Hydrocortisone Acetate 10%W/W Rectal Foam
2585
04.04.14[2]
PATIENT INFORMATION LEAFLET
Colifoam® 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 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 chicken-pox 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
1. What Colifoam is for 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 use 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 manic-depression (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. Taking other medicines
Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
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.
3. How to use 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.
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 until the foam stops expanding.
DO NOT fill the applicator in one go. Always release the canister top after a short press.
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.
For rectal use only Do not swallow
1. Shake the canister vigorously for 30 seconds before each use.
POM PL No: 20636/2585
7. 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.
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.
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 using Colifoam
Mental health problems can happen while using steroids like Colifoam (see 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 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.
4. Possible side effects
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.
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.
5. How to store Colifoam
Keep out of the sight and reach of children
Do not use Colifoam after the expiry date which is stated on the canister and carton. The expiry date refers to the last day of that month.
• Protect from sunlight and do not expose to temperatures above 50oC.
• Do not store above 25°C.
• Do not refrigerate or freeze.
• Keep away from sources of ignition - No smoking.
• Do not spray on a naked flame or any incandescent material.
• Do not pierce or burn the container even after use.
Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist.
If the medications become discoloured or show any other signs of deterioration, you should consult your pharmacist who will advise you what to do.
6. Further information What Colifoam contains:
Each canister contains 10% w/w hydrocortisone acetate.
The product also contains: propylene glycol, emulsifying wax (cetostearyl alcohol), polyoxyethylene 10 stearyl ether, cetyl alcohol, methyl paraben (E218), propyl paraben (E216), trolamine, isobutane/propane propellant and purified water Colifoam does not contain CFCs.
What Colifoam looks like and contents of the pack
Colifoam is available as a white foam in an aerosol canister of 20.8g with a plastic applicator for rectal use. Each canister contains approximately 14 doses.
Manufacturer and Product Licence Holder
Manufactured by Pharmasol Limited, North Way, Walworth Industrial Estate, Andover, SP10 5 AZ, UK and procured from the EU by Product Licence holder Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex, HA1 1XD. Repackaged by Servipharm Ltd.
Leaflet revision and issue date (Ref) 04.04.14[2] Colifoam is a trademark of Meda AB.
2585
04.04.14[2]
PATIENT INFORMATION LEAFLET
Hydrocortisone Acetate 10%w/w Rectal Foam
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 Hydrocortisone Acetate 10%w/w Rectal Foam is called Hydrocortisone Acetate Foam.
Important:
• Hydrocortisone Acetate Foam 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
• Hydrocortisone Acetate Foam 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 chicken-pox 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 Hydrocortisone Acetate Foam is for
2. Before you use Hydrocortisone Acetate Foam
3. How to use Hydrocortisone Acetate Foam
4. Possible side effects
5. How to store Hydrocortisone Acetate Foam
6. Further information
1. What Hydrocortisone Acetate Foam is for Hydrocortisone Acetate Foam - benefit information
Hydrocortisone Acetate Foam 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 Hydrocortisone Acetate Foam) is an effective way to treat various illnesses involving inflammation in the body. Hydrocortisone Acetate Foam reduces this inflammation, which could otherwise go on making your condition worse. You must use this medicine regularly to get maximum benefit from it.
Hydrocortisone Acetate Foam is used to treat inflammation of the colon and rectum.
2. Before you use Hydrocortisone Acetate Foam Do not use Hydrocortisone Acetate Foam:
• If you are allergic to hydrocortisone acetate or to any other ingredient in Hydrocortisone Acetate Foam (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 manic-depression (bipolar disorder). This includes having had depression before while using steroid medicines like Hydrocortisone Acetate Foam.
• 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 Hydrocortisone Acetate Foam.
Taking other medicines
Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
If you are pregnant, trying to become pregnant or breast-feeding ask your doctor or pharmacist for advice before using Hydrocortisone Acetate Foam.
3. How to use Hydrocortisone Acetate Foam
Always use Hydrocortisone Acetate Foam 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 until the foam stops expanding.
DO NOT fill the applicator in one go. Always release the canister top after a short press.
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.
7. 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.
POM PL No: 20636/2585
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 Hydrocortisone Acetate Foam than you should
If you use too much go to your doctor as soon as possible.
If you forget to use Hydrocortisone Acetate Foam
Do not use double the dose to make up for a missed dose. Simply take your next dose as planned.
If you stop using Hydrocortisone Acetate Foam
Do not stop using Hydrocortisone Acetate Foam without talking to your doctor. Your doctor may reduce your dose gradually.
Mental problems while using Hydrocortisone Acetate Foam
Mental health problems can happen while using steroids like Hydrocortisone Acetate Foam (see 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 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.
4. Possible side effects
Like all medicines, Hydrocortisone Acetate Foam 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.
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.
5. How to store Hydrocortisone Acetate Foam
Keep out of the sight and reach of children
Do not use Hydrocortisone Acetate Foam after the expiry date which is stated on the canister and carton. The expiry date refers to the last day of that month.
• Protect from sunlight and do not expose to temperatures above 50oC.
• Do not store above 25°C.
• Do not refrigerate or freeze.
• Keep away from sources of ignition - No smoking.
• Do not spray on a naked flame or any incandescent material.
• Do not pierce or burn the container even after use.
Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist.
If the medications become discoloured or show any other signs of deterioration, you should consult your pharmacist who will advise you what to do.
6. Further information
What Hydrocortisone Acetate Foam contains:
Each canister contains 10% w/w hydrocortisone acetate.
The product also contains: propylene glycol, emulsifying wax (cetostearyl alcohol), polyoxyethylene 10 stearyl ether, cetyl alcohol, methyl paraben (E218), propyl paraben (E216), trolamine, isobutane/propane propellant and purified water
Hydrocortisone Acetate Foam does not contain CFCs.
What Hydrocortisone Acetate Foam looks like and contents of the pack
Hydrocortisone Acetate Foam is available as a white foam in an aerosol canister of 20.8g with a plastic applicator for rectal use. Each canister contains approximately 14 doses.
Manufacturer and Product Licence Holder
Manufactured by Pharmasol Limited, North Way, Walworth Industrial Estate, Andover, SP10 5 AZ, UK and procured from the EU by Product Licence holder Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex, HA1 1XD. Repackaged by Servipharm Ltd.
Leaflet revision and issue date (Ref) 04.04.14[2]