CONDYLINE 0.5% %w/v Cutaneous Solution

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

PODOPHYLLOTOXIN

Dostępny od:

Takeda UK Limited

Kod ATC:

D06BB04

INN (International Nazwa):

PODOPHYLLOTOXIN

Dawkowanie:

0.5% %w/v

Forma farmaceutyczna:

Cutaneous Solution

Typ recepty:

Product subject to prescription which may be renewed (B)

Dziedzina terapeutyczna:

Antivirals

Status autoryzacji:

Authorised

Data autoryzacji:

2016-09-30

Ulotka dla pacjenta

PACKAGE LEAFLET: INFORMATION FOR THE USER
CONDYLINE
® 0.5% W/V CUTANEOUS SOLUTION
PODOPHYLLOTOXIN
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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. 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. This includes any
possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Condyline is and what it is used for
2. What you need to know before you use Condyline
3. How to use Condyline
4. Possible side effects
5. How to store Condyline
6. Contents of the pack and other information
1. WHAT CONDYLINE IS AND WHAT IT IS USED FOR
Condyline is a solution containing the active ingredient
podophyllotoxin. This
is a plant extract which is used to treat small clusters of genital
warts in adults
known as condylomata acuminate. The warts are found on the penis or on
the
external female genital organs.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE CONDYLINE
DO NOT USE CONDYLINE
• if you are allergic to podophyllotoxin or any of the other
ingredients in the
medicine (listed in section 6 ‘Contents of the pack and other
information’)
• on skin that is bleeding or inflamed, or on open wounds after an
operation
• if you are already using any products containing podophyllin
• on healthy skin, eyes or your face as you may get severe
irritation
• if you are pregnant or breast-feeding
• if you are a child under 12 years.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Condyline:
• If you are female, this medicine should only be used under close
medical
supervision
• If you are male and have a lot of warts, covering an area larger
than 4 cm
2
(approximately the size of a postage stamp). You should only use this
medicine under close

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Condyline 0.5 % w/v Cutaneous Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Condyline Solution contains 0.5 % w/v podophyllotoxin in bottles of 3.5 ml.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous Solution
Each pack of Condyline Solution consists of 3.5 ml of a clear, colourless, alcoholic cutaneous solution of 0.5% w/v
podophyllotoxin.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the topical treatment of condylomata acuminata (warts) affecting the penis or the female external genitalia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
By topical administration.
ADULTS AND THE ELDERLY
Apply twice daily for three days directly to the warts. Allow to dry after treatment.
Use the applicator provided, applying not more than 50 applicators-full for each treatment.
This three day treatment may be repeated, if necessary, at weekly intervals for a maximum of five weeks of treatment.
Only a small area or number of warts should be treated at any one time.
CHILDREN
Not recommended in children under 12 years of age.
4.3 CONTRAINDICATIONS
Podophyllotoxin is contraindicated in patients with the following conditions/diseases:
-
known or suspected hypersensitivity to podophyllotoxin or to any of the other ingredients (see section 6.1);
-
inflamed or bleeding lesions;
-
open wounds following surgical procedures;
-
in combination with other podophyllin containing preparations;
-
pregnant or breast-feeding women (see section 4.6);
-
children under 12 years of age.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Avoid contact with healthy skin as well as the eyes and face because of severe irritation.
Lesions in the female and lesions greater than 4cm
2
in the male should be treated under direc