Hydrocortisone Acetate 10%W/W Rectal Foam
PATIENT INFORMATION LEAFLET ltti6°/02°7i4/i/f
• 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 reach and sight of children.
• Do not store above 25°C.
• Do not use Colifoam after the expiry date which
is stated on the canister and carton.
• Do not expose to temperatures above 50°C
• Store in the original packaging to protect from sunlight.
• Do not refrigerate
• Keep away from sources of ignition - No smoking.
• Do not spray on a naked flame or anything hot.
• Do not pierce or burn the container even after use.
• Medicines should not be disposed of via waste water or household waste. Return any medicine you no longer need to your pharmacist.
• If your medicine become discoloured or show any other signs of deterioration, consult your pharmacist who will tell you what to do.
6. FURTHER INFORMATION What Colifoam contains
• The active substance in Colifoam is hydrocortisone acetate (10% w/w).
• The other ingredients are propylene glycol, emulsifying wax (cesosteartyl alcohol), polyoxyethylene (10) stearyl ether, cetyl alcohol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), trolamine, purified water, isobutane / propane propellant.
What Colifoam looks like and contents of the pack
• Colifoam is a white rectal foam contained in a pressurised canister.
• Each pack contains a canister and applicator.
• Available in pack sizes 20.8g.
Manufacturer and Licence Holder
This medicine is manufactured by Pharmasol Ltd., North Way, Walworth Industrial Estate, Andover, SP10 5AZ, UK and is procured from within the EU. Product Licence Holder LTT Pharma Limited,
B98 0RE and repackaged by Lexon (UK) Limited, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.
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.
Your medicine is called Colifoam 10% w/w Rectal Foam and will be referred to as Colifoam throughout the rest of this leaflet.
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
PL 33723/0160 - Colifoam 10% w/w Rectal Foam Colifoam is a registered trademark of Meda AB. Leaflet revision date: 02/07/14
Blind or partially sighted?
Is this leaflet hard to see or read? Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.
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.
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.
For rectal use only.
Do not swallow
1. Shake the canister vigorously for 30 seconds before each use.
5. Wail 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.
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.
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.
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.
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.
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.
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.
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 HYDROCORTISONE ACETATE
• Keep out of the reach and sight of children.
• Do not store above 25°C.
• Do not use Hydrocortisone Acetate after the expiry date which is stated on the canister and carton.
• Do not expose to temperatures above 50°C
• Store in the original packaging to protect from sunlight.
• Do not refrigerate
• Keep away from sources of ignition - No smoking.
• Do not spray on a naked flame or anything hot.
• Do not pierce or burn the container even after use.
• Medicines should not be disposed of via waste water or household waste. Return any medicine you no longer need to your pharmacist.
• If your medicine become discoloured or show any other signs of deterioration, consult your pharmacist who will tell you what to do.
6. FURTHER INFORMATION What Hydrocortisone Acetate contains
• The active substance in Hydrocortisone Acetate is hydrocortisone acetate (10% w/w).
• The other ingredients are propylene glycol, emulsifying wax (cesosteartyl alcohol), polyoxyethylene (10) stearyl ether, cetyl alcohol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), trolamine, purified water, isobutane / propane propellant.
What Hydrocortisone Acetate looks like and contents of the pack
• Hydrocortisone Acetate is a white rectal foam contained in a pressurised canister.
• Each pack contains a canister and applicator.
• Available in pack sizes 20.8g.
Manufacturer and Licence Holder
This medicine is manufactured by Pharmasol Ltd., North Way, Walworth Industrial Estate, Andover, SP10 5AZ, UK and is procured from within the EU. Product Licence Holder LTT Pharma Limited,
B98 0RE and repackaged by Lexon (UK) Limited, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.
PL 33723/0160 - Hydrocortisone Acetate 10% w/w Rectal Foam
Leaflet revision date: 02/07/14
Blind or partially sighted?
Is this leaflet hard to see or read? Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.
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.
Your medicine is called Hydrocortisone Acetate
10% w/w Rectal Foam and will be referred to as
Hydrocortisone Acetate throughout the rest of this
leaflet.
Important:
• Hydrocortisone Acetate 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 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 is for
2. Before you use Hydrocortisone Acetate
3. How to use Hydrocortisone Acetate
4. Possible side effects
5. How to store Hydrocortisone Acetate
6. Further information
Hydrocortisone Acetate - benefit information
Hydrocortisone Acetate 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 Coli foam) is an effective way to treat various illnesses involving inflammation in the body. Hydrocortisone Acetate 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 is used to treat infammation of the colon and rectum
2. BEFORE YOU USE HYDROCORTISONE ACETATE
Do not use Hydrocortisone Acetate:
• If you are allergic to hydrocortisone acetate or to any other ingredient in Hydrocortisone Acetate (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.
• 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.
For rectal use only.
Do not swallow
1. Shake the canister vigorously for 30 seconds before each use.
5. Wail 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.
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.
2. Withdraw the plunger until it stops at the catch line.
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.
3. HOW TO USE HYDROCORTISONE ACETATE
Always use Hydrocortisone Acetate 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.
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.
APPLICATOR
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.
If you forget to use Hydrocortisone Acetate
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
Do not stop using Hydrocortisone Acetate without talking to your doctor. Your doctor may reduce your dose gradually.
Mental problems while using Hydrocortisone Acetate
Mental health problems can happen while using steroids like Hydrocortisone Acetate (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.
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.
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.
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 than
you should
If you use too much go to your doctor as soon as
possible.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Hydrocortisone Acetate 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
Ref: LTT160/020714/2/B