Makmiror complex®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT MACMIROR COMPLEX®

Composition:

Active substances: nifuratel, nystatin;

100 g of cream contain: nifuratel 10 g, nystatin 4,000,000 IU;

Excipients: xyliphin 15; methylparahydroxybenzoate (E 218); propylparahydroxybenzoate (E 216); glycerol; sorbitol solution, non-crystallizing (E 420); propylene glycol; carbomer; triethanolamine; purified water.

Pharmaceutical form. Vaginal cream.

Main physicochemical properties: liquid, homogeneous yellow cream.

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

Pharmacological properties.

Pharmacodynamics.

MACMIROR COMPLEX® combines the active ingredients nifuratel and nystatin. Nifuratel is a synthetic medicinal substance developed 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 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 action.

Pharmacokinetics.

When the drug is applied, 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, and Candida species fungi.

Contraindications.

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

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 concomitantly with latex contraceptives, the risk of their damage increases.

Special precautions for use.

The use of the drug, especially over a prolonged period, 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 the excipients methylparahydroxybenzoate (E 218) and propylparahydroxybenzoate (E 216), which may cause allergic reactions (possibly delayed).

50 mg of propylene glycol is contained in 1 g of this medicinal product.

Use during pregnancy or breastfeeding.

The drug should not be used during pregnancy. Breastfeeding should be discontinued during treatment.

Fertility.

No studies on the effect on fertility in humans have been conducted.

Ability to influence reaction rate when driving or operating machinery.

No effect.

Method of Administration and Dosage

Apply 2.5 g of vaginal cream once or twice daily, in the evening and/or in the morning.

The required dose of vaginal cream should be administered using the provided dosing syringe.

Instructions for Using the Dosing Syringe

Screw the dosing syringe onto the tube of vaginal cream, then squeeze the tube until the required amount of cream reaches the syringe (refer to the markings indicating the amount in grams).

Unscrew the syringe from the tube, insert the syringe into the vagina, and press the plunger to administer the cream.

If necessary, the nozzle can be detached from the plunger and screwed onto the opposite end of the syringe before insertion into the vagina.

The plastic syringe is included in the packaging. After use, the syringe must be thoroughly washed for subsequent applications.

The duration of treatment is determined individually by the physician; usually, the treatment course lasts 8 days.

Children. The drug must not be used in children.

Overdose.

There are no risks associated with overdose.

Adverse reactions.

Adverse reactions are listed according to MedDRA system organ class and frequency: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).

Skin and subcutaneous tissue disorders: very rare: due to the presence of excipients methylparahydroxybenzoate (E 218) and propylparahydroxybenzoate (E 216), allergic reactions (possibly delayed) including rash, itching, contact dermatitis, urticaria may occur. Skin irritation may occur due to the presence of the excipient propylene glycol.

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

Immune system disorders: frequency not known: hypersensitivity reactions.

Shelf life. 3 years. Shelf life after first opening: 12 days.

Storage conditions.
Store at temperatures not exceeding 25 °C. Keep out of the reach and sight of children.

Packaging. 30 g of vaginal cream in an aluminum tube with an applicator (graduated syringe), packed in a cardboard box.

Prescription status. Prescription only.

Manufacturer. Doppel Farmaceutici S.r.l.

Address of manufacturer and place of business. Via Martiri delle Foibe, 1 – 29016 Cortemaggiore (PC) – Italy.