Hydrocortisone Acetate 10%W/W Rectal Foam
1. What Colifoam is for
3. How to use Colifoam
PACKAGE LEAFLET: INFORMATION FOR THE USER COLIFOAM® / HYDROCORTISONE ACETATE 10% W/W RECTAL FOAM (hydrocortisone acetate)
Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor or pharmacist
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours
• Throughout this leaflet Colifoam/ Hydrocortisone Acetate 10% W/W Rectal Foam is called Colifoam.
Important:
• Colifoam is a steroid medicine, prescribed for many different conditions, including serious illnesses
• You need to use it regularly to get the maximum benefit
• Don’t stop using this medicine without talking to your doctor - you may need to reduce the dose gradually
• Colifoam 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 using your medicine, 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 use it for more than 3 weeks, you will get a blue ‘steroid card’:
always keep it with you and show it to any 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 chicken pox or shingles, see your doctor straight away.
Now read the rest of this leaflet.
It includes other important information on the safe and effective use of this
medicine that might be especially important for you.
In this leaflet:
1. What Colifoam is for
2. Before you use Colifoam
3. How to use Colifoam
4. Possible side effects
5. How to store Colifoam
6. Further information
Colifoam - benefit information
Colifoam 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 corticosteroid (such as Colifoam) is an effective way to treat various illnesses involving inflammation in the body. Colifoam reduces this inflammation, which could otherwise go on making your condition worse. You must take this medicine regularly to get maximum benefit from it.
Colifoam is used to treat inflammation of the colon and rectum.
2. Before you use Colifoam
Do not use Colifoam:
• If you are allergic to hydrocortisone acetate or to any other ingredient in Colifoam (see section 6)
• If you have bowel obstruction, abscess, perforation, recent intestinal anastomosis or extensive fistulae.
• If you are suffering from fungal or viral infection, tuberculosis or peritonitis.
If any of the above applies to you talk to your doctor or pharmacist.
Check with your doctor first:
• If you have ever had severe depression or manicdepression (bipolar disorder). This includes having had depression before while using steroid medicines like Colifoam.
• If any of your close family has had these illnesses
• If you have diseases of the bowel (rectum).
If any of these applies to you, talk to your doctor before using Colifoam.
Pregnancy and breast-feeding
If you are pregnant, trying to become pregnant or breast-feeding ask your doctor or pharmacist for advice before using Colifoam.
Always use Colifoam exactly as your doctor has told you.
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 is not, or you are not sure, ask your doctor or pharmacist.
Remember:
• You need to use your medicine regularly to get the maximum benefit.
• Do not use for long periods in children or pregnant women.
• Treatment should be given carefully in cases of severe ulcerative disease.
The usual dose for adults including children and the elderly is one applicator of foam once or twice per day for two to three weeks and every second day thereafter, applied into the rectum.
For rectal use only.
Do not swallow
1. Shake the canister vigorously for 30 seconds before each use.
2. Withdraw the plunger until it stops at the catch line.
3. Hold the applicator upright and insert the canister top into the applicator tip. Make sure you hold the plunger and applicator body FIRMLY with your fingers.
4. Press down gently on the canister top with your fingers, so that the foam fills about % of the applicator body. Only a short press is needed to do this.
5. Wait for a few seconds expanding. DO NOT fill go. Always release the short press.
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until the foam stops the applicator in one canister top after a
Taking other medicines
Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
6. Repeat steps 4 & 5 above until the foam expands to just reach the 'Fill' line. This normally takes 2 to 4 short press/wait.
Stand with one leg raised on a chair, or lie down on your side. Hold the applicator as shown. Insert gently into the back passage and push the plunger fully into the applicator.
5. How to store Colifoam
6. Further information
7.
After using the applicator
• Always take the applicator apart and wash it thoroughly after use
• The canister top should also be removed and washed
• Replace the canister top with care. Make sure it is placed vertically on top of the canister, and not at an angle.
If you use more Colifoam than you should
If you use too much go to your doctor as soon as possible.
If you forget to use Colifoam
Do not use double the dose to make up for a missed dose. Simply take your next dose as planned.
I If you stop using Colifoam
Do not stop using Colifoam without talking to your doctor. Your doctor may _ reduce your dose gradually.
Mental problems while taking Colifoam
“ Mental health problems can happen while using steroids like Colifoam (see
I also section 4 Possible Side Effects).
• 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 using this medicine), show any signs of mental problems. This is particularly important if you are depressed, or might
I be thinking about suicide. In a few cases, mental problems have happened when doses are being lowered or stopped.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Reporting of 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. By reporting side effects, you can help provide more information on the safety of this medicine.
CAUTION: The can is under pressure so do not leave it in the sun or very hot places (above 50°C). It contains a flammable propellant. Do not spray on a naked flame or any incandescent material. Keep away from sources of ignition - No Smoking. Do not pierce or burn, even when empty.
• Do not put in the fridge or freezer. Store up to 25°C.
• Do not use the product after the expiry date on the canister.
• REMEMBER - KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
• If your doctor tells you to stop using this medicine, please take it back to the pharmacist for safe disposal. Only keep your medicine if your doctor tells you to.
• If the foam becomes discoloured or the product shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
What Colifoam contains:
The canister contains 10% w/w of the active ingredient hydrocortisone acetate in the form of a rectal foam.
The product also contains propylene glycol, stearyl alcohol ethoxylate, polyoxyethylene-10-stearyl ether, cetyl alcohol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), triethanolamine, purified water and isobutane and propane as the propellant.
Colifoam does not contain CFCs.
Colifoam contains cetyl alcohol and stearyl alcohol ethoxylate which may cause local skin reactions (e.g. contact dermatitis).
Colifoam contains propylene glycol which may cause skin irritation.
Colifoam contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).
What Colifoam looks like and the contents of the pack
Colifoam is available in packs of 20.8g rectal foam contained in a white aerosol canister with white plastic cap. The pack also contains a clear plastic applicator with a blue plunger.
The canister contains white odourless foam which gives approximately 14 doses.
Manufacturer
Colifoam is manufactured by: Pharmasol Ltd, North Way, Walworth Industrial Estate, Andover, SP10 5AZ, UK and is procured from within the EU by the Product Licence holder: G. Pharma Ltd., Salford M50 2PU.
PL 16369/1328
POM
Colifoam is a registered trademark of Meda AB.
Like all medicines, Colifoam can cause side effects, although not everybody gets them.
Serious effects: tell your doctor straight away
Steroids can cause serious mental health problems. These are common in both adults and children. They can affect about 5 in every 100 people taking medicines that contain steroids.
• Feeling depressed, including thinking about suicide
• Feeling high (mania) or moods that go up 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 having feelings of being alone.
If you notice any of these problems talk to a doctor straight away.
Other side effects
If you get any of the following, keep using the medicine but tell your doctor:
• Unexpected fattening of the face, neck and body
• Irregular periods
• Hair starts to grow on your body (women)
• Dusky complexion with purple patches
• Itching.