Active ingredient
- prednisolone sodium phosphate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 36301/0029 .
Prednisolone 20mg/100ml Rectal Solution
Package leaflet: Information for the patient
Prednisolone, 20mg/100ml Rectal Solution Prednisolone
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet:
1. What Prednisolone Rectal Solution is and what it is used for
2. What you need to know before you use Prednisolone Rectal Solution
3. How to use Prednisolone Rectal Solution
4. Possible side effects
5. How to store Prednisolone Rectal Solution
6. Contents of the pack and other information
1. What Prednisolone Rectal Solution is and what it is used for
Prednisolone 20mg/100ml Rectal Solution (referred to as Prednisolone Rectal Solution in this leaflet) contains 20mg of the active substance prednisolone as the sodium phosphate ester.
Prednisolone Rectal Solution belongs to a group of medicines called steroids. Their full name is corticosteroids.
These corticosteroids occur naturally in the body and help to maintain health and well being.
Boosting your body with extra corticosteroids (such as Prednisolone Rectal Solution) is an effective way to treat various illnesses involving inflammation in the body. Prednisolone Rectal Solution reduces this inflammation, which could otherwise go on making your condition worse. You must use this medicine regularly to get the maximum benefit.
Prednisolone Rectal Solution is used to reduce tenderness, heat and swelling in ulcerative colitis and Crohn’s disease, where the bowel becomes inflamed.
You must talk to a doctor if you do not feel better or if you feel worse.
2. What you need to know before you use Prednisolone Rectal Solution
Do not use Prednisolone Rectal Solution:
Warnings and precautions
Talk to your doctor or pharmacist before using Prednisolone Rectal Solution
If either of the above applies to you, talk to your doctor before using Prednisolone Rectal Solution.
If any of the above applies to you, talk to your doctor before using Prednisolone Rectal Solution
Mental problems while using Prednisolone Rectal Solution;
Mental health problems can happen while taking steroids like Prednisolone Rectal Solution (see also section 4 on possible side effects).
Talk to a doctor if you (or someone who is using this medicine), shows any signs of mental problems. This is particularly important if you are depressed, or might be thinking about suicide. In a few cases, mental problems have happened when doses are being lowered or stopped.
Chickenpox, shingles or measles
You should avoid contact with anyone who has either, chickenpox, shingles or measles as it could be extremely serious if you caught it from them.
Tell your doctor immediately if you suspect you may have come into contact with a person who has chickenpox, shingles or measles.
Children
The size of the Prednisolone Rectal Solution bottle means that this product is not suitable for children.
Other medicines and Prednisolone Rectal Solution
Please tell your doctor if you are taking, have recently taken or might use any other medicines, including medicines obtained without a prescription.
Some medicines may increase the effects of Prednisolone Rectal Solution and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat)
Pregnancy
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.
There is a small risk of cleft palate or retarded growth in the foetus. Also, underactivity of the adrenal glands may occur in a newborn child.
When steroids are essential, patients with normal pregnancies may be treated as though they are not pregnant. Patients with high blood pressure or fluid retention require close monitoring.
Breast-feeding
Small amounts of this medicine pass into breast milk. Infants of mothers taking steroids should be monitored carefully for signs of adrenal suppression.
Driving and using machines.
There are no known effects on driving or using machines.
Warnings about visual problems when using Prednisolone Rectal Solution
Contact your doctor if you experience blurred vision or other visual disturbances.
Prednisolone Rectal Solution contains parahydroxybenzoates which may cause allergic reactions.
3. How to use Prednisolone Rectal Solution
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Important:
Your doctor will choose the dose that is right for you. Your dose will be shown clearly on the label that your pharmacist puts on your medicine. If it does not, or you are not sure, ask your doctor or pharmacist.
The recommended dose is one enema used each night for two to four weeks. After this, treatment depends on how your body has responded to the medicine.
Some people prefer a warm enema. If you do, put the bottle in warm water for a few minutes before use.
1. Hold the bottle upwards and remove the cap.
2. Attach the nozzle.
3. Place your hand in the protective plastic bag.
4. Grease the nozzle with petroleum jelly.
5. Lie in bed on the left side with knees drawn up (semi-prone position). Gently insert about half the length of the nozzle into your rectum (back passage). Squeeze the bottle until all the liquid goes into your back passage, taking a minute or so to do it. Slowly remove the nozzle from your back passage making sure that no liquid goes back into the bottle.
6. Invert the plastic bag around the bottle and discard the whole unit without getting up from the semi-prone position.
7. Roll over and lie face down for 3 to 5 minutes. You can then go to sleep in any comfortable position.
While you are using this medicine, your doctor may ask you to have check-ups. These are to make sure that your medicine is working properly and that the dose you are using is right for you.
If you use more Prednisolone Rectal Solution than you should
Do not use more Prednisolone Rectal Solution than you should.
If you accidentally use two enemas within a shorter period of time than prescribed by your doctor, let your doctor know. Treatment is unlikely to be needed in cases of serious overdose.
If you forget to use Prednisolone Rectal Solution
If you forget to use your enema, contact your doctor who will tell you what to do. If you only remember at the time of your next enema, use a single enema and continue as usual. Do not take a double dose to make up for the missed dose.
If you stop using Prednisolone Rectal Solution
Do not stop using Prednisolone Rectal Solution without first talking to your doctor.
It is very important that you do not suddenly stop using Prednisolone Rectal Solution even if you feel better, unless your doctor tells you to.
If you stop using your medicine too suddenly, you may suffer from some of the following: Fever, joint and muscle pain, itching eyes, nose or skin, mood changes, loss of weight, low hormone levels, and low blood pressure, symptoms of which may include dizziness, headaches, or fainting. In extreme cases this can be fatal. Your doctor will tell you how to stop using Prednisolone Rectal Solution.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Steroids including prednisolone can cause serious mental health problems, and the following very serious effects may occur.
These are common in both adults and children.
Common: may affect up to 1 in 10 people
If you notice any of these problems talk to a doctor straight away.
Not known: frequency cannot be estimated from the available data.
Additional care should be taken if this medicine is given to elderly patients, as side-effects may be more serious.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme on the MHRA website (www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Prednisolone Rectal Solution
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP.
The expiry date refers to the last day of that month.
Do not store above 25°C. Keep the bottle in the outer carton in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Prednisolone Rectal Solution contains
The active substance is Prednisolone Sodium Phosphate. Each 100ml bottle contains 20mg Prednisolone (as Prednisolone Sodium Phosphate).
The other ingredients are Nipastat, Disodium edetate, Sodium acid phosphate, Disodium phosphate anhydrous, Sodium hydroxide and purified water.
What Prednisolone Rectal Solution looks like and contents of the pack
Prednisolone Rectal Solution is a clear liquid in a 100ml plastic bottle with a separate nozzle and a separate plastic bag. Each bottle, nozzle and plastic bag is only used once. A pack contains seven bottles, seven nozzles and seven plastic bags.
Marketing Authorisation Holder
Manufacturer
Carrying your steroid card
A steroid card may be obtained from your doctor, pharmacist, or local Family Health Service Authority.
In Scotland, steroid cards are available from the Scottish Office of Home and Health.
This leaflet was last revised in May 2018.
If this leaflet is difficult to see or read or you would like it in a different format, please contact
11001899
Box 603, 101 32 Stockholm, Sweden
+44 (0)845 023 0467
+44 207 862 1716
+44(0)845 023 0467
+44(0)845 023 0467