Warticon 0.15% w/w Cream

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Podophyllotoxin

Fáanlegur frá:

Phoenix Labs

ATC númer:

D06BB; D06BB04

INN (Alþjóðlegt nafn):

Podophyllotoxin

Skammtar:

0.15 percent weight/weight

Lyfjaform:

Cream

Gerð lyfseðils:

Product subject to prescription which may be renewed (B)

Lækningarsvæði:

Antivirals; podophyllotoxin

Leyfisstaða:

Marketed

Leyfisdagur:

1996-09-25

Upplýsingar fylgiseðill

June 2020
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
WARTICON
® 0.15% W/W CREAM
Podophyllotoxin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their
signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
_ _
WHAT IS IN THIS LEAFLET
1.
What Warticon Cream is and what it is used for
2.
What you need to know before you use Warticon Cream
3.
How to use Warticon Cream
4.
Possible side effects
5.
How to store Warticon Cream
6.
Contents of the pack and other information
1.
WHAT WARTICON CREAM IS AND WHAT IT IS USED FOR
Warticon Cream contains a medicine called podophyllotoxin. This is a
plant extract which belongs to a group
of medicines called ‘antivirals’.
Warticon Cream is used to treat genital warts. It is used for warts on
the penis in men or external
warts on the vagina in women.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE WARTICON CREAM
DO NOT USE WARTICON CREAM IF:

you are
ALLERGIC
(
_hypersensitive_
) to podophyllotoxin or any of the other ingredients of Warticon Cream
(listed in section 6)

your warts are on areas of broken/damaged or bleeding skin

you are already using another medicine containing podophyllotoxin.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using this medicine if:

your warts cover an area bigger than 4 centimetres (approximately the
size of a postage stamp). You may
need to have this medicine applied by a nurse/doctor in a clinic.
WARTICON CREAM IS ONLY TO BE USED ON THE AFFECTED SKIN.
Do not take Warticon Cream by mouth.
DO NOT APPLY WARTICON CREAM TO WARTS ON THE INSIDE OF THE PENIS,
VAGINA OR RECTUM.
Warticon Cream
shoul

Vara einkenni

Health Products Regulatory Authority
29 May 2020
CRN009JPJ
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Warticon 0.15% w/w Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Podophyllotoxin 1.5 mg/g (0.15% w/w).
Excipients with known effect:
Methyl parahydroxybenzoate (E218) 0.100 %w/w
Propyl parahydroxybenzoate (E216) 0.030 %w/w
Sorbic acid 0.120 %w/w
Stearyl alcohol 2.000 %w/w
Cetyl alcohol 2.000 %w/w
Butyl hydroxyanisole (BHA) (E320) 0.015 %w/w
FOR THE FULL LIST OF EXCIPIENTS, SEE SECTION 6.1
3 PHARMACEUTICAL FORM
Topical cream
A homogenous white cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_ROUTE OF ADMINISTRATION:_ _TOPICAL_
For the topical treatment of condylomata acuminata affecting the penis
or the external female genitalia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The affected area should be thoroughly washed with soap and water, and
dried prior to application.
Using a fingertip, the cream should be applied twice daily morning and
evening (every 12 hours) for 3 consecutive days using
only enough cream to just cover each wart. The cream should then be
withheld for the next 4 consecutive days.
Application to the surrounding normal tissue should be avoided.
Residual warts should be treated with further courses of twice daily
applications for three days at weekly intervals, if necessary
for a total of 4 weeks of treatment.
Hands should be washed thoroughly after application.
_Paediatric population_
The safety and efficacy of topical podophyllotoxin have not been
established in children under the age of 18.
4.3 CONTRAINDICATIONS
Health Products Regulatory Authority
29 May 2020
CRN009JPJ
Page 2 of 5
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.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Where the area of treatment is greater than 4 cm
2
, it is recommended that treatment takes place under the direct
supervision
of a healthcare