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GYNO-PEVARYL 150MG VAGINAL PESSARIES

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

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PACKAGE LEAFLET: INFORMATION FOR THE USER

© J-C 2016 GB-IE - P1608288A R

Gyno-Pevaryl® 150mg vaginal pessaries
Econazole nitrate
Gyno-Pevaryl is a registered trademark

Read all of this leaŲ
Ųet carefully
before you start using this
medicine because it contains
important information for you.

• Keep this leaŲŲet. 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 eŮ
Ůects, talk to your
doctor or pharmacist. This includes any
possible side eŮ
Ůects not listed in this
leaŲŲet. See section 4.

What is in this leaŲ
Ųet
1 What Gyno-Pevaryl 150 pessaries are
and what they are used for
2 What you need to know before you
use Gyno-Pevaryl 150 pessaries
3 How to use Gyno-Pevaryl 150 pessaries
4 Possible side eŮ
Ůects
5 How to store Gyno-Pevaryl
150 pessaries
6 Contents of the pack and other
information

1 What Gyno-Pevaryl 150 pessaries are and what
they are used for
The name of your medicine is Gyno-Pevaryl
150mg vaginal pessaries. They are called
‘Gyno-Pevaryl 150 pessaries' in this leaŲŲet.
This pack contains 3 pessaries.
Gyno-Pevaryl 150 pessaries are solid, torpedoshaped pessaries (vaginal suppositories).
When inserted into the vagina they release

a medicine called econazole nitrate. This
belongs to a group of medicines called
‘antifungals’.
Gyno-Pevaryl 150 pessaries are 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 150 pessaries
Do not use Gyno-Pevaryl 150
pessaries 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 150 pessaries.

Warnings and precautions

Talk to your doctor or pharmacist before
using Gyno-Pevaryl 150 pessaries if:
• You are using 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 150 pessaries can damage
the rubber and stop them working properly.
• You are using a spermicidal contraceptive

Other medicines and Gyno-Pevaryl
150 pessaries

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 using this medicine.
You may still be able to use Gyno-Pevaryl 150
pessaries if your doctor thinks you need to.

3 How to use Gyno-Pevaryl 150 pessaries
Always use this medicine exactly as your
doctor has told you. Check with your doctor
or pharmacist if you are not sure.

Using the pessaries

• Always wash your hands thoroughly before
using this medicine. This is particularly
important if you are pregnant

• The full course is 3 pessaries
• Use one pessary each day, for 3 days
• Use the pessary just before going to bed.
This helps it to stay in place
• Do not swallow the pessary

© J-C 2016

GB-IE - P1608288A V

3 How to use Gyno-Pevaryl 150 pessaries (continued)
Inserting the pessary

• Tear down the groove between two
individually wrapped pessaries
• Remove one pessary from its plastic
packet using the easy open tab (ŰŰgure 1)
• Lie down with your knees bent and spread
apart
• Push the pessary with your foreŰŰnger as far
as you can into your vagina (ŰŰgure 2)
1

2

When to stop using Gyno-Pevaryl
150 pessaries
Use the full course of 3 pessaries. Do this,
even if the soreness, itching and discharge
go away before the end of the course.

If you swallow Gyno-Pevaryl 150
pessaries

If a 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 eŮ
Ůects
Like all medicines, this medicine can cause
side eŮ
Ůects, although not everybody gets them.
Stop using Gyno-Pevaryl 150 pessaries
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 (aŮ
Ůects fewer than
1 in 10,000 people)

Other side eŮ
Ůects:

Common side eŮ
Ůects (aŮ
Ůects more than
1 in 100 patients)
• Itchy skin
• Burning sensation (skin)
Uncommon side eŮ
Ůects (aŮ
Ůects fewer than
1 in 100 patients)
• Rash
• Burning sensation (around or inside the
vagina)

Rare side eŮ
Ůects (aŮ
Ůects fewer than
1 in 1000 patients)
• Reddening of your skin
Frequency unknown:
• Pain, swelling or irritation (around or inside
the vagina)
• InŲŲammation of the skin (contact dermatitis)
• Peeling, Ųaky skin

Reporting of side eŮ
Ůects

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

5 How to store Gyno-Pevaryl 150 pessaries
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 150 pessaries:
• 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 pessaries are not white to oŮ
Ů-white
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 150 pessaries
contain

The active substance is econazole nitrate.
Each pessary contains 150 mg econazole
nitrate.
The other ingredients are Wecobee M and
Wecobee FS.

What Gyno-Pevaryl 150 pessaries
looks like and contents of the pack
Gyno-Pevaryl 150 pessaries come in a
plastic strip containing 3 pessaries. The
pessaries are torpedo-shaped and white to

Ů-white 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 leaŲŲet was last revised in September
October
2016.

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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