Scheriproct 1mg + 1mg suppositories

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Prednisolone; Cinchocaine Hydrochloride

Disponibil de la:

KARO PHARMA AB

Codul ATC:

C05AA; C05AA04

INN (nume internaţional):

Prednisolone; Cinchocaine Hydrochloride

Dozare:

1 mg/1 milligram(s)

Forma farmaceutică:

Suppository

Zonă Terapeutică:

Corticosteroids; prednisolone

Statutul autorizaţiei:

Marketed

Data de autorizare:

1978-04-01

Prospect

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 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 mentioned in this leaflet. See
section 4.
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
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.
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 following cases: 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 E

Caracteristicilor produsului

Health Products Regulatory Authority
13 January 2021
CRN00C3WF
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Scheriproct 1mg + 1mg suppositories
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains prednisolone caproate equivalent to 1 mg
prednisolone and 1 mg cinchocaine hydrochloride.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suppository
White to yellowish suppositories.
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.
One suppository daily as directed. If symptoms are severe one
suppository two or three times on the first day.
Only on the first day may more than 1 suppository be used if the
symptoms are severe.
Duration of treatment should not usually exceed 1 week.
Specific treatment of the condition giving rise to the haemorrhoids
may be required.
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 for referral to an ophthalmologist for evaluation
of possible causes which may include cataract, glaucoma or rare
diseases such as central serous chorioretinopathy (CSCR)
whic