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GYNO-PEVARYL ONCE 150MG VAGINAL PESSARY

Active substance(s): ECONAZOLE NITRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Gyno-Pevaryl® Once
150mg vaginal pessary
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 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 ‘GynoPevaryl 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 are caused by fungi and
yeasts such as thrush (Candida).

2 What you need to know 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 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 pharmacist before using GynoPevaryl Once.

Warnings and precautions

Talk to your doctor or pharmacist before using
Gyno-Pevaryl Once if:
• You are using any other treatment for your
vagina.
Talk to your doctor about using another type
of contraception while you are using this
medicine if:
• You are using a ‘barrier’ method of
contraception. This includes condoms
or diaphragms. This is because Gyno-Pevaryl
Once can damage the rubber and stop
them working properly
• You are using a spermicidal contraceptive

Other medicines and Gyno-Pevaryl
Once

Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. This includes medicines that you
buy without a prescription or herbal medicines.
In particular tell your doctor if you are taking:
• Medicines to thin the blood (anticoagulants)
such as warfarin or acenocoumarol.
Your doctor may check that the anticoagulant
is working properly

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think
you may be pregnant or are planning to have
a baby, ask your doctor or pharmacist for
advice before taking this medicine.
You may still be able to use Gyno-Pevaryl
Once if your doctor thinks you need to.

Driving and using machines

This medicine is not likely to affect you being
able to drive or use any tools or machines.

3 How to use Gyno-Pevaryl Once
Always use this medicine exactly as your
doctor has told you. Check with your doctor
or pharmacist if you are not sure.

Using the pessary

• Always wash your hands thoroughly before
using this medicine. This is particularly
important if you are pregnant
• Use the pessary just before going to bed.
This helps it to stay in place
• Do not swallow the pessary

Inserting the pessary with the
applicator

• Remove the pessary from the plastic packet
using the easy open tab
• Pull the plunger of the applicator out until
it sticks

© J-C 2014

3 How to use Gyno-Pevaryl Once (continued)
• Gently push the pessary into the cup.
Do not force it because it might stick

• Push the plunger to release the pessary
• Remove the applicator and dispose of it
safely in your household waste

If you swallow Gyno-Pevaryl Once
• Lie down with your knees bent and spread
apart. Insert the applicator high into your
vagina, pessary first

If the pessary is eaten or swallowed talk
to a doctor or go to the nearest hospital
casualty department straight away.
If you have any further questions on the
use of this product, ask your doctor
or pharmacist.

4 Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets them.

Stop using Gyno-Pevaryl Once and
tell your doctor straight away if
you notice the following. You may
need urgent medical treatment.

• Sudden swelling of the face or throat.
Hives (also known as nettle rash or urticaria),
severe irritation, reddening or blistering of
your skin. These may be signs of a severe
allergic reaction (affects fewer than 1 in
10,000 people)

Other side effects:

Common side effects (affects more than
1 in 100 patients)
• Itchy skin
• Burning sensation (skin)

Uncommon side effects (affects fewer than
1 in 100 patients)
• Rash
• Burning sensation (around or inside the vagina)
Rare side effects (affects fewer than 1 in
1000 patients)
• Reddening of your skin
Frequency unknown:
• Pain, swelling or irritation (around or inside
the vagina)
• Inflammation of the skin (contact dermatitis)
• Peeling, flaky skin

Reporting of side effects

If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can
also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide
more information on the safety of this medicine.

5 How to store Gyno-Pevaryl Once
Keep this medicine out of the sight and reach
of children. Store in the original container.
Do not store above 30°C. Keep away from
heat and sunlight.
Do not use Gyno-Pevaryl Once:
• After the expiry date which is stated on the
label. The expiry date refers to the last day
of that month
• If the plastic packet is broken or missing
• If the pessary is not light beige in colour

Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you
no longer use. These measures will help
protect the environment.

6 Contents of the pack and other information
What Gyno-Pevaryl Once contains

The active substance is econazole nitrate.
The pessary contains 150mg econazole nitrate.
The other ingredients are polygel, colloidal
silicon dioxide, Witepsol H 19, Wecobee FS,
stearyl heptanoate.

Manufacturer:
Janssen Pharmaceutica NV, Turnhoutseweg 30,
B-2340 Beerse, Belgium
OR
McGregor Cory Ltd, Middleton Close,
Banbury, Oxfordshire OX16 4RS, UK

What Gyno-Pevaryl Once looks like
and contents of the pack

For information in large
print, tape, CD or Braille,
telephone 0800 7318450.

Marketing Authorisation Holder:
Janssen-Cilag Ltd., 50-100 Holmers Farm
Way, High Wycombe, Bucks, HP12 4EG, UK.

This leaflet was last revised in August 2014.

Gyno-Pevaryl Once comes in a plastic strip
containing one pessary. It is torpedo-shaped
and light beige in colour.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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