MACMIROR COMPLEX®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT MACMIROR COMPLEX®

Composition:

Active substances: nifuratel, nystatin;

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

Excipient: dimethicone (dimethylpolysiloxane AK 1000);

Capsule shell composition: gelatin, sodium ethylparahydroxybenzoate (E 215), sodium propylparahydroxybenzoate (E 217), glycerin, titanium dioxide (E 171), yellow iron oxide (E 172).

Pharmaceutical form. Vaginal soft capsules.

Main physicochemical properties: soft oval-shaped gelatin capsules of mustard color containing a light yellow oily suspension.

Pharmacotherapeutic group. Antimicrobial and antiseptic agents used in gynecology. Antibiotics. Nystatin combinations. ATC code G01A A51.

Pharmacological properties.

Pharmacodynamics.

The medicinal product MACMIROR COMPLEX**®** combines the active ingredients nitrofurantoin and nystatin. Nitrofurantoin is a chemical medicinal substance synthesized by the POLI research laboratory, capable of effectively destroying trichomonads, bacteria, and fungal microorganisms.

Nystatin is a well-known antifungal antibiotic, effective in the treatment of candidiasis.

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

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

Pharmacokinetics.

When the drug is administered, its components are not absorbed and do not produce systemic effects.

Clinical characteristics.

Indications.

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

Contraindications.

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

Interaction with other medicinal products and other forms of interaction.

Clinically significant interaction of the drug with other medicinal products has not been established.

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

Special precautions for use.

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

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

Sexual intercourse should be avoided during treatment with this drug.

Simultaneous treatment of the sexual partner is necessary to prevent re-infection.

This medicinal product contains sodium ethylparahydroxybenzoate and sodium propylparahydroxybenzoate, which may cause allergic reactions (possibly delayed).

Use during pregnancy or breastfeeding.

The use of the drug is not recommended during pregnancy. Breastfeeding should be discontinued during treatment.

Ability to influence reaction rate while driving or operating machinery.

The drug does not affect the reaction rate while driving or operating machinery.

Method of Administration and Dosage.

Insert 1 vaginal capsule every evening before bedtime.

To achieve maximum therapeutic effect, the capsule should be inserted into the upper part of the vagina.

Treatment duration: 8 days.

Children. The drug is not intended for use in children.

Overdose.

Cases of overdose are unknown.

Side effects.

Skin and subcutaneous tissue disorders: very rare – allergic reactions including rash, pruritus, contact dermatitis, urticaria.

General disorders and administration site conditions: very rare – vaginal pruritus, burning sensation.

Immune system disorders: frequency unknown – hypersensitivity reactions.

Shelf life. 3 years.

Storage conditions.

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

Packaging. 8 vaginal capsules in one blister, packed in a cardboard box.

Prescription category. Prescription only.

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

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

Manufacturer’s name and address of the manufacturing site.

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

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

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