Warticon 0.5% solution

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Podophyllotoxin

Saadav alates:

Phoenix Labs Ltd

ATC kood:

D06BB04

INN (Rahvusvaheline Nimetus):

Podophyllotoxin

Annus:

5mg/1ml

Ravimvorm:

Cutaneous solution

Manustamisviis:

Cutaneous

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 13070000; GTIN: 5011091102387

Infovoldik

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
_ _
WARTICON
®
podophyllotoxin 0.5% w/v solution
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 only. 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 of 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 is and what it is used for
2.
What you need to know before you use Warticon
3.
How to use Warticon
4.
Possible side effects
5.
How to store Warticon
6.
Contents of the pack and other information
1.
WHAT WARTICON IS AND WHAT IT IS USED FOR
Warticon contains a medicine called podophyllotoxin. This is a plant
extract which belongs to a group of
medicines called ‘antivirals’.
Warticon is used to treat genital warts. It is used for warts on the
foreskin of the penis in men or external
warts on the vagina in females.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE WARTICON
DO NOT USE WARTICON IF:
•
you are allergic to podophyllotoxin or any of the other ingredients of
this medicine (listed in Section 6)
•
your warts are on areas of broken/damaged or bleeding skin
•
you are already using another medicine containing podophyllotoxin.
Do not use Warticon if any of the above apply to you. If you are not
sure, talk to your doctor or pharmacist
before using this medicine.
WARNINGS AND PRECAUTIONS
Talk to your doctor before using this Warticon if:
•
your warts cover an area larger than a 4 centimetre area
(approximately the size of a postage stamp). You
may need to have this medicine applied by your doctor or nurse in a
clinic.
WARTICON SOLUTION IS ONLY TO BE USED ON THE AFFECTED SKIN.
Don’t take Warticon Solution by mouth.
DON’T APPLY

Toote omadused

OBJECT 1
WARTICON SOLUTION
Summary of Product Characteristics Updated 21-Jan-2014 | Stiefel
1. Name of the medicinal product
Warticon
®
2. Qualitative and quantitative composition
Podophyllotoxin 5 mg/ml (0.5% w/v). The quality of podophyllotoxin
fulfills in-house specification.
3. Pharmaceutical form
Topical solution
4. Clinical particulars
4.1 Therapeutic indications
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.
Warticon should be applied twice daily, morning and evening (every 12
hours) for 3 consecutive days.
The treatment should then be withheld for the next 4 consecutive days.
Application to the surrounding normal tissue should be avoided.
If residual warts persist, this 3-day treatment may be repeated weekly
until there is no visible wart tissue
or for a total of 4 weeks of treatment.
Warticon solution should be applied to the warts with the applicator
supplied with the solution.
Due to the flammable nature of Warticon solution, patients should
avoid smoking or being near an open
flame during application and immediately after use.
The solution should be allowed to dry before opposing skin surfaces
are returned to their normal position.
_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 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 solution to warts occurring on mucous membranes of
the genital area (including the
urethra, rectum and vagina).
Avoid applying