VANIQA

Country: Iżrael

Lingwa: Ingliż

Sors: Ministry of Health

Ingredjent attiv:

EFLORNITHINE AS HYDROCHLORIDE MONOHYDRATE

Disponibbli minn:

MEDISON PHARMA LTD

Kodiċi ATC:

P01CX03

Għamla farmaċewtika:

CREAM

Kompożizzjoni:

EFLORNITHINE AS HYDROCHLORIDE MONOHYDRATE 11.5 %W/W

Rotta amministrattiva:

TOPICAL

Tip ta 'preskrizzjoni:

Required

Manifatturat minn:

ALMIRALL S.A., SPAIN

Grupp terapewtiku:

EFLORNITHINE

Żona terapewtika:

EFLORNITHINE

Indikazzjonijiet terapewtiċi:

Vaniqa is indicated for the reduction of unwanted facial hair in women.

Data ta 'l-awtorizzazzjoni:

2022-02-28

Fuljett ta 'informazzjoni

Vaniqa-cream-11.5-PIL-ENG-D4-F
Vaniqa-PIL-0622-V1
1986
-
REGULATIONS (PREPARATIONS)
PHARMACISTS'
PATIENT LEAFLET IN ACCORDANCE WITH THE
This medicine is dispensed with a doctor’s prescription only
VANIQA CREAM 11.5% W/W
ACTIVE INGREDIENT: EFLORNITHINE 11.5% W/W (AS HYDROCHLORIDE
MONOHYDRATE
)
Inactive ingredients and allergens in the medicine - See section 2
"IMPORTANT
INFORMATION ABOUT SOME OF THIS MEDICINE’S INGREDIENTS" and section 6
"ADDITIONAL INFORMATION".
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains concise information about this medicine. If you have any
further questions,
consult your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It
may harm them, even if it seems to you that their medical condition is
similar to yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Vaniqa is indicated for reduction of excessive facial hair growth
(hirsutism) in women.
Vaniqa contains the active substance eflornithine. Eflornithine slows
down the growth
of hair by its effect on a specific enzyme (a protein in the body
involved in hair
production).
THERAPEUTIC GROUP: ornithine decarboxylase enzyme inhibitor.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to eflornithine or to any of the other
ingredients
in this medicine (see section 6).
•
You are pregnant or breastfeeding
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
BEFORE USING VANIQA, TELL YOUR DOCTOR OR PHARMACIST IF:
•
You suffer from other medical problems (particularly those related to
kidneys or
liver)
•
You suffer from polycystic ovary syndrome (PCOS)
•
You suffer from specific hormone producing tumors
•
You take medicines that can accelerate hair growth, e.g.:
o
cyclosporine (for prevention of transplant rejection)
o
glucocorticoids (for treatment of joint disease or allergies)
o
minoxidil (for treatment of hypertension)
o
phenobarbitone, phenytoin (for treatment of epilepsy)
o
hormone replacement therapy

Karatteristiċi tal-prodott

1
Physician Prescribing Information
1.
NAME OF THE MEDICINAL PRODUCT
Vaniqa
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains 115 mg of eflornithine (as hydrochloride
monohydrate).
Excipients with known effect:
Each gram of cream contains 47.2 mg of cetostearyl alcohol, 14.2 mg of
stearyl alcohol, 0.8 mg of
methyl parahydroxybenzoate and 0.32 mg of propyl parahydroxybenzoate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cream.
White to off white cream
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATION
Vaniqa is indicated for the reduction of unwanted facial hair in
women.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Vaniqa cream should be applied to the affected area twice daily, at
least eight hours apart. Efficacy has
only been demonstrated for affected areas of the face and under the
chin. Application should be
limited to these areas. Maximal applied doses used safely in clinical
trials were up to 30 grams per
month.
Improvement in the condition may be noticed within eight weeks of
starting treatment.
Continued treatment may result in further improvement and is necessary
to maintain beneficial effects.
The condition may return to pre-treatment levels within eight weeks
following discontinuation of
treatment.
Use should be discontinued if no beneficial effects are noticed within
four months of commencing
therapy.
Patients may need to continue to use a hair removal method (e.g.
shaving or plucking) in conjunction
with Vaniqa. In that case, the cream should be applied no sooner than
five minutes after shaving or use
of other hair removal methods, as increased stinging or burning may
otherwise occur.
Special population
_Elderly: _
(> 65 years) no dosage adjustment is necessary.
_Paediatric population: _
The safety and efficacy of Vaniqa in children aged 0 to 18 years has
not been established. There is no
data available to support use in this age group.
2
_Hepatic/renal impairment: _
the safety and efficacy of Vaniqa in women with hepatic or renal
impairment h