Macmiror complex 500
Poland
Table of Contents
Package leaflet: information for the patient
Macmiror Complex 500, (500 mg + 200,000 I.U.), globules
Nifuratel + Nystatin
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any further questions, please 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 any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Table of contents:
- What Macmiror Complex 500 is and what it is used for
- Important information before using Macmiror Complex 500
- How to take Macmiror Complex 500
- Possible side effects
- How to store Macmiror Complex 500
- 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 effective against protozoa, bacteria, and fungi most commonly causing vaginal infections.
Nystatin is an antifungal antibiotic, acting primarily against Candida spp.
Indications for Macmiror Complex 500:
- Treatment of vaginal and vulvar infections caused by: Candida spp., Trichomonas vaginalis, and bacteria.
The combination of nifuratel and nystatin makes Macmiror Complex 500 effective in treating 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 drug does not destroy Lactobacillus acidophilus, the protective lactic acid bacteria naturally present in the vagina of healthy women. Nystatin and nifuratel, when administered locally into the vagina, do not penetrate into the bloodstream and do not exert systemic effects.
2. 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
medicine (listed in section 6).
Warnings and precautions
Before starting treatment with Macmiror Complex 500, discuss this with your doctor or
pharmacist.
As with all antimicrobial agents, hypersensitivity may occur during prolonged use of Macmiror Complex 500. If during treatment symptoms such as burning sensation or itching appear or worsen, discontinue the medicine and inform your doctor, who may change the treatment if necessary.
During treatment, patients should abstain from sexual intercourse. It is recommended that the sexual partner concurrently takes nifuratel orally.
This medicine 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 with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
No interactions with other medicines have been reported so far.
Do not use other vaginal medications, including those available without a prescription, without first consulting your doctor.
Macmiror Complex 500 with food and drink
Macmiror Complex 500 may be used regardless of meals or fluid intake.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
The decision to use Macmiror Complex 500 in pregnant or breastfeeding women is made by the doctor. It is not known whether the medicine passes into human milk.
In any case, during pregnancy and breastfeeding, Macmiror Complex 500 may only be used under direct medical supervision and only when absolutely necessary, weighing 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 p-hydroxybenzoate and sodium propyl p-hydroxybenzoate. This medicine may cause allergic reactions (including delayed-type reactions).
3. How to use Macmiror Complex 500
Always use this medicine exactly as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
Macmiror Complex 500 is administered as vaginal globules.
Recommended dose:
One globule once daily, in the evening.
The globule should be inserted deeply into the posterior fornix of the vagina. For instructions on how to insert the globule, consult your doctor.
The duration of treatment is determined by the doctor.
Treatment should be completed before the onset of menstruation.
Use of more than the recommended dose of Macmiror Complex 500
Due to the route of administration and the fact that the medicine is not absorbed systemically, overdose is highly unlikely.
No cases of overdose have been reported to date.
Stopping treatment with Macmiror Complex 500
Do not discontinue treatment without consulting your doctor, as this may render the treatment ineffective.
If you have any further questions 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 in the vaginal area at the application site 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 your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store Macmiror Complex 500
Keep this medicine out of sight and reach of children.
Store 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Contents of the pack and other information
What Macmiror Complex 500 contains
- The active substances are nifuratel and nystatin. Each globule contains 500 mg of nifuratel and 200,000 I.U. of nystatin.
- The other ingredients are: dimethylpolysiloxane AK 1000, gelatin, glycerol, sodium ethyl p-hydroxybenzoate, sodium propyl p-hydroxybenzoate, titanium dioxide, yellow iron oxide.
What Macmiror Complex 500 looks like and contents of the pack
Macmiror Complex 500 is in the form of vaginal globules. The medicine is packed in
an Al/PVC-PVDC blister in a cardboard box.
8 globules
12 globules
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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
Doppel Farmaceutici S.r.l
Via Martiri delle Foibe, 1
I-29016-Cortemaggiore – Piacenza
Italy
Representative of the Marketing Authorisation Holder:
Angelini Pharma Polska Sp. z o.o.
Aleje Jerozolimskie 181B, 02-222 Warsaw
tel.: (22) 70 28 200
e-mail: [email protected]
representative of the marketing authorisation holder.