Scheriproct suppositories

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Prednisolone hexanoate; Cinchocaine hydrochloride

Available from:

Karo Healthcare UK Ltd

ATC code:

C05AX03

INN (International Name):

Prednisolone hexanoate; Cinchocaine hydrochloride

Dosage:

1.3mg ; 1mg

Pharmaceutical form:

Suppository

Administration route:

Rectal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01070200; GTIN: 5016703002840

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SCHERIPROCT
®
Ointment
(1.9 mg prednisolone hexanoate / 5.0 mg cinchocaine hydrochloride per
1 g)
SCHERIPROCT
®
Suppositories
(1.3 mg prednisolone hexanoate / 1.0 mg cinchocaine hydrochloride per
suppository)
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 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 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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Scheriproct® Suppositories
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each yellowish-white suppository contains:
Prednisolone hexanoate 1.3 mg
Cinchocaine hydrochloride 1.0 mg
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Suppository
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
One Scheriproct suppository to be inserted daily. In severe cases one
suppository two
to three times daily at the beginning of treatment. The suppositories
should be
inserted after defaecation.
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 excipient (hard fat) in Scheriproct suppositories may reduce the
effectiveness of
latex products such as condoms.
VISUAL DISTURBANCE:
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 consid