PEVARYL 6 OV VAG 150MG

PEVARYL

active ingredients

PEVARYL 1% vaginal cream 100 g vaginal cream contain: active ingredient: nitrate econazole 1g. Excipients with known effect: This medicine contains butilate hydroxanesol and benzoic acid. PEVARYL 50 mg ovum 1 ovum contains: active ingredient: econazole nitrate 50 mg. PEVARYL 150 mg ovum 1 ovum contains: active ingredient: nitrate econazole 150 mg. PEVARYL 150 mg prolonged release egg 1 prolonged release egg contains: active ingredient: micronized nitrate econazole 150 mg. PEVARYL 1% cutaneous solution for external genitals 100 ml cutaneous solution for external genitals contain: active ingredient: econazole 1,033 g. Excipients with known effect: This medicine contains benzyl alcohol and linalol (as fragrance in perfume). For the full list of excipients, see paragraph 6.1.

Excellent

Vaginal cream: stearic acid ester mixture with glycols; mix of fatty acids with macrogol; vaseline oil; hydroxyanisol buti; ; benzoic acid; purified water. Ovuli 50 mg: synthetic triglyceride mixture; synthetic glyceride mixture. Ovuli 150 mg: synthetic triglyceride mixture; synthetic glyceride mixture. Prolonged release eggs 150 mg: polisaccaride galattomannano; colloidal silica; mixture of triglycerides of saturated fatty acids; synthetic triglyceride mixture; stearil eptanoato. . Skin solution for external genitals: polysorbed 20; alcohol benzig; single-laurated sorbitan; acid N-[2-idrossietil] -NO-[2-(laurilamino) -etil] -aminoacetic sodium salt of 3,6,9-triossadocosilsulphate; macrogol 6000 distearate; lactic acid; perfume n.4074; purified water.

Therapeutic indications

Mycosis vulvovaginal Balanitis Mycotic

Contraindications

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

Population

Women. . Vaginal cream: 1 applicator (5 cc) filled with vaginal cream inserted in the vagina for 15 days each evening before bedtime. Treatment should also be protracted after the disappearance of subjective disorders (pruritus, leucorrea). 50 mg eggs: 1 egg introduced deeply into the vagina, preferably in supine position, every evening for 15 days. Treatment should also be protracted after the disappearance of subjective disorders (pruritus, leucorrea). 150 mg eggs: 1 egg introduced deeply into the vagina, preferably in supine position, every evening for three consecutive days. In the event of relapse or in the event that after a week of treatment the check crop examination will be positive, a second cycle of therapy will be repeated. Prolonged release ovules from 150 mg: therapy involves the treatment of one day and consists in introducing deeply into the vagina, preferably in supine position, an ovum in the morning and one in the evening. Skin solution for external genitals: this pharmaceutical form is a suitable supplement to therapy with ovules or vaginal cream. Determine the external genitals with 10 cc (1 dose) of dissolved solution in hot water. Treatment can be done once or twice a day. Men: Wash and dry the penis and then apply the cream on the glans and foreskin once a day for 15 consecutive days. Mode of use. Cream: Fill the applicator: 1. Remove the cap from the pipe. 2. Use the tip on the top of the cap to drill the operculum on the tube. 3. Screw the applicator on the pipe. 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. Put the cap on the pipe. Use the applicator: 1. In a relaxed position, keep your knees bent and widened. 2. Keeping the applicator at the end of the cannula, introduce the filler into the vagina until it feels comfortable. 3. Slowly push the piston to release the cream in the vagina. 4. Remove the applicator from the vagina and throw it away (but not inside the cabinet). Children (2-16 years): Safety and effectiveness in children has not been established. Seniors: There is no sufficient data on the use of PEVARYL in elderly patients aged over 65.

Conservation

Prolonged release eggs and eggs: do not store at temperature greater than 30°C. Vaginal cream: do not store at a temperature greater than 25°C.

Warnings

Pevaryl Vaginal cream and eggs are only for intra-vaginal use. Pevaryl is not for ophthalmic or oral use. The contemporary use of latex condoms or diaphragms with vaginal antimicrobial preparations can decrease the effectiveness of latex contraceptives. Therefore, products as PEVARYL should not be used together with diaphragms or latex condoms. Patients using spermicides should consult their physician since each local vaginal treatment can make spermicide inactive. PEVARYL should not be used together with other products for treatment, internal or external, of genitals. If marked irritation or sensitization occurs, treatment must be stopped. Imidazole sensitive patients may be sensitive to nitrate econazole. Important information about some excipients: PEVARYL 1% vaginal cream contains hydroxyanisol butilato. It can cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucosa. 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 can cause local irritation. PEVARYL 1% cutaneous solution for external genitals 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 can cause allergic reactions. Benzyl alcohol can cause mild local irritation. PEVARYL 1% cutaneous solution for external genitals contains linalol. This medicine contains fragrance with linalol. Linalol can cause allergic reactions.

Interactions

Econazole is a well-known cytochrome inhibitor CYP3A4 and CYP2C9. Despite the limited systemic availability of the product after the vaginal application (see paragraph 5.2 Pharmactical Properties) clinically relevant interactions may occur that have been reported in patients in oral anticoagulant therapy. In patients taking oral anticoagulants such as warfarin or acenocumarol it is necessary to use caution and the anticoagulant effect must be monitored. An adjustment of the dosage of the oral anticoagulant drug may be necessary during treatment with econazole and after its interruption.

Effects

The safety of Pevaryl's gynecological formulations has been assessed on 3630 patients in 32 clinical studies. Based on the safety data collected by these clinical trials, the most commonly reported adverse drug reactions (Adverse Drug Reactions, ADRs) were (with % incidence): itching (1.2%) and burning sensation of the skin (1.2%) The table below shows the ADRs of gynecological formulations of PEVARYL, deriving from both clinical studies and post-marketing experience, including adverse reactions already mentioned above. The frequencies are given in accordance with the following convention: Very common (≥1/10); Common (≥1/100, ≥ 1/10.000, Table 1: Adverse reactions from Farmaco

Classification for systems and organs	Drug adverse reactions
	Frequency
	Town	Not common	Rare	Note
Immune system disorders				Hypersensitivity
Pathologies of skin and subcutaneous tissue	Prurito, Burning sensation of the skin	Rash	Eritema	Angioedema, Orticaria, Contact Dermatitis, Skin Exfoliation
Pathologies of the reproductive apparatus and of the breast		Vulvovaginal burning sensation
Systemic pathologies and conditions for administration				Pain to the application site, Irritation to the application site, Inflator to the application site

In addition, cases of local allergic reactions were reported. With the skin solution, in particular, local sensitization phenomena can occur. Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

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

Pregnancy

: Animal studies showed reproductive toxicity (see paragraph 5.3). Because of vaginal absorption, PEVARYL should not be used in 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 quarter if potential benefits exceed the possible risks to the fetus.

Nursing:

After oral administration of nitrate econazole in nursing rats, econazole and its metabolites were excreted in milk and were found in small ones. It is not known if nitrate econazole is excreted in human milk. Use PEVARYL with caution in breastfeeding patients.

Fertility

: The results of animal reproduction studies showed no effect on fertility (see paragraph 5.3).

Source: Farmadati