Proctofoam H.C. 1.0% w/w & 1.0% w/w Rectal Foam

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Pramocaine hydrochloride; HYDROCORTISONE ACETATE

متاح من:

Mylan IRE Healthcare Limited

ATC رمز:

C05AA; C05AA01

INN (الاسم الدولي):

Pramocaine hydrochloride; HYDROCORTISONE ACETATE

جرعة:

1 / 1 percent weight/weight

الشكل الصيدلاني:

Rectal foam

نوع الوصفة الطبية :

Product subject to prescription which may not be renewed (A)

المجال العلاجي:

Corticosteroids; hydrocortisone

الوضع إذن:

Not marketed

تاريخ الترخيص:

1978-04-01

نشرة المعلومات

PATIENT INFORMATION LEAFLET
PROCTOFOAM HC
1% W/W & 1%W/W RECTAL FOAM
(Hydrocortisone acetate / pramocaine hydrochloride)
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 had been prescribed for you. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.

Throughout this leaflet Proctofoam HC 1% w/w & 1% w/w Rectal Foam is
called Proctofoam.
IMPORTANT:

PROCTOFOAM IS A STEROID MEDICINE, prescribed for many different
conditions, including
serious illness

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).
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.
IN THIS LEAFLET:
1.
What Proctofoam is and what it is used for
2.
What you need to know before you use Proctofoam
3.
How to use Proctofoam
4.
Possible side effects
5.
How to store Proctofoam
6.
Contents of the pack and other information
1.
WHAT PROCTOFOAM IS AND WHAT IT IS USED FOR
PROCTOFOAM – BENEFIT INFORMATION
Proctofoam belongs to a group of medicines called steroids. Their full
name is
corticost

خصائص المنتج

Health Products Regulatory Authority
26 November 2020
CRN00C1XS
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Proctofoam H.C. 1.0% w/w & 1.0% w/w Rectal Foam
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydrocortisone Acetate 1.0 % w/w
Pramocaine Hydrochloride 1.0 % w/w
Excipients: contains cetyl alcohol 0.300% w/w, methyl
parahydroxybenzoate (E216) 0.050% w/w, propyl parahydroxybenzoate
(E218) 0.005%w/w and propylene glycol 7.000% w/w. Also contains
cetostearyl alcohol as a constituent of emulsifying wax.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Rectal foam.
White, aerosol foam.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the short term (not more than 5 - 7 days) relief of the symptoms
of itching, irritation, discomfort or pain associated with
local, non infective anal or perianal conditions. In the management of
anorectal inflammation fissures, pain and oedema
associated with haemorrhoids or occurring post-operatively pruritis
ani.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
One applicator full per rectum (3to 5mg hydrocortisone acetate) two or
three times dailyand after each bowel evacuation (upto
a maximum of four times daily). For perianal administration, apply a
small quantity on two fingers.
_Paediatric population_
Not recommended for use in children.
Method of administration
Shake the canister vigorously for 30 seconds before each use. Use at
room temperature. For rectal use only.
4.3 CONTRAINDICATIONS

Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.

Use in the presence of infections of viral, treponemal, fungal,
tuberculosis and other bacterial infections.

Use in the presence of ulcerations, fistulae or perforations.
Health Products Regulatory Authority
26 November 2020
CRN00C1XS
Page 2 of 6
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Not for prolonged use.Contact sensitisation to local anaesthetics is
common following prolonged application.
Seek medical advice if symptoms worse