VANIQA eflornithine hydrochloride 139mg/g cream tube

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

eflornithine hydrochloride

Tilgjengelig fra:

A Menarini Australia Pty Ltd

INN (International Name):

Eflornithine hydrochloride

Autorisasjon status:

Registered

Informasjon til brukeren

VANIQA
®
_eflornithine_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET?
Read this leaflet carefully before
using VANIQA. This leaflet answers
some common questions about
VANIQA.
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 or pharmacist
has weighed the risks of you taking
VANIQA against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT IS VANIQA USED
FOR?
VANIQA is used to delay the
regrowth of unwanted facial hair in
women.
VANIQA interferes with an enzyme
found in the hair follicle of the skin
needed for hair growth. This results
in slower hair growth and shorter or
fewer hairs where VANIQA is
applied.
VANIQA does not permanently
remove hair or "cure" unwanted
facial hair. It is not a depilatory.
Your treatment program should
include continuation of any hair
removal techniques you are currently
using. VANIQA will help you
manage your condition.
Reduction of hair growth occurs
gradually. Don't be discouraged if
you see no immediate improvement.
Improvement may be seen as early as
after 4 to 8 weeks of treatment.
Improvement may take longer in
some people. If no improvement is
seen after 6 months of use, stop using
VANIQA. Clinical studies show that
in about 8 weeks after stopping
treatment with VANIQA, the hair
will return to the same condition as
before beginning treatment.
BEFORE YOU USE
VANIQA
_WHEN YOU MUST NOT USE IT_
DO NOT USE VANIQA IF YOU HAVE AN
ALLERGY TO VANIQA OR ANY OF THE
INGREDIENTS LISTED AT THE END OF THIS
LEAFLET.
DO NOT USE VANIQA IF YOU HAVE
SEVERE RENAL IMPAIRMENT, WHICH IS
A SERIOUS FORM OF KIDNEY DISEASE.
TALK TO YOUR DOCTOR IF YOU THINK
THIS MAY APPLY TO YOU.
DO NOT USE VANIQA ON A CHILD
UNDER 12 YEARS, UNLESS DIRECTED BY
THE CHILD’S DOCTOR.
The safety and effectiveness of
VANIQA in children less t

Preparatomtale

AUSTRALIAN PRODUCT INFORMATION –
VANIQA
® (EFLORNITHINE HYDROCHLORIDE) CREAM
VANIQA PI vA03-0
Page 1 of 8
1
NAME OF THE MEDICINE
Eflornithine hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
VANIQA cream contains 11.5% (115 mg/g) of eflornithine as eflornithine
hydrochloride
monohydrate (150 mg/g).
Excipients with known effect: Contains phenoxyethanol, methyl
hydroxybenzoate and propyl
hydroxybenzoate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
A smooth white to off-white cream.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
VANIQA delays the regrowth of unwanted facial hair, following
depilation, in women.
4.2 DOSE AND METHOD OF ADMINISTRATION
A thin layer of VANIQA should be applied to affected areas of the face
and adjacent involved
areas under the chin, and rubbed in thoroughly. The treated areas
should not be washed for
at least 4 hours. VANIQA should be used twice daily at least 8 hours
apart or as directed by
your doctor. The patient should continue to use hair removal
techniques as needed in
conjunction with VANIQA. (VANIQA should be applied at least 5 minutes
after hair removal.)
Cosmetics or sunscreens may be applied over treated areas after cream
has dried.
4.3 CONTRAINDICATIONS
VANIQA is contraindicated in patients with a history of sensitivity to
any components of the
preparation.
VANIQA is also contraindicated in patients with severe renal
impairment.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
VANIQA has only been studied on the face and adjacent involved areas
under the chin of
affected individuals. Usage should be limited to these areas of
involvement.
General
FOR EXTERNAL USE ONLY.
Discontinue use if hypersensitivity occurs.
Transient stinging or burning may occur when applied to abraded or
broken skin.
Information for patients
Patients using VANIQA should receive the following information and
instructions:
1.
This medication is not a depilatory, but rather appears to retard hair
growth to
improve the condition and the patient’s