PROCTOFOAM HC RECTAL FOAM
Active substance(s): HYDROCORTISONE ACETATE / PRAMOCAINE HYDROCHLORIDE / HYDROCORTISONE ACETATE / PRAMOCAINE HYDROCHLORIDE / HYDROCORTISONE ACETATE / PRAMOCAINE HYDROCHLORIDE
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
• 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.
• Proctofoam is a steroid medicine, prescribed
for many different conditions, including serious illnesses
• You need to use it regularly to get the maximum
• 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 chickenpox 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 Proctofoam is for
Before you use Proctofoam
How to use Proctofoam
Possible side effects
How to store Proctofoam
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
Mock ups Proctofoam leaflet UK 2017-05.indd 1
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
Warnings and precautions:
• Contact your doctor if you experience blurred vision
or other visual disturbances.
Proctofoam is not for use in children
If any of the above applies to you talk to your doctor
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
• 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
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
Proctofoam 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 Proctofoam.
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
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
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
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.
3. How to use Proctofoam
Always use Proctofoam exactly as your doctor has
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.
• 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
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.
Proctofoam can be applied in the rectum (internal use)
For topical use
Shake the canister vigorously for 30 seconds before
each use. Expel a small quantity of foam onto a tissue,
pad or two fingers and apply the foam to the affected
• 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.
After using the applicator
• Always take the applicator apart and wash it
thoroughly after use
• The canister top should also be removed and
• Replace the canister top with care. Make sure it is
placed vertically on top of the canister, and not at
If you notice any of these problems talk to a doctor
If you use more Proctofoam than you should
If you use too much go to your doctor as soon as
If you repeatedly use too much Proctofoam you may
experience fattening of the face, neck and body, hair
growing on your body (women), a dusky complexion
with purple patches and skin thinning.
If you forget to use Proctofoam
Do not use double the dose to make up for a missed
dose. Simply take your next dose as planned.
If you stop using Proctofoam
Do not stop using Proctofoam without talking to your
doctor. Your doctor may reduce your dose gradually.
Mental problems while using Proctofoam
Mental health problems can happen while using
steroids like Proctofoam (see also section 4 Possible
• 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, Proctofoam 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
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
• Skin thinning
• Allergic skin reaction
• Burning sensation
• Blurred vision (frequency not known).
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.
By reporting side effects you can help provide more
information on the safety of this medicine.
What Proctofoam looks like
Proctofoam is a white rectal foam contained in a
Contents of the pack
Each pack contains canister and a plastic applicator.
Each canister contains approximately 40 doses.
Marketing Authorisation Holder in the UK:
Meda Pharmaceuticals Ltd, Skyway House, Parsonage
Road, Takeley, Bishop’s Stortford, CM22 6PU, UK.
Pharmasol Limited, North Way, Walworth Industrial
Estate, Andover, SP10 5AZ, UK.
This leaflet was last approved in January
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
5. How to store Proctofoam
Keep out of the reach and sight of children.
Do not use Proctofoam 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
• 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 Proctofoam contains:
The active substances in Proctofoam are
hydrocortisone acetate (1% w/w) and pramocaine
hydrochloride (1% w/w).
The other ingredients are cetyl alcohol, emulsifying
wax (cetyl alcohol, sorbitan solution), methyl
parahydroxybenzoate (E218), polyoxyethylene
(10); stearyl ether, propylene glycol, propyl
parahydroxybenzoate (E216), trolamine, purified
water and propellant HP-70 consisting of isobutane
Proctofoam is a registered trademark of Meda AB.
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Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.