WARTICON Cutaneous Solution 0.5%w/v %w/v
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
PODOPHYLLOTOXIN
Available from:
Stiefel Laboratories (U.K.) Ltd.
Dosage:
0.5%w/v %w/v
Pharmaceutical form:
Cutaneous Solution
Authorization date:
1993-11-17
Summary of Product characteristics
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Warticon Solution 0.5% w/v Cutaneous Solution.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Podophyllotoxin 0.5% w/v
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Cutaneous solution.
A blue coloured solution for cutaneous use.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of anogenital warts (Condylomata Acuminata)
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
The following doses and schedules are applicable to adults and
the elderly.
The affected area should be thoroughly washed with soap and
water and dried prior to application.
Using the applicator provided, the warts should be painted
twice daily for three days.
The treated area should be allowed to dry.
Residual warts should be treated with
further courses of twice daily applications for 3
days after a 4 day treatment-free
period. Normally 3 - 4 treatment courses are sufficient.
The majority of patients will not require in excess of 30
loops for each application, however, a maximum of 50 loops
per application (equivalent to 250µl of Warticon solution) may
be applied. Where lesions are greater in area than 4cm
2
,
it is recommended
that treatment takes place under the direct supervision
of medical staff.
4.3 CONTRAINDICATIONS
Open wounds following surgical procedures should not be treated
with podophyllotoxin. Hypersensitivity to
podophyllotoxin is a contraindication.
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Be careful to apply Warticon solution to the warts only; if any
spreads onto healthy skin it should be washed off with
soap and water.
Avoid contact with the eyes. Following
accidental spillage the skin should be washed well with soap and
water. In the
IRISH MEDICINES BOARD
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