Faktu: Package Leaflet: Information For The User

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PACKAGE LEAFLET: INFORMATION FOR THE USER

FAKTU
(50 mg + 10 mg) / g ointment

POLICRESULEN, CINCHOCAINE

• This leaflet is a copy of the Summary of Product Characteristics and Patient Information
Leaflet for a medicine, which outlines the conditions under which the medicine should be
used and information on its known safety • The product information may be updated
several times within its shelf life, and there could be differences between the version of
information shown here and other information in the public domain or in the package
insert • This leaflet may not contain all the information about the medicine or the
information may not be the most up to date version for this product • If you have any
questions or are not sure about anything, ask your doctor or pharmacist • Read all of this
leaflet carefully before you start taking this medicine because it contains important
information for you.

• Keep this leaflet • You may need to read it again • If you have any further questions, ask
your doctor or pharmacist • This medicine has been prescribed for you only • Do not pass
it on to others • It may harm them, even if their signs of illness are the same as yours • If
you get any side effects, talk to your doctor or pharmacist • This includes any possible side
effects not listed in this leaflet •

What is in this leaflet?


1. What FAKTU tablets is and what it is used for
2. Before you take FAKTU
3. How to take use FAKTU
4. Possible side effects
5. How to store FAKTU
6. Further information

1. WHAT FAKTU IS AND WHAT IT IS USED FOR

FAKTU is used for the treatment of Hemorrhoids, particularly when accompanied by inflammatory symptoms
and bleeding, anal fissures, anal rhagades (minor injury of the lining of the colon) anal pruritus, anal eczema,
caused by anorectal conditions, wound treatment after proctological operations.

2.BEFORE YOU TAKE FAKTU

Do not take FAKTU


•If you are allergic to Policresulen, cinchocaine, or any of the other ingredients of this medicine

Taking other medicines


Interactions unknown.

Pregnancy and breastfeeding


During pregnancy policresulen must be used only when strictly indicated, with due assessment of the risks to
the mother and child. Studies in animals have not yielded any evidence of malformations. No studies are

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available on the risk of use during pregnancy in humans. It is not known whether the active ingredient passes
into milk.

3. HOW TO TAKE FAKTU

Always take FAKTU exactly as you are told by your doctor. If you are unsure, check with your doctor or
pharmacist.
Unless otherwise prescribed, the following dosage scheme applies. Please follow these instructions, otherwise
there is a risk that the drug may not act properly!

How many you should use and how often?


You should apply the ointment to the affected area 2 to 3 times a day.

When and how to use the ointment?


If possible, ointment should be rubbed. For rectal use, ointment is applied after a bowel movement. For use in
the rectum use the enclosed applicator / cannula. Attach the applicator / cannula to the tube and insert it into
the anus. Gently squeeze the tube so that the ointment evenly passes through the holes along the applicator /
cannula to the affected area. Gently rotate the tube to facilitate the distribution of fat.

How long should I use FAKTU ointment?


The length of treatment is determined by the doctor.

If you take more FAKTU than you should


If you have used too much FAKTU ointment, tell your doctor.

If you forget to take FAKTU


If you miss a dose, apply the next dose at the usual time and continue to use the medicine as instructed by a
doctor.

Talk to your doctor or pharmacist if you have any additional questions.

4. POSSIBLE SIDE EFFECTS

Like all medicines, FAKTU can cause side effects, although not everybody gets them.
The occasional discomfort (e.g. burning or itching) is caused by the active ingredient and in most cases
disappears after a short time. There have been isolated cases of allergic contact sensitivity, manifested as
inflammatory reddening of the skin (erythema) with the formation of vesicles (papules) accompanied by
persistent itching (pruritus).

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.

Countermeasures
If you experience undesirable effects, stop treatment and consult your doctor.

5. HOW TO STORE FAKTU

Keep out of the reach and sight of children.

Do not store above 25 ºC.

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Do not use FAKTU after the expiry date which is stated on the on the tube and the folding box, 5 years from the
date of manufacture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose
of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What FAKTU contains

The active substances are polikrezulen and cinchocaine hydrochloride. 1 gram of ointment contains 50 mg of
polikrezulena and 10 mg of cinchocaine hydrochloride.

Other ingredients: cetomacrogol, butylated hydroxytoluene, edetic acid, disodium edetate (Ph. Eur.), Colloidal
silica, macrogol 300, macrogol 400, macrogol 1500, sodium hydroxide, water.

What FAKTU looks like and contents of the pack

FAKTU ointment is white to light brown.


Packaging
20 grams of ointment in a tube. Tube with applicator in cardboard packaging.

Regime of dispensing
The medicine is issued without a doctor's prescription.

Manufacturer
NYCOMED GMBH
BYK-GULDEN-STRAΒE 2, KONSTANZ, GERMANY

Manufacturer of the medicinal product


NYCOMED GMBH
PRODUCTION SITE IN SINGEN
ROBERT BOSCH STRASSE 8, SINGEN, GERMANY

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