Gynoxin 2% vaginal cream

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Fenticonazole nitrate

Commercializzato da:

Recordati Pharmaceuticals Ltd

Codice ATC:

G01AF12

INN (Nome Internazionale):

Fenticonazole nitrate

Dosaggio:

20mg/1gram

Forma farmaceutica:

Vaginal cream

Via di somministrazione:

Vaginal

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 07020200; GTIN: 5391519920015

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GYNOXIN 2% VAGINAL CREAM
Fenticonazole nitrate
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 side effects, tell 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 Gynoxin 2% vaginal cream
is and what it is used for
2.
What you need to know before you use Gynoxin 2% vaginal cream
3.
How to use Gynoxin 2% vaginal cream
4.
Possible side effects
5.
How to store Gynoxin 2% vaginal cream
6.
Contents of the pack and other information
1.
WHAT GYNOXIN 2% VAGINAL CREAM IS AND WHAT IT IS USED FOR
Gynoxin 2% vaginal cream
contains fenticonazole nitrate as the active ingredient, which is an
anti-
fungal agent.
Gynoxin prevents the growth of certain types of fungi. It is
particularly effective against
_Candida _
_albicans_
, which causes thrush.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE GYNOXIN 2% VAGINAL CREAM
DO NOT USE GYNOXIN:

if you are allergic to fenticonazole or any of the other ingredients
(listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist if:
-
You are pregnant or breastfeeding (see section “Pregnancy,
breast-feeding and fertility”).
-
You are using a “barrier” method of contraception made of latex
(see section “Other medicines
and Gynoxin”). Consequently, you should use alternative precautions
while using this product.
-
You are using spermicides, intravaginal douches or other vaginal
products (see section “Other
medicines and Gynoxin vaginal cream).
-
You experience any irritation or sensitivity to the product.
-
Your symptoms are not reduced within one week or in case of seve

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Gynoxin 2% vaginal cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Gynoxin contains 20 mg of the active ingredient fenticonazole nitrate
in 1 g of cream.
Excipients with known effect: propylene glycol, wool fat hydrogenated,
cetyl alcohol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Vaginal cream
White homogenous cream
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Treatment of vulvovaginal candidiasis.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Route of Administration:
Intravaginal
Adults:
One applicator full (about 5 g) is administered into the vagina by a
re-usable
applicator (morning and evening for three days).
Gynoxin is not greasy, does not soil and can easily be removed with
water.
_ _
Paediatric population
The safety and efficacy of Gynoxin in children under 16 years have not
been
established. No data are available. The dose recommendation for
children aged 16
years or above is the same as for adults.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Some excipients of the vaginal cream (wool fat hydrogenated, cetyl
alcohol) may
cause local skin reactions (e.g. contact dermatitis). This medicine
contains 50 mg of
propylene glycol in 1 g of cream.
Should local sensitisation or an allergic reaction occur, the
treatment should be
discontinued.
The patients should be advised to consult their physician if:
-
the symptoms have not been relieved within one week
-
in case of recurrent symptoms (more than 2 infections in the last 6
months)
-
previous history of a sexually transmitted disease or exposure to
partner with
sexually transmitted disease
-
age over 60
-
known hypersensitivity to imidazoles or other vaginal antifungal
products
-
any abnormal or irregular vaginal bleeding
-
any blood staining of a vaginal discharge
-
any vulval or vaginal sore, ulcer or blisters
-
any associated lower abdominal pa