Warticon 0.15% cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Podophyllotoxin

Available from:

Phoenix Labs Ltd

ATC code:

D06BB04

INN (International Name):

Podophyllotoxin

Dosage:

1.5mg/1gram

Pharmaceutical form:

Cutaneous cream

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13070000; GTIN: 5011091102400

Patient Information leaflet

PRODUCT NAME:
PIP CODE
SIZE
ITEM NUMBER
MARKET
PROD SITE
PH CODE
SCALE
COLOURS
DATE
VERSION
AMENDED BY
B.MCCOMBE
PHARMATECH
WartecCreme PIL
190 x 295mm
UK
100%
BLACK
05.07.18
1
•
If you accidentally get Warticon Cream in your mouth, rinse at
once with water.
•
If you accidentally swallow some of the cream see your doctor
or go to hospital straight away. Take the tube of cream with you
so that the doctor knows what you have swallowed.
If you use more Warticon Cream than you should
If you accidentally use too much cream, wash the cream from the
treatment area immediately and see a doctor.
If you forget to use Warticon Cream
Apply Warticon Cream as soon as you remember. If it is nearly time
for your next dose, wait until then. Do not use a double dose to
make up for a forgotten dose.
4. Possible side effects
Like all medicines, Warticon Cream can cause side effects,
although not everybody gets them.
If you experience any of the following serious side effects, stop
using Warticon Cream and seek medical attention:
•
severe burning, stinging, pain, bleeding, itching or swelling of
the treated skin. If these symptoms occur, wash Warticon
Cream from your skin with soap and water immediately.
➔ Contact your doctor as soon as possible.
Very common side effects
These may affect more than 1 in 10 people:
•
wearing away of the top layers of skin, application site irritation
including redness, itching, burning sensation
Other side effects with frequencies that cannot be estimated from
the available data include:
•
allergic reaction, pain, swelling, bleeding
•
damage to or loss of the top layer of skin, weeping wound
•
skin ulcer, scab, skin discoloration, dry skin, blister.
These effects can occur on the area of skin where you use the
cream.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly via (see details below). By
reporting
side effects you can help provide mo

Summary of Product characteristics

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
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
professional.
Avoid applying the cream to warts occurring on mucous membranes of the
genital area (including the urethra, rectum and vagi