Macmiror Complex

Package leaflet: information for the patient

MACMIROR COMPLEX 500 mg/200,000 I.U. soft vaginal capsules

Nifuratel and Nystatin
Please read this leaflet carefully before using this medicine because it contains
important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen.

Contents of this leaflet:

1. What MACMIROR COMPLEX is and what it is used for
2. What you need to know before using MACMIROR COMPLEX
3. How to use MACMIROR COMPLEX
4. Possible side effects
5. How to store MACMIROR COMPLEX
6. Contents of the pack and other information

1. What MACMIROR COMPLEX is and what it is used for

MACMIROR COMPLEX contains the active substances nifuratel and nystatin.
Nifuratel is an antibacterial, antimycotic and trichomonacidal agent, meaning it is able to inhibit the growth of microorganisms such as bacteria, fungi, yeasts and protozoa.
Nystatin is an antibiotic with fungicidal activity, meaning it is able to kill fungi.
MACMIROR COMPLEX is used in women for the treatment of genital tract infections (vulvovaginitis) caused by microorganisms such as Candida, Trichomonas and bacteria.
The most commonly observed symptoms of these infections are: abundant and/or unusual vaginal discharge, itching, redness, burning, burning on urination, and pain during sexual intercourse.
Consult your doctor if you do not feel better or if you feel worse.

2. What you should know before using MACMIROR COMPLEX

Do not use MACMIROR COMPLEX

• if you are allergic to nifuratel and/or nystatin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using MACMIROR COMPLEX.
The use, especially if prolonged, of topical products may cause allergic reactions (see section “Possible side effects”). If this occurs, stop treatment and consult your doctor, who will start appropriate therapy.
MACMIROR COMPLEX is for vaginal topical use only. Do not swallow.
Children
This medicine is not recommended for use in young girls, as safety and efficacy have not been established.
Other medicines and MACMIROR COMPLEX
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
MACMIROR COMPLEX 500 mg/200,000 I.U. vaginal soft capsules contains sodium ethyl-p-
hydroxybenzoate and sodium propyl-p-hydroxybenzoate.
These may cause allergic reactions (including delayed reactions).

3. How to use MACMIROR COMPLEX

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is 1 soft vaginal capsule per day.
How to use
Insert the capsule deep into the vagina.
During treatment, abstain from sexual intercourse.
If you use more MACMIROR COMPLEX than you should
Given the recommended dose and route of administration, overdose is
unlikely.
If you forget to use MACMIROR COMPLEX
Do not use a double dose to make up for the missed dose.
If you stop using MACMIROR COMPLEX
If you have any doubts about using MACMIROR COMPLEX, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please contact your doctor or pharmacist. You may also report side effects directly through the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MACMIROR COMPLEX

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month. The expiry date applies to the product in its original, undamaged packaging, correctly stored.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What MACMIROR COMPLEX 500 mg/200,000 IU vaginal soft capsules contains

• The active substances are nifuratel and nystatin. One capsule contains 500 mg of nifuratel and 200,000 IU of nystatin.
• The other components are: dimethylpolysiloxane AK 1000, gelatin, glycerol, sodium ethyl-4-hydroxybenzoate, sodium propyl-4-hydroxybenzoate (see section “MACMIROR COMPLEX contains sodium ethyl-4-hydroxybenzoate and sodium propyl-4-hydroxybenzoate”), titanium dioxide (E 171), yellow iron oxide (E 172).

Description of the appearance of MACMIROR COMPLEX and pack sizes
It is presented as soft capsules for gynecological use. It is available in packs of 8 and 12 vaginal soft capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Farmitalia S.r.l.
Via Pinciana 25
00198 Rome

Manufacturer
Doppel Farmaceutici S.r.l. - Quinto de’ Stampi facility - Rozzano (MI)
and/or
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC)

Patient information leaflet

MACMIROR COMPLEX 10 g/4,000,000 I.U. vaginal cream

Nifuratel and Nystatin
Please read this leaflet carefully before using this medicine, as it contains
important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If any side effects occur, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen.

Contents of this leaflet:

1. What MACMIROR COMPLEX is and what it is used for
2. What you need to know before using MACMIROR COMPLEX
3. How to use MACMIROR COMPLEX
4. Possible side effects
5. How to store MACMIROR COMPLEX
6. Contents of the pack and other information

1. What MACMIROR COMPLEX is and what it is used for

MACMIROR COMPLEX contains the active substances nifuratel and nystatin.
Nifuratel is an antibacterial, antifungal, and antiprotozoal agent, meaning it is able to inhibit the growth of microorganisms such as bacteria, fungi, yeasts, and protozoa.
Nystatin is an antibiotic with fungicidal activity, meaning it is able to kill fungi.
MACMIROR COMPLEX is used in women for the treatment of genital tract infections (vulvovaginitis) caused by microorganisms such as Candida, Trichomonas, and bacteria.
The most commonly observed symptoms of these infections include: abundant and/or unusual vaginal discharge, itching, redness, burning, burning during urination, and pain during sexual intercourse.
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before using MACMIROR COMPLEX

Do not use MACMIROR COMPLEX

• if you are allergic to nifuratel and/or nystatin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using MACMIROR COMPLEX.
The use, especially if prolonged, of topical products may lead to allergic reactions (see section “Possible side effects”). If this occurs, discontinue treatment and consult your doctor, who will initiate appropriate therapy.
MACMIROR COMPLEX is for vaginal topical use only. Do not swallow.
Children
This medicine is not recommended for use in young girls, as safety and efficacy have not been established.
Other medicines and MACMIROR COMPLEX
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
MACMIROR COMPLEX 10 g/4,000,000 I.U. vaginal cream contains methyl p-
hydroxybenzoate and propyl p-hydroxybenzoate.
These may cause allergic reactions (including delayed reactions).
MACMIROR COMPLEX 10 g/4,000,000 I.U. vaginal cream contains propylene glycol.
It may cause skin irritation.

3. How to use MACMIROR COMPLEX

Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is 1 application once or twice daily, in the evening and/or in the morning.
How to use
Insert the contents of one applicator deeply into the vagina.
Instructions for use

1. Screw the applicator onto the tube
2. Fill the applicator with cream
3. Unscrew the applicator from the tube and insert it into the vagina
4. Press the plunger to empty the contents of the applicator
5. Remove the applicator.
   Each applicator must not be used for more than 2 applications.
   During treatment, abstain from sexual intercourse.
   If you use more MACMIROR COMPLEX than you should
   Given the recommended dose and route of administration, an overdose is
   unlikely.
   If you forget to use MACMIROR COMPLEX
   Do not use a double dose to make up for the missed dose.
   If you stop using MACMIROR COMPLEX
   If you have any doubts about using MACMIROR COMPLEX, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist.
You may also report side effects directly through the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MACMIROR COMPLEX

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month. The expiry date applies to the product in its original undamaged packaging, stored correctly.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What MACMIROR COMPLEX 10 g/4,000,000 I.U. vaginal cream contains

• The active substances are nifuratel and nystatin. 100 g of cream contain 10 mg of nifuratel and 4,000,000 I.U. of nystatin.
• The other components are: xalifin 15, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate (see section “MACMIROR COMPLEX contains methyl p-hydroxybenzoate and propyl p-hydroxybenzoate”), glycerin, sorbitol 70%, propylene glycol, carbomer, triethanolamine 30%, deionized water.

Description of the appearance of MACMIROR COMPLEX and contents of the package
It is a yellow vaginal cream supplied in a 30 g tube. Each
package contains one tube and six applicators.
It is possible that not all pack sizes are marketed.
Marketing Authorization Holder
Farmitalia S.r.l.
Via Pinciana 25
00198 Rome
Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC)
Special Product’s Line – Via Fratta Rotonda Vado Largo, 1 Anagni (FR)