SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Scheriproct® Ointment

2    QUALITATIVE AND QUANTITATIVE    COMPOSITION

A colourless to slightly yellowish translucent ointment containing in 1 g:

Prednisolone hexanoate 1.9 mg

Cinchocaine hydrochloride 5.0 mg

For the full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Ointment

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

Apply in a thin layer twice daily. In order to obtain a rapid improvement, Scheriproct ointment may be applied three to four times on the first day. The nozzle provided facilitates intra-rectal application.

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.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Fertility, pregnancy and lactation

There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development, including cleft palate and intra-uterine growth retardation. There may therefore be a very small risk of such effects on the human foetus.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

As with all topical steroids, there is a risk of developing skin atrophy following extensive therapy.

Allergic skin reactions may occur.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

None stated.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Prednisolone hexanoate - On local application, exerts a powerful anti-inflammatory action which is superior to that of both cortisone and hydrocortisone. Its effects include a reduction of capillary dilatation, intercellular oedema and inflammatory infiltration within tissues, and the inhibition of vascularisation.

Cinchocaine hydrochloride - Has a local anaesthetic effect on mucous membranes and, in combination with prednisolone hexanoate, provides a quick relief of painful and pruritic symptoms.

5.2 Pharmacokinetic properties

No data are available on the rectal absorption of prednisolone hexanoate in humans. However, the extent of the rectal absorption from a similar lipophilic corticosteroid ester, flucortolone pivalate, amounted to only about 15% of the dose with the cream and only 5% of the dose from the suppository.

No data are available on the elimination of prednisolone hexanoate in humans. It is known that corticosteroids are excreted in the urine.

In-vitro and in-vivo investigations with corticosteroid esters (halogenated and non-halogenated corticoids) have shown that these compounds are split extremely rapidly into the corticoid and fatty acid by the esterases which are ubiquitously present in the body. For this reason, after topical application and percutaneous absorption of prednisolone hexanoate, the steroid alcohol, prednisolone becomes systemically available.

Inactivation of free prednisolone is carried out by the liver and to a small extent by the kidneys.

5.3 Preclinical safety data

There are no preclinical safety data which could be of relevance to the prescriber and which are not already included in other relevant sections of the SPC.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Polyethylene glycol 400 monoricinoleate, hydrogenated castor oil, castor oil, 2 octyldodecanol, chypre No. 6466 perfume oil.

6.2    Incompatibilities

None known.

6.3    Shelf life

2 years

6.4    Special precautions for storage

Do not store above 25^oC

6.5    Nature and contents of container

Collapsible aluminium tubes of 30 g with white HDPE screw caps.

6.6 Special precautions for disposal

Keep out of the reach of children.

7    MARKETING AUTHORISATION HOLDER

Bayer plc Bayer House Strawberry Hill Newbury

Berkshire RG14 1JA United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

PL 00010/0647

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 02 June 1964 Date of latest renewal: 28 October 1999

10 DATE OF REVISION OF THE TEXT

09/09/2015