Active substance: ECONAZOLE NITRATE

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© J-C 2011

GB - 981328

Pevaryl® 1% topical cream
Econazole nitrate
Pevaryl is a registered trademark

Read all of this leaflet carefully
before you start using this medicine.

• 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. Do
not pass it on to others. It may harm them,
even if their symptoms are the same as yours
• If you get side effects and they become serious
or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist

In this leaflet

1 What Pevaryl is and what it is used for
2 Before you use Pevaryl
3 How to use Pevaryl
4 Possible side effects
5 How to store Pevaryl
6 Further information

1 What Pevaryl is and what it is used for
The name of your medicine is Pevaryl topical
cream. It is called ‘Pevaryl’ in this leaflet.

Pevaryl is used for skin infections caused by
fungi, yeasts and moulds.

Pevaryl contains a medicine called econazole
nitrate. This belongs to a group of medicines
called ‘antifungals’.

2 Before you use Pevaryl
Do not use Pevaryl if:

• You are allergic to anything in Pevaryl (listed in
section 6 below)
Do not use this medicine if this applies to you.
If you are not sure, talk to your doctor or
pharmacist before using Pevaryl.

Take special care with Pevaryl

• Talk to your doctor before using this medicine if
you have inflamed, red dry and scaly skin
• Keep this medicine away from your eyes and
mouth. If you get any cream in your eyes, rinse
with water straight away. Keep your eyes open
when you rinse

Taking other medicines

Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines. This includes medicines that you buy
without a prescription or herbal medicines.

Pregnancy and breast-feeding

Please tell your doctor before using Pevaryl if you
are pregnant, think you may be pregnant or might
become pregnant or if you are breast-feeding.
You may still be able to use Pevaryl if your
doctor thinks you need to.
Ask your doctor or pharmacist for advice before
taking any medicine if you are pregnant or

Driving and using machines

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

Important information about some of
the ingredients of Pevaryl
• The cream 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

In particular tell your doctor if you are taking:
• Medicines to thin the blood (anticoagulants)
such as warfarin or acenocoumarol. Your doctor
will need to check that the anticoagulant is
working properly

3 How to use 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.

981328.pdf - Page 1 of 3 - April 13, 2011 - 12:36:31

Skin infections

• Use the cream twice a day
• Rub the cream gently into the affected skin
• Keep the affected area clean and dry

© J-C 2011

GB - 981328

3 How to use Pevaryl (continued)
Nail infections

• Use the cream once a day
• Cover the affected area completely with a
• Keep the affected area clean and dry

When to stop using Pevaryl

If you swallow 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.

Keep using the cream until the infection has
completely healed.

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

Stop using Pevaryl and tell your
doctor straight away if you notice the
• Severe irritation or reddening of the skin, or
other signs of allergy during the first few days
of treatment. This only happens in a small
number of people
• Swelling of the face, lips, mouth, tongue or
throat which may cause difficulty in swallowing
or breathing.
• Skin rash or hives (also known as nettle rash
or urticaria)
• Peeling or blistering of the skin

Other side effects:
Common (affects 1 to 10 people in 100)
• Itching or redness of the treated area. This is
much milder than an allergic reaction. Tell your
doctor or pharmacist if this feeling lasts for
more than a few minutes or gets worse (rash,
burning or swelling)
• Pain of the treated area
Uncommon (affects 1 to 10 people in 1,000)
• Redness or swelling of the treated area
• Discomfort of the treated area
If you get side effects and they become serious
or if you notice any other side effects not listed in
this leaflet, please tell your doctor or pharmacist.

5 How to store Pevaryl
Keep out of the reach and sight of children. Do
not store above 25°C. Keep away from heat and
Do not use 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 Further information
The active substance in Pevaryl is econazole
nitrate. Pevaryl contains 1% econazole nitrate.
The other ingredients are purified water,
Pegoxyl-7-stearate, liquid paraffin, Peglicol-5oleate, benzoic acid (E210), flower perfume
4074, butylated hydroxyanisole (E320).

What Pevaryl looks like and contents
of the pack
Pevaryl comes in an aluminium tube containing
15 g or 30 g of white cream.
The product licence is held by:
JANSSEN-CILAG LTD, 50-100 Holmers Farm
Way, High Wycombe, Bucks, HP12 4EG, UK
Pevaryl is made by:
Janssen Pharmaceutica NV, Turnhoutseweg 30,
B-2340 Beerse, Belgium
McGregor Cory Ltd, Middleton Close, Banbury,
Oxfordshire OX16 4RS, UK

981328.pdf - Page 2 of 3 - April 13, 2011 - 12:36:31

For information in large
print, tape, CD or Braille,
telephone 0800 7318450.
This leaflet was last approved in February 2011

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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.