EPI PEVARYL

EPI PEVARYL Cream

Important notes (mandatory information)

Epi-Pevaryl 1% cream. Active ingredient: econazole nitrate. Areas of application: for mucolytic treatment of acute and chronic diseases of the bronchi and lungs with viscous mucus. Warning: Contains lactose.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist!


PACKAGE LEAFLET: INFORMATION FOR THE USER

Epi-Pevaryl 1% cream for use in infants, children and adults
Active ingredient: econazole nitrate

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or even worse after 5 days, contact your doctor.

What this package leaflet contains

1. WHAT IS EPI–PEVARYL 1% CREAM AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING EPI–PEVARYL 1% CREAM?
3. HOW TO USE EPI–PEVARYL 1% CREAM?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE EPI–PEVARYL 1% CREAM?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS EPI-PEVARYL 1% CREAM AND WHAT IS IT USED FOR?

Epi-Pevaryl 1% cream is a fungicidal medicine for external treatment of fungal skin infections (antimycotic). Epi-Pevaryl 1% cream is used for fungal skin and skin infections, e.g. athlete's foot or pityriasis versicolor. Epi-Pevaryl 1% cream can also be used for fungal infections that occur during treatment with antibiotics or certain anti-inflammatory substances (steroids).

2. WHAT SHOULD YOU CONSIDER BEFORE USING EPI-PEVARYL 1% CREAM?

Epi-Pevaryl 1% cream must not be used if you are allergic to econazole nitrate or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

Please talk to your doctor or pharmacist before using Epi-Pevaryl 1% cream. Epi-Pevaryl 1% cream is for external use only and must not be taken orally. Epi-Pevaryl 1% cream must not get into the eyes. If the cream does get into the eyes, rinse them with plenty of water. If eye irritation persists, see your doctor. If there are signs of a hypersensitivity reaction such as redness, itching, skin irritation or blistering, including on untreated parts of the body, you must not use Epi-Pevaryl 1% cream again. The use of Epi-Pevaryl 1% cream in the genital area can impair the safety of certain latex diaphragms or condoms used to prevent pregnancy. Therefore, Epi-Pevaryl 1% cream should not be used at the same time as a diaphragm or a latex condom.

Use of Epi-Pevaryl 1%

cream together with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. Econazole nitrate applied to the skin is absorbed by the body only to a very small extent. Nevertheless, clinically relevant interactions with other medicines can occur. Patients taking oral blood thinners, e.g. warfarin or acenocoumarol, should only use Epi-Pevaryl 1% cream after consulting their doctor. During and after treatment with Epi-Pevaryl 1% cream, it may be necessary to adjust the dosage of oral blood thinners. The simultaneous use of other medicines on the skin is not recommended.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine. During pregnancy and breast-feeding, you should only use Epi-Pevaryl 1% cream after consulting your doctor. If your doctor assesses the benefit-risk ratio as positive, avoid using Epi-Pevaryl 1% cream over a large area. Please do not use Epi-Pevaryl 1% cream in the breast area while breast-feeding. This will prevent the infant from coming into direct contact with Epi-Pevaryl 1% cream.

Driving and using machines

Epi-Pevaryl 1% cream has no or negligible influence on the ability to drive and use machines.

Epi-Pevaryl 1%

cream contains benzoic acid and butylhydroxyanisole

Benzoic acid can cause mild irritation to the skin, eyes and mucous membranes. Butylhydroxyanisole can cause local skin irritation (e.g. contact dermatitis), irritation of the eyes and mucous membranes.

3. HOW TO USE EPI-PEVARYL 1% CREAM?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The recommended dose is: Apply a small amount of cream to the affected skin and the surrounding skin area (approx. 1 to 2 cm) twice a day (preferably in the morning and evening).

Method of administration

Wash the affected skin areas thoroughly before each application and dry them carefully. Massage the cream in with your finger until it has been absorbed. After applying the cream, you should wash your hands thoroughly (exception: treating the hands).

Duration of use

The total treatment time is on average 2 - 5 weeks. The signs of the fungal infection usually recede significantly within 5 days of starting treatment with Epi-Pevaryl 1% cream. Continue treatment for about 2 weeks after the symptoms have disappeared to prevent recurrence.

Please talk to your doctor or pharmacist if you have the impression that the effect of Epi-Pevaryl 1% cream is too strong or too weak.

If you have used more Epi-Pevaryl 1%

cream than you should

If Epi-Pevaryl 1% cream is accidentally ingested, especially in children, it can cause nausea, vomiting and diarrhoea. If necessary, your doctor will treat these symptoms symptomatically.

If you forget to use Epi-Pevaryl 1%

cream

Do not use a double dose to make up for a forgotten application.

If you stop using Epi-Pevaryl 1%

cream

If you stop treatment with Epi-Pevaryl 1% cream too early, the fungal infection may recur.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

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

Possible side effects

Common (may affect up to 1 in 10 people):

• Itching, burning of the skin.
• Pain.

Uncommon (may affect up to 1 in 100 people):

• Redness of the skin.
• Discomfort, swelling.

Not known (frequency cannot be estimated from the available data):

• Swelling (angioedema), skin inflammation* skin rash, hives, blistering, scaling of the skin.
• Hypersensitivity.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Pharmacovigilance Department, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE EPI-PEVARYL 1% CREAM?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and tube after "Use by". The expiry date refers to the last day of the month indicated. Do not store above 25°C. Note on shelf life after opening: Epi-Pevaryl 1% cream can be stored for 3 months after opening the tube. Medicines should be disposed of in accordance with local requirements. Therefore, ask your pharmacist how to dispose of the medicine when you no longer use it. This will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Epi-Pevaryl 1%

cream contains

The active ingredient is: econazole nitrate. 1 g of cream for application to the skin contains 10 mg of econazole nitrate. The other ingredients are: Purified water, macrogol stearate, macrogolglycerol oleates (Ph. Eur.), liquid paraffin, benzoic acid, fragrance, butylhydroxyanisole (Ph. Eur.).

What Epi-Pevaryl 1%

cream looks like and contents of the pack

Epi-Pevaryl 1% cream is a white cream. Epi-Pevaryl 1% cream is available in aluminium tubes containing 25 g, 30 g, 50 g and 70 g of cream. Not all pack sizes may be marketed.

Further information

Opening instructions for the tube: Pierce the seal of the tube with the tip located in the cap. Econazole nitrate, the active ingredient in Epi-Pevaryl 1% cream, has a broad spectrum of activity against skin, yeast, mould and other fungi. Before using Epi-Pevaryl 1% cream, you should wash the affected skin areas carefully and then dry them thoroughly. When treating athlete's foot, it is particularly important to dry between the toes. Use fresh towels every day - preferably disposable towels. This will prevent the fungi from being spread to other skin areas by the towel. After each application, you should wash your hands carefully (exception: treating the hands) to prevent the fungal infection from spreading to other parts of the body or to other people. After a few days, Epi-Pevaryl 1% cream will relieve the symptoms (itching) and heal the affected skin areas. Even if there are no more visible skin changes, you should continue treatment for about 2 weeks. There are still fungi in the deeper layers of the skin that can cause the fungal infection to recur. Changing socks and underwear daily will support the effectiveness of Epi-Pevaryl 1% cream. Avoid wearing laundry that cannot be washed at 60°C or higher.

Pharmaceutical entrepreneur

Johnson & Johnson GmbH
Johnson & Johnson Platz 2
41470 Neuss
Tel.: 00800 260 260 00 (free of charge)

Manufacturer

Janssen Pharmaceutica N.V.
Turnhoutseweg 30
2340 Beerse
Belgium

This package leaflet was last revised in September 2015.

Source: Information from the package leaflet
Status: 04/2018
Active ingredient: econazole nitrate. Areas of application: for mucolytic treatment of acute and chronic diseases of the bronchi and lungs with viscous mucus. Warning: Contains lactose.