Hydrocortisone Acetate 10%W/W Rectal Foam
Package Leaflet: Information for the user
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 take 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 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 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.
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.
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.
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.
• 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 label or carton after EXP. The expiry date refers to the last day of that month.
• Do not store above 25oC.
• Store in original package to protect from sunlight.
• Keep away from sources of ignition - No smoking.
• Do not spray on a naked flame or anything hot.
• Keep pressurized container away from heat and light.
• Do not expose to temperatures above 50oC.
• Do not refrigerate or freeze.
• Do not pierce or burn container even when empty.
• If your medicine becomes discoloured or shows any sign of deterioration, return it to your pharmacist.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
What Colifoam contains
The active substance is hydrocortisone acetate (10% w/w). Each canister contains 10% w/w hydrocortisone acetate.
The other ingredients are:
Propylene glycol, emulsifying wax (cetostearyl alcohol), polyoxyethylene (10) stearyl ether, cetyl alcohol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), trolamine, purified water and propellant HP-70 consisting of isobutane and propane.
What Colifoam looks like and contents of the pack
Colifoam is a white, odourless rectal foam contained in a pressurised canister. Each pack contains a canister and an applicator.
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.
Colifoam is available as a 20.8g canister. Each canister contains approximately 14 doses.
Manufacturer
Pharmasol Ltd.,
North Way, Walworth Industrial Estate,
Andover, SP10 5AZ, UK.
It is procured from within the EU by the Product Licence holder: MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall, WS9 8ER, UK.
Repackaged by MPT Pharma Ltd.
PL: 33532/0520 Colifoam® 10% w/w Rectal Foam
Leaflet date: 20th October 2015 Leaflet code: XXXXXXXXXX
POM
Colifoam® is a registered trademark of MEDA AB.
Package Leaflet: Information for the user
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.
Important:
• Hydrocortisone acetate is a steroid medicine, prescribed for many different conditions, including serious illnesses
• You need to take 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
1. What Hydrocortisone acetate is for
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 Hydrocortisone acetate) 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 take this medicine regularly to get maximum benefit from it.
Hydrocortisone acetate is used to treat inflammation 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.
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.
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.
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.
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.
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.
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.
• 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 sight and reach of children.
• Do not use Hydrocortisone acetate after the expiry date, which is stated on the label or carton after EXP. The expiry date refers to the last day of that month.
• Do not store above 25oC.
• Store in original package to protect from sunlight.
• Keep away from sources of ignition - No smoking.
• Do not spray on a naked flame or anything hot.
• Keep pressurized container away from heat and light.
• Do not expose to temperatures above 50oC.
• Do not refrigerate or freeze.
• Do not pierce or burn container even when empty.
• If your medicine becomes discoloured or shows any sign of deterioration, return it to your pharmacist.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
What Hydrocortisone acetate contains
The active substance is hydrocortisone acetate (10% w/w). Each canister contains 10% w/w hydrocortisone acetate.
The other ingredients are:
Propylene glycol, emulsifying wax (cetostearyl alcohol), polyoxyethylene (10) stearyl ether, cetyl alcohol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), trolamine, purified water and propellant HP-70 consisting of isobutane and propane.
What Hydrocortisone acetate looks like and contents of the pack
Hydrocortisone acetate is a white, odourless rectal foam contained in a pressurised canister. Each pack contains a canister and an applicator.
Hydrocortisone acetate is available as a 20.8g canister. Each canister contains approximately 14 doses.
Manufacturer
Pharmasol Ltd.,
North Way, Walworth Industrial Estate,
Andover, SP10 5AZ, UK.
POM
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.
It is procured from within the EU by the Product Licence holder: MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall, WS9 8ER, UK.
Repackaged by MPT Pharma Ltd.
PL: 33532/0520 Hydrocortisone acetate 10% w/w Rectal Foam
Leaflet date: 20th October 2015 Leaflet code: XXXXXXXXXX