PEVARYL 1% Cream

Зміст інструкції

1. Pevaryl 1% cutaneous emulsion
   1. What is Pevaryl and what is it used for
   2. What you need to know before using Pevaryl
   3. How to use Pevaryl
   4. Possible side effects
   5. How to store Pevaryl
   6. Contents of the pack and other information

MARKETING AUTHORISATION HOLDER
Karo Pharma AB
Box 16184
SE-103 24 Stockholm
Sweden

MANUFACTURER RESPONSIBLE FOR BATCH RELEASE:
Janssen Pharmaceutica NV
Beerse (Belgium)

Pevaryl 1% cutaneous emulsion

econazole nitrate

Read this leaflet carefully before you start using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet, or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If you get any side effects, see section 4.
• If your symptoms do not improve or get worse, talk to your doctor.

Contents of 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 is Pevaryl and what is it used for

Pevaryl is an antifungal medicine for the local treatment of infections caused by certain fungi and yeasts
including suspected concomitant infections caused by Gram-positive bacteria.
This product is indicated for the treatment of:

• skin mycoses caused by dermatophytes, cutaneous candidiasis and suspected concomitant infections by Gram-positive bacteria;
• Pityriasis Versicolor.

Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before using 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).

Warnings and precautions
Talk to your doctor or pharmacist before using Pevaryl.
Pevaryl is only for external use.
Pevaryl is not for use in the eyes or mouth.
If allergic reactions occur or irritation develops, stop treatment and
contact your doctor.

Children and adolescents
No data are available

Other medicines and Pevaryl
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Warn your doctor or pharmacist if you are taking oral anticoagulants (medicines that prevent blood from
clotting) such as warfarin and acenocoumarol: Pevaryl may alter their effect. Pevaryl
should be used with caution if you are being treated with anticoagulants: your doctor will monitor your blood
tests more frequently and assess a possible adjustment of the dosage of the oral anticoagulant medicine
during treatment with econazole and after it is stopped.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
If pregnancy is confirmed or suspected, consult your doctor who will assess whether to prescribe Pevaryl.
Do not use Pevaryl during the first trimester of pregnancy unless your doctor considers it necessary
for your health.
Pevaryl may be used during the second and third trimesters of pregnancy if your doctor determines
that the potential benefit to the mother outweighs the possible risks to the baby.

Breastfeeding
It is not known whether econazole is excreted in breast milk.
Pevaryl should be used with caution during breastfeeding and under the supervision of your doctor

Driving and using machines
The effects of Pevaryl on the ability to drive and operate machines are unknown.

Pevaryl cutaneous emulsion contains butylhydroxyanisole
Butylhydroxyanisole may cause skin reactions at the application site (e.g., contact dermatitis) or
irritation of the eyes and mucous membranes.

Pevaryl cutaneous emulsion contains benzoic acid
This medicine contains 60 mg of benzoic acid in each 30 g bottle, which is equivalent to
2 mg/g of cream.
Benzoic acid may cause local irritation.
Benzoic acid may increase jaundice (yellowing of the skin and eyes) in newborns up to 4
weeks of age.

Pevaryl cutaneous emulsion contains fragrance
This medicine contains a fragrance which in turn contains linalool, citronellol, 3-methyl-4-(2,6,6–
trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, geraniol, hydroxycitronellal, coumarin, benzyl salicylate,
hexyl cinnamal aldehyde, d-Limonene, citral, cinnamyl alcohol, lilial, eugenol, benzyl benzoate,
isoeugenol, farnesol, benzyl alcohol and cinnamal. Linalool, citronellol, 3-methyl-4-(2,6,6–trimethyl-2-
cyclohexen-1-yl)-3-buten-2-one, geraniol, hydroxycitronellal, coumarin, benzyl salicylate, hexyl
cinnamal aldehyde, d-Limonene, citral, cinnamyl alcohol, lilial, eugenol, benzyl benzoate, isoeugenol,
farnesol, benzyl alcohol and cinnamal may cause allergic reactions.

3. How to use Pevaryl

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Unless otherwise prescribed by your doctor, Pevaryl should be applied to the infected skin areas, with a
light massage, twice a day, morning and evening.

Duration of treatment:
The usual duration of treatment is 2-4 weeks.
Consult your doctor if symptoms do not improve after 4 weeks.
If you notice the presence of exudate (fluid or blood) between the lesions, clean the area (for example the
spaces between the toes, or the folds of the buttocks) with gauze or bandages before applying Pevaryl.
Regular use and adherence to the prescriptions of Pevaryl is crucial for healing.
Pevaryl: child-resistant closure - how to open the bottle

If you use more Pevaryl than you should
Pevaryl is for external use only.
In case of contact with the eyes, rinse with clean water or saline solution and consult your doctor if
symptoms persist.
In case of accidental ingestion/intake of an excessive dose of Pevaryl, nausea, vomiting and diarrhea may occur, but in any case, immediately inform your doctor or go to the nearest
hospital. If you have any doubts about the use of Pevaryl, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The use of topical products, especially if prolonged, can give rise to sensitization phenomena;
if this occurs, stop treatment and consult your doctor.
In case of particularly intense local reactions, it is necessary to stop treatment and consult your
doctor.
Below is a list of side effects that have occurred with Pevaryl.

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

• Itching
• Burning sensation of the skin
• Pain

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

• Erythema
• Discomfort
• Swelling

Side effects with unknown frequency include:

• Angioedema (swelling of the face, mouth, lips and/or tongue)
• Contact dermatitis
• Rash
• Urticaria
• Blister formation
• Skin peeling
• Hypersensitivity

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse. By reporting side effects you can help provide more information
about the safety of this medicine.

5. How to store Pevaryl

Keep this medicine out of the sight and reach of children.
Store at a temperature below 25°C.
Do not use this medicine after the expiry date which is stated on the packaging after the word
Exp. The expiry date refers to the last day of that month.
The expiry date refers to the product in intact packaging, correctly stored.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Pevaryl cutaneous emulsion contains:
The active ingredient is econazole nitrate. 100 g of cutaneous emulsion contains 1 g of econazole nitrate.
The other ingredients are: precipitated silica; mixture of stearic acid esters with glycols; mixture of
fatty acids with polyethylene glycol; petrolatum oil; butylhydroxyanisole; benzoic acid; fragrance
(containing linalool, citronellol, 3-methyl-4-(2,6,6–trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, geraniol,
hydroxycitronellal, coumarin, benzyl salicylate, hexyl cinnamal, d-Limonene, citral, cinnamyl alcohol,
linalyl acetate, eugenol, benzyl benzoate, isoeugenol, farnesol, benzyl alcohol and cinnamal);
purified water.

Description of the appearance of Pevaryl and contents of the pack
Cutaneous emulsion 1%: 30 ml bottle

MARKETING AUTHORISATION HOLDER
Karo Pharma AB
Box 16184
SE-103 24 Stockholm
Sweden

MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Janssen Pharmaceutica NV
Beerse (Belgium)