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COMPOUND PODOPHYLLIN PAINT B.P.

Active substance(s): PODOPHYLLUM RESIN

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Compound Podophyllin Paint B.P.

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Podophyllum Resin B.P. 15.0% w/v
For excipients, see 6.1.

3.

PHARMACEUTICAL FORM
Medicinal Paint

4.

CLINICAL PARTICULARS

4.1.

Therapeutic Indications
Anogenital and plantar warts

4.2.

Posology and Method of Administration
Plantar Warts
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
Not recommended.
Anogenital Warts
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.
Children
Not recommended.

4.3.

Contra-indications
Pregnancy and breastfeeding, facial warts, hypersensitivity to the product.

4.4.

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
reported.

4.5.

Interactions with other Medicaments and other forms of Interaction
None known.

4.6.

Pregnancy and Lactation
Not to be used in pregnancy or lactation.

4.7.

Effects on Ability to Drive and Use Machines
None known.

4.8.

Undesirable Effects

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.

4.9.

Overdose
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
mucous membranes.
Treatment is symptomatic and supportive with gastric lavage if needed. Anticonvulsant therapy may also be needed.

5.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic Properties
Not applicable.

5.2.

Pharmacokinetic Properties
Not applicable.

5.3.

Preclinical Safety Data
No relevant data.

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of Excipients
Compound Benzoin Tincture B.P.

6.2.

Incompatibilities
None known.

6.3.

Shelf Life
Three years.

6.4.

Special Precautions for Storage
This preparation is flammable. Keep away from naked flames.

6.5.

Nature and Contents of Container
Dispensing Pack
100 ml ribbed amber glass bottle with plastic cap
Patient Packs
5 ml and 10 ml amber glass bottles with a polypropylene, unwadded cap,
having a small spatula attached to the cap.

6.6.

Instruction for Use/Handling

No further data.

7.

MARKETING AUTHORISATION HOLDER
Wise Pharmaceuticals Limited
Hani Wells Business Park
Unit 7
Hardicker Street
Manchester
M19 2RB
United Kingdom.

8.

MARKETING AUTHORISATION NUMBER
PL 18374/0036

9.
DATE OF FIRST AUTHORISATION/RENEWAL OF
AUTHORISATION
14th April 2005

10

DATE OF REVISION OF THE TEXT
14/04/2005

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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