Macmiror complex vaginal suppositories No. 8

Instructions for use Macmirror complex vaginal suppositories No. 8

Composition

active ingredients: nifuratel, nystatin;

1 capsule contains: nifuratel 500 mg, nystatin 200,000 IU;

excipient: dimethicone (dimethylpolysiloxane AK 1000);

shell composition: gelatin, sodium ethyl parahydroxybenzoate (E 215), sodium propyl parahydroxybenzoate (E 217), glycerin, titanium dioxide (E 171), iron oxide yellow (E 172).

Dosage form

Soft vaginal capsules.

Main physicochemical properties: soft gelatin capsules of an oval shape, mustard color, containing an oily light yellow suspension.

Pharmacotherapeutic group

Antimicrobial and antiseptic agents used in gynecology. Antibiotics. Nystatin, combinations. ATX code G01A A51.

Pharmacological properties

Pharmacodynamics

The drug MACMIROR COMPLEX® combines the active ingredients nifuratel and nystatin. Nifuratel is a chemical drug synthesized by the POLI research laboratory, capable of effectively destroying trichomonads, bacteria and fungal microorganisms.

Nystatin is a well-known antifungal antibiotic that is effective in treating candidiasis.

The combination of the active ingredients nifuratel and nystatin provides high antifungal efficacy, destroys trichomonads and bacteria, while the interaction of the two active ingredients has no negative consequences.

Moreover, the two medicinal substances complement and enhance each other's antifungal effects.

Pharmacokinetics

When using the drug, its components are not absorbed and do not cause systemic effects.

Indication

Complex therapy of vulvovaginal infections caused by pathogens sensitive to the drug: bacteria, trichomonads, fungi of the genus Candida.

Contraindication

Known individual hypersensitivity to the active ingredients of the drug or to other components of the drug.

Interaction with other medicinal products and other types of interactions

Clinically significant drug interactions with other drugs have not been established.

When used simultaneously with latex contraceptives, the risk of their damage increases.

Application features

Use of the drug, especially over a long period of time, may cause hypersensitivity reactions.

If signs of an allergic reaction occur, the drug should be discontinued.

You should refrain from sexual intercourse while using the drug.

It is necessary to treat the sexual partner at the same time to avoid re-infection.

This medicine contains sodium ethyl parahydroxybenzoate and sodium propyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed).

Use during pregnancy or breastfeeding

It is not recommended to use the drug during pregnancy. Breastfeeding should be discontinued during treatment.

Ability to influence reaction speed when driving vehicles or other mechanisms

The drug does not affect the reaction speed when driving or working with other mechanisms.

Method of administration and doses

Insert 1 vaginal capsule every evening before bedtime.

To achieve maximum therapeutic effect, it is necessary to insert the capsule into the upper part of the vagina.

The course of treatment is 8 days.

Children

The drug should not be used in children.

Overdose

Cases of overdose are unknown.

Side effects

Skin and subcutaneous tissue disorders: very rarely - allergic reactions, including rash, itching, contact dermatitis, urticaria.

General disorders and administration site conditions: very rarely - vaginal itching, burning.

On the part of the immune system: frequency unknown - hypersensitivity reactions.

Expiration date

3 years.

Storage conditions

Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.

Packaging

8 vaginal capsules in one blister, placed in a cardboard pack.

Vacation category

According to the recipe.

Producer

Doppel Pharmaceutici S.r.l., Italy (responsible for primary, secondary packaging, control and batch release);

Doppel Pharmaceutici S.r.l., Italy (responsible for the full production cycle); Catalent Italia S.p.A., Italy (bulk product manufacturer).

Location of the manufacturer and its business address.

Via Volturno, 48 – Quinto De'Stampi – 20089 Rozzano (MI), Italy;

Via Martiri delle Foibe, 1 – 29016, Cortemaggiore (RS), Italy;

Via Nettunense Km 20, 100 04011 Aprilia (LT), Italy.