Macmiror^® (Tablets) Instructions for Use

Marketing Authorization Holder

Polichem S.r.L. (Italy)

Manufactured By

Doppel Farmaceutici, S.r.l. (Italy)

ATC Code

G01AX05 (Nifuratel)

Active Substance

Nifuratel (Rec.INN registered by WHO)

Dosage Form

Macmiror®

Film-coated tablets, 200 mg: 20 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white, round, biconvex.

Excipients: corn starch – 60 mg, rice starch – 5 mg, macrogol-6000 (polyethylene glycol-6000) – 15 mg, talc – 30 mg, magnesium stearate – 2.5 mg, gelatin – 2.3 mg, acacia gum (gum arabic) – 2.3 mg.

Shell composition sucrose – 150 mg, magnesium carbonate – 33 mg, titanium dioxide – 0.9 mg, wax – 0.3 mg.

10 pcs. – blisters (2) – cardboard packs.

Clinical-Pharmacological Group

Antibacterial drug, a derivative of nitrofuran

Pharmacotherapeutic Group

Antimicrobial agents and antiseptics used in gynecology; antimicrobial agents and antiseptics, except combinations with corticosteroids; other antimicrobial agents and antiseptics

Pharmacological Action

Antimicrobial drug, a derivative of nitrofuran. It has antiprotozoal, antibacterial, and antifungal action. It has low toxicity.

Highly active against Gram-positive and Gram-negative microorganisms (at MIC 12.5-25 µg/ml it suppresses from 44.3% to 93.2% of cultures).

Active against Enterococcus faecalis, Enterococcus faecium, Staphylococcus aureus, Bacillus subtilis, Escherichia coli, Shigella flexneri, Shigella sonnei, Salmonella typhi, Salmonella typhimurium, Salmonella enterica, Klebsiella spp., Enterobacter spp., Serratia spp., Citrobacter spp., Morganella spp., Rettgerella spp., Pragia fontium, Budvicia aquatica, Rachnella aquatilis, Acinetobacter spp., other atypical enterobacteria, as well as protozoa (including against the causative agents of intestinal amoebiasis and giardiasis), fungi of the genus Candida, Trichomonas vaginalis; less active against Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa. Suppresses the activity of Lactobacillus acidophilus.

It is the drug of choice for the therapy of salmonellosis, shigellosis and other intestinal bacterial infections.

Especially effective against Helicobacter pylori strains resistant to metronidazole.

Pharmacokinetics

After administration, it is rapidly absorbed from the gastrointestinal tract. Penetrates the blood-brain barrier and the placental barrier, excreted in breast milk. Biotransformed in the liver and in muscle tissue. Completely excreted in the urine (30-50% unchanged).

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to nifuratel: vulvovaginal infections; urinary tract infections; intestinal amoebiasis; giardiasis; chronic inflammatory diseases of the upper gastrointestinal tract associated with Helicobacter pylori.

ICD codes

Dosage Regimen

Administer the tablets orally with water.

For adults, the typical single dose is 200 mg to 400 mg.

For children, calculate the dose based on 10 mg/kg to 30 mg/kg per single administration.

For urogenital infections in adults, take 600 mg daily, divided into three doses of 200 mg each.

Continue this urogenital treatment for a minimum of 7 days.

For intestinal amoebiasis, administer 400 mg two to three times daily.

The treatment course for intestinal amoebiasis is typically 10 days.

For giardiasis in adults, take 400 mg two to three times daily for 7 days.

For giardiasis in children, administer 15 mg/kg twice daily.

In Helicobacter pylori eradication regimens, use a dose of 400 mg twice daily.

Adhere strictly to the duration of therapy prescribed for the specific indication.

Do not exceed the recommended daily dosage.

For vaginal infections, concurrent local therapy is often required.

Adverse Reactions

From the digestive system nausea, vomiting, bitter taste in the mouth, diarrhea, heartburn, gastralgia.

Allergic reactions skin rash, itching.

Contraindications

Hypersensitivity to nifuratel.

Use in Pregnancy and Lactation

Use during pregnancy is possible only for strict indications, when the intended benefit to the mother outweighs the potential risk to the fetus, because Nifuratel penetrates the placental barrier.

If it is necessary to use the drug during lactation, the issue of discontinuing breastfeeding should be decided, because Nifuratel is excreted in breast milk.

Special Precautions

When treating vaginal infections, local therapy is carried out simultaneously with oral administration of nifuratel.

During treatment, sexual intercourse should be avoided.

Drug Interactions

Nifuratel enhances the antifungal effect of nystatin.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.