Condyline

País: Nueva Zelanda

Idioma: inglés

Fuente: Medsafe (Medicines Safety Authority)

Ingredientes activos:

Podophyllotoxin 5 mg/mL; Podophyllotoxin 5 mg/mL

Disponible desde:

AFT Pharmaceuticals Ltd

Designación común internacional (DCI):

Podophyllotoxin 5 mg/mL

Dosis:

5 mg/mL

formulario farmacéutico:

Topical solution

Composición:

Active: Podophyllotoxin 5 mg/mL Excipient: Ethanol Lactic acid Purified water Sodium lactate Active: Podophyllotoxin 5 mg/mL Excipient: Ethanol Lactic acid Purified water Sodium lactate

Unidades en paquete:

Bottle, 3.5 mL

clase:

Prescription

tipo de receta:

Prescription

Fabricado por:

Zydus Takeda Healthcare Pvt. Ltd.

indicaciones terapéuticas:

Condyline topical solution is indicated for external condylomata acuminata.

Resumen del producto:

Package - Contents - Shelf Life: Bottle, - 3.5 mL - 36 months from date of manufacture stored at or below 25°C

Fecha de autorización:

1988-10-20

Información para el usuario

1
CONSUMER MEDICINE INFORMATION
CONDYLINE
®
0.5% (5MG/ML)
PODOPHYLLOTOXIN TOPICAL SOLUTION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Condyline
®
solution. It does not contain all
the available information. It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you using this
medicine against the expected benefits.
Use Condyline
®
as instructed. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK
YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET. You may need to read it again.
WHAT CONDYLINE
® IS USED FOR
Condyline
®
contains a solution of podophyllotoxin, a plant extract, which is used
to treat
anogenital warts (warts around the anus, on the penis in males, or
outside the vagina in
females) in adults.
This medicine works by stopping the warts growing and causing the
warts to shrivel.
This medicine belongs to a group of medicines which stops cells
dividing. It is for EXTERNAL
USE only. It must not be swallowed.
Your doctor may have prescribed Condyline
®
for another reason. Ask your doctor why this
medicine has been prescribed for you.
This medicine is available only with a doctor’s prescription.
BEFORE YOU USE CONDYLINE
®
_WHEN YOU MUST NOT USE CONDYLINE_
_®_
_ _
DO NOT USE THIS MEDICINE IF YOU:
•
ARE PREGNANT OR BREASTFEEDING
•
ARE CURRENTLY USING OTHER PREPARATIONS CONTAINING PODOPHYLLOTOXIN
•
HAVE AN ALLERGY TO ANY MEDICINE CONTAINING PODOPHYLLOTOXIN
•
HAVE AN ALLERGY TO ANY OF THE OTHER INGREDIENTS LISTED AT THE END OF
THIS LEAFLET (see
PRODUCT DESCRIPTION). Some of the symptoms of an allergic reaction may
include
shortness of breath, wheezing or difficulty breathing; swelling of the
face, lips, tongue or
other parts of the body; rash, itching or hives on the skin.
DO NOT USE CONDYLINE
® TO TREAT CHILDREN.
2
IF YOU ARE NOT SURE WHETHER YOU SHOULD START USING THIS MEDICINE, TALK
TO YOUR DOCTOR.
_BEFORE YOU START TO USE CONDYLINE_
_®_
_ _
TELL YOUR DOCTOR IF:
•
YOU ARE PRE

Ficha técnica

1
NEW ZEALAND DATA SHEET
1.
CONDYLINE
®
Topical solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Podophyllotoxin 5mg/ml solution
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Condyline
®
is a topical solution which contains podophyllotoxin 5mg/ml as its
active ingredient in an
ethanol solution. A clear, colourless solution with a smell of
alcohol.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
External condylomata acuminata in adults.
4.2 DOSAGE AND METHOD OF ADMINISTRATION
Apply Condyline
®
carefully on the condylomata with one of the plastic stick applicators
enclosed in
the package, and allow to dry.
Take care that the preparation does not come into contact with the
healthy skin.
Condyline
®
should be applied twice a day for 3 consecutive days. This treatment
can be repeated
every week, for a maximum of 5 successive weeks.
4.3 CONTRAINDICATIONS
Condyline
®
should not to be used during pregnancy and lactation or in children.
Condyline
®
may not
be used in combination with any other podophyllin preparation because
of possible symptoms of
toxicity.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Condyline
®
should be allowed to dry thoroughly after application in order to
avoid inadvertent
spreading. This particularly applies to condylomata which are
localized on the preputium.
Condyline
®
should not come into contact with the eyes as it will cause very
severe irritation. Should
this accidentally happen rinse the eyes immediately and for a long
time with water.
Local irritation and/or ulceration of healthy mucosa of the skin in
the vicinity or at the base of the
condylomata through inadvertent contact with Condyline
®
can be prevented by applying a protective
layer of neutral cream, vaseline or zinc ointment on the surrounding
skin prior to treatment.
Application of this preparation on relatively large mucosal surfaces
may lead to general reactions and
should be avoided. In addition (as has been mentioned under
DOSAGE AND METHOD OF ADMINISTRATION
)
each contact of the sub