Condyline 5 mg/ml Cutaneous Solution

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Podophyllotoxin

Disponible desde:

Takeda Products Ireland Ltd

Código ATC:

D06BB; D06BB04

Designación común internacional (DCI):

Podophyllotoxin

Dosis:

5 milligram(s)/millilitre

formulario farmacéutico:

Cutaneous solution

tipo de receta:

Product subject to prescription which may be renewed (B)

Área terapéutica:

Antivirals; podophyllotoxin

Estado de Autorización:

Not marketed

Fecha de autorización:

1988-04-11

Información para el usuario

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CONDYLINE 5 MG/ML 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 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. 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
of this 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 of age.
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 on

Ficha técnica

Health Products Regulatory Authority
31 May 2021
CRN00C2QM
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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Condyline 5 mg/ml Cutaneous Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Condyline Solution contains 5 mg/ml podophyllotoxin in bottles of 3.5
ml.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous Solution.
Each pack of Condyline Solution consists of a 3.5 ml clear,
colourless, alcoholic cutaneous solution of 5 mg/ml 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
Apply twice daily for three consecutive 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.
_SPECIAL PATIENT POPULATIONS_
_ _
ELDERLY
No dose adjustment is needed.
PAEDIATRIC POPULATION
Not recommended in children under 12 years of age.
4.3 CONTRAINDICATIONS
Condyline solution is contraindicated in patients with the following
conditions/diseases:
- hypersensitivity to the active substance or to any of the excipients
listed in 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 direct medical supervision.
Health Products Regulatory Authority
31 May 2021
CRN00C2QM
Page 2 of 5
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