Macmiror complex

Leaflet attached to the packaging: patient information

Macmiror Complex, (100 mg + 40,000 IU)/g, vaginal cream
Nifuratel + Nystatin

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

• Please keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a 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 Complex and what is it used for
• 2. Important information before using Macmiror Complex
• 3. How to use Macmiror Complex
• 4. Possible side effects
• 5. How to store Macmiror Complex
• 6. Contents of the packaging and other information

1. What is Macmiror Complex and what is it used for

Macmiror Complex contains two active substances: nifuratel and nystatin.
Nifuratel is a synthetic compound that effectively acts against protozoa, bacteria, and fungi that most commonly cause vaginal infections.
Nystatin is an antibiotic with antifungal action, primarily acting on fungi of the Candida spp.genus.
Indications for using Macmiror Complex:

• Treatment of vaginal and vulvar infections caused by: fungi of the Candida spp.genus, vaginal trichomoniasis (Trichomonas vaginalis), bacteria.

The use of nifuratel and nystatin in one medicine makes Macmiror Complex effective in treating vaginal and vulvar infections caused by fungi of the Candida spp.genus, vaginal trichomoniasis (Trichomonas vaginalis), and bacteria.
Nifuratel and nystatin used together are more effective in patients with fungal and other vaginal infections than either of these substances used separately. Effective treatment of vaginal infections leads to the restoration of physiological conditions and reduces the risk of future infections. The medicine does not destroy lactic acid bacteria, which play a protective role and are present in the vagina of healthy women. Nystatin and nifuratel used locally - in the vagina - do not penetrate the bloodstream and do not affect the entire body.

2. Important information before using Macmiror Complex

When not to use Macmiror Complex

Warnings and precautions

Before starting to use Macmiror Complex, you should discuss it with your doctor or pharmacist.
Like all anti-infective medicines, during long-term use of Macmiror Complex, an allergy may occur. If during treatment, an allergy occurs or worsens, e.g., burning sensation, itching, you should stop using the medicine and inform your doctor, who may change the treatment method if necessary.
During treatment, patients should not have sexual intercourse. It is recommended that the sexual partner takes nifuratel orally at the same time.
The medicine is intended for use under medical supervision.

Using Macmiror Complex in elderly patients

Macmiror Complex can be used by elderly patients.

Macmiror Complex and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
No interactions with other medicines have been reported so far.
You should not use other vaginal medicines, including those available without a prescription, without consulting your doctor.

Macmiror Complex with food and drink

Macmiror Complex can be used independently of food and drink.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
The use of Macmiror Complex during pregnancy and breastfeeding is decided by the doctor. It is not known whether the medicine's metabolites pass into breast milk.
In any case, during pregnancy and breastfeeding, Macmiror Complex should only be used under the direct supervision of a doctor, in a situation of absolute necessity, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the mother.

Driving and using machines

Macmiror Complex does not affect the ability to drive and use machines.

Macmiror Complex contains:

• 50 mg of propylene glycol in 1 gram of cream,
• methyl p-hydroxybenzoate (E 218) and propyl p-hydroxybenzoate. The medicine may cause allergic reactions (possible late reactions).

3. How to use Macmiror Complex

This medicine should always be taken according to the doctor's or pharmacist's recommendations.
If you have any doubts, you should consult a doctor or pharmacist.
Recommended dose
Macmiror Complex should be used once a day (in the evening) or twice a day (in the morning and evening) according to the doctor's recommendations.
One dose is 2.5 g of cream, applied to the vagina using an applicator with a scale.

Using Macmiror Complex in children and adolescents

School-age girls should be given half the dose recommended for adult patients, i.e., 1.25 g of cream using a micro-applicator.
Method of administration
The cream should be inserted deep into the vagina using a scaled applicator or a micro-applicator in patients who have not started sexual intercourse.
The packaging includes one plastic applicator with a micro-applicator for multiple use.
The frequency of use and duration of treatment will be determined by the doctor, taking into account the effectiveness of the treatment in the individual patient.
Treatment should be completed before menstruation.

Instructions for using the applicator (see diagram below point 1):

The applicator should be screwed onto the tube and the required amount of cream should be squeezed into it (the numbers on the applicator correspond to the number of grams of cream) - during squeezing, the plunger will move out automatically.
Then, unscrew the applicator, insert its tip into the vagina, and press the plunger to introduce the cream into the vagina.

Instructions for attaching the micro-applicator (see diagram below):

• 1. The applicator should be screwed onto the tube and the required amount of cream should be squeezed into it (the numbers on the applicator correspond to the number of grams of cream) - during squeezing, the plunger will move out automatically.
• 2. Pull out the micro-applicator, which is located inside the plunger.
• 3. The micro-applicator should be screwed onto the transparent applicator tube with a scale after unscrewing it from the tube.
• 4. Insert the tip of the micro-applicator into the vagina and press the plunger to introduce the cream into the vagina.
• 5. After use, the applicator and/or micro-applicator should be thoroughly washed to prepare for the next use.

Using a higher dose of Macmiror Complex than recommended

Due to the route of administration and the fact that the medicine is not absorbed and does not act systemically, overdose is very unlikely.
So far, no cases of overdose have been reported.

Stopping the use of Macmiror Complex

You should not stop treatment without consulting your doctor, as it may be ineffective.
If you have any further doubts about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Macmiror Complex can cause side effects, although not everybody gets them.
Very rare(may occur less frequently than in 1 in 10,000 people): contact dermatitis, urticaria, vaginal burning, vaginal itching.
Vaginal burning and itching at the site of application are usually mild and resolve on their own.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to:
Department for Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje 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.
Reporting side effects will allow for more information to be collected on the safety of the medicine.

5. How to store Macmiror Complex

The medicine should be stored out of sight and reach of children.
Store at 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 specified month.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Macmiror Complex contains

• The active substances of the medicine are nifuratel and nystatin. 1 g of cream contains 100 mg of nifuratel and 40,000 IU of nystatin.
• The other excipients are: xalifin 15 (polyglycolic acid ester), methyl p-hydroxybenzoate (E 218), propyl p-hydroxybenzoate, glycerol, sorbitol 70%, propylene glycol, carbomer, triethanolamine, purified water.

What Macmiror Complex looks like and what the packaging contains

Macmiror Complex is a vaginal cream.
The packaging of the medicine is an aluminum tube containing 30 g of cream, in a cardboard box.
The cardboard box also contains a scaled applicator used to insert the cream into the vagina.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Polichem S.A.
50, Val Fleuri

• L – 1526 Luxembourg

Manufacturer:

Doppel Farmaceutici S.r.l
Via Martiri delle Foibe, 1
I-29016-Cortemaggiore -Piacenza
Italy

Representative of the marketing authorization holder:

Angelini Pharma Polska Sp. z o.o.
Aleje Jerozolimskie 181B, 02-222 Warsaw
tel.: (22) 70 28 200
e-mail: angelini@angelini.pl
A 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 update of the leaflet:May 2023