Gyno-Pevaryl 1% cream

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Econazole nitrate

Saadav alates:

Karo Healthcare UK Ltd

ATC kood:

D01AC03

INN (Rahvusvaheline Nimetus):

Econazole nitrate

Annus:

10mg/1gram

Ravimvorm:

Vaginal cream

Manustamisviis:

Vaginal

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 07020200

Infovoldik

- 1 -
PACKAGE LEAFLET: INFORMATION FOR THE USER
GYNO-PEVARYL
®
CREAM
Econazole nitrate
Gyno-Pevaryl is a registered trademark
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 Gyno-Pevaryl is and what it is used for
2. What you need to know before you use Gyno-Pevaryl
3. How to use Gyno-Pevaryl
4. Possible side effects
5. How to store Gyno-Pevaryl
6. Contents of the pack and other information
1. WHAT GYNO-PEVARYL IS AND WHAT IT IS USED FOR
The name of your medicine is Gyno-Pevaryl cream. It is called
‘Gyno-Pevaryl’ in
this leaflet.
Gyno-Pevaryl contains a medicine called econazole nitrate. This
belongs to a
group of medicines called ‘antifungals’.
Gyno-Pevaryl is used for infections caused by fungi and yeasts such as
thrush
(_Candida_).
•
In women, it is used for infections of the vagina and the skin around
the
vagina
•
In men, it is used for infections of the penis and the skin around the
penis
Your sexual partner should also be treated. They may have the
infection even
if they have no symptoms. If they are not treated, they may give the
infection
back to you.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE GYNO-PEVARYL
DO NOT USE GYNO-PEVARYL IF:
•
You are allergic to econazole nitrate or any of the other ingredients
of this
medicine (listed in section 6)
•
You are allergic to any other medicine used to treat thrush or other
fungal
infections
•
You are under 16 years old
Do not use this medicine if any of the above applies to you. If you
are not sure,
talk to your doctor or pharmacis

Toote omadused

OBJECT 1
GYNO-PEVARYL CREAM
Summary of Product Characteristics Updated 09-Aug-2016 | Janssen-Cilag
Ltd
1. Name of the medicinal product
Gyno-Pevaryl Cream
2. Qualitative and quantitative composition
Each 100 g of cream contains 1 g econazole nitrate (1% w/w).
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Vaginal cream.
4. Clinical particulars
4.1 Therapeutic indications
For the treatment of mycotic vulvovaginitis and mycotic balanitis.
4.2 Posology and method of administration
Route of Administration
For vaginal/penile administration.
Females: One applicator full (approximately 5 g) intravaginally once
daily at night for not less than 14
days. The cream should also be applied to the vulva. The full 14 days
treatment should be carried out
even if the symptoms of vaginal itching or discharge have disappeared.
In pregnant women, it is recommended that administration takes place
without the use of an applicator, or
is performed by a physician. Pregnant women should thoroughly wash
their hands before self-
administering Gyno-Pevaryl cream.
Males: Apply the cream to the penis, including under the foreskin,
once daily for not less than 14 days.
The sexual partner should also be treated.
4.3 Contraindications
Hypersensitivity to any imidazole preparation, other vaginal
antifungal products or to any ingredients of
Gyno-Pevaryl cream.
4.4 Special warnings and precautions for use
Not for ophthalmic or oral use.
Hypersensitivity has rarely been recorded; if it should occur
administration should be discontinued.
Contact between contraceptive diaphragms or condoms and this product
must be avoided since the rubber
may be damaged by the preparation.
Patients using spermicidal contraceptives should consult their
physician since any local vaginal treatment
may inactivate the spermicidal contraceptive (see section 4.5).
Gyno-Pevaryl Cream should not be used in conjunction with other
internal or external treatment of the
genitalia.
Gyno-Pevaryl Cream is not indicated for use in children under the age
of 16 y