Pevaryl 1% cream

Country: Ingilterra

Lingwa: Ingliż

Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredjent attiv:

Econazole nitrate

Disponibbli minn:

Sigma Pharmaceuticals Plc

Kodiċi ATC:

D01AC03

INN (Isem Internazzjonali):

Econazole nitrate

Dożaġġ:

10mg/1gram

Għamla farmaċewtika:

Vaginal cream

Rotta amministrattiva:

Cutaneous

Klassi:

No Controlled Drug Status

Tip ta 'preskrizzjoni:

Valid as a prescribable product

Sommarju tal-prodott:

BNF: 07020200

Fuljett ta 'informazzjoni

PACKAGE LEAFLET: INFORMATION FOR THE USER
PEVARYL
® 1% TOPICAL CREAM
Econazole nitrate
Pevaryl is a registered trademark
READ ALL OF THIS LEAFL ET CAREFULLY BEFORE
YOU START USING THIS MEDICINE BECAUSE
IT CONTAINS IMPORTANT INFORMATION FOR
YOU.
• Keep this leafl et. 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 eff ects, talk to your doctor
or pharmacist. This includes any possible side
eff ects not listed in this leafl et. See section 4.
WHAT IS IN THIS LEAFL ET
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 EFF ECTS
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 leafl et.
Pevaryl contains a medicine called econazole
nitrate. This belongs to a group of medicines
called ‘antifungals’.
Pevaryl is used for skin infections caused by
certain fungi and yeasts.
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 infl amed, 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 me

Karatteristiċi tal-prodott

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Pevaryl 1% Topical cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Econazole nitrate - 1.0% w/w.
Each gram of cream contains 10 mg econazole nitrate
Excipients: each gram of cream contains 2 mg benzoic acid and
52 micrograms butylhydroxyanisole
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Cream.
4.1
THERAPEUTIC INDICATIONS
For the treatment of cutaneous candidiasis, dermatophytosis and
pityriasis
versicolor.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For cutaneous administration.
DOSAGE
The dosage regimen is the same for all patients.
Apply twice daily to the affected part and rub into the skin gently
with the
finger.
THE USUAL TREATMENT DURATION IS 2 TO 4 WEEKS.
_If no improvement in symptoms is experienced after 4 weeks, the
treatment _
_should be reassessed. _
4.3
CONTRAINDICATIONS
Pevaryl Topical Cream is contraindicated in individuals who have shown
hypersensitivity to any of its ingredients.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For external use only. Care should be taken not to get Pevaryl Topical
Cream in the
eyes or mouth. If the product is accidently applied to the eyes the
patient should wash
with clean water or saline and seek medical attention if symptoms
persist.
If a reaction suggesting sensitivity or chemical irritation should
occur, use of the
medication should be discontinued.
Care should be taken in the presence of eczematous dermatitis
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Econazole administered systemically is known to inhibit CYP3A4/2C9.
Due to the
limited systemic availability after topical application, clinically
relevant interactions
are rare. However, in patients on oral anticoagulants, such as
warfarin and
acenocoumarol, caution should be exercised and anticoagulant effect
should be
monitored more frequently.
Adjustment of the oral anticoagulant dosage may be necessary during
the treatment
with econazole and after its termination
4.6
FERTILITY, PREGNA