Scheriproct 1.5mg/g + 5mg/g rectal ointment

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PREDNISOLONE CAPROATE; Cinchocaine hydrochloride

Available from:

LEO Pharma A/S

ATC code:

C05AA; C05AA04

INN (International Name):

PREDNISOLONE CAPROATE; Cinchocaine hydrochloride

Dosage:

1.5mg/g + 5 milligram(s)/gram

Pharmaceutical form:

Rectal ointment

Therapeutic area:

Corticosteroids; prednisolone

Authorization status:

Marketed

Authorization date:

1978-04-01

Patient Information leaflet

IIT001-01 - Page 1 + 2 - 165 x 300 mm – DRA_90036
IIT001-01 - 28/01/2019 - OMA: Updated for CI project (CAPA 173674)
Insert, 50 g
165 x 300 mm
IIT001-01
09/08/2018
JUG
28/01/2019
OMA
100%
All products
Used for:
Segrate keyline DRA_90036
Comments:
Approval:
Date:
Production site approval:
Graphic approval:
Revision info:
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, pharmacist or nurse.
•
This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
•
If you experience any side effects, talk to your
doctor, pharmacist or nurse. 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
inflammation, swelling, itching and soreness of
piles (haemorrhoids) and to relieve itching of the
anus (back passage). It is used short-term usually
for 5 to 7 days.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
SCHERIPROCT®
DO NOT USE SCHERIPROCT IF YOU:
•
are allergic (hypersensitive) to prednisolone
caproate, cinchocaine hydrochloride, other local
anaesthetics or any of the other ingredients of
Scheriproct.
•
have a viral infection (e.g. herpes, shingles,
chicken-pox)
•
have any bacterial or fungal infections of the
skin for which you are not receiving treatment
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before
using Scheriproct in the fol

Summary of Product characteristics

Health Products Regulatory Authority
23 December 2019
CRN008YXR
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Scheriproct 1.5mg/g + 5mg/g rectal ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of ointment contains prednisolone caproate equivalent to 1.5 mg of
prednisolone and 5 mg of cinchocaine hydrochloride.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Rectal ointment
Colourless to faintly yellow homogeneous translucent ointment.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the management of symptoms of internal or external haemorrhoids,
anal fissures and proctitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The anal region should be cleaned thoroughly before using Scheriproct,
which is best applied after defaecation.
Usual application twice daily. On the first day, for faster
symptomatic relief, up to four times. Protruding lumps should be
smeared and carefully pressed back with the finger.
Duration of treatment should not usually exceed 1 week. Specific
treatment of the condition giving rise to the haemorrhoids
may be required.
Before applying within the rectum, the enclosed applicator should be
screwed onto the tube (for use and cleaning of the
applicator see section 6.6).
4.3 CONTRAINDICATIONS
Use in the presence of untreated infections of bacterial, viral,
tuberculous or fungal origin.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Additional specific therapy is required in bacterial and/or fungal
infections.
There have been a few reports in the literature of the development of
cataracts in patients who have been using corticosteroids
for prolonged periods of time. Although it is not possible to rule out
systemic corticosteroids as a known factor, prescribers
should be aware of the possible role of corticosteroids in cataract
development.
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
considere