IMPETEX 10 мг/г + 1 мг/г Крем

Содержание инструкции

1. IMPETEX 10 mg/g + 1 mg/g cream
   1. What Impetex is and what it is used for
   2. What you need to know before using Impetex
   3. How to use/Impetex
   4. Possible side effects
   5. How to store Impetex
   6. Contents of the pack and other information

IMPETEX 10 mg/g + 1 mg/g cream

Chlorquinaldol + Diflucortolone

Read this leaflet carefully before you use/give this medicine to your child 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 only for you and/or your child. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If you and/or your child experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Impetex is and what it is used for

Impetex is a cream for local use containing two active ingredients: clorchinaldol and diflucortolone valerate.
Clochinandolo is an antiseptic capable of blocking or reducing the growth of bacteria and/or fungi.
D iflucortolone valerate is a corticosteroid, used to reduce the symptoms of inflammation.

• Impetex is indicated in adults, infantsand childrenin the treatment or prevention of all skin diseases of an inflammatory and allergic nature, accompanied by bacterial and/or fungal infections:
• eczema (skin inflammation associated with itching, not contagious) in the following forms: nummular eczema, contact eczema, common eczema (acute and chronic phase), seborrheic eczema, varicose eczema (not directly on the lesion), children's eczema, anal eczema, dyshidrosis and dyshidrotic eczema, eczematide
• contact dermatitis (skin irritation of inflammatory or allergic origin)
• psoriasis (chronic skin inflammation not always associated with itching, not infectious or contagious)
• microbide (alteration of the skin caused by allergic reactions to infectious agents and their toxins, substances produced by bacteria and harmful to the body)
• skin infections caused by bacteria and characterized by strong inflammation: pyoderma (skin inflammation with pus formation), folliculitis (superficial infections of the hair follicle, the structure that surrounds the hair root)
• impetigo (contagious skin infection, which manifests with blisters, pustules and scabs on the skin)
• dermatomycoses (skin diseases caused by infections by fungi) accompanied by acute inflammation or secondary inflammation: tinea (superficial infection of skin areas devoid of hair), candidiasis (infection caused by fungi belonging to the Candida genus, predominantly at the vaginal level, but also on other body surfaces), pityriasis versicolor (infection characterized by alterations in skin color). The formulation of Impetex is particularly indicated in the treatment of skin infections that produce fluid and in moist areas of the skin, such as the anal region and armpits, where it is appropriate to use a base with

high water content. Impetex allows the fluid to flow and induces rapid evaporation and
drying of the skin. The preparation does not leave a greasy residue on the skin and is therefore also suitable for
application on the face and on exposed areas of the skin.
See your doctor if you do not feel better or if you feel worse.

2. What you need to know before using Impetex

Do not use Impetex

• if you are allergic to chlorchinaldole or diflucortolone or any of the other ingredients of this medicine (listed in section 6)
• if the area of skin to be treated is affected by tuberculosis (an infectious disease)
• if the area of skin to be treated is affected by viral infections (for example herpes, chickenpox, etc.)
• if the area of skin to be treated is affected by rosacea acne (redness and scaling that characterize certain areas of the face)
• if you have lesions and/or wounds on the area of skin to be treated (skin ulcers).

Do notuse Impetex for the eyes.

Warnings and precautions
Consult your doctor or pharmacist before using/giving Impetex to your child.
During treatment, the doctor will monitor your condition to detect early any signs and
symptoms that may occur due to excessive use of corticosteroids (anti-inflammatory drugs) due to
long-term and/or high-dose treatments (see section 4 “Possible side effects”).
Contact your doctor if you experience blurred vision or other visual disturbances.

If you use Impetex for a long period of time and/or if you use it on large areas of the body, the

following effects may occur:

• allergic reactions (see section 4 “Possible side effects”). The use, especially if prolonged, of topical products like Impetex can give rise to this effect
• reactions affecting the whole body following absorption: Cushing's syndrome (a disease that manifests with a moon face, weight gain, fluid retention, reduced sugar tolerance and increased risk of diabetes, swelling of the legs, headache, etc.) and hormonal disorders
• development of bacteria and/or fungi against which this medicine is not effective. In this case, the doctor will adopt the appropriate therapy.

Occlusive dressing (dressing with gauze or other material to locally maintain the applied medicines

on the skin)

Do notapply an occlusive dressing during treatment with Impetex, as the above-mentioned effects
(Cushing's syndrome and hormonal disorders) occur more frequently with occlusive dressing.
However, if your doctor deems an occlusive dressing necessary, avoid using plastic wrap (household wrap) for the dressing as it can cause allergic reactions.

Children and adolescents
In infants and children under 4 years of age, the doctor will generally notcontinue therapy beyond
3 weeks, especially if the areas to be treated are covered by diapers or plastic pants, as the
skin folds and the diaper can act as an occlusive dressing (see section “Warnings and
precautions”).
In children, the development of systemic side effects (Cushing's syndrome and hormonal disorders) due to
local application of the corticosteroid contained in this medicine to large areas of the skin and/or for
long periods of time is more frequent compared to adults, especially in case of occlusive dressing.

Other medicines and Impetex
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
No known possible interactions with other medicines have been reported.

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

Pregnancy
Generally, if you are pregnant, use this medicine only if necessary under
direct medical supervision.
During the first 3 months of pregnancy, do not use large amounts and/or for long periods of time topical medicines based on corticosteroids.

Breastfeeding
If you are breastfeeding, use this medicine under direct medical supervision.

Driving and operating machinery
Impetex does not impair the ability to drive vehicles or operate machinery.

Impetex containsStearyl alcohol
It may cause localized skin reactions (e.g., contact dermatitis).

3. How to use/Impetex

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.
The recommended dose will be established by your doctor.
Generally, in the initial phase of treatment, the cream should be applied 2-3 times a day, spreading it in a thin layer. Based on the doctor's assessments, treatment may continue with only 1 application per day.
In the treatment of conditions requiring prolonged therapies, the doctor will assess how to reduce the dose and the frequency of applications to the minimum necessary to control your symptoms and prevent them from recurring, and will stop using this medicine as soon as possible.
In case of application to the face, avoidcontact with the eyes (see paragraph “Do not use/give to your child Impetex”).

Use in children
In infants and children under 4 years of age, the doctor will generally notcontinue therapy for more than 3 weeks, especially if the areas to be treated are covered by diapers or plastic underwear, as the folds of the skin and the diaper can act as an occlusive dressing (see paragraph “Warnings and precautions”).

Duration of treatment
The duration of therapy is established by your doctor.
In all cases, the doctor will limit the use of this medicine to short periods of time.

If you use more Impetex than you should
There are no known cases of overdose with this medicine.

If you forget to use Impetex
Do not use a double dose to make up for a missed dose.

If you stop using Impetex
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience the following side effects during treatment with Impetex, contact your doctor immediatelyas they will STOPtreatment with Impetex:

• allergic reactions that may manifest with the following symptoms:
• local redness
• edema (swelling)
• desquamation (scaling)
• pruritus (itching). These side effects occur especially after prolonged use of this medicine. In these cases, the doctor, after stopping treatment with Impetex, will adopt appropriate therapy.

Blurred vision may occur with an unknown frequency (cannot be defined based on available data).
In addition, the following side effects may occur for which the frequency has not been established.

Effects relating to the skin

• increased hair growth (hypertrichosis)
• acne, pustules (acneiform eruptions)
• skin atrophy (the skin becomes thin and inelastic)
• presence of lighter areas of skin (hypopigmentation)
• red streaks on the skin
• red spots on the skin (purpura)
• inflammation of the skin with pustules, especially on the face, which may occur after discontinuation of therapy (rebound pustular dermatitis). This side effect occurs after prolonged treatments.

Effects relating to the heart and blood vessels

• permanent dilation of capillaries (telangiectasias)
• fragility of blood vessels.

The following effects may occur due to excessive use of corticosteroids (such as that contained in
Impetex, diflucortolone valerate) due to long-term treatments and/or high doses:

• high blood pressure (arterial hypertension)
• heart rhythm disturbances.

Effects relating to the whole organism

• weakness, even severe (asthenia and adynamia). The following effects may occur due to excessive use of corticosteroids (anti-inflammatory drugs, such as diflucortolone valerate) due to long-term treatments and/or high doses. Effects relating to metabolism and nutrition
• decreased potassium levels in the blood
• decreased acids in the blood (metabolic alkalosis). The following effects may occur due to excessive use of corticosteroids (anti-inflammatory drugs, diflucortolone valerate) due to long-term treatments and/or high doses.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. .
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Impetex

Keep this medicine out of the sight and reach of children.
This medicine does not require any particular storage conditions.
Do not use this medicine after the expiry date which is reported on the pack after EXP. The expiry date
refers to the last day of that month.
Do not use this medicine if you notice if the tube is not intact.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines that are no longer used. This will help protect the environment.

6. Contents of the pack and other information

What Impetex contains

• the active ingredients are: chlorquinaldol and diflucortolone valerate (100g of cream contain 1g of chlorquinaldol and 0.1g of diflucortolone valerate respectively)
• the other ingredients are: polyethylene glycol monostearate, stearyl alcohol(see paragraph “Impetex contains stearyl alcohol”), liquid paraffin, white petrolatum, sodium edetate, carbomer, sodium hydroxide, purified water.

Description of the appearance of Impetex and contents of the pack
Impetex is presented as a slightly yellow cream for topical use packaged in a 30 g tube.

Marketing Authorisation Holder
TEOFARMA S.r.l. – Via F.lli Cervi, 8 – 27010 Valle Salimbene (PV)

Manufacturer
TEOFARMA S.r.l. – Viale Certosa, 8/A – 27100 Pavia