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GYNO-PEVARYL ONCE 150MG VAGINAL PESSARY

Active substance(s): ECONAZOLE NITRATE / ECONAZOLE NITRATE / ECONAZOLE NITRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

© J-C 2016
GB - P1608291A

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
‘Gyno-Pevaryl Once’ in this leaflet.
Gyno-Pevaryl Once is a solid, torpedoshaped 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
Gyno-Pevaryl 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 GynoPevaryl 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.

• Lie down with your knees bent and spread
apart. Insert the applicator high into your
vagina, pessary first

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
• Gently push the pessary into the cup.
Do not force it because it might stick

P1608291A.pdf - Page 1 of 3 - March 7, 2017 - 12:07:33

• 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
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.

© J-C 2016

GB - P1608291A

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

Rare side effects (affects fewer than 1 in
1000 patients)
• Reddening of your skin

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

Frequency unknown:
• Pain, swelling or irritation (around or inside
the vagina)
• Inflammation of the skin (contact dermatitis)
• Peeling, flaky skin

• 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)

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.

Uncommon side effects (affects fewer than
1 in 100 patients)
• Rash
• Burning sensation (around or inside the
vagina)

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.

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

Gyno-Pevaryl Once comes in a plastic strip
containing one pessary. It is torpedo-shaped
and light beige in colour.
Marketing Authorisation Holder:
Janssen-Cilag Ltd., 50-100 Holmers Farm
Way, High Wycombe, Bucks, HP12 4EG, UK.

Manufacturer:
Lusomedicamenta - Sociedade, Técnica
Farmacêutica, S.A.,
Estrada Consiglieri Pedroso, 69-B,
Queluz de Baixo,
2730-055 Barcarena,
Portugal
OR
Janssen Pharmaceutica NV,
Turnhoutseweg 30,
B-2340 Beerse, Belgium

For information in large
print, tape, CD or
Braille, telephone
0800 7318450.
This leaflet was last revised in November
2016.

P1608291A.pdf - Page 2 of 3 - March 7, 2017 - 12:07:34

Expand Transcript

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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