Active ingredients: Metronidazole, Clotrimazole
MECLON "100 mg + 500 mg ova"
Meclon package inserts are available for pack sizes:- MECLON "100 mg + 500 mg ova"
- MECLON “20% + 4% vaginal cream
- MECLON "200 mg / 10 ml + 1 g / 130 ml vaginal solution"
Indications Why is Meclon used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Gynecological anti-infectives and antiseptics.
THERAPEUTIC INDICATIONS
Cervicitis, cervico-vaginitis, vaginitis and vulvo-vaginitis due to Trichomonas vaginalis even if associated with Candida or with a bacterial component
Contraindications When Meclon should not be used
Hypersensitivity to the active substances or to any of the excipients.
Precautions for use What you need to know before taking Meclon
Avoid contact with eyes.
The recommended simultaneous use of oral metronidazole is subject to the contraindications, side effects and warnings described for the aforementioned product.
Interactions Which drugs or foods can modify the effect of Meclon
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
Warnings It is important to know that:
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
According to the current regulations on the use of drugs and until you have more extensive experience, MECLON ovuli should be used in early childhood and in pregnant women - particularly in the 1st semester - under the direct supervision of the doctor and only in cases of actual need.
Effects on ability to drive and use machines:
MECLON does not affect the ability to drive or use machines
Dose, Method and Time of Administration How to use Meclon: Posology
The optimal therapeutic scheme is the following:
1 egg of MECLON in the vagina, once a day.
Side Effects What are the side effects of Meclon
Given the poor absorption after intravaginal application of the active ingredients contained in Meclon, the reported side effects 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 <1 / 10,000): local irritation phenomena such as itching, allergic contact dermatitis, skin rashes.
The possible occurrence of undesirable effects involves the interruption of the treatment
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects. It is important to inform the doctor or pharmacist of any undesirable effect, even if not described in the package leaflet.
Expiry and Retention
Attention: see the expiry date printed on the package
The expiry date refers to the product in intact packaging, correctly stored.
Warning: do not use the medicine after the expiry date shown on the package
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Keep this medicine out of the reach and sight of children.
COMPOSITION
A 2.4 g egg contains: Active ingredients: Metronidazole 500 mg; Clotrimazole 100 mg. Excipients: Hydrophilic mixture of mono, di, tri-glycerides of saturated fatty acids.
PHARMACEUTICAL FORM AND CONTENT
Eggs - 10 eggs
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
MECLON OVULES
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
A 2.4 g egg contains:
Active ingredients: Metronidazole 500 mg; Clotrimazole 100 mg.
For the full list of excipients, see section 6.1
03.0 PHARMACEUTICAL FORM
Ovules
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Cervicitis, cervico-vaginitis, vaginitis and vulvo-vaginitis due to Trichomonas vaginalis even if associated with Candida or with a bacterial component.
04.2 Posology and method of administration
The optimal therapeutic scheme is the following:
1 egg of MECLON in the vagina, once a day.
04.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients.
04.4 Special warnings and appropriate precautions for use
Avoid contact with eyes.
The recommended simultaneous use of oral metronidazole is subject to the contraindications, side effects and warnings described for the aforementioned product.
MECLON ovuli should be used in early childhood under the direct supervision of the doctor and only in cases of real need.
Keep this medicine out of the reach and sight of children.
04.5 Interactions with other medicinal products and other forms of interaction
None.
04.6 Pregnancy and lactation
During pregnancy, the product should only be used in case of real need and under the direct supervision of the doctor.
04.7 Effects on ability to drive and use machines
Meclon does not affect the ability to drive or use machines.
04.8 Undesirable 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 (pruritus frequency, allergic contact dermatitis, skin rashes.
The possible occurrence of undesirable effects involves the interruption of the treatment.
04.9 Overdose
No symptoms of overdose have been described.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Gynecological anti-infectives and antiseptics / Associations of imidazole derivatives - ATC code: G01AF20.
Mechanism of action / pharmacodynamic effects:
MECLON is a combination of metronidazole (M) and clotrimazole (C). (M) is a nitroimidazole derivative with a broad spectrum of antiprotozoal and antimicrobial action.
It has a direct trichomonicidal effect and is active on anaerobic Gram-positive cocci, spore-forming bacilli, Gram-negative anaerobes. It exhibits marked activity on Gardnerella vaginalis. It is not active on the vaginal acidophilic flora. (C) is an imidazole with a very broad antifungal spectrum (Candida, etc.). It is also active on Trichomonas vaginalis, Gram-positive cocci, Toxoplasmas, etc.
It has been documented that the Clotrimazole-Metronidazole combination gives rise to additive effects, therefore it is able to achieve three main therapeutic advantages:
1) Broadening of the spectrum of antimicrobial action, by adding together the effects of the two active ingredients;
2) Enhancement of the antifungal, antiprotozoal and antibacterial activity;
3) Abolition or delay in the appearance of resistance phenomena.
In vitro microbiological studies have shown that the trichomonicide and antifungal activity is enhanced when (M) and (C) are associated in the same proportions that are present in MECLON. The antibacterial activity examined on different strains of microorganisms was also high. and it has emerged an enhancement of it when the two active ingredients of MECLON are combined.
05.2 Pharmacokinetic properties
Pharmacokinetic investigations on rabbits, dogs and rats show that after repeated topical applications of MECLON no appreciable concentrations of Clotrimazole and Metronidazole are detected in the blood.
For vaginal application in women, (M) and (C) are absorbed in a percentage that varies between about 10% and 20%.
05.3 Preclinical safety data
The acute toxicity of MECLON in mice and rats (os) was very low, with a mortality of just 20% after 7 days, at very high doses (600 mg / kg of (C) and 3000 mg / kg of ( M), both alone and in partnership).In the subacute toxicity tests (30 days) MECLON, administered locally (genitally) in dogs and rabbits, did not cause any type of lesion, neither local nor systemic, even for doses many times higher than those commonly used in human therapy ( 3-10 Dtd in dogs and 100-200 Dtd in rabbits; 1 Dtd = therapeutic dose / day for humans = about 3.33 mg / kg of (C) and about 16.66 mg / kg of (M )).
MECLON administered during pregnancy by topical vaginal route in rabbits and rats did not show any signs of fetal distress for daily doses of 100 Dtd, nor any negative influence on the gestational state.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Excipients: Hydrophilic mixture of mono, di, tri-glycerides of saturated fatty acids.
06.2 Incompatibility
Incompatibilities with other medicines are unknown.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package
10 eggs in PVC shells, enclosed in a cardboard box.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
ALFA WASSERMANN S.p.A.
Registered office: Via E. Fermi, n. 1 - Alanno (PE)
Administrative office: Via Ragazzi del "99, n. 5 - Bologna
08.0 MARKETING AUTHORIZATION NUMBER
A.I.C. n. 023703010
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
27.11.1978 (OJ 16.01.1979) /01.06.2010
10.0 DATE OF REVISION OF THE TEXT
AIFA Determination of 27 October 2010
