Scheriproct ointment

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cinchocaine hydrochloride; Prednisolone hexanoate

Available from:

Karo Pharma UK Ltd

ATC code:

C05AX03

INN (International Name):

Cinchocaine hydrochloride; Prednisolone hexanoate

Dosage:

5mg/1gram ; 1.9mg/1gram

Pharmaceutical form:

Rectal ointment

Administration route:

Rectal; Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01070200; GTIN: 5016703001782

Patient Information leaflet

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START USING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
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
only. Do not pass it on to others. It may harm
them, even if their signs of illness 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.
WHAT IS IN THIS LEAFLET
1. What Scheriproct® is and what it is used for
2. What you need to know before you use
Scheriproct®
3. How to use Scheriproct®
4. Possible side effects
5. How to store Scheriproct®
6. Contents of the pack and other information
1. WHAT SCHERIPROCT® IS AND WHAT IT IS USED FOR
Scheriproct contains a substance which reduces
inflammation (prednisolone) and a local
anaesthetic (cinchocaine) which relieves pain.
This medicine is used for the relief of the inflam-
mation, swelling, itching and soreness of piles
(haemorrhoids) and to relieve itching of the anus
(back passage). It is used shortterm usually for
5 to 7 days.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
SCHERIPROCT®
DO NOT USE SCHERIPROCT
•
if you are allergic to prednisolone hexanoate,
cinchocaine hydrochloride, other local
anaesthetics or any of the other ingredients of
this medicine (listed in section 6).
•
if you have a viral infection (e.g. herpes, shingles,
chicken-pox)
•
if you have any bacterial or fungal infections
of the skin or elsewhere for which you are not
receiving treatment.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using
Scheriproct
•
Long-term continuous treatment should be
avoided because it increases the possibility of
side effects. This is particularly important for
infants and small children because continuous
treatment with Scheriproct for long periods
may reduce the activity of the adrenal glands
and so lower resistance to disease. Also,

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Scheriproct® Ointment
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
A colourless to slightly yellowish translucent ointment containing in
1 g:
Prednisolone hexanoate 1.9 mg
Cinchocaine hydrochloride 5.0 mg
Excipients with known effect: 442.9 mg castor oil refined, 75 mg
castor oil
hydrogenated, 75 mg macrogol 400 monoricinoleate and 0.2 mg perfume
oil, chypre
(see section 4.4).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Ointment
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the symptomatic relief of haemorrhoids and pruritus ani in the
short term (5-7
days).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Apply in a thin layer twice daily. In order to obtain a rapid
improvement, Scheriproct
ointment may be applied three to four times on the first day.
The applicator provided facilitates intra-rectal application (for use
and cleaning of the
applicator see section 6.6).
4.3
CONTRAINDICATIONS
Viral infections. Primary bacterial or fungal infections. Secondary
infections of the
skin in the absence of appropriate anti-infective therapy. Known
sensitivity to local
anaesthetics.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Warnings: In infants, long-term continuous therapy with topical
corticosteroids
should be avoided. Occlusion is not appropriate on the perineum.
Adrenal
suppression can occur, even without occlusion. As with all topical
steroids, there is a
risk of developing skin atrophy following extensive therapy. The
application of
unusually large quantities of topical corticoids may result in the
absorption of
systemically active amounts of corticoid. Secondarily infected
dermatoses definitely
require additional therapy with antibiotics or chemotherapeutic
agents. This treatment
can often be topical, but for heavy infections systemic antibacterial
therapy may be
necessary. If fungal infections are present, a topically active
antimycotic should be
applied.
The excipients (castor oil refined, castor oil hydrogenated,
ma