Patient Information Leaflet

Proctofoam HC Rectal Foam

(Hydrocortisone acetate 1% w/w & Pramocaine hydrochloride 1% w/w)

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 Proctofoam HC Rectal Foam is called Proctofoam.

Important:

•    Proctofoam 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

•    Proctofoam 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)

•    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 Proctofoam is for
2.	Before you use Proctofoam
3.	How to use Proctofoam
4.	Possible side effects
5.	How to store Proctofoam
6.	Further information
1.	What Proctofoam is for

Proctofoam - benefit information

Proctofoam 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 Proctofoam) is an effective way to treat various illnesses involving inflammation in the body.

Proctofoam reduces this inflammation, which could otherwise go on making your condition worse. You must use this medicine regularly to get maximum benefit from it. Proctofoam is used for the relief of inflammation, itching, pain, swelling and irritation associated with haemorrhoids (piles) and certain other conditions of the anus (bottom) and anal region.

2. Before you use Proctofoam

Do not use Proctofoam:

•    If you are allergic to pramocaine hydrochloride or to any other ingredient in Proctofoam (see section 6)

•    If you are suffering from a bacterial infection, viral infection, or fungal infection

Proctofoam is not for use in children

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 Proctofoam.

•    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 Proctofoam.

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 Proctofoam.

3. How to use Proctofoam

Always use Proctofoam 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:

•    Do not use Proctofoam for more than 7 days

•    Talk to your doctor if symptoms worsen, or do not improve within 7 days or if bleeding occurs

•    You need to use your medicine regularly to get the maximum benefit.

Adult dose

Proctofoam can be applied in the rectum (internal use) or to the skin around the anus (external use).

•    The usual dose into the rectum is one applicator of foam two or three times per day and after each bowel evacuation up to a maximum of 4 times daily

•    For the anal area expel a small amount of foam onto two fingers and apply to the affected area.

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 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 V of the opplicater body. Only a short press is needed to do this.

SHORT

PRESS

5. Wait for a few seeonds until the foam stops expanding.

DO NOT fill the applicator in one go. Always release the canister top efter a short press.

FILL

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.

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.

Mock ups Proctofoam leaflet UK 2013-11.indd 1