PEVARYL 1% TOPICAL CREAM

Active substance: ECONAZOLE NITRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

© J-C 2014

Pevaryl® 1% topical cream
Econazole nitrate
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 Pevaryl is and what it is used for
2 What you need to know before you use
Pevaryl
3 How to use Pevaryl
4 Possible side effects
5 How to store Pevaryl
6 Contents of the pack and other information

1 What Pevaryl is and what it is used for
The name of your medicine is Pevaryl 1% topical
cream. It is called ‘Pevaryl’ in this leaflet.
Pevaryl contains a medicine called econazole
nitrate. This belongs to a group of medicines
called ‘antifungals’.

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

2 What you need to know before you use Pevaryl
Do not use Pevaryl:

• if you are allergic to econazole nitrate or any of
the other ingredients of this medicine (listed in
section 6).
Do not use this medicine if this applies to you. If
you are not sure, talk to your doctor or
pharmacist before using Pevaryl.

Warnings and precautions

• Talk to your doctor or pharmacist before using
Pevaryl if you have inflamed, red, dry and scaly
skin (eczema)
• 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.

Other medicines and 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 or pharmacist for advice before
using this medicine.
You may still be able to use 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.
Pevaryl contains benzoic acid (E210) and
butylated hydroxyanisole (E320). These can
irritate your skin, eyes, mouth and nostrils if they
come into contact with them.

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

The recommended dose is:
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 2014

3 How to use Pevaryl (continued)
Nail infections

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

When to stop using Pevaryl

Keep using the cream until the infection has
completely healed.

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.

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

Stop using Pevaryl and tell your
doctor straight away if you notice the
following.

• 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 more than 1 in 100
patients)
• 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 fewer than 1 in 100
patients)
• Redness or swelling of the treated area
• Discomfort of the treated area

Reporting of side effects

If you get any side effects, talk to your doctor or
pharmacist. 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 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 this medicine:
• 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)
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 Pevaryl contains

The active substance 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.
Marketing Authorisation Holder:
JANSSEN-CILAG LTD, 50-100 Holmers Farm
Way, High Wycombe, Bucks, HP12 4EG, UK

Manufacturer:
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 July 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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