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WARTICON

Active substance(s): PODOPHYLLOTOXIN

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Package leaflet: Information for the user

0.15% w/w C R E A M
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 should only be applied
to warts on the outside (external) skin.
Avoid applying Warticon Cream to healthy skin surrounding the
wart.
Avoid getting Warticon Cream in your eyes as it may cause
irritation. If you accidentally get Warticon Cream in your eyes
rinse immediately with plenty of water and see a doctor.
Do not put a dressing (such as a plaster) over the top of the area
treated with Warticon Cream.
➔ Check with your doctor if you think any of these may apply to
you.
What to avoid while using Warticon Cream
• It is advisable to avoid sex during treatment with
Warticon Cream. You should wait until your warts have gone
and your skin has healed
• Genital warts are contagious. You can give them to, or get
them from, a sexual partner.
➔ If you do have sex, you must use a condom to help prevent the
spread of genital warts and to protect your partner from coming
into contact with podophyllotoxin (since it is irritant).
Other medicines and Warticon Cream
Tell your doctor or pharmacist if you are using any other
medicines, have recently used, or might use other medicines.
This includes medicines bought without a prescription.
Children
The use of Warticon Cream is not recommended for children under
18 years as use in this age has not been established.

Pregnancy and breast-feeding
Warticon Cream is not recommended for use during pregnancy.
• Tell your doctor if you are pregnant or planning to become
pregnant
• Use a reliable method of contraception to prevent pregnancy,
while you are using Warticon Cream
• If you do become pregnant during treatment with
Warticon Cream, tell your doctor.
Breast-feeding is not recommended during treatment with
Warticon Cream. Discuss with your doctor whether you choose to
breast-feed or to use podophyllotoxin.
Important information about some of the ingredients in
Warticon Cream
Warticon Cream contains butyl hydroxyanisole (E320), sorbic acid,
stearyl and cetyl alcohols which may cause local skin reactions
(e.g.contact dermatitis). Butyl hydroxyanisole may also cause
irritation to the eyes and mucous membranes.
Warticon Cream also contains methyl and propyl
parahydroxybenzoates, E218 and E216, which may cause allergic
reactions (possibly delayed).
3. How to use Warticon Cream
Always use Warticon Cream exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
Using Warticon Cream
• Apply Warticon Cream twice a day, in the morning and evening
(every 12 hours) for 3 days.
• Do not apply any cream for the next 4 days. This completes
one treatment course.
• When you apply Warticon cream, after two or three days you
may notice mild irritation of the areas treated. This shows that
Warticon Cream is starting to work. However, Warticon cream
can cause severe skin reactions. If this occurs, stop using
Warticon Cream and seek medical attention. See ‘Possible side
effects’ in section 4 for further information.
• If you still have any warts remaining 7 days after you started
using the cream, repeat the treatment course (twice a day for
3 days followed by 4 days where you do not use the cream).
• A maximum of 4 treatment courses may be applied.
• If any warts remain after 4 treatment courses consult your
doctor.
How to apply Warticon Cream
1. Wash the affected areas with soap and water. Dry the area
gently with a clean towel.
2. It may help you to view the area to be treated, if you sit down
and place the mirror as shown in the diagram below.
3. Using a fingertip, apply Warticon Cream to cover each wart.
Use only enough cream to cover each wart.
4. Rub the cream into the wart. Be careful not to get the cream
onto healthy skin. If this happens, wash the cream off with
soap and water.
5. Wash your hands thoroughly.
6. Make sure you have screwed the lid back on tightly.

If you get Warticon Cream in your eyes or if you swallow it
• If you get Warticon Cream in your eye, rinse the eye thoroughly
with water and talk to your doctor.
7337J

8.5pt
9.5pt
100%
8.5pt
7337J

GSK-IRL-Sligo-IESLI

Ireland-IRL; Stiefel; United Kingdom-GBR

Warticon Cream

N/A

S8LFLT-2D

Offset

White paper

Yes

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• 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 more information on the safety of
this medicine.
United Kingdom
the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2;
Tel: +353 1 6764971; Fax: +353 1 6762517;
Website: www.hpra.ie; E-mail: medsafety@hpra.ie

Manufacturer:
Stiefel Laboratories (Ireland) Ltd.
Finisklin Business Park, Sligo, Ireland
Other formats:
To listen to or request a copy of this leaflet in Braille, large
print or audio please call, free of charge:

0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name
Warticon 0.15% w/w Cream
Reference number 19494/0073
This is a service provided by the Royal National Institute of
Blind People.
This medicinal product is authorised in the Member States of
the EEA under the following names:
Finland: Wartec 0.15% emulsiovoide
Ireland: Warticon 0.15% w/w Cream
Italy: Wartec
Spain: Wartec Crema
The Netherlands: Wartec, crème 1,5 mg/g
United Kingdom: Warticon 0.15% w/w Cream
This leaflet was last revised in July 2015.
PL 19494/0073
PA 1077/131/1
Warticon is a registered trade mark of Stiefel Laboratories Inc.
© 2015 Stiefel Laboratories, Inc. All rights reserved.

5. How to store Warticon Cream
• Keep this medicine out of the sight and reach of children.
• Do not use Warticon Cream after the expiry date which is
stated on the tube and carton (after “EXP:”). The expiry date
refers to the last day of that month.
• Warticon Cream does not require any special storage
conditions.
• Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no
longer required. These measures will help protect the
environment.
6. Contents of the pack and other information
What Warticon Cream contains
• The active substance is podophyllotoxin 0.15% w/w
(1.5 miligram per gram of Warticon Cream).
• The other ingredients are: purified water, methyl
parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216),
sorbic acid, phosphoric acid, stearyl alcohol, cetyl alcohol,
isopropyl myristate, liquid paraffin, trigylcerides – medium
chain, butyl hydroxyanisole (E320), macrogol – 7 stearyl ether,
macrogol – 10 stearyl ether.
What Warticon Cream looks like and contents of the pack
Warticon Cream comes in tubes containing 5 grams of a white
cream.
A small mirror is provided in each pack.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
GlaxoSmithKline UK Limited
Stockley Park West, Uxbridge,
Middlesex UB11 1BT, UK
GlaxoSmithKline (Ireland) Limited
12 Riverwalk,
Citywest Business Campus,
Dublin 24, Ireland.

7337J

8.5pt
9.5pt
100%
8.5pt
7337J

GSK-IRL-Sligo-IESLI

Ireland-IRL; Stiefel; United Kingdom-GBR

Warticon Cream

N/A

S8LFLT-2D

Offset

White paper

Yes

K

1

0

0

1

Page 2 of 2

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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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