MECLON - Vaginal Cream 20% + 4% for Vaginosis Vaginitis and Vulvovaginitis - 6 applicators

Meclon Vaginal Cream 30 g 20% ​​+ 4% + 6 Applications

Therapeutic indications

Vaginal cream Cervico-vaginitis and vulvo-vaginitis caused by Trichomonas vaginalis even if 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 the treatment of cervico-vaginitis, vulvo-vaginitis 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 recurrence.

Active ingredients

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

Excipients

Vaginal cream Excipients: Glycol stearate and polyethylene glycol; Liquid paraffin; Sodium methyl p-hydroxybenzoate; Sodium propyl p-hydroxybenzoate; Purified water. Vaginal solution 10 ml bottle Excipients: Ricinoleic alcohol; Ethanol; Purified water. 130 ml bottle Excipients: Sodium methyl p-hydroxybenzoate; Sodium propyl p-hydroxybenzoate; Purified water.

Contraindications

Hypersensitivity to the active substances or to any of the excipients.

Dosage

Vaginal cream Administer deeply into the vagina the contents of one applicator once a day for at least six consecutive days, preferably in the evening before going to bed, or as prescribed by a doctor. In trichomoniasis, greater certainty of the therapeutic result occurs with the simultaneous use of oral Metronidazole in both the non-pregnant woman and the male partner. For optimal administration, a supine position is recommended, with the legs slightly bent at an angle. To obtain better sterilization, it is preferable to spread a little MECLON vaginal cream also externally, at the perivulvar and perianal level. If the doctor prescribes treatment for the partner for prophylactic purposes, the cream must be applied to the glans and the foreskin for at least six days. Instructions for use : After filling an applicator with cream, administer the cream into the vagina by pressing the piston until completely empty. Vaginal solution Administer the ready-made vaginal solution once a day, preferably in the morning, or as prescribed by your doctor. In the attack phase, the use of the vaginal solution must be associated with adequate topical and/or oral therapy. Irrigation should preferably be performed in a supine position. Slow emptying of the bottle will allow the active ingredients to remain in the vagina for longer and therefore provide a more effective antimicrobial and cleansing action. Instructions for use : After pouring the contents of the vial into the bottle, insert the vaginal cannula into the neck of the bottle. Insert the cannula into the vagina and administer the entire contents.

Pregnancy and breastfeeding

During pregnancy, the product should be used only in case of real need and under the direct supervision of a doctor.

Conservation

This medicinal product does not require any special storage conditions.

Warnings

Instruct the patient to avoid contact with eyes. Concomitant oral use of Metronidazole is subject to the contraindications, side effects and warnings described for the above-mentioned product. Avoid treatment with Meclon during menstruation. Cases of severe hepatotoxicity/acute liver failure, including fatal cases, with very rapid onset after initiation of treatment in patients with Cockayne syndrome have been reported with metronidazole-containing medicinal products for systemic use. Therefore, in this population metronidazole should be used after careful risk-benefit assessment and only in the absence of alternative treatments. Liver function tests should be performed just before the start of therapy, during and after the end of treatment, until liver function parameters have returned to normal or baseline values ​​have been reached. If liver function test values ​​increase markedly during treatment, the drug should be discontinued. Patients with Cockayne syndrome should be advised to immediately report any symptoms of potential liver injury to their physician and to discontinue treatment with metronidazole.

interactions

None.

Side effects

Given the poor absorption of the active ingredients Metronidazole and Clotrimazole following local application, the adverse reactions observed with topical formulations are limited to: Immune system disorders : Not known (frequency cannot be estimated from the available data): hypersensitivity reactions. Skin and subcutaneous tissue disorders : Very rare (frequency <1/10,000): local irritation phenomena such as itching, allergic contact dermatitis, skin rashes. Any occurrence of side effects requires discontinuation of treatment.

Overdose

No symptoms of overdose have been described.