Pevaryl Econazole Nitrate
Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.
What Pevaryl Is And What It Is Used For
This cream is used to treat fungal infections of the skin. Pevaryl cream is suitable for the treatment of all fungal infections of the skin, regardless of type or location.
This cream is easy to use e.g. athlete’s foot. The powder can be used inside socks and shoes.
This cream or powder can be used for infection on particularly sensitive skin areas.
Econazole nitrate contained in Pevaryl may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
You must talk to your doctor if your symptoms worsen or do not improve within 7 days.
What You Need To Know Before You Use This Cream
Do Not Use
If you are allergic to econazole nitrate or any of the other Pevaryl cream ingredients (listed in section 6).
Warnings And Cautions
This cream should only be used on the skin, not in the eyes or mouth. When applying cream, avoid contact with the eyes. Therefore, wash your hands after each treatment, except when the treatment is intended for your hands.
This cream powder contains talc that can irritate the respiratory tract. Therefore, avoid inhalation of the powder, especially in infants and children.
Other Medicines And Pevaryl
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The treatment effect may be affected if this cream is used at the same time as certain other medicines.
Therefore, you should not use this cream at the same time as the following medicines without first consulting your doctor or pharmacist:
- Blood-thinning drugs
- Warfarin
- Acenocoumarol
Pregnancy And Breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
Pevaryl should only be used during the first trimester of pregnancy on the advice of a doctor. This cream can be used during the second and third trimesters if the potential benefit to the mother outweighs the potential risks to the fetus.
Breast-feeding
It is not known if cream passes into breast milk. Talk to your doctor before using Pevaryl during breastfeeding.
Driving And Using Machines
This cream has no known effect on the ability to drive or perform precision work.
Pevaryl Cream Contains Benzoic Acid And Butyl Hydroxyanisole
This medicine contains 2 mg / g of benzoic acid. Benzoic acid can cause local irritation. Benzoic acid may increase the risk of jaundice (yellowish skin and eyes) in newborns (up to 4 weeks of age).
This medicine contains butyl hydroxyanisole which may cause local skin reactions (eg contact dermatitis) or be irritating to the eyes and mucous membranes.
How To Use Pevaryl
Pevaryl cream uses
- Always use Pevaryl exactly as described in this leaflet or as directed by your doctor, pharmacist, or nurse. If you are not sure, talk to your doctor, pharmacist, or nurse.
- When treating an athlete’s foot
- Before treatment, the feet should be washed and dried thoroughly. Wear airy socks and shoes.
- The cream is gently massaged into the infected skin area morning and evening.
- Powder is suitable to use as a supplement to Pevaryl cream. You should powder inside both socks and shoes. Powders can also be used to prevent an athlete’s foot if the symptoms recur frequently.
- Treatment should be continued for another 2 weeks after the symptoms have disappeared.
- Children under the age of 10 should not be treated without a doctor’s prescription.
- In case of infection on your hands, treatment is recommended after each hand wash.
- This cream does not stain clothes and skin and can be washed off with soap and water.
If You Use More Pevaryl Than You Should
If you have ingested too much medicine or if e.g. a child ingested the medicine accidentally contact a doctor or hospital for risk assessment and advice. If you get this cream in your eyes, wash with clean water or saline and see a doctor if symptoms persist.
If You Forget To Use Pevaryl
- Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible Pevaryl Side Effects
Like all medicines, this creamcan cause side effects, although not everybody gets them.
Common (affects more than 1 user in 100):
Uncommon Pevaryl side effects (affects less than 1 user in 100 ):
- Reddening of the skin
- Discomfort
- Swelling
Has been reported (occurs in an unknown number of users):
- Hypersensitivity
- Contact dermatitis
- Rash
- Blisters
- Skin flaking
Stop using Pevaryl and contact a doctor immediately if you get any of the following symptoms ( Angioedema ):
- Swelling of the face, tongue, or throat
- Difficulty swallowing
- Hives and difficulty breathing
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information.
How To Store Pevaryl
- Keep out of sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.
- This cream should not be stored above 25 ° C.
- This cream has no special storage instructions.
- Close the tube tightly.
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 to protect the environment.
Contents Of The Pack And Other Information
Content Declaration
- Pevaryl 1% cream:
- The active substance is econazole nitrate.
- The other Pevaryl cream ingredients are
- Benzoic acid (E 210)
- Butyl hydroxyanisole
- Pegoxol-7-stearate
- Oleoyl macrogol glyceride
- Liquid paraffin
- Purified water
- Pevaryl 1% powder:
- The active substance is econazole nitrate.
- The other ingredients are
- Zinc oxide
- Silica
- Talc
- Perfume 4074
What The Medicine Looks Like And The Contents Of The Pack
- Pevaryl 1% cream is white with a slight odor and is supplied in an aluminum tube containing 30 g, 70 g, and 78 g respectively. Not all pack sizes may be marketed.
- Pevaryl 1% powder is white and lightly perfumed.
- It is provided in a plastic jar containing 30 g.
Marketing Authorization Holder And Manufacturer
Marketing Authorisation Holder
Trimb Healthcare AB
Box 16184
103 24 Stockholm
Tel: 08-12135200
Email: medical@trimb.se
Manufacturer of Pevaryl cream
Janssen Pharmaceutica NV, 30 Turnhoutseweg, B-2340 Beerse, Belgium.
Manufacturer of Pevaryl powder
Lusomedicamenta – Sociedade Técnica Pharmacêutica, SA
Estrada Consiglieri Pedroso 69 B, Queluz de Baixo, 2730–055 Barcarena, Portugal.