Faktu痔克妥

Faktu

Manufacturer:

Takeda

Distributor:

Zuellig
/
Firma Chun Cheong
Full Prescribing Info
Contents
Policresulen (condensation product of metacresolsulfonic acid & methanal), cinchocaine HCl.
Description
Each gram of ointment contains policresulen 50 mg and cinchocaine HCl 10 mg.
Each suppository contains policresulen 100 mg and cinchocaine HCl 2.5 mg.
The essential active principle of Faktu is a polycondensation product consisting of methylene-bridged metacresolsulfonic acids buffered for proctologic use. In addition, it contains the local anesthetic cinchocaine HCl.
Action
Pharmacology: Policresulen exerts an elective action upon necrotic tissue without affecting healthy epithelium. Pathologically altered tissue is coagulated to be subsequently cast off. Bleedings are promptly controlled since a protective film is formed upon wound areas, consisting of denatured protein, and anal capillaries are constricted and closed. Oozing and itching are removed. Regeneration is further promoted by the hyperaemic effect induced by the preparation. The bactericidal effect of Faktu prevents or controls infections and inflammatory processes.
Cinchocaine has been shown to be useful in proctology, providing relief of pain and itching. Faktu quickly eliminates bleeding, oozing and itching in haemorrhoidal diseases and other anorectal disorders, prevents inflammation and infection and stimulates the regeneration of the affected tissue.
Toxicology: Animal trials have not produced any evidence relating to the possible toxicity of the drug.
Indications/Uses
Hemorrhoids, especially those associated with inflammatory conditions or bleeding; anal fissures and rhagades; anal pruritus; anal eczema due to anorectal disorders. Wound treatment following proctologic surgery.
Dosage/Direction for Use
Ointment: If not prescribed otherwise the ointment is applied 2-3 times daily to the affected area.
Suppository: Insert into the anal canal 2-3 times a day after defecation. After cessation of symptoms, treatment may be maintained with 1 supp daily.
Contraindications
Hypersensitivity to cinchocaine.
During pregnancy, Faktu should only be administered if absolutely necessary taking into account all the possible risks for mother and child.
Animal experiments have failed to indicate any malformations.
Studies on the risk of the application to pregnant women are not available. It is not known whether the active principle is excreted in the milk of nursing mothers.
Side Effects
Mild local discomfort such as burning or itching, associated with the therapeutic mechanism of the 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.
Caution For Usage
Rectal insertion of ointment requires prior evacuation of bowel.
For application of the ointment into the rectum use the enclosed dispenser.
Screw the dispenser onto the tube and insert into the rectum by gently squeezing the tube. Faktu ointment is evenly released through the side openings onto the affected areas. Gently rotating the tube ensures that the Faktu ointment is evenly spread.
Possible variations in the colour of the ointment are of no significance and do not influence the effectiveness.
Storage
Store below 25°C.
Store drug carefully and out of the reach of children.
ATC Classification
C05AD04 - cinchocaine ; Belongs to the class of local anesthetics. Used in the topical treatment of hemorrhoids and anal fissures.
Presentation/Packing
Oint 20 g (with dispenser). Supp 10's, 120's.
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