Meclon vaginal solution 200 mg/10 ml + 1 g/130 ml 5 bottles + 5 cannulas

NAME
MECLON VAGINAL CREAM - VAGINAL SOLUTION

PHARMACOTHERAPEUTIC CATEGORY
Gynecological anti-infectives and antiseptics / combinations of imidazole derivatives.

ACTIVE PRINCIPLES
Metronidazole; clotrimazole.

EXCIPIENTS
Vaginal cream: glycol stearate and polyethylene glycol; liquid paraffin; sodium methyl p-Hydroxybenzoate; sodium propyl p-Hydroxybenzoate; purified water. >> Vaginal solution. 10 ml bottle: ricinoleyl alcohol; ethanol; purified water. Bottle of 130 ml: sodium methyl p-Hydroxybenzoate; sodium propyl p-Hydroxybenzoate; purified water.

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

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active ingredients or to any of the excipients.

DOSAGE
Vaginal cream: administer the contents of an applicator deeply into the vagina once a day for at least six consecutive days, preferably in the evening before going to bed, or according to medical prescription. In trichomoniasis, greater certainty of therapeutic result occurs with the simultaneous use of metronidazole by mouth both in the non-pregnant woman and in the male partner. For optimal administration, a supine position is recommended, with the legs slightly bent at an angle. To obtain a better sterilization it is preferable to spread a little vaginal cream also externally, at the perivulvar and perianal level. If treatment of the partner for prophylactic purposes is prescribed, the cream should be applied to the glans penis and 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 vaginal solution once a day, preferably in the morning, or according to medical prescription. During 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 the supine position. A slow emptying of the bottle will favor a more prolonged 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 vial into the bottle, insert the vaginal cannula on the neck of the bottle itself. Introduce the cannula into the vagina and administer the entire contents.

STORAGE
This medicinal product does not require any special storage conditions.

WARNINGS
Avoid contact with eyes. The simultaneous use of oral metronidazole is subject to the contraindications, side effects and warnings described for the aforementioned product. Avoid treatment with the drug during the menstrual period. Cases of severe hepatotoxicity / acute hepatic failure, including fatal outcome, with very rapid onset after initiation of treatment have been reported with metronidazole-containing medicinal products in patients with Cockayne syndrome. 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 are reached. If liver function test values increase significantly during treatment, the drug should be discontinued. Patients with Cockayne syndrome should be advised of the need to immediately report any symptoms of potential liver injury and to discontinue treatment with metronidazole.

INTERACTIONS
None.

SIDE EFFECTS
Given the poor absorption by local application of the active ingredients Metronidazole and Clotrimazole, the adverse reactions encountered with topical formulations are limited to. Disorders of the immune system. Not known: hypersensitivity reactions'. Skin and subcutaneous tissue disorders. Very rare (frequency <1 / 10,000): local irritation phenomena such as itching, allergic contact dermatitis, skin rashes. The possible occurrence of side effects involves the interruption of the treatment.

PREGNANCY AND BREASTFEEDING
During pregnancy, the product should be used only in case of real need.