Vaniqa
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
26-09-2022
Fachinformation
(SPC)
26-09-2022
Öffentlichen Beurteilungsberichts
(PAR)
15-04-2013
Wirkstoff:
Eflornithine
Verfügbar ab:
Almirall, S.A.
ATC-Code:
D11AX
INN (Internationale Bezeichnung):
eflornithine
Therapiegruppe:
Other dermatological preparations
Therapiebereich:
Hirsutism
Anwendungsgebiete:
Treatment of facial hirsutism in women.
Produktbesonderheiten:
Revision: 23
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2001-03-19
Gebrauchsinformation
15
B. PACKAGE LEAFLET
16
PACKAGE LEAFLET: INFORMATION FOR THE USER
VANIQA 11.5% CREAM
eflornithine
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 symptoms 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.
WHAT IS IN THIS LEAFLET
1.
What Vaniqa is and what it is used for
2.
What you need to know before you use Vaniqa
3.
How to use Vaniqa
4.
Possible side effects
5.
How to store Vaniqa
6.
Contents of the pack and other information
1.
WHAT VANIQA IS AND WHAT IT IS USED FOR
Vaniqa contains the active substance eflornithine. Eflornithine slows
down the growth of hair through
its effect on a specific enzyme (a protein in the body involved in the
production of hair).
Vaniqa is used to reduce the growth of excessive hair (Hirsutism) on
the face of women older than
18 years of age. 2.
WHAT YOU NEED TO KNOW BEFORE YOU USE VANIQA
DO NOT USE VANIQA
•
if you are allergic to eflornithine or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Vaniqa.
•
tell your doctor of any other medical problems you may be experiencing
(especially related to
your kidneys or liver).
•
if you are unsure whether or not to use this medicine, contact your
doctor or pharmacist for
advice.
Excessive growth of hair may be a result of underlying diseases. Talk
to your doctor if you suffer from
polycystic ovary syndrome (PCOS) or specific hormone producing
tumours, or if you take medicines
that can induce hair growth, e.g. cyclosporine (following organ
transplants), glucocorticoids (e.g.
against rheumatic or allergic diseases), minoxidil
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Vaniqa 11.5% cream
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 INDICATIONS
Treatment of facial hirsutism 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.
_Hepatic/renal impairment:_
the safety and efficacy of Vaniqa in women with hepatic or renal
impairment have not
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