Colifoam 10% aerosol

Main information

  • Trade name:
  • Colifoam 10% aerosol
  • Dosage:
  • 100mg/ 1gram
  • Pharmaceutical form:
  • Foam
  • Administration route:
  • Rectal
  • Class:
  • No Controlled Drug Status
  • Prescription type:
  • Valid as a prescribable product
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Colifoam 10% aerosol
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Product summary:
  • BNF: 01050200; GTIN: 7317510000189

Status

  • Source:
  • eMC
  • Authorization number:
  • PL 15142/0088
  • Last update:
  • 11-07-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

1. Shake the canister vigorously

for 30 seconds before each

use.

2. Withdraw the plunger until it

stops at the catch Iine.

3. Hold the applicater upright

and insert the canister top into

the opplicater tip. Make sure

you hold the plunger and

applicater body FIRMLY with

your fingers.

4. Press down gently on the

canister top with your fingers,

so that the foam fills about ¼

of the opplicater 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’ Iine. 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 applicater as

shown. lnsert gently into the

back passage and push the

plunger fully into the applicator.

CATCH

LINE

APPLICATOR

CANISTER

FULL

SHORT

PRESS

FILL

LINE

SHORT

PRESS

/WAIT

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 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:

What Colifoam is for

Before you use Colifoam

How to use Colifoam

Possible side effects

How to store Colifoam

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

Please tell your doctor if you are taking or have

recently taken any other medicines, including

medicines obtained without a prescription.

Some medicines may increase the effects of Colifoam

and your doctor may wish to monitor you carefully

if you are taking these medicines (including some

medicines for HIV: ritonavir, cobicistat).

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

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Colifoam is a registered trademark of Meda AB.

MOCK UPS

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 medi-

cine 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, phar-

macist 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 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.

Do not expose to temperatures above 50°C.

Store in the original packaging to protect from

sunlight.

Store below 25°C.

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 wastewater

or household waste. Return any medicine you no

longer need to your pharmacist.

6. Further information

What Colifoam contains:

The active substance in Colifoam is hydrocortisone

acetate (10% w/w).

The other ingredients are cetyl alcohol, emulsifying

wax (contains cetostearyl alcohol), methyl

parahydroxybenzoate (E218), polyoxyl (10); stearyl

ether, propylene glycol, propyl parahydroxybenzoate

(E216), trolamine, purified water and propellant

HP-70 consisting of isobutane and propane.

What Colifoam looks like

Colifoam is a white rectal foam contained in a

pressurised canister.

Contents of the pack

Each pack contains a canister and an applicator.

Each canister contains approximately 14 doses.

Marketing Authorisation Holder in the UK:

Meda Pharmaceuticals Ltd, Skyway House, Parsonage

Road, Takeley, Bishop’s Stortford, CM22 6PU, UK.

Manufacturer

Pharmasol Limited, North Way, Walworth Industrial

Estate, Andover, SP10 5AZ, UK.

This leaflet was last approved in February 2017

If this leaflet is difficult to see or

read or you would like it in a

different format, please contact:

Meda Pharmaceuticals Ltd,

Skyway House, Parsonage Road,

Takeley, Bishop’s Stortford, CM22

6PU, UK

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