Macmiror Complex - Package Leaflet

Indications Contraindications Precautions for use Dosage and method of use Undesirable Effects Shelf Life and Storage

Active ingredients: Nifuratel, Nystatin

MACMIROR COMPLEX 500 mg + 200,000 I.U. ova

Macmiror Complex package inserts are available for pack sizes:
  • MACMIROR COMPLEX 500 mg + 200,000 I.U. ova
  • MACMIROR COMPLEX 10 g + 4.000.000 I.U. cream

Why is Macmiror Complex used? What is it for?

PHARMACOTHERAPEUTIC CATEGORY

Antiprotozoal, antibacterial, antifungal.

THERAPEUTIC INDICATIONS

Polyvalent therapy of vulvovaginal diseases caused by pathogenic microorganisms: Candida, Trichomonas and bacteria.

Contraindications When Macmiror Complex should not be used

The product is contraindicated in patients hypersensitive to nystatin and nifuratel.

Precautions for use What you need to know before taking Macmiror Complex

The use, especially if prolonged, of the product can give rise to sensitization phenomena.

In the event of hypersensitivity reactions, the administration of the drug must be interrupted.

During the treatment refrain from sexual intercourse.

Dosage and method of use How to use Macmiror Complex: Dosage

One egg per day or according to medical prescription.

To obtain the most favorable therapeutic result, it is necessary that the eggs are brought, with a finger, to the highest part of the vagina.

Side Effects What are the side effects of Macmiror Complex

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 the appearance of undesirable effects, even those not described in the package leaflet.

Expiry and Retention

WARNING: Do not use the medicine after the expiry date indicated on the package.

This date refers to the intact product correctly stored.

Keep this medicine out of the reach and sight of children

COMPOSITION

Each egg contains: 500 mg nifuratel; nystatin U.I. 200,000;

Excipient: dimethylpolysiloxane AK 1000;

Components of the gelatinous shell: gelatin; glycerin; sodium ethyl-4-hydroxybenzoate; sodium propyl-4-hydroxybenzoate; titanium dioxide; yellow iron oxide.

PHARMACEUTICAL FORM AND CONTENT

12 vaginal suppositories

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.

More information on Macmiror Complex can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction04.6 Pregnancy and lactation04.7 Effects on the ability to drive and use machines04.8 Undesirable effects04.9 Overdose05.0 PHARMACOLOGICAL PROPERTIES05.1 Pharmacodynamic properties05.2 Pharmacokinetic properties05.3 Preclinical data of 06.0 PHARMACEUTICAL PARTICULARS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the immediate packaging and contents of the package 06.6 Instructions for use and handling 07.0 HOLDER OF THE ALL AUTHORIZATION "PLACING ON MARKETING 08.0 AUTHORIZATION NUMBER" PLACING ON MARKET09.0 DATE OF PR IMA AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIOPharmaceuticals, FULL DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIOPharmaceuticals, ADDITIONAL DETAILED INSTRUCTIONS ON ESTEMPORAN PREPARATION AND QUALITY CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

MACMIROR COMPLEX 500 MG + 200.000 I.U. OVULES

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each egg contains: 500 mg nifuratel; nystatin U.I. 200,000.

03.0 PHARMACEUTICAL FORM

Vaginal suppositories.

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

Polyvalent therapy of vulvovaginal diseases caused by pathogenic microorganisms: Candida, Trichomonas and bacteria.


04.2 Posology and method of administration

1 egg per day or according to medical prescription.

In order to obtain the most favorable therapeutic effect, it is necessary that the eggs are brought to the highest part of the vagina.


04.3 Contraindications

The product is contraindicated in patients hypersensitive to nystatin and nifuratel.


04.4 Special warnings and appropriate precautions for use

The prolonged use of the product can give rise to sensitization phenomena.

In the event of a hypersensitivity reaction, the administration of the drug must be interrupted.

During the treatment refrain from sexual intercourse.


04.5 Interactions with other medicinal products and other forms of interaction

No drug interactions have been described with the components of MACMIROR COMPLEX.


04.6 Pregnancy and lactation

There are no contraindications in this regard.


04.7 Effects on ability to drive and use machines

No adverse effects are reported.


04.8 Undesirable effects

No undesirable effects were reported.


04.9 Overdose

Not to be considered, given the route of administration.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

MACMIROR COMPLEX is made up of the "association of nifuratel and nystatin. Nifuratel is a synthetic chemotherapy, developed in the POLI Research Laboratories, which performs an" intense and effective trichomonicide, antibacterial and mycostatic action.

Nystatin is a well-known antibiotic with fungicidal action, particularly active on fungi of the genus Candida.

The nifuratel-nystatin association presents "in vitro" a broad spectrum of action with antifungal, trichomonicide and antibacterial effects, without establishing negative interactions between the two active ingredients.

Indeed, in an antifungal sense, an evident positive synergism between the two drugs was noted.


05.2 "Pharmacokinetic properties

It has been documented that, after vaginal use in animals (rabbit and dog) of daily doses repeated over time, equal to 30 times the therapeutic ones, the substances making up the association are not absorbed and therefore do not cause systemic effects.


05.3 Preclinical safety data

Vaginal LD50 in dogs> 60 DTS (human single therapeutic dose).

Prolonged vaginal administration in rabbits of up to 30 DTDs (human daily therapeutic dose) did not cause any toxic effects.

06.0 PHARMACEUTICAL INFORMATION

06.1 Excipients

Dimethylpolysiloxane AK 1000.

Capsule components: gelatin; glycerine; sodium ethyl-4-hydroxybenzoate; sodium propyl-4-hydroxybenzoate; titanium dioxide; yellow iron oxide.


06.2 Incompatibility

No incompatibilities have been reported.


06.3 Period of validity

36 months.


06.4 Special precautions for storage

Nothing to report


06.5 Nature of the immediate packaging and contents of the package

Lithographed box containing 12 eggs packed in Al / PVC + PVDC blisters.


06.6 Instructions for use and handling

Nothing to report.

07.0 MARKETING AUTHORIZATION HOLDER

Farmitalia S.r.l.

Viale Alcide De Gasperi 165 / B Catania

08.0 MARKETING AUTHORIZATION NUMBER

AIC. n ° 023432038

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION

12-10-1976/31-05-2005

10.0 DATE OF REVISION OF THE TEXT

April 2007

11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL

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