SCHERIPROCT

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

PREDNISOLONE CAPROATE ; CINCHOCAINE HYDROCHLORIDE

Prieinama:

Primecrown 2010 Ltd

ATC kodas:

C05AA04

INN (Tarptautinis Pavadinimas):

PREDNISOLONE CAPROATE ; CINCHOCAINE HYDROCHLORIDE

Dozė:

1.5/5 mg/g

Vaisto forma:

Rectal Ointment

Recepto tipas:

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

Gydymo sritis:

prednisolone

Autorizacija statusas:

Authorised

Leidimo data:

2012-08-31

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE USER
SCHERIPROCT
®
1.5 MG/G + 5 MG/G RECTAL OINTMENT
Prednisolone, Cinchocaine hydrochloride
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 medicine to use with Scheriproct, to treat the
infection.

Do not allow Scheriproct to come into contact with the eyes.
If symptoms do not improve, consult the doctor again.
TAKING OTHER MEDICINES

Please tell your doctor or pharmacist if you are taking or have
recently
taken any other medicines, including medicines obtained without a
prescription.

Some medicines may increase the effects of Scheriproct and your
doctor may wish to monitor you carefully if you are taking these
medicines (including some medicines for HIV: ritonavir, cobicistat).
PREGNANCY AND BREAS

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Scheriproct 1.5 mg/g + 5 mg/g Rectal Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1g 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
_Product imported from the UK and Portugal_
Colourless to faintly yellow homogeneous translucent ointment
4 CLINICAL PARTICULARS
As per PA1410/071/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1410/071/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Octyldodecanol
Castor oil, refined
Castor oil, hydrogenated
Polyethylene glycol–400–monoricinoleate
Chypre perfume oil
6.2 INCOMPATIBILITIES
Not applicable
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer package of the product on
the market in the country of origin.
After first opening: 3 months
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C. Replace the cap tightly after use.
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6.5 NATURE AND CONTENTS OF CONTAINER
Aluminium tubes with 30g of ointment in an over-labelled cardboard
carton with a rectal cannula
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements
7 PARALLEL PRODUCT AUTHORISATION H