Warticon 0.15% cream

Ország: Egyesült Királyság

Nyelv: angol

Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktív összetevők:

Podophyllotoxin

Beszerezhető a:

CST Pharma Ltd

ATC-kód:

D06BB04

INN (nemzetközi neve):

Podophyllotoxin

Adagolás:

1.5mg/1gram

Gyógyszerészeti forma:

Cutaneous cream

Az alkalmazás módja:

Cutaneous

Osztály:

No Controlled Drug Status

Recept típusa:

Valid as a prescribable product

Termék összefoglaló:

BNF: 13070000; GTIN: 5055946806532

Betegtájékoztató

PATIENT INFORMATION LEAFLET
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.
The name of your medicine is Warticon 0.15% w/w Cream, but
will be referred to as Warticon Cream throughout the remainder
of the leaflet.
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 mout

Termékjellemzők

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