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:

Bayer Limited

ATC code:

C05AA; C05AA04

INN (International Name):

PREDNISOLONE CAPROATE; Cinchocaine hydrochloride

Dosage:

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

Pharmaceutical form:

Rectal ointment

Prescription type:

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

Therapeutic area:

Corticosteroids; prednisolone

Authorization status:

Marketed

Authorization date:

1978-04-01

Patient Information leaflet

Bayer Limited
The Atrium
Blackthorn Road
Dublin 18
Telephone:
[phone]
Fax:
[phone]
www.bayer.ie
15660
PATIENT INFORMATION
LEAFLET
SCHERIPROCT
® 1.5 MG/G +
5
MG/G RECTAL OINTMENT
SCHERIPROCT
® 1 MG + 1 MG
SUPPOSITORIES
PREDNISOLONE, CINCHOCAINE
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 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 you experience any side effect
and this becomes serious, tell
your doctor or pharmacist.
IN THIS LEAFLET:
1.
WHAT SCHERIPROCT IS AND WHAT
IT IS USED FOR
2.
BEFORE YOU USE SCHERIPROCT
3.
HOW TO USE SCHERIPROCT
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE SCHERIPROCT
6.
FURTHER 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.
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
TAKE SPECIAL CARE WITH SCHERIPROCT

Long-term continuous treatment
should be avoided because it can
cause the skin to thin and
deteriorate in the affected area
(see section 4. “Possible Side
Effects”) and some of the medicine
may be absorbed into the blood
stream.

If the area treated with Scheriproct
is also infected your doctor should
prescribe another me

Summary of Product characteristics

Health Products Regulatory Authority
16 August 2019
CRN0098J3
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
considered