Macmiror

Leaflet attached to the packaging: patient information

Macmiror, 200 mg, film-coated tablets

Nifuratel

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Macmiror and what is it used for
• 2. Important information before taking Macmiror
• 3. How to take Macmiror
• 4. Possible side effects
• 5. How to store Macmiror
• 6. Package contents and other information

1. What is Macmiror and what is it used for

Macmiror contains the active substance nifuratel. Nifuratel is a synthetic compound that effectively acts against protozoa, bacteria, and fungi that most commonly cause vaginal infections.

Indications for use of Macmiror:

• Treatment of urinary tract infections caused by microorganisms sensitive to nifuratel.
• Treatment of vaginal and vulvar infections caused by: Trichomonas vaginalis, Candida spp., aerobic and anaerobic bacteria sensitive to nifuratel.
• Treatment of intestinal amoebiasis and giardiasis.

Macmiror is effective in all types of urogenital tract infections. Nifuratel has antibacterial effects on aerobic and anaerobic Gram-negative and Gram-positive bacteria: Gardnerella vaginalis, Escherichia coli, Shigella, Salmonella spp., Bacillus sp., Proteus spp., Klebsiella pneumoniae. Nifuratel does not affect Lactobacillus spp., which is a physiological component of the normal vaginal bacterial flora, making it easier and faster to treat vaginal infections and reducing the frequency of their recurrence. Nifuratel does not cause cross-resistance of microorganisms to other drugs used in infections. During 30 years of use of nifuratel, there have been no reports of such resistance.

2. Important information before taking Macmiror

When not to take Macmiror

Warnings and precautions

Before starting to take Macmiror, the patient should discuss it with their doctor or pharmacist. During treatment, patients should not have sexual intercourse. Concurrent use of nifuratel by the sexual partner may help prevent recurrence of the disease.

Children

It is not recommended to give Macmiror to children under 6 years of age.

Elderly patients

Macmiror can be used by elderly patients.

Macmiror and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. So far, no interactions between nifuratel and other medicines have been found.

Macmiror with food, drink, and alcohol

Macmiror should be taken whole (without chewing) after meals. The patient should avoid consuming alcohol while taking Macmiror, as it may cause sudden facial flushing, malaise, or nausea, although these symptoms disappear spontaneously.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. The decision to use Macmiror during pregnancy and breastfeeding is made by the doctor. As a precaution, Macmiror should be avoided during pregnancy and breastfeeding, unless it is absolutely necessary and only under the direct supervision of a doctor.

Driving and using machines

Macmiror does not affect the ability to drive and use machines. Macmiror contains sucrose.If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine. If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

3. How to take Macmiror

This medicine should always be taken according to the doctor's or pharmacist's recommendations. In case of doubts, the patient should consult their doctor or pharmacist. The dosage of the medicine depends largely on the type of disease, so the patient should follow the doctor's recommendations for treatment. The doctor may recommend additional tests, the results of which may affect the treatment.

In case the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor. Recommended doses:

• Treatment of urinary tract infections caused by microorganisms sensitive to nifuratel

Adult patients The recommended dose is 1 to 2 film-coated tablets 3 times a day, after meals. The dose size should be adjusted according to the severity and etiology of the infection. Treatment should be continued for 7 to 14 days, until the subjective symptoms disappear and the urine test results, including bacteriological ones, are normal. Children over 6 years old The recommended daily dose is 10 mg/kg body weight to 20 mg/kg body weight, given in two divided doses, after meals. Treatment should be continued for 7 to 14 days, until the subjective symptoms disappear and the urine test results, including bacteriological ones, are normal. Macmiror is a safe medicine, and if necessary, the treatment cycle can be repeated.

• Treatment of vaginal and vulvar infections caused by: Trichomonas vaginalis, Candida spp., aerobic and anaerobic bacteria sensitive to nifuratel

Adult patients The recommended daily dose is 4 film-coated tablets (800 mg) or 6 film-coated tablets (1200 mg), given in two or three divided doses of 2 tablets (400 mg) each. Treatment lasts 7 days, but if necessary, the medicine can be given for a longer period or the treatment cycle can be repeated. In cases of severe infection, topical medicines are used concurrently. In such cases, both the patient and their sexual partner should be treated with 3 tablets (600 mg) of Macmiror per day for 7 days, given in three divided doses of 1 tablet (200 mg) each. Macmiror should be taken after meals. Girls over 6 years old The recommended daily dose is 10 mg/kg body weight, given in two divided doses. Treatment usually lasts 7 days. The medicine should be taken after meals.

• Treatment of intestinal amoebiasis and giardiasis

Intestinal amoebiasis

Adult patients The recommended daily dose is 6 film-coated tablets (1200 mg), given in three divided doses of 2 tablets (400 mg) each, after meals. Treatment should be continued for 10 days. Children over 6 years old The recommended daily dose is 30 mg/kg body weight, given in three divided doses, after meals, for 10 days. Intestinal giardiasis

Adult patients The recommended daily dose is 4 film-coated tablets (800 mg) or 6 film-coated tablets (1200 mg), given in two or three divided doses of 2 tablets (400 mg) each. The medicine should be given after meals for 7 days. Children over 6 years old The recommended daily dose is 30 mg/kg body weight, given in two divided doses, after meals, for 7 days. Administration The medicine should always be taken orally, after a meal, with a large amount of fluid, and without chewing. In people in close contact with patients (e.g., family members, sexual partners), appropriate tests should be performed. If the microscopic examination of stool reveals the presence of parasites (cysts or trophozoites), treatment should be initiated. After completing the treatment cycle, its effectiveness should be verified by performing microscopic examinations of stool. In case of re-infection or if the treatment was ineffective, it should be prolonged or the treatment cycle repeated.

Taking a higher dose of Macmiror than recommended

No cases of overdose with Macmiror have been reported. If a higher dose of the medicine than recommended is taken, the patient should immediately consult their doctor.

Stopping treatment with Macmiror

Treatment should not be stopped without consulting a doctor, as it may be ineffective. If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Macmiror can cause side effects, although not everybody gets them. Rarely(may affect up to 1 in 10,000 people but more than 1 in 100,000 people):

• nausea.

Very rarely(may affect less than 1 in 10,000 people):

• vomiting, indigestion,
• allergic reactions such as skin rash, urticaria, or local edema.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel. +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Macmiror

The medicine should be stored out of sight and reach of children. Store in a temperature below 25°C. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Macmiror contains

• The active substance of Macmiror is nifuratel. One film-coated tablet contains 200 mg of nifuratel.
• The other ingredients are: cornstarch, polyethylene glycol 6000, talc, magnesium stearate, sucrose, magnesium carbonate, rice starch, gelatin, arabic gum, titanium dioxide, wax E.

What Macmiror looks like and what the pack contains

Macmiror is a film-coated tablet. The packaging is an Al/PVC blister pack in a cardboard box. The pack contains 20 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Polichem S.A. 50, Val Fleuri

• L – 1526 Luxembourg

Manufacturer:

Doppel Farmaceutici S.r.l Via Volturno 48 Quinto De’Stampi 20089 Rozzano (Milano) Italy

Representative of the marketing authorization holder:

Angelini Pharma Polska Sp. z o.o. Aleje Jerozolimskie 181B, 02-222 Warsaw tel.: (22) 702 82 00 e-mail: angelini@angelini.pl. The patient leaflet in a format suitable for the blind and visually impaired is available at the representative's office of the marketing authorization holder.

Date of last revision of the leaflet: