Faktu

Suppository: Cream-coloured to reddish-brown suppositories of identical appearance and with an intact surface.
1 suppository contains 100 mg of Policresulen and 2.5 mg of Cinchocaine hydrochloride.
Ointment: White to brownish ointment. The principal active component of Policresulen + Cinchocaine HCl (Faktu) is a polycondensation product consisting of methylene-bridged metacresolsulfonic acids buffered for proctologic use. In addition, it contains the local anesthetic cinchocaine hydrochloride.
1 g of ointment contains 50 mg of Policresulen and 10 mg of Cinchocaine hydrochloride.

Antihemorrhoidal.
Pharmacology: Pharmacodynamics: Mechanism of Action: Policresulen + Cinchocaine HCl (Faktu) has multiple actions predominantly attributable to Policresulen. It arrests to bleeding by coagulating blood protein and inducing the muscle fibers of small blood vessels to contract. The coagulating properties and the acid pH brings out the antimicrobial action against Escherichia coli, staphylococci, and streptococci, Pseudomonas aeruginosa, Proteus vulgaris, candida and other bacteria. Thus, the wound is protected against infection. In vitro periodic investigations on the different pathogens have revealed no change in sensitivity. The coagulation of necrotic and pathologically altered tissues cleans the wound and promotes wound healing. Cinchocaine has local anesthetic action which relieves pain and itching. The main active ingredient of Policresulen, is a high molecular organic acid with selective protein-precipitating properties. The pH of the Policresulen and Cinchocaine hydrochloride product is 4.0. Policresulen coagulates necrotic or pathologically altered tissue in anorectal conditions and expels this from the body. Healthy tissue surrounding the affected area is unaffected. Policresulen acts as a local haemostatic to coagulate blood protein and cause a contraction of the small blood vessels. This means that bleeding in the anal canal and in the perianal region is quickly controlled. At the same time, policresulen induces reactive hyperaemization at the affected area, thereby stimulating healing and promoting reepithelialization. In addition, the antiseptic effect of policresulen prevents secondary infection of the anorectal wound region. In this way, inflammation is prevented. Weeping, a common accompanying symptom of haemorrhoids, is prevented by the astringent properties of policresulen. Cinchocaine, a proven topical anaesthetic, reversibly and locally restricts the sensitivity and capacity of sensory nerves. Pain and itching, common symptoms of anorectal conditions are thus eliminated. The combination of the two ingredients policresulen and cinchocaine rapidly eliminates bleeding, pain, itching and weeping, prevents inflammation and promotes the regeneration of the affected tissue.
Pharmacokinetics: General pharmacokinetics: After oral administration of policresulen about 10% of the dose was absorbed in animal experiments. The absorption after local intravaginal or intrarectal application was slightly less with 6-8%. Absorbed policresulen constituents were eliminated with a half-life between 4 and 5 hours. No biotransformation was detected. Intravenously administered policresulen was eliminated mainly via urine, and less than 10% were excreted through feces, whereas orally or rectally administered drug was excreted mainly in the feces due to its low absorption, and less than 10% were eliminated via urine. After dermal application of cinchocaine, 15.3% of the applied dose was absorbed by rats within 12 h. The terminal elimination half-life of the unchanged drug was 12 min after intraperitoneal administration in rats. The drug is largely metabolised by different species and excreted in urine and bile in nearly equal amounts by rats. Because of these findings and based on long-term human experience only minor amounts are expected to be absorbed after local administration on skin and mucous membranes.

For hemorrhoids and other anorectal disorders (external and internal hemorrhoids associated with inflammatory symptoms or superficial bleeding, anal fissures, anal rhagades, incised or spontaneously perforated perianal thrombosis, anitis, cryptitis, anal eczema, pruritus and postoperative wound treatment following proctological operations).

Ointment: Apply 2 to 3 times daily to the affected areas and rub in if possible. When used rectally, apply after defecation.
Suppositories: Insert one suppository into the rectum 2 to 3 times daily (in the morning and evening and, if necessary, during the day) after defecation.
When symptoms have improved, treatment can be continued with one suppository per day.
Pediatric Patients: The use and safety in children and adolescents have not been studied to date.
Method of Administration: For ointment: For rectal application use the applicator provided. Screw the applicator onto the tube and insert into the anus. Gently squeeze the tube so that the ointment flows uniformly through the holes in the side of the applicator and onto the affected area. Slightly turning the tube helps to spread the ointment.
For suppositories: Insert into the rectum.

Unknown.
Drug Abuse and Dependence: Policresulen + cinchocaine hydrochloride has no known potential for abuse or dependence.

Policresulen + Cinchocaine HCl (Faktu) must not be used in patients with hypersensitivity to policresulen, cinchocaine hydrochloride or to any of the excipients.
Policresulen + Cinchocaine HCl (Faktu) suppositories contain soya lecithin. If the patient is allergic to soya or peanut, do not use Policresulen + Cinchocaine HCl (Faktu) suppositories.
Like any drug, it is generally not advisable to use Policresulen + Cinchocaine HCl (Faktu) during the first trimester of pregnancy.
This product is not intended for use in children.

Effects on Ability to Drive and Use Machines: Effects on the ability to drive and use machines have not been investigated. Based on the adverse-effect profile, no or negligible influence is expected.

Pregnancy: During pregnancy, policresulen must only be used when strictly indicated, with due assessment of the risks to the mother and child. Studies in animals with policresulen have not shown any evidence of malformations. No nonclinical data on cinchocaine-mediated effects on reproduction are available.
No studies are available on the risk of use during human pregnancy.
Lactation: It is not known whether the active ingredient passes into milk.
Fertility: Policresulen did not impair female fertility in rats. No nonclinical data on cinchocaine-mediated effects on fertility are available.

Clinical Trials/Post-Marketing: The following convention is used for the classification of the frequency of an adverse drug reaction (ADR) and is based on the Council for International Organizations of Medical Sciences (CIOMS) guidelines: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). (See table.)

Click on icon to see table/diagram/image

Mild local discomfort such as burning or itching associated with the therapeutic mechanism of preparation may sometimes be noted at the beginning of treatment, usually subsiding rapidly. Discontinuation of medication, therefore, is generally not required.
Very Rare: Anaphylactic reactions, including skin reactions (angioneurotic oedema, laryngeal oedema, urticaria and others) and generalized reactions up to anaphylactic shock.

Coadministration of other topical medications and policresulen, cinchocaine hydrochloride may lead to local interaction with other drugs. Hence, other topical medications should not be used in the affected region during the application of the policresulen, cinchocaine hydrochloride.

Store at temperatures not exceeding 25°C.

Anorectal Preparations

C05AX03 - other preparations, combinations ; Belongs to the class of other agents used topically in the treatment of hemorrhoids and anal fissures.

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