Faktu痔克妥

Faktu

Manufacturer:

Takeda

Distributor:

Zuellig
/
Firma Chun Cheong
Full Prescribing Info
Contents
Policresulen, cinchocaine hydrochloride.
Description
Ointment: 1 g ointment contains: Active substance: 50 mg policresulen, 10 mg cinchocaine hydrochloride.
Excipients: Macrogol 300, Macrogol 400, Antioxidant: Butylhydroxytoluene (E 321) and other excipients.
Suppository: 1 suppository contains: Active substance: 100 mg policresulen, 2.5 mg cinchocaine hydrochloride.
Excipients: Soy lecithin (made from genetically modified soy) and other excipients.
Indications/Uses
Hemorrhoids are usually associated with symptoms such as pain, bleeding, oozing and itching. The main active ingredient of Faktu, policresulen, only acts on diseased tissue in hemorrhoids, eliminating it while leaving healthy tissue intact. Wound surfaces heal over, while small blood vessels constrict and close. This very rapidly stops bleeding, and oozing and stinging disappear. It also increases blood flow, which accelerates the healing process. The bactericidal effect of Faktu prevents colonization with germs, preventing or eliminating inflammation. Cinchocaine, a topical anesthetic agent, reduces pain and itching. Faktu ointments/suppositories may only be used if prescribed.
Dosage/Direction for Use
The safety and use of Faktu in children and adolescents have not been tested thus far. Faktu must not be used in children under 12 years of age.
Do not change the prescribed dosage. Monitor if the effect of the medicine is too weak or too strong.
Ointment: Adults: Unless otherwise directed, apply the ointment to affected areas 2 to 3 times daily and massage, if possible, in the rectum after a bowel movement.
To introduce the ointment in the rectum, use the special cannula (dispenser) provided.
Screw the dispenser onto the tube and insert into the anus. Squeeze the tube gently to ensure even flow of Faktu ointment to affected areas through the lateral perforations. Rotate the tube slightly to ensure even distribution of Faktu ointment.
Suppository: Adults: Unless otherwise directed, introduce one suppository into the rectum 2 to 3 times daily after a bowel movement. After improvement of the symptoms, treatment may be continued with one suppository daily.
Contraindications
Faktu must not be used in cases of hypersensitivity to the active substances policresulen and cinchocaine and some local anesthetic medicines unless expressly permitted by the doctor.
Faktu must not be used in children under 12 years of age.
Suppository: Faktu contains soy lecithin, which can cause allergic reactions. Faktu must not be used in case of hypersensitivity to soy or peanuts (cross allergy).
Special Precautions
If allergic reactions occur, treatment should be discontinued, and patients must be advised. During treatment with Faktu, patients should not use any other medicinal products at the same location. Patients must be advised to inform their doctor or pharmacist if they have any other illnesses, if they have allergies, or if they are taking or using any other medicines (including any that they have purchased themselves).
Regular bowel movements should be ensured. In addition to sufficient fluids, this requires a varied diet that should contain a lot of fiber, but only a few hard-to-digest fats and no hot spices. Anal hygiene is particularly important in case of hemorrhoids. After a bowel movement, start by carefully wiping the anus with soft, absorbent toilet paper and then clean again with a damp cloth.
Use In Pregnancy & Lactation
There are no clinical data on the use of Faktu in pregnant women. Therefore, Faktu may only be used during pregnancy if strictly necessary and unless prescribed.
It is not known whether the active ingredients of Faktu are excreted in human milk. The use of Faktu should therefore be avoided during breast-feeding.
Side Effects
The following side effects may occur when using Faktu.
Occasional abnormal sensations (e.g. burning sensation or itching) are caused by the active substance and usually disappear after a short time.
In isolated cases, allergic contact dermatitis (eczema) may occur. This may manifest as redness, inflammation and blistering of the skin associated with prolonged itching. In such cases, treatment should be discontinued, and patients must be advised.
Allergic reactions (e.g. swelling of the face and throat, hives) have been reported in isolated cases. In such cases, treatment should be discontinued, and patients must be advised.
Side effects should be reported. This particularly includes any side effects not previously listed.
Caution For Usage
Possible fluctuations in the color of the ointment/suppositories and the appearance of light spots (fat bloom) on the suppositories are harmless and have no impact on efficacy.
Storage
Do not store above 25°C.
MIMS Class
Anorectal Preparations
ATC Classification
C05AD04 - cinchocaine ; Belongs to the class of local anesthetics. Used in the topical treatment of hemorrhoids and anal fissures.
Presentation/Packing
Form
Faktu oint
Packing/Price
(w/ dispenser) 20 g x 1's
Form
Faktu supp
Packing/Price
10's;120's
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