Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Phoenix Labs, Suite 12, Bunkilla Plaza, Bracetown Business Park, Clonee, County Meath, IRELAND
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Open or bleeding wounds.
Concomitant use with other podophyllotoxin containing preparations.
Where the area of treatment is greater than 4 cm², it is recommended that treatment takes place under the direct supervision of a healthcare professional.
Avoid applying the cream to warts occurring on mucous membranes of the genital area (including the urethra, rectum and vagina).
Avoid applying the cream to surrounding healthy tissue.
Avoid contact with eyes. Should the cream accidentally come into the eye, the eye should be thoroughly rinsed with water and medical advice sought.
Occlusive dressings should not be used on areas treated with the cream.
Local irritation may occur on the second or third day of application associated with the start of wart necrosis. In most cases, the reactions are mild. If severe local skin reactions occur (bleeding, swelling, excessive pain, burning, itching) the cream should be washed immediately from the treatment area with mild soap and water, treatment discontinued and the patient advised to seek medical advice.
Warticon Cream is not recommended during pregnancy or in women of childbearing potential not using contraception (see section 4.6).
It is recommended that patients refrain from sexual intercourse while treating warts with the cream and until the skin has healed. If a patient does engage in sexual intercourse, a condom must be used.
This cream contains:
None presently known.
There are limited data from the use of podophyllotoxin in pregnant women.
Although there is very limited systemic absorption from topically applied podophyllotoxin, antimitotic products such as podophyllotoxin are known to be embryotoxic. Warticon Cream is not recommended during pregnancy or in women of childbearing potential not using contraception.
There is insufficient information on the excretion of topically applied podophyllotoxin in human milk.
A risk to the newborns/infants cannot be excluded.
A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from podophyllotoxin therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
None presently known.
The frequency of adverse reactions listed below is defined using the following convention: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Very Common: Skin erosion, application site irritation (including erythema, pruritus, skin burning sensation)
The following adverse drug reactions are based on post-marketing reports. Since these reports are from a population of uncertain size and are subject to confounding factors, it is not possible to reliably estimate their frequency, however in reality systemic reactions are rarely seen.
Not known: Application site hypersensitivity
Not known: Skin ulcer, scab, skin discoloration, blister, dry skin
Not known: Application site pain, swelling, application site bleeding
Not known: Caustic injury, excoriation, wound secretion
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
Not applicable.
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