Gynoxin 200 mg Vaginal Capsules

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Fenticonazole nitrate

Inapatikana kutoka:

Recordati Industria Chimica e Farmaceutica SpA

ATC kanuni:

G01AF; G01AF12

INN (Jina la Kimataifa):

Fenticonazole nitrate

Kipimo:

200 milligram(s)

Dawa fomu:

Vaginal capsule, soft

Dawa ya aina:

Product subject to prescription which may be renewed (B)

Eneo la matibabu:

Imidazole derivatives; fenticonazole

Idhini hali ya:

Not marketed

Idhini ya tarehe:

1992-02-24

Taarifa za kipeperushi

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GYNOXIN 200 MG VAGINAL CAPSULES
GYNOXIN 600 MG VAGINAL CAPSULES
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, 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 Gynoxin is and what it is used for
2. What you need to know before you use Gynoxin
3. How to use Gynoxin
4. Possible side effects
5.
How to store Gynoxin
6. Contents of the pack and other information
1.
WHAT GYNOXIN IS AND WHAT IT IS USED FOR
Gynoxin contains fenticonazole nitrate. Fenticonazole is an antifungal
agent. It slows the growth of
some types of fungi and kills some. It is particularly good at killing
Candia albicans. Candida is the
organism that causes thrush.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE GYNOXIN
DO NOT USE GYNOXIN:
-
if you are allergic to fenticonazole or any of the other ingredients
of this medicine (listed in section
6).
-
Gynoxin 600 mg vaginal capsules contains soya lecithin. If you are
allergic to peanut or soya, do
not use this medicinal product.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist if:
-
You are pregnant or breast-feeding (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”).
-
You experience any irritation or sensitivity to the product.
-
Your s

Tabia za bidhaa

Health Products Regulatory Authority
23 September 2020
CRN009277
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gynoxin 200 mg Vaginal Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vaginal capsule contains 200 mg of the active ingredient
fenticonazole nitrate.
Excipients with known effect: also includes ethyl parahydroxybenzoate
sodium (E215) 800 micrograms per vaginal capsule, and
sodium propyl parahydroxybenzoate (E217) 400 micrograms per vaginal
capsule.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Vaginal capsule, soft. (Vaginal capsule)
Ivory white, opaque, soft gelatin capsules.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the topical treatment of vulvo vaginal infections due to
superficial dermatophytes of _C. albicans_, sensitive to the drug.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Dosage
One 200 mg vaginal capsule at bedtime for 3 days or one 600 mg vaginal
capsule at bedtime once only.
If necessary treatment may be repeated after 3 days.
Administration
Intravaginal, inserted deeply into vagina.
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 capsules (parahydroxybenzoates) may
cause allergic reactions (possibly delayed).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