Summary of Product Characteristics Updated 01-Dec-2020 | Karo Pharma AB
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.
For the symptomatic relief of haemorrhoids and pruritus ani in the short term (5-7 days).
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).
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.
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 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
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.
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.
As with all topical steroids, there is a risk of developing skin atrophy following extensive therapy.
Allergic skin reactions may occur.
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.
Topical agents for the treatment of hemorrhoids and anal fissures - C05AA04.
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 quick relief of painful and pruritic symptoms.
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, fluocortolone 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.
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.
Castor oil, refined
Castor oil, hydrogenated
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).
Do not store above 25°C.
Collapsible aluminium tubes of 30 g with white HDPE screw caps and a separate rectal polypropylene applicator with a PE cap.
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.
Karo Pharma AB
103 24 Stockholm
Date of first authorisation: 02 June 1964
Date of latest renewal: 28 October 1999