Proctosedyl ointment

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cinchocaine hydrochloride; Hydrocortisone

Available from:

Phoenix Labs Ltd

ATC code:

C05AX03

INN (International Name):

Cinchocaine hydrochloride; Hydrocortisone

Dosage:

5mg/1gram ; 5mg/1gram

Pharmaceutical form:

Rectal ointment

Administration route:

Cutaneous; Rectal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01070200; GTIN: 5013841100865

Patient Information leaflet

PROCTOSEDYL OINTMENT
Cinchocaine h_y_drochloride 0.5%w/w
Hydrocortisone 0.5%w/w
PACKAGE LEAFLET: INFORMATION FOR THE USER
3. HOW TO USE PROCTOSEDYL OINTMENT
2. WHAT YOU NEED TO KNOW BEFORE YOU USE PROCTOSEDYL
OINTMENT
1. WHAT PROCTOSEDYL OINTMENT IS AND WHAT IT
IS USED FOR
IS THIS LEAFLET HARD TO SEE OR READ? PHONE [phone] FOR HELP
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
• If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist
WHAT IS IN THIS LEAFLET
1. What Proctosedyl ointment is and what it is used for
2. What you need to know before you use Proctosedyl Ointment
3. How to use Proctosedyl ointment
4. Possible side effects
5. How to store Proctosedyl ointment
6. Contents of the pack and other information
The name of your medicine is Proctosedyl ointment. Proctosedyl
ointment contains two different medicines called: cinchocaine
hydrochloride and hydrocortisone.
• Cinchocaine hydrochloride belongs to a group of medicines
called local anaesthetics. It works by causing numbness in the
area to which it is applied. This stops you feeling pain in this
area and helps lessen the spasm of the back passage
• Hydrocortisone belongs to a group of medicines called
corticosteroids. It works by lowering the production of
substances that cause inflammation. This helps lower swelling,
itching and discharge
Proctosedyl ointment can be used for the short-term relief (not
more than 7 days) of:
• Pain, irritation, discharge and itching associated with enlarged
or swollen blood vessels around your back passage
(haemorrhoids)
• Itching around your back passage
DO NOT USE THIS MEDICINE AND TELL YOUR DOCTOR IF:
You are allergic (hypersensitive) to ci

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Proctosedyl Ointment
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cichocaine Hydrochloride (Micro) BP 0.5 %ww, Hydrocortisone (Micro) EP
0.5
%ww
3
PHARMACEUTICAL FORM
Yellowish-white translucent greasy ointment.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The local anaesthetic cinchocaine relieves pain and relaxes
sphincteric spasm. Pruritis
and
inflammation
are
relieved
by
hydrocortisone,
which
also
decreases
serious
discharge.
Proctosedyl is, therefore, useful for the short term relief (not more
than 7 days) of
pain, irritation and pruritis associated with haemorrhoids and
pruritis ani.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Apply the ointment in small quantities with the finger, on the painful
or pruritic area,
morning and evening and after each stool. For deep application attach
cannula to
tube, insert to full extent and squeeze tube gently from lower end
whilst withdrawing.
The ointment may be used separately or concurrently with the
suppositories.
4.3
CONTRAINDICATIONS
Known hypersensitivity to any of the ingredients.
Not for use in the presence of infections.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Apply only to the region of the rectum and anus and surrounding skin.
Hydrocortisone can cause thinning and damage to the skin especially of
the
face.
As with all preparations containing topical steroids, the possibility
of systemic
absorption should be considered. In particular, long-term continuous
therapy
should be avoided in infants. Adrenal suppression can occur even
without
occlusion.
VISUAL DISTURBANCE
Visual disturbance may be reported with systemic and topical
corticosteroid
use. If a patient presents with symptoms such as blurred vision or
other visual
disturbances, the patient should be considered for referral to an
ophthalmologist for evaluation of possible causes which may include
cataract,
glaucoma or rare diseases such as central serous chorioretinopathy
(CSCR)
which have been reported after use of systemic and topical