Macmiror complex
Poland
Table of Contents
Package leaflet: Information for the patient
Macmiror Complex, (100 mg + 40,000 I.U.)/g, vaginal cream
Nifuratel + Nystatin
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, please consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, 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 is and what it is used for
- Important information before using Macmiror Complex
- How to use Macmiror Complex
- Possible side effects
- How to store Macmiror Complex
- Contents of the pack and other information
1. What Macmiror Complex is and what it is used for
Macmiror Complex contains two active substances: nifuratel and nystatin.
Nifuratel is a synthetic compound that acts effectively against protozoa, bacteria, and fungi most 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:
- 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 preparation makes Macmiror Complex 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 lactobacilli (lactic acid bacteria), which play a protective role and are present in the vagina of healthy women. Nystatin and nifuratel, when applied topically into the vagina, do not penetrate into the bloodstream and do not exert systemic effects.
2. Important information before using Macmiror Complex
When not to use Macmiror Complex
- 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, discuss it with your doctor or
pharmacist.
As with all antimicrobial agents, prolonged use of Macmiror Complex may lead to sensitization. If during treatment symptoms such as burning or itching appear or worsen, discontinue the medicine and inform your doctor, who will change the treatment if necessary.
During treatment, patients should abstain from sexual intercourse. It is recommended that the sexual partner receives concomitant oral nifuratel treatment.
This medicine is intended for use under medical supervision.
Use of Macmiror Complex in elderly patients
Macmiror Complex may be used by elderly individuals.
Macmiror Complex with other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.
No interactions with other medicines have been reported to date.
Do not use other vaginal medicines concurrently, including those available without prescription, without consulting your doctor.
Macmiror Complex with food and drink
Macmiror Complex may be used regardless of food or drink 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 her doctor or pharmacist before using this medicine.
The decision to use Macmiror Complex during pregnancy or breastfeeding is made by the physician. It is not known whether metabolites of the drug pass into human milk.
In any case, during pregnancy and breastfeeding, Macmiror Complex should be used only 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 has no effect on the ability to drive or operate machinery.
Macmiror Complex contains:
- 50 mg of propylene glycol per 1 gram of ointment,
- methyl p-hydroxybenzoate (E 218) and propyl p-hydroxybenzoate. The medicine may cause allergic reactions (including delayed-type reactions).
3. How to use Macmiror Complex
This medicine should always be used exactly as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
Recommended dose
Macmiror Complex should be used once daily (in the evening) or twice daily (morning and evening), as directed by the physician.
For single application, 2.5 g of ointment should be administered intravaginally using the dosing applicator provided.
Use in children and adolescents
For school-aged girls, half the adult dose should be administered, i.e., 1.25 g of ointment using a micro-applicator.
Method of administration
The ointment should be inserted deep into the vagina using the calibrated applicator or micro-applicator, especially in patients who have not yet had sexual intercourse.
The package contains one reusable plastic applicator with a micro-applicator.
The frequency and duration of treatment will be determined by the physician, based on the individual response to therapy.
Treatment should be completed before the onset of menstruation.
Instructions for using the applicator (see diagram below section 1):
Screw the applicator onto the tube and squeeze the required amount of ointment into it (the numbers on the applicator correspond to grams of ointment). During squeezing, the plunger will extend automatically.
Then unscrew the applicator, insert its tip into the vagina, and press the plunger to administer the ointment.
Instructions for assembling the micro-applicator (see diagram below):
- Screw the applicator onto the tube and squeeze the required amount of ointment into it (the numbers on the applicator correspond to grams of ointment) – during squeezing, the plunger will extend automatically.
- Pull out the micro-applicator threaded inside the plunger.
- Screw the micro-applicator onto the transparent graduated tube of the applicator after unscrewing it from the tube.
- Insert the tip of the micro-applicator into the vagina and press the plunger to administer the ointment.
- After use, the applicator and/or micro-applicator should be thoroughly washed in preparation for the next use.
Use of more than the recommended dose of Macmiror Complex
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.
Interrupting treatment with Macmiror Complex
Do not discontinue 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 effects
Like all medicines, this medicine can cause adverse effects, 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 effects
If any adverse effects occur, including any adverse effects not listed in the leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to:
Department of Monitoring of Adverse Drug Reactions, 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.
5. How to store Macmiror Complex
Keep the 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 stated 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 packaging and other information
What Macmiror Complex contains
- The active substances are nifuratel and nystatin. 1 g of the ointment contains 100 mg of nifuratel and 40,000 I.U. of nystatin.
- Other excipients: xalifin 15 (polyglycol ester of fatty acids), methyl p-hydroxybenzoate (E 218), propyl p-hydroxybenzoate, glycerol, sorbitol 70%, propylene glycol, carbomer, triethanolamine, purified water.
What Macmiror Complex looks like and contents of the pack
Macmiror Complex is a vaginal ointment.
The medicine is packed in an aluminium tube containing 30 g of ointment, placed in a cardboard box.
The cardboard box also contains a calibrated applicator for inserting the oint游戏副本