PEVARYL 1% TOPICAL CREAM
Active substance: ECONAZOLE NITRATE
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PACKAGE LEAFLET: INFORMATION FOR THE USER
J-C 2011
GB - 981328
Pevaryl 1% topical cream
Econazole nitrate
Pevaryl is a registered trademark
Read all of this leaet carefully before you start using this medicine.
In this leaet
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
1 What Pevaryl is and what it is used for 2 Before you use Pevaryl 3 How to use Pevaryl 4 Possible side eects 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 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 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.
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 breast-feeding.
Take special care with Pevaryl
Talk to your doctor before using this medicine 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
Driving and using machines
This medicine is not likely to affect you being able to drive or use any tools or machines.
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. 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
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
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.
Skin infections
Use the cream twice a day Rub the cream gently into the affected skin Keep the affected area clean and dry
981328.pdf - Page 1 of 3 - April 13, 2011 - 12:36:31
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 dressing Keep the affected area clean and dry
If you swallow Pevaryl
When to stop using 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 eects
Like all medicines, Pevaryl can cause side effects, although not everybody gets them. Other side eects: Common (aects 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.
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
5 How to store Pevaryl
Keep out of the reach and sight of children. Do not store above 25C. Keep away from heat and sunlight. 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).
For information in large print, tape, CD or Braille, telephone 0800 7318450.
This leaflet was last approved in February 2011
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 OR McGregor Cory Ltd, Middleton Close, Banbury, Oxfordshire OX16 4RS, UK
981328.pdf - Page 2 of 3 - April 13, 2011 - 12:36:31
J-C 2011
GB - 981328
Pevaryl 1% topical cream
Econazole nitrate
Pevaryl is a registered trademark
Read all of this leaet carefully before you start using this medicine.
In this leaet
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
1 What Pevaryl is and what it is used for 2 Before you use Pevaryl 3 How to use Pevaryl 4 Possible side eects 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 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 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.
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 breast-feeding.
Take special care with Pevaryl
Talk to your doctor before using this medicine 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
Driving and using machines
This medicine is not likely to affect you being able to drive or use any tools or machines.
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. 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
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
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.
Skin infections
Use the cream twice a day Rub the cream gently into the affected skin Keep the affected area clean and dry
981328.pdf - Page 1 of 3 - April 13, 2011 - 12:36:31
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 dressing Keep the affected area clean and dry
If you swallow Pevaryl
When to stop using 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 eects
Like all medicines, Pevaryl can cause side effects, although not everybody gets them. Other side eects: Common (aects 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.
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
5 How to store Pevaryl
Keep out of the reach and sight of children. Do not store above 25C. Keep away from heat and sunlight. 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).
For information in large print, tape, CD or Braille, telephone 0800 7318450.
This leaflet was last approved in February 2011
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 OR McGregor Cory Ltd, Middleton Close, Banbury, Oxfordshire OX16 4RS, UK
981328.pdf - Page 2 of 3 - April 13, 2011 - 12:36:31
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
