Pevaryl 1% 60 ml cutaneous solution external genitalia

Pevaryl 1% 60 ml cutaneous solution for external genitalia is a topical antifungal specifically formulated for the treatment of fungal infections affecting the external genitalia, such as vulvovaginal mycosis and mycotic balanitis . Its effectiveness is guaranteed by the presence of econazole , an active ingredient known for its action against a broad spectrum of fungal infections and yeasts responsible for itching, irritation and redness of the intimate area.

This 60 ml skin solution is ideal for external use and is a valid complement to local therapies, such as vaginal ovules or creams, for a targeted and complete action. Pevaryl 1% acts quickly by alleviating the symptoms of intimate itching and genital irritation , promoting the restoration of skin well-being and the natural protective barrier of the skin. The formulation is enriched with selected ingredients to ensure tolerability and comfort during application, making it suitable for both female and male hygiene.

Thanks to its targeted antifungal action , Pevaryl 1% cutaneous solution is particularly suitable for those seeking an effective treatment of external genital mycosis , offering a practical and safe solution to combat fungal infections and prevent relapses. The 60 ml format guarantees prolonged and practical use, ideal for daily hygiene and support for specific therapies prescribed by the doctor.

ACTIVE INGREDIENTS

Active ingredients contained in Pevaryl 1% 60 ml external genital skin solution - What is the active ingredient of Pevaryl 1% 60 ml external genital skin solution?

PEVARYL 1% vaginal cream 100 g of vaginal cream contain: active ingredient: econazole nitrate 1 g. Excipients with known effect: This medicine contains butylated hydroxyanisole and benzoic acid. PEVARYL 50 mg ovules 1 ovule contains: active ingredient: econazole nitrate 50 mg. PEVARYL 150 mg ovules 1 ovule contains: active ingredient: econazole nitrate 150 mg. PEVARYL 150 mg prolonged-release ovules 1 prolonged-release ovule contains: active ingredient: micronized econazole nitrate 150 mg. PEVARYL 1% cutaneous solution for external genitalia 100 ml of cutaneous solution for external genitalia contain: active ingredient: econazole 1.033 g. Excipients with known effect: This medicine contains benzyl alcohol and linalool (as a fragrance in perfume). For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Pevaryl 1% 60 ml external genital skin solution - What does Pevaryl 1% 60 ml external genital skin solution contain?

Vaginal cream: mixture of stearic acid esters with glycols; mixture of fatty acids with macrogol; vaseline oil; butylated hydroxyanisole ; benzoic acid ; purified water. Ovules 50 mg: mixture of synthetic triglycerides; mixture of synthetic glycerides. Ovules 150 mg: mixture of synthetic triglycerides; mixture of synthetic glycerides. Prolonged-release ovules 150 mg: galactomannan polysaccharide; colloidal silica; mixture of triglycerides of saturated fatty acids; mixture of synthetic triglycerides; stearyl heptanoate . Cutaneous solution for external genitalia: polysorbate 20; benzyl alcohol ; sorbitan monolaurate; N-[2-hydroxyethyl]-N-[2-(laurylamino)-ethyl]-aminoacetic acid; sodium salt of 3,6,9-trioxadocosyl sulfate; macrogol 6000 distearate; lactic acid; perfume n.4074 ; purified water.

DIRECTIONS

Therapeutic indications Pevaryl 1% 60 ml external genital skin solution - Why is Pevaryl 1% 60 ml external genital skin solution used? What is it used for?

Vulvovaginal mycoses Mycotic balanitis

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Pevaryl 1% 60 ml external genital skin solution - When should Pevaryl 1% 60 ml external genital skin solution not be used?

Pevaryl is contraindicated in patients with known hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1.

DOSAGE

Quantity and method of taking Pevaryl 1% 60 ml external genital skin solution - How to take Pevaryl 1% 60 ml external genital skin solution?

Women . Vaginal cream: 1 applicator (5 cc) filled with vaginal cream inserted into the vagina for 15 days every evening before going to bed. Treatment must be continued even after subjective complaints (itching, leukorrhea) have disappeared. 50 mg ovules: 1 ovule inserted deeply into the vagina, preferably in the supine position, every evening for 15 days. Treatment must be continued even after subjective complaints (itching, leukorrhea) have disappeared. 150 mg ovules: 1 ovule inserted deeply into the vagina, preferably in the supine position, every evening for three consecutive days. In the event of a relapse or if the control culture test is positive one week after treatment, a second cycle of therapy must be repeated. 150 mg prolonged-release ovules: therapy involves one day's treatment and consists of deeply inserting one ovule into the vagina, preferably in the supine position, in the morning and one in the evening. External genital skin solution: This pharmaceutical form is a suitable complement to therapy with vaginal ovules or cream. Cleanse the external genitals with 10 cc (1 dose) of solution dissolved in warm water. The treatment can be carried out once or twice a day. Men: Wash and dry the penis and then apply the cream to the glans and foreskin once a day for 15 consecutive days. Directions for use. Cream : Fill the applicator: 1. Remove the cap from the tube. 2. Use the tip on the top of the cap to pierce the operculum on the tube. 3. Screw the applicator onto the tube. 4. Press the tube from the bottom and fill the applicator until the piston stops. If the piston offers some resistance, pull it gently. Unless otherwise prescribed by your doctor, the applicator must be completely filled. 5. Unscrew the applicator from the tube. Replace the cap on the tube. Using the applicator: 1. Lying down, keep your knees bent and apart. 2. Holding the applicator at the end of the cannula, insert the filled applicator into the vagina as far as you feel comfortable. 3. Slowly push the plunger to release the cream into the vagina. 4. Remove the applicator from the vagina and throw it away (but not down the toilet). Children (2-16 years) : Safety and efficacy in children have not been established. Elderly : There are insufficient data on the use of PEVARYL in elderly patients over 65 years of age.

CONSERVATION

Storage Pevaryl 1% 60 ml external genital skin solution - How is Pevaryl 1% 60 ml external genital skin solution stored?

Ovules and prolonged-release ovules: do not store above 30°C. Vaginal cream: do not store above 25°C.

WARNINGS

Warnings Pevaryl 1% 60 ml external genital skin solution - About Pevaryl 1% 60 ml external genital skin solution it is important to know that:

Pevaryl Vaginal Cream and Ovules are for intra-vaginal use only. Pevaryl is not for ophthalmic or oral use. The simultaneous use of latex condoms or diaphragms with vaginal antimicrobial preparations may decrease the effectiveness of the latex contraceptive. Therefore, products such as PEVARYL should not be used together with diaphragms or latex condoms. Patients using spermicides should consult their doctor as any local vaginal treatment may render the spermicide inactive. PEVARYL should not be used together with other products for the internal or external treatment of the genitals. If marked irritation or sensitization occurs, treatment should be discontinued. Patients sensitive to imidazoles may be sensitive to econazole nitrate. Important information about some of the excipients : PEVARYL 1% vaginal cream contains butylated hydroxyanisole. May cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes. PEVARYL 1% vaginal cream contains benzoic acid. This medicine contains 10 mg of benzoic acid in each applicator equivalent to 2 mg/g of cream. Benzoic acid may cause local irritation. PEVARYL 1% cutaneous solution for external genitalia contains benzyl alcohol. This medicine contains 10.33 mg of benzyl alcohol per dose (10 cc) which is equivalent to 1.03 mg/ml of solution. Benzyl alcohol may cause allergic reactions. Benzyl alcohol may cause mild local irritation. PEVARYL 1% cutaneous solution for external genitalia contains linalool. This medicine contains fragrance with linalool. Linalool may cause allergic reactions.

INTERACTIONS

Interactions Pevaryl 1% 60 ml cutaneous solution external genitalia - Which medicines or foods can modify the effect of Pevaryl 1% 60 ml cutaneous solution external genitalia?

Econazole is a known inhibitor of cytochromes CYP3A4 and CYP2C9. Despite the limited systemic availability of the product after vaginal application (see section 5.2 Pharmacokinetic properties), clinically relevant interactions may occur and have been reported in patients receiving oral anticoagulants. Caution should be exercised and the anticoagulant effect should be monitored in patients taking oral anticoagulants such as warfarin or acenocoumarol. Dosage adjustment of the oral anticoagulant may be necessary during treatment with econazole and after its discontinuation.

SIDE EFFECTS

Like all medicines, Pevaryl 1% 60ml external genital skin solution can cause side effects - What are the side effects of Pevaryl 1% 60ml external genital skin solution?

The safety of Pevaryl gynaecological formulations has been evaluated in 3630 patients in 32 clinical studies. Based on the safety data collected from these clinical studies, the most commonly reported adverse drug reactions (ADRs) (incidence ≥ 1%) were (with incidence%): pruritus (1.2%) and burning sensation of the skin (1.2%). The table below reports the ADRs of PEVARYL gynaecological formulations, derived from both clinical studies and post-marketing experience, including the adverse reactions already reported above. The frequencies are reported according to the following convention: Very common (≥1/10); Common (≥1/100, <1/10); Uncommon (≥1/1,000, <1/100); Rare ( ≥1 /10,000, <1/1,000); Very rare (<1/10,000), Not known (frequency cannot be estimated from the available data). Table 1: Adverse Drug Reactions

Classification by systems and organs	Adverse drug reactions
	Frequency
	Common	Uncommon	Rare	Not Known
Immune system disorders				Hypersensitivity
Skin and subcutaneous tissue disorders	Itching, Burning sensation of the skin	Rash	Erythema	Angioedema, Urticaria, Contact dermatitis, Skin exfoliation
Reproductive system and breast disorders		Vulvovaginal burning sensation
Systemic disorders and conditions related to the administration site				Application site pain, Application site irritation, Application site swelling

In addition, cases of local allergic reactions have been reported. With the cutaneous solution, in particular, local sensitization phenomena may occur. Reporting of suspected adverse reactions . Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

Overdose Pevaryl 1% 60 ml external genital skin solution - What are the risks of Pevaryl 1% 60 ml external genital skin solution in case of overdose?

Adverse events associated with overdose or misuse of PEVARYL should be consistent with the adverse drug reactions listed in section 4.8 (Undesirable effects). Pevaryl is for topical use only. In case of accidental ingestion, treat with symptomatic therapy. If the product is accidentally applied to the eyes, wash with clean water or saline and consult a doctor if symptoms persist.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Pevaryl 1% 60 ml cutaneous solution external genitalia.

Pregnancy : Studies in animals have shown reproductive toxicity (see section 5.3). Due to vaginal absorption, PEVARYL should not be used during the first trimester of pregnancy unless the doctor considers it necessary for the health of the patient. PEVARYL can be used during the second and third trimesters if the potential benefits outweigh the possible risks to the fetus. Breastfeeding: After oral administration of econazole nitrate in lactating rats, econazole and its metabolites were excreted in milk and were found in the pups. It is not known whether econazole nitrate is excreted in human milk. Use PEVARYL with caution in breastfeeding patients. Fertility : Results from reproduction studies in animals have shown no effects on fertility (see section 5.3).

DRIVING AND USE OF MACHINERY

Taking Pevaryl 1% 60 ml external genital skin solution before driving or using machines - Does Pevaryl 1% 60 ml external genital skin solution affect driving or using machines?

None known.