COMPOUND PODOPHYLLIN PAINT B.P.
Active substance(s): PODOPHYLLUM RESIN
NAME OF THE MEDICINAL PRODUCT
Compound Podophyllin Paint B.P.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Podophyllum Resin B.P. 15.0% w/v
For excipients, see 6.1.
Anogenital and plantar warts
Posology and Method of Administration
Adults, the elderly and children over 5 years
Apply the minimum amount 2 or 3 times a week to affected areas, cover with
a piece of plaster and leave until the wart is soft; dead skin may be removed at
intervals by rubbing with a pumice stone. The product should be kept off
normal healthy skin and away from sensitive areas such as the eyes.
Children under 5 years
The product should be applied in a genitourinary clinic, or at a general
practitioner’s surgery after screening for other sexually transmitted diseases.
Adults and the elderly
Apply weekly to anogenital warts. Once applied the paint should be covered
with soft paraffin and left for a maximum of 6 hours after which it should be
washed off. During application care should be taken to avoid splashing the
surrounding skin, which must be covered with soft paraffin as a protection.
Pregnancy and breastfeeding, facial warts, hypersensitivity to the product.
Special Warnings and Precautions for Use
The paint is very irritant to the eyes and tender parts of the skin. Avoid using
on normal skin and broken skin.
Where there is a large number of warts, only a few should be treated at any
one time as severe toxicity caused by absorption of podophyllum has been
Interactions with other Medicaments and other forms of Interaction
Pregnancy and Lactation
Not to be used in pregnancy or lactation.
Effects on Ability to Drive and Use Machines
Poisoning due to systemic absorption has been reported – where there are a
large number of warts only a few should be treated at any one time.
May cause pain on application.
Podophyllum is strongly irritant to skin and mucous membranes and care must
be taken to avoid healthy tissue.
This preparation is for external use only. If ingested podophyllum has a
drastic purgative action and produces violent peristalsis. Podophyllum may
cause severe systemic toxicity after ingestion or extensive topical application.
The toxic effects of podophyllum are usually reversible but fatalities have
occurred. Symptoms of toxicity include nausea, vomiting, abdominal pain and
diarrhoea. Thrombocytopenia, leucopenia, renal failure and hepatotoxicity
have also been reported. Central effects are delayed in onset and prolonged in
duration and include acute psychotic reactions, hallucinations, confusion,
dizziness, stupor, ataxia, hypotonia, seizures and coma. EEG changes may
persist for several days. Peripheral and autonomic neuropathies develop later
and may result in paraesthesias, reduced reflexes, muscle weakness,
tachycardia, apnoea, orthostatic hypotension, paralytic ileus and urinary
retention. Neuropathy may improve but full recovery is unusual.
In addition to application to large areas with excessive amounts for prolonged
periods, the risk of toxicity is increased by the treatment of friable, bleeding or
recently biopsied warts and by inadvertent application to normal skin or
Treatment is symptomatic and supportive with gastric lavage if needed. Anticonvulsant therapy may also be needed.
Preclinical Safety Data
No relevant data.
List of Excipients
Compound Benzoin Tincture B.P.
Special Precautions for Storage
This preparation is flammable. Keep away from naked flames.
Nature and Contents of Container
100 ml ribbed amber glass bottle with plastic cap
5 ml and 10 ml amber glass bottles with a polypropylene, unwadded cap,
having a small spatula attached to the cap.
Instruction for Use/Handling
No further data.
MARKETING AUTHORISATION HOLDER
Wise Pharmaceuticals Limited
Hani Wells Business Park
MARKETING AUTHORISATION NUMBER
DATE OF FIRST AUTHORISATION/RENEWAL OF
14th April 2005
DATE OF REVISION OF THE TEXT