MECLON CREAM VAG 30G 20%+4%+6A

MECLON

active ingredients

Vaginal cream 100 g contain: Active ingredients: Metronidazole 20 g; Clotrimazole 4 g. Excipient: contains sodium methyl p-hydroxybenzoate and sodium propyl p-hydroxybenzoate. For the full list of excipients, see paragraph 6.1. Vaginal solution 10 ml bottle 10 ml contain: Active ingredient: Clotrimazole 200 mg. 130 ml bottle 130 ml contain: Active ingredient: Metronidazolo 1 g. For the full list of excipients, see paragraph 6.1.

Excellent

Vaginal cream. Excipients: Glycol and polyethyleneglycol stearate; Liquid paraffin; Methyl sodium p-hydroxybenzoate; Sodium propile p-hydroxybenzoate; Purified water. Vaginal solution. 10 ml bottle: Excipients: Ricinol alcohol; Ethanol; Purified water. 130 ml bottle: Excipients: Hydroxide sodium (for pH adjustment); Hydrochloric acid (for pH adjustment); Purified water.

Therapeutic indications

Vaginal cream: Cervico-vaginiti and vulvo-vaginiti caused by Trichomonas vaginalis although associated with Candida albicans, Gardnerella vaginalis and other sensitive bacterial flora. MECLON vaginal cream can also be used in the partner for prophylactic purposes. Vaginal Solution: Adjuvant in cervico-vaginiti therapy, vulvo-vaginiti caused by Trichomonas vaginalis even if associated with Candida albicans, Gardnerella vaginalis and other sensitive bacterial flora. MECLON vaginal solution can also be used after other topical or oral therapy, in order to reduce the risk of relapse.

Contraindications

Hypersensitivity to active ingredients or any of the excipients.

Population

Vaginal cream: Deeply administer in the vagina the content of an applicator once a day for at least six consecutive days, preferably in the evening before bedtime, or second prescription. In trichomoniasis, greater safety of therapeutic result occurs with the contemporary use of Metronidazole by mouth both in the non-pregnant woman and in the male partner. A supine position is recommended for optimal administration, with the legs slightly folded at the corner. To get better sterilization it is preferable to spread a little bit of MECLON vaginal cream also externally, at perivulva and perianal level. If the doctor prescribes the treatment of the partner for prophylactic purposes, the cream must be applied on the glans and on the foreskin for at least six days. Instructions for use: After filling with cream an applicator, administer the cream in the vagina by pressure on the piston, until completely emptying. Vaginal Solution: Administer the vaginal solution ready once a day, preferably in the morning, or second prescription. In the attack phase the use of the vaginal solution must be associated with adequate topical and/or oral therapy. Irrigation should be done preferably in supine position. A slow emptiness of the bottle will favour a longer stay in the vagina of the active ingredients and therefore a more effective antimicrobial and cleansing action. Instructions for use: After pouring the contents of the bottle into the bottle, insert the vaginal cannula on the neck of the bottle itself. Introduce the cannula into the vagina and administer the entire content.

Conservation

Vaginal cream: does not require any particular condition for conservation. Vaginal Solution: do not store at temperature above 25°C.

Warnings

Tell the patient to avoid contact with the eyes. The contemporary use of Metronidazole by mouth is subject to contraindications, side effects and warnings described for the above product. Avoid treatment with Meclon during the menstrual period. With metronidazole-containing medicines for systemic use, severe hepatotoxicity/acute liver failure was reported, including cases with fatal outcome, with very quick start after treatment in patients with Cockayne syndrome. Therefore, in this metronidazole population it must be used after careful assessment of the risk-benefit ratio and only in the absence of alternative treatments. The analysis of liver function must be carried out just before the start of therapy, during and after the end of treatment, until the parameters of liver function are returned to the norm or the values will not be reached at the base. If the values of liver function analysis should increase significantly during treatment, the drug must be stopped. Patients suffering from Cockayne syndrome should be advised of the need to immediately report to the doctor any symptoms of potential liver injury and to stop treatment with metronidazole.

Interactions

None.

Effects

Given the low absorption by local application of the active ingredients Metronidazole and Clotrimazole, the adverse reactions found with the topical formulations are limited to: Immune system disorders. Notable (frequency cannot be defined on the basis of available data): hypersensitivity reactions. Pathologies of skin and subcutaneous tissue. Very rare (frequency 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-reazioniavverse.

Overdosing

No overdose symptoms have been described.

In pregnancy the product must be used only in case of actual need and under the direct control of the doctor.

Source: Farmadati