Pevaryl 150 mg 6 ovules

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

INDICATIONS

Vulvovaginal mycosis Mycotic balanitis

ACTIVE INGREDIENTS

PEVARYL 1% vaginal cream 100 g of vaginal cream contain: active ingredient: econazole nitrate 1g. Excipients with known effect: This medicinal product 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: econazole micronized nitrate 150 mg. PEVARYL 1% cutaneous solution for external genitalia 100 ml of cutaneous solution for external genitalia contains: active ingredient: econazole 1.033 g. Excipients with known effect: This medicinal product contains benzyl alcohol and linalool (as fragrance in perfume). For the full list of excipients, see section 6.1.

EXCIPIENTS

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: blend of synthetic triglycerides; mixture of synthetic glycerides. Ovules 150 mg: blend of synthetic triglycerides; mixture of synthetic glycerides. Prolonged-release ovules 150 mg: galactomannan polysaccharide; colloidal silica; saturated fatty acid triglyceride mixture; blend of synthetic triglycerides; stearyl heptanoate. Skin 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-trioxadocosylsulfate; macrogol 6000 distearate; lactic acid; perfume n.4074; purified water.

CONTRAINDICATIONS AND SIDE EFFECTS

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

DOSAGE

Women. Vaginal cream: 1 applicator (5 cc) filled with vaginal cream inserted into the vagina for 15 days every evening before bedtime. The treatment must be continued even after the disappearance of the subjective complaints (itching, leukorrhea). 50 mg ovules: 1 egg inserted deeply into the vagina, preferably in a supine position, every evening for 15 days. The treatment must be continued even after the disappearance of the subjective complaints (itching, leukorrhea). 150 mg ovules: 1 egg inserted deeply into the vagina, preferably in a supine position, every evening for three consecutive days. In case of relapse or if the control culture test is positive one week after treatment, a second cycle of therapy will be repeated. 150mg Extended Release Ovules: the therapy involves a one-day treatment and consists of inserting one egg deeply into the vagina, preferably in a supine position, one egg in the morning and one in the evening. Skin solution for external genitalia: this pharmaceutical form is a suitable complement to therapy with ovules or vaginal cream. Cleanse the external genitalia 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. Instructions 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 below 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. Place the cap back on the tube. To use the applicator: 1. In a lying position, keep your knees bent and spread apart. 2. Holding the applicator at the end of the cannula, insert the filled applicator into the vagina as far as it feels comfortable. 3. Slowly push the piston 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 effectiveness in children has not been established. Elderly: There are insufficient data on the use of PEVARYL in elderly patients over 65 years of age.

CONSERVATION

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

WARNINGS

Pevaryl Vaginal Cream and Ovules are for intra-vaginal use only. Pevaryl is not for ophthalmic or oral use. Concomitant 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 make the spermicide inactive. PEVARYL must not be used together with other products for the treatment, internal or external, 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 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 medicinal product 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 can cause allergic reactions.

INTERACTIONS

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 used in patients taking oral anticoagulants such as warfarin or acenocoumarol and the anticoagulant effect should be monitored. A dosage adjustment of the oral anticoagulant drug may be necessary during treatment with econazole and after its discontinuation.

SIDE EFFECTS

The safety of Pevaryl gynecological formulations was evaluated on 3630 patients in 32 clinical studies. Based on the safety data collected from these clinical studies, the most commonly reported adverse drug reactions (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 the gynecological formulations of PEVARYL, deriving from both clinical studies and post-marketing experience, including the adverse reactions already reported above. 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

System organ class - Adverse drug reactions: Frequency.

System Organ Class - Adverse drug reactions: Common. Uncommon. Rare. Not Known.

Immune system disorders - Hypersensitivity

Skin and subcutaneous tissue disorders - Adverse drug reactions: Itching, burning sensation of the skin. Rash. Erythema. Angioedema, Urticaria, Contact dermatitis, Skin exfoliation.

Reproductive system and breast disorders - Vulvovaginal burning sensation.

General disorders and administration site conditions - Application site pain, Application site irritation, Application site swelling.

Furthermore, 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 medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. 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

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 or saline water and consult a doctor if symptoms persist.

PREGNANCY AND BREASTFEEDING

Pregnancy: Animal studies have shown reproductive toxicity (see section 5.3). Due to vaginal absorption, PEVARYL should not be used in the first trimester of pregnancy unless the doctor considers it necessary for the patient's health. 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 to 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 conducted in animals showed no effects on fertility (see section 5.3).

EFFECTS ON DRIVING ABILITY

None known.