PEVISONE <1% + 0,1% Skin emulsion

Зміст інструкції

1. Pevisone 1%+0.1% cutaneous emulsion
   1. What is Pevisone and what is it used for
   2. What you need to know before using Pevisone
   3. How to use Pevisone
   4. Possible side effects
   5. How to store Pevisone
   6. Contents of the pack and other information

Pevisone 1%+0.1% cutaneous emulsion

econazole nitrate and triamcinolone acetonide

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Pevisone and what is it used for

Pevisone contains two active ingredients called econazole nitrate and triamcinolone acetonide.
Econazole nitrate belongs to a group of medicines called “antifungals” used to treat
fungal infections.
Triamcinolone acetonide belongs to a group of medicines called “corticosteroids” used to
treat inflammation.
Pevisone is a dermatological medicine indicated for the treatment of fungal infections
of the skin characterized by the presence of a severe inflammatory component or allergic
manifestations such as, for example, fungal eczema, Hebra's marginated eczema, circinate herpes,
intertrigo, trichophytic folliculitis, beard fungus, dermatitis which can manifest with
redness, blisters, scabs, itching and scaling, etc.
See your doctor if you do not feel better or if you feel worse.

2. What you need to know before using Pevisone

DO NOT use Pevisone

• if you are allergic to econazole nitrate, triamcinolone acetonide, corticosteroids or any of the other ingredients of this medicine (listed in section 6).
• like all medicinal products containing corticosteroids for local use, do not use Pevisone if you have any specific skin conditions such as:
• tuberculosis
• varicella (chickenpox)
• herpes simplex (an illness caused by a virus that presents with painful blisters on the skin)
• or other skin infections caused by skin viruses.

Do not apply Pevisone to areas of skin where a vaccination has just been administered.

Warnings and precautions
Consult your doctor or pharmacist before using Pevisone.
Stop treatment and contact your doctor if allergic reactions or irritation occur.
Pevisone is only for external use.
Pevisone is not indicated for ophthalmic or oral use.
Keep in mind that corticosteroids (anti-inflammatory medicines) applied to the skin can:

• be absorbed in sufficient quantity to produce systemic effects (throughout the body), including alteration of the function of the adrenal glands (suppression of the adrenal glands).
• also cause:
• thinning of the skin
• striae (stretch marks)
• rosacea (a pathological alteration of the skin that causes redness)
• perioral dermatitis (red skin rashes around the mouth)
• acne
• dilation of superficial blood vessels (telangiectasias)
• purpura (a skin rash characterized by bright red hemorrhagic spots)
• hypertrichosis (increased hair growth)
• delayed wound healing
• increase the risk of dermatological superinfections (new infections that develop in subjects with another infection still in progress and not yet healed), opportunistic infections (infections that affect subjects with already compromised immune systems)

Systemic absorption (by the entire organism) can be increased by several factors
such as:

• application to a large area of the skin surface
• application to damaged skin
• application with occlusive bandaging of the skin (bandaging with a non-porous material such as non-flexible film)
• prolonged therapy.

Repeated and/or prolonged application of corticosteroids in the periorbital region can induce cataracts
(clouding of the eye's lens), ocular hypertension, or increase the risk of glaucoma
(increased pressure inside the eye).
Contact your doctor if you experience blurred vision or other visual disturbances.
In case of too frequent use, in extensive areas or incorrectly for prolonged periods, you
may experience a withdrawal reaction after stopping treatment.
If you develop a recurrence of your symptoms shortly after stopping treatment, do not start
using the skin emulsion again without first consulting your doctor, unless he/she has
previously advised you to do so. If your condition has resolved and at the time of recurrence the
redness extends beyond the initial treatment area and you feel a burning sensation, consult
your doctor before restarting treatment.

Children and adolescents
Following the use of corticosteroids on children's skin, suppression of the activity of the adrenal glands
(glands located near the kidneys that produce hormones) and the onset of Cushing's syndrome (a condition in which the body produces too much cortisol, which is a type of steroid) is
higher than in adults.
Therefore, Pevisone must be used with caution in children and treatment must be
interrupted if signs of suppression of adrenal gland activity or Cushing's syndrome occur.

Other medicines and Pevisone
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 hinder blood clotting) such as warfarin and acenocoumarol: Pevisone may modify their effect. Use Pevisone with caution if you are being treated with anticoagulants. The doctor will monitor the effect of the anticoagulant more frequently. The doctor will assess a possible adjustment of the dosage of the oral anticoagulant medicine during treatment with Pevisone and after its discontinuation.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before using this or any other
medicine.

Pregnancy
Do not use Pevisone during the first trimester of pregnancy, unless your doctor considers it
necessary for your health, due to absorption throughout the body.
Pevisone can be used during the second and third trimesters of pregnancy if the potential
benefit for the mother outweighs the possible risks to the fetus (unborn baby).
Medicines of this class should not be used in large quantities, on large areas of the
skin surface or for a prolonged period of time in pregnant patients.

Breastfeeding
Use Pevisone with caution during breastfeeding as there is insufficient data to establish whether
Pevisone passes into breast milk.

Driving and operating machinery
Not applicable

Pevisone contains butylhydroxyanisole
Butylhydroxyanisole may cause local skin reactions (e.g. contact dermatitis) or irritation
of the eyes and mucous membranes.

Pevisone contains benzoic acid
This medicine contains 60 mg of benzoic acid in each tube of 30 g skin emulsion which is
equivalent to 2mg/g of skin emulsion.
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).

3. How to use Pevisone

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts, consult your doctor or pharmacist.
Apply Pevisone no more than twice a day, preferably once in the morning and once in the evening, to the affected skin surface with a light massage.
Pevisone should not be applied with an occlusive skin dressing or to a large area of the skin surface.
The duration of treatment with Pevisone should not exceed eight days; at the doctor's discretion, therapy should then be continued until complete healing with the antimycotic medicine alone.
If you use Pevisone too frequently, on extensive areas or incorrectly for prolonged periods, you may experience a withdrawal reaction, especially if you suddenly stop treatment (see sections 2 and 4). Ask for advice from the doctor who prescribed the treatment.

Use in children and adolescents
No data are available.

If you use more Pevisone than you should
Pevisone 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 Pevisone, immediately inform your doctor or go to the nearest hospital.
In case of any doubt about the use of Pevisone, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Below is a list of side effects that have occurred with Pevisone.

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

• skin burning sensation
• skin irritation
• erythema

Side effects with unknown frequency (frequency cannot be estimated based on available
data) include:

• hypersensitivity
• angioedema
• contact dermatitis
• skin atrophy
• pruritus
• skin exfoliation
• striae (stretch marks) of the skin
• telangiectasia (dilatation of superficial blood vessels)
• pain at the application site
• swelling at the application site
• blurred vision
• steroid withdrawal reaction: In the case of too frequent use, on extensive areas or incorrectly for prolonged periods, after discontinuation of treatment a withdrawal reaction may occur, with some or

all of the following characteristics: redness of the skin that may extend beyond the
initially treated area, burning or stinging sensation, intense itching, scaling of the
skin, open and weeping sores.
Locally, on the treated skin, dryness, local inflammation, acneiform eruptions, light spots or hair growth may sometimes also occur.
However, the occurrence of side effects may be favored when extensive skin areas are treated with high doses and for prolonged periods, or if the treated areas are kept covered
with a bandage.
The use, especially if prolonged, of products for local use can lead to sensitization phenomena
which manifest with redness and intense itching. In these cases, discontinue treatment and
consult your doctor.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell 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 Pevisone

Do not store at a temperature above 25°C.
Keep this medicine out of the sight and reach of children.
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.
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 Pevisone contains
100 g of cutaneous emulsion contains

• The active ingredients are: econazole nitrate and triamcinolone. 100g of cutaneous emulsion contains econazole nitrate g 1; triamcinolone acetonide g 0.10.
• The other ingredients are: polyethylene glycol palmitostearate, polyoxyethylene oleic glyceride, liquid paraffin, butylated hydroxyanisole, benzoic acid, purified water.

Description of the appearance of Pevisone and contents of the pack
Cutaneous emulsionfor cutaneous use: bottle of 30 ml

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

Manufacturer
JANSSEN PHARMACEUTICA N.V.
Turnhoutseweg, 30
B-2340 Beerse (Belgium)