Macmiror complex 500 mg

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Macmiror Complex 500 (Macmiror Complex)
500 mg + 200,000 I.U., vaginal soft capsules
Nifuratel + Nystatin
Macmiror Complex 500 and Macmiror Complex are different trade names for the same medicinal product.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Macmiror Complex 500 is and what it is used for
2. Important information before using Macmiror Complex 500
3. How to use Macmiror Complex 500
4. Possible side effects
5. How to store Macmiror Complex 500
6. Contents of the pack and other information

1. What Macmiror Complex 500 is and what it is used for

Macmiror Complex 500 contains two active substances: nifuratel and nystatin.
Nifuratel is a synthetic compound that acts effectively against protozoa, bacteria, and fungi commonly causing vaginal infections.
Nystatin is an antibiotic with antifungal activity, acting primarily against fungi of the genus Candida spp.

Indications for use of Macmiror Complex 500:

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

The combination of nifuratel and nystatin in a single medicinal product makes Macmiror Complex 500 effective in the treatment of vaginal and vulvar infections caused by Candida spp., Trichomonas vaginalis, and bacteria.
The simultaneous use of nifuratel and nystatin results in greater efficacy in patients with fungal and other vaginal infections than either substance used alone. Effective treatment of vaginal infections restores physiological conditions and reduces the risk of future infections. The medicine does not destroy Lactobacillus bacteria (lactic acid bacilli), which play a protective role and are present in the vagina of healthy women. Nystatin and nifuratel, when applied locally into the vagina, do not penetrate into the bloodstream and do not exert systemic effects on the body.

2. Important information before using Macmiror Complex 500

When not to use Macmiror Complex 500
If the patient is allergic to the active substances or to any of the other ingredients of this
medicinal product (listed in section 6).

Warnings and precautions
Before starting treatment with Macmiror Complex 500, consult a doctor or
pharmacist.
As with all antimicrobial agents, prolonged use of Macmiror Complex 500 may lead to sensitization. If irritation or worsening of symptoms such as burning sensation or itching occurs during treatment, discontinue use and inform the doctor, who may change the treatment if necessary.
During treatment, patients should abstain from sexual intercourse. Concurrent oral administration of nifuratel by the sexual partner is recommended.
This medicinal product is intended for use under medical supervision.

Use of Macmiror Complex 500 in elderly patients
Macmiror Complex 500 may be used by elderly individuals.

Macmiror Complex 500 and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for future use.
No interactions with other medicinal products have been reported to date.
Do not use other vaginal medicines concurrently, including those available without prescription, without consulting your doctor.

Macmiror Complex 500 with food and drink
Macmiror Complex 500 may be used independently of food and drink intake.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicinal product.
The decision on using Macmiror Complex 500 during pregnancy and breastfeeding must be made by a physician.
It is unknown whether the drug passes into human milk.
In any case, during pregnancy and breastfeeding, Macmiror Complex 500 should only be used under direct medical supervision and only when absolutely necessary, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the mother.

Driving and operating machinery
Macmiror Complex 500 has no influence on the ability to drive or operate machinery.

Macmiror Complex 500 contains sodium ethyl parahydroxybenzoate (E 215) and sodium propyl parahydroxybenzoate (E 217). The product may cause allergic reactions (including delayed-type reactions).

3. How to use Macmiror Complex 500

This medicine should always be used as directed by a doctor or pharmacist.
If in doubt, consult a doctor or pharmacist.
Macmiror Complex 500 is available as soft vaginal capsules for vaginal use.
Recommended dose:
One soft vaginal capsule should be administered once daily, in the evening.
The soft vaginal capsule should be inserted deeply into the posterior fornix of the vagina. For instructions on how to insert the soft vaginal capsule, please consult your doctor.
The duration of treatment is determined by the doctor.
Treatment should be discontinued prior to menstruation.
Use of a higher than recommended dose of Macmiror Complex 500
Due to the route of administration and the fact that the medicine is not absorbed and does not have systemic effects, overdose is highly unlikely.
No cases of overdose have been reported to date.
Interrupting treatment with Macmiror Complex 500
Do not interrupt treatment without consulting your doctor, as this may render the treatment ineffective.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Very rare (may occur in fewer than 1 in 10,000 people): contact dermatitis,
urticaria, vaginal burning, vaginal itching.
Burning and itching at the site of application are usually mild and resolve spontaneously.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions enables continued monitoring of the medicine's safety and helps provide more information on its safe use.

5. How to store Macmiror Complex 500

Keep the medicine out of sight and reach of children.
Store below 25°C in the original packaging.
Do not use this medicine after the expiry date stated on the container.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Macmiror Complex 500 contains

• The active substances are nifuratel and nystatin. One soft vaginal capsule contains 500 mg of nifuratel and 200,000 IU of nystatin.
• The other ingredients are: dimethicone, gelatin, glycerol, sodium ethylparaben (E 215), sodium propylparaben (E 217), titanium dioxide (E 171), yellow iron oxide (E 172).

What Macmiror Complex 500 looks like and contents of the pack
Macmiror Complex 500 is a soft vaginal capsule for vaginal use.
The medicine is packed in an Al/PVDC-PVC blister containing 12 soft vaginal capsules, placed in a cardboard box.
For more detailed information, please contact the responsible party or the parallel importer.
Responsible party in Romania, country of export:
POLICHEM SA
50 Val Fleuri
L-1526 Luxembourg, Luxembourg
Manufacturer:
Doppel Farmaceutici S.r.l, Via Volturno no.48, Quinto de Stampi, 20089 Rozzano, Milan, Italy
Doppel Farmaceutici S.r.l, Via Martiri delle Foibe no.1, 29016 Cortemaggiore – Piacenza, Italy
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Marketing authorization number in Romania, country of export: 12576/2019/01
Parallel import authorization number: 80/26