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

  • Alfasigma S.p.A.
  • 023703046

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 therapy 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 relapse.

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

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 therapy 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 relapse.

Dosage and method of use

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 bedtime, or according to medical prescription. In trichomoniasis, greater safety 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 MECLON vaginal cream also externally, at the perivulvar and perianal level. If the doctor prescribes the partner's treatment for prophylactic purposes, 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 plunger, until completely empty.Vaginal solution:Administer the prepared vaginal solution once a day, preferably in the morning, or according to medical prescription. 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 the supine position. A slow emptying of the bottle will favor 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 vial into the bottle, insert the vaginal cannula on the neck of the bottle. Introduce the cannula into the vagina and administer the entire contents.

Contraindications

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

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 (frequency cannot be estimated from the available data): hypersensitivity reactions.Skin and subcutaneous tissue disorders. Very rare (frequency Reporting of suspected adverse reactions. Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reaction via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioniavverse.

Special warnings

Tell the patient to 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 Meclon during the menstrual period. Cases of severe hepatotoxicity / acute hepatic failure, including cases with a fatal outcome, 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 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 to their physician and to discontinue treatment with metronidazole.

Pregnancy and breastfeeding

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

Expiration and retention

Vaginal cream:it does not require any particular conditions for conservation.Vaginal solution:do not store above 25 ° C.

Interactions with other drugs

None.

Overdose

No symptoms of overdose have been described.

Active principles

Vaginal cream100 g contain:Active principles: 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 10 ml bottle10 ml contain:Active principle: Clotrimazole 200 mg.Bottle of 130 ml130 ml contain:Active principle: Metronidazole 1 g. 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: Ricinoleyl alcohol; Ethanol; Purified water. Bottle of 130 ml: Excipients: Sodium hydroxide (for pH adjustment); Hydrochloric acid (for pH adjustment); Purified water.

023703046

Data sheet

Packaging
20% + 4% vaginal cream 30 g + 6 disposable applicators
Product Type
HUMAN DRUG
ATC code
G01AF20
ATC description
Associations of imidazole derivatives
Therapeutic Group
Antifungals
Active principle
clotrimazole + metronidazole
Class
C.
Pharmaceutical form
cream
Type of Administration
vaginal
Container
gel / ointment / cream / paste / ointment in tube
Quantity
1 tube
Capacity
30 grams
Quantity of the Active Ingredient
4G (clotrimazole) + 20G (metronidazole)
Recipe required
SOP - non-prescription medicine
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