SCHERIPROCT OINTMENT - summary of medicine characteristics

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

Excipients with known effect: 442.9 mg castor oil refined, 75 mg castor oil hydrogenated, 75 mg macrogol 400 monoricinoleate and 0.2 mg perfume oil, chypre (see section 4.4).

For the full list of excipients, see section 6.1.

Ointment

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 applicator provided facilitates intra-rectal application (for use and cleaning of the applicator see section 6.6).

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 excipients (castor oil refined, castor oil hydrogenated, macrogol-400-monoricinoleate and perfume oil chypre) in Scheriproct ointment 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 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) which have been reported after use of systemic and topical corticosteroids.

This medicine contains castor oil, castor oil hydrogenated and macrogol 400 monoricinoleate that may cause skin reactions.

This medicine contains fragrance (perfume oil, chypre) with allergens that may cause allergic reactions. For the complete allergen’s com­position, see section 6.1

4.5 Interaction with other medicinal products and other forms of interaction

Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.

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.

Eye disorders

Not known (frequency cannot be estimated from the available data):

Vision, blurred (see also section 4.4).

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

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 nonhalogenated 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.

6.1 List of excipients

2 Octyldodecanol

Castor oil, refined

Castor oil, hydrogenated

Macrogol-400-monoricinoleate

Perfume oil, chypre

Perfume oil, chypre contains the following allergens: 3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one; benzyl alcohol; benzyl benzoate; benzyl cinnamate; benzyl salicylate; cinnamal; cinnamyl alcohol; citral; citronellol; coumarin; eugenol; farnesol; geraniol; hydroxycitronella; isoeugenol; linalool; limonene (d-and l-limonene); oak moss (see section 4.4).

6.2 Incompatibilities

None known.

6.3

2 years

6.4 Special precautions for storage

Do not store above 25oC

6.5 Nature and contents of container

Collapsible aluminium tubes of 30 g with white HDPE screw caps and a separate rectal polypropylene applicator with a PE cap.

6.6 Special precautions for disposal

Keep out of the reach of children.

Use of the applicator:

Do not use the applicator if damaged. Screw the applicator completely on the tube. After each use, clean externally the applicator with a paper towel, then remove the remaining product in the applicator with a cotton swab and clean it again with a paper towel. Rinse the applicator under warm water for about 1 minute and dry externally the applicator with towel paper.

7 MARKETING AUTHORISATION HOLDER

Karo Pharma AB

Box 16184

103 24 Stockholm

Sweden

8 MARKETING AUTHORISATION NUMBER(S)

PL 50567/0005

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION

Date of first authorisation: 02 June 1964

Date of latest renewal: 28 October 1999

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