CONDYLINE 0.5 % W/V CUTANEOUS SOLUTION

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PODOPHYLLOTOXIN

Available from:

Nycomed Danmark ApS

Dosage:

0.5% %w/v

Pharmaceutical form:

Cutaneous Solution

Authorization date:

1998-04-11

Summary of Product characteristics

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 (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.
CHILDREN
Not recommended.
4.3 CONTRAINDICATIONS
Podophyllotoxin is contraindicated in patients with the following conditions/diseases:
- known or suspected hypersensitivity to podophyllotoxin or any component of the
formulation;
- inflamed or bleeding lesions;
- open wounds following surgical procedures;
- in combination with other podophyllin containing preparations;
- pregnant or breast-feeding women;
- children under 12 years of age.
IRISH MEDICINES BOARD
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_Date Printed 09/03/2011_
_CRN 2095632_
_page number: 1_
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