Gyno-Pevaryl Once 150 mg Vaginal Pessary

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ECONAZOLE NITRATE

Available from:

Janssen Sciences Ireland UC

ATC code:

G01AF; G01AF05

INN (International Name):

ECONAZOLE NITRATE

Dosage:

150 milligram(s)

Pharmaceutical form:

Pessary

Therapeutic area:

Imidazole derivatives; econazole

Authorization status:

Marketed

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
GYNO-PEVARYL
® ONCE 150MG VAGINAL PESSARY
Econazole nitrate
Gyno-Pevaryl is a trademark
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to use
Gyno-Pevaryl Once 150mg vaginal pessary carefully to get the best
results
from it.

Keep this leaflet. You may need to read it again

Ask your pharmacist if you need more information or advice

You must contact a doctor if
-
your symptoms worsen or do not improve after 7 days
-
you have more than 1 of these infections within 6 months

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 Once is and what it is used for
2 What you need to know before you use Gyno-Pevaryl Once
3 How to use Gyno-Pevaryl Once
4 Possible side effects
5 How to store Gyno-Pevaryl Once
6 Contents of the pack and other information
1 WHAT GYNO-PEVARYL ONCE IS AND WHAT IT IS USED FOR
The name of your medicine is Gyno-Pevaryl Once 150mg vaginal pessary.
It is
called ‘Gyno-Pevaryl Once’ in this leaflet.
Gyno-Pevaryl Once is a solid, torpedo-shaped pessary (vaginal
suppository).
When inserted into the vagina, it releases a medicine called econazole
nitrate.
This belongs to a group of medicines called ‘antifungals’.
Gyno-Pevaryl Once is used for infections of the vagina and the skin
around the
vagina. The infections, such as thrush (_Candida_), are caused by
fungi and
yeasts.
2 BEFORE YOU USE GYNO-PEVARYL ONCE
DO NOT USE GYNO-PEVARYL ONCE 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 believe or suspect that your symptoms are not due to thrush_ _
(_Candida_)
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
You think you may have

Summary of Product characteristics

Health Products Regulatory Authority
18 November 2019
CRN009GF8
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gyno-Pevaryl Once 150 mg Vaginal Pessary
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pessary contains 150 mg econazole nitrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pessary
The pessary is light beige and torpedo-shaped
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of vaginitis due to _Candida albicans_ and other
yeasts.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For vaginal use.
One pessary to be inserted deep into the vagina.
In pregnant women, it is recommended that administration takes place
without the use of the applicator, or is performed by a
physician. Pregnant women should thoroughly wash their hands before
self-administering Gyno-Pevaryl Once 150mg vaginal
pessaries.
4.3 CONTRAINDICATIONS
Hypersensitivity to any imidazole preparation other vaginal antifungal
products or to any other ingredient of Gyno-Pevaryl
Once 150mg vaginal pessaries.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For intravaginal use only.
This preparation is not for oral use.
Gyno-Pevaryl should be used only by those women who have symptoms of
candidosis.
If they believe or suspect that they might have some other sexually
transmitted disease, either as well as, or instead of,
candidosis, they should consult their own doctor.
The preparation should not be used if they are pregnant, or think that
they might be pregnant, without first consulting a
doctor.
It should not be used by those under 16 years of age or over 60 years
without first consulting a doctor.
The woman should see her doctor if, after treatment:
- There is not complete relief of symptoms within 7 days.
- There is recurrence of symptoms within 4 weeks of treatment.
Health Products Regulatory Authority
18 November 2019
CRN009GF8
Page 2 of 5
- She has more than one episode of infection within a 6 month period,
even if they completely resolve with treatment.
-Adverse effects s