Properties
- Form
- kafsula
- Dosage mg
- 500
- Pack
- 8
What is it?
Trade name of the preparation – Macmiror Complex International nonproprietary or group name Nifuratel + Nystatin Dosage form: Soft vaginal capsule Composition: One soft vaginal capsule contains: Active substance: Nifuratel 500 mg, Nystatin 200,000 IU; Excipients: Dimethicone Shell composition: Gelatin, Glycerin, Sodium ethyl parahydroxybenzoate, Sodium propyl parahydroxybenzoate, Titanium dioxide (E 171), Iron yellow oxide (E 172). See blog: Macmiror — gynecological antimicrobial and antiseptic agent Description: Soft vaginal oval-shaped beige capsules containing a yellowish oily suspension. Pharmacological group: Gynecological antimicrobial and antiseptic agents, excluding combinations with corticosteroids, antibiotics, Nystatin in combination with Nifuratel. Pharmacological properties Pharmacodynamics Macmiror Complex is a combination of Nifuratel and Nystatin. Nifuratel is a synthetic chemotherapeutic agent that has intense and effective trichomonacidal, antibacterial, and antifungal action. Nystatin is a well-known fungicidal antibiotic that is particularly active against Candida type fungi. The combination of Nifuratel and Nystatin provides a broad spectrum of antimicrobial action with in vitro antifungal, trichomonacidal, and antibacterial effects without causing any negative interactions between the two active substances. A positive interaction between the two active substances has indeed been confirmed regarding antifungal properties. Pharmacokinetics It is documented that during daily vaginal use in animals (rabbits and dogs) with daily dosages repeated over time, and equal to 30 times the therapeutic dose, the substances forming the combination are not absorbed and therefore do not cause systemic effects. Indications for use: Complex therapy of vulvo-vaginal infections caused by microorganisms sensitive to the preparation: Candida, Trichomonas, and bacteria. Contraindications: Hypersensitivity to any of the active ingredients or excipients. Method of administration and dosage regimen: 1 vaginal capsule once a day in the evening before bedtime for 8 days, or as recommended by a doctor. For maximum effect, the capsule should be inserted into the upper part of the vagina. Side effects The side effects listed below are classified according to MedDRA. Frequency is established as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), frequency unknown (frequency cannot be established based on available data). Organ system class | Frequency | Adverse reactions Disorders of the skin and subcutaneous tissues | Very rare | Isolated cases of allergic reactions (dermatitis, urticaria) General disorders and administration site conditions | Very rare | Burning sensation in the vagina, itching in the vagina Overdose No reports of overdose with Macmiror Complex have been reported. Interaction with other drugs: No reports of pharmacological interactions of Macmiror Complex with other drugs have been reported. Special instructions: The use of the preparation, especially for a prolonged period, may cause hypersensitivity reactions. It is necessary to discontinue the use of the preparation if hypersensitivity reactions occur. Sexual contact should be avoided during treatment. This preparation contains excipients such as sodium ethyl parahydroxybenzoate and sodium propyl parahydroxybenzoate, which may cause allergic reactions (including delayed). Use during pregnancy and lactation Pregnancy: There is no data, or only limited data, on the use of the combination of Nifuratel and Nystatin in pregnant women. During pregnancy, the preparation should be used only when absolutely necessary under strict medical supervision. Breastfeeding: It is not determined whether Nifuratel or Nystatin/metabolites are excreted in breast milk. In any case, during breastfeeding, it should be used only when absolutely necessary, taking into account the necessity of therapy for the woman and the benefit of breastfeeding for the child. Fertility: Fertility studies involving humans have not been conducted. Driving and operating machinery: Macmiror Complex does not affect the ability to drive vehicles and operate machinery. Dosage form and packaging: 8 capsules in an aluminum/PVC/PVDC blister. 1 blister is placed in a cardboard box with instructions for medical use. Shelf life: 3 years. Do not use after the expiry date. Storage conditions: Store below 25°C. Keep out of reach of children. Dispensing regime: Pharmaceutical product group - III, available without a prescription