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GYNO-PEVARYL CREAM

Active substance(s): ECONAZOLE NITRATE

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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 pharmacist before using Gyno-Pevaryl.
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Warnings and precautions
Talk to your doctor or pharmacist before using this medicine if:
• You are using any other treatment for your genitalia (vagina or penis)
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 can damage the rubber and
stop them working properly.
• You are using a spermicidal contraceptive
Other medicines and Gyno-Pevaryl
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 for advice before taking this medicine.
You may still be able to use Gyno-Pevaryl 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.
Gyno Pevaryl contains:
• Benzoic acid (E210) and butylated hydroxyanisole (E320). These can irritate
your skin, eyes, eyelids, mouth and nostrils if they come into contact with
them

3. How to use Gyno-Pevaryl
Always use this medicine exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.
Women - using the cream
• Always wash your hands thoroughly before using this medicine. This is
particularly important if you are pregnant
• If you are pregnant, you should use Gyno-Pevaryl without an applicator
• Use the cream once a day just before going to bed
• The cream is used inside and outside of your vagina
• Place an applicatorful (about 5 g) of cream into your vagina
• Also lightly cover your vagina and the skin around your vagina with a thin,
even layer of cream
• Keep using the cream for 14 days
Gyno-Pevaryl does not include a vaginal applicator. It can be bought
separately at the chemist.
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Men - using the cream
• Use the cream once a day
• Lightly cover the penis and the skin around the penis (including under your
foreskin if you have one) with a thin, even layer of cream
• Keep using the cream for 14 days
When to stop using Gyno-Pevaryl
Keep using the cream until the course is finished (14 days). Do this, even if the
soreness, itching and discharge go away before 14 days.
If you swallow Gyno-Pevaryl
If a large amount of cream 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 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.
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5. How to store Gyno-Pevaryl
Keep this medicine out of the sight and reach of children. Do not store above
25°C. Keep away from heat and sunlight.
Do not use Gyno-Pevaryl:
• After the expiry date which is stated on the label. The expiry date refers to
the last day of that month
• If the tube seal is broken or missing
• If the cream is not white in colour or has become runny (liquefied)
Medicines should not be disposed of via wastewater or household waste. Ask
your pharmacist how to dispose of medicines no longer required. These
measures will help protect the environment.

6. Contents of the pack and other information
What Gyno-Pevaryl contains
The active substance in Gyno-Pevaryl is econazole nitrate. The cream
contains 1% econazole nitrate.
The other ingredients are Tefose 63, labrafil M 1944 CS, mineral oil, butylated
hydroxyanisole (E320), benzoic acid (E210), purified water.
What Gyno-Pevaryl looks like and contents of the pack
The cream is white and comes in a 15 g or 30 g white and blue aluminium tube.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation is held by:
JANSSEN-CILAG LTD, 50-100 Holmers Farm Way, High Wycombe, Bucks
HP12 4EG, UK
Gyno-Pevaryl is made by:
Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
OR
McGregor Cory Ltd, Middleton Close, Banbury, Oxfordshire OX16 4RS, UK.

For information in large print, tape, CD or Braille, telephone
0800 7318450.
This leaflet was last revised in February 2014.

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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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