in the blood.
PREDSOL may cause other side effects, check with your doctor.
Check with your doctor as soon as possible if you have any problems while using PREDSOL even if you do not think the problems are connected with the medicine or are not listed on this leaflet.
Do not be alarmed by the list of side effects or their discussion. You may not experience any of them.
After using PREDSOL
Keep where children cannot reach. A locked cupboard at least one and a half metres above the floor is a good place to store medicines.
Keep PREDSOL in a cool, dry place where the temperature stays below 25 °C and protect from light. Do not store PREDSOL or any other medicines in a bathroom or near a sink.
Discard any unused enema bags THREE MONTHS after first opening the outer plastic bag.
Do not leave PREDSOL in the car or on window sills.
If your doctor tells you to stop using PREDSOL, or they pass their expiry date, ask your pharmacist what to do with any left over.
What it looks like
PREDSOL SUPPOSITORIES are white to off-white bullet shape with no defects. They are packed in blister and a carton pack contains 10 suppositories.
PREDSOL RETENTION ENEMA is a clear solution sealed in plastic, disposable bags fitted with individual nozzles. Each carton contains seven (7) bags.
Each PREDSOL SUPPOSITORY contains prednisolone 5mg (as sodium phosphate) in an suppository of hard fat called Witepsol H15. There are no preservatives or colouring agents in PREDSOL SUPPOSITORIES
Each PREDSOL RETENTION ENEMA contains 20mg/100ml of prednisolone (as sodium phosphate) in an aqueous solution. The excipients or non-active ingredients are sodium hydroxide, sodium phosphate-dibasic (anhydrous), sodium phosphate-monobasic, disodium edetate, Nipastat GL75 (preservative) and purified water.
Nipastat GL75 contains methyl hydroxybenzoate, ethyl hydroxybenzoate, propyl hydroxybenzoate, butyl hydroxybenzoate and isobutyl hydroxybenzoate.
Sponsor or Supplier
Sigma Pharmaceuticals Ltd (A.C.N. 004 118 594)
1408 Centre Road
Clayton, Victoria 3168
Phone:(03) 9839 2800
The Australian Registration Number for PREDSOL SUPPOSITORIES and PREDSOL RETENTION ENEMA is AUST R 56510 and AUST R 12518, respectively.
This leaflet was prepared in
December 1997 and revised February 2004.