Proctosedyl suppositories

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 ; 5mg

Pharmaceutical form:

Suppository

Administration route:

Rectal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01070200; GTIN: 5013841100872

Patient Information leaflet

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1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROCTOSEDYL SUPPOSITORIES
Cinchocaine hydrochloride 5mg
Hydrocortisone 5mg
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 Suppositories are and what they
are used for
2. What you need to know before you use Proctosedyl
Suppositories
3. How to use Proctosedyl Suppositories
4. Possible side effects
5. How to store Proctosedyl Suppositories
6. Contents of the pack and other information
1. WHAT PROCTOSEDYL SUPPOSITORIES ARE AND
WHAT THEY ARE USED FOR
The name of your medicine is Proctosedyl
Suppositories. Proctosedyl Suppositories contain 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 Suppositories can be used for the short
term relief (not more than 7 days) of:
• Pain, irritation, discharge and itching associated
with enlarged or swollen vessels around your back
passage (haemorrhoids)
• Itching around your back passage
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
PROCTOSEDYL SUPPOSITORIES
DO NOT TAKE USE THIS ME

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Proctosedyl Suppositories
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cinchocaine Hydrochloride (micro) BP 5mg
Hydrocortisone (micro) EP 5mg
3
PHARMACEUTICAL FORM
Smooth off-white suppositories.
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 serous
discharge. Proctosedyl is, therefore, useful for the short term relief
(not more than 7
days) of pain, irritation and pruritis associated with haemorrhoids,
pruritis ani.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Adults (including the elderly) and children: _
A suppository is inserted morning and evening, and after each stool.
The
ointment may be used 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
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
corticosteroids.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Co-treatment with CYP3A inhibitors, including cobicistat-containing
products, is expected to increase the risk of systemic side-effects.
The combination should be avoided unless the benefit outweighs the
increased
risk of systemic